o 1st the one about me only parroting management’s comments. Total lie. I have taken the criticism of the past to heart and when searching for a new investment - I was looking for a new company and found one with my three criteria – game changing product, World Class Board of Directors and a CEO with wall street savvy who would not bury investors in a Wainwright type warrant deal. I also wanted access to NON-EMPLOYEE personnel to independently corroborate management statements/claims. I challenge any individual investor to do more than my group has done to not parrot management but due real due diligence. The shorts can lie but in less than one yr I have:
- Assembled 20 of the smartest investors including institutional investors I know on 7 calls with management (last call actually included 100 of my investor friends) with unlimited Q&A time not stopped until the last question was answered.
- Sent different independent investing groups to BioSig meeting in Florida, CA and Texas and asked for detailed feedback both pro and con from these top quality teams.
- - Had a one-hour call in Q1-19 with former CELG CMO Dr Jerry Zeldis who is a large investor but at the time was independent from BSGM. He raved about Ken, the board, PURE EP and the EP sector. (Since then Jerry has rejoined the board and has added to his investment – but at the time of the call was independent of the company).
- - Asked to have access to PURE EP inventor and new VP Engineering in LA R&D office to have an independent engineering evaluation of the software and hardware system – results of his visit discussed here:
-Took a money manager and engineer to the Roth conference and talked with BSGM investors and the Roth Analyst who had recently initiated it in December 2018 with a $14 target. Had dinner with CEO and some employees including two who recently left JNJ from BSGM.
- -Took 10 of the smartest investors (who flew in from multiple states) I know including one who was founder of a medical device company he sold and one who was part owner of a software company he sold to the Heart Rhythm Society (HRS) annual meeting in San Francisco CA – we were given access to Board Members and Advisory board members – as well as two of the Drs who have performed the human ablation procedures using PURE EP and confirmed there is nothing like it in development that they know of. While there are new cardiac mapping systems in development – there is nothing like the signaling technology BSGM has 26 patents on out there. You can see the summary of the HRS meeting including the actual doctors (independent verification of management comments once again). A good summary of our HRS meetings including the doctors comments can be found here – a must read for new or prospective investors:
- - Took an independent fund manager and former sell side analyst to the Mayo Clinic in Rochester MN to independently corroborate managements claims of the enhanced Mayo interest. This included meetings with many Mayo Drs including the head of Cardiology Dr Friedman. Also, one of the biggest supporters of the company is 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” Mayo Clinic just presented today at JP Morgan and had little BioSig Highlighted as one of their most important public sponsors along with Google and a few others. Amazing. Just today. Remember the multiple deal enhancements done with the Mayo Clinic covered in this post
- - After our Mayo meeting the fund manager and myself went to the manufacturer of PURE EP, Minnetronix in St Paul, MN – and we insisted on having no BioSig employees with us so we could not be restricted in any way since in 2018 BioSig and Minnetronix had some growing pains. We got to meet the President of Minnetronix and his number 2 for an hour in a conf room and had a plant tour. What’s very important again countering the “parroting managements comments” this again was real independent due diligence without company participation. The good news also is Minnetronix said the relationship now is exemplary and cited the hiring in July of Ms. Manasi Patwardhan joined the Company (from Google) as Director of Strategic Planning. It’s now a well-oiled machine and I believe prepaid inventory has now been delivered in Dec and Jan as promised and ready for commerical sale.
o The short parrot lied about what I said about cash and also said that it was bull crap that the company has record levels of cash at last report end Q3– it’s not…..company just put that in writing in the November Shareholder letter:
BioSig ended the third quarter with a cash balance of approximately $12.3 million – the highest cash balance in our history and up 20% from the end of Q2 2019. We have increased our cash on hand 176% from the end of 2018.
o He repeated a purposeful misrepresentation included in the White Diamond short rag on Seeking Alpha – he (coincidently exactly like White Diamond – does the old word-smithing and switcheroo turning the company's words which are specific “results” and “early feedback” (see full bullet below) and exactly like the SA rag changed that to a promise to present “clinical data” at HRS 2019. This is – like it was when his short friends said it in SA article – a complete and utter lie. (have to wonder why is he in such sync with the shorts on their purposeful distortion?)
The company said this:
“Announced that the company will be presenting the results from the First-in-Human studies and the early feedback from the use of its PURE EP(tm) System to a larger community of physicians, and other potential customers, in May 2019”.
And delivered just that at HRS. Here they went over such results with Dr Nakagawa of Univ of Oklahoma. There were over 50 such demonstration of actual signal "results" and early feedback - exactly what was promised in the shareholder letter. I was there with 10 investors. the seeking alpha shorters and their parrots were not.
What’s important to counter the short lies that the company promised clinical data is to understand the process and the timeline. The PR and Shareholder letter came out on Feb 12 2019 and the press release announcing First in Human cases at TCAI was Feb 20 2019. HRS was early May. It would be utterly impossible for the company to present clinical data (the word the shorts turned “results” into) because:
- the company had no clinical trials running in Feb 2019
- to publish clinical data at HRS they would have had to have submitted the abstract to HRS by the Dec 2018 deadline – over one month before the TCAI first in human ablation procedures commenced.
