Postpartum hemorrhage is one of the leading causes of preventable maternal death around the world, and innovation in treatment for the issue has remained largely stagnant.
Menlo Park, Calif.-based Alydia Health has raised a $10 million Series B financing round to conduct a clinical trail for its novel vacuum-based solution to postpartum hemorrhage.
Alydia Health’s product is a medical-grade silicon device that is inserted into the uterus, creates negative pressure and stops bleeding by contracting the uterus.
Existing alternatives to treat postpartum hemorrhage include medications which contract the uterus, packing the uterus with gauze or using a device called intrauterine balloon tamponade, which inflates within the uterus and stops bleeding. In some extreme cases, a hysterectomy will be performed.
Alydia argues that its product is superior to other methods because of the fast deployment of the device and the potential of the intrauterine balloon tamponade to hide bleeding.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“With clinicians, I put the device in their hands and their brain clicks and they relax, it makes sense to them,” Alydia CEO Anne Morrissey said in a phone interview. “As a mom and as a woman, it’s low-hanging fruit, it’s such a big problem and we have this incredibly simple solution.”
The financing round was led by the Global Health Investment Fund, an investment fund structured by J.P. Morgan Chase and the Bill & Melinda Gates Foundation, which is focused on technologies with a global reach. Astia Angels, an investment group focused on supporting women entrepreneurs, also participated in the capital raise.
“Alydia Health’s solution for postpartum hemorrhage offers tremendous potential for mothers and families around the world, starting right here at home,” Curt LaBelle, a managing partner at the Global Health Investment Fund said in a statement.
“At GHIF, we invest in therapies that improve and save lives around the world while generating attractive financial returns. Alydia’s promising clinical results thus far indicate strong potential to achieve on both of these measures. We look forward to the U.S. clinical evaluation and subsequent commercialization of this postpartum hemorrhage device.”
The company, formerly known as InPress Technologies, was initially founded back in 2011 by Cal Poly student Jessie Becker, who developed the technology as part of a biomedical engineering contest to help solve postpartum hemorrhage in the developing world.
While the company’s current focus is commercialization in the United States, Alydia eventually wants to distribute the device globally.
“The founding vision of the company and a part of why we’re all doing this is because there are women all over the world suffering from this issue,” Morrissey said.
The 10-person startup will use the funding to conduct a clinical trial featuring 107 participants at hospitals including the University of Utah, the University of Alabama and Columbia University.
The study has been developed in collaboration with the FDA and Morrissey said she anticipates the trial will be completed by the end of 2019 with a 510(k) clearance from regulators in the first half of 2020.
“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 United States,” Mary D’Alton, the Chair of the Columbia University Department of Obstetrics and Gynecology and principal investigator for the Alydia study.
“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.”
Photo: Abscent84, Getty Images
