Welcome to our dedicated page for FEMASYS news (Ticker: FEMY), a resource for investors and traders seeking the latest updates and insights on FEMASYS stock.
About Femasys Inc.
Femasys Inc. (NASDAQ: FEMY) is a pioneering biomedical company focused on transforming women's healthcare through the development of innovative, minimally invasive, and accessible therapeutic and diagnostic solutions. Headquartered in Atlanta, Georgia, the company addresses critical unmet needs in reproductive health, permanent birth control, and cancer diagnostics. With a comprehensive portfolio of FDA-cleared and globally approved products, Femasys is dedicated to improving clinical outcomes, patient accessibility, and overall healthcare economics.
Core Product Portfolio
Femasys offers a range of patented, office-based medical technologies designed to enhance patient care in key areas of women's health:
- FemaSeed® Intratubal Insemination: An FDA-cleared infertility treatment that delivers sperm directly to the fallopian tube, the natural site of conception. It serves as a cost-effective, less invasive alternative to in vitro fertilization (IVF).
- FemBloc® Permanent Birth Control: Currently in late-stage clinical development, this first-of-its-kind, non-surgical solution provides a safer, more accessible option for permanent contraception without the need for anesthesia or implants.
- FemVue® and FemVue® MINI: Diagnostic solutions for fallopian tube assessment using ultrasound, offering a reliable and non-invasive method for evaluating reproductive health.
- FemCath®: An intrauterine catheter designed for selective fallopian tube evaluation, complementing diagnostic procedures.
- FemCerv®: The first FDA-cleared endocervical tissue sampler for cervical cancer diagnosis, enabling comprehensive and uncontaminated sample collection during a pain-free office procedure.
- FemChec®: A contrast-generating product used in conjunction with FemBloc to confirm procedural success via ultrasound, eliminating the need for radiation-based methods.
Regulatory and Market Achievements
Femasys has achieved significant milestones, including FDA clearances and regulatory approvals in major markets such as the European Union, Canada, Japan, Israel, and the UK. The company's in-house manufacturing capabilities ensure compliance with stringent quality standards, including 21 CFR 820 and ISO 13485, reinforcing its commitment to delivering high-quality medical products. Additionally, its robust intellectual property portfolio, comprising over 180 patents globally, underscores its leadership in women's healthcare innovation.
Business Model and Market Position
Femasys operates within the highly regulated medical device and women's health industry, leveraging direct sales and strategic partnerships with healthcare providers and distributors to commercialize its products. The company’s focus on non-surgical, office-based solutions positions it as a disruptor in a market traditionally dominated by invasive and hospital-based procedures. By addressing gaps in affordability, accessibility, and patient convenience, Femasys caters to a growing demand for innovative healthcare solutions that align with modern clinical practices.
Competitive Landscape
Femasys competes with established players in the reproductive health and diagnostics sectors. However, its differentiation lies in the development of minimally invasive, cost-effective alternatives that can be administered in office settings. This approach not only reduces healthcare costs but also enhances patient satisfaction and provider efficiency.
Commitment to Women’s Health
Femasys is guided by a mission to empower women globally with better healthcare options. Its experienced management team, supported by world-class medical advisors, drives the company’s vision of innovation, integrity, and excellence. By focusing on underserved areas in women’s health, Femasys continues to make significant strides in improving patient outcomes and advancing medical science.
Femasys Inc. (NASDAQ: FEMY) reported its financial results for Q2 and the first half of 2022, highlighting important advancements in women's reproductive health technologies. Revenue for the six months decreased by 4.8% to $624,518, with R&D expenses rising significantly by 53.1% to $2.9 million due to increased clinical costs. The net loss grew to $5.5 million, or $0.47 per share. Upcoming product launches, including FemCerv® and FemCath™, are expected by year-end. Enrollment for the FemBloc® study is on track, with an interim analysis for FemaSeed® due in Q4.
Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on women's health, will hold one-on-one virtual meetings during the BTIG Biotechnology Conference on August 8-9, 2022, at the St. Regis New York Hotel. The company develops minimally invasive technologies for reproductive health, including its lead products, FemBloc® for permanent birth control and FemaSeed® for infertility. Interested participants are encouraged to contact their BTIG representative for scheduling.
