Startups, Pharma

Michigan medtech company raises $77M for renal denervation solution to hypertension

While the development of renal denervation technologies stalled after a failed Medtronic study in 2014, recent positive research results have led to increasing interest - and investment -  in the space.

heart, doctor, cardiac

Hypertension is a condition that affects millions of people around the world and can lead to serious health issues including cardiac arrest, stroke and heart failure. It also represents a significant burden and cost to the healthcare system as a whole.

One potential innovative pathway to addressing hypertension outside of traditional medication is through a process known as renal denervation, where nerves in the renal system are targeted to reduce blood pressure.

While the development of renal denervation technologies stalled after a failed Medtronic study in 2014, recent positive research results have led to increasing interest – and investment –  in the space.

Case in point, Kalamazoo, Michigan-based Ablative Solutions has recently raised $77 million in Series D funding to further develop and test its Peregrine System Infusion Catheter for use in renal denervation treatments.

The new funding round is being led by European investment firm Gilde Healthcare and existing investor BioStar Ventures.

Nicole Haratani, Ablative Solutions vice president of global clinical affairs, said the company is using the funding to support clinical research and efficacy tests into its technology, which infuses dehydrated alcohol into the renal system as a neurolytic agent to block nerves that can trigger higher blood pressure.

According to Haratani, the company has largely been in a holding pattern for the past two years due to a lack of funding for the company’s clinical research efforts due to the initial poor results of research into renal denervation.

“It was like they killed us, then they helped us,” Haratani said of competitors like Medtronic and ReCor Medical which recently published studies indicating significant reduction in blood pressure after early clinical stumbles.

The new cash infusion will go to support a small proof-of-efficacy study of Ablative’s technology and a larger randomized trial meant to act as a clinical validator of the technology for regulators in Europe and the U.S.

“Hypertension is largely a silent disease and we know that half the people with the condition are not being successfully treated for it,” Haratani said. “A reduction of 10 mmHg of systolic blood pressure by Office BP measurement will reduce approximately 20 percent of cardiovascular events.”

The promising results from recent studies into renal denervation was one of the aspects that attracted investors like Geoff Pardo of Gilde Healthcare, who also pointed to the ReCor Medical’s acquisition by Otsuka as another major market validator.

“We approach every med device investment with thesis that we’re going to acquired by one of the players out there so there has to be an attractive M&A environment,” Pardo said in an interview.

Pardo said that Ablative Solutions’ technology is differentiated in the market by its ability to target nerves at a shallower depth than competitors leading to a minimally invasive and short administration with potentially greater efficacy.

“We’re extremely excited to work with a strong syndicate with enough money to achieve these clinical objectives and deliver something that hits on better outcomes, being better for patients and reducing costs,” Pardo said.

Ablative’s product also differs from other companies in its use of its dehydrated alcohol as the primary method of denervation, which means that the company is going through a drug development regulatory process instead a traditional medical device pathway.

Haratani positioned this as an advantage due to regulators ‘previous experience working with medication with hypertension allowing for a smoother and more collaborative approval process.

As part of this reorientation, Haratani said the company has been bringing in experts in the drug development process and plans to increase headcount to around 30 employees by the end of the year.

Photo: BrianAJackson, Getty Images

Shares0
Shares0