New Mayo-Backed Device for Treating Deadly Type of Stroke Nearing FDA Notification

Partnering company MRI Interventions says the next step will be filing a 510(k), which will come in the third quarter.

New Mayo-Backed Device for Treating Deadly Type of Stroke Nearing FDA Notification
A new medical device being co-developed by the Mayo Clinic to treat an especially deadly type of stroke is on target for an initial U.S. Food and Drug Administration application in the next quarter, according to newly filed documents.
The device, called the ClearAway catheter, is being developed by a Mayo neurosurgeon at the clinic’s Scottsdale, Arizona, facility, and by MRI Interventions Inc. (OTCQB: MRIC) of Irvine, California.
The two parties struck a joint development agreement last year to perfect the device, which would for the first time allow neurosurgeons to suction out blood clots in the brain while monitoring the procedure in real time via highly sensitive magnetic resonance imaging.
The device is to be used in conjunction with MRI Interventions’ ClearPoint Neuro Navigation System, which allows doctors performing brain surgery to view detailed, real-time MRI images of the brain’s interior, better enabling them to carry out precise, minimally invasive procedures.
ClearAway is a “neuro-aspiration device” meant to provide a new therapy for spontaneous intra-cerebral hemorrhage (ICH), the most serious subtype of stroke.
ICH afflicts between 200,000 and 300,000 Americans each year and has a fatality rate of up to 50 percent of all occurrences, but it’s also the only major stroke subtype without a clearly effective current treatment. Its deadly nature is due to the accumulation of blood that clots in the brain, which compresses the adjacent brain tissue and proves toxic to brain cells surrounding the damaged area.
One of the effort’s lead developers is renowned Mayo neurosurgeon Dr. Bernard Bendok. It is part of five-year company strategy of expansion into the therapeutics market.
The financial and intellectual property terms of the joint development agreement have not been revealed; however, past “JDAs” involving Mayo have seen the clinic claiming patent protection over innovations and then licensing the technology to corporate partners, with any resulting revenues being sunk back into the clinical practice by the nonprofit Mayo Foundation.
MRI’s latest quarterly filing with the U.S. Securities Exchange Commission, made last week, indicated the company is on a fast track for filing a premarket notification with the FDA known as a 510(k) submission, which is the first step to having a medical device cleared for patient use.
“With regard to our expansion into therapy, we continue to progress, in collaboration with the Mayo Clinic, in the development of what we believe is the first-of-its-kind neuro-aspiration device, and we are planning to submit a 510(k) with the FDA in the third quarter of 2018, with first-human-use of the product following in December of this year,” company CEO Joe Burnett said in a statement.
The 20-year-old company reported a net loss of $1.6 million on revenues of $2 million during the first quarter, with research and development costs of $546,000. It reported $7.5 million in cash on hand and the completion of an internal corporate restructuring, which Burnett called “hitting the reset button” after failing to meet “our internal targets” for generating new cases for the ClearPoint system.
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