What happens when three female engineers meet at Dartmouth and question why most women’s health devices were designed by men more than a hundred years ago?
They team up with a seasoned physician and improve said devices.
Reia is a healthcare startup with a mission of “improving the treatment experience for people with pelvic organ prolapse.” Its first device, currently in clinical trials, is a nonsurgical pessary that treats prolapse — a condition that occurs when the muscles supporting the uterus, bladder or rectum become weak and the organs sag, often protruding down into or out of the vagina.
Pelvic organ prolapse affects 50 percent of women over the age of 50, says co-founder and CEO Kaitlin Maier.
Maier and her fellow co-founders met at the Thayer School of Engineering, where they formed an independent study on devices used in women’s health. Maier (now chief executive officer), Ariana Sopher (now chief operating officer), and Meegan Daigler (now chief technical officer) interviewed Dartmouth-Hitchcock urogynecologist Paul Hanissian (now chief medical officer) — among many other practitioners — about top women’s health issues, current solutions, and their shortcomings.
The condition he complained most about? Prolapse.
The problematic solution? Pessaries.
A pessary is a device that is inserted into the vagina to support fallen organs. Because of its size and the difficulty of insertion and removal, pessaries are nearly impossible to use without the assistance of a physician, Maier says.
The undergraduate student trio was shocked they had never heard about prolapse, particularly being women who may one day experience it or know someone who does. Maier was even more shocked that the pessary had scarcely been updated since 400 B.C., when a pomegranate was used to treat prolapse. The modern-day pessary is basically a medical-grade pomegranate.
With such a device, you can imagine there are problems.
“With the traditional pessary, patients typically go to a practitioner every three to four months,” Maier says. “The practitioner removes the device, cleans it and reinserts it. When it is inserted, it can be difficult or impossible to have penetrative sexual intercourse, and patients can develop vaginal erosion or other complications from the long-term foreign body presence. Especially for rural areas like New Hampshire, where some patients drive multiple hours (for an office visit), going to these quarterly maintenance visits can be very time consuming.”
Reia developed a nonsurgical pessary that supports the organs and empowers users to insert and remove the device without the need for a doctor’s visit. It collapses for insertion and deploys once in place.
With Reia’s pessary, patients can maintain the device themselves. They can remove and insert it for cleanings, or to engage in sexual intercourse, and easily reinsert it. For those with only minor prolapse issues, the device can be inserted only when needed, such as during intense physical activity or exercise. Finally, patients can also take it out to give the vaginal tissue a rest when irritated.
Reia has raised just over $2 million through two National Institutes of Health Small Business Innovation Research Grants. The startup completed its early feasibility pilot last winter at Dartmouth-Hitchcock Medical Center, testing the device with 15 patients in the form of a typical pessary fitting visit.
It is currently in the process of launching its clinical trial at four medical sites across the Northeast. Beyond DHMC, it is also testing in New York, Massachusetts and Rhode Island. During clinical trials, the device will be used by 50 patients. They will take the pessary home for three months, interact with it on a regular basis and report back on how it performs.
The clinical trial will conclude in spring 2022, at which time the Reia team will use the evidence gathered to submit for FDA clearance, with hopes of obtaining clearance to bring the device to market by the end of the year.
Peter Rosenblatt, director of urogynecology at Mount Auburn Hospital in Cambridge, Mass., is one clinician investigating use of Reia’s pessary during the clinical trial.
“I was very excited to get involved in the study because for many women with advanced prolapse, the pessaries we have been using for many years are uncomfortable to place and especially to remove, which needs to be done regularly,” Rosenblatt says.
“Pessaries have not changed for the most part in several decades,” Rosenblatt continues. “The unique and innovative characteristic of the Reia pessary is that it has the advantages of a durable and effective pessary with the benefit of making it more comfortable to place and remove by making it collapsible during insertion and removal. I have been very impressed with the Reia team and their ability to innovate and modify the Reia device based on feedback from us and other physicians who deal with pessaries on a regular basis.”
While the team is currently composed of just its four co-founders, Maier says she anticipates team growth as Reia approaches product launch, particularly regarding expansion of its marketing and sales capacities.
Maier says the company’s next project is the development of an applicator that will help patients insert the device. It began product discovery during the COVID-19 pandemic when all clinical testing was halted. They mailed prototypes to patients and conducted video-based and socially-distanced, outdoor feedback sessions.
“We’re working on making the device usable by the greatest population,” Maier says. “People with prolapse do tend to be older, and arthritis, for example, does eventually come into the picture, and there is a decent overlap (in patients having both conditions). While you can collapse the device with limited hand dexterity, we are developing an applicator to make it even easier.”