For doctors, there’s nothing more distressing than not being able to adequately care for a patient, particularly when it’s a child. That was the case for Ignacio Lugones, a pediatric congenital cardiac surgeon who has been working to address limitations in valve reconstruction options for children ever since losing a young patient with a heart defect he wasn’t able to successfully treat.
Together with his brother, a physicist, he began designing an aortic valve that can accommodate children’s growth, making it more durable and adaptable over time, and giving young patients the chance to experience a healthy, normal childhood.
That venture has grown into AVaTAR MedTech, launched by Lugones and co-founder and CEO Tomás Armendariz. The company is taking aim at valvular heart disease by combining a novel surgical method and set of innovative medical devices to enable aortic or pulmonary valve reconstruction using a patient’s own tissue, eliminating the need for long-term anticoagulation in pediatric and adult patients.
The company recently joined Fogarty Innovation’s Company Accelerator Program (CAP), a six-month program designed to help early-stage companies achieve specific objectives within their broader business plan.
A large, underserved market
More than 200 million people worldwide are affected by aortic and pulmonary valve disease, including 40,000 children born each year with congenital heart defects in the U.S. Yet until now, procedures for pediatric patients had been complicated by a lack of appropriately sized valves and children’s natural rapid growth. Additionally, surgical options, largely designed for adult patients, present several limitations.
While initially developed for children, AVaTAR’s approach also shows strong promise for adults. Although these patients have more options, such as mechanical or bioprosthetic valves, this new solution potentially offers durability that allows adults to maintain an active lifestyle without concerns about damaging an implant.
An entrepreneur at heart
Armendariz came to the company to realize his goal of making a difference through entrepreneurship. He had always been drawn to health technology and took multiple jobs in the industry to build a base of expertise.
First, he worked at a medical device distributor where he learned about commercialization, ranging from the approval process to strategies for approaching physicians. Then, to prepare for the demands of the business side, he joined Accenture Argentina as a strategy consultant, working to structure and solve complex business problems, including projects with life sciences companies.
Finally, Armendariz did a stint at GRIDX, the leading biotechnology company builder and venture capital fund in Latin America, which focuses on transforming scientific research into companies. There, as part of a talent matching program for business and life sciences companies, he met Lugones.
“My role was to combine business expertise with his surgical technique to determine how to scale it,” Armendariz said.
Armendariz and Lugones launched the company in 2023 and since have raised seed funding from GRIDX, the American Heart Association, Cardiovascular Research Foundation (CRF), UCSF-Stanford Pediatric Device Consortium, and the Southwest Pediatric Device Innovation Consortium in collaboration with the American Academy of Pediatricians.
Their current team of nine, plus three advisors, spans business, medicine, engineering, design, regulatory and physics. “One of our biggest challenges has been to build a team that has all the capabilities necessary to not only build the technology, but also to market it successfully,” Armendariz said.
Tapping the expertise of the Fogarty team
That’s where Fogarty Innovation comes in. “Being selected to join Fogarty Innovation’s CAP is a tremendous opportunity for us to get expert advice on elements like reimbursement and the regulatory environment that would have been challenging to decipher on our own,” he said.
AVaTAR is working with the Fogarty team to develop a plan for product evolution in coordination with regulatory strategy and clinical evidence. The company is refining their functional prototypes with near-term goals of scaling up manufacturing, establishing an appropriate quality management system, and confirming the functionality through testing.
Concurrent with regulatory approval, Armendariz says they are working on the commercialization strategy. “The Fogarty team, especially Marga Ortigas-Wedekind, have been invaluable in helping us understand reimbursement, billing codes and the U.S. healthcare and payer system,” he said.
Armendariz first became acquainted with Fogarty when AVaTAR MedTech was named a winner at the UCSF-Stanford Pediatric Device Consortium last year, where Fogarty CEO Andrew Cleeland was a judge. “We didn’t even know everything we needed to learn so we are extremely grateful to be part of the Fogarty ecosystem,” Armendariz said.