Healionics is a privately held Seattle medical-device company developing STARgraft, a synthetic biomaterial vascular graft intended to improve vascular access for dialysis patients. STARgraft is designed to resist occlusion and infection, two common failure modes of existing grafts. The company positions the graft against a large clinical need: more than 550,000 U.S. patients require frequent dialysis and the U.S. spends roughly $50 billion annually treating kidney failure. Healionics was awarded a $1.25 million Small Business Innovation Research grant from the National Heart, Lung, and Blood Institute to support commercialization. The award is part of the NIH Commercialization Readiness Pilot Program, which provides additional technical assistance and late‑stage R&D support. Healionics intends to use the funds to complete testing, pursue regulatory clearance, and prepare for market launch. Healionics Corporation is a privately held medical device company in Seattle developing biomaterial-based products, notably the STARgraft vascular graft. STARgraft is based on proprietary synthetic biomaterial technology designed to resist occlusion and infection. The product targets reliable vascular access for dialysis patients, addressing frequent graft failure and infection. More than 550,000 people in the U.S. require dialysis, and the country spends roughly $50 billion annually to treat kidney failure—underscoring the market need. Healionics recently closed a $5.5 million Series A-3 equity financing to advance the program. Proceeds will be used to complete an ongoing human trial and to pursue regulatory clearance and commercialization of STARgraft. Management cited excellent clinical results to date in the human trial and plans to move toward regulatory approval and commercial launch. Healionics develops the STARgraft vascular graft and a pipeline based on its STAR® biomaterial, which the company says resists infection and scarring. The company completed an initial human study last year and is conducting a follow-on human study now. Led by CEO Mike Connolly, Healionics is preparing to commercialize STARgraft for safer dialysis access by addressing infection and occlusion issues of current devices. The company intends to use the new financing to complete the ongoing human study and pursue FDA market clearance. Healionics is clinical-stage and focused on translating its platform biomaterial into implanted-device solutions for patients with kidney failure. Healionics develops the STARgraft vascular graft intended to improve dialysis access by resisting occlusion and infection. The company’s STAR biomaterial platform is already in human use as a commercial implant for glaucoma treatment and has shown promising preclinical results for other implantable applications. In preclinical studies STARgraft demonstrated improved ability to maintain blood flow compared to on-market vascular grafts. The company has initiated its first human study of STARgraft and is working toward regulatory approval and commercial launch of the product. To support that clinical program, Healionics completed a $4.5M convertible note financing. Company leadership thanked a number of angel and venture investors as well as existing backers for their participation in the round. Healionics develops STARgraft, a vascular graft aimed at addressing dialysis access failures in patients with kidney failure. In multiple preclinical studies STARgraft demonstrated much better reliability than on-market devices, with the potential to reduce cost, illness and death among dialysis patients. The company’s broader pipeline is based on its STAR biomaterial platform, which the article says can prevent scarring and infection and improve performance of implantable devices. STAR biomaterial is already in human use as a commercial implant for glaucoma treatment and has shown promising preclinical results for other applications. Management intends to use proceeds from the recent financing to support the company’s first human study of STARgraft. The company is based in Seattle, Washington.

Total raised

$16M

Funding rounds

5

Latest round

Grant

Latest activity

May 2024