410 Medical

Industry
Medical Devices & Equipment
Founded Year
2013
Headquarters
Durham, North Carolina, USA
Employee Count
65

Key People

  • Kyle Chenet - President and CEO
  • Mark Piehl - Co-founder and Chief Medical Officer
  • Michael Ball - Vice President of Sales & Marketing
  • Kristen Johnson - Manager of Business Development & Account Management
  • Julie Bianco - Clinical Education Coordinator
  • Festus Adejumo - Senior Clinical Research Associate

Assessment

Team
Aspect: First-time physician innovator
Summary: The leadership team includes a first-time physician innovator with significant clinical experience.

The company's leadership is spearheaded by Dr. Mark Piehl, a pediatric intensivist with extensive clinical experience. While his medical background is robust, the team lacks seasoned MedTech entrepreneurs, which may pose challenges in navigating the complexities of medical device commercialization.

Clinical Need
Aspect: Very Strong
Summary: The product addresses a critical need in rapid fluid resuscitation for life-threatening conditions.

LifeFlow is designed to enhance the speed and efficiency of fluid resuscitation, crucial for patients with conditions like sepsis and shock. Rapid fluid delivery is vital in these scenarios, and existing methods often fall short, underscoring the strong clinical need for such a device.

Competition
Aspect: Somewhat crowded
Summary: The market has several competitors, but LifeFlow offers unique advantages.

Competitors like Prytime Medical Devices and Belmont Medical Technologies offer rapid infusion solutions. However, LifeFlow's design emphasizes simplicity and speed, potentially differentiating it in the market. Nonetheless, the presence of established players indicates a somewhat crowded competitive landscape.

Technical Challenge
Aspect: Predictable
Summary: The technology is based on established principles with manageable development challenges.

LifeFlow's design leverages existing medical device technologies, focusing on user-friendly operation and rapid fluid delivery. The technical challenges are predictable and manageable, reducing the risk associated with product development.

Patent
Aspect: Strong
Summary: The company holds strong patents protecting its technology.

410 Medical has secured patents for LifeFlow, providing a strong intellectual property foundation. This protection is crucial for maintaining a competitive edge and preventing market encroachment by competitors.

Financing
Aspect: Well-funded
Summary: The company has secured substantial funding from reputable investors.

With over $46 million in total funding from investors like Hatteras Venture Partners and OSF Healthcare, 410 Medical is well-positioned financially to advance product development and expand market reach.

Regulatory
Aspect: 510k/PMA
Summary: The product has obtained FDA clearance, facilitating market entry.

LifeFlow received FDA clearance for human use in 2016, allowing the company to market and distribute the device in the U.S. This regulatory milestone is essential for product adoption in clinical settings.

Opportunity Rollup

Odds of Success
3.1
Peak Market Share
4.2
Segment CAGR
5.4%
Market Segment
Medical Devices & Equipment
Market Sub Segment
Fluid Resuscitation Devices
Year Post Launch Market Penetration (%)
1 0.21
2 0.63
3 1.47
4 2.94
5 4.20

Key Takeaway

410 Medical's LifeFlow addresses a critical need in rapid fluid resuscitation, supported by strong clinical demand and substantial funding, but faces challenges in a competitive market with established players.