First Patient Treated in Pivotal Trial for FemaSeed, a first in class, localized directional insemination product candidate for infertility : Femasys (NASDAQ: FEMY)
Clinical Trials Underway on Key Female Oriented Healthcare Advances from new IPO Launch: Femasys (NASDAQ: FEMY)
Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on transforming women’s healthcare, today announced the initiation and first patient treated in a pivotal trial evaluating FemaSeed, a first in class, localized directional insemination product candidate for infertility.
“For more than 20 years, current approaches to infertility treatment have been limited during the initial stage of therapeutic care, but with the advancement of FemaSeed, we believe a next generation intrauterine procedure may have the opportunity to truly change this traditional paradigm,” said Michael Glassner, MD, Founding Partner and Medical Director of Main Line Fertility & Reproductive Medicine in Pennsylvania, where the first patient in the LOCAL trial was treated in July 2021. “The LOCAL trial is the next step in proving the FemaSeed localized directional insemination approach. My colleagues and I are thrilled to be a part of this patient care evolution.”
The LOCAL trial will be conducted across approximately 20 centers in the United States and is expected to enroll up to 792 patients diagnosed as infertile. The primary endpoints of the study are to determine the effectiveness (clinical pregnancy rate) and safety over a period of 7 weeks.
“Infertility has become a global issue and the commencement of the LOCAL trial underscores our commitment to ensure that women struggling to become pregnant receive the best, lowest cost treatment option by developing our innovative directional delivery platform technology,” said Kathy Lee-Sepsick, founder, President & Chief Executive Officer of Femasys.
– Commitment and Company Focus on Transforming Women’s Healthcare.
– $34.45 Million IPO Completed to Fund Operations and Clinical Trials.
– IPO Process Managed by Experienced Global Investment Bank Chardan.
– Developing Novel Solutions and Next Generation Medical Advances.
– Significant Clinical Impact to Address Severely Underserved Areas.
Femasys, Inc. (NASDAQ: FEMY) is a woman-led company under the direction of Kathy Lee-Sepsick, President, CEO and Founder. FEMY has developed a suite of products and product candidates that address several large global market segments in which there has been little advancement for many years. FEMY has an expansive, internally created intellectual property portfolio with over 100 patents globally. With proven ability to develop and commercialize products, FEMY is positioning to become a leading company in the women’s healthcare space with solutions to address multi-billion dollar global opportunities.
FEMY will use the proceeds of its recent $34.45 Million IPO to fund the completion of enrollment in the stage 2 clinical trial and commencement of the stage 3 clinical trial for the company’s Permanent Birth Control FemBloc system and for the initiation and completion of the pivotal trial for its Fertility FemaSeed system. FEMY also has other fertility products in development for Occlusion Confirmation, Localized Directional Insemination, Infertility Diagnosis and Endocervical Tissue Sampler Biopsy. The FEMY IPO proceeds will further be used to fund product development and research and development activities, to hire additional personnel, and for working capital and general corporate purposes.
– FEMY Announces Appointment of New Board Member
On June 24th FEMY announced the appointment of Anne Morrissey to the company’s board of directors. “
Ms. Morrissey brings decades of experience to FEMY. Most recently, she served as President and Chief Executive Officer of Alydia Health from 2016 to 2020, and thereafter as an advisor until it was acquired by Merck in March 2021. Ms. Morrissey co-founded Vivant Medical in 1998 where she served as Director of Business Development until 2000, also served as Vice President of Astia prior to founding Ucan Products in 2011, where she served as CEO until 2016. Previously, she also served as Marketing Manager at General Surgical Innovations, subsequently acquired by Tyco. She also held positions with Mentor Worldwide, LLC, a Johnson & Johnson Company and Kimberly-Clark. She holds several patents on medical devices and advises medical device companies, including Raydiant Oximetry.
– Chardan Acts as Lead Left Bookrunner in FEMY $34.45 Million IPO
On June 21st Chardan, a global investment bank, announced that it acted as lead left bookrunner in the successful closing of the $34.45 million IPO of Femasys with trading symbol FEMY listed on the NASDAQ exchange. FEMY is a biomedical company focused on transforming women’s healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely underserved areas. The proceeds if the IPO will fund clinical trials for the FEMY FemBloc and FemaSeed systems, as well as the development of novel products and solutions.
“We are delighted to work with the outstanding team at Femasys in support of their commitment to women’s healthcare,” said Matthew Mrozinski, a partner in the investment banking group at Chardan. “Chardan’s goal as a bank is to identify and support companies that address areas of significant unmet need. Femasys’ mission of transforming women’s healthcare is a substantial market opportunity.”
The FEMY transaction further solidifies Chardan’s dedication to ESG and healthcare companies with novel and differentiated platforms. Since 2020, Chardan has acted as book runner or lead placement agent in 32 transactions including for healthcare companies: 4D Pharma plc (PIPE), Forge Biologics (Private offering) Forte Biosciences (FO), GenSight Biologics (PIPE), Immunome (IPO), Immunovant (FO), MeiraGTx (FO), NeuBase Therapeutics (FO), and Renovacor (announced PIPE).
For more information on Femasys, Inc. (NASDAQ: FEMY) visit: https://www.femasys.com.
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