Acessa Health

New Clinical Results from the Acessa System to be Presented at AAGL Global Congress on Minimally Invasive Gynecology

AUSTIN, Texas – Nov. 11, 2019 – Acessa Health Inc., developer of the Acessa ProVu® System, announced today that clinical results after the Acessa Procedure will be the focus of two presentations at the 2019 American Association of Gynecologic Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology Nov. 11-13, 2019 in Vancouver.

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 and myomectomy. Over 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. It has been the subject of 47 peer-reviewed publications across 850 study patients.

“Twenty nineteen has been a pivotal year for Acessa Health with the availability of the Acessa ProVu® System and the growing demand from physicians and women who see the benefits of this treatment option for fibroids,” said Kim Rodriguez, President and CEO, Acessa Health. “The presentations at AAGL showcase the growing amount of real-world clinical evidence as well as the proven safety of the procedure.”

The presentations include:

  • “Post-Market Surgeon Safety Outcomes and Experience Performing Laparoscopic Ultrasound- Guided Radiofrequency Ablation using the Acessa System” presented by Bala Bhagavath, M.D. – Department of Obstetrics and Gynecology, University of Rochester, Rochester, New York. The study analyzed results of real-world, post IDE, safety and learning curve with 100 patients across 26 surgeons.
  • “An Observational Study of Reproductive Outcomes in Clinical Trials and Commercial Settings After Laparoscopic Radiofrequency Ablation of Symptomatic Myomas” presented by Jay M. Berman, M.D. – Professor and Vice Chair, Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan. The study analyzed safety of pregnancy outcomes after laparoscopic radiofrequency ablation of uterine myomas.In addition, Soyini Hawkins, M.D., and a panelist of Acessa users presented a case study using pre- recorded surgical video footage at a professional education event on Sunday. The well-attended event highlights the company’s intense focus on educating physicians who care for women suffering from uterine fibroids.

    About the Acessa Procedure

    Unlike many alternative interventions, the Acessa Procedure can treat nearly all sizes and locations of fibroids – including those outside the uterine cavity and within the 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, under laparoscopic ultrasound guidance, and is continuing to develop technologies that give women more options. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.

    Note

    Insufficient data exist on which to evaluate the safety and effectiveness of Acessa procedure in women who plan future pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning future pregnancy.

Acessa Health

Dr. Jonathan Faro completes Acessa Procedure for fibroids using Acessa ProVu at Woman’s Hospital of Texas

August 2, 2019 – Houston, Texas – Acessa Health Inc., developer of the Acessa ProVu System is proud to announce that Jonathan Faro, MD of Specialists in Obstetrics and Gynecology completed the Acessa procedure for uterine fibroids using the latest Acessa ProVu technology at Woman’s Hospital of Texas, joining over 100 physicians offering the procedure with over 3,000 women treated to date.

Also known as laparoscopic radiofrequency ablation (Lap-RFA), the Acessa Procedure is a minimally invasive procedure used to treat symptomatic uterine fibroids. It is a uterine-sparing alternative to hysterectomy. Comprehensive data on the procedure includes over 35 publications with 750 patients studied.  The Acessa Procedure revolutionizes the current standard of care for fibroids, hysterectomy or myomectomy, by treating fibroids laparoscopically without cutting or suturing of the uterine tissue – including fibroids outside the uterine cavity and within the uterine walls. Patients typically go home the same day, experience minimal discomfort, and return to a normal state of activity within three to five days(2).

Uterine fibroids cause abnormally heavy menstruation, pelvic pain and bulk symptoms, and studies have shown that over 70% of women experience them(1). “The women of Texas deserve all the options when dealing with uterine fibroids, including options that spare the female anatomy,” said Dr. Faro. “The Acessa Procedure is the solution we have been waiting for. I’m able to treat nearly all sizes and locations of fibroids and relieve woman’s symptoms with minimal downtime and remarkable outcomes proven to be the same or better than other surgical fibroid alternatives.”

When asked about how the Acessa procedure changes his practice, Dr. Faro said, “Women present to me with such debilitating symptoms, like heavy bleeding, bulk, and pelvic pain, that they are unable to perform routine activities. Before Acessa, the options were often limited to major surgery (myomectomy or hysterectomy). Those surgeries can require a recovery period of six to eight weeks. Acessa changes the options for women.”

Dr. Faro explained that Woman’s Hospital of Texas is the ideal facility for performing Acessa, with a woman-first mentality to providing healthcare. The Acessa Procedure allows Woman’s Hospital of Texas to do just that, as together Acessa Health and Woman’s Hospital of Texas are improving upon the current standard of care offered to women in Texas. Offering Acessa as a viable, uterine-sparing option for patients aligns well with Woman’s Hospital of Texas’ reputation as a premier site for women to receive safe, compassionate and accessible healthcare.

