www-ivbh-9-23-test

Mammogen Taps Life Sciences Leadership Architect, Denise "DeeDee" DeMan, as Chairwoman of the Board of Directors

Mon, 30 Jun 2025 21:38:46 GMT

Renowned global builder of boards and executive teams aligns with leading women's health innovator, signaling next phase of commercial growth

NEWPORT BEACH, Calif., June 30, 2025 /PRNewswire/ -- Mammogen, a women-built and women-led predictive health company redefining what's possible in early disease detection, today announced the appointment of Denise "DeeDee" DeMan as Chairwoman of its Board of Directors.

DeMan, Founder, Chair, and CEO of Bench International, is one of the most respected leadership architects in global life sciences. With more than five decades of experience placing board directors, chairpersons, and C-level executives for some of the world's most successful and enduring healthcare companies, DeMan has built the leadership teams behind healthcare's most transformative innovations and industry-defining growth stories. Through initiatives such as Bench's acclaimed Bank of Women®, DeMan has helped organizations unlock the power of inclusive governance and executive excellence, aligning with Mammogen's commitment to having women's voices represented at every level of the company.

Her appointment reflects Mammogen's evolution from a research-stage innovator to a clinical-stage company preparing for commercialization, as it advances its blood-based early detection test for breast cancer towards market launch.

Mammogen's flagship product, genTRU™, is designed to detect breast cancer at its earliest and most treatable stages, focusing on quality-of-life preservation. The genTRU™ assay has demonstrated over 99% sensitivity and 89% specificity for Stage I disease, supported by several peer-reviewed publications and extensive clinical validation.

"Mammogen combines validated science, disciplined execution, and purpose-driven leadership—qualities that define the companies that change clinical landscapes and build commercial titans," said DeMan. "I've spent my career guiding organizations from inflection to impact, and it's rare to see this level of readiness and rigor at such a formative stage. I'm honored to serve as Chairwoman as we guide Mammogen into its next era of growth, and I'm committed to ensuring its leadership and governance are as differentiated as its science."

With pivotal trials underway, the company is preparing for commercialization as the world's first and most accurate targeted screening test for breast cancer, addressing an urgent unmet need for over 25 million U.S. women currently at-risk based on Mammography Quality Standards Act (MQSA) Guidelines.

"DeeDee's decision to join Mammogen at this critical juncture sends a clear message: we are building for scale, staying true to science, and ready to deliver paradigm-shifting value at a time when the market is demanding exactly that," said Elizabeth Cormier-May, CEO of Mammogen. "Her expertise in building governance and leadership for companies that endure is invaluable as we prepare for what's next."

As Chairwoman, DeMan will lead Mammogen's board governance strategy and support the company in strengthening its industry position as it accelerates towards this next stage of growth.

Media Contact
katherine@mammogen.bio

About Mammogen
Mammogen is a predictive health company pioneering the future of women's health diagnostics. Its flagship product, genTRU™, is a first-in-class blood-based assay with best-in-class accuracy for early detection of breast cancer, particularly in Stage I disease. Mammogen's mission is to preserve quality of life through earlier, more accessible detection powered by cutting-edge science. The company is proudly women-built, women-led, and purpose-driven. Learn more at www.mammogen.bio .

About Bench International
Bench International is the longest-serving woman-founded executive search firm in life sciences and healthcare. For over 50 years, Bench has built and advised boards and C-suites for many of the industry's most innovative and successful companies. With a 98% project completion rate and a track record of more than $150 billion in client exits, Bench specializes in executive search, board services, talent mapping, gap analysis, and interim and fractional leadership through Bench On Demand. Clients benefit from a global network, deep domain expertise, and a relentless focus on leadership that drives innovation, growth, and value. Learn more at www.benchinternational.com .

Mammogen to Showcase New Data at SABCS 2023 Demonstrating Clinical Efficacy of Its genTRU-breast™ qPCR Blood Test in Early-Stage Breast Cancer

Sat, 02 Dec 2023 16:38:43 GMT

Groundbreaking data unveiled in San Antonio: CLIA validated genTRU-breast assay achieves >99% sensitivity in stage I breast cancer

NEWPORT BEACH, Calif., Dec. 1, 2023 /PRNewswire/ -- Mammogen , a pioneering leader in women's health and a subsidiary of early detection parent company, IVBH , is set to present groundbreaking clinical data at the 2023 San Antonio Breast Cancer Symposium (SABCS). The poster, titled "Development of a plasma-based real-time qPCR gene expression assay for targeted screening and diagnosis of early-stage breast cancer," showcases the strength and innovation of Mammogen's proprietary genTRU-breast clinical assay.

Poster Session Details:

Presentation ID: PO1-28-06
Abstract Title: Development of a plasma-based real-time qPCR gene expression assay for targeted screening and diagnosis of early-stage breast cancer.
Session: Poster Session 1
Date: Wednesday, December 6, 2023
Time: 12:00 PM - 2:00 PM
Location: Henry B. Gonzalez Convention Center, San Antonio, Texas

"The statistically significant >99% sensitivity and 89% specificity in stage I breast cancer, achieved during CLIA validation of our novel real-time qPCR assay, reinforces Mammogen's position as a leader in accurate, affordable, scalable, and socially responsible diagnostics in women's health." —Elizabeth Cormier-May, CEO of Mammogen

This presentation follows Mammogen's successful CLIA validation of the genTRU-breast assay, announced last month , a landmark achievement for the company and a transformative milestone in early-stage breast cancer detection.

Elizabeth Cormier-May, CEO of Mammogen, commented, "This data is a testament to our commitment to unlocking the quality-of-life preservation that exists in the earliest stages of breast cancer. The statistically significant >99% sensitivity and 89% specificity in stage I breast cancer, achieved during CLIA validation of our novel real-time qPCR assay, reinforces Mammogen's position as a leader in accurate, affordable, scalable, and socially responsible diagnostics in women's health."

About Mammogen

Mammogen is a female-led precision diagnostics company dedicated to radically improving the detection, diagnosis and treatment of diseases that affect some, mostly or only women. Our flagship liquid detection program, genTRU-breast, is a CLIA validated PCR-based gene expression blood test designed to detect breast cancer in the earliest stages. The genTRU-breast assay is anticipated to launch commercially as a laboratory developed test (LDT) in 2H 2024. For more information, visit mammogen.bio .

About IVBH

IVBH is the world's first disease-agnostic AI-powered early detection platform, creating first-in-class blood tests that detect the body's response to disease in the earliest stages. With a mission to unlock the quality-of-life preservation at stage zero, IVBH provides highly accurate, affordable, and accessible diagnostic solutions for all of humanity. For more information, visit ivbh.studio .

For media inquiries, please contact: info@mammogen.bio

SOURCE Mammogen

272 | "Changing Lives Through Early Disease Detection" with Marty Keiser from IVBH Studio

Sat, 02 Dec 2023 16:29:07 GMT

272 | "Changing Lives Through Early Disease Detection" with Marty Keiser from IVBH Studio

✅ Overcoming Health Challenges: Marty Keiser's personal story involves his father's business, the sacrifices made in prioritizing Marty's health, facing financial struggles while trying to treat a rare condition, and ultimately succeeding against the odds.

✅ Role of Failure in Entrepreneurship: Highlighting the importance of discussing the experiences of children of founders, Marty emphasizes the lessons from failure, mindset shifts, and the ability to find silver linings crucial for entrepreneurship.

✅ Importance of Early Disease Detection: Emphasizing the significance of early detection, Marty discusses IVBH's goal to preserve quality of life at stage zero, sharing details about the success of their early detection breast test.

�� Episode Summary:

In this episode 272, Marty Keiser, CEO of IVBH Studio, shares a deeply personal journey from family hardship to entrepreneurial success. Growing up in the shadow of his father's business failure due to the cost of treating Marty's rare medical condition, Marty delves into the sacrifices his family made to secure his health. The story unfolds into an inspiring narrative of resilience, unexpected skills, and the silver linings found in adversity.

Keiser emphasizes the impact of childhood experiences on his career, revealing how early challenges, such as not participating in sports, led him to the drama program. This unexpected turn became a pivotal experience, shaping his ability to communicate effectively and succeed in a 13-year Wall Street career.

Transitioning to his role as the founder of IVBH, Marty introduces the company's mission in the medical tech space—developing early detection blood tests for diseases. The focus extends beyond conventional late-stage diagnoses, emphasizing preserving quality of life at stage zero. IVBH's unique approach combines big data, AI, and strategic partnerships, fostering innovation while prioritizing capital efficiency.

Keiser concludes by announcing a breakthrough in IVBH's early detection breast test and articulates the company's bold vision. IVBH aspires to evolve from an early detection company to an "early everything" company, revolutionizing disease prediction, detection, and treatment.

Chapters:

00:00 Intro

01:02 Marty's Personal Story: Overcoming Health Challenges

04:48 The Impact of Marty's Childhood Experiences on His Career

06:49 The Role of Failure in Entrepreneurship

08:26 Introduction to IVBH and Its Mission

09:48 The Importance of Early Disease Detection

10:55 The Success of IVBH's Early Detection Breast Test

12:49 The Unique Approach of IVBH in the Medical Tech Space

14:45 The Importance of Capital Efficiency in Healthcare Innovation

19:42 How to Connect with IVBH for Collaboration

20:37 The Future Vision of IVBH

Introduction:

In a world where personal and professional success stories are often glorified, we rarely hear about the challenges faced by the children of founders, entrepreneurs, or business owners. Marty Keiser, the CEO of IVBH Studio, is one such individual who has a story that goes beyond the norm. Marty's journey from a life-altering medical condition to leading a global leader in liquid biopsy is nothing short of inspiring. In this blog post, we delve into Marty's personal experiences, his mission to revolutionize early disease detection, and the remarkable products being developed by IVBH Studio.

Section 1: Early Life Challenges

When Marty was born, his father was carrying an expensive insurance policy as a self-employed person. However, a few months later, Marty's parents noticed a difference in the shape of his right leg. After a series of doctor's appointments, Marty was diagnosed with congenital suit arthrosis of the tibia, a condition that left him missing a part of his shinbone. Unfortunately, this condition was classified as a pre-existing condition, making it nearly impossible for Marty's family to secure insurance coverage for necessary treatments. Marty's parents made tremendous sacrifices to prioritize his health, resulting in financial struggles and the loss of their house and cars.

Section 2: Overcoming Adversity

Despite the challenges, Marty's parents were determined to find alternative treatments and surgeries for their son's condition. They explored every option, even though successful procedures meant potential long-term consequences for Marty. Eventually, they found a surgeon at Columbia Presbyterian in New York City who had only performed the risky procedure a few times before. Marty became the first and youngest child to successfully undergo the procedure, ultimately saving his leg and providing a renewed sense of hope.

Section 3: The Impact on Marty's Journey

Marty's early experiences had a profound influence on his personal and professional development. Unable to participate in sports due to his medical condition, he decided to pursue drama in high school. This led to him becoming the class actor and honing his ability to communicate effectively and engage with an audience. Marty's theatrical experiences later translated into his successful career in finance and sales on Wall Street.

Section 4: The Founding of IVBH Studio

Marty's ambition to make a lasting impact on society and leave a meaningful legacy led him to found IVBH Studio. IVBH is a trailblazer in the field of liquid biopsy, specializing in early disease detection and precision diagnostics. Their groundbreaking blood tests have the potential to detect diseases at their earliest stages, offering patients better treatment outcomes and preserving their quality of life. IVBH's focus goes beyond just catching diseases early; they aim to revolutionize the field by unlocking the potential for quality of life preservation at stage zero.

Section 5: Advancing Medical Technology

IVBH Studio's products are powered by cutting-edge technology, including the use of big data and artificial intelligence (AI). Marty and his team leverage AI throughout the entire process, from biomarker discovery to commercialization. By combining scientific and business perspectives, IVBH has been able to develop best-in-class products at a fraction of the cost typically associated with the healthcare industry. Their capital efficiency approach ensures that their products can be priced affordably, maximizing their social and financial impact.

Section 6: Collaborating for a Better Future

IVBH Studio's commitment to collaboration and partnership sets them apart in the healthcare industry. Marty emphasizes the importance of leveraging existing expertise and infrastructure to speed up the development process and improve outcomes. By working together with scientific advisors, business partners, investors, and patients, IVBH aims to evolve from an early detection company to an "early everything" company. Their vision is to predict, detect, and treat diseases earlier, ultimately making disease a manageable part of everyday life.

Conclusion:

Marty Keiser's journey from adversity to success exemplifies the power of resilience and the ability to find silver linings in challenging situations. Through IVBH Studio, Marty and his team are leading the charge in revolutionizing early disease detection and prioritizing quality of life preservation. By combining scientific innovation, capital efficiency, and the collaborative spirit, IVBH Studio is poised to forever transform the world of healthcare. We are excited to see the continued impact of IVBH's products and their unwavering commitment to making a difference in the lives of countless individuals.

#Entrepreneurship #BusinessSuccess #MedicalTech #EarlyDetection #Resilience #Innova tion #HealthcareRevolution #QualityOfLife #BusinessJourney

Mammogen Achieves CLIA Validation of gen-TRU-breast™ Assay

Thu, 16 Nov 2023 13:59:58 GMT

World's First Early Detection Blood Test to Unlock Stage I Diagnosis of Breast Cancer

NEWPORT BEACH, Calif., Nov. 15, 2023 /PRNewswire/ -- Mammogen, a leader in women's health and bellwether subsidiary of early detection parent company IVBH , has announced the successful completion of Clinical Laboratory Improvement Amendments (CLIA) validation for its pioneering plasma-based clinical assay, genTRU-breast, a test designed to detect the earliest stages of breast cancer. This achievement represents a momentous step forward in revolutionizing breast health.

The Science Behind genTRU-breast

genTRU-breast, a state-of-the-art real-time qPCR assay, is designed to detect early-stage breast cancer with unparalleled precision. This assay hinges on the quantification of messenger RNA (mRNA) expression profiles of proprietary gene targets, offering a powerful tool for the identification of breast cancer at its earliest, most treatable stages. The technology is based on the dynamic response of the patient, as opposed to the detection of circulating cancer cells — a hallmark of parent company IVBH's RNA-focused early detection platform.

Since the inception of the program, genTRU-breast has been extensively validated across six independent patient cohorts, totaling over 500 patients, to ensure the utmost accuracy and reliability in its results.

After two decades effecting change in commercial diagnostics, this achievement is the brightest spot of my career, with a profound culmination of scientific, clinical, and social impact," —Elizabeth Cormier-May, Mammogen CEO.

