New positive coverage further validates Laparoscopic Radiofrequency Ablation (Lap-RFA), the Acessa procedure, as an important treatment option for uterine fibroids

AUSTIN, Texas – July 1, 2020 – Acessa Health Inc. announced today that the total number of people covered by insurance carriers for the Acessa procedure (CPT Code 58674) has grown by more than 30 million over the past 12 months, bringing the total to more than half of the covered lives in the United States. (1) More than 156 million Americans are covered for the Acessa procedure, with expanded coverage over the last 12 months in Maryland, Massachusetts, North Carolina, North Dakota, Ohio, Pennsylvania, and Washington DC. (1)

“Payers are responding to significant demand from physicians, patients and employers around the country for the Acessa procedure—a comprehensive, uterine preserving, safer, effective and cost-effective surgical option,” said Shonu Gandhi, Vice President of Market Access and Clinical Strategy.(2,3,4) “The COVID-19 pandemic makes it more critical than ever that patients and physicians have access to surgical options that place the least amount of stress possible on the healthcare system. This short, outpatient procedure involves significantly less blood loss, less OR time, less time in the hospital, less hospital admissions and less ER visits than either hysterectomy or myomectomy.” (1,2,3,5)

 “This is a procedure I have been waiting to make available to patients for years. I am thrilled about the shift in insurance coverage, which has made it possible for me to offer women a safe and effective alternative to hysterectomy,” said Dr. Craig Sobolewski, Head of the Minimally Invasive Gynecology Program at Duke University.(2,3)

“The treatment of fibroids has largely remained the same for years. Acessa is a critical innovation, especially for women seeking symptom relief with uterine preservation. I’m thrilled to see payers make it possible for women to access this safe and effective option,” said Dr. Keith Isaacson, Director of Minimally Invasive Gynecologic Surgery and Infertility at Newton Wellesley Hospital, Associate Professor of Obstetrics and Gynecology at Harvard Medical School, and past president of AAGL, the medical society representing 7,000 gynecologists focused on minimally invasive gynecology.

“There is a strong body of literature supporting the fact that women suffering from fibroids need more information, more education and more options. I’m excited to see new therapies like laparoscopic radiofrequency ablation gaining payer coverage which will make minimally invasive procedures more accessible to women broadly,” said Dr. Linda Bradley, Vice Chair of the Women’s Health Institute and Director of The Fibroid and Menstrual Disorders Center at the Cleveland Clinic, and Medical Director of the AAGL.

The Acessa procedure is designed to treat women with uterine fibroids and is clinically proven with long-term data as a safe alternative to hysterectomy and myomectomy.(2,3) Over 3,800 procedures have been performed to-date.(1) The Acessa ProVu system is the third generation of Acessa Health’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. (1) It has been the subject of 49 peer-reviewed publications. (1)

About the Acessa procedure

Unlike many alternative interventions, the Acessa procedure can treat nearly all 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.(2) The treated tissue shrinks over time. There is no cutting or suturing of uterine tissue. Women experience minimal discomfort after the procedure and typically return to normal activities in 4-5 days. (2)

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 under laparoscopic ultrasound guidance for the treatment of uterine fibroids. Acessa is continuing to develop technologies that give women more options. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.

Sources

  1. Data on file at Acessa Health
  2. SG Chudnoff, et al. Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas. Obstetrics and Gynecology, 2013;121(5):1075–82.
  3. 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
  4. Wakely Actuarial Firm claims analysis, pending publication, data on file at Acessa Health
  5. Kim, Tana et al. Myomectomy associated blood transfusion risk and morbidity after surgery. Fertility and Sterility, Feb 2020.

Notes and Disclaimers

Results may vary

There are potential risks associated with the Acessa procedure. It may not be appropriate for all patients and all patients may not benefit. For information about the indications, contraindications, warnings, and precautions, visit: www.acessaprocedure.com. Rx Only.

Although many patients may benefit from the Acessa Procedure, this treatment is not for everyone and results may vary. Patients should talk to their doctor about the potential benefits and risks and whether this treatment is right for them. Information contained in this article is not to be used as a substitute for talking to your doctor. You should always talk to your doctor about diagnosis and treatment information.

Physicians neither pay nor receive any fees in connection with their listing on in this article

This document is for informational purposes only and is not legal advice or official guidance from payors. It is not intended to increase or maximize reimbursement by any payor. Hospitals and physicians are solely responsible for being in compliance with Medicare and other payor rules and requirements for the information submitted with all claims and appeals. Acessa Health does not warrant or guarantee that the use of this information will result in coverage or payment for any particular therapy. Before any claims or appeals are submitted, hospitals and physicians should review official payor instructions and requirements, should confirm the accuracy of their coding or billing practices with these payors and should use independent judgment when selecting codes that most appropriately describe the services or supplies provided to a patient. ICD-10 codes and CPT codes and descriptions only are copyright by the American Medical Association. All rights reserved. The American Medical Association assumes no liability for data contained or not contained herein.

