Healionics

Healionics

Is this your company? Claim your profile to update info and connect with investors.
Claim profile

Private Company

Total funding raised: $16.5M

Overview

Healionics is a private, clinical-stage medical device company pioneering a novel synthetic biomaterial platform called STAR (Sphere Templated Angiogenic Regeneration). Its lead product, the STARgraft vascular graft, is designed to address the critical unmet needs of infection and occlusion in dialysis access, having received FDA Breakthrough Device designation based on promising human study data. The company leverages its deep roots in Seattle's dialysis innovation ecosystem to advance a solution that could significantly improve patient outcomes and reduce the high cost of dialysis care. Healionics appears to be in a late-stage development phase, positioning its lead graft for potential regulatory submission and commercialization.

Renal DiseaseVascular Access

Technology Platform

STAR® (Sphere-Templated Angiogenic Regeneration) biomaterial scaffold, a synthetic porous material engineered with a specific pore size and structure to promote angiogenesis, minimize foreign body response/scarring, and impart high resistance to infection.

Funding History

3
Total raised:$16.5M
Series B$10M
Grant$1.5M
Series A$5M

Opportunities

The STARgraft addresses a massive, costly unmet need in dialysis care, with the potential to significantly reduce infection and failure rates, improving patient outcomes and lowering healthcare costs.
The underlying STAR biomaterial platform is versatile and could be expanded into other high-value vascular and soft tissue implant markets, creating multiple future revenue streams.

Risk Factors

The company faces significant regulatory risk, as FDA approval for the STARgraft is not guaranteed despite its Breakthrough Device status.
Commercial risks include establishing reimbursement, competing against lower-cost incumbent devices, and scaling manufacturing.
Long-term clinical data will be required to fully validate the product's superiority in real-world use.

Competitive Landscape

Healionics competes in the vascular access graft market against large, established players like Becton Dickinson (BD) and W. L. Gore & Associates, who market traditional ePTFE grafts. Its primary competitive advantage is the demonstrated reduction in infection and occlusion offered by its novel STAR biomaterial, a claim not made by existing synthetic grafts. It also competes with the surgical preference for native arteriovenous fistulas.