Femasys Receives AMA Approval for New CPT Code
Femasys announced that it has received notice from the American Medical Association, AMA, CPT Editorial Panel approving a new Category III Current Procedural Terminology, CPT, code covering the use of FemaSeed for intratubal insemination, ITI, a procedure that delivers sperm directly into the fallopian tube where conception occurs. The approved Category III CPT code is expected to be issued publicly by the AMA with an effective date of January 1, 2027. Approval of this Category III CPT code represents an important step in advancing the reimbursement strategy for FemaSeed to support broader clinical adoption, provider utilization, and expanded patient access to this first-step infertility treatment option. "The creation of a new Category III code for the FemaSeed ITI procedure reflects the innovation and differentiated approach of our technology," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. "As we initiate the rollout of FemaSeed to gynecologists and their clinical teams, supported by the availability of our FemSperm product line, we intend to expand our provider footprint, accelerate adoption, and increase access to care for more than 10 million women in the U.S. affected by infertility. Together, these offerings advance our scalable commercialization strategy and position us for sustainable long-term growth."
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- Stock Option Grant: Femasys granted 185,000 stock options to two new employees in February 2026, with exercise prices set at $0.50 and $0.57, reflecting the company's commitment to incentivizing new talent.
- Vesting Schedule: The stock options will vest 25% on the first anniversary of employment, with the remaining shares vesting at 25% each year over the next three years, ensuring long-term employee retention and contribution.
- Market Positioning and Innovation: Femasys focuses on developing fertility and non-surgical permanent birth control products, with its FemaSeed and FemBloc offerings providing a unique competitive edge, particularly in European and international markets.
- Clinical Trials and Regulatory Progress: Femasys's FemBloc product received regulatory approvals in Europe, the UK, and New Zealand in 2025, and is currently undergoing the FINALE pivotal trial for FDA approval, indicating strong growth potential in the reproductive health sector.
- MDSAP Certification Achievement: The FemBloc permanent birth control system has achieved certification under the Medical Device Single Audit Program (MDSAP), significantly enhancing the company's regulatory and commercial execution capabilities across key markets such as the U.S., Canada, Japan, Australia, and Brazil, which is expected to accelerate global market entry.
- Manufacturing Credibility Boost: The MDSAP certification not only enhances FemBloc's manufacturing credibility but also supports ongoing commercialization in Europe, reducing regulatory risks and providing greater operational flexibility for market expansion in high-value regions.
- Non-Surgical Solution: FemBloc is the first non-surgical permanent birth control solution that safely creates natural scar tissue in the fallopian tubes using a patented delivery system, eliminating the risks and complexities associated with traditional surgical sterilization, which is expected to significantly lower healthcare costs and improve contraceptive options for women.
- Global Market Potential: The launch of FemBloc addresses the urgent global demand for permanent contraception while providing a safer, more convenient, and cost-effective option, enhancing the company's competitiveness in underpenetrated markets and is anticipated to attract strategic partnerships to drive future growth.
- Strategic Partnership: Femasys has announced a new strategic distribution partnership with OR Consulting to support the commercial launch of its product portfolio in Switzerland, including FemBloc permanent birth control and FemaSeed intratubal insemination, further advancing Femasys' European expansion strategy.
- Market Expansion Plan: This partnership signifies Femasys' continued market entry following successful launches in Spain and France, demonstrating the company's commitment to building a robust commercial platform across multiple countries.
- Product Innovation Advantage: FemBloc, the first non-surgical permanent birth control method, received full regulatory approval in Europe in 2025, and is expected to meet the growing demand in women's health with its effective and safe profile.
- Market Potential: Switzerland is recognized as a key market for women's health innovation, and the collaboration between Femasys and OR Consulting aims to enhance patient options through close cooperation with physicians, facilitating effective navigation in complex markets.

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- NASDAQ Compliance Extension: Femasys (FEMY) received NASDAQ approval for a 180-day extension to meet the minimum $1.00 bid price requirement, with stock climbing 10.68% to $0.72, providing the company until July 13, 2026, to regain compliance, alleviating investor concerns.
- Successful Financing: Foghorn Therapeutics (FHTX) closed a $50 million registered direct financing at a 30% premium, resulting in a 4.02% stock increase to $6.26, demonstrating market confidence and support for its future development.

- Compliance Extension: Femasys has received Nasdaq approval for a 180-day extension until July 13, 2026, to meet the minimum closing bid price requirement of $1.00 per share, ensuring the company's continued listing status on the capital market.
- Stable Listing Status: The extension notice does not immediately affect Femasys's listing status on Nasdaq, indicating the company's resilience and operational capability amid market challenges.
- Market Reaction: FEMY shares fell 0.81% in premarket trading to $0.5809, reflecting cautious investor sentiment regarding the company's compliance progress, which may impact future financing and market confidence.
- Financing Context: Recently, Femasys secured $12 million in financing and received FDA approval for the final FemBloc trial, demonstrating positive advancements in product development and fundraising despite compliance pressures.

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