NIH awards $2.9M to Annoviant to advance heart disease technology

ATLANTA — Annoviant Inc. a health technology company and member startup in the Center for MedTech Excellence at Georgia Tech's Enterprise Innovation Institute, is receiving a $2.99 million National Institutes of Health (NIH) grant to further scale the development and commercialization of its TxGuard™ pulmonary-valved conduit for pediatric heart disease.

The award follows two Phase I NIH grants the company received, the most recent being in 2021.

Annoviant's patented TxGuard™ stands at the forefront of technological innovation in conduit replacements for treating congenital heart disease (CHD), the most prevalent birth defect globally and a leading cause of birth-related mortality, the company said.

CHD encompasses a broad range of abnormalities that disrupt blood flow to and from the heart. It affects approximately 40,000 newborns annually — or 1% of births in the U.S. — and 1.35 million worldwide. With an estimated 2.9 million CHD patients in the U.S. alone, the need for advanced solutions is paramount.

"This marks a significant milestone for Annoviant as we accelerate our pursuit of impactful innovation to save lives," said Annoviant CEO and co-founder Ajay Houde, Ph.D. "It validates our hypothesis and shows the NIH's confidence in our ability to make good progress. Because we are a small startup, it gives private investors the confidence to invest with us and more companies working with us across the broader ecosystem."

Addressing critical shortcomings observed in current commercial devices, TxGuard™ offers clinical advantages, notably its resistance to calcification, thrombosis, infection, and the host cell integration. This cutting-edge technology marks a new era in pediatric cardiac interventions, providing durable pulmonary valved grafts that adapt and regenerate alongside patients, minimizing the need for multiple re-operations over their lifetimes.

"Heart disease is the leading killer of men and women in the U.S. and is the most common birth defect in our newborns," said Center for MedTech Excellence Director Nakia Melecio, who worked with Annoviant to help it scale and reviewed its federal funding submissions.

The Center for MedTech Excellence, which launched in 2022, works with early-stage life sciences startups that have specific obstacles that young tech companies in other sectors don't face.

"This is a critical milestone for the company, and validates its research and work, thus far," Melicio said. "Annoviant's technology is tackling several challenges that the market currently faces and elevating the possibility for better patient outcomes in management of congestive heart failure."

Pediatric patients with CHD often undergo multiple cardiovascular surgeries throughout their lives, with associated costs totaling billions for the U.S. healthcare industry. TxGuard™ offers a transformative solution to this ongoing challenge, promising extended durability and reduced healthcare burden for patients and providers alike.

He credited the company's work with the Center for MedTech Excellence and being a health tech startup in the Advanced Technology Development Center (ATDC), the Enterprise Innovation Institute's startup incubator, as being pivotal in Annoviant's growth.

ATDC SBIR/STTR Catalyst Connie Casteel, who works with the incubator's portfolio companies to help the prepare for these federal, non-dilutive funding grants, had worked with Annoviant on its federal funding approach and strategy.

"We went through the 16-week program with the MedTech Center and it really helped us think through the various aspects of the commercialization process and operational challenges we would face," Houde said. "Greg Jungles at ATDC was also instrumental in helping us.  I'm really thankful for Nakia and his work with the MedTech Center and Greg and the team at ATDC."