FEMSelect

Key People

• Sasha Schrode - Chief Executive Officer
• Debbie Garner - President
• Rakesh Tailor - Board Member
• Boaz Harari - Founder, VP Research & Development
• Prof. Menahem Neuman - Co-Founder

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with successful track records in the MedTech industry.

The appointment of Sasha Schrode as CEO, who previously led Serpex Medical to a successful acquisition, and the inclusion of Rakesh Tailor, known for his role in the development and sale of Bulkamid, indicate a strong leadership team with relevant industry experience.

Clinical Need

Aspect: Very Strong
Summary: Pelvic Organ Prolapse (POP) affects nearly 50% of women over 50, indicating a significant unmet clinical need.

With a substantial portion of the female population affected by POP and limited minimally invasive treatment options available, FEMSelect's EnPlace system addresses a critical gap in women's health.

Competition

Aspect: Somewhat crowded
Summary: The market for POP treatments includes several players, but FEMSelect's unique approach differentiates it.

Traditional POP treatments often involve mesh implants, which have been associated with complications. FEMSelect's EnPlace system provides a safer alternative, potentially positioning it favorably in the market.

Technical Challenge

Aspect: Predictable
Summary: The EnPlace system utilizes established medical device technologies, suggesting manageable technical challenges.

By leveraging existing medical device technologies in a novel application, FEMSelect minimizes technical uncertainties, facilitating smoother development and regulatory approval processes.

Patent

Aspect: Very Strong
Summary: FEMSelect's EnPlace technology is protected by global and US patents.

Comprehensive patent coverage safeguards FEMSelect's intellectual property, preventing competitors from replicating their technology and ensuring market exclusivity.

Financing

Aspect: Well-funded
Summary: FEMSelect has secured significant funding, including a $9 million Series B round.

The successful Series B financing, led by reputable investors, provides FEMSelect with the necessary capital to advance commercialization efforts and expand its market presence.

Regulatory

Aspect: 510k/PMA
Summary: The EnPlace system has received FDA clearance and CE Mark approval.

Achieving both FDA clearance and CE Mark approval demonstrates the EnPlace system's compliance with stringent regulatory standards, enabling its commercialization in key markets.

Opportunity Rollup

Odds of Success

3.8

Peak Market Share

4.85

Segment CAGR

5.9%

Market Segment

Nephrology and Urology Devices

Market Sub Segment

Pelvic Organ Prolapse Treatment Devices

Key Takeaway

FEMSelect's EnPlace system addresses a significant unmet need in women's health with a minimally invasive, mesh-free solution for pelvic organ prolapse, supported by strong leadership and substantial funding.