CLIA Validation: A Landmark Achievement

In CLIA validation, leveraging proprietary AI/ML, the genTRU-breast clinical assay achieved a statistically significant >99% sensitivity, 89% specificity in stage I breast cancer (p<0.001), with an overall accuracy reported at 94.5%. These peer-reviewed data were accepted for a poster presentation at the upcoming 2023 San Antonio Breast Cancer Symposium and selected for publication in Cancer Research later this year.

"After two decades effecting change in commercial diagnostics, this achievement is the brightest spot of my career, with a profound culmination of scientific, clinical, and social impact," stated Mammogen CEO, Elizabeth Cormier-May.

"From the beginning, Mammogen has been steadfast in our commitment to unlocking the quality-of-life preservation that exists in the earliest stages of breast cancer and being a true partner to the patients that we serve, from end-to-never-end. This unprecedented data changes everything for our community and solidifies Mammogen as the leader in accurate, affordable, scalable, and socially responsible diagnostics in women's health. We look forward to publishing and presenting this breakthrough achievement at San Antonio and accelerating this paradigm-shifting technology to market."

Commercialization and Market Impact

With CLIA validation of this assay now complete, Mammogen will work diligently to commercially launch genTRU-breast in 2H 2024, a timeline aligned with the nationwide implementation of the Mammography Quality Standards Act (MQSA). This federal regulation, set to take effect in September 2024, defines a major unmet clinical need in breast health. According to management, the MQSA ruling unlocks an estimated $2.5 billion to $12 billion in immediate market opportunity and a total addressable market exceeding $35 billion (US).

For inquiries, please contact: info@mammogen.bio

About Mammogen

About IVBH

IVBH is the world's first disease-agnostic AI-powered early detection platform, conceiving, creating and internally developing first-in-class blood tests that detect your body's response to disease in the earliest possible stages. Our mission is to unlock the quality-of-life preservation that exists at stage zero through highly accurate, affordable, and accessible diagnostic solutions, for all of humanity, at scale. For more information visit ivbh.studio .

IVBH Presents Groundbreaking Data for Early Lung Cancer Detection at the ASCO® 2023 Annual Meeting

Eric@adsneeded.com (Eric Kristiansen) — Sun, 04 Jun 2023 12:26:31 GMT

IVBH's novel RNA approach to early detection demonstrates strong sensitivity and specificity for early lung cancer detection, in a large, predominantly early-stage, independent validation cohort

NEWPORT BEACH, Calif., June 2, 2023 /PRNewswire/ -- IVBH, a leader in liquid biopsy technology, specializing in noninvasive early detection, will unveil groundbreaking data from an independent validation study of the company's proprietary LiquidLung lung cancer detection technology, at the ASCO® 2023 Annual Meeting. This study of 3,744 subjects, including patients with pre-operative lung cancer and non-cancer controls, demonstrated accurate detection of early-stage lung cancer across prevalent histologic types and subgroups of patients with lung cancer, including never-smokers.

"Traditionally, the liquid biopsy field has focused on detecting cancer cells shed into the bloodstream by a tumor," said Marty Keiser, IVBH Founder-CEO. "IVBH is revolutionizing this approach, not by sequencing cancer cells, rather by harnessing the dynamic response of the patient — through changes in RNA gene expression — enabling more sensitive and specific disease detection in the earliest stages of disease."

In the poster, the LiquidLung RNA-model, which used machine learning, detected lung cancer with 98% sensitivity, 89% specificity in the held-out test set of the independent validation cohort. Incorporating age and gender brought balance to the overall accuracy of the technology, achieving 95.5% sensitivity, 90.3% specificity in the held-out test set.

This peer-reviewed research represents a significant step forward in the early detection of lung cancer.

"This peer-reviewed research represents a significant step forward in the early detection of lung cancer," said Dr. Brendon Stiles, Professor and Chief, Thoracic Surgery and Surgical Oncology, Department of Cardiothoracic & Vascular Surgery at Montefiore-Einstein. "It moves us away from tumor-only approaches, which have limited sensitivity or specificity. The machine learning approach, combined with blood-based RNA gene expression profiles, and available demographics and clinical data, is immediately scalable and holds tremendous potential for guiding clinically actionable decisions across the entire lung cancer care continuum, and a promising new direction for early detection for a wide variety of diseases."

Abstract 8557/Poster Bd #184: Development of a novel blood-based RNA gene expression platform for early-stage lung cancer diagnosis

Authors: Keiser M, et al.

Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Date/Time: June 4, 2023, 8 – 11am CT

Location: Hall A

About IVBH:

Since its founding in 2018, IVBH has pioneered a new frontier in early detection — harnessing the dynamic genomic response of the patient, through changes in RNA gene expression, to detect disease in the earliest stages. IVBH has conceived, created and developed an extensive pipeline of industry-first clinical assays, addressing major unmet needs in breast, lung and metabolic health. Visit ivbh.studio and follow the company on LinkedIn.

Contact: info@ivbh.studio

SOURCE IVBH

AI Can Now Scale Humans

Wed, 22 Mar 2023 21:44:18 GMT

A decade in the making, AI is suddenly everything, everywhere, all at once. In this article I outline three major themes emerging in the current environment.

1. Industrialization. We have officially entered the industrialization era of AI. With the most complex technical foundation already having been laid, success is no longer about the quality of your code, but rather the quality of your prompts. Any person with the right idea, the right focus, and the right prompts, can now solve any problem, in any industry, regardless of their background, socioeconomic status or geography. The floodgates for innovation have officially been opened.

2. Business disruption. Big missions no longer require big teams, big infrastructure, or big budgets. In fact, in the age of abundance, these things are detractors from the mission. Regime change is underway and small, nimble, multi-disciplinary teams who leverage big data and generalized AI tools in a highly specialized way should not be underestimated or undervalued. Size is no longer an advantage, it’s an Achilles heel.

3. People disruption. AI has reached a point where it can now scale humans. The net effect of this is a devaluing of humans without AI, and a devaluing of AI without humans. The two can no longer be treated as mutually exclusive. Humans who fully embrace AI with intention and purpose will win, and they will win big. (The humans who do this most effectively within this decade will be the winners for the next century.)

If it feels like industries that were once considered bedrocks of our society are collapsing before our eyes, it’s because they are. If it feels like companies that were once considered industry stalwarts are on the brink of extinction, it’s because they are. If it feels like it’s happening on an accelerated time frame, it’s because it is.

By itself, this may sound like a dark message. However, for those willing to act, there is quite literally unlimited opportunity. But make no mistake, action must be taken. Learn it, invest in it or build in it, and you will thrive. Sit by as a passive observer and risk getting left behind.

Building Accomplishment as an Entrepreneur: The Importance of Your Team with Marty Keiser

Eric@adsneeded.com (Eric Kristiansen) — Fri, 17 Mar 2023 00:50:05 GMT

"Marty Keiser, an accomplished entrepreneur and finance professional, shares his wealth of knowledge and experience in growing and scaling a successful business. From navigating the transition into the science industry (from the finance world), key lessons learned in building a strong and effective team, the challenges faced during growth, and the importance of preserving company culture, Marty sheds light on topics that any entrepreneur or leader can benefit from.

He also offers practical insights on defining core values, using those values to guide the hiring process, and identifying the right individuals for your teams. All valuable information for those seeking to grow their own business or improve their leadership within their organization. Marty is also sharing practical resources for listeners!"

IVBH Debuts Real Early Detection "R.E.D." Campaign at 41st Annual JP Morgan Healthcare Conference

Eric@adsneeded.com (Eric Kristiansen) — Tue, 10 Jan 2023 00:13:42 GMT

R.E.D. campaign to solidify IVBH's leadership position within noninvasive early detection after achieving >90% sensitivity in stage I disease detection in expanded data across 5,000+ case-control subjects

SAN FRANCISCO, Jan. 9, 2023 /PRNewswire/ -- IV BioHoldings (IVBH), a global leader in liquid biopsy technology specializing in early detection precision diagnostics, today debuted its Real Early Detection "R.E.D." campaign at the 41st annual JP Morgan Healthcare (JPM) Conference in San Francisco.

IV BioHoldings, a leader in liquid biopsy technology specializing in early detection precision diagnostics, released its Real Early Detection "R.E.D." campaign at the 41st annual JP Morgan Healthcare Conference in San Francisco. The company is meeting with investors, strategic partners and other stakeholders to accelerate development of its clinical-stage liquid biopsy programs within breast cancer, lung cancer and non-alcoholic fatty liver disease to fuel its growth and expansion plans.

"The R.E.D. campaign is intended to be the signal within the noise," said IVBH Founder-CEO Marty Keiser. "We're drawing a clear line in the sand by defining real early detection as stage 0-II disease and calling attention to the clinical and commercial differentiators that put IVBH in a category of its own within the coveted and elusive field of early detection."

The campaign focuses on three bold positions taken by the company:

Defining "early detection" as stage 0-II
Defining "encouraging data" as >90% sensitivity across all stages, including 0-II
Defining "impact" by accuracy, accessibility and affordability, and the corresponding improvement to mental, emotional, physical and financial outcomes

"2022 was a transformational year for IVBH, with our having successfully evolved from an R&D phase of development to an organization with the clinical and commercial capabilities — as well as the infrastructure — required to speed our novel technologies to market," said IVBH Partner-Chief Commercial Officer Elizabeth Cormier-May. "More importantly, with the expansion of our industry-leading data dossier, having now achieved >90% sensitivity in the earliest stages of disease for all our programs across 5,547 patients, we're committed to making a larger physical presence at major industry conferences and taking a more proactive approach in communicating the things that define us within the industry — starting at JPM."

IVBH leadership will be meeting with investors, strategic partners and other stakeholders, with the aim of accelerating development of its clinical-stage liquid biopsy programs within breast cancer, lung cancer and non-alcoholic fatty liver disease (NAFLD) as it fuels its ambitious plans for future growth and expansion.

To explore partnership opportunities, email info@ivbh.studio .

Visit: ivbh.studio

About IVBH

IVBH is a global leader in liquid biopsy technology, specializing in early detection precision diagnostics. The company is defined by its progressive AI-powered platform and the conception, development and commercialization of highly accurate, affordable and accessible RNA technologies designed to rule more of the right patients into established imaging and care pathways earlier, and eliminating unnecessary procedures that are invasive, risky, expensive and stressful. IVBH currently oversees and manages a vast clinical pipeline of blood tests, addressing major unmet needs within oncology and metabolic health and wellness. The company's flagship liquid biopsy programs in breast cancer, lung cancer and non-alcoholic fatty liver disease (NAFLD) have been extensively validated with the successful completion of 137 R&D studies — including 73 independent cross-cohort validations — across 18 independent patient cohorts (totaling 5,547 case-control subjects). IVBH has achieved industry-leading sensitivity and specificity for all programs, across all stages, including the earliest stages 0-II. Visit: ivbh.studio

IVBH PRESS CONTACT: Jeff Pizzino, APR (351647@email4pr.com | +1 480.606.8292)

SOURCE IV BioHoldings

Safe & Green Holdings Corp. Taps Global Life Sciences & Diagnostics Executive, Elizabeth Cormier-May, to Join Company Board of Directors

Eric@adsneeded.com (Eric Kristiansen) — Tue, 10 Jan 2023 00:05:19 GMT

Elizabeth Cormier-May, CEO of Mammogen, Inc., and Dragonfly Data Ventures, Partner and CCO of IV BioHoldings, joins SGH Corp. board of directors to provide expertise and strategy to the Company’s medical arm

JACKSONVILLE, Fla., January 09, 2023 --(BUSINESS WIRE)--Safe & Green Holdings Corp. (NASDAQ: SGBX) ("Safe & Green Holdings" or the "Company"), a leading developer, designer, and fabricator of modular structures, announced today that the Company is adding diagnostics, life sciences, and biotechnology leader Elizabeth Cormier-May to its board of directors.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230109005294/en /

(Photo: Business Wire) Elizabeth Cormier-May

The addition comes at a time in which the Company is growing its medical footprint with working plans in place to expand within the diagnostic healthcare space, via Safe & Green Holdings’ sustainable, modular solutions.

Elizabeth Cormier-May began her career as a medicinal chemist, specializing in early discovery oncology at the Novartis institute for Biomedical Research. Ms. Cormier-May currently serves as CEO and Board Director of Mammogen, Inc., as well as the Chairman of the Board, Co-Founder, and CEO of Dragonfly Data Ventures. Mammogen, Inc. is a women’s health diagnostics company focused on the noninvasive detection of disease in its earliest stages. Mammogen is one of 3 companies within the IV BioHoldings (IVBH) ecosystem, where Ms. Cormier-May also serves as the SVP and Chief Commercial Officer. IVBH is a privately held bio-innovation platform that seeks to conceive, create and develop first-in-category precision health technologies and companies that radically improve detection, diagnosis and treatment of disease.

Dragonfly Data Ventures, a privately held company, is building a Data Influence PlatformTM designed to redefine personal wellness by allowing wearable and smartphone users to focus on the persona most important to them, to establish the goals most critical to their success, which enables Dragonfly to give them the personalized tools to extrapolate clinical, wellness and financial value.

"We couldn’t be happier to add Elizabeth Cormier-May to our Board of Directors," Paul Galvin, Chairman and CEO of Safe & Green Holdings Corp. explained. "She is a well-rounded bio-tech professional with a fantastic blend of science and executive experience. As we seek to grow our medical segment, we believe Ms. Cormier-May is a perfect team member to have, with vast experience in the life sciences and biopharma markets and a distinct focus on the critical disruption necessary for meaningful progress."

In January of 2022, Ms. Cormier-May was named Biotechnology CEO of the year for Mammogen, Inc., in the 2021 Global Corporate Excellence Awards, by Business Worldwide Magazine. Ms. Cormier-May was awarded for her visionary approach and mission to "shatter complacency and radically improve the way women's diseases are detected, diagnosed and treated," according to Business Worldwide Magazine.

"In a market and landscape that so desperately needs more efficient, sustainable, and cost-friendly solutions for the patients we all collectively serve, I could not be prouder to be joining the Board of Directors at Safe & Green Holdings Corp," stated Cormier-May. "I very much look forward to working with the incredible team to shape and help grow their already impressive capabilities within the medical space during a time when critical disruption is so needed."

Ms. Cormier-May received her B.A. in organic chemistry from Wheaton College and attended Northeastern University’s chemical biology and organic chemistry program. She resides in Central Connecticut with her family.

About Safe & Green Holdings Corp.

Safe & Green Holdings Corp., a leading modular solutions company, operates under core capabilities which include the development, design, and fabrication of modular structures, meeting the demand for safe and green solutions across various industries. The firm supports third party and in-house developers, architects, builders and owners in achieving faster execution, greener construction, and buildings of higher value. Safe and Green Development Corporation is a leading real estate development company. Formed in 2021, the company focuses on the development of sites using purpose built, prefabricated modules built from both wood & steel, sourced from one of Safe & Green Holdings factories and operated by SG Echo. For more information, visit www.safeandgreenholdings.com.

