Mayo Clinic Radiologists Closing in on Financing for Stroke Treatment Device
A Rochester-based startup founded by a pair of Mayo Clinic radiologists who invented a new device for improving the treatment of ischemic strokes is close to wrapping up a $1 million financing round.
Marblehead Medical LLC, led by Mayo colleagues Drs. Waleed Brinjikji and David Kallmes, revealed its fundraising intentions earlier this year and that it would be seeking regulatory approvals for its innovation.
Now, Dr. Brinjikji, an assistant professor of radiology at the Mayo Medical School and Marblehead Medical’s CEO, tells TCB the round is nearly completed and that his young company is currently laying the groundwork to submit its patent-pending device for “mechanical thrombectomies” to U.S. and European market regulators.
“We’re starting to do all the necessary validation testing for the 510 (k) submission in the United States and the C.E. Mark (in the European Union),” he said. “We’re hoping to have those in hand by the end of the summer.”
Marblehead has licensed the stroke technology from Mayo Clinic Ventures after developing it with help from the clinic’s Employee Entrepreneurship Program, which allows experts to take inventions outside of the clinic and launch their own companies.
Dr. Brinjikji is an expert on brain aneurysms – weak spots in the walls of blood vessels which cause strokes when they leak or burst. His mentor Dr. Kallmes is a full radiology professor at Mayo whose research is likewise focused on finding new ways to heal brain aneurysms.
But the pair have also authored research on treating acute ischemic stroke with mechanical thrombectomies – a quickly growing, newer kind of surgical procedure to remove blood clots with long, snake-like catheters inserted into the femoral artery in the groin and maneuvered into the brain with the aid of imaging.
Specifically, they looked into the performances of a new of generation of devices called balloon guide catheters, which they found are becoming “increasingly recognized as critical” for successful mechanical thrombectomies. These balloon catheters are used to first arrest the blood flow upstream from the blockage (or “occlusion”), then to vacuum out the clot out by applying suction.
The coming of balloon guide catheters is regarded as part of a boom in interest in treating ischemic strokes through interventional devices in addition to the long-time gold standard of clot-busting drugs given through an IV in the arm.
Late last year, Drs. Brinjikji and Kallmes were listed as inventors in a patent application submitted by the Mayo Clinic for a 90-centimeter-long, balloon-guiding sheath designed for such stroke treatment catheters. That patent is the focus of Marblehead Medical.
Brinjikji said it is specifically aimed at making mechanical thrombectomies a viable option for many more stroke victims, especially older patients.
“It’s really a challenge right now to deliver the existing thrombectomy devices for patients who are older and who have more complex anatomies,” he said. “And given the fact that more than 50 percent of the patients who have these strokes are 75 years of age or older, some the current balloon guide catheters just don’t work as well – you can’t guide them to where they need to go.
“So we’ve made a device that can get you where you need to go and allow for a more effective delivery of the thrombectomy device.”
The physician said he and his investors have been in contact with many of the major medical corporate players in the neurological medical device space in the U.S., Europe and Japan and are exploring potential strategic partnerships with them.
“The optimum outcome for us would be to license the product to a strategic corporate partner, but we are also prepared to manufacture and distribute it ourselves if need be,” Brinjikji said. “We are working with a contract manufacturer in Minneapolis, Benson Medical Instruments, who have been involved in the design of the device.”