News

MENLO PARK, Calif., November 7, 2019 – AEGEA Medical announced today the publication of the Post-Ablation Cavity Evaluation (PACE) clinical study in the Journal of Minimally Invasive Gynecology. The PACE study evaluated hysteroscopic access to the uterine cavity for women who previously underwent endometrial ablation for heavy menstrual bleeding as part of a pivotal trial of the company’s Mara™ Water Vapor Ablation System. Additionally, the study assessed the projected feasibility of minimally invasive diagnostic and therapeutic interventions, and evaluated the potential correlation between ease of long- term access to the uterine cavity and menstrual bleeding status more than four years after the water vapor ablation treatment.

Data for the PACE study were collected from 70 patients at eight centers in a prospective, multi-center, international, observational study designed to evaluate long-term hysteroscopic uterine cavity access in subjects who had completed 36-month follow-up in the pivotal trial. The study was first conducted at seven U.S. sites, followed by a second cohort enrolled at one site in Mexico. A qualified/expert, blinded independent reviewer was utilized to provide an assessment of the uterine cavities.

“The PACE study findings should give physicians confidence in both the short- and long-term benefits of water vapor endometrial ablation,” said Dr. D. Alan Johns, Medical Director, Baylor Research Institute, Fort Worth, and Principal Investigator for PACE. “Publication in a prestigious journal like JMIG increases our clinical community’s awareness of the importance of long-term uterine cavity access post-ablation.”

In addition to the JMIG publication, three leading investigators will present on this important clinical research at the upcoming AAGL (American Association of Gynecologic Laparoscopists) meeting in Vancouver, B.C. The following abstracts will be presented on Monday, November 11, 2019 during the meeting:

1. There is No Correlation Between Long-Term Hysteroscopic Access to the Uterine Cavity and Menstrual Bleeding Status Following Use of Water Vapor Ablation To Treat Heavy Menstrual Bleeding – Presenter: Dr. José Gerardo Garza Leal
2. Long-Term Bleeding Status and Hysteroscopic Cavity Access Results Following Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding in Subjects Who Have Large Cavities, Uterine Myoma and/or Intratubal Contraceptive Inserts – Presenters: Dr. David Levine
3. Post-Ablation Cavity Evaluation: A Prospective, Multicenter, Observational Study to Assess Hysteroscopic Evaluation of the Uterine Cavity in Subjects Who Have Undergone Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding – Presenter: Dr. Cindy Basinski

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 ≤ 75³, 99 percent of patients experienced an improvement in their quality of life based on MIQ (Menorrhagia Impact Questionnaire) scores², 91 percent of patients were very satisfied or satisfied with the procedure³, and 93 percent said they would recommend it to a friend.³ Sustained results were reported three years after treatment.³

About Heavy Menstrual Bleeding (Menorrhagia)
Many women experience heavy menstrual bleeding at some point in their lives. One in three women 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.aegeamedical.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 aegeamedical.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. 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.
3. AEGEA Medical Instructions For Use

All references on file at AEGEA Medical, Inc.

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