Acessa Health

Dedicated to Women OBGYN completes first Acessa Procedures using Acessa ProVuTM in Delaware – Expanding minimally invasive uterine fibroid options for women at Delaware Surgery Center

Highmark Inc. health insurance overturned its medical policy and now covers the Acessa Procedure, also known as Laparoscopic Radiofrequency Ablation for Fibroids

February 11, 2018 – Dover, Delaware – Acessa Health Inc., developer of the Acessa System® and Dedicated Women ObGyn are excited to announce they completed the first Acessa Procedures for uterine fibroids using the latest Acessa ProVu technology in Delaware. In addition to first procedures in Delaware, Acessa Health Inc. is also proud to announce the medical policy decision by Highmark Inc., one of the largest insurance carriers in Delaware, Pennsylvania and West Virginia, to cover the procedure.

The Acessa Procedure, also known as laparoscopic radiofrequency ablation (RFA) for fibroids, is a minimally invasive procedure to treat uterine fibroids. Studies have shown over 70% of women have uterine fibroids(1). Uterine fibroids cause abnormal heavy menstruation, pelvic pain and bulk symptoms. Hysterectomy prevails as the primary surgical treatment in the United States, even though studies show women increasingly desire less invasive options. The Acessa Procedure revolutionizes the standard of care for fibroids. The Acessa Procedure treats 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.(2)

Dedicated to Women ObGyn is one of the largest OBYN groups in the North East with 17 providers and is nationally recognized for their Collaborative Care Approach. Dr. Laura Moylan and Dr. Robert Hartmann are the two physicians offering the Acessa Procedure for patients with surgeries being performed locally at the Delaware Surgery Center.

Dr. Laura Moylan and Dr. Robert Hartmann recently completed Acessa procedures marking the first in Delaware. Both patients had successful outcomes and are already seeing positive symptom relief.

“We are excited to bring this offering to women in the Delaware region,” said Dr. Moylan, who is a board certified OBGYN. “The Acessa System allows us to treat nearly all fibroids in nearly all locations. Before, when a patient came to us with symptomatic fibroids, I could offer her a myomectomy or hysterectomy, or I could refer them to a radiologist for uterine artery embolization (UAE). As a clinician, I would prefer to offer a less invasive option as a first line surgical treatment. Now, with the Acessa Procedure, I can offer them an outpatient, same day procedure that is proven to solve their fibroid symptoms. It is a game changer.”

“The technology is outstanding and aligns with our mission,” said Dr. Hartmann who has served patients in Dover for over 20 years. The Acessa ProVu system integrates radiofrequency ablation, laparoscopic ultrasound and guidance mapping. “Dedicated to Women’s mission is to provide exceptional, progressive women’s health care in a compassionate environment. With the Acessa Procedure, we are compounding our ability to provide exceptional care for women with fibroids.”

To schedule a consultation to evaluate if you have fibroids and if the Acessa Procedure is an appropriate treatment option, contact Dedicated to Women ObGyn at 302-674-0223.

Highmark Inc, with over 4.6 million members across Delaware, Pennsylvania, West Virginia overturned its policy and now covers the procedure. Highmark’s Medical Policy team conducted a third-party independent review of the technology, outcomes and clinical studies which resulted in overwhelming evidence that the Acessa system is safe, effective, and proven. This decision comes at a pivotal moment where women across the nation are seeking minimally invasive alternatives to hysterectomy.

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, Texas. For more information, visit AcessaProcedure.com.

Yelena Havryliuk, MD, Robert Setton, MD, John Carlow, EdD, MPH, Barry D. Shaktman, MD, Management of Symptomatic Fibroids: Review and Meta-Analysis of the Literature (2006 -2016), Journal of the Society of Laparoendoscopic Surgeons, Vol. 21 (3) Jul-Sept 2017

Day Baird D, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188(1):100–107. doi: 10.1067/mob.2003.99.

Contacts

Acessa Health, Inc. Kim Rodriguez, 877-412-3828 krodriguez@acessahealth.com

Acessa Health

Acessa Health Receives FDA Clearance For The Acessa Pro Vu System® – The Next- Generation Advancement In Uterine Fibroid Treatment Technology

Acessa ProVu System® Now Available to Treat Women Suffering from Symptomatic Uterine Fibroids.

