With $2 million in seed funding, a local women's health startup is making progress towards clinical trials for a less painful intrauterine device.
IUDs are a common form of birth control, and are one of the most effective methods of contraception. Traditional IUDs are T-shaped, and to insert them properly, doctors use a measuring tool called a sounder to measure the uterus. The measuring and insertion can be very painful, particularly when either hits the top of the uterus.
3Daughters, based in Mansfield, says its IUD is different, designed to eliminate three pain points, according to Mary Beth Cicero, co-founder and CEO of 3Daughters. It is made of three tiny elliptical units and is coated in copper. The device is magnetic, making retrieval easier, and eliminating the need for the potentially painful measuring process. 3Daughters describes it as frameless and self-conforming to the body.
The startup has filed patents for both the device and a less intrusive inserter, said Cicero, who co-founded the startup with Shelley Amster. Amster is one of the founding board members of the Mansfield Bio-Incubator and an original organizer of the Massachusetts Life Sciences Innovation (MALSI) Day.
“Women’s health lacks innovation. Women have been putting up with IUD insertion pain for 40, more like 50, years,” Cicero said. “We believe we have the full package for what women want.”
The elliptical-style device is a borrowed idea from veterinarian and professor of veterinary and animal science at the University of Massachusetts Amherst, Carlos Gradil, who invented the technology. Its first intended use was in horses, and 3Daughters has adapted the design for humans.
3Daughters plans to file an Investigational New Drug Application — the first step toward U.S Food and Drug Administration approval — before the end of this year, Cicero said.
The first part of the seed round was led by Thairm Bio, and included participation from the Argosy Foundation, Wexford Science and Technology LLC, UMass Amherst, and other undisclosed investors.
A plan to find a commercialization partner
The startup originally planned to complete its first-phase clinical trial in 2024, but that goal has shifted to 2025, Cicero said. It’s in part because fundraising took longer than expected, and because more development was happening on the business side. The startup brought on more team members and added more scientific advisers, as well as continued development of the device and the inserter. It pivoted to raising its seed round in 2023 rather than a previously planned series A for the year.
3Daughters has set a goal for a $10 million Series A round, Cicero said, but it is first looking for an additional one million in this Seed round. It aims to raise that million before this first quarter of 2024 is over.
The 3Daughters team has had multiple conversations already with the FDA, and the first phase of the clinical trial is designed to prove product concept, Cicero said. It will answer, “is it easy to get in? Is it easy to take out? Where does it reside in the uterus? Can we eliminate the pain points? Do the patients have less pain?” said Cicero.
The eventual plan is to find a commercialization partner for the device, she said.
“This asset, we believe, can be totally disruptive,” she said. A small startup does not have the capacity to bring it to what Cicero said is a $ 1.5 billion market.
“It's Big Pharma that's going to do the social media, the advertising,” for this kind of product, she said.
Cicero said 3Daughters expects to begin those commercialization conversations early, once data is available from the phase 1 trial. This type of pharmaceutical is classified as a drug by the FDA, meaning it will have to go through a three phase trial.
