Halt Medical, Inc. Announces First Clinical Experience for the Halt Fibroid System™ in Canada
Procedures performed in preparation for a proposed clinical trial to demonstrate clinical and economic benefits of the procedure.
Livermore, CA (PRWEB) June 29, 2012
Halt Medical, Inc. announced today the first clinical experience for the Halt Fibroid System in Canada. Licensed in September 2011 for use in Canada, the system utilizes RF energy to ablate symptomatic uterine fibroids. The procedures were performed in preparation for a proposed clinical trial to demonstrate the clinical and economic benefits of the procedure. Over 7.8 million women in North America suffer from symptoms of uterine fibroids, with no clear alternative to more-invasive myomectomy and hysterectomy procedures.
"We are truly excited to be the first site in Canada to perform this unique procedure for treating symptomatic uterine fibroids," said John Thiel, MD FRCSC, Clinical Professor of Obstetrics, Gynecology, and Reproductive Sciences, Department of Obstetrics and Gynecology, Regina Qu'Appelle Health Region, University of Saskatchewan, Regina, Saskatchewan, Canada. "Fibroid ablation may offer many benefits to patients and healthcare systems; including resolution of symptoms such as abnormal uterine bleeding and pelvic pain, significantly-improved quality of life, and very low re-intervention rates. Our patients tolerated the procedure well and returned to normal activity after only a few days. We look forward to further opportunities to offer our patients this breakthrough therapy."
Jeff Cohen, Halt Medical CEO, added, "While we see opportunities to expand the clinical studies for global fibroid ablation (GFA), this marks the first evaluation cases for the Halt fibroid System. With approval in Canada and Europe, we will begin measured market introductions of this exciting technology; and introduction in the U.S. is pending FDA clearance. Our commercialization initiatives are in final planning stages, and we hope to begin generating revenue in late 2012."
About Halt Medical, Inc.
Founded in 2004, Halt Medical is a medical device company focused on women's health. The company has developed a procedure and related equipment for treating uterine fibroids that is more effective and less invasive than other alternatives – the Halt Fibroid System. In June 2010, the U.S. Food and Drug Administration cleared the Halt 2000GI™ Electrosurgical System for soft tissue ablation using radiofrequency energy. The results of Halt Medical's international studies have led to recent approvals for treating uterine fibroids in Canada and the European Union. The company recently completed a 137 patient IDE clinical trial at 11 sites in 3 countries to demonstrate clinical safety and efficacy in the treatment of symptomatic uterine fibroids. The company will file for FDA clearance in the coming months. The Company is located in Livermore, CA.
Information about the Halt Fibroid Study may be found at http://www.clinicaltrials.gov, study number NCT00874029.
CONTACT: Jeffrey M. Cohen, CEO of Halt Medical, Inc., jcohen(at)haltmedical(dot)com, (925) 634-7943