October 2, 2018–AUSTIN, T.X., 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 to enable physicians to effectively and safely treat women with symptomatic uterine fibroids.  

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

Uterine fibroids affect 70–80% of women under the age of 55. Hysterectomy is the second most common surgery performed on reproductive-aged women and it continues to be the primary treatment for uterine fibroids in the United States, while less invasive alternatives are underutilized and often not discussed with patients. “The FDA clearance of Acessa ProVu is a significant step in terms of offering patients more minimally invasive options to address their fibroids” said Regina Benjamin, MD the 18th Surgeon General of the United States.

“The Acessa System is the most utilized and advanced procedure for laparoscopic radiofrequency ablation of symptomatic uterine fibroids. After treating over 300 cases 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’re 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 System

Unlike many alternative interventions, Acessa 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 smalls incisions, uses radiofrequency ablation (or heat) to destroy each targeted fibroid by applying controlled energy through a small needle array. The destroyed 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.

 

Contacts

Acessa Health Inc.

Kim Rodriguez

krodriguez@acessahealth.com

(877) 412-3828

Acessa Health

Acessa Health Receives FDA Clearance For The Pro Vu System® – The Next Generation Advancement In Uterine Fibroid Treatment Technology

Acessa ProVu System® Now Available to Treat Women Suffering from Symptomatic Uterine Fibroids.

September 28, 2018–AUSTIN, aT.X., 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 to enable physicians to effectively and safely treat women with symptomatic uterine fibroids.  

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

Uterine fibroids affect 70–80% of women under the age of 55. Hysterectomy is the second most common surgery performed on reproductive-aged women and it continues to be the primary treatment for uterine fibroids in the United States, while less invasive alternatives are underutilized and often not discussed with patients. “The FDA clearance of the Acessa ProVu is a significant step in terms of offer patients more minimally invasive options to treat fibroids” said Regina Benjamin, MD the 18th Surgeon General of the United States.

“The Acessa ProVu System is the most utilized and advanced procedure for laparoscopic radiofrequency ablation of symptomatic uterine fibroids. After treating over 300 cases 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.

“The next generation Acessa ProVu System provides a fully integrated and seamless approach to identifying and treating all available 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; in our initial experience, we saw easy tracking in complex conditions combined with an enhanced user interface, with the potential to optimize our overall treatment and reduce procedure times.”

“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 System

Unlike many alternative interventions, Acessa 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 smalls incisions, uses radiofrequency ablation (or heat) to destroy each targeted fibroid by applying controlled energy through a small needle array. The destroyed 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.

Contacts

Acessa Health, Inc.

Kim Rodriguez

krodriguez@acessahealth.com

310.897.8889

 

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Acessa Health

Congressional Black Caucus 2018 – Acessa Health Partners With The White Dress Project To Present On Healthcare Disparities And Uterine Fibroids

Exclusive Coverage of Healthcare Policy, Patient Access, Outcomes and Disparities in Treatment, Which Impact African American Women.

September 13, 2018–AUSTIN, TX – Acessa Health Inc., developer of the Acessa System®, announced today it is continuing its collaboration with The White Dress Project, a nonprofit group that promotes fibroid awareness and advocacy, to present a session at this year’s Congressional Black Caucus Annual Legislative Conference. Earlier this year, both organizations announced the launch of the Goodbye Fibroids initiative which aims to unite women, physicians and leaders to raise awareness and elevate the standard of care for uterine fibroids.

“We are focused on ensuring that women have access to all available treatment options for their uterine fibroids. Unfortunately, there is a well-established racial barrier to women receiving less invasive alternatives to hysterectomy and this joint session aims to elevate the discussion among civil leaders surrounding this disparity,” said Acessa Health President and CEO Kim Rodriguez.

