Piccolo Medical, Inc.

Key People

• Augustus (Augie) Shanahan - CEO
• Kevin McDermott - Senior Engineer
• Daniel Tsay - Product Development Engineer
• Joan Gallego - Senior R&D Technician
• Sanket Phadke - Quality Engineer
• Connie Meng - Principal Technician
• Aaron Miller - Clinical Affairs

Assessment

Team

Aspect: First-time 10+ yrs
Summary: The leadership team, including CEO Augustus Shanahan, brings over 15 years of experience in medical device development and commercialization.

CEO Augustus Shanahan has a background in engineering and has led the development and launch of advanced technologies in vascular access, respiratory care, and orthopedics over the past 15 years. This experience is crucial for the development and commercialization of Piccolo Medical's catheter navigation technology.

Clinical Need

Aspect: Very Strong
Summary: The SmartPICC System addresses a significant clinical need by providing accurate bedside confirmation of PICC placement, reducing reliance on chest X-rays.

Over 8 million central venous access devices are inserted annually in the U.S., with a significant percentage requiring confirmation of correct placement. The SmartPICC System's ability to provide accurate bedside confirmation using intravascular ECG and ionic dilution technology addresses this need effectively.

Competition

Aspect: Somewhat crowded
Summary: The market for catheter navigation and tip confirmation devices includes several established players, indicating a competitive landscape.

The catheter navigation market features multiple companies offering similar solutions. However, Piccolo Medical's proprietary ionic dilution technology and recent FDA clearance for its second-generation SmartPICC technology may provide a competitive edge.

Technical Challenge

Aspect: Predictable
Summary: The development of the SmartPICC System involves predictable technical challenges, given the team's expertise and prior FDA clearances.

Piccolo Medical has successfully developed and obtained FDA clearance for its SmartPICC System, indicating a well-managed development process and the ability to navigate technical challenges effectively.

Patent

Aspect: Strong
Summary: Piccolo Medical holds patents for its catheter navigation technology, providing a strong intellectual property position.

The company has been granted patents for devices and methods related to vascular navigation, assessment, and diagnosis, reinforcing its technological leadership in the field.

Financing

Aspect: Well-funded
Summary: Piccolo Medical has secured significant funding, including a $5.5M Series B round led by Event Capital Strategies.

The Series B financing, along with grants from the National Institute on Aging, provides the financial resources necessary for product development, regulatory processes, and market entry.

Regulatory

Aspect: 510k/PMA
Summary: The SmartPICC System has received FDA 510(k) clearance, facilitating its commercialization in the U.S. market.

FDA 510(k) clearance indicates that the SmartPICC System meets regulatory standards for safety and efficacy, allowing Piccolo Medical to market the device in the United States.

Opportunity Rollup

Odds of Success

3.3

Peak Market Share

4.3

Segment CAGR

4.4%

Market Segment

Peripheral Vascular Devices

Market Sub Segment

Catheter Navigation and Tip Confirmation Devices

Key Takeaway

Piccolo Medical's innovative catheter navigation technology addresses a significant clinical need, supported by a strong team and substantial funding, positioning the company well in a competitive market.