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AEGEA Medical Receives FDA Approval for and Performs First Commercial Cases With the Mara™ Water Vapor Ablation System

MENLO PARK, Calif., March 24, 2020 – AEGEA Medical today announced it has received U.S. Food and Drug Administration (FDA) PMA Approval for and performed first commercial procedures with the next generation Mara™ Water Vapor Ablation System. Mara is the only endometrial ablation treatment that utilizes natural water vapor to safely treat heavy menstrual bleeding, specifically designed for use in the doctor’s office without the need for general anesthesia.

Mara is a one-time, two-minute in-office treatment that uses natural water vapor to gently eliminate the lining of the uterus, the source of heavy menstrual bleeding in women who have not reached menopause. When eliminated, the lining can no longer re-grow to cause heavy menstrual bleeding, also known as menorrhagia, a common condition for which about one-third of women seek treatment during their lifetimes.1 Mara’s innovative technology incorporates a proprietary double pre-procedure safety assessment for both uterine cavity integrity and correct probe positioning as well as automated real-time safety monitoring throughout the procedure.2

Utilizing the expansive properties of water vapor, Mara conforms to each woman’s uterus and is FDA approved to treat women with varying uterine anatomies, including those traditionally not indicated for endometrial ablation such as women with long uterine cavities, any uterine width, cavities with certain types of fibroids, a history of low-transverse c-section and/or Essure®, a form of permanent birth control.2

“Endometrial ablation is a commonly used procedure for heavy menstrual bleeding,” said Kirk Brody, MD, a board-certified obstetrician-gynecologist in private practice in Chattanooga, Tenn. who performed the first commercial Mara case in the U.S. “I believe Mara with its natural water vapor technology and safety features will bring my patients a better treatment experience and positive outcomes.”

“We at AEGEA have dedicated ourselves to pioneering a new water vapor ablation technology we believed held enormous potential to safely, effectively and conveniently benefit the numerous women with heavy menstrual bleeding,” said Maria Sainz, president and CEO of AEGEA Medical. “We are proud to now introduce Mara, an in-office treatment intended to bring physical, social and emotional relief to women who suffer with heavy menstrual bleeding and to enable physicians to offer this treatment option to a greater range of patients than previously thought possible.”

Clinical study data demonstrate that Mara safely and effectively reduces heavy menstrual bleeding and improves quality of life. One year after treatment in an international, multi-center pivotal clinical study that enrolled 155 women, 79 percent of patients had their heavy menstrual bleeding reduced to a normal level or less, 99 percent of patients experienced an improvement in their quality of life, 91 percent of patients were very satisfied or satisfied with the procedure, and 93 percent said they would recommend it to a friend.2,3 Moreover, sustained results were reported three years after treatment.2,4

Mara is the only endometrial ablation modality with published clinical data about the long-term impact of ablation on uterine cavity access to help physicians manage patients post ablation. The PACE clinical study demonstrated that a mean of four years following water vapor ablation treatment, Mara preserved uterine cavity accessibility and visualization in 90 percent of patients studied with minimal findings of severe adhesions.2,5

“Although common, menorrhagia can have an outsized negative impact on women’s lives and has long been challenging to treat,” said David Adair, MD, MBA Professor Emeritus and former vice chairman of the Department of Obstetrics and Gynecology at the University of Tennessee College of Medicine and chairman of AEGEA’s Board of Directors. “Mara will be an important new treatment option that will enable my colleagues in the OB/GYN community to expand and elevate the level of care they can provide to women suffering from menorrhagia.”

About the Mara™ Water Vapor Ablation Treatment
AEGEA’s Mara Water Vapor Ablation Treatment is the first FDA-approved endometrial ablation procedure for heavy menstrual bleeding that is specifically designed for use in the doctor’s office without the need for general anesthesia. By utilizing the naturally expansive properties of water vapor, Mara safely and effectively treats patients with a wider range of uterine anatomies than alternative endometrial ablation treatment options. One year after treatment in the pivotal trial, 79 percent of patients met the primary endpoint of the study with a PBLAC score of ≤ 75, 99 percent of patients experienced an improvement in their quality of life based on MIQ (Menorrhagia Impact Questionnaire) scores, 91 percent of patients were very satisfied or satisfied with the procedure, and 93 percent said they would recommend it to a friend.2,3 Sustained results were reported three years after treatment.2,4 Over the 36-month duration of the trial, there were 10 (6.5% percent, 10/155) reported hysterectomies.2,4 There were no reported serious adverse device effects (SADEs), nor any reported serious adverse events (SAEs) that were procedure related.2,3

About Heavy Menstrual Bleeding (Menorrhagia)
Many women experience heavy menstrual bleeding at some point in their lives. One in three women in the U.S. seek treatment for heavy menstrual bleeding.1 Healthcare professionals call this condition “heavy menstrual bleeding (HMB)” or “abnormal uterine bleeding (AUB)” or “menorrhagia.” The increase in quantity and duration of menstrual bleeding can negatively impact a woman’s physical, social and emotional well-being, and can make it difficult to engage in activities such as work, family care, exercise and sex.

Important Safety Information
The Mara Water Vapor Ablation System is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. Pregnancy following the Mara procedure can be dangerous. The Mara procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. As with all surgical procedures, there are risks and considerations associated with the use of the Mara Water Vapor Ablation System. Please refer to the device labeling at www.maratreatment.com. for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.

About AEGEA Medical
AEGEA Medical is pioneering the application of its water vapor ablation technology to deliver therapies that provide high quality patient outcomes to a wider range of patients. AEGEA’s FDA approved Mara Water Vapor Ablation Treatment enables the delivery of a safe and effective endometrial ablation for the treatment of heavy menstrual bleeding in a simple, office-based procedure that takes only minutes. With a vision to expand treatment options to more patients and provide physicians with the confidence and convenience necessary to perform office-based procedures, AEGEA is inspiring new approaches to women’s healthcare. Founded in 2008, AEGEA Medical is located in Menlo Park, Calif. For more information, visit www.maratreatment.com.

References

  1. The American College of Obstetricians and Gynecologists. FAQ June 2016. https://www.acog.org/Patients/FAQs/Heavy-Menstrual-Bleeding?IsMobileSet=falseAEGEA Medical, AEGEA Water Vapor System, SmartSeal, and IntegrityPro, and associated logos, are trademarks and/or registered trademarks of AEGEA Medical.
  2. AEGEA Medical Instructions For Use
  3. Levie MD, Chudnoff SG. A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System. J Minim Invas Gynecol. May/June 2019; 26(4); 679-87.
  4. Levie H, et al. Endometrial Ablation Using Water Vapor: 36-Month Follow-up. J Minim Invasiv Gynecol 2018 25 (7) Suppl S46.
  5. Johns DA, Garza-Leal JG. Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding. J Minim Invas Gynecol. Published Online Sept 2019.

All references on file at AEGEA Medical, Inc.

 

MEDIA CONTACT:
Diana Soltesz
Pazanga Health Communications
818-618-5634
dsoltesz@pazangahealth.com

 

 


Important Safety Information:

The Mara Water Vapor Ablation System is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. Pregnancy following the Mara procedure can be dangerous. The Mara procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. As with all surgical procedures, there are risks and considerations associated with the use of the Mara Water Vapor Ablation System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.