Minerva Surgical | Top Gynecology Solutions Company 2022

MedTech Outlook Magazine

Minerva Surgical
Streamlining AUB Treatment with a Complete Suite of Minimally Invasive Devices

Dave Clapper, President and CEO, Minerva SurgicalDave Clapper, President and CEO
According to the American College of Obstetrics and Gynecology (ACOG), abnormal uterine bleeding (AUB) impacts one in three women in the U.S., equating to 18 million women between the ages of 25 and 50. AUB is also the leading cause of hysterectomy, an invasive procedure performed in over 500,000 U.S. women per year, generally requiring the administration of general anesthesia, a multiple-night hospital stay, a recovery time of four to six weeks, and has an associated procedure mortality rate of over 1 per 1000 patients.

This is where Minerva Surgical steps in.

Founded in 2008, Minerva Surgical eliminates unnecessary hysterectomies for treating AUB. The company’s flagship offering is the Minerva Endometrial Ablation System (Minerva ES) which received the FDA premarket approval (PMA) in 2015. It is designed to treat AUB due to benign causes in pre-menopausal women for whom childbearing is complete. The Minerva devices are inserted transvaginally and transcervically through the cervical canal into the uterus, which then opens into a triangular shape that mimics the shape of the uterine cavity. It then creates plasma energy, which generates a lot of heat that is transferred to and destroys the endometrial tissue that lines the uterus. In the FDA-approved clinical studies, the Minerva treatment yielded “statistically significant greater efficacy” when the FDA compared Minerva to the objective performance criteria (OPC) composed of the efficacy data from the five previously FDA-approved endometrial ablation devices. It further stated that the Minerva treatment successfully reduced bleeding to a normal of less level in 93 percent of patients and totally eliminated bleeding in 72 percent of patients. This compares very favorably to the leading competitive product’s treatment success rate of 77.7% and zero bleeding rate of just 36%.

“Through the three year post-treatment follow-up period, less than one percent of the Minerva-treated patients had to undergo a hysterectomy compared to a 6.3 percent hysterectomy rate for today’s leading competitive product,” says Dave Clapper, the President and CEO, Minerva Surgical.

In May 2020, Minerva Surgical expanded its uterine health portfolio offerings by acquiring three additional products from Boston Scientific—a leading medical equipment manufacturer. The most sought-after acquired product is the Symphion tissue resection system for removing uterine fibroids and polyps that cause AUB.

Unlike the competitive devices that only cut tissue, Symphion also coagulates tissue to reduce bleeding.
And, Symphion is the only device that volumetrically eliminates the very serious patient risk of fluid overload within the vascular system (intravasation). Minerva Surgical also acquired the Genesys HTA endometrial ablation product that many physicians prefer for irregularly shaped uterine cavities.

The Genesys HTA device circulates hot saline inside the uterine cavity to destroy the endometrium. The final product delivered by Minerva Surgical is Resectr, a low-cost manual resection device used to resect polyps and small fibroids from the uterus. This suite of minimally invasive devices is currently sold to hospitals, ambulatory surgery centers, and physicians’ offices in the U.S.

These solutions allowed Minerva Surgical to treat more than 40,000 women in 2021 and add 250 new accounts that ordered the Minerva endometrial ablation device or the Symphion uterine tissue device for the very first time. It is also witnessing a surge in interest from many hospitals to enter into contracts. In fact, in 2021, the company signed contracts with three group purchasing organizations (GPOs) and 18 independent delivering networks (IDNs) representing over 500 new accounts.

At their October 2021 IPO, Minerva Surgical raised $75 million for propelling its commercialization strategy by growing its salesforce and launching a direct-to-patient marketing initiative. The company is leveraging various social media platforms to make patients aware of its products. It has also launched an informational patient portal, AUBandMe.com—created by women for women.

