Renata Medical has raised $25m to advance commercial and developmental activities surrounding its paediatric stent.
The California-based company’s Series D financing round was led by PE firm Archimed and included participation from existing investors.
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Renata’s lead product is Minima, a balloon expandable growth stent specifically designed for use in paediatric patients and young children with pulmonary artery stenosis or coarctation of the aorta, two types of congenital heart defect (CHD).
Renata intends to use the latest funds to advance Minima’s commercialisation into international markets following its pre-market approval (PMA) from the US Food and Drug Administration (FDA) in August 2024.
FDA approval for Renata’s stent was supported by findings from its GROWTH pivotal trial (NCT05086016), in which 97.6% of 42 enrolled patients fitted with Minima experienced effective stenosis relief, with 100% free from additional surgical intervention at six months following implantation.
Renata’s CEO, Dustin Armer, said: “Adoption of the Minima stent system has exceeded our expectations since commercial launch in 2024.
“The support and participation of Archimed is further validation of what we are building and of the growing opportunity to transform care for children with congenital heart disease.”
Left untreated, CHDs can lead to heart failure and death. Delivered through the vein or artery in the groin or neck with a small needle, Minima is designed to expand over the course of a child’s life. Designed with long, thin frames, the stent can be crimped down to < 2mm, which Renata asserts helps overcome a key challenge for paediatric interventional cardiologists in gaining access to very small veins and arteries in this patient population.
Renata also intends to allocate portions of its latest funding tranche towards advancing its pipeline of paediatric-specific CHD technology, and to support ongoing clinical evidence generation for Minima as its adoption rates continue to grow.
Reflecting on its lead role in Renata’s Series D financing round, Archimed’s managing partner, André-Michel Ballester, who formerly served as LivaNova’s CEO, said: “Children born with congenital heart defects have too often been treated with devices built for adults and many face repeat procedures simply because their implants cannot grow with them.
“We are proud to back the Renata team as they scale the business and advance a pipeline of purpose-built paediatric therapies.”
