Healionics Corporation
Healionics is dedicated to providing safer, more reliable solutions for bloodstream access in dialysis patients with kidney failure. Their mission is to improve health, longevity, and quality of life for these patients while reducing treatment costs. They develop innovative biomaterials, such as the _STARgraft_ vascular graft, which demonstrates superior resistance to occlusion and infection, leveraging their platform _STAR_ biomaterial scaffold for biointegration and tissue regeneration.
Industries
Nr. of Employees
small (1-50)
Healionics Corporation
Seattle, Washington, United States, North America
Products
Investigational synthetic vascular graft (implantable)
An investigational synthetic vascular graft for hemodialysis access based on sphere-templated porous biomaterial; designed to promote vascular in-growth and resist stenosis and infection, with clinical evaluations completed or underway.
Investigational synthetic vascular graft (implantable)
An investigational synthetic vascular graft for hemodialysis access based on sphere-templated porous biomaterial; designed to promote vascular in-growth and resist stenosis and infection, with clinical evaluations completed or underway.
Services
Development and commercialization of implantable biomaterial devices
End-to-end development of implantable devices based on sphere-templated porous biomaterials, from material design and preclinical testing to clinical evaluation.
In-house laboratory and cleanroom manufacturing
On-site laboratory and cleanroom capacity for research, prototyping and limited production of biomaterial-based implantable devices.
Clinical study conduct and results dissemination
Organization and execution of clinical evaluations for investigational vascular grafts, including presentation of outcomes at professional conferences.
Regulatory strategy and quality management
Management of quality systems and regulatory activities for medical device development, aligned with ISO 13485 and engagement with regulatory designations.
Development and commercialization of implantable biomaterial devices
End-to-end development of implantable devices based on sphere-templated porous biomaterials, from material design and preclinical testing to clinical evaluation.
In-house laboratory and cleanroom manufacturing
On-site laboratory and cleanroom capacity for research, prototyping and limited production of biomaterial-based implantable devices.
Clinical study conduct and results dissemination
Organization and execution of clinical evaluations for investigational vascular grafts, including presentation of outcomes at professional conferences.
Regulatory strategy and quality management
Management of quality systems and regulatory activities for medical device development, aligned with ISO 13485 and engagement with regulatory designations.
Expertise Areas
- Vascular access device development
- Biomaterials for biointegration and infection resistance
- Tissue-engineering scaffold design
- Preclinical and translational research
Key Technologies
- Sphere-templated porous biomaterials
- Controlled pore-size scaffold fabrication
- Microporous surface texturing
- Angiogenic scaffold design