AUSTIN, Texas – 06/11/2020 – Acessa Health Inc., the women’s health innovator that advances minimally invasive solutions for women with symptomatic fibroids, is proud to announce the addition of three new executive team members:  Shonu Gandhi, Vice President of Market Access and Clinical Strategy, Alfred Macdaniel, Chief Strategy Officer and General Counsel, and Carolyn Amato, Senior Vice President of Commercial.

Three executives, each with a commitment to change the standard of care in fibroid management and a passion to deliver solutions for women’s health, will scale the company’s next phase of growth and geographic expansion. 

“Shonu, Alfred and Carolyn bring more than 40 years of combined experience working in the medical device and healthcare industry. Their knowledge and skills make an immediate, positive impact for our company,” said Kim Rodriguez, President and CEO, Acessa Health.

With these new appointments, teammates of color hold 30% of leadership positions at or above Vice President and women make up 50% of Acessa Health’s executive team, a metric few medical device companies have achieved.  “I’m extremely proud of the men and women on our teamWe are fortunate to welcome these broad sets of experience into the Acessa family to advance innovation and growth while elevating our service to patients, physicians and teammates.”

About Executive Hires

Shonu Gandhi, Vice President of Market Access and Clinical Strategy, is focused on improving patient access to the Acessa procedure through expanding payer coverage and clinical evidence. In her few months at Acessa, she has already increased payer coverage by 25 million covered lives. Shonu brings to Acessa over a decade of experience partnering with health plans, employers and healthcare providers to develop and implement strategies to improve patient outcomes while reducing healthcare costs. Most recently, Shonu served as the leader of the inaugural business development team at the new Dell Medical School at the University of Texas, Austin. There, she was responsible for building multiple critical aspects of the emerging UT clinical practice, including forging the organization’s relationships with health plans, large employers and clinical partners to advance UT’s commitment to value-based care. Before Dell Medical, Shonu was an Associate Principal at McKinsey & Company, advising major health plans and employers on product design and pricing, payer/provider collaboration and consumer/ provider friendly cost containment strategies.

Alfred Macdaniel, Chief Strategy Officer and General Cousel, a veteran in the medtech startup world, will drive strategic initiatives that enable Acessa to scale predictably and explore opportunities for Acessa to expand innovative treatment options that benefit women. As former Chief Financial Officer, Chief Compliance Officer and General Counsel of TVA Medical, Alfred joins Acessa with 18 years of financial, legal, OUS market expansion and M&A expertise. TVA Medical, a VC-backed company developing minimally invasive therapies for end-stage renal disease, was acquired by Becton Dickinson & Company. After the acquisition, he facilitated the integration of TVA Medical into Becton Dickinson.  Before TVA Medical, Alfred served as Chief Financial Officer and General Counsel of Santé Ventures, a specialized healthcare, life sciences investment firm, focused on early stage and commercial growth startups, with over a quarter of billion dollars in capital under management during his tenure. 

Carolyn Amato, Senior Vice President of Commercial, will lead Acessa Health’s sales and marketing organizations to accelerate patient access to the Acessa procedure.  During 18 years with Boston Scientific, Carolyn’s market development experience spanned multiple new product and therapeutic categories.  Most recently she helped build the commercial team to launch Deep Brain Stimulation therapy in the United States and served as Vice President, US Corporate Accounts and Healthcare Solutions where her team negotiated product and service contracts generating $1B annual revenue.  Early career experience included roles of increasing responsibility in healthcare sales and marketing at Guidant Corporation and Merck & Company, Inc. 

“The Acessa ProVu system allows physicians to treat symptomatic fibroids with no surgical cutting or suturing.  As health systems bring this uterine-sparing technology into more communities, we’re eager to partner with fibroid centers of excellence on local education.” says Amato. “I’m humbled to work on behalf women seeking advanced treatment options.”

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 under laparoscopic ultrasound guidance for the treatment of uterine fibroids. Acessa is continuing to develop technologies that give women more options. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.

Sources: Shepherd, Maria, “The Clogged Pipeline: Women Executives in Medical Device” – based on data from MedTech 2018 – A Survey of Medical Device Executive Women

With a heavy heart, I write this letter. The violence erupting in our communities these last several days is symptomatic of a broader issue in our culture.  Our society continues to fail to treat each member with the dignity and equality that we would expect for ourselves and our loved ones.