Safe Harbor Statement

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding the Company growing its medical footprint, the Company’s plans to expand within the diagnostic healthcare space via SGH Corp’s sustainable, modular solutions and the expected contribution of Ms. Cormier-May to the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to grow its medical footprint and expand within the diagnostic healthcare space via its sustainable, modular solutions, the contribution of Ms. Cormier-May to the Company, the Company’s ability to expand within various verticals as planned, the Company’s ability to position itself for future profitability, the Company’s ability to maintain compliance with the NASDAQ listing requirements, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230109005294/en/

Lung Cancer Screening Dramatically Increases Long-Term Survival Rate

Eric@adsneeded.com (Eric Kristiansen) — Wed, 23 Nov 2022 23:29:23 GMT

Experts say lung cancer screening is an important and easy diagnostic test. Weedezign/Getty Images

Researchers say early screening significantly improves the 5-year survival rate for lung cancer.
Experts note, however, that many people who are at higher risk for lung cancer don’t get screened early.
They add that new tests, such as liquid biopsies, are making lung cancer screenings easier.

Lung cancer remains the leading cause of cancer death in the United States for both men and women.

The rates are decliningTrusted Source in the United States, according to the American Cancer Society, because there are fewer smokers, improvements in treatments for non-small cell lung cancer, and earlier screening.

Despite that decline, the SEER database of the National Cancer Institute reports that the average lung cancer 5-year survival rateTrusted Source

is nearly 23%.

A big reason why the survival rate is still so low is that most people still do not get screened.

According to the American Lung Association, only 16% of lung cancers are diagnosed at an early stage when it is easier to treat. More than half of people with lung cancer die within one year of being diagnosed.

Currently, the only recommended screening test for lung cancer is low-dose computed tomography (also called a low-dose CT scan, or LDCT).

The U.S. Preventive Services Task Force recommends annual screenings with LDCT for people between 50 and 80 years old who have a history of heavy smoking, smoke now, or have quit within the past 15 years.

Early screening for lung cancer saves live s

Diagnosing early-stage lung cancer with low-dose CT screening significantly improves the long-term survival rate, according to a 20-year international study presented today at the annual meeting of the Radiological Society of North America (RSNA).

Dr. Claudia Henschke , a professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai in New York and the study’s lead author, told Healthline that “the people who do get screened and detect the cancer early have a far greater chance of surviving.”

The key finding of the study, which hasn’t been published yet in a peer-reviewed journal, is that even after a long time interval these participants in the study are not dying of their lung cancer, Henschke said.

She noted that the screening process is relatively simple.

“Go into the scanner, stay in your street clothes, hold your breath in a single breath hold. That is how easy it is,” Henschke said. “The radiation dose is that of a mammogram or lower, and people have been getting mammograms for many years.”

Other lung cancer screening options

There are other options now for screening lung cancer, including liquid biopsies , which are blood tests that identify biomarkers in the blood that can tell the doctor if there is cancer in the body.

Marty Keiser , the founder and chief executive officer of IVBH, a company that specializes in liquid biopsy and early cancer detection, said there is a need for less invasive lung cancer screening.

“The idea is to more easily and accurately detect lung cancer and place those patients into evidence-based imaging pathways much earlier in the disease state,” Keiser said.

“It’s critical that our tests are both highly accurate and easy to administer, but that they also complement and enhance existing standards-of-care — eliminating time, cost, risk and stress, and improving patient outcomes within a clinical setting,” he added.

Grail’s Galleri test for lung cancer

Dr. Jeff Venstrom is the chief medical officer of GRAIL, whose multi-cancer liquid biopsy test Galleri is now available to consumers.

“ We know that lung cancers can hide from imaging, and are often aggressive, leading them to shed DNA into the bloodstream early in their natural history,” said Venstrom, who sees blood-based multi-cancer early detection (MCED) tests as complementary to imaging-based modalities for lung cancer screening.

“MCED tests like Galleri, which look for this circulating tumor DNA, offer real promise to complement existing low-dose CT screening to find more cancers earlier, especially for non-smokers,” Venstrom told Healthline.

“Blood-based MCED tests also avoid radiation exposure and may be more accessible for more people, including those who live in rural communities where access to imaging is limited,” he added.

More clinical trials for lung cancer liquid biopsies

Guardant , a liquid biopsy company that is currently developing its liquid biopsy for lung cancer and multiple other cancers, moved its lung cancer plans forward in January with a large, focused lung cancer study using blood screening.

“We plan on enrolling 9,000 people in that study for high-risk smokers,” Dr. Craig Eagle , the chief medical officer for Guardant, told Healthline. “Ultimately the goal is to provide a test and use data from regulatory trials.”

Dr. Scott Lippman , the associate vice chancellor for cancer research at the University of California San Diego, told Healthline that lung cancer screening research is promising.

“We all want these early cancer detection tests to work. But we need this to be proven in large, randomized trials,” he said. “To be approved for standard use, it has to show that the benefit is greater than the known harm.”

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IVBH’s Strategic Partnership with Sonrai Analytics to Advance Novel Early Detection Precision Diagnostics

Eric@adsneeded.com (Eric Kristiansen) — Tue, 28 Jun 2022 13:33:44 GMT

This multi-year partnership solidifies IV BioHoldings as an AI-powered organization and will further accelerate the company’s clinical and commercial efforts to transform the paradigm of precision health by detecting, diagnosing and treating patients as individuals, at scale.

NEWPORT BEACH, Calif. and BELFAST, NORTHERN IRELAND – June 28, 2022 – IV BioHoldings (IVBH) – a clinical-stage bio-platform company that conceives, creates and scales first-generation precision health solutions that improve the detection, diagnosis and treatment of disease – has partnered with Sonrai Analytics . Sonrai’s customized, advanced AI applications will bolster IVBH’s analytic capabilities, allowing for improvements on clinical insights for the company’s pipeline of noninvasive diagnostics for lung cancer, non-alcoholic fatty liver disease and breast cancer.

“In the digital age, abundance beats scarcity every single time,” said IVBH Founder-CEO Marty Keiser. “The IVBH-Sonrai partnership is the ultimate expression of abundance, leveraging AI to democratize healthcare R&D and accelerating massive value creation for all stakeholders through our novel and highly efficient decentralized partnership model.”

Over the last year, says Keiser, IVBH transitioned its time and resources institutionalizing the people, partners and infrastructure required to accelerate its diagnostic solutions to market with speed, efficiency, and a rigorous approach to risk mitigation.

“The collaboration with Sonrai closes the loop for us, providing IVBH with the dedicated data science, engineering and regulatory expertise — and the AI-powered solutions required to optimize the IVBH platform — from R&D through commercialization,” added Keiser.

Sonrai Analytics — based in Belfast, Northern Ireland — adopts artificial intelligence approaches to help biotech, CRO and pharma companies efficiently utilize their data. Sonrai’s cloud-based platform provides full transparency and user-control; the ability to manage structured and unstructured data sources and file types from small CSV files to terabytes of Gigapixel images; and advanced AI, machine learning and deep learning methods to extract maximum value from modern precision medicine digital approaches.

“From the very first meeting, it was evident that IVBH was approaching everything in a completely novel way,” said Sonrai Founder-CEO Darragh McArt, Ph.D. “Their unique focus on commercializing multi-modal RNA solutions in healthcare areas of poor clinical outcome fit within the context of an integrative diagnostic ensemble, which aligned perfectly not just with the experience of the Sonrai team but also with the intentional design of Sonrai’s platform, making this partnership a very natural fit.”

The collaboration comes at an important inflection for both companies, with promising early clinical data being generated across the IVBH offering through the company’s strategic lab partner P4 Diagnostix , and Sonrai having successfully navigated a new venture round supporting large AI-driven programs, such as with the United Kingdom’s National Health Service.

While the relationship between the two high-growth companies is expansive, both will be squarely focused on interrogating, interpreting and disseminating findings within all clinical data related to IVBH’s existing pipeline of noninvasive PCR technologies, with the first clinical data readout expected for the genTRU-breast cancer program this summer. This will be followed closely by the lung cancer and NAFLD programs, with plans for reaching a commercial launch-phase for all three programs by the end of 2023 and an eye toward future expansion within women’s health, pulmonary disease and metabolic disease — as well as entrance into new markets.

For more information about IVBH, visit ivbh.studio . For more information about Sonrai Analytics, visit sonraianalytics.com .

About IV BioHoldings (IVBH)

Driven by a deep and unwavering love for people and a relentless quest to replace sick-care with precision healthcare, Marty Keiser founded IV BioHoldings (IVBH) in 2018. IVBH is a bio platform company that conceives, creates, and scales first-generation precision health solutions that radically improve the detection, diagnosis, and treatment of disease. The company has successfully launched three bio startups: LiquidLung, HepGene and Mammogen. These companies are focused on pulmonary disease, metabolic disease, and women’s health, respectively. For more information: ivbh.studio

About Sonrai Analytics

Sonrai Analytics was founded in 2018 by Drs. Darragh McArt and Deva Senevirathne as a technology start-up within healthcare and precision medicine domains, spun-out of Queen's University Belfast. Sonrai's AI data discovery platform helps biotech and pharma companies identify high-value biomarkers, develop state-of-the-art algorithms, and get new products to the market much faster. Sonrai leverages proprietary artificial intelligence, machine learning and cloud technologies to help accelerate innovative research and clinical product development, which can lead to faster and more effective treatments for cancer and other diseases. For additional information, visit: sonraianalytics.com

4695 MacArthur Court, Suite 1100, Newport Beach, CA 92660 | info@ivbh.studio | ivbh.studio

Being a Servant and Imagineer in BioTech – with Marty Keiser

Eric@adsneeded.com (Eric Kristiansen) — Fri, 17 Jun 2022 22:32:10 GMT

Marty Keiser is the Walt Disney of BioTech. Marty is an imagineer at heart who is seeking to conceive, create and scale the detection, diagnosis and treatment of disease. At the core of everything Marty does is his love for people and his passion to save lives.

Listen in to learn more about Marty’s unique to developing solutions that break the norms of how biotech is done and his unique mindset to building a team of fellow imagineers to impact over a billion lives.

Some highlights of our conversation include:

1:32 – Who is Marty Keiser and what IV BioHoldings (IVBH) is up to?

5:09 – The Motivation Behind Everything

13:26 – Courage is required, not confidence

15:52 – Creating in the “negative space”

27:04 – Building a space to create and challenge norms

30:25 – A servant instead of a savior mindset in biotech

35:25 – A path to a servant approach

37:28 – The next billionaires will have impacted a billion lives

39:47 – Advice to my pre-CEO self

To learn more about Marty, follow him on LinkedIn: linkedin.com/in/marty-keiser-29181b4/

To learn more about IVBH: https://www.ivbh.studio/

A Very Special Episode of Family Ties

Eric@adsneeded.com (Eric Kristiansen) — Mon, 06 Jun 2022 15:25:39 GMT

"So my buddy Marty Keiser happened to be in NYC and dropped by OffScrip Health Studios, and we decided to turn on the mics and bromance out since we hadn't seen each other in person in over a year. #ThanksPandemic. Consider this "Very Special Episode of Family Ties" a mental exercise in friendship, camaraderie, purpose, frustration, intent, and belief that the good in the world far outweighs the bad in the world. Yogi Bera said, "If life were easy, we'd all do it." Truer words were never spoken. So that about sums up the episode. I hope you enjoy it."

Marty Keiser, Founder & CEO of IV BioHoldings

Eric@adsneeded.com (Eric Kristiansen) — Thu, 26 May 2022 16:08:50 GMT

"This week’s guest is founder and CEO of IV Bioholdings, Marty Keiser.

IV Bioholdings is on a quest to radically improve the detection, diagnosis and treatment of disease. Listen as I try to keep up with Marty as he shares their bold innovations that are radically improving patients ability to detect diseases like cancer earlier and potentially save lives."

S.E.E. Summit to Showcase Game-Changing Potential of Liquid Biopsy in Early Cancer Detection

Eric@adsneeded.com (Eric Kristiansen) — Mon, 04 Apr 2022 18:32:27 GMT

LOS ANGELES--(BUSINESS WIRE)--Advancements in liquid biopsies, enabling safer, easier and earlier detection of cancer, is the focus of the inaugural S.E.E. Summit, a virtual conference on April 21, 2022. Convened by Teen Cancer America (TCA), the summit will feature presentations by the leading researchers and oncologists from biotechnology companies that are turning the game-changing promise of liquid biopsies into reality. The presentations will be followed by an open panel discussion.

Liquid biopsies are blood tests designed to identify biomarkers in the blood that can detect cancer very early. Breakthroughs in genomics have accelerated the potential for liquid biopsies to change the paradigm for cancer screening, diagnosis and treatment as a non-invasive alternative to tissue biopsy.

The S.E.E. Summit is the first event to bring liquid biopsy out of stealth mode and begin a national dialogue about this technology’s potential for cancer patients.

The primary goal is to share information about this growing sector in a way that scientists appreciate but consumers, healthcare professionals, potential investors and the media can also understand. Presenters and panel discussion participants will include preeminent liquid biopsy experts from Caris Life Sciences, Exact Sciences/Thrive, Grail, Guardant, IV BioHoldings (IVBH), Natera, Pillar Biosciences and StageZero Life Sciences.

The online conference will feature pre-recorded presentations from the participating companies, followed by a live, independent panel of scientists, oncologists, patients, patient advocates and other stakeholders. The summit is produced by The Special Events Company, a world-class media group that has extensive experience in biotech and healthcare.

“Liquid biopsy research is aligned with President Biden's ‘Moonshot’ cancer initiative which calls for a focus on prevention and early detection,” said Simon Davies, Executive Director of TCA, the national non-profit co-founded by Roger Daltrey and Pete Townshend of the legendary rock band, The Who. “While our charity’s mission is to serve teens and young adults with cancer, where late detection and misdiagnosis is not uncommon, liquid biopsy is a major step forward in cancer detection among all age groups, and we are excited to shine a light on this important work.”

Equity and access are primary objectives in the development of liquid biopsies. The American Cancer Society estimates there will be 1.9 million new cancer cases in the U.S. in 2022. Due to the pandemic, nearly 10 million cancer screenings were missed in 2020, disproportionately impacting individuals from marginalized populations, potentially leading to increased diagnoses of late-stage cancers.

Due to the lower cost, non-invasiveness and reduced time required for screenings, liquid biopsies can have a significant impact on cancer detection, early treatment and outcomes for at-risk populations.

