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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 (NASDAQ: FEMY) announces a partnership with Boston IVF to offer FemaSeed intratubal insemination across nearly 30 fertility centers nationwide. FemaSeed, designed as a first-line treatment for artificial insemination, delivers sperm directly to the fallopian tube where conception occurs. The treatment has shown significantly higher efficacy compared to traditional intrauterine insemination for low male sperm count and serves as a cost-effective option before IVF procedures. Boston IVF, one of the largest U.S. fertility service providers, will integrate FemaSeed into their suite of treatment options.
Femasys Inc. (Nasdaq: FEMY) announces its participation in the American Society of Reproductive Medicine's (ASRM) 2024 Scientific Congress and Expo from October 19-23 in Denver, Colorado. The company will showcase its products at booth #243, with FemaSeed® and FemVue® featured in ASRM's KEEPR program for residents on October 23.
Notably, Femasys' VP of Education and Global Training, Andrew Young, has been elected chairman of the ASRM Corporate Member Council for a one-year term. This council facilitates dialogue between ASRM officers, directors, and corporate members to drive education and innovation in reproductive medicine.
CEO Kathy Lee-Sepsick emphasized the importance of ASRM's event for demonstrating Femasys' product value to healthcare practitioners and thought leaders, as well as engaging with young physicians through product training.
Femasys Inc. (FEMY), a biomedical company focusing on women's healthcare, announces its participation in the 2024 Maxim Healthcare Virtual Summit. Founder, President, and CEO Kathy Lee-Sepsick will engage in a fireside chat with Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group.
The virtual summit is scheduled for October 15-17, 2024, with Femasys' fireside chat taking place on Thursday, October 17, at 11:00 AM ET. Interested parties can access the webcast through the provided link. Additionally, Kathy Lee-Sepsick and CFO Dov Elefant will be available for one-on-one meetings throughout the summit.
Femasys is known for its broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products addressing significant unmet needs of women worldwide.
Femasys Inc. (Nasdaq: FEMY) has received a second order from its Spanish distribution partners following successful commercial FemaSeed® infertility treatments in Europe. The Femasys team traveled to Madrid to train healthcare practitioners on the innovative procedure, which enhances natural fertilization by delivering sperm directly to the fallopian tube.
CEO Kathy-Lee Sepsick emphasized the importance of providing a lower-cost infertility treatment option, especially in the public sector where women often face long waits for IVF. Femasys recently announced strategic partnerships with Comercial Medico Quirurigca, SA (CMQ) for northern Spain and Durgalab for southern Spain to distribute FemaSeed and FemVue products.
Femasys Inc. (Nasdaq: FEMY) has announced the onboarding of its first infertility medical clinic customers to offer FemaSeed treatment in California and Florida. FemaSeed is a unique form of artificial insemination that delivers sperm directly into the fallopian tube, aiming to enhance natural fertilization. It's positioned as a cost-effective and safe first-line treatment option compared to IVF and ICSI.
Reproductive Fertility Center in Los Angeles and Palm Beach Fertility Center in Boca Raton are the first clinics to offer FemaSeed. Both clinics expressed enthusiasm about providing this new option to patients, citing its potential benefits over traditional IUI and its affordability. Femasys anticipates broader acceptance of FemaSeed as its benefits become more widely recognized in the medical community.
Femasys Inc. (Nasdaq: FEMY) has secured strategic distribution partnerships for its CE-marked products, including FemaSeed® and FemVue®, in Spain. The company has partnered with Comercial Medico Quirurigca, SA (CMQ) for northern Spain and Durgalab for southern Spain, marking its first EU distribution agreements. These partnerships represent a significant step in Femasys' global expansion, with a commitment to purchase a minimum of $1.3 million of FemaSeed over the next year.
Femasys CEO Kathy-Lee Sepsick emphasized the importance of these partnerships in expanding access to affordable and effective women's healthcare solutions. The distributors' expertise in women's healthcare and understanding of Femasys' infertility portfolio are expected to drive market penetration in Spain.
Femasys Inc. (Nasdaq: FEMY) has received 510(k) clearance from the FDA for FemChec®, an innovative diagnostic solution for checking fallopian tubes. FemChec is designed for controlled delivery of contrast to confirm tubal status. It is a important component of Femasys' FemBloc® non-surgical permanent birth control solution, currently in late-stage pivotal trials. FemChec allows for procedure success confirmation by the same practitioner using natural contrast and ultrasound, eliminating the need for radiology referrals and radiation exposure. This clearance strengthens Femasys' position in providing safe and advanced diagnostic and therapeutic solutions for women's healthcare needs.
Femasys Inc. (Nasdaq: FEMY) will exhibit at the Canadian Fertility and Andrology Society's 70th Annual Meeting from September 12-14, 2024, in Vancouver. The company, focused on women's health, will showcase its portfolio of infertility products, including the recently Canadian-approved FemVue MINI, an eco-friendly fallopian tube assessment solution, and FemaSeed, a next-generation artificial insemination product.
CEO Kathy-Lee Sepsick highlighted the importance of connecting with practitioners whose patients could benefit from Femasys' suite of products. The FemVue MINI maintains the efficacy of its predecessor while embracing an eco-conscious design, aiming to improve resource management in women's healthcare. This Canadian approval is expected to expand access to advanced diagnostic technology for women across the country.
Femasys Inc. (FEMY), a biomedical company focusing on women's health, announces its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 at the Lotte New York Palace Hotel. Kathy Lee-Sepsick, Founder, President, and CEO of Femasys, will engage in a fireside chat hosted by Emily Bodnar, Life Sciences Analyst.
The presentation will be available on-demand starting September 9, 2024, at 7:00 AM ET. Investors can access the webcast through the provided link or the investor relations section of the Femasys website. The replay will be available for approximately 90 days after the event. Additionally, Kathy Lee-Sepsick and CFO Dov Elefant will be available for one-on-one meetings throughout the conference.
Femasys Inc. (NASDAQ: FEMY) has received CE mark certification and Health Canada approval for its FemVue® MINI, a compact and eco-friendly fallopian tube assessment solution. This new product maintains the high efficacy of its predecessor while embracing a smaller, more environmentally conscious design. The FemVue MINI aligns with Femasys' commitment to developing safe, affordable, and accessible technologies in women's health care.
The approvals open new opportunities for expanded access to advanced diagnostic technology for women across Europe and Canada. This development is part of Femasys' broader initiative to integrate environmentally impactful programs across its product lines, demonstrating the company's dedication to balancing technological advancement with responsible resource management.
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