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BioSig Tech. (BSGM) & Electrophysiology Sector (related stock BSGM)
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Nov. 22- The Future of Bioelectronic Medicine (BioSig & Dr. Kapa from the Mayo Clinic)First, let me thank Rob for alerting me to this BioSig event. I have a small-but-growing position in BSGM, and wanted to be able to talk to members of their team on the science and management. I met a couple other attendees from the CELG message board world (NJSUN and Moranpicks). The meeting was held in a beautiful NYC building, the University Club. Jacket and tie required. A very nice upscale buffet lunch was provided. I didn’t do an official count of attendees but including company personnel, there had to be between 50-75 people there. After most of us had finished eating, Ken Londoner, the Founder, Chairmen, and CEO stood up and gave some introductory remarks, before turning the presentation over to Dr. Suraj Kapa of the Mayo Clinic. Here are links to Dr. Kapa’s background and experience. https://www.mayoclinic.org/biographies/kapa-suraj-m-d/bio-20055752 https://www.mayo.edu/research/faculty/kapa-suraj-m-d/bio-20271547
The focus on his presentation was on explaining the significance of electrophysiology as a growing area of treatment/research focus, and more specifically, cardiophysiology, where he is working with the team from BioSig. He gave good analogies in trying to get us non-physicians to understand current state and future state. I thought it interesting that cardio physiologists can measure the age of your heart based upon diagnostic readings of electrophysiology. There was a time for Q&A at the end, which both Dr. Kapa and Ken Londoner participated in. One slide I found very interesting was the following, which shows the heart’s natural ‘pacemaker’, the Sinotrial node, and the ‘highways and byways’ of where the signals go in order for the heart to contract properly. In my one-on-one with Dr. Kapa afterwards, he agreed that you could think of this signal roadmap as being as unique to a person as a set of fingerprints. With most ablations, more time is spend by the doctor understanding this roadmap prior to the operation, than the time in the operation itself. Then, using the BSGM tech, the surgeon can more quickly identify the optimal places to ablate. Dr Suraj also mentioned how their alliance with Google helped them go through an enormous amount of data to look for insights. (Rob has mentioned before how Google and BSGM aligning with the Mayo Clinic will probably drive some significant synergies.) One thing to keep in mind with BSGM is that they already have approval to market the machine to hospitals. What the trial that is ongoing will allow them to do it make verifiable claims along with those sales. (If some of you take supplements like I do, think of some of the text on the label along the lines of “These statements have not been evaluated by the Food and Drug Administration.” ) According to the CEO, there are a number of different angles they can take as they collect more clinical information in this trial and any subsequent ones. (One possibility I could think of could be by using BSGM PureEP, there is X% reduction in subsequent ablations because the surgeon was able to better select the treatment area.) During Q&A I asked about any potential re-certification being needed from the FDA for hardware or software changes to the PureEP system. Ken said that because the FDA does not consider it a primary device, the threshold is not as stringent. He didn’t anticipate needing a re-cert for a few years, as the changes will be iterative versus major. NJSUN and I went up and introduced ourselves to Ken Londoner afterwards. Very down-to-earth guy. (In fact his whole team there was very approachable and enthusiastic.) He mentioned that BioSig will be a presenter at the AF Symposium (Atrial Fibrillation) on Thursday, January 23rd. https://www.afsymposium.com/program-nav They will also be presenting at a conference in April (I didn’t catch the name). Keeping in mind that the trial protocol said that February 2020 is given for the final data collection date for primary outcome measure. That is only ~3 months away. The goal of submitting an abstract for The Heart Rhythm Scientific Sessions in May 2020 seems reasonable. So, three presentations planned over the next 2 quarters, with trial data coming in, should help bring more visibility, and potential stock appreciation. They did talk about the Alliance for Advancing Bioelectronic Medicine. Someone asked if they would have regulators as participants, and Ken/Suraj indicated there would be.
One funny moment during the Q&A was when, I believe it was Dr. Malya (on the Advisory Board of BSGM) asked Dr. Kapa if BSGM’s tech could be used to make a better lie-detector. You could hear a gasp in the audience, and then Dr. Kapa diplomatically explained that there was potential there. (Now nobody from the company indicated they would be pursuing that…but we probably wouldn’t have been able to leave the room if they had, ha ha . ) All in all it was a great opportunity I was glad I could avail myself of. I will continue to build my position with regular buys.
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