BioSig Tech. (BSGM) & Electrophysiology Sector - My June 30th post on another board replying to someone who wanted BSGM feedback... - BioSig Tech. (BSGM) & Electrophysiology Sector - InvestorVillage
BioSig Tech. (BSGM) & Electrophysiology Sector

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Msg  199 of 271  at  7/7/2019 5:08:12 PM  by

Rob Cos

The following message was updated on 7/7/2019 5:10:09 PM.

My June 30th post on another board replying to someone who wanted BSGM feedback...

  
 

 

 
Re: BSGM-love some feedback - teauxjam...Mayo/TCAI/more    (teauxjam had asked for feedback on Biotec2k board)

teauxjam since you asked here is some info.....
 
When I brought BSGM to IV and this board around $4 some said it was risky/speculative and I said it is less risky and speculative than most of the bios on this board without revenues. I have done more early work on this stock than any in my 30 yrs of investing and disagree strongly with the statement "a hugely speculative stock with a low, manipulated float that in my opinion has reflected that". Early 2018 before it came on NASDAQ and had its industry changing product cleared by FDA maybe - but not now. Company just completed three series of human ablations procedures with comments like "jaw dropper" and "eye-opening" from 3 of the top ablation experts in the US (without any financial affiliation), is about to roll out to U Penn, Mayo and TCAI and others to have hundreds more successful cases and then later this year start the commerical roll out with revenues beginning and imo surging in 2020 just as guided last yr. I believe Mayo will exercise their option and invest in the company given recent filing and will likely expand relationship some time in Q3. As far as easily manipulated with stock in insiders and VERY strong hands its difficult to manipulate, the shorts tried with 3 Fake Diamond S/A lying pieces/updates and tripling the short interest and twitter attacks yet stock went up 40% instead of down. CEO is a savvy successful wall street veteran who used to short stocks himself and will not deal with the CVIs and Wainwrights of the world. Shorts really don't understand who they are dealing with. All of their $5 and $7.50 June put premium evaporated on the puts bought (when stock was in the $6's) before the SA attack (they were clearly tipped off) and the short is upside down by like 40%). I doubt the CEO is done with them yet despite multiple positives announced since. Definitely expect more news in Q3.
 
With a 10 yr deal with the Mayo clinic who recently praised the product inventor (see HRS summary below) and the top ablation doctors in the world behind it including Dr Natale at TCAI and this CEO and world class Board of Directors our investment is in good hands (I expect expansion of Mayo and TCAI relationship this yr). 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 who invented PURE RP “one of the most important inventors of our time”
 
Since early 2018,the BSGM CEO and world class board and amazing management team has delivered on 12 promises/guides in a row - to be honest I have never been involved in a small cap whose CEO has delivered on the first dozen commitments he gave me and my investor group. If you can only read two things read these 12 commitment deliveries in this link and my HRS summary pasted at the bottom of this post....
 
After being burned by 2 Board of Directors I helped get the Chairman and multiple board members removed at ZIOP and CRMD and now they are the path I originally hoped for. CRMD science, drug and Ph 3 panned out exactly as I predicted originally at 66 cents but the Board crimes behind the scenes were hidden and then when I had two alternatives ready they did the Wainwright deal behind my back or this stock would be multiples of the current price.
 
So learning from my mistakes I decided my next large investment would need to have
 
1) a world class product that would change the industry
2) A CEO/Chairman with great business acumen and wall street savvy who would put Shareholders at top of list and not use the Wainwrights of the world now that product is cleared by FDA
3) a world class Board of Directors that is actually a huge positive not negative like the ex-Vice Chairman of the NASDAQ, the ex Chairman of Wilmington Trust and recently added the ex Chief Medical Officer of Celgene and Sam Navarro probably the most successful medical device investor of our time from Gravitas
 
Then I got the 10 smartest investors I knew and had them and others on 6 conference calls with senior management and took them to the Heart Rhythm society meeting in San Fran flying from 6 states.
 
