February 4, 2013 -- Vascular Nanotransfer Technologies (VNT) says it has developed the industry’s most versatile Drug-Coated-Balloon (DCB) platform designed to deliver a wide variety of drugs for best-in-class DCB applications.
“We are the first drug-coated-balloon technology capable of nano-encapsulation of different antiproliferative drugs designed to achieve optimal therapeutic tissue levels over time,” says VNT’s CEO, John A. Williams. “We are truly the world’s first drug ‘eluting’ balloon platform.”
While Williams declined at this time to disclose the company’s initial application of its DCB platform technology “because we are talking to a number of strategics,” he explained that the company is able to produce nanocrystals of a wide variety of drugs that are encapsulated within organic nanocarriers and uniformly deposited on the surface of VNT’s balloon.
Prior to VNT, Williams was president and CEO of Ovatech LLC. Previously, he was CEO of Cappella and Physiometrix. Earlier in his career, he was employed by Medtronic (Andover Medical) and Johnson &?Johnson. A serial entrepreneur with both operational and fundraising successes, Williams has: led a successful IPO; raised more than $80 million for his companies; and sold three of his companies for handsome profits.
According to Williams, VNT is focused solely on Drug-Coated Balloons, which are emerging as the ideal therapeutic tool for patients with coronary in-stent restenosis (ISR) and peripheral vascular disease. However, despite the success of first-generation DCBs in clinical trials, they exhibit significant limitations related to the precision of drug delivery and tissue retention, raising concerns about overall vascular safety. There is a need for the development of reliable coatings that allow for controlled drug delivery at a lower dose and minimal dislodgement of the coating into the distal vessel.
“There are currently no DCBs approved for use in the U.S.,” says Williams. “While current DCBs show great promise, there are regulatory?concerns about the limitations of balloon coating technologies to maintain a reproducible dose throughout the balloon length and thus precisely transfer a drug to the targeted blood vessel tissue. VNT’s proprietary balloon coating addresses these limitations.”
VNT’s proprietary nanocoating technology makes possible DCBs that are designed with enhanced drug delivery and performance characteristics compared to currently marketed DCBs, according to Williams. “We expect to begin site enrollment imminently for VNT’s First-In-Man clinical trial with our initial application, which we cannot disclose at this time.”
There are currently no DCBs approved for use in the U.S. While current DCBs show great promise, there are FDA?concerns about the limitations of balloon coating technologies to maintain a reproducible dose throughout the balloon length and thus precisely transfer a drug to the targeted blood vessel tissue. VNT’s proprietary balloon coating addresses these limitations; in vivo data are extremely promising.
VNT’s Scientific Advisory Board is comprised of three eminent cardiologists: Juan F. Granada, M.D., Executive Director and Chief Scientific Officer, Skirball Center for Cardiovascular Research at the Cardiovascular Research Foundation (CRF); and, Assistant Professor of Medicine, Cardiology, Columbia University College of Physicians and Surgeons; Gregg W. Stone, M.D., Director, Cardiovascular Research and Education, Center for Interventional Vascular Therapy (CIVT) at New York Columbia-Presbyterian Hospital and Cardiovascular Research Foundation (CRF); Professor of Medicine, Columbia University Medical Center; and, Co-Director, annual “TCT” symposium; William A. Gray, M.D., Director, Endovascular Interventions, Center for Interventional Vascular Therapy (CIVT) at New York Columbia-Presbyterian Hospital; Associate Professor, Columbia University School of Medicine; reviewer: Journal of the American Medical Association (JAMA), Journal of the American College of Cardiology (JACC), and Circulation.