Acessa Health Inc. Launches Comprehensive Fibroid Management Website

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ACESSA HEALTH INC. LAUNCHES COMPREHENSIVE FIBROID MANAGEMENT WEBSITE

Pioneer in Laparoscopic Radiofrequency Ablation of Uterine Fibroids

Offers Web-Based Resource on Minimally Invasive, Uterine-Sparing Treatment Options

AUSTIN, Texas – October 10, 2017 – Acessa Health Inc., developer of the Acessa System®, an innovative laparoscopic radiofrequency ablation procedure for the treatment of uterine fibroids, has launched a comprehensive website for fibroid management. The interactive site, AcessaProcedure.com, offers women and physicians a broad range of information about uterine fibroids and treatment options. Consistent with Acessa Health’s mission of advancing minimally invasive, uterine-sparing solutions for the treatment of symptomatic fibroids, AcessaProcedure.com is designed to educate and empower women who seek to end their suffering from uterine fibroids without major surgery.

 

“Our team is driven to help women better understand all available treatment options, especially those that are uterine-sparing such as the Acessa procedure,” said Kim Bridges Rodriguez, chief executive officer of Acessa Health. “With the newly relaunched AcessaProcedure.com website, we seek to continue increasing awareness and education while connecting patients with physicians who are redefining the standard of care in fibroid management.”

 

According to the Women’s Health Journal, women with symptomatic fibroids wait, on average, more than 3.6 years before seeking treatment, mainly due to fear of surgery and time away from life.[1] The Acessa procedure offers a safe, effective, and minimally invasive treatment option. Acessa can treat almost all sizes and locations of fibroids and requires no cutting or suturing of uterine tissue. Patients typically go home the same day, experience minimal discomfort and a rapid return to normal activities. More than 2,000 women have been successfully treated with the Acessa System.

 

The new Acessa Health website includes a broad spectrum of information and tools to help patients and healthcare providers learn more about fibroids. For patients, key features of the site include:

 

For physicians, unique site areas include:

 

For more information, please visit AcessaProcedure.com.

 

About the Acessa System
The Acessa System is the only radiofrequency ablation system cleared by the U.S. Food and Drug Administration, and CE marked for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. It has been the subject of 21 peer-reviewed publications across 750 study patients. In January 2017, the American Medical Association (AMA) issued a new Category 1 CPT code specifically for Laparoscopic Radiofrequency (RF) Ablation of Uterine Fibroids, paving the way for the Acessa procedure to become the standard of care for as many as 30 million women in the United States. For more information, visit AcessaProcedure.com.

 

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.

[1] The Impact of Uterine Leiomyomas: A National Survey of Affected Women, Bijan J. Borah, PhD,1 Wanda K. Nicholson, MD, MPH, MBA,2 Linda Bradley, MD,3 and Elizabeth A. Stewart, MD4, Am J Obstet Gynecol. 2013 Oct; 209(4): 319.e1–319.e20.

(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4167669/)

 

MEDIA CONTACT:
Diana Soltesz
Nobles Global Communications
diana@noblesgc.com
818-618-5634

NEW EVIDENCE POINTS TO LESS INVASIVE MANAGEMENT FOR 
WOMEN SUFFERING FROM UTERINE FIBROIDS

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Hysterectomies represent the second most common women’s surgical procedure performed annually, despite results favoring minimally invasive, outpatient, uterus-preserving treatment options

AUSTIN, Texas – Oct. 3, 2017 – The Journal of the Society of Laparoendoscopic Surgeons has released a publication led by Dr. Yelena Havryliuk and her colleagues from the Weill Cornell Medical College, “Symptomatic Fibroid Management: Systematic Review of the Literature.” The authors set out to define the standard of care in treating symptomatic uterine fibroids (see the publication here).

The authors conducted a 10-year systematic review with a meta-analysis[1] that compared results across multiple studies and evaluated therapeutic approaches offering the most patient benefit. The authors assessed 143 articles between January 2006 and January 2016 which resulted in 45 papers qualifying a robust quantitative analysis. The results from hysterectomy trials were compared with those from uterine-preserving fibroid studies that included myomectomy, uterine artery embolization (UAE), laparoscopic radiofrequency ablation (Lap-RFA) and magnetic resonance-guided focused ultrasound (MRg-FUS). The authors concluded that procedures with short or no hospital stay, low complication and reintervention rates, and high levels of patient satisfaction in controlling symptoms may become the first line approaches for treating uterine fibroids.

Women’s health issues have recently taken center stage and underpin major issues facing the U.S. healthcare system. Hysterectomies are the second most common women’s surgical procedure in the U.S., with more than 400,000 inpatient surgeries performed annually. The overwhelming indication is symptomatic fibroids [2]. Despite these numbers, many women put off treatment because of the invasiveness and observed risks. Studies have shown women desire a treatment that does not involve invasive surgery, preserves the uterus and preserves fertility[3].

