Aegea Medical raises $17m, touts 3-year adaptive vapor ablation pivotal results

Aegea Medical

Aegea Medical said this week it raised $17 million in a new financing round and released three-year follow-up data from the pivotal study of its Adaptive Vapor Ablation technology designed for use in endometrial ablation procedures.

The funding round was led by Solas BioVentures and its affiliates, with funds slated to support the company’s PACE II trial exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures, the Menlo Park, Calif.-based company said.

Funds from the round will also support the 2019 commercial launch of the company’s next-gen Adaptive Vapor Ablation system, Aegea Medical said.

“Aegea’s Adaptive Vapor Ablation technology offers physicians and patients a simple, elegant and safe treatment for treating a complex, underserved condition. The importance of being able to re-access the uterine cavity after endometrial ablation cannot be overstated. Aegea’s unique ablative medium has the potential to preserve less invasive options for patients. We believe we are just beginning to see the technology’s full potential, and we have confidence in its ability to become the new standard of care for treating menorrhagia,” Solas BioVentures co-founder & managing partner Dr. David Adair said in a prepared statement.

“We are fortunate to have found a partner in Solas BioVentures that truly appreciates our mission to provide patients with a natural treatment option that relieves their symptoms and restores their lives. This funding is an important milestone towards the commercialization of our next-generation Adaptive Vapor Ablation system, as well as research into the feasibility of preserving uterine cavity access following treatment,” Aegea Medical prez & CEO Maria Sainz said in a press release.

The company also released three-year results from the pivotal Aegea vapor system study, with results presented at the AAGL Global Conference on Minimally Invasive Gynecologic Surgery in Las Vegas.

Results from the 155-patient study, conducted at 15 sites in the U.S., Canada, Mexico and the Netherlands, indicated that the 120-second endometrial ablation was safe and effective, with 95% of patients reporting normal menstrual bleeding or no menstrual bleeding.

Data also indicated that 92% of patients reported being very satisfied or satisfied with the procedure, and 95% said they would recommend it.

“We are very encouraged by these positive data, as they show that the results of Adaptive Vapor Ablation stand the test of time. These three-year follow-up data should assure physicians and patients that our innovative and natural vapor-based treatment will successfully deliver sustained safe and effective outcomes including improved quality of life,” Sainz said in a prepared statement.

“These results give me great confidence in Aegea’s Adaptive Vapor Ablation procedure. It’s safe and effective, and it delivers the long-term outcomes we are looking for as physicians. I believe Adaptive Vapor Ablation is a valuable new option for treating women with menorrhagia,” Aegea pivotal study principal investigator Dr. Mark Levie of the Albert Einstein College of Medicine said in a press release.

Late last month, Aegea Medical said that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures.

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Aegea Medical launches post-market Adaptive Vapor Ablation study

Aegea Medical

Aegea Medical said today that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures.

The PACE II study will look to enroll up to 50 women who were previously treated in the Menlo Park, Calif.-based company’s pivotal trial of the Adaptive Vapor Ablation tech and will analyze uterine cavity access and the feasibility of diagnostic and therapeutic interventions for three to four years post-treatment.

“While endometrial ablation technologies have served physicians and their patients well for some time, the issue of post-procedure uterine cavity access has never really been addressed. We believe this is a very important success metric for the therapy, as it speaks to the possibility of future uterine-related interventions. The PACE Pilot data on 11 patients treated with Adaptive Vapor Ablation technology is very promising in how Vapor Ablation can address this unmet need, preserving physician and patient options in the future,” prez & CEO Maria Sainz said in a press release.

In the pivotal PACE study, investigators found that post-procedure access to the mid-uterine cavity or beyond was possible in 82% of the 11 patients who had participated in an earlier Phase II study.

The observational endpoint of the trial includes endometrial biopsy and IUD placement, the ability to visualize the uterine cornia and ostia and the presence and characteristics of adhesions within the uterine cavity, Aegea said. The company is hopeful it will complete the trial within six months.

“Post-procedure uterine cavity access is the next big topic in endometrial ablation. Given the early performance of Aegea’s Adaptive Vapor Ablation technology in this area, I believe it has the potential to address this issue, providing physicians and patients with a more thoughtful approach to endometrial ablation that allows for future uterine interventions as necessary. Importantly, this multi-center study has been designed with objective criteria to avoid patient selection bias. Additionally, the study includes independent expert review of the hysteroscopy imagery to further increase the data’s scientific rigor,” study national principal investigator Dr. Alan Johns of Fort Worth, Texas’s Clinical Research Baylor Research Institute said in a prepared statement.

In May, Aegea Medical said that it tapped former Cardiokinetix prez & CEO Maria Sainz as its new president and chief executive officer.

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