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Its technology may double the success rate of quick clot removal leading to better patient outcomes
Every year, more than 795,000 people in the United States have a stroke; the vast majority of which are ischemic, meaning blood flow to the brain is blocked. When this happens, patients have a quick onset of symptoms such as slurred or lost speech, muscle weakness, loss of balance, and loss of consciousness.
"Time is of the essence in these cases and clinicians want to remove the blockage, and restore normal blood flow to the brain, as rapidly as possible," explained Sean McBrayer, CEO of RapidPulse, a medical device company developing a novel aspiration system to treat ischemic stroke, which announced a $10.5 million funding round on Tuesday.
The way patients are currently treated with either a stent retriever or an aspiration catheter; both are inserted via a small incision in the leg or arm and then, using computed tomography guidance, the doctor navigates the catheter to the clot. McBrayer described the stent retriever is as being "like a flexible metal basket," with which the doctors try to capture the clot in the basket and pull it out of the patient. Aspiration catheters are used to apply vacuum to aspirate the clot from the affected artery.
Currently, the gold standard for measuring the success of these catheter-based treatments. using the amount of restored blood flow or reperfusion achieved after the first attempt, is known as the first pass reperfusion effect, or FPE; clinicians use a scale called the modified Treatment in Cerebral Ischemia (mTICI) and consider a score of 2c, or near complete, or 3, complete, to be the target.
Patients who achieve these levels have significantly better outcomes compared to those with 2b or lower; however, today’s stent retrievers and aspiration systems only achieve FPE mTICI≥2c results in 35 to 42% of cases.
"While the devices and technologies available to doctors today are better than they were just 10 years ago, we believe more than 4 out of 10 patients should be treated with a technology that can help them achieve greater outcomes," said McBrayer.
"The reason today’s aspiration systems have these low percentages is because they use what is called static or constant aspiration. In essence, the vacuum pressure of these systems limits the results the doctors can achieve."
What RapidPulse has developed and patented is a technology to rapidly cycle the vacuum pressure from fully off to fully on multiple times per second, applying more energy to the clot, which allows the catheter to remove the clot faster and more thoroughly than the other technologies on the market today.
In fact, Data recently presented at the Society of NeuroInterventional Surgery showed the RapidPulse system achieving FPE results of mTICI≥2c for 69% of patients, almost 2x the results of the systems currently on the market.
"What makes RapidPulse different is the unique method of delivering precise, cyclic aspiration. If you’ve ever placed a vacuum hose close to an object and then turned on the power, you may have noticed there’s a quick burst of energy that pulls the object to the vacuum hose. But today’s aspiration systems get that effect just once when the clinician first activates the pump," McBrayer explained.
"Significant amounts of engineering analysis and design went into perfecting the RapidPulse concept, so the precise cyclic aspiration device delivers orders of magnitude more energy against the clot safely. We have three issued patents on this already with more to come."
With the RapidPulse system, doctors reported that they were able to removed a clot in less than 20 seconds, compared with the three to five minutes doctors often need to wait to see if their static aspiration system was successful in capturing the clot.
"When ‘time is brain’, that’s a meaningful difference," said McBrayer.
The company's new funding round, which was led by Syntheon and Santé Ventures, along with Epidarex Capital, Hatteras Venture Partners, and Broadview Ventures, brings its total funding to $25 million following a $15 million Series A in 2021.
RapidPulse plans to use the money to further advance its RapidPulse Cyclic Aspiration System through expanded clinical evaluation, which it says will further the development of its platform of new catheters and aspiration pump, and allow it to move towards FDA approval.
"Our regulatory timeline is ‘as soon as possible.’ Doctors are anxious to use the RapidPulse system in their daily practice and it appears patients will benefit from its availability. So, we are following the FDA process to get the necessary clearance so the technology can be commercialized," said McBrayer.
The ultimate goal for RapidPulse is to bring its technology to market so that patients who have an acute ischemic stroke can have better outcomes as a result of faster treatment with higher FPE mTICI≥2c results.
"We think the market will be primed for a rapid and thorough shift in market share from the devices available today to our precise, cyclic aspiration system. Most doctors tell us the results demonstrated in our early clinical study would make it hard to justify using the older technologies with FPEs only half those of the RapidPulse system."
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