The current racial disparities impacting uterine fibroids are significant and well established in medical literature. As an example, among women who underwent hysterectomy for benign indications, African American women were less likely to receive a minimally invasive hysterectomy compared to white women. They were also 40% more likely to develop complications, nearly three times as likely to have a long hospital stay, and three times as likely to die, even though African American women were younger on average1,2.

Tanika Gray Valbrun, founder of The White Dress Project, noted, “As a community we need to begin to address and change the clear, systematic and structural defect within the US healthcare system that disproportionately pushes women of color toward the most invasive option, which is hysterectomy.”

This session will bring together leaders such as Adrianna Hopkins, host of Good Morning Washington and fibroids patient; Dr. Alicia Christy, Deputy Director of Reproductive Health at the Veterans Administration; Dr. Nicole Williams from The Gynecology Institute of Chicago; and Patient Ambassadors from The White Dress Project, Rashetta Fairnot and Jennifer Branison.

“This multi-stakeholder panel brings together the perspectives of patients, physicians and policy makers to begin tackling this complex topic,” said Dr. Nicole Williams, Founder and CEO of The Gynecology Institute of Chicago. “I am honored to be included in this panel and I believe that in order to effect change we need to open discussions about what is contributing to the overuse of hysterectomy to treat fibroids.”

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

1 Rosemarie B. Hakim, PhD, M. Beth Benedict, DrPH, JD, and Nancy J. Merrick, MD, MSPH, Quality of Care for Women Undergoing a Hysterectomy: Effects of Insurance and Race/Ethnicity, Am J Public Health. 2004 August; 94(8): 1399–1405.

2 Whitney R. Robinson, Mariah M. Cheng, Annie Green Howard, William R. Carpenter, Wendy R. Brewster and Kemi M. Doll, For U.S. Black women, shift of hysterectomy to outpatient settings may have lagged White women: a claims-based analysis, 2011–2013, BMC Health Serv Res. 2017; 17: 526.

 

Contacts

Acessa Health, Inc.

Kim Rodriguez

krodriguez@acessahealth.com

310.897.8889

Acessa Health

This Fibroid Awareness Month, Acessa Health Partners With The White Dress Project To Launch The Goodbye Fibroids Education And Advocacy Initiative

Goodbye Fibroids aims to empower women to raise their voices, get the treatment they want, and elevate the standard of care for uterine fibroids.

July 10, 2018–AUSTIN, Texas–Acessa Health Inc., developer of the Acessa System®, announced today it is honoring Uterine Fibroid Awareness Month by partnering with The White Dress Project, a nonprofit group that promotes fibroid awareness and advocacy, to launch the Goodbye Fibroids initiative. Goodbye Fibroids will provide a forum for women to share their stories, learn about treatment options and patient-doctor discussions, and unite to raise awareness to elevate the standard of care for uterine fibroids.

“We are at a turning point where women are changing the conversation about reproductive healthcare, and uterine fibroids are a leading topic. Acessa is thrilled to partner with The White Dress Project to launch Goodbye Fibroids, a powerful new voice created to educate and empower women to pursue care that’s right for them,” said Acessa Health President and CEO Kim Rodriguez.

Uterine fibroids affect 70–80% of women under age of 55, and 15–30% experience severe symptoms, such as heavy bleeding, long periods, pelvic pain or pressure, and urinary complications.1-3 Hysterectomy, the second most common surgery performed on reproductive-aged women, continues to be the primary treatment for uterine fibroids in the United States, while less invasive alternatives are underutilized and often not discussed with patients.4 Soberingly, a retrospective study of over 3,000 women showed nearly 1 in 5 hysterectomies are unnecessary.4

Tanika Gray Valbrun, founder of The White Dress Project, noted, “Today, many women with uterine fibroids think hysterectomy is the only treatment, a misconception fostered by inadequate patient education and insurance access. Education and empowerment are powerful tools we are using to reverse this health crisis for millions of women. Goodbye Fibroids continues our organization’s work to build a community of women overcoming fibroids, drawing strength from each other and finding power in numbers.”

