KALAMAZOO — Innovative Cardiovascular Solutions LLC will support further development of its medical device thanks to $5 million in new capital it raised from angel investors.
The Kalamazoo-based company’s Emblok Embolic Protection Catheter that’s used in heart procedures is presently undergoing a clinical trial in Italy, with pending plans for a U.S.-based clinical trial.
Innovative Cardiovascular Solutions is continuing the trial to prepare for regulatory approval in Europe, which would then ease the process for gaining approval back home from the U.S. Food and Drug Administration. If the present trial in Italy leads to approval in Europe, the process for regulatory approval in the U.S. should be “simpler, less costly and (take) less time,” co-founder and CEO Kevin Plemmons told MiBiz.
Developed by Dr. William Merhi, an interventional cardiologist at Spectrum Health in Grand Rapids, the Emblok device is designed for use in transcatheter aortic valve replacement. The device collects debris in the blood dislodged during the procedure, reducing the chance of a blockage and preventing a potential stroke or other neurocognitive damage in the patient.
Procedures involving 10 patients in Europe have been “very promising,” Plemmons said. Midway through the European trial, the device has collected debris in blood every time it’s been used, he said.
As the European clinical trial continues to test the Emblok device’s safety, Innovative Cardiovascular Solutions is preparing for a U.S. trial that could begin in early 2018 and involve about 100 patients at five or six sites, he said.
With the recent influx of angel capital, Innovative Cardiovascular Solutions has raised a total of $10 million to support development of the device.
According to Plemmons, the capital raise that closed this month was oversubscribed. Investors in the company come from across the U.S., and many are physicians who perform the procedure, he added.
After completing the most recent capital raise, the company should have enough to finish commercializing the new device, “if we play our cards right and with a little luck,” he said.
Plemmons called the latest capital round a “strong vote of confidence from our investors supporting the pursuit of this innovative and comprehensive approach to embolic protection.”
The device offers a new technology to improve safety for patients undergoing the heart procedure, an area medical device companies have focused on in recent years.
A competitor, Santa Rosa, Calif.-based Claret Medical, received FDA clearance for its device to collect debris and protect against the risk of strokes during and after a transcatheter aortic valve replacement.
Claret Medical said clinical trials proved its device reduced strokes within 72 hours of a procedure by 63 percent and “maintained a substantial difference at 90 days.” Claret Medical received FDA approval in early June and already reported that several hospitals, including Cleveland Clinic, had started using the device in aortic valve replacement procedures.
Innovative Cardiovascular Solutions started putting together data for an upcoming meeting with the FDA on a future application seeking regulatory approval, Plemmons said.
The company has worked with a Chicago-area contract design and manufacturing firm to develop the Emblok device. The same company will likely produce it, he said.
Innovative Cardiovascular Solutions could continue on a path of taking the device to market on its own or with a strategic partner, or it could sell the intellectual property and record an exit for investors.
“We are prepared to take it on our own — whatever’s best for investors,” he said.