- TCAI had done 7 human ablations in Feb – the company showed the actual signal enhancements vs non-PURE EP signals to over 50 EP doctors who were universally blown away. This was so visually obvious it was even impactful than some summarized data of 7 cases. (Should be noted TCAI was so stunned by the improvement vs standard cardio mapping that they enhanced the BSGM relationship, have been since November performing human ablation procedures with PURE EP (my guess is over 50 more successful ablations with better signaling since Nov) and now Dr Natale who was so impressed is about to represent not TCAI but Biosig at the AFIB 2020 meeting Jan 23 (I hear 7000+ attend that conf). He also for the first time is making PURE EP and BioSig part of the important EP LIVE session in a few months.
Getting TCAI to do another series of human ablation procedures, participate in the trial prior to one of the top ablation experts in the field appearing at the following conferences is infinitely more important IMO...
o January 23-25, 2020 - 25th Annual International AF Symposium
This intensive three-day symposium brings together the world's leading medical scientists to share in a highly interactive environment the most recent advances in the field of atrial fibrillation.
Notice who is representing BioSig in the Kickoff session:
8:10-10 AM SPOTLIGHT SESSION: Early Stage and Emerging New Technologies and Drugs in Cardiac EP
Chair: Jeremy Ruskin, MD
Ablacon, Vivek Reddy, MD
Acesion Pharma, A. John Camm, MD
BioSig Technologies , Andrea Natale, MD
(See previous post for full list)
Dr Natalie is in the middle of weeks more human ablation procedures including being part of the clinical trial which I believe is completed successfully - now he is talking BioSig - some consider him the number one influencer in the AFib Ablation field.....what happens when he praises PURE EP after using it extensively for a couple of months.
o April 2-3, 2020 PURE EP LIVE AUSTIN. (TCAI - Dr Natale's home base)
21 Live Cases, 7 Recorded Cases - Leading Experts in the field of Electrophysiology
This is important to understand the short and distort campaign going on. It was not published clinical data (impossible timing) promised but results and early feedback. My group of investors were on 3 calls with mgt from Feb to May and it was crystal clear they were going to show the actual signal differences at the booth (never ever did they promise formal clinical data (shorts wording not the PR wording - there was no trial) which would have had to be submitted the previous December before the human ablations took place – silly purposeful distortion . The distortion by a guy who admits little due diligence is not what the 10 investors who went to HRS with me expected – and they were in contact with company. Not only did we get the actual visual signals with and without PURE EP – we got to talk to 2 of the 3 doctors who actually performed the human ablations. 1000% better than some published data on 7 TCAI patients inaccurately described as promised.
The KOLs who have actually used the PURE EP system during human ablation procedures
One of the really pleasant surprises at HRS was that all three of the doctors who performed actual human ablation procedures using the PURE EP system for the first time were present at HRS. All three of these Drs are Key Opinion Leaders often speaking at industry events. I had the privilege of having some one on one time with two of these doctors and was blown away by their enthusiasm as to how much better the ablation procedure was with the PURE EP system.
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 this BSGM heart sticker on his lapel as he walked the HRS floor. Amazing.
Lastly were the comments on competition – the company and my investors have done a deep dive into the competition. JNJ has been searching for better signals from their CARTO system and expensive catheters for a decade without success. (Think Kowalski comes to BSGM without doing a deep dive into competitive signal companies). Most of the private companies have contacted BioSig but CEO of BSGM is not interested. Companies like VytronUS founded in 2006 have failed miserably. Like the basher said there are a couple of well financed private companies trying to build a better 3D mapping system to compete with JNJ – the company he mentioned is 45 minutes from my house and has burned through a ton of cash since 2011 and has had some failures and the founder left and it had to be recapitalized and has a trial that will be completed in 2025 for its whole system – Dr Natale is not impressed. They are not even at the new technology section of the AFIB meeting this month. Its product is a mapping system and will compete in marketplace with Carto, St. Jude, Rythmia, Abbott. BioSig’s Pure EP System is Electrophysiology information system - new information Electrophysiologist can use from intracardiac signals with Presently no competitor and no patent applications showing near term competition.
This company is more likely a buyer of BSGM technology than a competitor. BSGM has 26 patents including the new ones mentioned today. Company and Andrew Filler keep constant watch for new signal patents and see nothing that is a competitive threat. If anything, if this company has any success (as opposed to their early struggles) it would make it more likely that JNJ and Boston Scientific come after BSGM not less likely. And remember with the Mayo Ventures BSGM is much more than PURE EP. Again, Remember the multiple deal enhancements done with the Mayo Clinic covered in this post
This Mayo relationship and TCAI relationship with Dr Natale both will become better understood in 2020 starting with Natale Jan 23 presentation (raving about my guess over 100 human ablations using PURE EP at TCAI since November) and AFIB 2020 and Mayo human ablations starting this month. Neither of these relationships with the leaders in the industry are closed to being priced into this stock IMO
Heading out to my PT and MRI – will edit the above post later to clean it up and add more so read it again in a couple of days