Materna Medical
- Industry
- Medical Device
- Founded Year
- 2010
- Headquarters
- Mountain View, California, United States
- Employee Count
- 54
Key People
- Tracy MacNeal - CEO & President
- Kelly Ashfield - Chief Operating Officer
- Edward Evantash, MD - Chief Medical Advisor
- Lisa Molloy - Vice President, Engineering
- Joshua Freeman - Vice President, Clinical Affairs
- Debbie Donovan - Head of Commercial Operations
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: Materna Medical's leadership team comprises experienced professionals with extensive backgrounds in medical device development and commercialization.
The leadership includes individuals with significant experience in MedTech, such as CEO Tracy MacNeal, an engineer with a Duke MBA, and COO Kelly Ashfield, who has a background in launching medical devices at C.R. Bard and Ximedica. This depth of experience is a strong asset for the company's growth and innovation.
- Clinical Need
-
Aspect: Very Strong
Summary: Materna Medical addresses significant unmet needs in women's pelvic health, a $25 billion market.
With products like the Milli Vaginal Dilator and the Ellora System, Materna Medical targets prevalent issues such as vaginismus and pelvic floor injuries during childbirth. These conditions have historically lacked effective solutions, indicating a strong clinical need for the company's innovations.
- Competition
-
Aspect: First mover
Summary: Materna Medical is pioneering in the women's pelvic health device market with limited direct competition.
By focusing on underserved areas within women's health, such as vaginismus treatment and pelvic floor injury prevention, Materna Medical has established itself as a leader in this niche market, facing minimal direct competition.
- Technical Challenge
-
Aspect: Moderate
Summary: Developing devices for pelvic health presents moderate technical challenges, including ensuring safety and efficacy.
The development of devices like the Milli Vaginal Dilator and the Ellora System involves addressing anatomical variability and ensuring patient comfort. However, the company's experienced engineering team is well-equipped to handle these challenges.
- Patent
-
Aspect: Strong
Summary: Materna Medical holds strong patents protecting its innovative pelvic health devices.
The patents cover key aspects of the company's products, ensuring protection against competitors and solidifying its position in the market.
- Financing
-
Aspect: Well-funded
Summary: Materna Medical has secured substantial funding, including a $20 million Series B2 round led by InnovaHealth Partners.
The recent financing round enables the company to advance its clinical trials, obtain regulatory approvals, and expand its market presence, positioning it for future growth.
- Regulatory
-
Aspect: 510k/PMA
Summary: Materna Medical has obtained FDA clearance for its Milli Vaginal Dilator and is pursuing De Novo classification for the Ellora System.
Achieving over-the-counter FDA clearance for the Milli device and progressing towards De Novo classification for the Ellora System demonstrates the company's commitment to meeting regulatory requirements and ensuring product safety and efficacy.
Opportunity Rollup
- Odds of Success
- 3.8
- Peak Market Share
- 5.1
- Segment CAGR
- 5.9%
- Market Segment
- Women's Pelvic Health Devices
- Market Sub Segment
- Vaginal Dilators and Pelvic Floor Injury Prevention Devices
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.26 |
| 2 | 0.76 |
| 3 | 1.78 |
| 4 | 3.57 |
| 5 | 5.10 |
Key Takeaway
Materna Medical is well-positioned to capitalize on the growing demand for women's pelvic health solutions, supported by a strong team, innovative products, and substantial funding.