Is Ablative Solutions’ Latest Financing a Positive Sign for Renal Denervation?

In 2014, renal denervation procedures to treat resistant hypertension took a crippling blow, when Medtronic failed to meet the primary endpoints in a trial, but recent activity from the Dublin-based firm and others indicates that the space is hot once again.

Peregrine System kit

Courtesy of Ablative Solutions

Ablative Solutions latest financing might have just significantly improved investor faith in renal denervation procedures for the treatment of uncontrolled hypertension.

The Kalamazoo, MI-based company revealed the first close of its $77 million series D round, which will be used to get its Peregrine System kit through regulatory trials. The firm’s device is a minimally invasive renal denervation technology designed to help reduce blood pressure for people with uncontrolled hypertension, while taking antihypertensive medication.

The Peregrine System kit is engineered to target nerves known to influence the body’s regulation of blood pressure. The technology delivers dehydrated alcohol in small doses directly to the space outside of the renal artery to block the overactive signaling of the sympathetic nerves.

“We have been supported the past few years by an amazing team of clinicians who, along with our very hard-working team, are committed to making this treatment available to patients,” Ablative Solutions’ CEO and CMO Tim Fischell, M.D., said in a release “We are excited to have the support of this thoughtful and high-powered group of investors, which will allow the company to complete the studies required to seek regulatory approvals in Europe and in the U.S.”

Two things stand out about Ablative Solutions’s news. The first thing is that $77 million is a pretty sizeable financing for a medtech company. The second thing is that such a sizeable amount is being used to support renal denervation for uncontrolled hypertension technology.

Recall that in the past, renal denervation therapies for hypertension were ‘elusive’ for many medtech companies – large and small. That’s what makes Ablative Solutions announcement so significant. The company’s series D round shows that Investors are still interested in renal denervation to help treat hypertension and its promise for patients.

The round was led by new investor Gilde Healthcare and co-led by existing investor BioStar Ventures and an undisclosed new strategic corporate investor. Existing investors including Michigan Accelerator Fund, Novus Biotechnology and other individual investors also participated the Series D funding round.

“BioStar Ventures focuses on transformational health care investments, and we believe Ablative Solutions fits that model perfectly. We are enthusiastic about the company’s innovative approach to treating high blood pressure, a serious condition that impacts more than one billion people worldwide,” Michael Fulton, M.D., senior managing director of BioStar Ventures, an investor in the company since its Series A round in 2012, said in a release. “Ablative Solutions’ patented technology enables a streamlined procedure that has the potential to become an important adjunctive therapy to improve difficult-to-control blood pressure.”

But questions and doubt came up about these hypertension-treatment procedures in 2014, when Medtronic failed to meet its primary endpoints in the SYMPLICITY HTN-3 trial. The Dublin-based company was able to occupy a presence in the space when it acquired Ardian for $800 million in 2010.

Medtronic's failed endpoints led to Boston Scientific and Covidien (before it was acquired by Medtronic) to abandon their hypertension therapy technologies.

It wasn’t until four years after Medtronic released its SYMPLICITY HTN-3 trial results that the medtech giant would announce it gained FDA approval for a 433-patient pivotal trial of its Symplicity Renal Denervation System. This move reigniting the space.

Just two months after Medtronic revealed it was re-entering the scene to treat uncontrollable hypertension, Tokyo-based Otsuka Holdings made a play to enter the space and acquired ReCor Medical for an undisclosed sum.

The acquisition also came just days after Palo Alto, CA-based ReCor Medical received approval from FDA for a pivotal trial of Paradise, an ultrasound renal denervation system. Enrollment for the trial began in October.

Vascular Dynamics announced it was taking a different route to treat resistant hypertension – by developing a stent-like application that will give therapy to patients. In September of last year, the Mountain View, CA-based company said it had enrolled the first patients in its CALM-2 300-patient pivotal trial.

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