Later in the summer our group will be on a call with ex CELG CMO who just joined the board if you want to truly learn more - until then a good start is our summary of the HRS meeting.....
 
My detailed summary of our Investor Trip to the Heart Rhythm Society scientific sessions to meet with BioSig
I attended the 40th Annual Heart Rhythm Society Scientific Sessions which took place May 8th to 11th in San Francisco. The idea was to walk the floor and visit companies like Medtronic, BioSense Webster (JNJ), Abbott, Boston Scientific, Phillips, and others but of course our primary goal was to spend time with BioSig Technologies (BSGM) CEO and Senior Management, Board of Directors, Advisory Board Members, key ablation/AFib doctors/KOLs who have experience using BioSig’s PURE EP system on humans during actual ablation procedures as well as some key investors. An additional goal was to meet with various former A team employees who came to BSGM from JNJ’s multi-billion device unit Biosense Webster to discuss why they made such a move.

With this trip, we continued the extensive due diligence that has previously included at least 6 conference calls with participation from about 20 of the smartest investors I know (including 2 Board Members from another of my investments) as well as attendance and meetings with the CEO and other management members in Redondo Beach CA, Houston, Boca Raton, and Miami. Please see previous posts and emails on those meetings. In addition, given yesterday’s news let me mention I had a one hour call in February with former Celgene CMO Dr Jerry Zeldis who is a large investor in BioSig and at the time was a former BSGM Board Member but as of yesterday is back on the BSGM Board of Directors. On our call in Feb, he seemed willing to have another call with a larger group of ex Celgene investors and others. Let’s let him get settled but let me know if you would be interested in that if we could pull that off.

In addition I took the smartest electrical engineer friend I know up to BioSig Headquarters in LA - Marty's company is a long term 50 yr successful multi-faceted engineering company as well as Siemens distributor and also worked on the he propulsion unit for Elon Musk's hyperloop and has the electrical engineering background to challenge the BSGM Chief Technology Officer and new BP Engineering who is an industry star. The visit exceeded my expectations as almost every conversation or in person meeting, I have had with anyone associated with BioSig has. If you have not read Marty’s summary of this meeting it is a MUST for any current or prospective BSGM investor.

https://www.investorvillage.com/groups.asp?mb=19723&mn=64&pt=msg&mid=19371777

This time I was lucky to have 9 of my investor friends travel from NJ, Texas, Conn, Nevada, Washington and CA to join us for a 90 minute investor meeting at the booth with BioSig employees, board members, advisory board members, executives and KOLs followed by a company event sponsored at a local restaurant for 3 hours where all the key personnel were available to us. These were some of the smartest investors I know including one guy who does more detailed due diligence than anyone I know including attending ASCO, ASH, HRS and other scientific conferences, one investor who founded and sold his own device company, a finance guy who sold part of his software venture to Bain, one of the smartest portfolio managers I know and some other very astute investors. Most were highly impressed across the board. Its always easy to not do something like this and I give these guys a lot of credit for traveling and making it. Most found it extremely worthwhile because we got to meet all the key people including board members, management and KOLs all in one place in a span of about 5 hours.
 

Discussion with Founder, Chairman and CEO Ken Londoner and with Board of Directors and Advisory Board members

We were extremely fortunate to get to spend some time as an investor group with BSGM Founder, Chairman and CEO Ken Londoner as at an event like this he was booked solid with meetings with KOLs, industry leaders, potential commerical partners and potential customers, and industry companies that have interest in what BioSig is doing and even foreign companies that show continued interest in perhaps distributing in Asia and elsewhere. I also got some one on one time with Ken once at the BSGM Booth and again at the BSGM 3-hour event.

