Guest: Mark K. Borsody, M.D., Ph.D.
Presenter: Wayne Bucklar
Guest Bio: Mark K. Borsody, M.D., Ph.D. is a vascular neurologist and the inventor of the VitalFlow stimulator. He began his research career at Emory University where he earned his Doctoral degree in neuroscience and subsequently attended medical school at the Ohio State University. He then studied clinical neurology at the Northwestern Memorial Hospital and subspecialized in vascular neurology at the Detroit Medical Center / Wayne State University, where he won an American Heart Association research award. In 2012, he began full-time work on the VitalFlow program, founding Nervive Inc for which he now serves as Chief Medical Officer.
Segment overview: In today’s Health Supplier Segment, Nervive Inc. Chief Medical Officer Mark Borsody joins us today to talk about a new treatment for brain ischemia. They are currently developing the VitalFlow stimulator, a novel and non-invasive medical device that treats stroke. The company is focused on research, development and commercialization of medical devices that can be used to improve patient care in the neurology critical care space.
Health Professional Radio – NERVIVE
Wayne Bucklar: You’re listening to Health Professional Radio. My name is Wayne Bucklar and my guest today is Mark Borsody. Now Mark is the chief medical officer with Nervive. Mark welcome to Health Professional Radio.
Mark Borsody: My pleasure Wayne.
W: Now Mark tell us a little bit about Nervive, it’s not a name that sort of tells me what the firm does so introduce that for us.
M: Nervive is a medical device company that we founded to advance the development and bring to market a medical device that’s an emergency treatment for stroke. The device is called the “VitalFlow Stimulator.” The company is based in Akron, Ohio and it is at the juncture of taking the VitalFlow into clinical testing with our research partner at Metropolitan University in Mexico City.
W: Now Mark we should say upfront that you’re not a strange into this. You’re a neurologist and the inventor of the VitalFlow Stimulator. And I understand you’ve got over 20 years experienced in pre-clinical and clinical neuroscience, as well as six years executive experience in stroke pharmaceutical R&D.
M: That’s correct Wayne. I actually began my interest in neuroscience as a neurophysiology basic science researcher and subsequently went into medicine to pursue uses for various manipulations of neurophysiology as treatment of disease. So in that sense the VitalFlow is a combination of a research interest beginning in very basic science.
W: Now most of our audience are clinicians at one sort or other working in mostly in acute care – doctors, nurses, and allied health professionals. And I’ve described myself as being a lapsed nurse so once upon a time in the distant past I did some nursing. But I was intrigued to read about the VitalFlow on your website. It says that it’s a non-invasive platform technology that can treat conditions of brain in ischemia and it does it with pulsed magnetic stimulation on the facial nerves, did I get that right?
M: That’s correct. The technology that underlies the VitalFlow is in fact very well established technology dating back many decades. It is well known in physics that a rapidly changing magnetic field can induce electrical currents in the conductor – whether that be a wire, or a neuron –the principle is fundamentally the same. Similarly I would say to the physiology behind using the facial nerve to dilate the brain arteries is very well established and that is something that has been demonstrated since let’s say at least 1930 in numerous animal studies and to that end, we capitalize on very well established physiology. And very well established technology and combine these two to make a very simple straight forward medical device.
W: Now Mark given that the technologies are well established as you say, this hasn’t been put together by anyone else, has it?
M: Not to our knowledge. We certainly have been looking for such efforts. We’ve spoken to countless people who are both authorities on the science and the technology and the business end of such efforts and no one has ever pointed out to us an effort along this line.
W: And so the next step for you I think you mentioned earlier is clinical trials?
M: That is correct. We are at the moment proving the safety and the power ability of the VitalFlow prototype in normal subjects and we’ll be conducting a pilot study in patients with stroke like condition called “cerebral artery base spasm” that will provide that proof of concept in humans to show that the VitalFlow would make a useful emergency therapeutic device in the treatment of ischemic stroke.
W: You’re listening to Health Professional Radio with Wayne Bucklar. I’m in conversation with Mark Borsody who’s telling an intriguing story of a device that they’re currently bringing to market through their company Nervive. And this is a device to provide emergency treatment for stroke and stroke like symptoms. Now Mark how big a study do you think this will be?
M: Well the pilot study that we intend to conduct is of course quite small, it’s less than a dozen patients. And the purpose is of course always to confirm as much as you can the safety and power ability of the device but also to demonstrate the ability of the device to adjust biomarkers of stroke such as the loss of cerebral blood flow that would be meaningful and impactful clinical outcomes. And so these pilot studies took particularly longer at planning to do is really focused on such measures of brain perfusion and brain ischemic to … injury.
W: And do you have any sense when you have that work completed?
M: Work to be completed by the end of the calendar year and after that point in time we will be able to begin conducting larger and larger clinical studies to prove the balance of such a treatment on the clinical outcome of patients with stroke. And most studies of course become larger and complicated. At the end they will involve a comparative analysis of active stimulation versus sham of control stimulations, and they will be involved the accepted clinical outcome measures of efficacy that has underlay stoke treatment for quite some time.
W: Now Mark the device is called the “VitalFlow.” Paint me a word picture, what does this looks like?
