Halt Medical, Inc. announced today that on January 18, 2013, COFEPRIS, a division within the Mexican Ministry of Health (Secretaria de Salud) responsible for medical device oversight, issued registration for the Acessa System to treat symptomatic uterine fibroids.
"Mexico is the second largest market for medical devices in Latin America," said Jeffrey Cohen, Halt's Chief Executive Officer. "We are very excited to have the opportunity to expand our market reach to virtually all of North America." According to the Centers for Disease Control, fibroids are the leading cause for hysterectomy procedures worldwide. The Acessa System is used in a minimally invasive same-day surgery procedure where a slender Handpiece is used to deliver radiofrequency energy to the fibroid, after which the fibroid is re-absorbed by the surrounding tissue.
Acessa treats just the fibroids, preserving the normal function of the uterus. Patients typically go home the same day with little pain and experience rapid recovery and return to normal activities.
"The Acessa Procedure will be of great benefit to many women suffering from symptomatic uterine fibroids in Mexico," added Dr. Jose G. Garza Leal, Department of Gynecology and Obstetrics, Hospital Universitario Nuevo Leon, Monterrey, Mexico. "We look forward to the continued advancement of care for our fibroid patients with this technology." Cohen further stated, "From Canada to Mexico, over 10 million women are at risk to the debilitating symptoms of uterine fibroids; including heavy menstrual bleeding, pain, and bulking. According to 94% of the patients in our IDE trial, their symptoms were resolved following treatment with the Acessa Procedure." About Halt Medical, Inc.
Founded in 2004, Halt Medical is a medical device company focused on establishing a new standard of care for women with symptomatic uterine fibroids. The Company has developed and launched the Acessa System and Procedure, using radiofrequency energy to destroy uterine fibroids.
The results of both U.S. and international trials have led to the clearance of the product by the FDA for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa System also has regulatory approval to treat symptomatic uterine fibroids in the European Union, Canada, and Mexico. The Company is located in Brentwood, CA. For information about the Acessa System, please visit www.haltmedical.com.