Ken continues to be upbeat and focused on execution. At the Redondo Beach event he had committed to having successful First in Human testing at 2 different locations by the HRS meeting and to my surprise he delivered not only the two but three including Univ of Indiana right before HRS started. He also discussed the probability of more successful human ablations in the next quarter or two including 10 yr partner Mayo clinic and other locations - my guess UPENN (see logic below in the JNJ A Team comments below). Ken noted they were extremely please with the 22 successful human ablation procedures at TCAI, Greenville and Indiana. He showed us a picture of the new machines that were about to be completed manufacturing wise. It’s the generation 2 system with upgraded hardware, wiring and software so they will take some time maybe 10 weeks for Validation and Verification – safety tests like drop test, electrical, leakage, EMC, heat etc. They have strict quality management systems and will ensure documentation of these tests for that quality mgt system. After testing 10 or 11 machines will then be ready to be deployed to more hospitals. This will go a long way to ensuring successful human procedures in more than 10 locations as we move towards the commercialization phase of the company.

Ken said he was extremely pleased with the quality of personnel the company has been able to attract including the key addition of John Kowalski as VP of sales, one of the 5 stars at JNJ BioSense Webster BioSig has added over the past yr. He also invited over later their newest hire Kelsey Tarzia who was literally on her 4th day on the job at BioSig and later took our investor group through their set up presentation and simulation by herself like she had been with the company for yrs. We talked with Ken a little about the quality of the team and the Board of Directors including several from fortune 500 companies. He gave his continued commitment to continue to add quality employees and Board members as needed.

As a side note as he was talking, I saw Dr Barry Keenan walk by, the new superstar VP Engineering hired in March to help drive new product development. I had met Barry recently in LA with my engineering friend Marty – discussed above – and we extremely impressed and it just reinforced that Ken and his team has delivered everything he/they have promised since I first entered this stock in May of 2018 through a PIPE. From FDA approval and the move to the NASDAQ they promised me happening within the guided timeline, to the promise of hiring top tier talent which they have delivered on more than a half dozen times recently, to the promise to do small raise mostly with existing shareholders this yr and delivering an $8.6 million raise with no investment banker or warrants, to his commitment to buy shares on the open market from time to time, to the announcement yesterday of the former Celgene Chief Medical Officer Jerry Zeldis rejoining the board of directors. Its just so nice to have a CEO you can trust and who works for his shareholders. This week he delivered twice already:

Jerome Zeldis, M.D., Ph.D, Former Chief Medical Officer of Celgene, to Join BioSig Board of Directors:

https://www.biosig.com/news-media/press-releases/detail/144/jerome-zeldis-m-d-ph-d-former-chief-medical-officer-of

CEO Ken Londoner again buys shares on open market this week:

https://www.sec.gov/Archives/edgar/data/1449534/000118518519000784/xslF345X03/ownership.xml

(update: later in the month Dr Zeldis exercised options/warrants EARLY including $6.85 strike 2021 expiration and 2026 options and held all shares didn't even sell any for taxes or to pay the premium). CEO Ken Londoner has added many times this month on the open market cash buys (not option exercise) see multiple form 4s constant buying on the open market.)

https://www.investorvillage.com/groups.asp?mb=19723&mn=140&pt=msg&mid=19465344

Ken noted the company operates in $4.6 bill electrophysiology market which is growing at the rate of 14%+ annually. He has been buying in the open market this yr as he believes the company is undervalued vs industry peers given BSGM now has an approved product that is now proven in human ablation procedures at 3 top ablation centers with more coming in the next few months. Company should be entering commercialization stage over the next 6 to 12 months with a team experienced in sales of cardiac mapping and other cardiac devices who already have relationships with most of the key personnel at top EP centers including those making the purchasing decisions and the top Drs that would be using the machines. (To me this is of paramount importance – see more detail on the key personnel in the next section).