We strongly believe Black Lives Matter, and that belief is core to who we are at Acessa Health and what we wake up to do every day. I co-founded Acessa Health with a mission to serve women and give all women access to better healthcare options.  The more I learned about the racial disparities in outcomes for women suffering from fibroids, the more compelled I was to bring our company to life. In partnership with their determined physicians, we daily confront the reality of underserved women, especially women of color, and advocate on their behalf for improved healthcare. Yet, from this past week’s events, we can and must do more.

Stretching far beyond women’s health, other vast issues of inequality surround us and need constructive reform. A call to action cries out from current events.  I want each of you to know that we are listening and learning.  Acessa Health is now even more committed to collaborating with our patients and physicians in the communities where we live and work.  The moment is here to act and create a more just society where every life matters. Acessa Health wants to be a force for change, and I welcome your thoughts on how to best do that.

Please stay safe and be loud. Voices heard are the first instruments of change.

In love and support,

Kim Rodriguez

President and CEO

Acessa Health

Re-introducing Acessa Health – We are more than our (new) good looks

Hi, we are Acessa, and we would like to reintroduce ourselves.

Here are the basics:

  1. We are on a mission to change the standard of care for uterine fibroids
  2. Our vision is a world where women have the options they deserve
  3. We are a women-led women’s health company

We offer a minimally invasive alternative to hysterectomy and myomectomy for treating uterine fibroids, the Acessa procedure, because women deserve to have access to all their options. Kim Rodriguez, CEO, co-founded Acessa Health in 2017 and built one of the only women’s health medical device companies led by a woman. Not only are we led by a woman at the top, women also make up 50% of the executive leadership.

Back to the reintroduction — If you have been following us for a while, you likely noticed a few (MAJOR) aesthetic changes on our website and social media channels. With gorgeous photos of women, a refreshed logo and an engaging color scheme, we are proud of the new look and feel. Like most, we love an opportunity to freshen up our looks, but, here is the thing, this brand refresh is not just about our looks.

It is about building a community.

The Why: Building Community

Women dealing with fibroid symptoms are suffering in silence. A survey found that it took on average 3.6 years for women to seek treatment for their fibroid symptoms.(1)

Acessa recognizes fibroids are personal. We are women. We get it. We are taught at a young age to hide our period products. It is no wonder that women feel ashamed or embarrassed about the symptoms associated with fibroids.

Between carrying “arsenal bags” with massive pads that may as well be adult diapers, to fearing white couches, to dealing with the disappointing question “how far along are you?” by strangers, when the belly bump they thought was a pregnancy is actually the result of fibroids – it can be lonely and stressful to deal with this unwanted symptoms.

But 3.6 years(1) is an awful long amount of time to be suffering alone. We listened to our fellow women to learn what could help speed up the journey from suffering to relief.

One answer rung true throughout: Community.

Community means: sharing stories, speaking up, listening, learning and gathering together. With community, it is easier to talk about heavy periods, looking pregnant when we’re not pregnant, fibroids, uteruses, vaginas and our health.

Getting To Work

We began the brand refresh process mid 2019, after launching the latest version of the Acessa technology, Acessa ProVu in late 2018. After a monumental listening and research effort, we landed on the core message of the campaign – Making Women’s Health Healthy.

Acessa Health Headquarters, Austin, TX

In addition to the core message, we evaluated color pallets, fonts, and all things ‘brand’. We leveraged consumer research platforms to evaluate every detail of the brand evolution. If we were going to spend the time changing our look, we wanted to do it with everyone in mind!

With a new color pallet and refreshed blue logo, we began on the biggest step yet: building a brand-new website. The website needed to break the mold of medical device marketing. It needed to spark frank conversations and provide medical content in a easy-to-understand format. And most importantly, it needed to build community.

To integrate community with a brand refresh, we aimed to create content that spanned three themes:

  1. Testimonial
  2. Education
  3. Inspiration

We wanted to create a safe space where women could see themselves through the content. No stock imagery for us, we needed real stories.

We wanted to provide a educational hub, because the more information we have, the more empowered we are to advocate for ourselves. Thus, the website provides information on all the fibroid treatment options, not just the Acessa procedure.

And finally, we wanted to inspire. Advocating for women to stop suffering in silence takes more than facts and figures, we wanted to be a light for the community.

Keeping It Real

Making Women’s Health Healthy means being real and honest when it comes to women’s health. We knew if keeping it real was important, we couldn’t just talk the talk – we had to walk the walk. In February 2020, we flew 6 women who suffered from fibroids to New York City for a photo and video shoot. No stock imagery for us!

