Closure Medical Corp. (Nasdaq: CLSR) has received approval from the FDA to initiate a clinical study to support pre-market approval for its vascular sealant product, the company’s first to be used inside the body.
The FDA approval was based on the positive results of a ten-patient pilot study that Raleigh-based Closure completed enrollment in last December, the company said.
The upcoming study will enroll 150 patients, with four- and twelve-week follow-up visits, at approximately 14 medical institutions in the United States and Europe. Alan Lumsden of Baylor College of Medicine and the DeBakey Heart Center at the Methodist Hospital in Houston will act as the principal investigator of the study.
Closure says the study will assess the ability of the company’s biodegradable and transparent vascular sealant to prevent leakage following reconstruction of vascular structures in patients receiving femoral-popliteal bypass or arteriovenous access grafting.
“Attaining FDA approval to initiate the pivotal clinical study is a major milestone for the company,” said Daniel Pelak, president and CEO of Closure. “We are encouraged by the positive results of our pilot study and plan to enroll the first patient in the pivotal study within the next few weeks.”
Pelak says he expects Closure to complete the study by the end of 2004, and if all goes according to plan, to commence commercialization of the product outside the U.S. in 2005, upon receipt of European CE Mark approval.
With the FDA approval Thursday, shares of CLSR jumped almost $1 to near $30 in early trading. The stock’s 52-week range is from roughly $12 to $40.