3 Startups Developing New Ischemic Stroke Treatments
What’s the Definition of an Ischemic Stroke?
While the brain only makes up about 2% of your body weight, it actually consumes 20% of your energy and oxygen intake. With all that oxygen needed to keep your brain running, any sort of disruption to the oxygen supply can cause the brain to sustain damage. When the blood that carries oxygen to the brain ceases flowing due to a blood clot, we call that an “ischemic stroke” or more typically, we just refer to it as “a stroke”. 87% of all strokes are “ischemic” while the remainder is caused by internal bleeding in the brain.
Surprisingly, “strokes” are the leading cause of adult disability in the U.S. and the third leading cause of death annually. 800,000 Americans have a stroke every year, with 5 million stroke survivors living today of which 20% are disabled. Having a stroke is a painless but scary experience as your limbs start to become numb and stop working for no apparent reason. Now we know that an “ischemic stroke” is pretty much what we refer to as a “common stroke”.
Current Ischemic Stroke Treatments
Incredibly, there is only one FDA approved treatment at the moment for ischemic strokes. Approved in 1996, a “tissue plasminogen activator” or tPA is a protein they administer to you through an IV which helps break down the blood clot. If administered within 3 hours, the tPA may improve the chances of recovering from a stroke. The problem is that a significant number of stroke victims don’t get to the hospital in time for tPA treatment leaving just 4% of ischemic stroke victims who actually receive tPA. So what’s the takeaway for investors? A company that develops a new and effective treatment for ischemic strokes can stand to capture a great deal of market share very quickly. Here are 3 startups developing treatments for ischemic strokes.
Founded in 2009, Cerevast Therapeutics has taken in $23.44 million in funding so far to develop Clotbust ER, a first-in-class non-invasive ultrasound device for the treatment of ischemic strokes. Essentially you slap this headband on the patient, and the ultrasound energy emitted helps break up blood clots:
Covered by over 75 patents, the device received European CE mark clearance in December 2011 and as of the last update in September 2014, was undergoing a Phase 3 clinical trial which had successfully completed a first interim analysis on 250 randomized patients. The study is designed to randomize up to 800 ischemic stroke patients on a 1:1 basis with either Clotbust ER ultrasound in combination with tPA therapy or standard tPA therapy alone. Cerevast needed 200 of these devices for their clinical study and was facing a 7 figure cost to produce each device. Working with a company called TransducerWorks, they managed to reduce the cost of these devices by 75% to a “manageable 6 figure sum” and improve performance by 50% at the same time. Cerevast envisions that this device will one day be in every emergency room and every ambulance in the world.
Founded in 2012, Vesselon has taken in $1 million in funding so far to develop their non-invasive ultrasound device which will allow paramedics to treat stroke victims on the spot. So what’s the difference between this device and the Clotbust device from Cerevast we just discussed? Apparently, the Vesselon device is used in conjunction with microbubbles that are injected intravenously into the patient’s circulatory system. When ultrasound energy transmitted from the device interacts with the microbubbles that reach the clot, the microbubbles oscillate and act like “scrubbing bubbles” to dissolve the clot. Vesselon would have had to already combed through the 75 Cerevast patents and consequently feels confident with their intellectual property position.
Founded in 2000, Brainsgate has taken in $60.5 million in funding so far from names such as Johnson and Johnson, Boston Scientific, and Elron Electronic Industries. The BrainsGate approach is rather different from the other two companies we just profiled. So it turns out there is this nerve center next to your nasal cavity called the “Spheno-Palatine Ganglion” or SPG that when electrically stimulated, increases the blood flow to your brain. BrainsGate has invented a device that is implanted at the roof of the mouth in a bedside, minimally invasive, local anesthesia procedure comparable to dental treatment.
Stimulating the device then increases cerebral blood flow bypassing the blocked section of the cerebral artery and bringing needed oxygen to damaged areas of the brain. This can help improve stroke outcome even when initiated within the first 24 hours following stroke onset. BrainsGate is said to be undergoing Phase 3 clinical trials for their device with positive outcomes thus far.
If anyone of these companies is successful in getting their device FDA approved, they’ll need to scale quickly to capture market share for what is recognized worldwide as a significant unmet medical need. An IPO could provide the capital required to scale along with publicity for the new device.
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