“Goodbye Fibroids joins two leaders in the fibroid realm who are supporting women get treatment that’s right for them – Acessa Health, through science, and The White Dress Project, through advocacy,” said Dr. Jessica Shepherd, a gynecologist at Baylor Scott & White Women’s Health Group in Dallas, Texas. “I perform the minimally invasive Acessa procedure for patients with symptomatic uterine fibroids because it preserves the uterus and results in less physical trauma and recovery time than hysterectomy. Women need and deserve to know that this and other treatment options exist, which is why I’m excited about Goodbye Fibroids.”

Uterine fibroids take a physical and psychological toll on sufferers. One study showed women had significant negative emotions about fibroids and about themselves.5 Half felt helpless about the condition.5 Goodbye Fibroids wants to shed light on those feelings and give women the tools they need to take control of this condition.

“Millions of women are suffering from uterine fibroids, keeping their experiences to themselves, and putting off treatment because they are afraid of major surgery,” said Dr. Regina M. Benjamin, former Surgeon General of the United States and Founder and CEO of BayouClinic, Inc., in Bayou La Batre, Alabama. “With the help of organizations like The White Dress Project and Acessa Health and initiatives like Goodbye Fibroids, I think women will speak up, make their voices heard, and fundamentally change how we approach uterine fibroids.”

 

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.

  1. Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188(1):100-7.
  2. Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol. 2013;209(4):319 e1- e20.
  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(3):211 e1-9.
  4. Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. American journal of obstetrics and gynecology. 2015 Mar;212(3):304, e301–307
  5. Ghant MS, Sengoba KS, Recht H, Cameron KA, Lawson AK, Marsh EE. Beyond the physical: a qualitative assessment of the burden of symptomatic uterine fibroids on women’s emotional and psychosocial health. J Psychosom Res. 2015 May;78(5):499-503.

 

Contacts

Pascale Communications, LLC

Audra Friis

audra@pascalecommunications.com

917.519.9577

Acessa Health

Acessa Health Expands Leadership Team with Key Executive Hires

AUSTIN, Texas–(BUSINESS WIRE)–Acessa Health Inc., developer of the Acessa System®, a comprehensive, minimally invasive treatment for uterine fibroids, today announced the company has strengthened its existing leadership team through the appointment of three experts in medical device and healthcare business operations. Ryan Graver has joined the company as vice president, market access and reimbursement; Kathleen Malaspina has been named chief innovation officer and vice president of marketing; and Brian Bergeron, has been appointed chief technology officer and vice president of operations.

“Ryan, Kathleen and Brian bring vital expertise to Acessa Health at an exciting time for the company, as we recently announced Medicaid programs adding 20 million more female covered lives to our Acessa procedure,” said Kim Rodriguez, president and chief operating officer of Acessa Health. “Our expanded team is poised to drive the clinical and commercial expansion of the Acessa procedure, fulfilling our mission to improve the standard of care for women who seek uterine-sparing solutions for uterine fibroids.”Market access expert Ryan Graver brings to the company more than two decades of diverse healthcare experience spanning care delivery, research, business development and strategy, consulting, payer policy, market access and healthcare economics. Before joining Acessa, Mr. Graver served as president of MedAxiom, where he led national strategic initiatives with more than forty industry partners spanning pharma, medtech, health IT and numerous health-related service organizations. Prior to that, he held a global leadership role with Zimmer; directed U.S. healthcare economics and reimbursement for St. Jude Medical; and held multiple positions in major health systems. Mr. Graver received his MPH in healthcare administration and pharmaceutical economics and a BA in communication and health policy from the University of Arizona.Seasoned marketing executive Kathleen Malaspina has over 25 years of international business experience, primarily in the consumer healthcare, medical device and technology sectors. She joins Acessa after filling the same role at OrthoAccel Technologies, Inc., an innovative Houston-based start-up ranked one of the fastest-growing companies in North America for the past three years. Previously, Ms. Malaspina held international operational management positions with Motorola, Sanyo and Philips. While global marketing director at Philips, she was instrumental in the development and growth of the Sonicare brand. Later, as president of Malaspina Healthcare Consulting, Inc., she created business growth strategies for clients such as LivaNova (previously Cyberonics) and Cardiac Science. Ms. Malaspina earned her BA at University of Pittsburgh and an International MBA from IESE Business School in Barcelona, Spain.