“Liquid biopsies have reached a tipping point,” said S.E.E. Summit co-creator Jamie Reno, an acclaimed journalist, bestselling author, patient advocate and three-time survivor of stage IV cancer. "There is still much work to be done in the lab, in clinical trials, and in the clinic, but the evidence overwhelmingly shows that this technology works. Once people understand how safe, easy and accurate these tests are becoming, then we will see the full potential of this new science."

According to Precedence Research, the liquid biopsy market, valued at $7.1 billion in 2020, is expected to grow at an annual rate of 14%, topping $26.2 billion by 2030.

The organizations participating in the S.E.E. Summit plan to extend the program into a series of educational media initiatives to educate and inform cancer patients, healthcare professionals, and the general public.

The event takes place on Thursday, April 21 beginning at 12 p.m. ET, 9 a.m. PT.

Online attendance is free, and registration is available at this LINK .

About Teen Cancer America

Teen Cancer America helps hospitals and healthcare professionals bridge the gap between pediatric and adult oncology care by supporting hospitals and outpatient facilities in the development of specialized units and programs for this age group. TCA brings together physicians and allied healthcare professionals in both pediatric and adult oncology. Age-targeted care for this population is necessary for medical and appropriate psychosocial development. Outcomes associated with some cancers that target this age group have not improved in over 30 years. Teens and young adults with cancer are long overdue for an upgrade and TCA can hopefully light the fire in America’s health systems. For more information, contact Michelle Aland michelle@teencanceramerica.org or visit www.teencanceramerica.org .

Marty Keiser, Founder-CEO, IV BioHoldings (IVBH)

Mon, 07 Mar 2022 19:08:53 GMT

IV BIOHOLDINGS, FIRST-IN-CATEGORY BIO-PLATFORM TO RADICALLY IMPROVE THE DETECTION, DIAGNOSIS, AND TREATMENT OF DISEASE

IV BioHoldings (IVBH) is a bio innovation studio that conceives, creates, and develops first-in-category bio-platform companies that radically improve the detection, diagnosis, and treatment of disease. The company is defined by speed, efficiency, and risk management, made possible through advanced data science, exponential technologies,powerful partnerships and over 60 years of combined multi-disciplinary expertise.

The studio has founded three bio startups under the able leadership of Marty Keiser, Founder-CEO, IV BioHoldings (IVBH). The bio startups; Liquid Lung, HepGene, and Mammogen, are focused on pulmonary disease, metabolic disease, and women’s health, respectively. The IVBH ecosystem comprises three flagship liquid biopsy programs consisting of 8 first-in-class, non-invasive, patented, and patent-pending clinical-stage diagnostic tests addressing urgent unmet clinical needs across the care continuum for lung cancer, non-alcoholic fatty liver disease (NAFLD), and breast cancer.

Marty leads IVBH with partner Elizabeth Cormier-May, a trained medicinal chemist with nearly 20-years veteran of diagnostics industry experience, who serves as SVP and Chief Commercial Officer of IVBH, as well as CEO of Mammogen. While they bring enormous passion, enthusiasm, an obsessive appreciation for execution, and strong business acumen, the blend of their different backgrounds, networks, and complementary skillsets makes for a very powerful dynamic and has contributed greatly to the success across the IVBH platform.

MORE ABOUT MARTY KEISER

Marty Keiser is a creative entrepreneur rooted in family, faith, and unwavering love for people. He grew up in Fairfield, Connecticut, a blue collar-kid in a white-collar town. In 2018, after a wonderful decade-long run-on Wall Street, he decided to leap into the world of entrepreneurship, to take advantage of what he believed to be the early innings of a bio revolution.

ENTREPRENEURIAL JOURNEY

Blessed with an optimistic outlook on life, a very persistent personality, a keen sense of resourcefulness, and a strong work ethic, entrepreneurship feels right to Marty. He entered the world of entrepreneurship as most people do, he was driven by personal frustration, the vision of a better solution, and an “if not me, then who” and “if not now, then when” calling. From 2016 to 2018, he did extensive research on the challenges that he was likely to face before making the jump to entrepreneurship. These challenges led him to rethink, imagine and reinvent nearly every aspect of the business.

IVBH centralizes all key executive and operational functions at the studio, keeping the burn rate low across company creations, allowing for shared knowledge and resources, and creating a “rising tide” effect across the entire ecosystem. Marty jokingly added that they were virtual before COVID made it cool, and the model has paid off very nicely for both before and during the pandemic. While most competitors were struggling to keep the lights on, their growth was exploding.

Marty further added, “My entrepreneurial journey has been far from linear, but much of that intense planning and preparation on the front-end not only helped me avoid many of the common challenges and pitfalls for first-time entrepreneurs but also resulted in entirely new models, processes, and proprietary know-how that added significant value to the overall IVBH platform, putting us in a competitive class of our own.”

FUTURE & CAREER

Marty’s mission in life is to radically improve the detection, diagnosis, and treatment of disease. Right now, the collective technologies across the IVBH platform are positioned to positively impact the lives of over 200 million Americans and over 1 billion people globally. While the impact of that is massive, he is laser-focused on every single step that needs to be taken to save that first life. The first person that he positively impacts will be the domino that leads to achieving their global vision for humanity.

“So much of my early focus was on leveraging data and technology to compress and eliminate the time, cost, and risk that lie ahead of me from an R&D standpoint, that I didn’t fully recognize or appreciate the value that a great team brings to both risk reduction and rapid acceleration of growth. Fortunately, I figured that out soon. I tend to think my leadership style is a blend of authoritative, democratic, and affiliative,” asserts Marty.

For the founder, the reward of bringing once-in-a-century change to healthcare, unlocking previously unknown scientific and technical insights about life-threatening diseases, and positively impacting the lives of hundreds of millions of people, was a risk worth taking and therefore, inconsequential.

INDUSTRIAL AND ORGANIZATIONAL ETHOS

There has been very little change across the healthcare industry, which is precisely why Marty entered the field. IVBH exists not to create incremental change but to create exponential change. The motto is as powerful as it is simple: Detect earlier. Diagnose easier. Treat more precisely. To achieve it, one must be willing to boldly challenge the status quo and bring massive change to an industry rooted in tradition. And the best way to encourage it is to think creatively!

IVBH is the most creative and imaginative place you can think of, where diversity of thought, experience, and perspective is encouraged, facilitated, and integrated into everything that they do. One exercise that they practice at IVBH is spending time looking at products, services, processes, and protocols that are universally accepted as the best, identifying a problem with it, and then thinking of ways you would reinvent, recreate or rewrite it to make it better for yourself. The thinking behind this exercise is that if something is better based on your own high standards, it would likely be better for everyone.

“I am proud of the team and partners that I have assembled, collectively working towards the common objective of radically improving the detection, diagnosis, and treatment of disease, driven by an unwavering ‘patient first’ approach to every single decision that we make,” emphasized Marty.

ROLE AS A LEADER

The most important decision a CEO can make is to ensure that near-term decisions do not detract from or prevent the organization from reaching its long-term objective. Finding harmony between the short- and long-term is a unique skill set that keeps the idea and the business moving forward in the right direction with the following points:

Trust your gut.
Do what you’re BEST at and hire the rest
Make decisions with 70-80% of the information available to you, wait for more, and you’ll miss the opportunity.
If you’re not sure if you’re a leader, you’re probably not a leader – this isn’t for everyone

Core values should be communicated early and often from the top-down and the bottom up. Core values are most important during times of great stress or when making critical, make-or-break decisions. When the proper foundation has been laid and the core values are interwoven throughout every aspect of the organization, difficult decisions tend to be much easier to make, regardless of the outcome.

ADVICE TO READERS

People are the most precious resource in life and business. Take time to cherish and nurture deep interpersonal relationships. Look for the best in people. Look for ways to bring out the best in them. Follow this advice and you’ll gain more than you ever could have dreamed.

Company website: https://www.ivbh.studio/

Conceive, Create and Develop with Marty Keiser Founder and CEO of IV BioHoldings S4|Ep2

Eric@adsneeded.com (Eric Kristiansen) — Wed, 09 Feb 2022 16:15:57 GMT

Transforming Early Detection & Precision Health

Marty Keiser is an entrepreneur and the founder of IV BioHoldings, a bio platform company founded in 2018 where they conceive, create and develop 1st class liquid biopsy companies all focused on early detection and precision health.

Over the last 3 years, Marty and his team have since launched three companies out of IVBH

Liquid Lung -Pulmonary disease
Hepgene -Metabolic disease
Mammogen - Women’s health

In this week’s episode, Marty shares his story of how he got into the industry having previously worked on Wall Street.

Marty’s passion for change and eagerness to dismantle healthcare silos translates throughout the interview and is completely awe-inspiring.

IVBH- Redefining the HealthCare We Have Known

Eric@adsneeded.com (Eric Kristiansen) — Thu, 27 Jan 2022 15:50:54 GMT

“Based on industry norms, what would have taken seven years and would have cost between $100 million to $700 million in R&D, the team of IVBH finished in three years with a capital investment of less than $5 million. This has stunned the world. This has unlocked previously unknown deep scientific and technical insights for lung cancer, NAFLD, and breast cancer, bringing the field exponentially closer to positively impacting the lives of over 200 million Americans and over 1 billion people worldwide”

The civilization wherein we reside is forever evolving, and the world in which the current generation lives is no longer the same. We claim that the world is changing, but what is causing this shift? It’s important to consider what’s causing this shift. Because the world is a ‘living structure,’ it is always developing. Great leaders emerge from time to time and bring about tremendous improvements in people’s lives. The act of seeing develops concepts. When these concepts are put into action, they result in transformation, which is regarded as a sign of development. If done correctly, such life observations unleash technological revolutions.

“Imagination is the highest form of research,” Albert Einstein famously stated. And in one short sentence, he encapsulated the concept that to bring about changes, we must look beyond our immediate surroundings to potential answers.

This article brings forward an inspirational story of how ‘Marty Keiser’ started IV BioHoldings ( IVBH ), a bio innovation studio that conceives, creates, and develops first-in-category bio-platform companies that radically improve the detection, diagnosis, and treatment of disease.

Certain expectations and understandings that have been formed over decades, a style of thinking that is taught and generally accepted throughout business school, medical school, and corporate training departments, are the enemy of development, believes Marty. Through execution and outcomes, he intends to question and reframe those understandings, as well as set a new baseline of expectations from which the world can continue to develop and progress. Marty Keiser, the founder, and CEO of IVBH steers,

“I want to demonstrate that developing and commercializing a novel medicine or diagnostic test does not have to take 10 years and cost a billion dollars. I want to establish that finding fewer than 10% of lung tumours in stages I is not the best we can accomplish. I will prove that we don’t need to cram people into skyscrapers to get the job done. I will show that when properly taught, individuals can and will take action to avoid disease using the correct techniques. I work to convey that profit and purpose are not mutually exclusive.”

IVBH is Distinguished By Its Life-Saving Techniques

IVBH is defined by speed, efficiency and risk management, advanced data science, exponential technologies, powerful partnerships, and over 60 years of multi-disciplinary expertise. LiquidLung, HepGene, and Mammogen are the three firms that have come out of the studio so far. Across the portfolio you will find three flagship liquid biopsy programs comprising non-invasive, clinical-stage diagnostics for lung cancer, non-alcoholic fatty liver disease (NAFLD), and breast cancer.

The technologies of IVBH are distinguished by three factors. First is their focus on RNA, providing the real-time telemetry of the body’s biological response to the presence or absence of disease and allowing for consistent and accurate detection across all stages. Second is the comprehensive nature of their scientific and technical platforms, allowing them to answer important unmet clinical questions across the entire care continuum of disease, from early detection to confirmatory diagnosis to earlier and more precise treatment decisions. Third, is their strategic decision to commercialize their technologies as PCR tests, an affordable, reliable, and portable solution with rapid turnaround times that is easily accessible in most labs, especially now.

According to Marty, IVBH is now directing the transformation. “We will continue to rethink, innovate, reinvent, and remake what we have reinvented as long as IVBH exists. Our current focus is on dismantling healthcare silos, developing more efficient business models and procedures, and figuring out how to combine data, technology, and people to deliver the most effective, economical, and accessible precision health solutions to patients in need.”

Viewing Challenges From The Lens Of Opportunities

The majority of diagnostics firms do not produce therapies, and the majority of therapeutic firms do not develop diagnostics. The two have been viewed as wholly different entities for a long time, with no contact or collaboration. One of the many beneficial outcomes of COVID was a renewed understanding of the critical role diagnostics plays in the treatment chain.

“Simply said, you can’t properly address an issue if you can’t accurately diagnose it. As these traditional barriers fall, and we begin to collect and integrate data from better-informed and more engaged patients, I see a century’s worth of precision health opportunities, from disease prevention to earlier detection to targeted treatments that are far more tolerable and effective than current treatment standards.”

Meet Marty Keiser

Marty joined the field of entrepreneurship in the same way that most people do: with personal frustration, a vision of a better solution, and an “if not me, then who” and “if not now, then when” calling. For him, the personal frustration was with the time, expense, and risk involved in practically every area of healthcare, as well as with the diagnostics and therapeutics communities’ acceptance of 7-10-year development schedules, billion-dollar R&D expenditures, and 80-90 percent failure rates. There had to be a better way, he always thought.

“ From 2016-2018 I entered one of the most creative periods of my life, pinpointing all of the traditional elements of success and approaching them in non-traditional ways, reimagining business models, inverting processes, breaking down silos, performing deep diligence on various data sources and technologies and establishing powerful partnerships that I would need in order to be successful. I picked up the baton of entrepreneurship with great excitement in 2018, confident in my plan and driven by a strong desire to make a positive difference for mankind.”

After years of experience, Marty thinks that the most important mental exercise for entrepreneurs is being able to find harmony between the short- and long-term. He believes that one must be laser-focused on the short-term in order to execute important tasks that move the idea or the business forward, while at the same time never losing sight of the longer-term goal. He cites an anecdote,

“ Growing up travelling in and out of New York City I learned that there is a trick to successfully navigating its crowded and chaotic sidewalks without tripping over people. I learned that in order to avoid physical contact with those approaching you, you must keep your focus in the distance. In this process, you may miss an opportunity to bump into an old friend, but you may end up making a new connection, or even meet the love of your life. The point being, know where you’re going and keep an eye towards the destination, the long-term goal, but don’t be afraid to take some short-term risks, to change course, or to take a different route on the way there. I learned the importance of this very early in my entrepreneurial journey and worked hard to find that harmony every single day.”