Ken noted to me that he has been traveling a lot and presenting the story to major institutional personnel In Boston, NY, LA, Houston, several Florida cities and then a 2-week trip in Europe including Geneva, Frankfurt, London, Dublin and Munich meeting with investors, funds, brokers. Company has a large insider ownership about 38% and then another says 12%-15% from a Houston group of mostly very successful physician investors led by an advisory board member. Investors are extremely loyal and literally asked for the recent PIPE to add more, exercise earlier warrants to increase their long-term shares and often don’t even register their shares even after the holding period – just keep for the long term. Interest from funds are gaining now, some appear to be waiting for the revenue generation stage of the company which is approaching – others have shown more interest recently.

Ken then invited Kelsey Tarzia over to address the group, another new ex Biosense Webster employee in her 4th day at BioSig already performing at a high level addressing our group. More on our discussion with Kelsey in next section of this note. Ken introduced us to others including those listed in the next session and some board and advisory members.

We 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 are extremely confident in the company’s IP position – Andy mentioned that machine inventor and BioSig Chief Technology Officer Budi Drakulic 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.

In addition, we were also introduced to other Board of Directors including David Wield IV former Vice Chairman of the NASDAQ (again amazing B of D quality) who coincidently for many of us had a hand in the early funding of Celgene while at Prudential. Also met Don Foley former Chairman/CEO of Wilmington Trust and Jeff O’Donnell. Won’t go into all the discussions but in general the pride this group had in being on the BioSig board and the confidence they have in Ken and his team and their products exuded from them during the discussions. After battling recently to get the Chairman and multiple board members replaced at two different companies, it is just such a pleasure to have a world class Board of Directors at this company that’s an actual large asset instead of a liability shareholder have to fight against.

I got to meet 3 Advisory Board Members as well during the visit at the booth and during the 3-hour company event.

o Dr Ramachandra Malya – I actually know Dr Malya from another private investment we are in together and have always found him to be thoughtful and engaging. In some ways, I have him to thank for my initial investment in BioSig in May 2018 since it was kind of a payback for his investment in IBBQ.com (www.ibbq.com). Dr. Malya brings to BioSig over 40 years of experience in the medical field. His strong business acumen has allowed Dr. Malya to serve as Founding Board Member of several successful healthcare entities and two Texas savings banks with valuations in excess of one billion dollars. Throughout his career, Dr. Malya raised capital for a number of promising healthcare start-ups and managed an important family office funds with extensive medical relationships. Some of my investor friends met Dr Malya at the Houston investor meeting they went to and heard him actually say his investor group wanted to put $3 million more directly into the company for the long term. This was the beginning of the $8.6 million PIPE raise recently the CEO accomplished without an Investment Bank or warrants as promised. Dr Malya’s group owns just under 15% of the company and are extremely loyal, long-term investors. Dr Malya expects the company to be the target of larger companies but has already informed the CEO and told me he would not take a $25 cash offer for BioSig because he believes it will be worth a lot more as an independent company. Dr Malya believes that there is great promise outside of the ablation and cardiac area with Budi and Barry Keenan in charge of driving future pipeline together with the Mayo Clinic. He has mentioned Neurology, Hypertension and other areas.

o Sim Farar – Fascinating gentleman. Several high-level government appointments including US Rep to the assembly of the United Nations and other positions. served as CEO, Chairman, Director, and consultant to a number of companies, including JDF Investment Co. LLC, IFC Financial Services Corp. Very bullish on BioSig and I believe has access to many potential future investors and has been an excellent advisor to the company. Again, the quality of people associated with this small company continues to amaze me. Spoke highly of Ken and the company.

o Frank Quintero - Principal at The Yucaipa Companies, a premier investment firm founded by legend Ron Burkle in 1986. Before that special assistant to CA Governor Gray Davis. Joined the Advisory board last month and has numerous financial and political ties that should be an asset to the company. Also spoke highly of Ken and the company as well.