Experienced medical device development, manufacturing and operations executive Brian Bergeron has held senior leadership positions at Fortune 500 companies such as Boston Scientific and Abbott Laboratories. He was also a founder of two start-up companies, Genesys Orthopedics and Auspine, where he specialized in executing launch strategies for new medical technologies and became deeply involved in leading the development and commercialization of multiple diagnostic and implantable technologies. Mr. Bergeron earned a BS in mechanical engineering from Worcester Polytechnic Institute and holds an MS in engineering management from the University of Texas at Austin.

About the Acessa System

The Acessa System is the only radiofrequency ablation system cleared by the U.S. Food and Drug Administration 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 70 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. Founded by gynecologist Dr. Bruce Lee, a pioneer in treating fibroid tumors, Acessa Health introduced the use of radiofrequency ablation for the treatment of uterine fibroids and is continuing to develop technologies that will improve the lives of patients with uterine fibroids. Acessa Health’s headquarters is located in Austin, Texas.

Contacts

Nobles Global Communications
Diana Soltesz, 818- 618-5634
diana@noblesgc.com

Acessa Health

Acessa Procedure Now Available to 20 Million More Women as a Result of Medicaid Programs Adding Coverage

More than 70 Million covered women now have access to the most comprehensive uterine fibroid treatment option with the least invasive technique

AUSTIN, Texas–(BUSINESS WIRE)–Acessa Health Inc., developer of the Acessa System®, announced today that 32 state Medicaid programs have listed the Acessa procedure on their fee schedules, providing improved access to this minimally invasive, uterine sparing alternative option to hysterectomy to millions of women suffering from symptomatic fibroids. These Medicaid states join national carriers such as Aetna, Molina and Tricare as well as several Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, Montana, Michigan and South Carolina in covering the procedure.

Acessa procedure now available to an additional 20 million women in the US #fibroids #medicaid #acessa

Despite this substantial momentum of insurance coverage, inconsistencies in benefit administration continue across the country. Today, most state Medicaid programs are administered by large, for-profit insurance carriers. As an example of the significant inconsistency in patients’ access to care, a Medicaid patient in Texas who has her benefits administered by Cigna (Health-Spring) or United Healthcare (Community Plan) can have access to the Acessa procedure; however, women who pay for commercial insurance with Cigna or United Health will not have the procedure covered. Providers, patients and Acessa Health are actively working with commercial payers to ensure all women have access to the less invasive procedure.

“The expansion of Medicaid coverage for the Acessa procedure represents another significant step forward in terms of recognizing the medical necessity of this procedure as well as increasing the number of options women have as alternatives to hysterectomy,” said Ryan Graver, vice president of market access at Acessa Health. “We are committed to improving awareness of all available treatment pathways for women with symptomatic uterine fibroids.”

Hysterectomy is the second most common surgery performed on reproductive-aged women and continues to be the primary treatment for women with uterine fibroids in the United States. As a result, one in three women in the U.S. will have had a hysterectomy by age 60. Uterine fibroids have been shown to impact between 70% and 80% of women before they reach the age of 55 with severe symptoms occurring in 15–30% of these patients1,2,3. Recent studies have concluded that less invasive alternatives to hysterectomy are underutilized in women suffering from symptomatic uterine fibroids and that providers are in many cases are not discussing or offering patients these alternatives4.

The Acessa procedure is a minimally invasive, uterine sparing alternative option to hysterectomy. Acessa can treat almost all sizes and locations of fibroids, including those within the uterine walls. The procedure requires no cutting or suturing of uterine tissue, and patients typically go home the same day and have been shown to return to work and normal function within three to five days. FDA approved in 2012, the Acessa System has been used to successfully treat more than 2,000 women. A recent article published in the Journal of Minimally Invasive Gynecology noted that the Acessa procedure holds unique promise among surgeons because it avoids the need for fibroid enucleation (morcellation) and suturing, while retaining all the advantages of minimally invasive surgery5.

