Endometriosis Affects Approximately 190
Million Women Worldwide
Non-invasive MET™ Diagnostic Test for
Endometriosis Leverages Novel Biomarker: A Specific Deletion
in Mitochondrial DNA
Pearsanta’s MET is Seeking to Become the
First and Only Validated and Commercialized Blood-based
Biomarker Test for Endometriosis
Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), an
innovation platform dedicated to accelerating promising health
innovations, today announced that its majority-owned subsidiary,
Pearsanta, Inc. (“Pearsanta”), has entered into a Market
Development Collaboration Agreement (the “Agreement”) with women’s
health pioneer Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM)
focused on Pearsanta’s blood-based diagnostic test for
endometriosis.
Endometriosis is a chronic disease associated with severe,
life-impacting pain. It affects approximately one in ten women of
reproductive age around the world – approximately 190 million women
and girls - according to the World Health Organization.1
Pearsanta’s Mitomic® Endometriosis Test (“MET™”) looks for a
specific deletion in mitochondrial DNA (“mtDNA”), which is a novel,
proprietary biomarker for endometriosis. There are currently no
validated blood-based tests for endometriosis available in the
United States or anywhere around the world.
Under the Agreement, Evofem and Pearsanta will collaboratively
develop a comprehensive go-to-market strategy and MET commercial
plan ahead of the planned U.S. launch in mid-2025. To date, over
300 endometriosis cases have been evaluated using the MET; 600 are
planned to support its clinical validation.
This collaboration supports Evofem’s strategy to expand its
commercial offering of innovative products that address key
challenges in women’s health. The company currently commercializes
a single-dose oral treatment for bacterial vaginosis and
trichomoniasis and a hormone-free contraceptive vaginal gel. Its
long-term goal is to deliver comprehensive healthcare solutions
spanning prevention, diagnosis and treatment of sexual and
reproductive health concerns facing women at every stage of
life.
“We believe that Evofem's proven expertise and strategic focus
on women’s health make them the ideal partner for the U.S. launch
of our Mitomic Endometriosis Test. Their deep industry knowledge
and established relationships will be invaluable as we introduce
this innovative diagnostic to the market and pave the way for
future applications of our mitochondrial DNA platform,” said
Christopher Mitton, President of Pearsanta.
Endometriosis has a profound impact on women's health, with
significant implications beyond painful symptoms. Studies indicate
that approximately 70% of women with endometriosis experience
chronic pelvic pain, which can be debilitating and affect daily
functioning. Moreover, nearly 50% of women with endometriosis also
face challenges with infertility, as the condition is a leading
cause of female infertility. Additionally, endometriosis is
associated with a higher risk of comorbid conditions such as
irritable bowel syndrome (IBS) and interstitial cystitis,
complicating overall health management. The condition can lead to
substantial psychological stress, with many women reporting
anxiety, depression, and a reduced quality of life due to
persistent pain and infertility issues.
Early diagnosis of endometriosis is important to allow medical
or surgical intervention to alleviate its symptoms and potentially
slow or halt the natural progression of the disease. At present,
there are no validated blood-based diagnostic tests for
endometriosis1. Pearsanta aims to address this unmet need with its
MET.
Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, said,
“This partnership showcases the Aditxt platform in action,
accelerating growth and transforming high-impact innovations into
reality. By seeking to advance Pearsanta toward the
commercialization of its Mitomic Endometriosis Test in 2025, while
simultaneously supporting Evofem’s goals to expand its portfolio
and diversify revenue streams through its existing infrastructure,
we demonstrate how our platform seeks to drive progress for both
current and incoming subsidiaries. We at Aditxt are proud to
empower innovation and strive to help companies deliver
transformative healthcare solutions to the market.”
“Knowledge is power and using Pearsanta’s Mitomic Endometriosis
Test physicians will be able to diagnose and improve the lives of
women who suffer from this debilitating chronic disease,” said
Saundra Pelletier, CEO of Evofem Biosciences. “We look forward to
leveraging our strong relationships with OB/GYNs and allied
healthcare providers to plan and execute the successful U.S. launch
of this first-in-class non-invasive diagnostic.”
Beyond the MET, this collaboration has the potential to further
expand Evofem’s women’s health business with future tests developed
by Pearsanta, such as the Mitomic Ovarian Test for early detection
of ovarian cancer.
About the Mitomic Technology Platform
Pearsanta’s proprietary Mitomic® Technology Platform harnesses
the unique properties of mitochondrial DNA (“mtDNA”) to detect
disease through non-invasive, blood-based liquid biopsies. This
platform is designed to identify specific mutations in mtDNA
indicative of various diseases. Due to its high mutation rate and
continued persistence in cells, mtDNA has the potential to be an
excellent biomarker for early disease detection. The program
currently focuses on developing tests for early cancer detection
(ovarian, prostate, and lung cancers), as well as non-cancerous
conditions like endometriosis.