“We could not be more thrilled to have Dr. Faro and Woman’s Hospital of Texas as partners in advancing options for women,” said Kim Rodriguez, President and Chief Executive Officer of Acessa Health Inc. “Given the hospital’s outstanding reputation in the woman’s health arena and Dr. Faro’s excellence in minimally invasive gynecology surgery, we are poised to do great things for women in Houston.”

About Jonathan Faro, MD – Dr. Jonathan Faro is board certified in Ob/Gyn and has practiced in Houston since graduating from residency in 2011. After completing a combined MD/PhD at Rush University Medical Center in Chicago, Dr. Jonathan Faro moved to Houston to start his residency at The University of Texas Health Science Center. Here, he served as an Administrative Chief Resident during his final year of training. After completing his residency training, he joined the faculty as an Assistant Professor at UT-Houston in the department of Ob/Gyn. Dr. Jonathan Faro’s research interests have focused on robotic surgery and the development of a novel test for use in identifying certain infectious diseases. He has had abstracts accepted to conferences hosted by the Society of Maternal Fetal Medicine, American Society of Microbiology, the Central Association of Ob/Gyn, and the Infectious Diseases Society of Ob/Gyn. In addition, he was awarded a grant from Intuitive Surgical in 2012 as the PI of a study examining surgeon fatigue following laparoscopy. Dr. Jonathan Faro is looking forward to continuing his research in Ob/Gyn, and providing the best care possible to his patients. Dr. Jonathan Faro currently maintains privileges at The Woman’s Hospital of Texas, and is excited to start the next step in his career there, in a unique Practice with his father, Sebastian, and cousin, Connie

About Acessa Health Inc. – Acessa Health is a woman’s health innovator dedicated to advancing minimally invasive, uterine-sparing solutions for women with symptomatic fibroids. The company introduced the use of laparoscopic radiofrequency ablation for the treatment of uterine fibroids and is committed to ensuring that women have more options by developing technologies that improve the lives of its patients. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.

  1. 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.
  2. 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 201

Media Contact: Kim Rodriguez

Acessa Health Inc. 877.412.3828

Acessa Health

Dr. Jerome C. Young completes first Acessa Procedure using Acessa ProVuTM in the greater Houston area

Dr. Jerome C. Young completes first Acessa Procedure using Acessa ProVuTM in the greater Houston area: Expanding minimally invasive uterine fibroid options for women at HCA Houston Healthcare Conroe

Conroe, Texas – Acessa Health Inc., developer of the Acessa ProVu System is excited to announce that Jerome C. Young, MD, FACOG, of Conroe Women’s Associates completed the first Acessa procedure for uterine fibroids using the latest Acessa ProVu technology in the greater Houston area.

The Acessa Procedure, also known as laparoscopic radiofrequency ablation (Lap-RFA) for fibroids, is a minimally invasive procedure to treat uterine fibroids. It is a uterine-sparing alternative to hysterectomy, the current standard of care.

Studies have shown over 70% of women have uterine fibroids(1). These fibroids cause abnormal heavy menstruation, pelvic pain and bulk symptoms. The Acessa Procedure revolutionizes the standard of care for fibroids by treating almost all sizes and locations of fibroids laparoscopically – including those outside the uterine cavity and within uterine walls. The procedure uses fully-integrated Lap-RFA, ultrasound visualization and guidance mapping. Unlike myomectomy, no cutting or suturing of uterine tissue is needed. Patients typically go home the same day, experience minimal discomfort, and a return to normal activities in three to five days, compared to the typical six to eight weeks for other fibroid surgery.(2)

“At Conroe Women’s Associates, we are committed to providing patients the full spectrum of treatment options,” said Dr. Young. “I am thrilled to incorporate the Acessa Procedure for fibroids into my practice. Many patients who face fibroids suffer from multiple symptoms simultaneously, including heavy bleeding, bulk and pelvic pain.  Before Acessa, when medical management (e.g., birth control) failed to help relieve their symptoms, I was often limited to only offering major surgery: hysterectomy or myomectomy. With the adoption of the Acessa Procedure, I can offer an even less invasive procedure with a much shorter recovery time and great outcomes. Our Acessa patients are experiencing a significant improvement in symptoms. We expect more and more women to choose Acessa as their preferred treatment option.”

Dr. Young explained that he and the hospital were compelled to begin offering the procedure after reviewing the comprehensive data on the procedure. Data includes over 35 publications with 750 patients studied and over 3,000 procedures performed to-date.

“Dr. Young is a terrific partner” said Kim Rodriguez, President and Chief Executive Officer of Acessa Health Inc. “We are excited that women in Conroe and the greater Houston area are now among the many that have more options, including Acessa, for symptomatic uterine fibroids.”

