Sam Navarro 30 years wall street and medical device experience – 30 strategic medical device partnerships. Amazing Board of Directors addition on top of former CELG CMO added to board last month.
This Founder/Chairman/CEO, Board of Directors and Management team just continue to deliver as promised now with 2 world class Board of directors in the past several weeks. I find it very appropriate that the first section of the new shareholder letter is captioned "Keeping our promises" - because this is exactly what this team has done since I invested in April 2018. Some day will do a more detailed list - but here are a few
1) Promised FDA 410 (k) clearance by end 2018 - received clearance earlier than guide early Aug 2018.
2) Move to NASDAQ by Yr end 2018 - Begins trading on NASDAQ earlier than guide Sept 21 2018 .
3) Add top tier employees – Added former JNJ Biosense Webster top tier talent Amy Scott, Stephanie Jasa, Mary Ann Edzards, Kelsey Tarzia and Sales VP John Kowalski to the team as well as VP Engineering hall of famer Barry Keenan and Mr. Fui Veavea:
A good recap of 5 of the former JNJ top tier talent that are now with BSGM who were at HRS can be found in my HRS Investor Visit Summary:
For more on Barry Keenan see here:
And added to his team:
4) Add key personnel to the Advisory Board – Added Yucaipa’s Frank J Quintero, Sim Farer and D. A. Wallach to the advisory board. See HRS summary and BSGM Press Releases including todays for the detailed backgrounds.
5) Add Key Board of Directors additions – in the last several weeks this small cap somehow added the ex-Chief Medical Officer of Celgene and Wall Street and Medical Device Deal veteran Sam Navarro to an already world class Board of Directors. See today’s Press Release.
6) Execute a raise to ensure cash for over 1 yr without using predatory firms or warrants and place in great mostly existing long-term investors hands –In March BioSig completed an upsized $8.6 million private placement mostly with existing shareholders without warrants or an investment bank. Earlier this month the company said in a press release “BioSig has more cash on its balance sheet today than any other time in our 10-year corporate history, which should be sufficient to finance our operations for at least 12 months.”
7) Continue to advance the company’s technology in the Cardiac, Neurology and other areas under the Mayo Clinic 10 yr – During the visit of the LA offices with my electrical engineer friend, the VP of Engineering and Chief Technology Officer just returned from a multi-day trip to Mayo raving about what was accomplished, Mayo’s excitement and the potential of this technology outside of the Cardiac area. Remember my comments in the HRS summary linked above, Dr Samuel J. Asirvatham, Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory was the keynote speaker at the Abbott half day HRS event that I believe had 250 people attending said during his speech that the BioSig’s Chief Technology Officer Budi D is “one of the most important inventors of our time”. Of course, Dr Asirvatham has worked closely with Budi and BioSig given the 10-year R&D collaboration between the companies signed in November 2018. To me this collaboration has only just begun and is not currently priced into the BSGM share price.
8) Lock up Key Patents this yr on the PURE EP system and software. - at HRS meeting 10 of my investor friends had a good discussion of intellectual property with Board Member Andy Filler, Partner and General Counsel for Sherpa Technology Group, with over 20 years of experience in intellectual property for technology and medical device companies. He currently serves as Partner and General Counsel for Sherpa Technology Group. Both Ken and Andy exuded confidence in the company’s IP position – Andy mentioned that machine inventor and BioSig Chief Technology Officer Budi has done an extremely good job supporting the Sherpa-BioSig IP effort with amazingly detailed documentation, drawings, etc. He also mentioned that because the company waited to file IP the 20 yr clock started later than most medical device companies which is a positive now. Since this conversation the company was allowed the following patents, without one follow up from the US Patent office given the solid application submitted. Again, they overdelivered – not only the expected patents on the PURE EP system but one on a simulator that doesn’t need approval and that the company believes could be a good source of incremental revenue in the coming yrs that is definitely not in current stock price.
9) Company promised to get on the road and meet investors when stock was in the $4 area – Ken and team have met with institutional and retail investors in meetings in LA, Houston, Orlando, Miami, Boca Raton, Boston, Conn, NY, London, Dublin, Munich, Zurich and in San Francisco during HRS. They did a fabulous job making the Management Team, Board of Directors members, Advisory Board members, key employees, and doctors who actually performed the ablation procedures with the PURE EP system available to investors who attended these meetings and HRS.
10) CEO had indicated in December that he felt the BSGM stock was undervalued vs comparative companies in the medical device field but felt with proper execution the stock should be able to get up to a market cap that could put it into highly visible indices that could add ETF buyers. – During HRS in early May we heard that a sell side firm had indicated to clients that BSGM had made it into the Russell based on May 10 “Rank Day” and would be added into the related indices on June 28th (THIS FRIDAY). I have received definitive confirmation that BSGM has indeed made it into the Russel Microcap, Russel 2000 and Russel 3000 indices. The NASDAQ informed the company to expect heavy volume on Friday and Barron’s and this seeking Alpha article explain how the smaller companies that are added to the Russel outperform during the reconstitution period and for months afterwards…..This Friday should be interesting.
