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Autus Valve Technologies, Inc.
a novel synthetic size
healthcare/medical devices (pediatric heart valve replacement)
StageGrant/Angel
Raised$300K
Founded2019
Employees2
LocationBoston, MA
Business modelB2B (medical device developer supplying to clinicians/hospitals); regulatory/clinical pathway implied
About
Autus Valve Technologies, Inc. is a medical device company developing a novel synthetic size-adjustable pulmonary valve replacement device for pediatric patients. The Autus Valve is currently in an FDA-approved clinical investigation in the United States. The Autus Valve Pivotal Study is a prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve Pivotal Study is actively enrolling patients. Please contact the enrolling study centers for any inquiries. Enrolling centers are listed on: https://clinicaltrials.gov/study/NCT05006404
Product
- Value proposition
- Size-adjustable, biomimetic bileaflet pulmonary valve designed for pediatric patients that can be balloon-expanded via minimally invasive transcatheter approach as the patient grows
- Target customers
- Pediatric cardiology centers, hospitals, medical device distributors
- Regulatory
- Investigational device; limited by Federal law to investigational use in the US
Founders
- Sophie-Charlotte Hofferberth
- Pedro J. Del Nido
- Elazer R. Edelman
Categories
Products
Autus Valve (size-adjustable pulmonary valve)
Key features
Novel expandable size-adjustable valveBiomimetic bileaflet designInspired by geometry of the human venous valveBalloon-expandable via minimally invasive transcatheter approachFunctions across a wide range of diametersCustomizable implant diameter
Technologies
Synthetic size-adjustable valveBalloon expansion technologyBiomimetic bileaflet design
Integrations
EHR/clinical workflow integrations not specified
Target conditions
Congenital heart diseasePulmonary valve diseasePediatric heart valve disease
Care settings
HospitalClinical settingSurgical suiteInterventional cath lab
Certifications
Investigational device status (CAUTION)Regulatory/US investigational device status notedFederal (United States) law to investigational use
Traction metrics
40,000 children born with congenital heart disease each year (US)6,300 children born with pulmonary valve disease each year (US)1,000,000+ children (0-18) living with congenital heart disease (global)110,000 children (0-18) living with pulmonary valve disease (global)
Investors
U.S. Department of Health and Human Services (HHS)UCSF-Stanford Pediatric Device Consortium
News
- Novel Pulmonary Valve Aims to Reduce Invasive Surgeries for Kids... · 2024-11-10T00:00:00.000Z
- Edwards Lifesciences Boosts 2026 Outlook After Acquiring Autus Valve Technologies:: AktienSensor · 2026-06-10T01:38:51.000Z
- Dr. Oliver Barry: A Novel Approach to Pediatric Pulmonary Valve Replacement | NYP · 2024-10-28T06:25:47.000Z
- Did Higher 2026 TAVR Guidance and Autus Deal Just Shift Edwards Lifesciences' (EW) Investment Narrative? - Simply Wall St News · 2026-06-07T23:15:02.000Z
