Announces 180-Day Follow-up First-In-Man Data
SANTA ROSA, Calif.--(BUSINESS WIRE)--Sapheon Inc. announced successful enrollment in a 30-patient, prospective, single-arm clinical study of the Sapheon Closure System - a single-use, minimally invasive approach to the treatment of saphenous vein reflux disease. The Sapheon Closure System consists of a proprietary vein sealant and custom delivery system that eliminates the need for painful and time consuming deep tissue injections of tumescent anesthesia. The procedure is performed under ultrasound imaging guidance and requires only local anesthesia at the catheter entry site. The study was conducted by leading physician-investigators from the United States and Germany at the Clinica Canela in the Dominican Republic under local bio-ethics committee and government approvals as well as U.S. Food and Drug Administration clinical trial export permitting. The fully monitored study is overseen by a U.S.-based Data Safety Monitoring Board and is being conducted to support the international regulatory approvals and marketing efforts of the Company.
Sapheon reports that complete closure of the great saphenous vein was accomplished with no adverse events in all patients. All patients were fully ambulatory and released home immediately post-procedure with only a Band-Aid after the 20-minute treatment. Twenty-nine patients returning for monitoring 24-72 hours post-procedure were examined by ultrasound imaging; all treated vein segments remained closed with no reports of discomfort or severe adverse events. Patients reported relief of venous reflux symptoms as early as 24 hours post procedure.
Dr. Rodney Raabe, Sapheon's Chief Medical Officer said, "Eliminating significant pain, tumescent anesthesia, compression stockings, and extended recovery time for patients who require treatment of the saphenous vein is a tremendous accomplishment and an unmatched medical benefit. Physicians familiar with current treatment methods will be able to learn and use the Sapheon approach with minimal training." Dr. Thomas Proebstle of the University of Mainz, Germany, commented "The Sapheon procedure has the potential to completely revolutionize the treatment of vein disease and varicosities. We are very excited to adopt and begin treating patients with the Sapheon Closure System in Germany later this year after CE Marking."
Sapheon also announced follow-up results in an eight patient human safety trial commenced in December 2010. At the 180-day follow-up visit, 100% of the treated great saphenous vein segments remained completely closed by ultrasound criteria. All patients reported a substantial reduction in symptoms compared to baseline. No device or procedure related adverse events were reported at this interval.
"We are very excited to have developed a commercially viable medical device for the treatment of saphenous vein disease that can effectively address the 1,000,000 new patients each year who undergo invasive and painful surgery or ablation procedures," said Don Crawford, President and CEO of Sapheon. "The Sapheon Closure System eliminates pain, the need for patient sedatives, and post procedure compression hose. We believe that the approach embodied in the Sapheon Closure System is the future of vein disease treatment."
In a statement, the study's chief clinical investigator Dr. Jose I. Almeida of Vascular Device Partners said: "Last week we performed a carefully controlled cohort study of 30 patients with incompetent great saphenous veins and signs and symptoms of chronic venous disease. Thirty great saphenous veins were treated with a new proprietary medical adhesive. At the 24-hour follow-up all veins were closed, and most notable was the absence of pain and ecchymosis in the treated areas. The procedures were easy to perform and no complications were noted. Sapheon is currently in the process of obtaining a CE Mark for the product to commence sales in the OUS market. We anticipate that the product will be well received overseas."
Sapheon is an early stage medical device company whose mission is to develop new approaches for the treatment of vascular disease. Our current focus is on developing technology to improve the treatment of venous reflux disease. Sapheon's newly developed vein closure technology responds to the inadequacies of existing venous reflux treatment options by using a catheter-based, single-use disposal medical device to close and eliminate the saphenous vein without burning or the use of harsh chemicals. Please visit www.sapheoninc.com to learn more about our business.