Five former JNJ BioSense Webster “A Team” members were exemplary leading BioSig effort at first ever HRS Booth

One of the areas I highlighted early this yr was the exodus from JNJ’s multi-billion-dollar device unit to small cap BioSig in previous emails and in this post which includes a Roth report on the exodus and 4 press releases with the backgrounds – it’s a must read as background to the changes in the past yr as part of the build up to the commercialization phase of BioSig….

https://www.investorvillage.com/groups.asp?mb=19723&mn=4&pt=msg&mid=19163220

 
One of the highlights of HRS was watching the following five industry stars and others at HRS leading the BioSig tremendous HRS effort including:
 
o John Kowalski – BioSig Vice President of Sales - 30 yr medical device sales veteran incl 20 yrs at Biosense Webster (JNJ mutli-billion-dollar device unit where he received a record 18-yr Founders Club Award and Several Area and Region of the Year Awards) – see more on his background at above link). Have been on a few group conference calls with John and my investor friends but meeting him for the first time I find all of the praise I had heard well deserved. One of the early industry professionals that help make the medical device industry what it is today. John openly told the group he took a pay cut to take the BioSig job because of the tremendous opportunity and upside he sees. He also openly discussed on the floor that he has and continues to buy a substantial amount of BSGM stock on the open market because he believes it is undervalued vs the current prospects of the company.

 

o Amy Scott – BioSig VP of Strategic Partnerships – former Biosense Webster (JNJ) Director of Strategic Partnerships responsible for U.S. engagement of physicians and management of the company’s Scientific Advisory Board. 30 years of experience in medical devices, (20 years in electrophysiology), and like Kowalski, literally helps create the medical device industry and paradigms. Amy both on my previous investor group call and at HRS was asked about all the Biosense Webster people coming to this small company and she expresses confidently it’s the right move. They are confident they have a product that the industry not only needs but has been clamoring for - for a long time. Amy was engaging with booth visitors and it was repeated by many in senior management positions what a key factor she, Stephanie and MaryAnn have been in the successful use of PURE EP during the human procedures this yr at TCAI, Greenville and Univ of Indiana.
 

o Stephanie Jasa - Directing BioSig’s Education and Training initiative - former Biosense Webster (JNJ) Senior Director of Global Training and Education. Heavily involved onsite during the three recent human testing weeks at TCAI, Indiana and Greenville, I couldn’t think of anyone better in the industry who together with MaryAnn E below to choose to lead the hospital and BioSig employee training and education in getting full utilization of the PURE EP system to dramatically enhance the signal clarity during human ablation procedures to ensure more efficient and accurate burns inside the heart.

o MaryAnn Edzards BioSig Senior Director – Account Manager – was New Technology Education Mgr at Biosense Webster (JNJ) responsible for all internal and external marketing and training programs for two global product launches - training of over 300 employees. She brings to BioSig extensive experience in converting Voice of Customer feedback into commercially valuable solutions. Holds numerous JNJ awards, including 2016 Standards of Leadership Award and 2017 Gold Encore Award from Commercial Marketing. This is the second time I met MaryAnn in person (at a dinner at the Roth conference in Q1 also) – she’s a genius who can explain complicated engineering in layman’s terms and was also a nurse before going to JNJ. She told us that when she was a nurse the EP lab doctors and nurses said there was a desperate need for better signal clarity during ablation. “They have been asking for this for yrs and now we are delivering exactly what they asked for”

o Kelsey Tarzia – Brand new BioSig Account Manager – young bioelectrical engineer who had U Penn (Kowalski’s and Biosense Webster’s largest client) as her largest customer/client. Normally I wouldn’t even mention someone this new but this lady was extremely impressive her 4th day on the job at BioSig (just leaving Biosense Webster (JNJ)) she literally took over our investor group conversation and brought us over to the booth and went over the presentation and was engaging, professional and enthusiastic. Another budding superstar has joined BioSig from JNJ. Wow. The talent at all levels this small cap is attracting from industry behemoths is truly amazing. Her top client at JNJ was U Penn – also Kowalski’s top customer. My investors where unanimous as to what this will lead to.

