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Acessa Health Receives FDA Clearance for the Acessa ProVu System® - The Next Generation Advancement in Uterine Fibroid Treatment

October 2, 2018

AUSTIN, Texas--(BUSINESS WIRE)--Oct 2, 2018--Acessa Health Inc., developer of the Acessa System ®, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) and U.S. commercial availability of the Acessa System’s most advanced and proprietary technology, the Acessa ProVu System. A fully-integrated radiofrequency ablation, ultrasound visualization, and guidance mapping system, Acessa ProVu enables physicians to effectively and safely treat women with symptomatic uterine fibroids.

The Acessa Procedure™ is specifically designed to treat women suffering from uterine fibroids and is clinically proven with long-term data as a safe alternative to hysterectomy. Nearly 3,000 procedures have been performed to-date. Acessa ProVu is the third generation of Acessa’s minimally invasive, laparoscopic radiofrequency ablation solution – and is the first and only solution with a category 1 CPT reimbursement code and widely established coverage.

“The FDA clearance of Acessa ProVu is a significant step forward in terms of offering patients more minimally invasive options to address their fibroids,” said Dr. Regina Benjamin, MD, 18 th Surgeon General of the United States.

Uterine fibroids affect 70–80% of women under the age of 55. In the U.S., hysterectomy has historically been the primary treatment for fibroids. As a result, hysterectomy is the second most common surgery performed on reproductive-aged women. The Acessa Procedure™ is a safe, effective, and minimally invasive alternative. The procedure requires no cutting or suturing of uterine tissue and patients typically go home the same day, experiencing minimal discomfort and a rapid return to normal activities.

“The Acessa System is the most utilized and advanced procedure for laparoscopic radiofrequency ablation of symptomatic uterine fibroids. After personally treating over 300 patients to-date, I am thrilled to incorporate the Acessa ProVu System in my practice,” said Dr. Abraham Shashoua, Director of Minimally Invasive and Robotic Gynecologic Surgery at Advocate Illinois Masonic Medical Center.

“We have seen substantial benefits of laparoscopic radiofrequency ablation for the treatment of symptomatic fibroids,” said David Eisenstein, MD the Director of Henry Ford Health System’s Center of Excellence in Minimally Invasive Gynecology. “As the Principal Investigator of TRUST and Co-Investigator of COMPARE-UF, two large fibroid treatment studies, we are excited for Acessa ProVu, which integrates imaging and energy into one system which will improve surgeon efficiency and accuracy in providing this minimally invasive option to patients.”

“Acessa Health is delighted to usher in our next phase of innovation with the introduction of Acessa ProVu,” said Kim Rodriguez, President and Chief Executive Officer of Acessa Health Inc. “Each phase of innovation – the original Acessa System, Acessa Guidance System and now the Acessa ProVu System – represent a significant improvement in performance and the opportunity to further support our physician partners who help women suffering from uterine fibroid symptoms.”

About Acessa ProVu Procedure

Unlike many alternative interventions, the Acessa ProVu System can treat nearly all sizes and locations of fibroids – including those outside the uterine cavity and within uterine walls. The Acessa procedure is a minimally invasive, outpatient treatment that involves two small incisions and uses radiofrequency ablation (i.e., heat) to destroy each targeted fibroid by applying controlled energy through a small needle array. The treated tissue may then be completely reabsorbed. There is no cutting or suturing of uterine tissue, patients experience minimal post-procedure discomfort and typically return to normal activities in 3-5 days.

About Acessa Health Inc.

Acessa Health is a women’s health innovator dedicated to advancing minimally invasive, uterine-sparing solutions for women with symptomatic fibroids. The company introduced the use of radiofrequency ablation for the treatment of uterine fibroids and is continuing to develop technologies that improve the lives of its patients. Acessa Health’s headquarters are in Austin, TX. For more information, visit AcessaProcedure.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181002005690/en/

CONTACT: Acessa Health Inc.

Kim Rodriguez, 877-412-3828

krodriguez@acessahealth.com

KEYWORD: UNITED STATES NORTH AMERICA TEXAS

INDUSTRY KEYWORD: WOMEN VENTURE CAPITAL HEALTH MEDICAL DEVICES RADIOLOGY OTHER HEALTH PROFESSIONAL SERVICES FDA CONSUMER

SOURCE: Acessa Health Inc.

Copyright Business Wire 2018.

PUB: 10/02/2018 10:24 AM/DISC: 10/02/2018 10:24 AM

http://www.businesswire.com/news/home/20181002005690/en

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