The Lap-RFA procedure, also known as the Acessa® System, stood out in the publication. The Acessa procedure is a minimally invasive, uterine sparing option for women. Unlike many alternative interventions, Acessa can treat almost all sizes and locations of fibroids, including those outside the uterine cavity and within uterine walls. 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. FDA approved in 2012, the Acessa System has been used to successfully treat more than 2,000 women.

Dr. Havryliuk and her colleagues concluded that the Lap-RFA procedure was associated with low complication rates, minimal blood loss and low re-intervention rates. In addition, patients reported major improvement in their quality of life and symptom severity scores compared to reports of more traditional interventions, such as hysterectomy, myomectomy and UAE.

“Barriers such as negative coverage policies from commercial insurers that limit women’s access to less invasive, appropriate and effective care continues to be a major issue in the U.S.,” said Ryan Graver, vice president market access and reimbursement. “At Acessa Health, we are working with physicians and commercial insurers to expand women’s treatment options. We believe this study continues to build on the body of evidence that the Acessa procedure should be a first-line therapy for women suffering from symptomatic uterine fibroids.”


[1] Havryliuk Y, Setton R, Carlow JJ, Shaktman BD. Symptomatic fibroid management: systematic review of the literature. J Soc Laparoenosc Surg. 2017;21(3): e2017.00041
[2] Wright JD, Herzog TJ, Tsui J, Ananth CV, Lewin SN, Lu YS, Neugut AI, Hershman DL. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2):233–41.
[3] The Impact of Uterine Leiomyomas: A National Survey of Affected Women, Bijan J. Borah, PhD,1 Wanda K. Nicholson, MD, MPH, MBA,2 Linda Bradley, MD,3 and Elizabeth A. Stewart, MD4, Am J Obstet Gynecol. 2013 Oct; 209(4): 319.e1–319.e20 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4167669/)

About the Acessa System

The Acessa System is the only radiofrequency ablation system cleared by the U.S. Food and Drug Administration and CE marked for use of percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. It has been the subject of 21 peer-reviewed publications across 750 study patients. In January 2017, the American Medical Association (AMA) issued a new Category 1 CPT code specifically for Laparoscopic Radiofrequency (RF) Ablation of Uterine Fibroids, paving the way for the Acessa Procedure to become the standard of care for as many as 30 million women in the United States. For more information, visit AcessaProcedure.com.
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’s headquarters are in Austin, TX.

MEDIA CONTACT:
Diana Soltesz
Nobles Global Communications

diana@noblesgc.com

818-618-5634

Acessa Health Inc. Technology Featured in Ten-Year Review of Symptomatic Fibroid Management

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Acessa Health Inc. Technology Featured in Ten-Year Review of Symptomatic Fibroid Management
Acessa Procedure Demonstrated Minimal Blood Loss, Shorter Hospitalization, Low Readmission and Re-intervention Rates

AUSTIN, Texas – Sept. 7, 2017 – Acessa Health Inc., developer of the Acessa® System, announced today that its laparoscopic radio frequency ablation technology was featured in a ten-year systematic review and meta- analysis of treatment options for uterine fibroids. The review, presented at MIS Week 2017 by Dr. Yelena Havryliuk of Weill Cornell Medical College, included an assessment of 143 journal articles from 2006 to 2016 and featured a quantitative synthesis (meta-analysis) of 45 studies during that period.

The weighted combined results from hysterectomy trials were compared with those from uterine-preserving fibroid studies including myomectomy, uterine artery embolization (UAE), laparoscopic radiofrequency ablation (Lap-RFA), and magnetic resonance-guided focused ultrasound (MRg-FUS). Key findings of the review include:

  • Mean estimated blood loss following hysterectomy and myomectomy procedures exceeded 269 mL and 175 mL, respectively; Acessa’s Lap-RFA technology averaged 35 mL (nearly 8 times less than hysterectomy);
  • Hospitalization after hysterectomy, myomectomy, and UAE averaged 2.0 – 2.4 days whereas Acessa’s Lap- RFA procedure was performed on an outpatient basis in all cases studied;
  • Weighted average re-intervention rates after UAE and MRg-FUS ranged from 14.8% to 30.5% at 13-14 months whereas Acessa’s Lap-RFA averaged only 4.2% at 27-35 months;
  • Readmission rates within 90 days of discharge for MRg-FUS, UAE, and myomectomy procedures were 7.4%, 3.4%, and 2.7%, respectively, whereas Acessa’s Lap-RFA was 0.7%; and
  • Patients treated with Acessa’s Lap-RFA reported superior improvement in health-related quality of life and symptom severity scores relative to patients receiving hysterectomy, myomectomy or UAE.

The Acessa team is thrilled with the results of this comprehensive data review that overwhelmingly supports our technology as a superior intervention for women with symptomatic fibroids,” said Kim Rodriguez, chief executive officer of Acessa Health Inc. “Acessa has been featured in more than 20 peer reviewed studies supporting its use. Dr. Havryliuk’s meta review provides yet another encouraging data point as we seek to redefine the standard of care for millions of women suffering from fibroids.

