Business
Femasys Inc. Announces Financial Results for the Third Quarter Ended September 30, 2023 and Provides Corporate Update
- 510(k) product clearance gained for lead product, FemaSeed potentially allowing sooner-than-expected product commercialization - - Patient enrollment has
About this update from Femasys Inc.
[{"type":"text","content":" - 510(k) product clearance gained for lead product, FemaSeed potentially allowing sooner-than-expected product commercialization - - Patient enrollment has commenced in landmark, pivotal FINALE trial for lead product candidate, FemBloc®, with academic sites enrolling trial participants - - Raised $11.3 million extending cash runway due to the exercise of warrants and sale of shares under its at-the-market facility - ATLANTA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (Nasdaq: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a leading late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update. “The past quarter was a watershed period for Femasys, gaining FDA clearance to market one of our two lead programs, FemaSeed, via a 510(k) pre-market submission allowing for the accelerated commercialization of this important and innovative infertility treatment,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Also, we have been rapidly initiating academic sites for participation in the landmark, pivotal FINALE trial of our leading, late-clinical stage product candidate, FemBloc, bringing us closer to making this much needed non-surgical permanent birth control alternative available to women.” Third Quarter 2023 and Recent Corporate Highlights: In October, Femasys announced that it successfully completed the Stage 2 European Union (EU) Medical Device Regulation (MDR 2017/745) onsite audit resulting in zero nonconformances and no findings. This is the final audit phase in the MDR designation process that was conducted by TUV SUD America Inc., a recognized Auditing Organization and Notified Body. Successful completion of both Stage 1 and Stage 2 MDR audits confirms Femasys is compliant in all areas of MDR and may progress to issuance of the MDR certification, allowing for Femasys’ products to secure CE Marking.In October, Femasys announced that it successfully completed the annual Medical Device Single Audit Program (MDSAP) surveillance audit with no nonconformances and no findings. This satisfies the relevant harmonized regulatory requirements for th...