About the Acessa System

The Acessa System is the only radiofrequency ablation system cleared by the U.S. Food and Drug Administration 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 70 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 Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188(1):100-7.
2 Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol. 2013;209(4):319 e1- e20.
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(3):211 e1-9.
4 Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. American journal of obstetrics and gynecology. 2015 Mar;212(3):304, e301–307
5 Gingold JA, Gueye NA, and Falcone T, Minimally Invasive Approaches to Myoma Management, Journal of Minimally Invasive Gynecology, 2017 Jul 19. pii: S1553-4650(17)30394-1.

Contacts

Nobles Global Communications
Diana Soltesz, 818-618-5634
diana@noblesgc.com

Acessa Health

Acessa Health Inc. Announces Presentations at the 46th Annual AAGL Global Congress on Minimally Invasive Gynecology

Acessa Health Logo

Acessa Health Inc. Announces Presentations at the 46th Annual AAGL Global Congress on Minimally Invasive Gynecology
Four-Year Data on the Acessa® System to be Presented

AUSTIN, Texas – Nov. 14, 2017 – – Acessa Health Inc., developer of the Acessa® System, an innovative laparoscopic radiofrequency ablation procedure for the treatment of uterine fibroids, announced today that four-year data along with community based evidence will be presented at the 46th Annual Global Congress on Minimally Invasive Gynecology Meeting, Nov. 12-16 in National Harbor, Greater Washington, D.C.

Tuesday, Nov. 14, 2017 from 1:09 PM – 1:15 PM
Title: Laparoscopic Radiofrequency Ablation (Lap-RFA) of Symptomatic Myomas and Laparoscopic Myomectomy (LM): Long-Term Outcomes from a Randomized Trial of Uterine-Sparing Techniques
Authors: Bernard Krämer, MD; Felix Neis, MD; Andrei Taran, MD; Dorit Schöller, MD; Keith B. Isaacson, MD; Sara Brucker, MD
Wednesday, Nov. 15, 2017 from 9:57 AM – 10:03 AM
Title: Benefits to Treatment of Symptomatic Fibroids with Laparoscopic Radiofrequency Ablation (Lap-RFA) Alone and Lap-RFA Plus Concomitant Therapeutic Surgery: A Retrospective Comparative Cohort Analysis
Author: Alan Greenberg, MD

“We are thrilled with the continued positive and long-term accumulation of clinical evidence associated with the Acessa procedure,” said Kim Rodriguez, chief executive officer, Acessa Health. “Our team is committed to transforming the delivery of women’s healthcare services focused on the treatment of uterine fibroids. Our continued collaboration with AAGL and clinical leaders across the field of minimally invasive gynecologic surgeons is critical to ensure women have broader access to the Acessa procedure.”

 

Symptomatic uterine fibroids are a significant societal and healthcare burden, and there is no clear consensus among medical professionals as to which procedural treatment is most appropriate for each symptomatic patient.1 With an estimated cumulative incidence of up to 70% and 80% in white and African American premenopausal women, respectively, severe symptoms occur in 15 to 30% of these patients.2 3

 

Hysterectomy remains a primary treatment option for women who have completed childbearing. It offers a complete solution to existing and recurrent fibroids and concomitant disorders, including adenomyosis and cervical neoplasia. However, adverse events are common among hysterectomy patients. One study reported a 28% risk of complications (such as major blood loss, wound complications, and febrile episodes) as well as a 10% risk of transfusion among Medicaid patients undergoing abdominal hysterectomy.4
Because of the invasiveness and observed risks associated with hysterectomy, many women delay treatment. Most patients express a desire for treatment that does not involve invasive surgery and preserves the uterus.3

 

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’s headquarters are in Austin, Texas.

 

[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] Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100–7.
[3] Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol. 2013;209:319.e1–319.e20.
[4] Gliklich RE, Leavy MB, Velentgas P, et al. Identification of future research needs in the comparative management of uterine fibroid disease: a report on the priority-setting process, preliminary data analysis, and research plan. Report No. 31. Rockville, MD. Agency for Healthcare Research and Quality. 2011.

 

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

Acessa Health

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

Acessa Health

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