I have used the Acessa System and been impressed with minimal blood loss, quick recovery, low re- intervention rates, and resolution of symptoms expressed by my patients,” said Dr. Havryliuk.

Uterine fibroids are typically benign tumors that can cause heavy menstrual bleeding, painful periods, uncomfortable pressure, and distention of the abdomen.[1] Approximately 70 percent of women in the U.S. will develop fibroids by age 50; prevalence is higher among African Americans.[2] Annual direct and indirect costs of symptomatic fibroids in the U.S. are estimated to exceed $34 billion [3].

The Acessa System offers a safe, effective, and minimally invasive treatment. With Acessa, physicians use a laparoscopic instrument to deliver radiofrequency energy to fibroids. After the procedure, treated fibroids shrink and are reabsorbed by surrounding tissue.

Unlike many alternative interventions, Acessa can treat almost all sizes and locations of fibroids, including those outside the uterine cavity and within uterine walls. 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. More than 1,700 women have been successfully treated with the Acessa System.

About the Acessa System
The Acessa System is the only radiofrequency ablation system cleared by the U.S. Food and Drug Administration and CE marked for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. It has been the subject of 20 peer-reviewed publications across 750 study patients. In January 2017, the American Medical Association (AMA) issued a new Category 1 CPT code specifically for Laparoscopic Radiofrequency (RF) Ablation of Uterine Fibroids, paving the way for the Acessa procedure to become the standard of care for as many as 30 million women in the United States. For more information, visit acessaprocedure.com.

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 patients. Acessa Health is headquartered in Austin, TX.

1 www.womenshealth.gov
2 Baird DD et al. High cumulative incidence of uterine leiomyoma in black and white women: Ultrasound evidence. Am J Obstet Gynecol 2003; 188 (1):100-107.
3.Cardozo ER, Clark AD, Banks NK, Henne MB, Stegmann BJ, Segars JH. The estimated annual cost of uterine leiomyomata in the United States. Am J Obstet Gynecol. 2012;206:211.e1-211.e9

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MEDIA CONTACT:

Diana Soltesz
Nobles Global Communications
Email: diana@noblesgc.com
Phone: 818-618-5634

Acessa Health, Inc. Acquires the Acessa® System for Treatment of Symptomatic Uterine Fibroids

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ACESSA HEALTH INC. ACQUIRES THE ACESSA® SYSTEM FOR TREATMENT OF SYMPTOMATIC UTERINE FIBROIDS
Company Completes Asset Purchase Agreement with Halt Medical Inc.

AUSTIN, Texas – June 22, 2017 – Acessa Health Inc. announced today that it has acquired the Acessa® System for the treatment of symptomatic uterine fibroids, following the close of an asset purchase agreement with Halt Medical Inc. Concurrent with the acquisition, Acessa Health completed the first closing of a planned $30 million Series A financing with a syndicate of institutional venture investment firms. The company plans to expand the Acessa clinical portfolio, develop next generation technology, and broaden commercial adoption of the Acessa procedure.

“This is a great day for the millions of women currently suffering from symptomatic fibroids, who will now have access to a less invasive, uterine-sparing solution,” said Kim Bridges, chief executive officer of Acessa Health. “With substantial clinical and commercial momentum behind us, together with an exceptional investor base, Acessa is poised to improve the standard of care in a clinical segment that has not seen significant innovation in decades.”

Acessa Health is leading an innovative radiofrequency ablation therapeutic category that aims to free women from the debilitating symptoms of fibroids while preserving the uterus. Its Acessa procedure is a safe, effective and minimally invasive alternative to both hysterectomy and myomectomy. With Acessa, physicians use a laparoscopic instrument to deliver radiofrequency energy to fibroids. After the procedure, treated fibroids shrink and are reabsorbed by surrounding tissue.

Unlike many alternative interventions, Acessa can treat almost all sizes and locations of fibroids –including those outside the uterine cavity and within uterine walls. 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. More than 1,500 women have been successfully treated with the Acessa System.

Bruce Lee, M.D., Acessa inventor and board-certified gynecologist, will join the company as a medical advisor. “This is an exciting new chapter for Acessa and the many millions of women around the world who suffer from symptomatic fibroids,” said Dr. Lee. “I’m thrilled to be part of the new Acessa Health team, advancing this important technology, and making the Acessa procedure available to women who stand to benefit from it.”

About the Acessa System
The Acessa System is the only radiofrequency ablation system cleared by the U.S. Food and Drug Administration and CE marked for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. It has been the subject of 20 peer-reviewed publications across 750 study patients. In January 2017, the American Medical Association (AMA) issued a new Category 1 CPT code specifically for Laparoscopic Radiofrequency (RF) Ablation of Uterine Fibroids, paving the way for the Acessa procedure to become the standard of care for as many as 30 million women in the United States. For more information, visit acessaprocedure.com.

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 is headquartered in Austin, Texas.

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MEDIA CONTACT:

Diana Soltesz
Nobles Global Communications
Email: diana@noblesgc.com
Phone: 818-618-5634