Halt Medical, Inc. Announces BlueCross & BlueShield of IL, TX, OK, NM and MT Issue Positive Coverage Decisions for the Acessa™ Procedure for Women with Symptomatic Fibroids

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Oct 16, 2014, 08:50 ET

LIVERMORE, Calif., Oct.16, 2014 /PRNewswire/ -- Halt Medical, Inc. announced today that BlueCross & BlueShield of Illinois, Texas, Montana, New Mexico and Oklahoma, part of Health Care Service Corporation (HCSC), published updates to their Laparoscopic and Percutaneous Techniques for the Treatment of Uterine Fibroid Policies, and are now providing benefits for Halt Medical's Acessa™ Procedure as a treatment option for women with symptomatic uterine fibroids effective October 15, 2014.

Treat all the fibroids - just the fibroids.

HCSC is the fourth largest health insurance company in the United States with more than 14.5 million members. HCSC offers a wide variety of insurance products through BlueCross & BlueShield of Illinois, Texas, Montana, New Mexico, and Oklahoma.

"The decision from this leading insurer is a welcomed recognition of demonstrated clinical and cost benefits of the Acessa Procedure, a minimally invasive treatment for women with symptomatic uterine fibroids," said Jeffrey M. Cohen, Chief Executive Officer of Halt Medical, Inc. "Over the past several months, most major insurers have provided benefits for Acessa on a case-by-case basis, which is a time-consuming process for physicians and their staff. With the policy update from HCSC, in addition to Aetna's and Coventry's recent policy announcements, Acessa is now a timely and viable option available to a greater number of women." Bruce B. Lee, MD, inventor of the Acessa Procedure said: "Rigorous clinical studies and experience of my own patients with extensive fibroids have proven that Acessa is safe and effective with the additional advantages of mild postoperative pain and rapid recovery. This coverage policy brings much-needed benefits to women who currently suffer from the pain, bleeding, and emotional distress caused by fibroids."

The Center for Medicare and Medicaid Services (CMS) has provided coverage for the Acessa Procedure since July 2013, and updated the Ambulatory Payment Classification (APC) schedule to include coverage and payment for Acessa services reported under CPT 0336T. This change occurred pursuant to the recommendations of the American Medical Association's development of separate and unique reporting for the Acessa Procedure, which went into effect on January 1, 2014.

Halt Medical is working with independent physicians to conduct independent post-market studies of the Acessa Procedure, including randomized controlled trials and registry data collection. The Company has recently concluded a three-year follow up on patients treated with Acessa during the pivotal trial.

About the Acessa Procedure

The Acessa Procedure is a minimally invasive laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids. After treatment, the fibroid is re-absorbed by the surrounding tissue. Acessa allows the surgeon to treat only the fibroids, while preserving normal function of the uterus. Patients typically go home the same day with little pain, and enjoy a rapid return to normal activities. The Acessa System is FDA-cleared for the treatment of symptomatic uterine fibroids and is now available at leading medical centers throughout the U.S.

About Uterine Fibroids

Fibroids are benign, non-cancerous tumors in a woman's uterus that often appear during childbearing years. Also called leiomyomas, fibroids are made up of muscle and connective tissue and may range in size from microscopic to larger than a grapefruit. The rate at which they grow is unpredictable, and a woman may have more than one fibroid at a time. While some fibroids are asymptomatic, others can be very painful and cause heavy bleeding, pressure on the bladder or rectum, a distended abdomen, and a lack of energy stemming from anemia. The majority of American women will develop fibroids at some point in their lives. According to the National Institutes of Health (NIH), at least 70 percent of women in the U.S. will develop fibroids by age 50, and the prevalence is even higher among African American women.

About Halt Medical, Inc.

Founded in 2005, Halt Medical is a medical device innovator 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, Mexico and Israel. The Company is located in Brentwood, CA. For information about the Acessa Procedure, please visit www.haltmedical.com.

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SOURCE Halt Medical, Inc.