Raydiant Oximetry

Industry
Medical Devices & Equipment
Founded Year
2015
Headquarters
San Ramon, California, USA
Employee Count
22

Key People

  • Neil P. Ray - Founder and CEO
  • Mark Rosen - Chief Medical Officer
  • Rodney Chin - Chief Science Officer
  • Jennifer Cobb - Vice President of Market Development
  • Laura Kemp - Vice President of Clinical Affairs

Assessment

Team
Aspect: First-time physician innovator
Summary: Led by a first-time physician innovator with a strong medical background.

The company's leadership is spearheaded by Dr. Neil P. Ray, a pediatric anesthesiologist. While his medical expertise is invaluable, the absence of prior experience in MedTech entrepreneurship could present hurdles in navigating the complexities of medical device commercialization.

Clinical Need
Aspect: Very Strong
Summary: Addresses a critical unmet need in fetal monitoring during labor.

Current fetal heart rate monitoring methods have limitations in sensitivity and specificity, leading to unrecognized fetal distress and unnecessary cesarean sections. Raydiant Oximetry's Lumerah aims to provide more accurate detection of fetal distress, addressing a pressing clinical need.

Competition
Aspect: First mover
Summary: Pioneering non-invasive fetal pulse oximetry with limited direct competition.

Lumerah represents a novel approach in fetal monitoring, with no widely adopted non-invasive fetal pulse oximeters currently on the market. This positions Raydiant Oximetry as a pioneer, though it will need to invest in educating the market and establishing clinical credibility.

Technical Challenge
Aspect: Complex
Summary: Developing accurate non-invasive fetal monitoring is technically challenging.

Achieving reliable and accurate fetal oxygen saturation measurements non-invasively requires overcoming substantial technical challenges, including signal acquisition through maternal tissue and ensuring consistent performance across diverse patient populations.

Patent
Aspect: Very Strong
Summary: Protected by four families of patents.

The company's technology is safeguarded by multiple patent families, offering protection against potential competitors and enhancing its valuation.

Financing
Aspect: Well-funded
Summary: Secured significant funding from reputable investors.

The oversubscribed $7.5 million Series A3 extension round, led by Cross-Border Impact Ventures and supported by other notable investors, underscores the financial backing and belief in the company's potential.

Regulatory
Aspect: Pivotal Trial
Summary: Received FDA Breakthrough Device Designation and IDE approval for early feasibility study.

The FDA's Breakthrough Device Designation and approval for an Investigational Device Exemption (IDE) study reflect the technology's potential and facilitate an expedited regulatory process.

Opportunity Rollup

Odds of Success
2.75
Peak Market Share
3.45
Segment CAGR
3.6%
Market Segment
Patient Monitoring
Market Sub Segment
Fetal Monitoring Devices
Year Post Launch Market Penetration (%)
1 0.17
2 0.52
3 1.21
4 2.42
5 3.45

Key Takeaway

Raydiant Oximetry's Lumerah addresses a critical need in fetal monitoring with strong clinical potential, though technical and market adoption challenges remain.