Leadership transition comes as Company focuses
on clinical evaluation of its novel Ovarian Rebalancing™
technology, a one-time transvaginal ablation procedure designed to
restore ovulation in women with PCOS, a leading cause of
infertility
PARIS, March 10,
2025 /PRNewswire/ -- May Health, a Paris- and California-based, clinical-stage medical
device company dedicated to the development of a new treatment for
Polycystic Ovary Syndrome (PCOS), today announced that Colby Holtshouse has joined the Company as
President and CEO. Colby brings a wealth of senior leadership and
women's health expertise to the organization, having held executive
positions with Organon (NYSE: OGN), Alydia Health, and
Pelvalon.
"I am delighted to have Colby join and lead the company as we
look to complete the REBALANCE study, a landmark investigational
device exemption (IDE) clinical trial which is being conducted to
support marketing authorization for our Ovarian Rebalancing
procedure so that we can bring it to millions of women who
experience PCOS-related infertility," commented Dr. Robert Auerbach, May Health Chairman. "Colby has
deep experience bringing groundbreaking technologies to market,
making her the ideal fit to spearhead May Health as we continue to
validate the technology and drive towards commercialization."
"May Health is pioneering a first-of-its-kind treatment for
PCOS, a condition that affects 10% of women and presents serious
health challenges, including infertility," stated Antoine Papiernik, Chairman and Managing Partner
at Sofinnova Partners and the former Chairman of May Health. "We
are excited to welcome Colby to guide the company in bringing this
therapy to women around the world."
May Health's proprietary technology, Ovarian Rebalancing, is an
investigational treatment designed to restore ovulation in patients
with PCOS who are resistant to oral ovulation induction medication.
The ultrasound-guided, transvaginal procedure utilizes radio
frequency (RF) energy to ablate excess androgen-producing ovarian
tissue in order to establish regular ovulatory menstrual cycles.
The goal of this one-time, in-office procedure is to allow for
same-day recovery and return to normal activities with minimal
patient discomfort and downtime. May Health previously completed
clinical feasibility studies in Europe and the U.S. and is actively enrolling
for its IDE clinical study in the United
States.
"I am thrilled to join May Health at this important time.
Following the strong clinical feasibility results, we are
encouraged that the REBALANCE study will provide the evidence
necessary for U.S. FDA marketing authorization and for broad
adoption by physicians and patients seeking options for
PCOS-related infertility," Colby shared. "I look forward to
working with the May Health team to deliver the Ovarian Rebalancing
procedure to women suffering from PCOS-related infertility."
About Polycystic ovary syndrome (PCOS)
Polycystic ovary syndrome (PCOS) is a common endocrine condition
where the ovaries produce abnormal levels of androgens, which are
male sex hormones that are usually present in women in lesser
amounts. In many cases, those with PCOS are unable to ovulate and
become pregnant. PCOS is one of the most common causes of female
infertility, affecting roughly 10% of reproductive-aged women.
Other common, persistent symptoms of PCOS include irregular
menstruation, acne, thinning scalp, excess hair growth on the face
and body, high blood pressure, and sleep apnea. PCOS is a lifelong
challenge that can significantly increase a patient's risk for Type
2 diabetes, heart disease, and stroke. The condition is also
associated with an increased risk of pregnancy complications.
About May Health
May Health is a Paris- and
California-based clinical-stage
medical device company developing novel treatments for women with
Polycystic Ovary Syndrome (PCOS). The company is currently
investigating its Ovarian Rebalancing™ technology as a
treatment for PCOS-related infertility in the REBALANCE clinical
study. The FDA-approved IDE study is being conducted to support
marketing authorization. The May Health Ovarian Rebalancing
procedure is a novel approach to PCOS-related infertility issues
and is intended to induce ovulation in patients resistant to oral
medical therapy. May Health is led by a team of serial medtech and
women's health entrepreneurs and executives with extensive
experience in product development, therapy validation, and
commercial launch. In 2024, the Company completed a $25M Series B raise co-led by Trill Impact and
BPI France to complement the earlier €10M in a Series A led by
Sofinnova Partners. May Health, formerly known as Ziva
Medical and Ablacare was founded in 2012 by serial medical device
innovators Neil Barman, Andy Wu and Garrett
Schwab, and then acquired in 2017 by Sofinnova's medtech
acceleration team, Sofinnova MD Start. May Health is
headquartered in Paris, France,
with its US team based in Menlo Park,
CA. For more information, visit www.mayhealth.com.
About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm in
life sciences, specializing in healthcare and sustainability. Based
in Paris, London and Milan, the firm brings together a team of
professionals from all over the world with strong scientific,
medical and business expertise. Sofinnova Partners is a hands-on
company builder across the entire value chain of life sciences
investments, from seed to later-stage. The firm actively partners
with ambitious entrepreneurs as a lead or cornerstone investor to
develop transformative innovations that have the potential to
positively impact our collective future. Founded in 1972, Sofinnova
Partners is a deeply established venture capital firm in
Europe, with 50 years of
experience backing over 500 companies and creating market leaders
around the globe. Today, Sofinnova Partners has over €4 billion
under management. For more information,
visit: sofinnovapartners.com.
About Trill Impact
Trill Impact is an established Impact House with around
EUR 1.3 billion in assets under
management. Its impact investment strategies span Buyout, Ventures
and Microfinance, supported by experienced professionals based in
Europe and North America. Trill Impact aims to be a force
for positive change through impact private investments, delivering
Real Returns and Lasting Impact for the benefit of investors,
businesses and society at large – encouraging others to follow. For
more information, please visit: www.trillimpact.com.
About BPIFrance
Bpifrance Investissement is the management company that handles
Bpifrance's equity investments. Bpifrance is the French national
investment bank: it finances businesses – at every stage of their
development – through loans, guarantees, equity investments and
export insurances. Bpifrance also provides extra financial services
(training, consultancy) to help entrepreneurs meet their challenges
from innovation to export. For more information, please
visit: https://www.bpifrance.com/.
Media Contact
Charlene
Herndon
SPRIG Consulting
charlene@sprigconsulting.com
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