The weekend surpassed everyone’s expectations. During the professional photoshoot with an AMAZING photographer, Anna Wolf, the women strutted their stuff and showed the world the real faces of fibroids. Together, we celebrated everyone’s journey with fibroids. 

The women you see on the website, Rhonda, Chanel, Brandi, Patrice, Sharon, & Andrea, all suffered with symptomatic fibroids and, with their physician, chose the Acessa procedure as their treatment option. See those dates under their pictures on the website? They’re real. Hear their testimonials and stories? Yep, they’re real too. No scripts here.

Making Women’s Health Healthy

Wow. It was such a powerful thing to see these women connect over their shared experiences. They flew out from all over the country, and had never met before, but it felt like a group of old girlfriends.

The Acessa team sought out to do something different for medical device marketing. But in this magical weekend, with 6 women from different geographies, backgrounds and ages building friendships rooted in a foundation of shared experience with fibroids, we saw something more than marketing – we saw the power of community.

The weekend served as a powerful reminder that women all over the country suffer in silence while fighting their fibroid symptoms. The power of community can create bonds between us that builds strength and hope.

Acessa Health is a women’s health company where you can access information, learn what questions to ask, and gain the peace of mind that you have options – and most importantly, find community. You are not alone.

Making Women’s Health Healthy.

Disclaimers and Sources:

  1. Borah, Bijan J. et al. The impact of uterine leiomyomas: a national survey of affected women, American Journal of Obstetrics & Gynecology October 2013, Volume 209, Issue 4, 319.e1 – 319.e20

 Acessa Health encourages patients to seek medical attention for typical and atypical symptoms associated with fibroids to help achieve and maintain good health with as high a quality of life as possible. Although many patients may benefit from the Acessa Procedure, this treatment is not for everyone and results may vary. You should talk to your doctor about the potential benefits and risks and whether this treatment is right for you. Information contained on this site is not to be used as a substitute for talking to your doctor. You should always talk to your doctor about diagnosis and treatment information.

This link leads to a third party website. The views and opinions listed on the third party page does not reflect Acessa Health. Information contained on this site or any site is not to be used as a substitute for talking to your doctor. You should always talk to your doctor about diagnosis and treatment information.

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Acessa Health launches refreshed brand featuring real patients, marking 18 months
of commercial success with Acessa ProVu System

AUSTIN, Texas – May 14, 2020 – Acessa Health Inc. announced today the unveiling of their brand, including website acessaprocedure.com. The refresh showcases the women’s health company’s commitment to patients and their uterine fibroid journey, by featuring women who had the Acessa procedure, a minimally invasive alternative to hysterectomy and myomectomy. The new site serves as a resource for women and gynecologic physicians interested in learning about fibroid treatment options and the Acessa procedure.

This milestone coincides with a monumental first year launching the new Acessa ProVu system in the United States. With over 3,700 Acessa procedures performed to date and a record-breaking year for commercialization, Acessa Health is poised for catalytic movement. The brand refresh showcases the commercial learnings throughout 2019, as well sophisticated market research across thousands of women and numerous clinicians.

“Since the formation of Acessa Health in 2017, our vision has remained constant: a world where women have the options they deserve. I am extremely proud that our vision, culture and results, shine through the Acessa Health brand with even more strength,” said Kim Rodriguez, CEO, Acessa Health.

The Acessa Health team wanted a brand and website with frank conversation and content for women who are looking for alternatives to a hysterectomy or myomectomy. The team set out to build a community of women sharing authentic stories and present a comprehensive resource about fibroid treatment options.

The new site features women who had fibroids and the Acessa procedure. The journey proved a testament to the power of community among women facing fibroids. During a weekend photoshoot in New York City in February 2020, five women spanning ages, ethnicities, and geographies, built friendships rooted in their shared experience with fighting fibroids.

“The Acessa Health team made a bold, and purposeful decision to push the envelope of medical device marketing by inviting women to voluntarily lead the campaign. Andrea, Sharon, Patrice, Rhonda and Brandi are heroes for women’s health. By sharing their faces and stories, they are encouraging millions of women to seek relief from fibroids. Women are speaking up, and Acessa is listening and providing more options,” said Elaine Horton, Director of Marketing, Acessa Health.

About the Acessa Procedure

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 shrinks and becomes softer, leading to significant symptom relief. There is no cutting or suturing of the uterus. Women experience minimal discomfort after the procedure and typically return to normal activities in 4-5 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 under laparoscopic ultrasound guidance for the treatment of uterine fibroids. It is continuing to develop technologies that give women more options. Acessa Health’s headquarters are in Austin, Texas. For more information, visit AcessaProcedure.com.

Sources:

SG Chudnoff, et al. Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas. Obstetrics and Gynecology, 2013;121(5):1075–82.

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