NIH awards $2.9M grant to Annoviant for heart disease technology advancement

Annoviant co-founders Ajay Houde and Naren Vyavahare, CEO and chief technology officer, respectively.

ATLANTA — Annoviant Inc. a health technology company and member startup in the Enterprise Innovation Institute‘s Center for MedTech Excellence, is receiving a $2.99 million National Institutes of Health (NIH) grant to further scale the development and commercialization of its TxGuardTM 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.”

Center for MedTech Excellence Host SBA Leaders for Summit on Local Startup Ecosystem

Visit to gather information on challenges startups face from government support

When the Center for MedTech Excellence launched in the fall of 2022, it sought to tackle the challenges that early-stage medical device and biotech companies face in successfully getting to market.

Nakia Melecio, MedTech Center of Excellence director, addresses the SBA officials visiting the Tech campus to hear from startup founders. (PHOTO: Chris Ruggiero)

Since then, the MedTech Center, a program of Georgia Tech’s Enterprise Innovation Institute, has worked with and evaluated 208 companies. It has 66 active startups in its portfolio and helped them to get $9.5 million in venture capital funding, and $3.5 million in non-dilutive grants from the Small Business Innovation Research and Small Business Technology Transfer federal programs. Those portfolio companies have created a total of 174 jobs.

Dilawar Syed is the deputy administrator of the Small Business Administration. (PHOTO Chris Ruggiero)

“We’re bringing the best of the resources together to make sure that we’re creating an innovative ecosystem that supports our scientists,” MedTech Center Director Nakia Melecio said at a Jan. 9 meeting with Small Business Administration (SBA) Deputy Administrator Dilawar Syed.

Syed and officials from the SBA were in Atlanta as part of a multi-city tour to hear from entrepreneurs, their challenges, and what the agency could do better to help them succeed.

“There is so much focus on driving innovation in the present administration,” Syed said during his visit at Georgia Tech. “This program is a successful program. We want to make sure it becomes relevant for the next generation of entrepreneurs, especially in communities of color, especially in regions like Atlanta that often have not been at the forefront of driving innovation.”

SBA officials met with several MedTech Center portfolio companies and heard what their main challenges were, chief among them being timing for grants and what’s considered too early in a startup’s lifecycle when it comes to seeking funds from federal agencies.

Nikhil L. Shah, CEO and co-founder of Nephrodite, shared some of the pain points his company had after getting initial funding for its fully implantable continuous dialysis device for patients with end-stage renal disease.

Even though the company had received a $1.8 million grant from a German government agency, it faced several hurdles with U.S. federal funding agencies.

“We applied for the NSF [National Science Foundation] at first and we had that conundrum where they said, ‘you know, this is really early technology. It’s too early,’” he said. “We applied to NIH [National Institutes of Health], but they said, ‘you haven’t done animal studies. We really need animal studies.’ I said, well, I need money to do all that.”

Mason Chilmonczyk, is CEO and co-founder of Andson Biotech, a MedTech Center of Excellence portfolio company. (PHOTO: Chris Ruggiero)

It was similar to the experience of Mason Chilmonczyk, CEO and co-founder of Andson Biotech, a company focused on accelerating the discovery, development, and manufacturing of advanced cell-based therapies.

He and his team sought out program officers with the agency to get guidance before pitching or applying for funds. But he said they were told they were not far enough along in product development, or they were too advanced in the company’s lifecycle.

“You’re too early, this tool is too experimental, or you have too much traction,” he said. “It’s like, it’s too developed almost.”

He and other founders who met with SBA officials welcome support from federal agencies and appreciate the rigorous evaluations process for medical device and life science companies. But the founders who spoke said it would be helpful to know exactly what federal agencies want and more specifics on why a given grant application was rejected.

“I only get a couple pages of feedback…one of the things we need is to just have better education, so you choose to invest your time or not.”

It’s a message that Syed said he would take back to Washington.

“It just strikes me every time we hear from founders how much more work we have to do to drive awareness,” he said, noting it must be an interagency effort. “It’s the entire federal government and SBA’s job is to coordinate that for everyone — better coordination, better communication, make sure people understand whether they’re ready to apply for this or not.”