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The company's investigational device, called the Jada System, is designed to treat PPH
While the maternal mortality rate has gone down by almost 40 percent globally since 2000, the United States has seen pregnancy-related deaths actually go up over the last 30 years, despite being among the most developed countries in the world. Even worse, around half of those deaths are considered to be preventable.
One of the most common problems that mothers face is what is called postpartum hemorrhage (PPH), a condition that causes a woman to have heavy bleeding after the delivery of a baby. This is an especially big problem for women of color in the U.S., who experience three to four times more maternal deaths than white women.
Alydia Health is a medical device company that is looking to put an end to this problem, and on Thursday it announced a new funding raise, as well as the appointment of a new CEO in Rob Binney, who joins the team from Intersect ENT.
"PPH, also known as abnormal postpartum uterine bleeding, leads to pharmacologic treatment in up to 10 percent of mothers, and emergency intervention including hysterectomy, expensive blood transfusions and, in some cases, maternal death," Binney explained to me.
"Today’s standard of care for postpartum hemorrhage includes drugs, which can work too slowly or not at all, devices, which are often used too late in the treatment paradigm and have other limitations, packing with gauze, which is exactly like it sounds, and hysterectomies."
Alydia, on the other hand, has developed a new way of dealing with the problem of PPH: the Jada System, which consists of a thin tube, made of medical-grade silicon, with a collapsible soft loop that is placed inside the uterus.
"The loop has small protected pores, which apply gentle suction to the uterus, removing blood and encouraging the uterus to contract and stop bleeding, as it should naturally do after childbirth. Most importantly, very rapid hemorrhage control has the potential to result in less blood loss, reduced transfusions, and lowered risk of further injury and mortality," Binney explained.
Right now, Alydia is still looking for FDA clearance for its device; the company recently completed the PEARLE IDE Study of the Jada System, the results of which have been submitted in a pending 510(k) submission to the FDA for potential marketing clearance of the device.
Pending FDA clearance, the company is going to begin selling the device, and now it has an additional $13.9 million to help that process along.
The Series C round 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. With this new funding, the company has now raised a total of $30 million.
"We are fortunate to have a such a committed group of investors in Alydia, who believe in the cause of improving maternal health globally, are encouraged by our data to date and the technology, support the advancement of businesses solving women’s health issues and see the financial potential of the Jada System," said Binney.
"The funds will help us take Alydia to the next level, allowing us to launch the Jada System in the U.S. upon potential FDA clearance. This will include the hiring of an initial sales team, building out our corporate support team, and investing in marketing tools and platforms to further support our commercialization efforts."
Along with the new funding, it was also announced that Dr. Zina Affas Besse, Managing Partner at Global Health Funds, will be joining the board of directors at Alydia.
"Dr. Besse's global business expertise will prove invaluable to Alydia as we turn our focus to the development and launch of our global device in the coming years. In the meantime, she will provide guidance to the team based on her extensive experience with multiple portfolio companies as we continue to build out our U.S. commercial capabilities."
A new CEO
Binney is taking over the CEO role from Anne Morrissey, who recently stepped down; interim CEO Colby Holtshouse, who was also the company's VP of Marketing, will now be taking on the role of Chief Operating Officer. Binney was previously the Chief Commercial Officer at Intersect ENT, where he helped lead the company through a successful initial public offering and the launch of three products.
Prior to Intersect ENT, he worked in leadership roles with both startups and large medical device companies, including Boston Scientific and AccessClosure.
"When looking for the next role, I knew I wanted to be a part of an organization that was making a meaningful impact in the world. Mothers everywhere deserve the right to safe childbirth and the astonishing rate of complications requiring treatment is unacceptable," Binney told me.
"I believe deeply in the potential of Alydia's technology to fill a growing clinical need in women’s health and I'm thrilled to have the opportunity to fundamentally change the course of maternal mortality around the world."
Specifically, he and Alydia were a good fit, because the company needed a leader "that had proven experience ramping up a company to commercialization and scaling to the next stage of growth."
"I’m fortunate that my experience scaling Intersect ENT and driving the adoption of the company’s innovative products has given me a unique background, making it a great fit on both sides. I have benefited and learned from strong female CEOs during my career and I am committed to helping advance the next generation of female CEOs."
There is a lot that Binney expects to happen for Alydia over the next year, including the potential FDA clearance of the Jada System, as well as building out the team and initiating clinical research on the device designed for developing countries in the next couple of years. His ultimate goal with the company, though, is to reverse the maternal mortality trends happening globally.
"It’s our team’s aspiration to ensure that the birth experience reflects what it should: joy, wonder, excitement, and love for mothers and families around the world," he said. "Our world-class team is committed to making childbirth safer for all women by bringing this device into the hands of those who need it most."
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