About Pearsanta, Inc.
Pearsanta is at the forefront of precision health, focusing on
early cancer detection through advanced diagnostic technologies.
Its proprietary Mitomic Technology Platform leverages the unique
properties of mitochondrial DNA to detect cancer and other diseases
with high accuracy via non-invasive, blood-based liquid biopsy
tests. Pearsanta's asset portfolio also includes a range of other
innovative diagnostic technologies, all aimed at transforming early
disease detection and monitoring, enabling more informed treatment
decisions, and ultimately improving patient outcomes.
Mitomic® is a registered trademark and MET™ is a trademark of
Pearsanta, Inc.
About Evofem Biosciences, Inc.
Evofem is commercializing innovative products to address unmet
needs in women's sexual and reproductive health. The Company's
first FDA-approved product, Phexxi® (lactic acid, citric acid and
potassium bitartrate), is a hormone-free, on-demand prescription
contraceptive vaginal gel. It comes in a box of 12 pre-filled
applicators and is applied 0-60 minutes before each act of sex.
In July 2024 Evofem broadened its commercial offering with the
acquisition of SOLOSEC® (secnidazole) 2g oral granules, an
FDA-approved oral antibiotic for the treatment of two sexual health
diseases: bacterial vaginosis (BV), a common vaginal infection, in
females 12 years of age and older, and trichomoniasis, a common
sexually transmitted infection (STI), in people 12 years of age and
older. SOLOSEC provides a complete course of therapy in just one
dose.
Follow us on:
LinkedIn: https://www.linkedin.com/company/evofem Facebook:
http://www.facebook.com/Evofem X (f/k/a Twitter):
https://x.com/Evofem
Phexxi® and SOLOSEC® are registered trademarks of Evofem
Biosciences, Inc.
About Aditxt, Inc.
Aditxt, Inc.® is an innovation platform dedicated to
accelerating promising health innovations. Aditxt’s ecosystem of
research institutions, industry partners, and shareholders
collaboratively drives their mission to "Make Promising Innovations
Possible Together." The innovation platform is the cornerstone of
Aditxt’s strategy, where multiple disciplines drive disruptive
growth and address significant societal challenges. Aditxt operates
a unique model that democratizes innovation, ensures every
stakeholder’s voice is heard and valued, and empowers collective
progress.
Aditxt currently operates two programs focused on immune health
and precision health. The Company plans to introduce two additional
programs dedicated to public health and women’s health. For these,
Aditxt has entered into an Arrangement Agreement with Appili
Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which
focuses on infectious diseases, and a Merger Agreement with Evofem.
Each program will be designed to function autonomously while
collectively advancing Aditxt’s mission of discovering, developing,
and deploying innovative health solutions to tackle some of the
most urgent health challenges. The closing of each of the
transactions with Appili and Evofem is subject to several
conditions, including but not limited to approval of the
transactions by the respective target shareholders and Aditxt
raising sufficient capital to fund its obligations at closing. No
assurance can be provided that all of the conditions to closing
will be obtained or satisfied or that either of the transactions
will ultimately close.
For more information, www.aditxt.com.
Follow us on: LinkedIn: https://www.linkedin.com/company/aditxt
Facebook: https://www.facebook.com/aditxtplatform/
Sources
1World Health Organization fact sheet: Endometriosis. 24 March
2023.
https://www.who.int/news-room/fact-sheets/detail/endometriosis.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements” within the meaning of federal
securities laws. Forward-looking statements include statements
regarding the Company’s intentions, beliefs, projections, outlook,
analyses, or current expectations concerning, among other things,
the Company’s ongoing and planned product and business development;
the Company’s ability to finance and execute its strategic M&A
initiatives; the Company’s ability to obtain the necessary funding
and partner to commence clinical trials; the Company’s intellectual
property position; the Company’s ability to develop commercial
functions; expectations regarding product launch and revenue; the
Company’s results of operations, cash needs, spending, financial
condition, liquidity, prospects, growth, and strategies; the
Company’s ability to raise additional capital; the industry in
which the Company operates; and the trends that may affect the
industry or the Company. Forward-looking statements are not
guarantees of future performance, and actual results may differ
materially from those indicated by these forward-looking statements
as a result of various important factors, as well as market and
other conditions and those risks more fully discussed in the
section titled “Risk Factors” in Aditxt’s most recent Annual Report
on Form 10-K, as well as discussions of potential risks,
uncertainties, and other important factors in the Company’s other
filings with the Securities and Exchange Commission. All such
statements speak only as of the date made, and the Company
undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240920482981/en/
Aditxt, Inc. Mary O’Brien Mobrien@aditxt.com
516-753-9933
Aditxt (NASDAQ:ADTX)
Historical Stock Chart
From Nov 2024 to Dec 2024
Aditxt (NASDAQ:ADTX)
Historical Stock Chart
From Dec 2023 to Dec 2024