KALAMAZOO — The launch of a clinical trial in Europe brings a Southwest Michigan medical device startup a step close to the marketplace and an eventual sale.
A successful trial with 30 patients could earn Kalamazoo-based Innovative Cardiovascular Solutions LLC regulatory approval to sell the Emblok Embolic Protection Catheter in Europe, CEO Kevin Plemmons told MiBiz. Securing European approval would then streamline the process for gaining regulatory approval back home from the U.S. Food and Drug Administration.
The European clinical trial should take about three months to complete, Plemmons said. The first few uses of the device in patients at hospitals in Italy “went great.”
“It’s really great to see the effort of the last four years come to fruition,” he said. “We’ve been working on this device diligently and have made countless changes to the device, and we now have the final device to bring to market, if that opportunity presents itself.”
Developed by Dr. William Merhi, an interventional cardiologist at Spectrum Health in Grand Rapids, the device is designed for use in transcatheter aortic valve replacement. It collects debris in the blood during the procedure, preventing a potential stroke or neurocognitive damage.
An FDA panel in February recommended clearance for a competitor’s device. Like the Kalamazoo company’s device, the product from Santa Rosa, Calif.-based Claret Medical Sentinel is designed to protect the brain from debris that breaks loose during transcatheter aortic valve replacement.
Final approval would make the Claret Medical device the first approved for use in the procedure, which in trials was proven to reduce the rate of stroke of protected patients versus non-protected patients, according to a February report in the trade journal Diagnostic and Interventional Cardiology.
Plemmons believes his company’s device will prove safe and effective as well. In the ongoing European clinical trial, patients needing a transcatheter aortic valve replacement undergo an MRI prior to the procedure and a follow-up scan afterward to check for particulate in the brain, he said. The procedure treats patients with aortic stenosis, a narrowing of the aortic valve opening that restricts blood flow in the heart.
Transcatheter aortic valve replacement offers a less invasive procedure that does not require open-heart surgery.
Research studies have indicated the incidence rates for stroke range from 2 percent to 6 percent in patients who undergo transcatheter aortic valve replacement, Plemmons said. The incidence rate for neurocognitive issues is higher, he added.
The Innovative Cardiovascular Solutions device not only protects from stroke but also from the potential for neurocognitive problems that can result from partial blockages or debris in the brain, Plemmons said.
“So we have to have filtration” during the procedure, he said. “We can’t have particulate going in the brain.”
Innovative Cardiovascular Solutions has raised $3.5 million toward a $5 million goal in Series B capital that “should get us across the finish line to an acquisition” and support European clinical trials, a buildup of inventory and perhaps a small U.S. clinical trial. That amount is on top of the $5 million raised in prior capital rounds.
All of the capital raised to date has come from about 75 angel investors nationally and globally, Plemmons said.
During the device’s development, Plemmons has kept in contact with medical device manufacturers who are interested in his progress and in a possible strategic acquisition. Plemmons eventually hopes to sell the device, perhaps within 12 to 18 months, after securing FDA approval and entering what he calls an “exploding” market.
“I think it should get us to an exit, or pretty close to it,” Plemmons said of the ongoing capital raise. “We’re right in the right spot at the right time. We’re catching the wave at the right moment.”