Prytime Medical Devices, Inc.

Key People

• David Spencer - Co-Founder, President, Chief Executive Officer, and Director
• Gena Marshall - Chief Financial Officer
• Julie Burgett - Senior Vice President, R&D and Supply Chain
• Brian Young - Senior Vice President, Quality and Regulatory
• Jeff Jung - Vice President, Marketing

Assessment

Team

Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with backgrounds in medical device development and commercialization.

David Spencer, the Co-Founder and CEO, has a strong background in medical device innovation. Other key executives, such as Gena Marshall (CFO) and Julie Burgett (SVP of R&D and Supply Chain), bring significant expertise in their respective fields, contributing to a well-rounded leadership team.

Clinical Need

Aspect: Very Strong
Summary: The company's products address critical needs in hemorrhage control, a significant concern in emergency and trauma care.

Prytime Medical Devices focuses on developing minimally invasive solutions for hemorrhage control, such as the ER-REBOA Catheter. These products are essential in managing severe bleeding in emergency settings, directly addressing a pressing clinical need.

Competition

Aspect: Somewhat crowded
Summary: The market for hemorrhage control devices includes several established players, though opportunities for innovation remain.

While the hemorrhage control device market has multiple participants, Prytime Medical Devices' focus on minimally invasive solutions and military-derived innovations provides a unique value proposition. However, the company must continue to innovate to maintain a competitive edge.

Technical Challenge

Aspect: Moderate
Summary: Developing minimally invasive hemorrhage control devices involves moderate technical challenges, manageable with the company's expertise.

The development of devices like the ER-REBOA Catheter requires expertise in medical device engineering and regulatory compliance. Prytime Medical Devices' experienced team is well-equipped to handle these challenges, though ongoing innovation is necessary to stay ahead.

Patent

Aspect: Strong
Summary: The company holds strong intellectual property rights for its flagship products, providing a competitive advantage.

Prytime Medical Devices' flagship product, the ER-REBOA Catheter, is based on intellectual property conceived by experienced military vascular and trauma surgeons. This strong patent foundation supports the company's competitive position in the market.

Financing

Aspect: Medium
Summary: The company has secured moderate funding from various investors, supporting its growth and development initiatives.

Prytime Medical Devices has raised approximately $16.9 million from investors, including the U.S. Department of Defense and National Institutes of Health. This funding has supported product development and commercialization efforts, though further investment may be required for scaling operations.

Regulatory

Aspect: 510k/PMA
Summary: The company's products have received necessary regulatory clearances, facilitating market entry.

The ER-REBOA Catheter received 510(k) clearance in October 2015, allowing Prytime Medical Devices to market the product in the U.S. This regulatory milestone is crucial for the company's commercial success.

Opportunity Rollup

Odds of Success

4.05

Peak Market Share

5.3

Segment CAGR

5.1%

Market Segment

Medical Devices

Market Sub Segment

Hemorrhage Control Devices

Key Takeaway

Prytime Medical Devices, Inc. is well-positioned in the hemorrhage control market with innovative products and a strong leadership team, though it faces challenges from competition and the need for continued funding.