Annoviant LLC, formerly TGen Tech LLC, today announced that it has been awarded a grant of $1.85 million for two years by the National Institutes of Health (NIH) to help further its development and commercialization of the TxGuard™ pulmonary-valved conduit. This is a continuation of the Phase I Small Business Technology Transfer (STTR) grant the company received in 2019.
The new conduit represents breakthrough technology in conduit replacements for the treatment of congenital heart disease (CHD). Tailored largely toward pediatric patients, the device is designed to resist early degeneration and allows regeneration with host cells, enabling the device to grow with children.
CHD affects approximately 40,000 newborns each year in the U.S. Valve and conduit replacements are needed for absent pulmonary valve, aortic stenosis (Konno procedure, Ross, procedure), double outlet right ventricle (Rastelli operation), extracardiac conduit (Fontan operation), and pulmonary valve replacement (Tetralogy of Fallot).
“We’re extremely pleased to receive this grant, and we are grateful for the National Heart, Lung, and Blood Institute’s financial support,” said Ajay Houde, Ph.D., MBA, co-founder and CEO, Annoviant. “The grant funding will enable us to address the clinical and cost challenges associated with treating CHD in children.”
The primary issues currently observed with commercial devices are (a) calcification; (b) thrombosis; and (c) infection. Annually, 40,000 (U.S.) and 1.3 million (global) children are born with CHD, resulting in 4%-6% of neonatal deaths. According to the Centers for Disease Control and Prevention (CDC), there are about 2.9 million CHD patients in the U.S.
Pediatric patients with CHD typically undergo 3 to 5 cardiovascular surgeries over their lifetimes with an estimated total cost of $5.61 billion1 to the U.S. healthcare industry for treatment of CHD patients.
The TxGuard “scaffolding” exhibits clinical advantages over commercial products, specifically its cutting-edge qualities that make it resistant to calcification (plaques), thrombosis, and infection. Its ability to regenerate and grow with patients also is a significant distinguishing benefit.