Mammogen Inc. CEO Elizabeth Cormier-May Wins Illustrious Award with Business Worldwide Magazine

Eric@adsneeded.com (Eric Kristiansen) — Sun, 23 Jan 2022 22:18:54 GMT

LONDON, Jan. 19, 2022 /PRNewswire/ -- Liz Cormier-May of Mammogen was named Biotechnology CEO of the Year – USA in the 2021 Global Corporate Excellence Awards.

The awards, run by Business Worldwide Magazine, seek to identify and honor the most respected companies and C level executives in the world. The aim is to reward outstanding performance, innovation, and ethics across international business and finance communities, covering a vast range of sectors. Liz Cormier-May won the award for her visionary approach, which is changing the face of healthcare for women all over the world.

Mammogen uses a combination of data, technology, science and personal experience to challenge the status quo. Liz is an outspoken leader in her field, and her mission is to shatter complacency and radically improve the way women's diseases are detected, diagnosed and treated.

Breast cancer affected over 2.3 million women globally in 2020, resulting in 685,000 deaths. Mammogen is at the forefront of emerging technologies that radically improve early detection rates, potentially saving millions of lives in the process. The company also empowers women in all areas of their lives, starting new conversations about the fears, anxiety, depression, marital challenges and body shame issues that come hand in hand with breast cancer.

Liz began her career as a medicinal chemist specialising in early discovery oncology at the Novartis institute for Biomedical Research. For almost 20 years, she has been developing new markets, products and companies, with one shared goal – to introduce novel options and technologies that enhance patient experiences and save lives.

As well as leading Mammogen, Liz is also the CCO of IV Bioholdings; a bio innovation studio that conceives, creates and develops first-in-category RNA bio platforms which radically improve the detection, diagnosis and treatment of disease. To date, IV BioHoldings has created three first in class new biopsy programs, eight clinical stage diagnostics, and has discovered over two hundred novel RNA biomarkers. Together these have the potential to save over a billion lives around the world.

To find out more about Mammogen's innovative, life saving technologies, visit https://www.mammogen.bio

Further information on the individuals and companies which picked up titles in the Global Corporate Excellence Awards 2021, can be found at: https://www.bwmonline.com/2021-global-corporate-excellence-awards-winners/

About Business Worldwide Magazine

Business Worldwide Magazine is the leading source of business and dealmaker intelligence throughout the world. Our quarterly magazine and online news portal enable an established audience of corporate dealmakers to track the latest news, stories and developments affecting the international markets, corporate finance, business strategy and changes in legislation. This readership includes of CEO/CFO - Banks, Corporate Lawyers and Venture Capital/Private Equity Companies to name a few.

Mammogen and Brilliantly Continue their Commitment to the Breast Cancer Community with Brilliantly Warm Giveaway

Eric@adsneeded.com (Eric Kristiansen) — Tue, 11 Jan 2022 15:59:35 GMT

Partnership between female-led women’s healthcare companies will give away 50 pairs of Brilliantly Warm wearable bra inserts - the world’s first-ever wearable designed specifically for women after reconstructive surgery - to the breast cancer community

PROVIDENCE, R.I.--( BUSINESS WIRE )-- Brilliantly and Mammogen, Inc. – two female-led women’s healthcare companies centered around breakthrough technologies designed to solve unmet clinical needs in the breast cancer space – announced their partnership in October. The companies are working on compiling a coffee table book, detailing the comprehensive journey of breast cancer with stories, letters, photos, and recipes. Brilliantly and Mammogen also announced that they are working together to create exercise routines and videos that accommodate the changes in physiology and mindset after breast cancer.

To demonstrate their collective commitment in 2022, Brilliantly and Mammogen today announced that Mammogen is sponsoring the giveaway of 50 Brilliantly Warm wearable bra inserts, the first-ever wearable designed specifically for women who have had breast reconstruction surgery. Individuals can sign up for consideration at home.brilliantlywarm.co/brilliantly-warm-giveaway with the give away limited to 50 participants. Participants will be asked to also help the companies gather further information on the product experience, and their own journey, to help inform future product releases.

Brilliantly Warm , Brilliantly’s flagship product, is the first-ever warming wearable designed by and for women who have had breast reconstruction surgery. Brilliantly Warm, a discreet, rechargeable, heated bra insert, was designed for women who have had breast implant reconstruction and, as a result, experience an overwhelming sense of coldness. The Brilliantly Warm iOS and Android app allows users to manage the temperature of their device with ease and in any environment – the office, outdoors, or at a social gathering or event.

“I’m excited to partner with Mammogen – working together, we can leverage our collective resources across the continuum of care for breast cancer patients, to help women like us build community and find answers to some of the most important and personal questions,” said Kristen Carbone, founder of Brilliantly.

“We stated our from-end-to-never-end commitment to our patient community on day one, and that has never waivered. This is a powerful way for us at Mammogen to contribute to our community while we are focusing on the clinical development of our genTRUTM-breast program, a suite of best-in-class early detection tests for breast cancer,” commented Elizabeth Cormier-May, CEO of Mammogen.

Dr. Monique Gary is a board certified, fellowship-trained Breast Surgical Oncologist and Medical Director of the Grand View Health/Penn Cancer Network Cancer Program in Sellersville, PA, where she also serves as director of the Breast Program. As the founder of Touch, The Black Breast Cancer Alliance , she will partner with The Breasties , and, together, they will help oversee distribution of Brilliantly Warm to ensure the products reach a diverse group of women in the breast cancer community.

“We are thrilled to be partnering with Brilliantly and Mammogen to gather such important clinical and patient data,” added Dr. Gary “We are committed to finding ways to innovate and close the gaps in the continuum of care, particularly post remission. Chronic coldness is a real problem for our patients, and we look forward to securing an improved understanding of the patient experience with Brilliantly Warm.”

About Brilliantly

Brilliantly helps women with the transition from confronting breast cancer to embracing life through innovative products, thoughtful content, and relevant services. The company has recently released their flagship technology, Brilliantly Warm, the first-ever wearable designed specifically for women who have had breast reconstruction surgery. For more information visit www.brilliantly.co .

About Mammogen

Mammogen is a female-led biotechnology company focused on meaningfully improving the detection, diagnosis and treatment of women’s health-related diseases, and creating an end-to-never-end community for women around the world. Mammogen is centered around its proprietary genTRUTM liquid biopsy platform. The company’s flagship genTRU-breastTM program leverages novel messenger RNA (mRNA) technology to non-invasively detect and diagnose breast cancer. The genTRUTM offering is positioned to unlock regular and reliable screening for millions of women around the world and eliminate many negative, invasive biopsy procedures. The company’s proprietary multi-gene expression signature for breast cancer detection has been extensively validated in blood, as well as saliva, and has shown statistical significance towards providing measurable improvement upon current standards of care. Mammogen’s product pipeline consists of an array of non-invasive prognostics and diagnostics for additional diseases that affect some-, mostly-, or only-women. For more information visit www.mammogen.bio .

LiquidLung Receives Notice of Allowance from U.S. Patent and Trademark Office, Unveils Novel RNA Technology for Non-Invasive Lung Cancer Detection

Eric@adsneeded.com (Eric Kristiansen) — Tue, 07 Dec 2021 15:20:54 GMT

Leading pulmonary disease company debuts to-be patented blood-based RNA technology platform with best-in-class sensitivity for early detection, confirmatory diagnosis and subtyping of lung cancer

NEWPORT BEACH, Calif.--( BUSINESS WIRE )--LiquidLung, Inc., a biotechnology company dedicated to radically improving the detection, diagnosis and treatment of pulmonary disease, is pleased to announce that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application No. 17/003,775 for claims related to the non-invasive diagnosis of lung cancer.

“The USPTO decision is a significant milestone for LiquidLung and further establishes IVBH’s position as a leader in the rapidly accelerating RNA revolution”

The technology, which is centered around a comprehensive portfolio of novel RNA biomarkers, developed in concert with Liquid Biosciences, a leading bio-analytics provider and dedicated partner to LiquidLung. The technology utilizes various mathematical gene expression signatures that uniquely span early detection and confirmatory diagnosis of lung cancer, both pre- and post-imaging, as well as the diagnostic classification of several prevalent histological subtypes of the disease.

In an independent validation study the lung cancer technology was applied to a blood-based dataset comprised of fully adjudicated in vivo patient samples consisting of patients with confirmed lung cancer and those without lung cancer, the technology achieved 97% sensitivity and 85% specificity for lung cancer detection.

Further, the technology correctly detected 100% of patients with stage I, 89.9% with stage II, 100% with stage III and 100% with stage IV. In addition to detecting lung cancer generally across all stages of disease, the technology also achieved strong sensitivity and specificity for distinguishing between small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), adenocarcinoma, squamous cell carcinoma and large cell carcinoma. Notably, all cited performance was derived from the biomarkers alone, with absolutely no mathematical or scientific value being derived from patient demographics, nodule information, smoking history or any other clinical risk factors, which introduces a defined opportunity to improve upon the already impressive early data with little investment in R&D.

“Imagine a non-invasive testing platform that can rule more high-risk patients with lung cancer into LDCT imaging for further evaluation earlier, reduce negative biopsy procedures for patients with suspicious pulmonary nodules discovered incidentally or through routine screening, and also accelerate the time to life-saving interventions and personalized treatments,” stated Founder and Chairman, Marty Keiser. “The comprehensive nature of our to-be patented technology enables us to accurately and efficiently unlock value for patients across the entire care continuum for lung cancer, all while fitting nicely into existing workflows and standards of care.”

LiquidLung is one of three companies created out of IV BioHoldings (IVBH), a bio innovation studio known for its progressive approach to R&D, company creation, productization and commercialization. IVBH made headlines in October when it aligned the public debut of its first-in-category pipeline of RNA technologies with the announcement of a strategic lab partnership with P4 Diagnostix, intended to accelerate clinical development and validation of the IVBH assets within lung cancer, non-alcoholic fatty liver disease (NAFLD) and breast cancer.

“The recent worldwide recognition and appreciation for the clinical utility of RNA, from prevention to detection to treatment, has created a timely tailwind for IVBH as we begin to publicly unveil the vast intellectual property portfolio that we have been quietly and strategically amassing since 2018,” stated IVBH Chief Commercial Officer, Elizabeth Cormier-May, who also leads the studio’s women’s health company, Mammogen. “The USPTO decision is a significant milestone for LiquidLung and further establishes IVBH’s position as a leader in the rapidly accelerating RNA revolution,” Cormier-May continued.

IVBH is currently scaling operationally to support the lung cancer, NAFLD and breast cancer programs through near-term clinical milestones with multiple phases of clinical data generation expected throughout 2022 across all programs.

About LiquidLung

LiquidLung is a transformative biotechnology company dedicated to radically improving the detection, diagnosis and treatment of pulmonary disease. The company is centered around a patented multi-RNA liquid biopsy technology platform, consisting of three first-in-class, clinical-stage assays positioned to unlock value across the care continuum for lung cancer, from earlier detection to easier and more precise diagnosis and treatment of disease. For more information, visit www.liquidlung.bio .

About IV BioHoldings

IV BioHoldings (IVBH) was established in 2018 with the vision of commercializing first-in-category precision health solutions that radically improve the detection, diagnosis and treatment of life-threatening diseases. IVBH’s novel distributed company platform is defined by speed, efficiency and risk management – from R&D to company creation to productization and commercialization – made possible through a unique integration of advanced data science, exponential technologies and powerful partnerships. The current IVBH ecosystem comprises three transformative bio startups born at the intersection of diagnostics and therapeutics, including LiquidLung, Inc., HepGene, Inc., and Mammogen, Inc., focused on pulmonary disease, metabolic disease, and women's health, respectively. For more information, visit www.ivbh.studio .

Mammogen Touts Growing List of 2021 Awards and Recognitions for its Work in Women’s Health and Breast Cancer Diagnostics

Eric@adsneeded.com (Eric Kristiansen) — Thu, 28 Oct 2021 23:40:07 GMT

After recent partnership announcements, female-led women’s health startup, Mammogen, showcases growing list of 2021 awards and recognitions

ALISO VIEJO, Calif.--( BUSINESS WIRE )--Mammogen, a female-led women’s health company, today has announced a list of 2021 awards and recognitions for its work in women’s health and, more specifically, breast cancer.

Mammogen named “ Best Breast Cancer Detection Technology Company - US ” by Global Health and Pharma Magazine (GHP)
Mammogen named “ 1 of 5 Biotech Companies to Watch in 2021 ” by The Silicon Review®
Mammogen selected as one of two women’s health companies featured throughout the 2021 American Association of Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo in Atlanta, GA

The awards and recognitions come off the heels of two recent partnership announcements. The first being a strategic lab partnership with P4 Diagnostix® (P4) that will cover all clinical development and validation of Mammogen’s genTRU-breastTM liquid biopsy diagnostic platform, a proprietary RNA-based technology for early detection testing and patient stratification post-imaging.

“Our purpose-built partnership model at Mammogen places us in a unique position to enter clinical development of our first-in-class breast cancer diagnostics with a level of speed and efficiency that the industry has never before experienced,” stated Elizabeth Cormier-May, CEO of Mammogen. “In addition to bypassing the time and cost typically associated with organically building a lab, sales force, and regulatory team, the partnership with P4 provides us with nearly 20 years of diagnostic commercialization expertise, seven CLIA certified labs and defined channels to market into women’s health,” Cormier-May continued.

The second partnership, announced intentionally during breast cancer awareness month and the one-year anniversary of Mammogen’s incorporation, is a comprehensive collaboration with Brilliantly, another female-led company helping women transition from confronting breast cancer to embracing life through innovative products, thoughtful content and relevant services. The collaboration will equip breast cancer previvors and survivors with the tools they need to live empowered lives through an exclusive book project and a corrective exercise program.

“The collaboration with P4 and Brilliantly is a clear demonstration of our commitment to ensuring the quality of our clinical diagnostic solutions and ensuring that we address all of the needs from the community that we serve, for all women, from end-to-never-end,” said Cormier-May.

According to management, the company plans to announce data from its upcoming clinical studies in 2022 and plans to share additional details related to the Brilliantly projects over the coming months.

About Mammogen

About P4 Diagnostix®

P4 Diagnostix® is a network of several nationally recognized testing and diagnostic facilities integrated into one unified lab services organization, offering clients unparalleled access to connectivity, healthcare resources and consultative partnerships. P4 is made up of these industry-leading companies: Theranostix, Long Island Pathology, Platinum Pathology, Metamark Laboratories and P4 Clinical. P4's progressive integration of diagnostic testing and office workflow is rooted in partnership with VitalAxis, an industry-leader in the delivery of healthcare informatics. For more information visit www.p4dx.com .