M: The analogy that we often use Wayne is the “cardiac defibrillator.”
M: We envision the VitalFlow to, in many ways to look and serve as does a cardiac defibrillator for a potentially fatal arrhythmias. So the VitalFlow that we envision is in its first form a heart based device, that can be used in the emergency department setting, and that can be brought to treat a stroke patient in an emergency department bay from some local storage. The second version of the device condition is smaller and more portable, somewhere along the lines of a suitcase and can be placed into the ambulances that will initially receive and actually even treat stroke patient. So by doing so, we can carry out to the stroke patient the initial treatment for their condition.
W: Now it occurs to me Mark that someone who was having some sort of cerebral bleed might in fact the by heart by stimulating in the way the VitalFlow hopes to do. Is that a consideration?
M: It’s a huge consideration for us Wayne. The issue of having stroke in the field not being clearly identified as a stroke cause by a blood clot including an artery of the brain versus a ruptured artery, it’s actually very problematic for that pre-hospital treatment. The issue that we have then is to identify stroke patients in that pre-hospital setting. As for ischemia stroke patients prior to applying the VitalFlow to those patients, we’re expecting at the near future that there will be diagnostic testing modality available in emergency, in the ambulance setting, in fact we see many of those already in development. And so we expect fully by the time that the VitalFlow is ready for miniaturization and placement at the ambulance, that there will be available such technologies for identifying ischemic stroke patients there. We’ve also made a discovery quite serendipitously that stimulation with the VitalFlow in the context of brain hemorrhage to a ruptured cerebral artery…
W: Uh huh.
M: Does not appear to worsen that condition.
M: As some studies have published animal studies and something that will of course would need very exact evaluation and confirmation in patients, in humans with hemorrhagic stroke but it does offer this opportunity to potentially apply the VitalFlow without the need for diagnostic evaluation in a stroke patient because I should mention nothing that our device does say, it is in fact from what we can tell the property of the facial nerve that we stimulate with the VitalFlow…
W: Uh huh.
M: That appears to be self-regulating and self-limiting.
W: That’s an intriguing finding Mark.
M: It’s the finding and it’s a very actually useful finding again…
M: A great deal of confirmation in the context of an undifferentiated stroke patient, but the potential opportunity that would allow us to take technology like the VitalFlow into the ambulance setting and treat stroke patients prior the diagnostic confirmation of the ischemic or hemorrhagic sub-types that would of course greatly reduce the treatment time and improve the quality of the outcome in the ischemic stroke subgroup.
W: It certainly does sound like it’s on the verge of one of those magic therapies in medicine which we see every 20 or 30 years when something suddenly changes, a bit like the vaccines that came out a few years ago for cervical cancer that just kind of changes the whole world of medicine. It has that kind of flavor to it.
M: We believe we obviously we did far good … on this Wayne to prescribe help for them and of course with a testing for the opposite. They’re testing to see where this is weak, not where it is strong.
W: Mark, it’s always a pleasure to talk to people who are passionate about their subject and knowledge. I certainly thank you for sharing your time with me this morning. My final question is about misconceptions. In every piece of work, there are misconceptions that drive people nuts and keep them awake at night. What’s the biggest misconception in your field that fits that bill of keeping you awake at night?
M: That is the perception that stroke is a difficult area for medical therapy development. It has a terrible reputation and that reputation of course scares away funders and investors and supporters who would rather spend their money and their efforts and their time on things that they feel would be more successful. And they look at the numbers of products that have come to market for stroke versus the number of products that have attempted to be developed for stroke, the odds is actually really quite good. The numbers are about one in a thousand products, if you look at the industry average for other areas in medicine in terms of the pharmaceutical productivity, it’s about 1 in 5 thousand or 1 in 8 thousand.
M: Stroke is actually a very easy area to develop products for, more of this perception that in fact keeps that denominator to be low at least to that striking positive treatment that we have for this medical condition which at the end of the day is really just a plumbing problem of the brain.
W: Mark, seriously only a neurologist and a neuroscientist could explain that it’s a plumbing problem, I’m sure. My brother who is a plumber would be very pleased to hear that he’s got a leg into the field of medicine.
M: It’s a pleasure to link to such people, they know how to come out and fix problem very quickly. It’s a sad fact that a very good in analogy, anyone whose seeing such stroke is a complex physiological problem, need only look at some of the other medical conditions in neurology by comparison and to find very quickly that it’s about a simple problem as you can hope to have.
W: Well Mark I hope that in our conversation today we’ve managed to help with that misconception and convince a few more people that this is a relatively simple area and worthy of investment and funding to bring a device to market that has such promise to it. Thank you for your time today, it’s been a pleasure chatting with you.
M: It’s been my pleasure Wayne, thank you very much.
W: And we certainly look forward to hearing from you as the results of your research come to light. If you’d just missed my conversation with Mark Borsody, Mark is a neurologist and inventor of the VitalFlow Stimulator. And it’s been an intriguing chat about some emerging technology to treat ischemic episodes. You can find a transcript of this interview on our website at www.hpr.fm. There’s also a SoundCould archive and a YouTube archive. So if you’ve missed our chat, do head off to YouTube where there’s a transcript to have a listen. This is Wayne Bucklar for Health Professional Radio.