SafeHeal

Industry
Medical Devices
Founded Year
2015
Headquarters
Paris, France
Employee Count
0

Key People

  • Chris Richardson - President and Chief Executive Officer
  • Karl-Heinz Blohm - Vice President, International
  • Scott DePierro - Vice President U.S. Operations and Global Business Development

Assessment

Team
Aspect: First-time 10+ yrs
Summary: The leadership team comprises experienced professionals with significant industry experience.

The leadership team includes individuals with over a decade of experience in the medical device industry, enhancing the company's strategic direction and operational execution.

Clinical Need
Aspect: Very Strong
Summary: Colovac addresses a significant unmet need in colorectal surgery by potentially eliminating the need for diverting ostomies.

Anastomotic leakage is a serious complication in colorectal surgery, often managed by diverting ostomies. Colovac offers a less invasive alternative, potentially reducing complications and improving recovery.

Competition
Aspect: First mover
Summary: Colovac appears to be a pioneering solution with limited direct competition.

The device's unique approach to managing anastomotic leakage positions SafeHeal as a leader in this niche market, with few comparable alternatives currently available.

Technical Challenge
Aspect: Moderate
Summary: Developing and validating a novel medical device like Colovac involves moderate technical challenges.

The device's design and function require careful engineering and clinical validation to ensure safety and efficacy, presenting moderate technical hurdles.

Patent
Aspect: Strong
Summary: SafeHeal holds strong patent protection for Colovac.

The company's patents cover key aspects of Colovac's design and use, providing a competitive barrier to entry for potential competitors.

Financing
Aspect: Well-funded
Summary: SafeHeal has secured significant funding from reputable investors.

Recent financing rounds, including a 35 million Series C, provide the necessary capital to advance clinical trials and prepare for market entry.

Regulatory
Aspect: Pivotal Trial
Summary: Colovac is undergoing pivotal clinical trials and has received Breakthrough Device Designation from the FDA.

The device's current status in pivotal trials and its designation by the FDA indicate a clear regulatory pathway, though final approvals are pending.

Opportunity Rollup

Odds of Success
3.45
Peak Market Share
4.55
Segment CAGR
4.0%
Market Segment
General Surgery Devices
Market Sub Segment
Colorectal Surgery Devices
Year Post Launch Market Penetration (%)
1 0.23
2 0.68
3 1.59
4 3.18
5 4.55

Key Takeaway

SafeHeal's Colovac device addresses a critical need in colorectal surgery, offering a less invasive alternative to diverting ostomies, with strong financial backing and promising regulatory progress positioning it well for market success.