About Dr. Young – Dr. Jerome Clayton Young received his medical degree from Texas A&M University Health Science Center in College Station, Texas. After medical school, he received one year of Internal Medicine training at Scott and White hospital while volunteering in the Obstetrics and Gynecology department. The following year, he transferred to the OB/GYN department for his residency. Dr. Young is board certified by the American Board of Obstetricians and Gynecologist and is a fellow of the American Congress of Obstetrics and Gynecology. He is a member of the Texas Medical Association and The America Association of Physicians and Surgeons.  He lives with his wife, Virginia and four children in South Montgomery County, where they have resided since completing residency a Scott and White Hospital in 1998.

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 laparoscopic radiofrequency ablation for the treatment of uterine fibroids and is committed to ensuring that women have more options by developing technologies that improve the lives of its patients. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.

 

  1. 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.
  2. 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

 

Acessa Health

Dr. Soyini Hawkins completes first Acessa Procedure for fibroids using Acessa ProVu in Georgia

Atlanta, Georgia – Acessa Health Inc., developer of the Acessa ProVu System is proud to announce that Soyini Hawkins, MD of Fibroid and Pelvic Wellness Center of Georgia completed the first Acessa procedure for uterine fibroids using the latest Acessa ProVu technology in Georgia at Northside Hospital – Atlanta.

Also known as laparoscopic radiofrequency ablation (Lap-RFA), the Acessa Procedure is a minimally invasive procedure used to treat symptomatic uterine fibroids. It is a uterine-sparing alternative to the current standard of care – hysterectomy. Comprehensive data on the procedure includes over 35 publications with 750 patients studied and over 3,000 cases performed to-date.

Uterine fibroids cause abnormally heavy menstruation, pelvic pain and bulk symptoms, and studies have shown that over 70% of women experience them(1). The Acessa Procedure revolutionizes the current standard of care for fibroids by treating fibroids laparoscopically – including fibroids outside the uterine cavity and within the uterine walls. Using fully-integrated Lap-RFA, ultrasound visualization and guidance mapping, there is no cutting or suturing of uterine tissue, unlike myomectomy. Additionally, unlike hysterectomy, the procedure spares the female anatomy. Patients typically go home the same day, experience minimal discomfort, and return to a normal state of activity within three to five days(2).

“I am pleased to offer the Acessa Procedure and provide women of Georgia a full spectrum of treatment options,” said Dr. Hawkins. “Many patients suffer silently from uterine fibroids, including an array of symptoms such as bulk, heavy bleeding and pelvic pain. Fibroids also disproportionally affect African American women, as they are three to five times more likely to occur in these women compared to women of other races.” Her practice is a fibroid referral clinic, so Dr. Hawkins sees many patients who have been struggling with fibroids for years, often seeking second opinions after being told that their condition requires hysterectomy. “Women deserve to consider all the options for treating fibroids.” Dr. Hawkins said.

When asked about how the Acessa procedure changes her practice, Dr. Hawkins said, “Women come to me when struggling to complete normal activities because of their symptoms. Before Acessa, the options were often limited to major surgery (myomectomy or hysterectomy). Unfortunately, those surgeries can require a recovery period of six to eight weeks. Acessa changes the options for women, as my patients return to complete normal activity within three to five days. Now I can offer a less invasive procedure with a quick recovery and remarkable outcomes proven to be the same or better than other surgical fibroid alternatives.”

Dr. Hawkins explained that Northside Hospital – Atlanta is dedicated to the health and wellness of the greater Atlanta community, and as such pledges compassionate support and uncompromising standards to their patients. The Acessa Procedure allows Northside to do just that, as together Acessa Health and Northside Hospital are improving upon the current standard of care offered to women in Georgia. Offering Acessa as a viable, uterine-sparing option for patients aligns well with Northside’s reputation as an innovative leader in the healthcare industry.

“We could not be more thrilled to have Dr. Hawkins and Northside Hospital as partners in advancing options for women,” said Kim Rodriguez, President and Chief Executive Officer of Acessa Health Inc. “Given Northside’s outstanding reputation in the women’s health arena and Dr. Hawkins’ reputation in minimally invasive gynecology surgery, we are poised to do great things for women in Georgia.”

About Soyini Hawkins, MD – Dr. Soyini Mattis Hawkins is a fellowship trained Minimally Invasive Gynecology Surgeon. She is a solo Gynecology provider at Fibroid and Pelvic Wellness Center of Georgia in Alpharetta, GA. Dr. Hawkins received her medical degree in Georgia at Morehouse School of Medicine. She completed her Internship and Residency training at the University of Maryland Medical Center Department of Obstetrics, Gynecology and Reproductive Sciences. Dr. Hawkins’ provides a full-service gynecology practice that specializes in the management of abnormal uterine bleeding, pelvic pain, and general female health. She cares for all women across their lifespan starting with adolescent care, reproductive care, through the management of menopause and post-menopausal conditions.

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 laparoscopic radiofrequency ablation for the treatment of uterine fibroids and is committed to ensuring that women have more options by developing technologies that improve the lives of its patients. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.

  1. 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.
  2. 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 201
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

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 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