In the pre-market session today, Femasys Inc (FEMY) displayed a notable surge in its stock performance, with its price standing at $2.72, marking a substantial change of 18.78%.
It’s worth noting that the company released a press statement approximately 19 hours ago, which may have contributed to the US stocks market’s heightened interest and the stock’s significant pre-market fluctuations.
Company Overview
Based in Atlanta, Femasys Inc. (NASDAQ: FEMY) is a biomedical company committed to addressing significant unmet needs for women worldwide.
It offers a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products.
Key Product Candidates and Programs
Femasys boasts an impressive portfolio of products. Its lead product candidate, FemBloc®, is in late-stage clinical development for permanent birth control.
The company also has a newly FDA-cleared product, FemaSeed®, for infertility treatment, which has also received regulatory approval in Canada.
Diagnostic Products
Complementing its therapeutic offerings, Femasys has developed a range of diagnostic products.
These products, which include FemVue® for fallopian tube assessment by ultrasound, FemCath® for selective fallopian tube evaluation, and FemCerv® for cervical cancer diagnosis, have received regulatory approvals to market in the United States, Canada, and other non-U.S. territories.
Recent Developments
Recently, Femasys announced the successful completion of the annual Medical Device Single Audit Program (MDSAP) surveillance audit. The audit, carried out by TUV SUD America Inc., found no nonconformances or issues, reflecting the robustness of the Femasys Quality System.
The MDSAP Surveillance Audit
The MDSAP surveillance audit is a crucial regulatory requirement for medical device manufacturers. It is designed to ensure compliance with harmonized regulatory requirements for countries participating in the MDSAP program. The clean bill of health from this audit demonstrates Femasys’ commitment to regulatory compliance and product safety.
Looking Ahead
Femasys’ successful MDSAP surveillance audit result is a positive sign for the company’s future. It indicates a strong commitment to compliance, which is crucial in the highly regulated medical device industry. This commitment, coupled with the company’s innovative product pipeline, positions Femasys well for future growth.