Femasys Inc. (NASDAQ: FEMY) will host a significant webinar on July 28, 2022, at 10:30 AM EDT, featuring Dr. Paul D. Blumenthal, who will discuss the company's innovative FemBloc solution for permanent birth control. This event comes in response to the reversal of Roe v. Wade, emphasizing the unmet needs for permanent contraceptive options. FemBloc utilizes a unique delivery method that safely closes the fallopian tubes without surgery, aiming for confirmation of success within 90 days. A live Q&A session will follow the presentation.
Femasys Inc. (NASDAQ: FEMY) has been invited to present at the Women’s Health Panel Discussion hosted by Maxim Group LLC on July 13, 2022, at 11:00 a.m. ET. Kathy Lee-Sepsick, CEO, will discuss the implications of the Supreme Court's decision to overturn Roe v. Wade on women's health and contraception. This virtual event will spotlight the critical issues in women's reproductive health, bringing together key industry players. Femasys is known for its innovations in minimally invasive reproductive health technologies, including FemBloc and FemaSeed.
Femasys Inc. (NASDAQ: FEMY) announced the appointment of Charles Larsen as the new non-executive Chair of the Board, succeeding founder Kathy Lee-Sepsick. With over 40 years in the medical device industry, Larsen is expected to enhance corporate governance and aid Femasys in advancing its product candidates like FemBloc and FemaSeed. Kathy Lee-Sepsick emphasized Larsen's leadership experience and insight in strategic transformations as vital for the company's mission to improve women's health globally.
Femasys Inc. (NASDAQ: FEMY) announced that its CEO, Kathy Lee-Sepsick, will present at the LSX World Congress USA in Boston from June 21-22, 2022. She will lead a session on overcoming regulatory hurdles for women’s health products, focusing on FemaSeed and FemBloc. The Women’s Health CEO Forum will also feature her insights on industry collaboration. This event gathers leaders in biotech and medtech to drive innovation and growth in women's reproductive health.
Femasys Inc. (NASDAQ: FEMY) announced Q1 2022 financial results, reporting a net loss of $2.88 million or $0.24 per share. General and administrative expenses rose by 62.3% to $1.45 million, and R&D expenses increased by 42.8% to $1.42 million. Sales of FemVue® decreased by 2.5% to $321,405. Despite these challenges, Femasys is set to commercialize FemCerv® and FemCath™ by year-end and is making progress in clinical trials for FemBloc and FemaSeed. The company aims to enhance women's health solutions with its expanding product portfolio.
Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on women's reproductive health, will participate in the 2022 Virtual Growth Conference from March 28-30. CEO Kathy Lee-Sepsick will join the panel titled “Advances in Women's Health: From Clinical to Commercial” on March 28 from 3:00 pm to 4:30 pm ET. The conference will discuss innovations in women's health, highlighting Femasys's ongoing development of minimally invasive technologies, including FemBloc® and FemaSeed® for permanent birth control and infertility treatment respectively. For more details, registration is available online.
Femasys Inc. (NASDAQ: FEMY) reported its 2021 financial results, showcasing a revenue increase of 13.7% to $1.18 million from FemVue® sales. R&D expenses slightly decreased by 1.1% to $4.08 million, while G&A expenses surged by 67.5% to $4.26 million due to increased professional costs. The net loss was $7.54 million, equating to $1.12 per share, a rise from the previous year's loss of $6.91 million. The company anticipates significant clinical advancements, including the upcoming launch of FemCerv® and completion of the FemBloc study enrollment.
Femasys Inc. (NASDAQ: FEMY) has appointed Dov Elefant as Chief Financial Officer, effective February 28, 2022. With 25 years of experience in financial management in the biotech sector, Elefant's expertise includes fundraising and mergers and acquisitions. He aims to enhance Femasys' growth and strategic direction in women's health technologies, including their lead products, FemBloc® and FemaSeed®. Additionally, an inducement option has been granted for 100,000 shares to Elefant, vesting over four years. This leadership change is expected to strengthen the company's financial strategy.
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