About Brilliantly

Mammogen and Brilliantly Combine Forces to Advance Community Efforts for Breast Cancer Previvors and Survivors

Eric@adsneeded.com (Eric Kristiansen) — Thu, 14 Oct 2021 13:39:01 GMT

Female-led women’s health companies announce comprehensive partnership designed to empower breast cancer community

ALISO VIEJO, Calif. & PROVIDENCE, R.I.--( BUSINESS WIRE )--Brilliantly and Mammogen, Inc., two female-led women’s health companies centered around breakthrough technologies designed to solve unmet clinical needs associated with breast cancer, announce a comprehensive partnership expected to improve quality of care for the breast cancer community, both inside and outside of the physician’s office.

The collaboration, which will equip breast cancer previvors and survivors with the tools they need to live empowered lives, is an intentional step towards each company’s commitment to advancing every aspect of women’s health, beyond traditional product-related decisions.

“Over my nearly twenty years in the diagnostics industry, it has always baffled me that companies never invest time or resources to empower the communities that they serve,” said Elizabeth Cormier-May, CEO of Mammogen. “Whether you’re at a higher risk of developing breast cancer based on genetics or family history, newly diagnosed, or past your five-year mark, there’s no shortage of mental, emotional and physical anguish associated with this disease. At Mammogen, we work tirelessly to innovate around the clinical and the personal experience, not only because it makes great business sense; but, most importantly, because it is the right thing to do. We know that end-to-end care is good but creating an end-to-never-end community is far more powerful, and our partnership with Brilliantly brings us a step closer to fulfilling that mission.”

The comprehensive collaboration will first include an exclusive book project which will be a collection of short stories, interviews and creative writing pieces representing hundreds of voices that address everything from talking about hereditary risk with children to sexual dysfunction to career changes.

“For many of us, the aftermath of surgical intervention and treatment has simply been called ‘the new normal’, yet it doesn’t feel normal at all,” stated Kristen Carbone, Founder and CEO of Brilliantly and breast cancer previvor. “How can we feel normal again? Where do we even start? The issues faced by this community are so multifaceted, I struggle to think of even a single part of everyday life that isn’t impacted in some way by an experience with breast cancer,” continued Carbone.

The second initiative is a corrective exercise program that will include various workout modalities to help regain strength and mobility safely for women who’ve had breast surgery and/or treatment. Specific exercise routines for breast cancer patients, survivors, and previvors have been proven to improve quality of life as well as decrease mortality.1 This collaboration between Mammogen and Brilliantly will ensure that all women have access to appropriate exercise routines throughout their journeys.

Both initiatives, while currently underway, will officially kick off in early 2022, upon successfully securing necessary sponsorship.

About Mammogen

About Brilliantly

JNCI J Natl Cancer Inst, 2021, Vol. 113, No. 1

How Liquid Biopsy Holds Promise for Early Detection of Breast Cancer with Marty Keiser & Liz Cormier-May, Mammogen, Inc.

Eric@adsneeded.com (Eric Kristiansen) — Fri, 08 Oct 2021 02:44:18 GMT

"Woman-led Mammogen Inc. is looking for breast cancers in a whole new way: using liquid biopsy to detect cancers far earlier, for more women, and with greater accuracy than traditional mammograms. They're also passionate about building a community to support women well beyond their initial diagnosis. A special look at the promising future for earlier breast cancer detection, in recognition of Breast Cancer Awareness Month!"

SPOTLIGHT INTERVIEW: LIZ CORMIER-MAY, CEO, MAMMOGEN, INC.

Eric@adsneeded.com (Eric Kristiansen) — Fri, 08 Oct 2021 02:32:47 GMT

About Elizabeth Cormier-May

Liz has been in the biotechnology industry for nearly 20 years, with a focus on early start-ups and company creation. She started her career as a medicinal chemist for Novartis Institute for Biomedical Research, working in early discovery oncology. She quickly realized that her ability to create meaningful change in this space was limited, and she pivoted to creating novel markets within diagnostics, where she was able to have greater impact on patients’ quality of care and individualized journey.

Liz has spent the majority of her career in oncology and women’s health. She has focused on creating new markets, launching novel products, and building industry-disrupting companies from the ground up. Currently, she is Chairman of the Board, Co-Founder, President and CEO of her digital health start-up, Persona Health, Inc. and CEO and Board Director of an innovative women’s health, diagnostic start-up, Mammogen, Inc. Liz takes a novel approach to both product development and commercialization, always with an eye towards patient empowerment.

An entrepreneur at heart, she has found innovative ways to simultaneously add value to her co mpanies’ end-users, as well as her investors. Liz is fueled by the notion that there is a patient, someone’s loved one, at the end of every decision she makes.

About Mammogen

Mammogen is a female-led biotechnology company focused on meaningfully improving the detection, diagnosis and treatment of women’s health-related diseases, and creating an end-to-never-end community for women around the world. Mammogen is centered around its proprietary genTRU™ liquid biopsy platform. The company’s flagship genTRU breast™ program leverages novel messenger RNA (mRNA) technology to non-invasively detect and diagnosis breast cancer. The genTRU breast™ offering is positioned to unlock regular and reliable screening for millions of women around the world and eliminate many negative invasive biopsy procedures. The company’s proprietary multi-gene expression signature for breast cancer detection has been extensively validated in blood, as well as saliva, and has shown statistical significance towards providing measurable improvement upon current standards of care. Mammogen’s product pipeline consists of an array of non-invasive prognostics and diagnostics for additional diseases that affect some-, mostly-, or only-women. For more information visit www.mammogen.bio .

Medical Travel & Digital Health News (MTDHN): Tell us how you got interested in this incredibly important field.

Liz Cormier-May (LCM): I started as a medicinal chemist for Novartis Pharmaceuticals working in early discovery oncology. One of the programs that I worked on happened to be breast cancer.

I’ve always had a distinct passion for women’s health, particularly fighting breast cancer, as there is still so much work to be done in these areas.

Now, especially in a time when women are making the majority of household health decisions and handling the majority of the family’s finances, there’s no reason why a company shouldn’t put resources towards women’s health.

Women are far more likely to take a medical action, handle logistics and pay bills.

This is a unique time as we come out of the pandemic with shifting dynamics. All the stars are aligning and women are finding their voice, speaking up and demanding better healthcare. They want companies that are dedicated to improving their outcomes.

It’s just a really special point in time for Mammogen to be debuting with novel partners, novel products, and really focusing all of our attention on creating products that serve women.

MTDHN: Why is this a global message?

LCM: Very simply: It’s a global message because women are across the globe. Women make up half the world’s population meaning half of our world is not served in the manner they deserve to be served.

Though women’s health is underserved in the U.S., it’s grossly underserved in other parts of the world. There are still areas where women don’t even have access to healthcare and that has to change.

One of the things that makes Mammogen’s technology so exciting is that all our tests are liquid biopsy based, which means we are validating our easily administered tests on saliva, blood, and biofluids that are inexpensive to test and easy to ship around the world.

Imagine a time where women and other people around the world who may not have access to healthcare can order a saliva-based test to see if they have a breast cancer.

MTDHN: Tell us the role of diagnostics in this fast-emerging digital world.

LCM: Digital diagnostics are especially important and of interest in the women’s healthcare market.

The world is a busy place. We are 100% engaged with our mobile devices, and there is absolutely no reason why diagnostics can’t conform to this new era of digitalization, especially in a world where telehealth has taken an enormous jump over the last 18 months.

Diagnostics are exceedingly important. As hard as scientists in the medical community are working to eradicate cancer, I do not think that will happen in our lifetime. Our best bet is to get ahead of it and detect cancer in its earliest stages.

Early detection is important because:

It allows us to get information to women at a point where they can intervene in a more meaningful manner. For example, early detection of breast cancer will create the opportunity to preserve eggs or start family planning for millions of women who, all too often, do not have that opportunity today.
When women under 40 get breast cancer, they often don’t have time to even think about setting up an appointment with a reproductive endocrinologist — they just start treatment. A lot of this is because women under 40 are often diagnosed with more aggressive forms of the disease, so time is truly of the essence.

The earlier we can catch this disease, the more time and options we give our patients. That is what this is all about.

MTDHN: How does digitized care impact this space?

LCM: When we combine that early detection message with the digitalization of medicine, we can think about easier ways to accomplish these goals. Maybe individuals can order a test from their mobile device, get their results on their mobile device or get an app that integrates with their Apple Health device.

All these things are coming together in a way that allows healthcare to be a part of one’s everyday life, not a once-a-year trip to see a physician.

MTDHN: Tell us about the role of artificial intelligence (AI) and machine learning in this brave new world of diagnostics.

LCM: It’s very important — but there are limitations. It is not a magic fix to everything.

When used properly, AI and machine learning allow us to comb through millions of data points in a way that the human brain could never do. Data gives us a more comprehensive view of the system biology behind a certain disease state.

For example, at Mammogen, our technology platform is exclusively licensed through a company called Liquid Biosciences . Their technology is based upon artificial intelligence and machine learning, but what makes it incredibly unique is that it uses evolutionary computing.

This means that it incorporates millions of clinical datapoints, generates millions and millions of corresponding algorithms and puts them into an ecosystem where they evolve, just like humans have done. These algorithms mate, mutate and migrate. This process is like natural selection, but probably more appropriately natural de-selection. All of the algorithms and biomarkers that are not associated with highest accuracy—and sensitivity and specificity—they all wash out and you’re left with a minimal set of biomarkers that have maximum accuracy.

That is a really intense and highly technical process. It’s unique to IV Bioholdings, which is the bio innovation studio that Mammogen is a part of and Liquid Biosciences is associated with. By approaching large datasets in this fashion, we’re able to get a far more robust understanding of the biology behind whatever disease state it is we’re looking at. This capability is disease state agnostic, it does not have to be oncology. This platform has been applied to Alzheimer’s, autism, Parkinson’s and addiction behavior.

However, for our flagship program at Mammogen, it allowed us to mine publicly available datasets in an extremely accelerated manner. It allowed us to see things that other people have never seen because we’re getting such a far more robust understanding of the biology and that’s very important.

Then secondary to that—if you put on your commercial brain—it allows us to create a very valuable intellectual property moat around what we’re developing, because this process is repeated over and over again. So multiple generations of evolution, which give us multiple sets of biomarkers that we move forward into clinical stage validation.

That protects our intellectual property, it accelerates our clinical development timelines, and it allows us to get products to patients in a hyper efficient manner. Statistically, the average diagnostic company takes five to seven years and about $18 million to get to the point where they have a set of biomarkers that have been analytically validated.

Mammogen did it in 22 days for a tiny fraction of that.

MTDHN: Wow. What does that mean for the future of Mammogen?

LCM: It means we are hyper efficient in our R&D process which translates to extremely reduced costs in development, and reduced costs in commercialization.

We don’t need to charge $3,000 for our tests to make a profit as a company. We can make a very reasonably priced test that is accurate, safe, sensitive, specific and get it into the hands of our women in a fraction of the time as compared to other diagnostic companies.

MTDHN: Your name implies mammograms for breast cancer, but what other medical conditions do you focus on?

LCM: Breast cancer is our flagship program. Beyond that, we are beginning development for endometriosis and other areas within women’s healthcare that have an unmet clinical need.

For endometriosis, for example, there is no way to definitively diagnose it except through a very invasive biopsy. The average woman suffers for 17 years before she’s accurately diagnosed. There’s no reason for that.

What we’re developing is a very simple liquid biopsy test that a woman can take to tell her whether or not she has endometriosis.

I’m someone who suffered from endometriosis. Having my family and living with the symptoms was terribly difficult. I was misdiagnosed over and over again. All of the time, resources, money, unnecessary spending and the physical and mental anguish that comes with being undiagnosed with a painful disease was very difficult.

Mammogen is focusing on areas like early detection of breast cancer, endometriosis detection and other issues that are traditionally very difficult to diagnose. These liquid biopsy tests are going to be simple to administer and completely noninvasive.

MTDHN: How will people go about getting this test when it is available? How will payers be involved?

LCM: People will be able to visit their provider who can order the test.

With payers there is still a huge disconnect with diagnostic innovation and recognizing the value of said diagnostics. It can be difficult for diagnostic companies in the beginning to span that gap, which is why I think it is so important to consider non-traditional models that get valuable diagnostics into the hands of patients on an accelerated timeline.

Now, I want to be clear I am not saying that we will not do all of the clinical trials, and all of the scientific validation necessary to satisfy payers and physicians and publication needs.

What I am saying is I believe there are other ways to bring a product to market aside from the traditional go through the payer route, which we will do, but we are also actively exploring other safe meaningful ways to get this product into the hands of patients.

MTDHN: Are you working with any advocacy organizations?

LCM: A big part of what we are building at Mammogen is based around community.

I’m a big believer that community engagement fuels market adoption and market adoption fuels the community.

We are actively engaging with other companies that are also focusing on innovative ways to treat either breast cancer and or the lasting effects of breast cancer. We are connecting with creators of everything from exercise routines to a company called Brilliantly, that just launched a breast warmer that fits right into breast cancer survivors’ bras after reconstructive surgery.

We were featured on a podcast that the founder of Mammogen and I did with Matthew Zachary, who is a tremendous advocate for all things oncology. We’re spending a lot of time working with him and his company called OffScrip Media to engage with our community, patients, survivors and advocacy groups.

MTDHN: Are you connecting with women in underserved communities?

LCM: Yes, that is a huge part of our organization. There are underserved women under 40 who struggle to get mammograms, which are important because women under 40 have the fastest growing rates of incidence.

There are also underserved communities where access to healthcare is not available because of age, race or ethnic background.

We are spending quite a bit of time to make sure those communities are represented fully in our clinical stage validation work so that we can, if necessary, create a test that is specific to certain populations. Currently, however, our science has proven effective for all women, regardless of age, ethnicity, stage of disease or genetic predisposition.

These are all things that we’re thinking about every single day as we prepare to bring these early detection tests to market.

MTDHN: Can you tell the readers how the company is funded, what your plans are, the size of your organization, etc.?

LCM: We are privately held and we just closed our $2 million seed round . That $2 million gets us through the next 12 to 18 months.

Mammogen is part of a bio innovation studio called IV Bioholdings, founded by Marty Keiser. IV Bioholdings has just opened the first round of fundraising at the studio level, as a means to provide capital to the three child companies below it.

Our process is hyper efficient, not just at Mammogen but across the other companies within the innovation studio. With this efficiency, the bottleneck is not R&D like it is for the rest of the industry, the bottleneck can then become financing. This approach eliminates that issue for the 3 companies within IV BioHoldings by providing capital to reach specific inflection points, which, in turn, make traditional fundraising more successful.

Mammogen will be raising a Series A round as well, of which planning and outreach has already begun.

MTDHN: How do you differentiate yourself from some of the other companies that are focused on women’s health?

