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Renata Medical

Growth Pediatric

Cardiovascular device company building implantable technology designed specifically for neonates, infants, and young children with congenital heart disease.

HQ

Newport Beach, CA

Website

renatamedical.com/

Payer Mix

Commercial Insurance, Medicaid

What They Do

Renata designs, manufactures, and sells cardiovascular devices for unmet pediatric needs rather than adapting adult devices downward. Its lead product, the Minima Stent System, is a balloon-expandable growth stent for neonates, infants, and young children with pulmonary artery stenosis or coarctation of the aorta. The design problem it solves is that children grow while conventional cardiovascular implants generally do not accommodate that growth, which historically forced repeat surgical intervention. Minima commercially launched in 2024 and is sold into congenital heart programs at pediatric hospitals.

Competitive Position

Renata occupies an unusual position: a pediatric-only implantable device company in a market where the standard critique is that pediatric device economics do not support the trial and regulatory cost. Its differentiation is not a feature set but a regulatory and reimbursement stack that competitors adapting adult devices cannot easily replicate. Pediatric-specific PMA plus an NTAP designation is a narrow path very few pediatric device companies have completed.

Funding Rounds

No funding rounds on record for this company.

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