Here is MaryAnn (with Amy and Budi, the machine’s inventor and BioSig Chief Technology Officer also watching) demonstrating the PURE EP system possibilities to Dr Nakagawa of the highly regarded Univ of Oklahoma Heart Rhythm Institute

https://www.oumedicine.com/heart-rhythm-institute/restoring-the-rhythm

 
The “JNJ A Team” as I refer to them did an amazing job taking both medical professionals, potential commercial customers and investors through the benefits of and possibilities using the PURE EP system. The professionalism and expertise in the area they exuded was impressive. I walked the floor and went to all the larger company displays and I have to say the “buzz” at the first ever BioSig booth was palatable. I heard a few visitors mention this was the most impressive new technology in the entire Heart Rhythm Society Scientific session – one guy called BioSig the “star of HRS”.
 

At HRS, the five former JNJ Biosense Webster people that have come over to BioSig in the past year who I have met were all consistent in their answers and consistent with what a separate group of my investor friends heard on a previous February group conference call we with John Kowalski and Amy Scott when asked the question “Why leave Johnson and Johnson for small cap BioSig”. While expressed in different ways, the gist of the answer was that they have been working in this field for awhile and one thing that EP Drs, nurses and clinicians have been seeking is some new technology that will deliver real time cardiac signals during ablation procedures with improved digital filtering, cardiac signal clarity and less radiofrequency interference or noise. They felt they were joining BioSig at the perfect time (post FDA approval about to be used in human ablation procedures in the top ablation centers in the country) to make a difference to patients and be part of delivering a new technology that is greatly needed to improve the outcomes of ablation in AFib and Ventricular Tachycardia. There was a feeling of being part of something that will change the cardiac ablation industry and help patients. The other thing I felt was a virtual certainty and confidence from all of them that this technology is not only needed but that BioSig has the technology that will definitely deliver exactly what Drs have requested. They cited the already completed successful human ablation procedures using PURE EP at TCAI, Greenville and Univ of Indiana and planned additional centers this quarter and next. (Certainly 10 yr partner Mayo will be one – my guess is Kowalski’s biggest customer and Kelsey’s largest client U Penn would also be a likely near-term target). There was a general pride expressed by these former JNJ employees that they were working with BioSig – and a consistent message that the quality of personnel throughout the company, executive ranks and Board of Directors was exemplary for a company of this or any size.

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.

 
Steady Stream of Large Company Interest and Wall St analysts at HRS to see BioSig
 

Again, I have to say at least for May 9 I found the “buzz” at the BioSig HRS booth to be better than the other companies booths – most that were considerably larger. There was a steady stream of investors, Wall Street Analysts, ablation doctors and clinicians that were potential customers, KOL’s and quite a lot of personnel from other medical device companies that were at the show. Some believe that the BioSig PURE EP system was literally the new technology star of the 2019 HRS Scientific Sessions. I certainly did not see anything at other booths that topped it so couldn’t argue against that.

I believe there were six or seven separate medical device wall street analysts that visited the BioSig booth with significant interest or the CEO during the show including Jefferies, Cowan, JMP, JP Morgan, BTIG and Chardan. Now like with Roth and others, CEO Londoner is very direct with analysts who show interest in the company. Cover BioSig to make your clients money – but don’t expect any investment banking fees – we do not intend to hire investment bankers in the near future. Another huge positive I have found with Ken Londoner, is his disdain for wall street firms that press for secondaries, leak to hedge funds, stocks tumble into the deal and then leave the hedge funds holding warrants that could be shorted against for yrs. Those of us that have seen the Wainwright and CVI deals that hurt other investments view this as a huge positive. In addition, Franklin Templeton and Granite Investment Group stopped by.

Then there was interest at the booth, BioSig Event and at side meetings regarding BioSig and the PURE EP system. At the Roth conference the CEO mentioned expectations of eventual European and Asian approvals. I believe the initial thought is to go it alone in Europe but the company would certainly need a Japanese distributor as a partner and they have been talking to potential partners for awhile now. I was CEO of $17 billion Mitsubishi Credit in the US and understand the Japanese take their time evaluating the situation but then at some point when they decide you have what they want are aggressive to partner. I think over the coming yr that time will come once sales begin in the US and adoption ramps up. Many from the Japanese medical device companies visited the BioSig booth – including I believe from the potential top possible distributor. Closing such a deal is likely a way out but it’s interesting so many visited.

