MENLO PARK, Calif.--(BUSINESS WIRE)--Alydia Health, formerly InPress Technologies, Inc., today announced that the company has closed an initial $10 million in a Series B financing led by the Global Health Investment Fund (GHIF) to support a U.S. pivotal study of the company’s innovative technology designed to prevent the maternal morbidity and mortality caused by postpartum hemorrhage. Astia Angels and other existing investors also participated in the round. Curt LaBelle, M.D., Managing Partner at the Global Health Investment Fund, will join the company’s board of directors.
Alydia’s product is designed to achieve rapid cessation of bleeding by encouraging the uterus to contract quickly, naturally compressing the open blood vessels. In a pilot study of 10 patients published in Obstetrics & Gynecology (the Green Journal)1, the device rapidly and effectively controlled postpartum bleeding, with hemorrhage controlled within minutes for each mother.
Building on the successful results of this feasibility trial, Alydia has initiated the PEARLE Study to support the company's planned 510(k) submission to the U.S. Food and Drug Administration (FDA) for marketing clearance. The study will evaluate the safety and effectiveness of the device in 107 deliveries at leading hospitals in the United States.
“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 States2,” said 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. “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.”
According to the Centers for Disease Control and Prevention (CDC), severe maternal mortality has been steadily increasing in recent years, nearly tripling between 1993 and 2014.3 Postpartum hemorrhage (PPH, excessive bleeding after delivering a baby) is a leading cause of maternal complications during birth, leading to emergency intervention including hysterectomy, expensive blood transfusions, and, in some cases, maternal death.
“We are grateful for the strong partnership from GHIF, Astia Angels, and our existing investors as we begin this new chapter for the company following the successful publication of our early clinical data,” said Anne Morrissey, CEO of Alydia Health. “Our new name, inspired by the Greek goddess of labor and delivery, reflects our mission to make childbirth safer for all mothers. We could not achieve this mission without the support of our forward-thinking investors and board members.”
“Alydia Health’s solution for postpartum hemorrhage offers tremendous potential for mothers and families around the world, starting right here at home,” said Curt LaBelle, Managing Partner at the Global Health Investment Fund. “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.”
“We are thrilled to back this experienced, women-led executive team in tackling an important problem in women’s health,” said Sharon Vosmek, CEO of Astia and Astia Angels. “Our members saw significant potential for this investment based on the early results and the strong clinical partners involved in the PEARLE study, which include pre-eminent U.S. centers and OB-GYN thought leaders. We are excited to work with the Alydia team to support the company’s mission.”
About Alydia Health
Alydia Health is a medical device company dedicated to making childbirth safer for all mothers. The device concept was developed in 2010 at Cal Poly in an effort to design a global solution for postpartum hemorrhage. With a goal of encouraging natural physiologic recovery, the device is designed to work with the normal contractions of the uterus to rapidly stop bleeding. In a study of 10 cases published in Obstetrics & Gynecology (the Green Journal)1, hemorrhage was controlled within minutes for each mother.
Alydia Health, originally named InPress Technologies, is a graduate of the Fogarty Institute for Innovation and the Cal Poly Center for Innovation and Entrepreneurship (CIE). Today, Alydia Health is a privately held, venture-backed company headquartered in Menlo Park, Calif., and its investigational postpartum hemorrhage device is currently being evaluated in the U.S.-based PEARLE study (clinicaltrials.gov: NCT02883673). For more information, please visit www.alydiahealth.com.
About Global Health Investment Fund
GHIF is a social impact investment fund structured by JPMorgan Chase & Co. and the Bill & Melinda Gates Foundation. With an emphasis on late-stage projects, GHIF finances the development of drugs, vaccines, devices, and diagnostics for diseases that disproportionately burden low-income populations. Key global health challenges targeted by the fund include malaria, tuberculosis, HIV/AIDS, cholera, and preventable causes of maternal and infant mortality, in addition to other neglected infectious diseases. GHIF’s definition of success requires meaningful improvements in the lives of those afflicted by these challenges, and the fund forecasts and measures its progress against this objective alongside traditional financial return benchmarks. For additional information about GHIF, please visit ghif.com.
About Astia and Astia Angels
A different kind of network performing in a different kind of way, Astia is a global nonprofit that levels the playing field for women entrepreneurs. Core to its mission is ensuring that companies led by women have access to investment capital, as today less than five percent of venture capital is invested into women CEOs. In 2013, Astia launched Astia Angels to enable members of the Astia community to invest directly into companies in the Astia pipeline. To date the group has invested $20.5M into 60 companies and has exceeded Astia’s expectations by delivering substantially above-market returns for its first four exits. The results include: nVision acquired by Boston Scientific (NYSE: BSX); Boku, a US-based fintech company listed on the London Stock Exchange’s Alternative Investment Market (AIM) in November; Cloudamize, a Philadelphia-based Cloud computing analytics company merged last summer with Blackstone-owned Cloudreach; and Ciel Medical, a medical device company which developed a catheter to prevent ventilator associated pneumonia. The group is managed by an investment team made up of CEO Sharon Vosmek (Silicon Valley) and Managing Directors Victoria Pettibone (NYC) and Evie Mulberry (UK). The group is international and made up equally of men and women. Members currently hail from the Bay Area, the East Coast, the UK, Germany, Australia, and Senegal.
1 Purwosunu Y, et al. "Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade." Obstetrics & Gynecology. Vol. 128, No. 1, July 2016.
2 NPR/ProPublica Special Series: Lost Mothers: Maternal Mortality in the U.S. https://www.npr.org/series/543928389/lost-mothers