11) In December the CEO/Chairman/Founder gave me his personal commitment that since he feels the stock is undervalued, he would demonstrate that publicly by buying stock on the open market – Ken Londoner delivered repeatedly by buying shares on the open market with cash (not option related) buys of BSGM shares when he is not in an earnings or news related blackout. I believe he has bought on the open market over 10 separate times this yr. He has not sold any stock on the open market during this time. There was one 144 transfer of stock to an Advisory board member per a previous private agreement but no sales on open market. Ken has bought like a dozen times this keeping yet another commitment to investors.
12) In December at Investor Meetings and on webcasts earlier in the yr, Chairman/CEO Londoner promised to have a series of human patient cases using PURE EP system during ablation procedures in at least two separate institutions before the Heart Rhythm Society in early May. BioSig ended up again exceeding expectations by delivering 22 cases in not 2 but 3 institutions before the HRS meeting. And the 3 doctors quotes in the press releases and at HRS were truly encouraging:
o Dr Andrea Natale, FACC, FHRS, FESC, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center – Dr Natale is one of the top ablation surgeons (some say the top) and AFib experts and Key Opinion Leaders in the world with a wide following. He performed the First In Human ablation procedures a few months ago in February and said this…. “With the use of the PURE EP System I was able to identify cardiac signals which were previously undetectable to me. I believe that the PURE EP System could change diagnostic and treatment strategies of arrhythmias, leading to more successful outcomes”. While at HRS Dr Natale praised the PURE EP system and his opinion was that eventually over time every EP center in the country should have this machine to assist in ablation procedures. He will help make this happen.
o Dr Andrew Brenyo, MD, FHRS, board-certified electrophysiologist and the medical director of electrophysiology laboratories at Greenville Health System - Dr Brenyo is an ablation surgeon, AFib expert and Key Opinion Leader. He performed the human ablation procedures last month and said this. “Over the last two days I have been amazingly surprised at the fidelity and utility of the BioSig’s PURE EP System. I made sure to use it in cases of the highest complexity and found in more than one circumstance the behavior of the system such that I could visualize waveform signals that I could not on my usual recording system. This led me towards a better understanding of a tachycardia event. I would count myself lucky to have had this eye-opening experience highlighting the signals that I have been missing” I had the privilege of having a nice one on one conversation with Dr Brenyo at HRS event. He reiterated to me that he actually planned his most difficult and complex cases and scheduled them for the week that the PURE EP system was scheduled to be used at Greenville. He told me that when he looked at his usual recording system, he has used in past ablations he did not see certain signals. He said once he saw the PURE EP system more refined signals that’s what he used for the rest of the procedures. He was beaming when talking about the “eye-opening” experience of seeing signals he could not see without PURE EP. He noted he would love to be part of data gathering and any head to head comparisons to document just how important PURE EP could be to enhanced efficiency and effectiveness of ablation. He was particularly emphatic about the improved ablation result in the more dangerous ventricular tachycardia patient. He is clearly sold on this technology.
o Prof. John M. Miller, MD FACC, FAHA, FHRS, board certified in internal medicine, cardiovascular disease and clinical cardiac electrophysiology Indiana University Health – “Jaw Dropper” - Dr Miller is a Professor at Indiana U and an ablation surgeon, AFib experts and Key Opinion Leader. He just performed the human ablation procedures earlier this month right before HRS and thankfully still was able to make the trip to San Fran. May 6th he said: “We found that the clarity of the signals made a great difference in the confidence with which we could continue applying ablation energy to an abnormal pathway that was in the region of the normal conduction system; BioSig technology allowed us to see a clear signal from the normal conduction pathway during ablation that was obscured by noise on our standard recordings. It was a jaw-dropper!" I had the privilege of having a nice one on one conversation at the BioSig Booth with Professor Miller. I heard from multiple people before and at HRS that Prof Miller was not one for verbal hyperbole. He speaks at many industry and KOL events and he is just very measured in what he says which makes his “Jaw Dropper” comment even more important to me. I asked him about this – why the superlatives when he is known to be conservative with praise. He told me this is true that he is not one for over the top comments – but that in this case the PURE EP system earned his “It was a jaw dropper” comment because it allowed him to perform more efficient and effective ablation and target areas that should be burnt because of the clear signals he saw with the PURE EP system. More importantly he told me he did not ablate a key area because of what he saw. He told me it indeed was jaw dropping. He was fired up for a conservative guy at the booth and even wore a BSGM heart sticker on his lapel as he walked the HRS floor. Amazing.