LCM: Mammogen is proud to be a women’s health company lead by women, which is something unique in the industry.

I can use my healthcare experiences as a woman to help others. Knowing what it feels like to have endometriosis, to struggle for years to get diagnosed, and then to have lived the entire journey through hysterectomy is an advantage.

Another differentiator is our technology. We are looking at RNA when most of the rest of the world is looking at DNA. That is exceedingly important because RNA—the language of cells—is the key to early detection.

When you can listen in on what the cells are doing, as they are healthy, living and thriving, and or adapting to the introduction of disease, then you get earlier information. When information comes from the tumor not the patient, as is the case in DNA, you can’t collect any of that information until the tumor cell is dying, which is why DNA technologies have been wonderful at later stager applications like patient stratification or targeted therapy, but struggle in screening or early detection. RNA, however, is being released by all healthy living cells, as well as disease cells within a patient’s body all day, every day. You get earlier, better and more information, which is a huge distinguisher. RNA allows us to learn about the biology of the patient, not just the tumor.

Finally, Mammogen’s engagement with the community is a competitive advantage. The first thing I did when I took this job was spend over 50 hours talking to breast cancer patients and survivors and their families to understand the patient population I’m serving.

Sitting with these patients and hearing their stories, identifying the gaps in care and crying as they talk about it, is not the same as market research.

MTDHN: What does your growth pattern look like?

LCM: We are pre-revenue. We are in clinical validation stages right now with our strategic lab partner, P4 Diagnostix. This collaboration extends from assay development through commercialization, and further preserves our hyper efficient model.

The goal is to have this test launched in 2023. That would be less than three years from the inception of the company, which is tremendously impressive.

IV BioHoldings Debuts Liquid Biopsy Portfolio; Partners with P4 Diagnostix to Scale Commercialization of Non-Invasive Lung, Liver and Breast Diagnostics

Eric@adsneeded.com (Eric Kristiansen) — Wed, 22 Sep 2021 15:16:33 GMT

Bio innovation studio behind liquid biopsy companies LiquidLung, HepGene, and Mammogen, comes out of stealth with eight clinical-ready diagnostics

Formed to make early detection, diagnosis and treatment of pulmonary, metabolic, and women's health diseases easier and more precise

Strikes P4 partnership to unlock market potential for non-invasive lung, liver and breast diagnostics positioned to positively impact 220 million Americans and over one billion globally

Newport Beach, Calif – September 22, 2021 – IV BioHoldings (IVBH) has announced today the public launch of its bio innovation studio, debuting with a portfolio of liquid biopsy companies, including LiquidLung, Inc., HepGene, Inc. and Mammogen, Inc. Collectively, the IVBH companies comprise eight clinical-ready diagnostics, spanning the care continuum for lung cancer, non-alcoholic fatty liver disease (NAFLD) and breast cancer, respectively.

IVBH has also announced today its partnership with P4 Diagnostix® (P4), a leader in diagnostic pathology, to fast-track commercial efforts of molecular diagnostic tests and meet clinical demand for earlier, easier and more precise detection, diagnosis and treatment of pulmonary, metabolic, and women's health disease. Offering best-in-class testing services and proprietary healthcare informatics, P4 will serve as the exclusive laboratory partner for all clinical assay development and clinical validation across the lung cancer, NAFLD and breast cancer programs for each of the IVBH companies.

“What we’re seeing out of the IVBH ecosystem is platform test development capabilities that are years ahead of traditional test development in the liquid biopsy space, representing an opportunity for P4 to get on the ground floor of this dynamic area of molecular medicine,” said Marcus Cognetti, Co-Founder of P4. “By partnering across the IVBH portfolio, we’re providing an industry-first opportunity to scale the speed and rate at which non-invasive diagnostics are made available to the millions of people for whom this testing is not available or are underserved by the existing standards of care. The novelty of the science, strength of the data, and competitive intellectual property built around these existing indications is quite astonishing, and is a testament to the efficiency of the IVBH business model and its progressive approach to R&D.”

IVBH was founded in 2018 by Marty Keiser, with the vision of dramatically reducing the time, cost and risk associated with healthcare innovation through unique applications of data analysis using advanced technology. Its business model was purpose-built to accelerate value creation of novel intellectual property by allowing each of its disease-specific companies to leverage shared resources and tap into strategic partnerships formed by the studio.

In just over two years since launching LiquidLung, the first home-grown property to emerge from the studio, and one month after announcing the closing of a $2M seed round at its women’s health startup, Mammogen, the studio has now emerged from stealth with its portfolio of intellectual property positioned to address unmet clinical needs for 220 million Americans and over one billion people globally.

IVBH partnered with Liquid Biosciences (LBS), whose Emerge bio-analytics platform has been radically reducing diagnostic and drug development time, cost and risk for a decade. IVBH and LBS collaborated on novel biomarker discovery and validation to develop the following liquid biopsy solutions:

LiquidLung, Inc. – Non-invasive early detection, confirmatory diagnosis, and histological typing and subtyping of lung cancer. In a study conducted in peripheral whole blood for lung cancer detection, the technology achieved 97% sensitivity, 85% specificity, including 100% detection of patients with stage I lung cancer, without the use of any demographics, clinical risk-factors, or radiological data.

HepGene, Inc. – Non-invasive early detection of NAFL, classification of NAFL versus non alcoholic steatohepatitis (NASH), and definitive diagnosis of NASH. HepGene’s technology was validated across a diverse range of tissue types and biofluids (including blood), achieving 92% sensitivity, 97% specificity for early detection of NAFL and 94% sensitivity, 86% specificity for definitive diagnosis of NASH. The company IP also includes a proprietary portfolio of promising novel therapeutic targets for the treatment of NASH, which emerged from robust in vivo analysis of diseased patients and is supported by strong proof-of-principle that establish and validate biological plausibility.

Mammogen, Inc. – Non-invasive early detection and confirmatory diagnosis of breast cancer. Mammogen’s core technology, validated across peripheral blood mononuclear cells as well as saliva, is initially geared towards women under 40 and women over 55, two populations of women who are underserved by existing screening guidelines and current standards of care for breast cancer. Optimizing for women under 40, Mammogen’s technology achieved 93% sensitivity, 97% specificity. Optimizing for women over 55, the technology achieved 97% sensitivity, 87% specificity. Results were achieved without the use of any demographics or clinical risk-factors.

The introduction to P4 was made by Elizabeth Cormier-May, CEO of Mammogen and commercialization expert within the inner echelons of the IVBH studio, who has had a longstanding working relationship with the molecular lab throughout the course of her near twenty-year career in diagnostics.

“P4’s repeated success in diagnostic commercialization, seven CLIA certified laboratories strategically located across the US, and its proprietary IT solutions enabling electronic health record (EHR) integration, ensures that our clinical and commercial phases of development will be consistent with the efficiency of our model, making them the ideal partner for IVBH,” stated Cormier-May.

“What normally takes the diagnostics industry at least six years to accomplish on a per product basis, we did for eight clinical-ready diagnostic products in just over two years,” said IVBH founder and CEO Marty Keiser. “There’s no question that accelerated R&D timelines, and the corresponding reduction in risk associated with over 200 novel scientific discoveries across the lung, liver and breast programs, were a direct result of IVBH’s powerful partnership model and intentional application of exponential technologies such as that of our partners at LBS. With the addition of P4, we’re able to progress from R&D to commercialization with a level of speed, efficiency and quality that all patients deserve.” IVBH is now scaling to support its flagship lung, liver and breast programs through clinical development and commercialization. Other plans on the horizon include a focus on pipeline expansion across pulmonary, metabolic and women’s health disease, and incubation of future company creations.

For more information on IV BioHoldings, visit www.ivbh.studio . To explore partnership opportunities, email info@ivbh.studio .

https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening,

https://www.the-nash-education-program.com,

https://www.statista.com/statistics/241488/population-of the-us-by-sex-and-age/

About IV BioHoldings

We are a bio innovation studio specializing in de novo company creation at the intersection of diagnostics and life sciences. We take a multi-disciplinary approach to building companies; cross-pollinating ideas and experience across a variety of industries, breaking down silos, upending the healthcare R&D process, and rethinking the startup model. We leverage powerful partnerships and advanced analytical science to provide greater insight into human biology in order to radically improve the detection, diagnosis and treatment of disease. The current IVBH ecosystem comprises three transformative bio startups, including LiquidLung, Inc., HepGene, Inc., and Mammogen, Inc., focused on pulmonary disease, metabolic disease, and women's health, respectively. For more information visit www.ivbh.studio .

About P4 Diagnostix®

P4 Diagnostix® is a network of several nationally recognized testing and diagnostic facilities integrated into one unified lab services organization, offering clients unparalleled access to connectivity, healthcare resources and consultative partnerships. P4 is made up of these industry-leading companies: Theranostix, Long Island Pathology, Platinum Pathology, Metamark Laboratories and P4 Clinical. P4's progressive integration of diagnostic testing and office workflow is rooted in partnership with VitalAxis, an industry leader in the delivery of healthcare informatics. For more information visit www.p4dx.com .

About Liquid Biosciences

Liquid Biosciences radically reduces diagnostic and drug development risk, time, and cost, from pre clinical research through regulatory approval. Our Emerge bio-analytics platform agnostically discovers and models the nonlinear dynamics of how biology, behavior, and circumstances interact to drive patient outcomes. Our mathematical evolution technology goes beyond artificial intelligence's capabilities, and has produced superior accuracy, novel insights, and explainability in every head-to-head comparison with other analytic methods. Liquid Biosciences' clients are major biopharma firms, diagnostic companies, and world-class research institutions. We've completed over 180 major analytic projects across 45 diseases, using the full spectrum of clinical trial, real-world, and multi-omics biomarker data. For more information about Liquid Biosciences, visit www.liquidbiosciences.com .

Unconventional Candidate For a Lung Cancer Hero

Eric@adsneeded.com (Eric Kristiansen) — Sat, 31 Jul 2021 19:08:07 GMT

"Although there is no shortage of problems to be solved across the health landscape, Marty made his bio debut by tackling one of the biggest addressable markets in oncology: lung cancer."

In 2018, at the height of his Wall Street career, at the age of 32, and with a wife and two young daughters to support, Marty Keiser made a life-changing decision to walk away from everything and go all in on what he believed to be the early innings of a bio revolution.

Marty believed that the next wave of medical innovation would derive from creative entrepreneurs who seamlessly integrate data, technology and capital; inject data and technology into the research and development process; rely on people and money to accelerate growth; and identify strategic partners to fast-track the commercialization of biomedical solutions.

Although there is no shortage of problems to be solved across the health landscape, Marty made his bio debut by tackling one of the biggest addressable markets in oncology: lung cancer.

LiquidLung, a startup launched in December 2018, is focused on radically improving the detection, diagnosis and treatment of lung cancer, and it is far from your average biotech startup. The company is entirely virtual — no lab, no overhead. What it does have, however, is a comprehensive portfolio of science required for the detection, diagnosis and treatment of lung cancer such as the industry has never seen.

Whereas academia and industry are heavily focused on circulating tumor DNA and cell free DNA, under Marty’s leadership as founder and president, LiquidLung’s focus is on the underlying biology of the patient, not the tumor. A combination of gene expression analysis and evolutionary computing methods is the key differentiator for the company.

What began with four novel biomarkers required to diagnose a prevalent subtype of non-small cell lung cancer is now a validated portfolio of 128 novel RNA gene expression biomarkers across six diagnostic categories (lung cancer detection, small cell lung cancer classification, non-small cell lung cancer classification, and classification of the three most prevalent histological subtypes of non-small cell lung cancer).

All markers have been prospectively validated across two independent cohorts with impressive accuracy. LiquidLung’s 23 mRNA lung cancer detection markers, for example, validated in a prospective validation study with 97% sensitivity and 79% specificity (out of sample). More importantly, when the lung cancer detection model was applied to the validation dataset, they prospectively detected 100% of stage 1 lung cancers, 89% of stage 2 cancers, 100% of stage 3 cancers, and 100% of stage 4 cancers — positioning the company to lead in the coveted (and currently untapped) early detection market.

Further, by mathematically optimizing their lung cancer detection model biased toward specificity, they demonstrated a positive predictive value of 100% and a negative predictive value of 98.9% (based on an assumed lung cancer prevalence of 3% in a high-risk population of patients). Interestingly, the new model was optimized purely from mathematics alone and did not require the discovery of any new biomarkers. This is another differentiator and example of the unique approach taken by the company.

If that weren’t enough, Marty has great expectations for the 105 type/subtype biomarkers in inventory and believes that these markers not only have the potential to further enhance the sensitivity and specificity profile of their lung cancer detection test, but that they may also unlock new product opportunities for downstream testing and procedures (definitive diagnosis, staging, therapy selection, treatment response and drug development).

Almost more impressive than the science is the fact that LiquidLung completed all biomarker discovery and research and development validation studies in less than six months on a very modest sum of seed capital. Marty’s hope, fueled by a deep and genuine love for people, is that the speed and efficiency related to their business model and research and development process will pass down to patients in the form of effective and affordable bio solutions that are easily accessible to people all around the globe.

Marty is an unconventional candidate for this award. He doesn’t have any of the degrees or industry accolades that most of the candidates will likely have. But through creative vision, resourcefulness and a willingness to take risks and embrace new technologies, Marty has made an incomprehensible contribution toward solving a major unmet medical need that has the potential to save many lives, reduce risks and generate significant economic value for patients with lung cancer, payers and all of his stakeholders.

I hereby nominate Marty Keiser for a Lung Cancer Heroes® award.

Our Founder, Marty Keiser, and our CEO, Elizabeth Cormier-May, were guests on Matthew Zachary’s OffScrip Media podcast, Out of Patients.

Eric@adsneeded.com (Eric Kristiansen) — Tue, 27 Jul 2021 15:57:57 GMT

Listen to Marty and Liz offer their thoughts and commercial insights into the diagnostics market! Approaching traditional hurdles with innovative solutions is the ONLY way to move the needle forward for our patients!

Women's Health Startup Mammogen, Inc. Announces Oversubscribed Seed Round and the Debut of genTRU™ Liquid Biopsy Platform

Eric@adsneeded.com (Eric Kristiansen) — Thu, 01 Jul 2021 15:46:55 GMT

ALISO VIEJO, Calif., Feb. 4, 2021 /PRNewswire/ -- Mammogen, Inc. , a women's health startup born at the intersection of data, technology and science, and Bench International, a leading global executive search firm, jointly announce the appointment of Elizabeth Cormier-May as Chief Executive Officer and member of the board of directors of Mammogen. She will begin her new role on March 1st, 2021.