There were also a steady stream of JNJ BioSense Webster personnel coming over – it’s tough to determine if it was for business purposes, friends of the “A Team”, others looking to move to BioSig from BioSense or a combination of all of the above – but one thing is crystal clear – JNJ is keenly aware of everything that is happening at BioSig. Also, I’m thinking the BioSig the manuscript entitled “Evaluation of Real Time Catheter Tissue Contact using Unipolar Intracardiac Signal Morphology” which has been accepted to the 41st International Engineering in Medicine and Biology Conference (EMBC), to be held in Berlin, Germany from July 23 – 27, 2019 per the BioSig May 2 press release is not a positive for the high end high margin JNJ catheter used in ablation. Many believe over the coming yr the large device companies like Medtronic, Phillips, Abbot and others will have their eye on BSGM as a possible acquisition given the acquisitive nature of the sector, and while CEO and certainly Dr Malya on the Advisory board have no interest in being acquired anytime soon, that doesn’t mean JNJ isn’t looking at this company closely at this point. Given yesterdays amazing news that former CELG CMO Jerry Zeldis has rejoined the BioSig Board, I think its important to understand that Jerry Zeldis was Sol Barer’s right hand man during a time when Celgene got multiple takeover offers (I believe something like 8) and helped management turn down each of them after much analysis I’m sure. Something tells me that skill set may be valuable over the coming yrs as a BioSig board member.
 

Separately, I met Nathan Pottinger a Rhythmia Specialist from the Electrophysiology group of Boston Scientific at the BioSig 3 hour night event and he who was absolutely raving about the PURE EP system and openly said he thinks Boston Scientific should partner with the company (have no idea If BSGM would be interested but thought this type of interest is worth noting to investors).

Lastly 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. In fact, the day Marty and I visited the LA offices, Budi and Barry K had just come back from a 3 day visit to Mayo.

https://www.biosig.com/news-media/press-releases/detail/122/biosig-technologies-announces-new-research-program-with

Summary

I could probably write another 10 paragraphs on the HRS meeting and BioSig but in the interest in getting this out now given the opportunity after the expected pullback after the huge runup into HRS helped by some apparent shorting, let me summarize. I was obviously extremely impressed with the professionalism and effort of the BioSig team at their first ever HRS booth and their 3-hour night event. They treated our investor group with respect and gave us amazing access to the entire management team, the former JNJ “A Team”, the Board of Directors, the Advisory Board, the CEO and even KOLs who have actually used the PURE EP system very recently during actual human ablation procedures. The CEO told all to be completely honest with investors, both positive and negative and when asked we were provided business cards for follow up post HRS. BioSig and CEO Ken Londoner continue to deliver on what they promise, are keenly focused on execution and moving forward with gen 2 of PURE EP into more and more hospitals as they drive towards the commercialization phase of the company. All indications are that once sales begin, EP centers with the PURE EP system will have significant competitive advantages over the competition that do not. Meanwhile, Mayo Clinic, Budi D and Barry K are driving efforts to continue to build the newer pipeline outside of the cardiac area in neurology and other areas.

We have found a company with a world class product that in my opinion will change ablation procedures for the better, that has a CEO that truly cares for and embraces shareholders, a Board of Directors that have members from Fortune 500 companies, the ex-Vice Chairman of the NASDAQ and now the ex CMO of Celgene. I see this as a growing core position of my portfolio and continue to add a lot to my Roth IRA, and while it is up substantially from the $4 I originally recommended it at earlier this yr, our recent visit to HRS has my investors and I highly confident in the employees, executive management, Board of Directors and continued success of the company. Please do your own due diligence.

 


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