A small startup is developing a device aimed at treating and preventing maternal bleeding. Menlo Park, CA-based Alydia has raised $10 million in a series B round to help it get the technology past clinical trials and onto the market in the U.S.
The technology works with the normal contractions of the uterus to rapidly stop bleeding. The concept of the device was developed in 2010 at the Cal Poly Center for Innovation and Entrepreneurship.
“What is used now are drugs, which work too slowly or might not work,” Anne Morrissey, CEO of Alydia Health, told MD+DI. “They also complicate the clinical picture. Our expectation based on the feedback we’ve gotten from clinicians is that our device will be used in that treatment path after initial prophylactic uterotonics are given. Our long-term hope is that this device is a tool that will allow [physicians]to act as soon as they can.”
The financing was led by the Global Health Investment Fund. Astia Angels and other existing investors also participated in the round.
“The proceeds for our series B financing are for two main purposes,” Morrissey said. “One is to help us to complete [the PEARLE] clinical study. We have 107 patients in the study. In addition to that, the funding will be used for our 510(k) submission to FDA.”
Morrissey said it was the company’s hope that the device could be cleared come sometime in 2020. Plans also call for the company to seek approval for the device in developing countries where the mortality rate for postpartum is much higher.
“It is enormously important to develop and research new methods for management of obstetric hemorrhage, as it is a leading cause of maternal mortality and morbidity in the U.S.,” Mary D’Alton, M.D., Chair of the Department of Obstetrics and Gynecology at Columbia University Vagelos College of Physicians and Surgeons, Chair of the Foundation for the Society for Maternal and Fetal Medicine, and study-wide principal investigator for the PEARLE Study, said in a release. “I am therefore thrilled to evaluate Alydia's device through the PEARLE Study. If it is shown to be effective, it will add significantly to our options to address hemorrhage, which remains one of the most challenging complications to manage, here at home and globally.”
In a pilot study of 10 patients published in Obstetrics & Gynecology (the Green Journal), the device rapidly and effectively controlled postpartum bleeding, with hemorrhage controlled within minutes for each mother.