Autus Valve Technologies, Inc.

healthcare/medical devices (pediatric heart valve replacement)

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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

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

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

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Profile updated Jul 29, 2026. Sources: autusvalve.com, linkedin.com