"We are glad the USPTO recognized the novelty of Optimum TAV’s design," stated Dr. 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.
Optimum TAV also demonstrated significantly lower pressure gradient and less calcification than approved valves, after 5 months in sheep. Dr. Susheel Kodali, a Company Medical Advisor, will present Optimum TAV on June 5 at the Transcatheter Valve Therapies Conference in Chicago.
The Company has completed nearly all required preclinical studies – within just $2 Million USD – and is in the process of raising funds to sponsor FIH studies.
In addition, the Company expects to obtain human data later this year from a partnership with a prominent South American cardiovascular company. The Company is currently in negotiations with a prospective partner in Asia; and is also evaluating various opportunities in other ex-US markets.
The Company has developed a low-profile, bovine pericardial, self-expanding valve for transcatheter aortic valve implantation (TAVI) – called the "Optimum TAV" – 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.
