Flowonix Medical, Inc.

Industry
Medical Devices
Founded Year
2005
Headquarters
Mount Olive, New Jersey, USA
Employee Count
43

Key People

  • Lou Altieri - Chief Financial Officer
  • Cory Brantley - Director of Clinical Engineering
  • Whitney Torning - Senior Director, Regulatory Affairs
  • Jessica Meyers - Corporate Accounting Manager
  • Doris Kaye - Senior Quality Technician

Assessment

Team
Aspect: First-time 10+ yrs
Summary: The leadership team comprises individuals with over a decade of experience in the medical device industry.

Flowonix's leadership includes seasoned professionals with significant tenure in medical device development, contributing to the company's innovative product offerings.

Clinical Need
Aspect: Very Strong
Summary: The Prometra pump addresses a critical need for effective chronic pain management.

Chronic pain affects a substantial portion of the population, and the Prometra pump provides a direct and efficient method of drug delivery, improving patient outcomes.

Competition
Aspect: Somewhat crowded
Summary: The intrathecal pump market includes several established players.

While the market is competitive, Flowonix's unique features, such as extended battery life and high dosing accuracy, provide a competitive edge.

Technical Challenge
Aspect: Predictable
Summary: The technology involves complex but manageable engineering challenges.

Flowonix's engineering team has a history of innovation, evidenced by multiple patents and successful product development.

Patent
Aspect: Very Strong
Summary: Flowonix holds numerous patents protecting its technology.

With 12 issued patents and additional pending applications, Flowonix has secured its innovations in implantable drug delivery systems.

Financing
Aspect: Medium
Summary: The company has secured significant funding but may require additional capital for expansion.

Flowonix has raised approximately $52 million in funding, including a $15.5 million round in 2016, indicating strong investor confidence.

Regulatory
Aspect: 510k/PMA
Summary: The Prometra pump has received FDA approval for multiple indications.

The FDA approved the Prometra pump for intrathecal infusion of baclofen in patients aged 12 and older, expanding its therapeutic applications.

Opportunity Rollup

Odds of Success
4.05
Peak Market Share
5.45
Segment CAGR
6.6%
Market Segment
Drug Delivery Devices
Market Sub Segment
Intrathecal Pumps
Year Post Launch Market Penetration (%)
1 0.27
2 0.82
3 1.91
4 3.82
5 5.45

Key Takeaway

Flowonix Medical's Prometra pump addresses a significant clinical need with innovative technology, positioning the company favorably in a growing market despite competitive challenges.