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Tag: FEMY

  • FEMY Stock: A Detailed Insight into the Company’s Recent Stock Market Performance

    FEMY Stock: A Detailed Insight into the Company’s Recent Stock Market Performance

    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.

  • Femasys Inc. (FEMY) stock is falling down to 8.21% – What’s happening?

    Femasys Inc. (FEMY) experienced a decrease of 8.21% in aftermarket despite any official news. However, the last trading session closed at $3.29 with an increase of 10.03%.

    Publication of Clinical Data – Latest News

    On 1st February 2022, it was announced the publishing of data about patients having awake plastic surgery. The team has published the article with the title “Awake Plastic Surgery Procedures” in the journal named Aesthetic Surgery Journal Open Forum.

    The advantages of awake plastic surgery include patient preference, affordability, and easier recovery. Moreover, oral analgesics often used are frequently insufficient to provide effective analgesia for these procedures. Furthermore, the findings of this study show that giving a single dose of SST 30 minutes before awake plastic surgery procedures can provide effective pain management with a low rate of adverse events.

    What’s Next?

    DSUVIA provides advantages to patients and clinicians in a variety of surgical conditions. FEMY is working hard to see the outcomes of several ongoing studies that will provide more real-world proof of DSUVIA’s uses.

    FEMY: Appointment of Wendy Perrow – Worth it?

    FEMY announced on 20th January 2022 that Wendy Perrow has been appointed as a new board member. Wendy offers a strong and established strong reputation of topline vision and management consulting, and also high-level tactical skills in marketing, business and product development, and financing, to the board. Moreover, all of this will be really helpful as the company moves forward with the commercial assets as the key product candidates continue to progress in clinical trials.

    FEMY: Third Quarter 2021 Financial Results – How was the quarter?

    FEMY reported third-quarter 2021 financial results on 10th November 2021. The company experienced research and developments costs of about $144,957 with a 14.6% increase. Moreover, the general and administrative expenses inclined by 82.2% and reached $490,585. Unfortunately, the sales of FEMY’s product i.e., FemVue experienced a downfall of 13.9% reaching almost $43,627. Lastly, net loss came out to be $2,259,701.

    So what?

    FEMY is getting ready for the pivotal trial for FemBloc. It is the permanent birth control product candidate, that will take place next year in conjunction with the anticipated IDE submission. FEMY is keen to address the existing constraints of infertility and birth control alternatives. They both are enormous and underserved markets within women’s reproductive health globally.