A Kalamazoo-based medical device company is one step closer to launching studies in the U.S. and Europe to test its innovative catheter system in the treatment of severe hypertension.
U.S. Food and Drug Administration approval of Ablative Solutions Inc.’s new Peregrine System Infusion Catheter verifies the device’s safety and effectiveness and allows the company to proceed with testing it for specific treatments.
In Ablative Solutions’ case, they plan to test using the device in the treatment of hypertension cases that are resistant to medication, CEO Tim Fischell told MiBiz.
Gaining FDA approval “is a very big deal” and “a huge hurdle” to clear for Ablative Solutions, Fischell said.
“We’re going to utilize this to move forward in our regulatory pathways. We’re going to finally be able to do a number of things for our company,” said Fischell, a serial entrepreneur and innovator who formed the company with his brother, David.
The agency’s action “definitely should make it a much easier pathway” to get subsequent approval of the company’s plans to conduct clinical trials and ultimately seek commercial approval to market the Peregrine System, Fischell said.
Federal regulations require an FDA review of a new medical device to check its safety and effectiveness. Upon receiving FDA 510(k) clearance, the device manufacturer can proceed with testing the product for specific situations, which for Ablative Solutions is the treatment of severe hypertension.
The Peregrine System could provide doctors a method to infuse a therapeutic into the wall of a blood vessel. Receiving the FDA’s approval “allows us, in theory, to do many things with this device,” which also has the potential for treating overactive nerves associated with metabolic syndrome, congestive heart failure and obesity, Fischell said.
In the company’s initial focus in treating hypertension, the catheter is used to deactivate nerves around the renal artery by injecting them with alcohol.
For Ablative Solutions, the FDA clearance came just four weeks after the company submitted its application and “puts the stamp of credibility and approval that this is a safe and very well-built device,” said Fischell, an interventional cardiologist and the medical director of the Department of Cardiovascular Research at Borgess Medical Center in Kalamazoo.
To date, Ablative Solutions’ development of the catheter system has been backed by venture capital investors. The company in February raised $9.5 million in a Series B preferred stock offering led by Petoskey-based BioStar Ventures and Michigan Accelerator Fund I in Grand Rapids.
Dale Grogan, co-managing director of Michigan Accelerator Fund I, said the FDA approval is a “huge step” that moves Ablative Solutions further down the road to getting the Peregrine device to the market and into the hands of doctors. He cautions, however, that the commercialization process remains a “very long road.” The payoff for investors comes once the company wins FDA approval to use the device in specific treatments, such as renal denervation for hypertension.
“There is no doubt that getting this approval was a major value inflection point for the company, but not one that we can necessarily monetize at this time,” Grogan said. “So the crux is that we cannot get doctors prescribing the Peregrine tool for its intended clinical use — yet.”
Earning regulatory clearance for the device could also help to expedite approval for a clinical trial using a treatment in Europe that is set to begin shortly, Fischell said.
Medical device manufacturers will often seek initial approval for using a new product in Europe, where the regulatory process is not as rigid as it is in the U.S. By going to Europe first, where review organizations focus on safety and not efficacy, companies can use a validation process that’s faster and less costly to get to market.
Companies can then use the data from the European review in their application to the FDA.
In the U.S., FDA approval enables Ablative Solutions to proceed “optimistically” this year with a pilot study using the catheter with an approved drug and then move into a pivotal clinical trial by the end of 2014 or in early 2015, Fischell said. Ablative Solutions is probably a year away from commercialization of the device in Europe and could get the catheter system to market in the U.S. by the end of 2016, he said.
Ablative Solutions presently uses a contract manufacturer in California to produce the device and “would love to do it in Michigan,” Fischell said. The company, however, was unable to find a manufacturer in Michigan capable of producing its “very complex” catheter device, he said.
“If there is such a manufacturer that thinks they can do it and do it at lower costs than California, we will need two sources for this device because we hope to sell thousands and thousands of them,” Fischell said.
The Fischells, who hold some 250 medical device patents and have started 16 companies, could ultimately exit Ablative Solutions through the sale of the company in the years ahead. Tim Fischell envisions the potential for an acquisition by a large medical device company.
“We expect that may be the way we exit, an acquisition from a major strategic (buyer),” he said.
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