  • We are changing the status quo of AUB treatment. Our goal is to educate patients on their AUB treatment options, and the advantages of Minerva treatments


Looking ahead, Minerva Surgical aims to respond to the over 36,000 U.S internet searches per month that utilize AUB symptom keywords. The company has already gained over 6000 website visitors per month, compared to just 1000 per month a year ago. It is currently focused on expanding its sales and marketing teams and increasing its installed base of controllers in both new and existing accounts. Minerva Surgical is driving disposable device sales growth in established accounts and continuing its DTC marketing strategy to increase overall awareness of its less-invasive procedures versus hysterectomy. “We are changing the status quo of AUB treatment. Our goal is to educate patients on their AUB treatment options, and the advantages of Minerva treatments,” concludes Clapper.

Top 10 Gynecology Solutions companies - 2022

Company
Minerva Surgical

Management
Dave Clapper, President and CEO

Description
Founded in 2008, Minerva Surgical eliminates unnecessary hysterectomies for treating AUB. The company’s flagship offering is the Minerva Endometrial Ablation System (Minerva ES) which received the FDA premarket approval (PMA) in 2015. It is designed to treat AUB due to benign causes in pre-menopausal women for whom childbearing is complete. The Minerva devices are inserted transvaginally and transcervically through the cervical canal into the uterus, which then opens into a triangular shape that mimics the shape of the uterine cavity. It then creates plasma energy, which generates a lot of heat that is transferred to and destroys the endometrial tissue that lines the uterus.

Minerva Surgical News

The HERizon Disposable Hysteroscope Aims to Redefine Industry Standards

SANTA CLARA -Minerva Surgical announces the immediate and exclusive distribution of a new disposable hysteroscopethat will be displayed at the Annual Clinical & Scientific Meeting of American College of Obstetricians and Gynecologists in San Francisco, CA. The company plans to soon rebrand the new disposable hysteroscope as HERizon, and their goal is to redefine the standards of efficiency and accessibility in gynecological care.
"This marks a significant milestone in the company's mission to address the needs of gynecologists and further advance Women's Health," states Minerva Surgical Chief Medical Officer Eugene Skalnyi, M.D. "HERizon embodies versatility as a hysteroscope, facilitating an array of procedures both in the operating room and office settings. It is one of a few technologies that our team plans to launch to better serve the evolving patterns in Gynecology."
The HERizon Disposable Hysteroscope is a cutting-edge system that is introduced in alignment with ACOG and AAGL's advocacy for the elimination of blind assessment practices in the uterine cavity. Several key features of the HERizon Disposable Hysteroscope include.
1. Disposable Design: Single-use hysteroscope eliminates the need for traditional hysteroscope reprocessing, reduces the risk of cross-contamination, and ensures compliance with sterility standards.
2. Angled Cannula Tip: Provides rigidity to help enter the cervical canal and articulation to navigate an array of uterine cavity positions.
3. Compact Footprint: 4.8mm outer diameter sheath requires minimal or no dilation and 6Fr working channel allows for a broad spectrum of procedures such as direct visualization polypectomy, endometrial biopsy, D&C, and IUD removal.
4. User-Friendly Interface: High-Definition image technology, two LED lights provide bright and clear visualization, and the intuitive interface enables seamless system navigation.
Dr. David Glassman, DO FACOG EMIGS, a prominent gynecologist in Phoenix, Arizona, shared his excitement about the new HERizon Disposable Hysteroscope, stating, "HERizon is a revolutionary advancement in hysteroscopy technology. Designed with precision and patient comfort in mind, HERizon offers unparalleled clarity and control, providing healthcare professionals with a clearer view and easier access to the uterine cavity. Its innovative features enhance procedural efficiency, reducing both patient discomfort and procedure times. With HERizon, healthcare providers can elevate their practice, delivering superior care and empowering women to take control of their health with confidence."
The introduction of the HERizon Disposable Hysteroscope underscores Minerva Surgical's commitment to providing gynecologists with solutions that improve patient outcomes.