Uncontrolled bleeding after giving birth is a common cause of severe maternal complications and even death, particularly in the U.S. and some developing nations. Alydia Health Inc. has developed a suction device that is placed in the uterus and is designed to halt hemorrhaging within a few minutes.
The Menlo Park, Calif.-based startup has raised a $13.9 million series C financing to support a launch for the device in the U.S. The company already has submitted for 510(k) clearance; it expects a decision from the U.S. FDA in the next few months, with a limited launch to follow. Alydia recently completed a pivotal trial of the device, which is known as the Jada system, and hopes to publish the results before year-end; the data are as yet undisclosed ahead of the regulator’s decision.
Restarting uterine contraction
“The Jada system is designed out of medical-grade silicone, which is the same material that is used in pacifiers,” Alydia CEO Rob Binney told BioWorld. “The distal tip is inserted into the uterus; it has a collapsible tip that is covered with pores. Those pores are essentially used to extract blood and air from the postpartum uterus by using just basic wall suction.
“Essentially, what it is attempting to do is mimic normal physiology,” he continued. “In the normal postpartum state, the uterus will collapse on itself, which in turn will stimulate muscle contraction and in turn will lead to blood cessation. That is the very simple, yet ingenious, design of the technology. It's designed to again instigate the uterus to contract itself using very gentle suction and, in turn, impede blood flow.”
Binney joined Alydia a few weeks ago. He was previously the CCO at sinusitis implant company Intersect ENT, where he worked prior to a U.S. FDA approval through three product launches. During his tenure, the company completed an IPO and achieved $100 million in annual revenue. Prior to that, Binney was with Access Closure, which was acquired by Cardinal Health in 2014 for $325 million, and Boston Scientific Corp.
Alydia is waiting until the FDA makes its decision to release the results of its recently completed pivotal trial, known as PEARLE. The 107-patient clinical trial was primarily conducted after vaginal births, but also included a subset of those with a Cesarean section. At this stage, Binney declined to speculate if an FDA-cleared indication was likely to include C-section patients.
The limited launch initially will focus on the 15 sites that participated in the PEARLE study, as well as some community hospitals that often don’t have the same resources – such as easy access to donated blood from blood banks – to support patients with postpartum hemorrhage.
“We have a very, very strong dataset,” said Binney. “One that is going to form the basis for a very strong clinical and patient value proposition. So, as I look out across the next year or so, I think that what we have right now is sufficient to support market entry and adoption.
“The feedback from the providers thus far has been a reaffirmation that we've got a trend line that's going in the wrong direction with regards to postpartum hemorrhage and maternal death. This technology really addresses that unmet need,” he added. “When you talk about the potential for a vacuum-induced, uterine tamponade type of approach, the light bulb goes off, and you get a very positive response from providers. It is somewhat intuitive – and just very innovative.”
After a normal vaginal delivery, there is an almost visible retraction of the uterus. But in the case of uncontrolled bleeding, that does not happen. Using gentle suction, the Jada device is inserted into the uterus to quickly stop bleeding by encouraging contraction, naturally compressing the open blood vessels. It induces bleeding cessation in about 10 minutes, and sometimes as quickly as one or two minutes. It is a disposable device, designed for individual use.
In 2018, on average, 17.4 women died for every 100,000 live births in the U.S. Maternal mortality is two to three times higher for Black and Native American women, as compared to their white peers.
Alydia expects to start developing a version of the device next year that would not require external wall suction, a feature often lacking in some birth environments. This iteration could be launched for use outside the U.S., particularly in developing nations that continue to have problems with maternal mortality.
With the financing, Zina Affas Besse, managing partner at Global Health Funds, will join the company’s board. Departing CEO Anne Morrissey remains on the board. The startup also tapped Colby Holtshouse, previously interim CEO and vice president of marketing, as COO.
“Rob has been instrumental in scaling up a number of commercial organizations, and his experience bringing medical technologies to market in diverse and competitive environments will prove invaluable to the organization,” said Curt LaBelle, managing partner at the Global Health Investment Fund and member of Alydia’s board, who also thanked Morrissey for seeing the company through the product development stage.
This financing will back the U.S. launch and support the initial development of an ex-U.S. version of the Jada system. It was led by AXA Investment Managers through its Impact Investing Strategy. Existing investors, including Global Health Investment Fund and Avestria Ventures, also participated in the round.
“Alydia Health’s device for postpartum hemorrhage has tremendous potential to improve outcomes for mothers and families around the world,” said Jonathan Dean, head of impact investing at AXA Investment Managers. “We are proud to invest in some of the most innovative technologies that address major public health issues worldwide, while generating attractive social and financial returns. Alydia’s technology addresses both of these measures, and we look forward to supporting the company through the upcoming launch of the Jada system.”