Boston-based startup Cerevasc Inc. scooped up $43.9 million in a series A round that was led by Perceptive Xontogeny Venture (PXV) Fund and Aton Partners LLC. The funds are earmarked to support a first-in-human trial of the company’s Eshunt system for the treatment of hydrocephalus, as well as subsequent clinical studies to support regulatory approvals. The minimally invasive technology uses an endovascular approach to remove excess cerebrospinal fluid (CSF) from the brain.

Hydrocephalus, also known as “water on the brain,” is a neurological disorder resulting from too much fluid pressing on the brain. It affects an estimated one million Americans of all ages and is the most common reason for brain surgery in children. Worldwide, roughly 85 in 100,000 people suffer from hydrocephalus.

The current treatment for hydrocephalus, a ventriculoperitoneal (VP) shunt, involves making an incision in the scalp, burring a hole in the skull and passing a catheter through the brain to the lateral ventricle. This allows CSF build-up to pass through the catheter. The catheter is then connected to a valve-like device implanted behind the ear, and a long catheter is threaded beneath the skin, across the chest and abdomen, to an incision in the peritoneum where the CSF is reabsorbed.

Avoids need for open surgery

Dan Levangie, chairman and CEO of Cerevasc Inc.

An estimated 130,000 VP shunt procedures are performed each year in the U.S. and Western Europe, according to Dan Levangie, Cerevasc’s chairman and CEO. Of those, roughly a third are for replacements or revisions due to failed shunt systems.

By contrast, the Eshunt procedure involves a small incision in the groin to access the femoral vein and uses a proprietary delivery catheter to navigate to the brain. Once there, it implants a very small device that allows CSF to pass from the subarachnoid space back into the venous system, where it is reabsorbed.

“We’re taking an open surgical procedure that’s pretty old, with a high failure rate, and we’re converting it to a minimally invasive, endovascular procedure,” Levangie told BioWorld.

The concept is not new, only the application, he pointed out, noting the technology draws on years of innovation in the treatment of neurologic diseases like stroke, as well as heart valve disease.

The Eshunt system is the brainchild of Tufts Medical Center neurosurgeons Carl Heilman and Adel Malek, co-founders of Cerevasc along with Levangie and Patrick Sullivan. The company licensed the intellectual property from Tufts and developed the current delivery system and implant.

Pilot study to begin enrolling this fall

Early tests in a simulated model, cadavers and animals have demonstrated that the Eshunt system can navigate to the appropriate spot in the brain, place the device and safely leave it there.

Cerevasc plans to begin enrolling patients in the first-in-human study in the second half of this year, with a target population of about 15 patients. The purpose of that study is to demonstrate the safety and short-term effectiveness of the Eshunt system. If the results are good, the company expects to file for an investigational device exemption to conduct a larger, U.S.-based, pivotal trial of more than 100 patients, Levangie said.

“Our plan would be to conduct a pivotal trial that would enroll several sites in the E.U. and use that data as the basis for our approval both in the U.S. and Europe,” he said.

“This round will get us through multiple clinical studies including a pivotal that, if the data is strong enough, could lead in a best scenario to an FDA-approved device,” said Chris Garabedian, CEO of Xontogeny and manager of the PVX Fund for Perceptive Advisors, told BioWorld.

Potential for wide adoption

This is the first med-tech investment for the PXV Fund, which has previously invested in three drug ventures. Perceptive Advisors created the fund in 2018 as an investment vehicle focused solely on early-stage, private venture investments in life sciences companies. The fund’s investments are mainly companies that have been seeded, incubated or are actively managed by Xontogeny, a life sciences incubator, though that was not the case with Cerevasc.

What attracted the PVX Fund to Cerevasc was the large body of data already in hand that demonstrated the technical feasibility of the Eshunt system and technique and the potential for a strong adoption curve. “We saw the more invasive surgery, the current shunts, as not only risky and more invasive, but the revision rate … was significant,” Garabedian said. “And we just thought this was a much needed, elegant approach, which should have at least as good of outcomes, potentially safer, and if that is true and these studies work out, we saw this as being adopted widely,”

With the $43.9 million series A, Cerevasc has raised a total of about $64 million.

Levangie echoed Garabedian’s enthusiasm about the round and the treatment. “We’re really delighted to be working with Perceptive Xontogeny, and the size of the investment gives us the resources we need to put in place the appropriate clinical trials, conduct those trials and gain regulatory approvals, which has been the goal from the beginning,” he said.

In conjunction with the financing, Garabedian and Fred Callori, head of corporate development at Xontogeny and PVX Fund, will be joining Cerevasc’s board of directors.

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