Renata Medical recently received approval from the U.S. Food and Drug Administration for an expandable heart valve stent specifically tailored for neonates, infants and young children.
The Newport Beach startup was founded in 2019 by two R&D engineers from Edwards Lifesciences Corp. (NYSE: EW), the second largest publicly traded company in Orange County.
โOur mission is to create purposeful devices for pediatric patients,โ co-founder and Chief Executive Dustin Armer told the Business Journal.
Renata most recently raised a Series C round to help fund the commercialization of the Minima Growth Stent and plans to raise the next round in the coming yearโs second quarter.
The Girl Who Couldnโt Be Treated
Armer said he didnโt know much about congenital heart disease before he started Renata.
He began his nearly 12-year stint at Edwards as a technical data package engineer, eventually working his way up to senior manager of research and development.
Armer, at the time, was working on the third generation of the companyโs flagship Sapien heart valve.
He was tasked with making the heart valve capable of fitting in patients as young as 18 years old with congenital heart disease.
Armer would sit in on medical procedures and watch how physicians operated on children to help inform the engineering process.
In one case, Armer watched an 11-year-old girl who was unable to be treated because the physicians didnโt possess the right-sized equipment.
โThe parents were crying, and she had to go home without any treatment,โ Armer said. โIt was eye opening to how hard these physicians were working but just didnโt have the tools to help.โ
Armer, who has three children, researched more about congenital heart disease and came up with the idea for a pediatric device with his colleague Eason Abbot.
The executive leadership team at Edwards supported them to take their idea and form their own company, Armer said.
After leaving Edwards, the two were able to obtain a patent and get started on a proof of concept.
โWe were having a lot of trouble, but something important to note is the growing and thriving ecosystem for life sciences here in Orange County,โ Armer said.
โThereโs the community of investors and accelerators that have lifted us and started us on our Series A to go into this journey.โ
In 2020, Renata was selected to join Los Angeles-based nonprofit accelerator MedTech Innovator.
The startup also participated in Octaneโs Launchpad SBDC accelerator program and won an award for outstanding innovation in medical technology/life sciences at Octaneโs High Tech Awards in 2022.
Smaller Children, Smaller Arteries
One of the biggest challenges pediatric interventional cardiologists face is a lack of appropriate devices, Armer said.
Not only do they need devices that are small enough to access their veins and arteries, but they also need to address the growth of the child.
The outer diameter of the Minima stent measures less than 2 millimeters, or about the size of the tip of a pen.
As children age, their vessels continue to grow and will require a larger stent to keep the narrowed vessel open, Armer said.
The Minima stent is designed to be expanded over the course of the childโs life all the way through adulthood. Its patented growth technology has the potential for it to expand up to 24 millimeters in diameter.
โWhat weโre really doing is solving the need for an extra surgery,โ Armer said.