In her new role, Cormier-May will lead efforts to develop, validate and commercialize the company's flagship liquid biopsy program for breast cancer, while working to position Mammogen as a global leader in women's health. The company has developed a proprietary methodology for early cancer detection using novel messenger RNA (mRNA) biomarkers, which has shown statistical significance towards providing measurable improvement upon current standards of care.

"When women think of their physical, mental and emotional health, I want Mammogen to be the first, second, and third thing that comes to mind," said Ms. Cormier-May. "Mammogen is working to detect earlier, diagnose easier, treat better, and to support all women throughout the life-long battle that comes with survivorship. Providing end-to-end care is good, but we think an end-to-never-end community is better."

"Providing end-to-end care is good, but we think an end-to-never-end community is better."

Mammogen's core technology is a non-invasive screening solution intended for all women, but particularly for the under-40 population who aren't eligible for annual mammography and the 55+ population who are only recommended for mammography every other year. "Mammogen's technology will provide regular and reliable screening and diagnostic tools for tens of millions of women who are grossly underserved by current standards of care," said the incoming CEO. "I am extremely excited to build off of Mammogen's strong scientific foundation and speed this innovation to market, so that we can get more women screened earlier and arm clinicians with actionable insights about their patients."

Ms. Cormier-May brings vast experience within medicinal chemistry, genetics, and both companion and molecular diagnostics while working with companies including Novartis Pharmaceuticals, Myriad Genetics, Qiagen, and Predictive Biosciences. Elizabeth built her career launching and selling diagnostic tests into the women's health, oncology and urology markets. During her tenure as Head of Commercial Operations at Exosome Dx (acquired by Bio-Techne), Elizabeth was responsible for building the infrastructure and defining the launch of the company's flagship diagnostic, ExoDx Prostate(IntelliScore).

"I am humbled by the fact that of all the opportunities in this space, Elizabeth chose Mammogen," stated company Founder and Chairman, Marty Keiser. "Denise (DeeDee) DeMan, the founder and CEO of Bench International, immediately connected with my passion for improving women's health and my vision to build Mammogen as a women-led organization. DeeDee not only brought us a top CEO, but she has also joined our board of directors, bringing extensive experience and connections in the life science community that will continue to add value at every stage of growth for Mammogen."

Mammogen is one of three joint venture companies established between IV BioHoldings (IVBH), a bio innovation studio founded by Keiser, and leading healthcare analytics provider, Liquid Biosciences. "When Marty first told me of his plans to apply his unique approach to venture creation to women's health, including finding ways to offer underserved women access to innovative technologies, it was obvious that people would be one of his greatest assets," said Ms. DeMan. "When you combine Elizabeth's experience in liquid biopsies and early-stage diagnostics, her track record in unlocking value for patients, payers and stakeholders, and her courageous and ambitious spirit, there is no question that we found the perfect person to build Mammogen into an industry leader in women's health."

About Mammogen

Mammogen is a female-led biotechnology company focused on meaningfully improving the detection, diagnosis and treatment of women's health-related diseases, and creating an end-to-never-end community for women around the world. Mammogen's flagship product is a liquid biopsy test that measures novel circulating messenger RNA (mRNA) biomarkers required for the non-invasive detection and diagnosis of breast cancer. The non-invasive test is positioned to unlock regular and reliable screening for millions of women around the world and eliminate many unnecessary biopsy procedures. The company's proprietary multi-gene expression signature for breast cancer detection has been extensively validated in blood, as well as saliva, and has shown statistical significance towards providing measurable improvement upon current standards of care. Mammogen's product pipeline consists of an array of non-invasive prognostics and diagnostics for breast cancer, ovarian cancer, endometriosis and other diseases that affect some-, mostly-, or only-women. For more information visit www.mammogen.bio.

About Bench International

Bench International is the oldest woman-founded executive search firm serving the Life Science and Healthcare sectors. The firm is also one of the most renowned experts in diversity recruitment at the board and executive level, as well as in R&D leadership. Bench's scorecard reflects over $150 billion in successful client exits, a 98% project completion record, with a 75% retention for five or more years. 33% of all leaders placed in Bench's 45+ year history have been gender and ethnically diverse. With headquarters in San Diego, California, and satellite offices in Los Angeles, New York, Boston, the United Kingdom and Switzerland, Bench is One Global Team, No Borders, No Boundaries and One Global Budget, thus mitigating internally competitive offices. For more information visit www.benchinternational.com.

About IV BioHoldings

IV BioHoldings (IVBH) is an innovation studio that specializes in de novo company creation exclusively within life sciences. The IVBH studio takes a multi-disciplinary approach to building companies; cross-pollinating ideas and experience across a variety of industries, breaking down silos, upending the healthcare R&D process, and rethinking the startup model. The studio uses advanced analytical science to provide greater insight into human biology and radically improve the detection, diagnosis, and treatment of disease. The current IVBH ecosystem comprises three transformative bio startups, including LiquidLung, HepGene and Mammogen, focused on pulmonary disease, metabolic disease, and women's health, respectively. For more information visit www.ivbh.studio.

About Liquid Biosciences

Liquid Biosciences (LBS) radically reduces diagnostic and drug development risk, time, and cost, from pre-clinical research through regulatory approval. LBS' Emerge bio-analytics platform agnostically discovers and models the nonlinear dynamics of how biology, behavior, and circumstances interact to drive patient outcomes. Our mathematical evolution technology goes beyond artificial intelligence's capabilities, and has produced superior accuracy, novel insights, and explainability in every head-to-head comparison with other analytic methods. Liquid Biosciences' clients are major biopharma firms, diagnostic companies, and world-class research institutions. We've completed over 165 major analytic projects across 44 diseases, using the full spectrum of clinical trial, real-world, and multi-omics biomarker data. For more information about Liquid Biosciences visit www.liquidbiosciences.com.

CONTACT: info@mammogen.bio

Leveling up in the biotech industry with Elizabeth Cormier-May

Eric@adsneeded.com (Eric Kristiansen) — Thu, 24 Jun 2021 16:03:26 GMT

Liz’s unique approach to diagnostics and what has driven her success in the industry.

The origin of Liz’s entrepreneurial journey and what led her to where she is now.

Discussion on the use of vision boards for personal development and innovation.

Taking the risks with Marty Keiser

Eric@adsneeded.com (Eric Kristiansen) — Thu, 03 Jun 2021 23:44:38 GMT

"Knowing the ups and downs of business and the risks that are involved, I'm always fascinated by people who take huge risks because I know it is NOT for the weak! Today I'm talking with Marty Keiser about uprooting his family, leaving a steady job, and moving across the country to become an entrepreneur and chase his dreams. Here's hoping that this inspires you to take more risks, adjust from a short-term to long-term mindset, and really lean into your faith through the process."

Brilliantly.co IG Live with Mammogen.bio

Eric@adsneeded.com (Eric Kristiansen) — Wed, 02 Jun 2021 16:16:44 GMT

Mammogen is a woman-led biotechnology company and we're using data, tech, science and personal experience to shatter complacency.

Founder, Marty Keiser, and CEO, Liz Cormier-May, share their plans to create an end-to-never-end community for women with breast cancer.

International Life Sciences Awards 2021

Eric@adsneeded.com (Eric Kristiansen) — Thu, 13 May 2021 00:03:53 GMT

Best Breast Cancer Detection Technology Company – USA

Mammogen is the third of three companies operating under the umbrella of a bio innovation studio called IVBioHoldings. Mammogen is a company incubated with a simple mission that has not and will never waiver: to meaningfully improve every aspect of the women’s health market, and to do so by building a company with an overwhelming presence of women at every level.

Biomarkers: Where Are All the Patents At?

Eric@adsneeded.com (Eric Kristiansen) — Fri, 12 Feb 2021 00:46:37 GMT

"On the show today, Bio Entrepreneur Marty Keiser, Founder of IV BioHoldings, LiquidLung, HepGene, and Mammogen. What is a biomarker? Hint - it's not inside a box of Crayola. Biomarkers are aspects of our genes that do so much more than determine our height, eye color, and predisposition to cancer. Diagnostics today can be used to detect earlier, diagnose easier, and treat better. That's what Marty and his entrepreneurial ventures are all about. It's not just making cancer suck less; it's using pioneering diagnostics to make radiation and chemo not just suck less, but perhaps not even be needed at all. Enjoy the show."

Veteran Biotechnology Executive Elizabeth Cormier-May Recruited to Lead Women's Health Startup Mammogen Inc.

Eric@adsneeded.com (Eric Kristiansen) — Thu, 04 Feb 2021 15:54:22 GMT

ALISO VIEJO, Calif., Feb. 4, 2021 /PRNewswire/ -- Mammogen, Inc. , a women's health startup born at the intersection of data, technology and science, and Bench International, a leading global executive search firm, jointly announce the appointment of Elizabeth Cormier-May as Chief Executive Officer and member of the board of directors of Mammogen. She will begin her new role on March 1st, 2021.

About Mammogen

About Bench International

About IV BioHoldings

About Liquid Biosciences

CONTACT: info@mammogen.bio

SOURCE Mammogen

www-ivbh-9-23-test

Mammogen Taps Life Sciences Leadership Architect, Denise "DeeDee" DeMan, as Chairwoman of the Board of Directors

Mammogen to Showcase New Data at SABCS 2023 Demonstrating Clinical Efficacy of Its genTRU-breast™ qPCR Blood Test in Early-Stage Breast Cancer

272 | "Changing Lives Through Early Disease Detection" with Marty Keiser from IVBH Studio

272 | "Changing Lives Through Early Disease Detection" with Marty Keiser from IVBH Studio

Mammogen Achieves CLIA Validation of gen-TRU-breast™ Assay

IVBH Presents Groundbreaking Data for Early Lung Cancer Detection at the ASCO® 2023 Annual Meeting

AI Can Now Scale Humans

Building Accomplishment as an Entrepreneur: The Importance of Your Team with Marty Keiser

IVBH Debuts Real Early Detection "R.E.D." Campaign at 41st Annual JP Morgan Healthcare Conference

Safe & Green Holdings Corp. Taps Global Life Sciences & Diagnostics Executive, Elizabeth Cormier-May, to Join Company Board of Directors

Lung Cancer Screening Dramatically Increases Long-Term Survival Rate

Early screening for lung cancer saves live s

Other lung cancer screening options

Grail’s Galleri test for lung cancer ﻿

More clinical trials for lung cancer liquid biopsies

IVBH’s Strategic Partnership with Sonrai Analytics to Advance Novel Early Detection Precision Diagnostics

About IV BioHoldings (IVBH)

About Sonrai Analytics

Being a Servant and Imagineer in BioTech – with Marty Keiser

A Very Special Episode of Family Ties

Marty Keiser, Founder & CEO of IV BioHoldings

S.E.E. Summit to Showcase Game-Changing Potential of Liquid Biopsy in Early Cancer Detection

About Teen Cancer America

Marty Keiser, Founder-CEO, IV BioHoldings (IVBH)

IV BIOHOLDINGS, FIRST-IN-CATEGORY BIO-PLATFORM TO RADICALLY IMPROVE THE DETECTION, DIAGNOSIS, AND TREATMENT OF DISEASE

MORE ABOUT MARTY KEISER

ENTREPRENEURIAL JOURNEY

FUTURE & CAREER

INDUSTRIAL AND ORGANIZATIONAL ETHOS

ROLE AS A LEADER

ADVICE TO READERS

Conceive, Create and Develop with Marty Keiser Founder and CEO of IV BioHoldings S4|Ep2

IVBH- Redefining the HealthCare We Have Known

IVBH is Distinguished By Its Life-Saving Techniques

Viewing Challenges From The Lens Of Opportunities

Meet Marty Keiser

Mammogen Inc. CEO Elizabeth Cormier-May Wins Illustrious Award with Business Worldwide Magazine

About Business Worldwide Magazine

Mammogen and Brilliantly Continue their Commitment to the Breast Cancer Community with Brilliantly Warm Giveaway

About Brilliantly

About Mammogen

LiquidLung Receives Notice of Allowance from U.S. Patent and Trademark Office, Unveils Novel RNA Technology for Non-Invasive Lung Cancer Detection

“The USPTO decision is a significant milestone for LiquidLung and further establishes IVBH’s position as a leader in the rapidly accelerating RNA revolution”

About LiquidLung

About IV BioHoldings

Mammogen Touts Growing List of 2021 Awards and Recognitions for its Work in Women’s Health and Breast Cancer Diagnostics

ALISO VIEJO, Calif.--( BUSINESS WIRE )--Mammogen, a female-led women’s health company, today has announced a list of 2021 awards and recognitions for its work in women’s health and, more specifically, breast cancer.

About Mammogen

About P4 Diagnostix®

About Brilliantly

Mammogen and Brilliantly Combine Forces to Advance Community Efforts for Breast Cancer Previvors and Survivors

Female-led women’s health companies announce comprehensive partnership designed to empower breast cancer community

About Mammogen

About Brilliantly

How Liquid Biopsy Holds Promise for Early Detection of Breast Cancer with Marty Keiser & Liz Cormier-May, Mammogen, Inc.

SPOTLIGHT INTERVIEW: LIZ CORMIER-MAY, CEO, MAMMOGEN, INC.

About Elizabeth Cormier-May

About Mammogen

IV BioHoldings Debuts Liquid Biopsy Portfolio; Partners with P4 Diagnostix to Scale Commercialization of Non-Invasive Lung, Liver and Breast Diagnostics

About IV BioHoldings

About P4 Diagnostix®

About Liquid Biosciences

Unconventional Candidate For a Lung Cancer Hero

Our Founder, Marty Keiser, and our CEO, Elizabeth Cormier-May, were guests on Matthew Zachary’s OffScrip Media podcast, Out of Patients.

Women's Health Startup Mammogen, Inc. Announces Oversubscribed Seed Round and the Debut of genTRU™ Liquid Biopsy Platform

Leveling up in the biotech industry with Elizabeth Cormier-May

Taking the risks with Marty Keiser

Brilliantly.co IG Live with Mammogen.bio

Mammogen is a woman-led biotechnology company and we're using data, tech, science and personal experience to shatter complacency. Founder, Marty Keiser, and CEO, Liz Cormier-May, share their plans to create an end-to-never-end community for women with breast cancer.

International Life Sciences Awards 2021

Best Breast Cancer Detection Technology Company – USA

Biomarkers: Where Are All the Patents At?

Veteran Biotechnology Executive Elizabeth Cormier-May Recruited to Lead Women's Health Startup Mammogen Inc.

Grail’s Galleri test for lung cancer

Mammogen is a woman-led biotechnology company and we're using data, tech, science and personal experience to shatter complacency.

Founder, Marty Keiser, and CEO, Liz Cormier-May, share their plans to create an end-to-never-end community for women with breast cancer.