Thubrikar Aortic Valve Receives U.S. Patent

The the number of firms pursuing the TAVI market continues to grow.

Thubrikar Aortic Valve Inc., a privately held medical device company developing a next-generation transcatheter aortic valve implantation (TAVI) system, received its first U.S. patent (US 8,992,599), titled “Valve Component, Frame Component and Prosthetic Valve Device Including the Same for Implantation in a Body Lumen” and issued on March 31.

“We are glad the USPTO (U.S. Patent and Trademark Office) recognized the novelty of Optimum TAV’s design,” said Mano Thubrikar, the company’s founder and president. “We also received a Notice of Allowance in the Canadian counterpart application, and expect the Canadian patent to formally issue shortly.”

Optimum TAV has surpassed 673 million cycles (simulates 18 years in vivo) in an ongoing durability test, while the control—a commercially available surgical valve—showed tears and holes at 500 million cycles, according to Thubrikar officials. Optimum TAV also demonstrated significantly lower pressure gradient and less calcification than approved valves, after five months in sheep testing.

The company has completed nearly all required preclinical studies—within just $2 Million—and is in the process of raising funds to sponsor first-in-human studies.

Company officials expect to obtain human data later this year from a partnership with a “prominent South American cardiovascular company.” In addition, the firm currently is negotiating with a prospective partner in Asia and also is evaluating various opportunities in other markets outside the United States.

Thubrikar was founded in October 2010. It is a privately held medical device company in Norristown, Pa., that has developed a low-profile, bovine pericardial, self-expanding valve for transcatheter aortic valve implantation as a treatment option for aortic stenosis. Optimum TAV is designed to mimic the natural aortic valve. It could also be used in valve-in-valve procedures and bicuspid patients. The Company has also designed delivery systems for transfemoral, transapical, subclavian, and direct aortic access.