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 conferences 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.
Now a poster who has never talked to John Kowalski wouldn’t know that John feels he could sell over 50 devices right now off HRS demand without published data (which will come) and in addition believes he could sell a substantial number of the simulators that were the subject of recent Patent receipt PR. There is probably no better expert in the sale of cardiac devices in the entire industry than John. Company is on track to have revenues later this yr and for sales to ramp next yr no matter.
Also remember U Penn was for instance Kowalski’s number one customer at JNJ and was the only key account serviced by recent BSGM addition Kelsey Tarzia who we also met at HRS…
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.
IMO some institutional investors are adding into clearly targeted world class ablation centers like UPenn (John Kowalski’s largest client – recently hired Kelsey Tarzia’s largest account while both were at JNJ), TCAI, NYU, Indiana, Dana Farber etc.…… Remember the company said in the recent Shareholder letter…. With the first phase successfully completed, we are working on bringing our PURE EP™ System to five more leading hospitals over coming months and install our technology, under contract, for a period of up to 90 days. At the end of the 90-day period, we intend to engage the hospitals to purchase our system and software. During this time, physicians and lab staff will use our system on a wide range of arrhythmia cases with the Company’s support on installation, training, operation of the technology, and case support. In exchange, we expect to receive valuable human clinical data, which should serve as a foundation for future evidence-based clinical trials and broader publication strategy (see below for more information). IMO its highly likely one of the 5 leading hospitals under contract noted above has to be UPenn and I would not be surprised if they, Mayo and TCAI are the first commerical customers this yr.
John Kowalski would not agree you need a large sales team or published data to sell to the top centers. This machine will change ablation procedures as we know it for the better and there is already significant first tier demand coming out of HRS. This is not a high volume "me-too" catheter that would need a large sales team - for instance Kowalski, Amy and Kelsey could sell multiple machines to U-Penn, Mayo, NYU without any lower level sales personnel .. different business and sales model - one that John and Amy basically created over the last 2 decades.
Our group has met just about every senior executive at the company at HRS, on conference calls and 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.
We also met the majority of the company’s Board members at HRS for more info on what they said to us you can read the HRS summary included in this post:
In addition to the six former JNJ employees my group has talked to we met the following advisory board members at HRS:
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.
All of these gentlemen feel the company is on schedule with their commercialization and sales roll out plan despite what some posters think.
Just as a reminder - I did indeed address my investment history in BSGM on this board – he must not have seen it – here is the post in response to biolurker…
As you can see – I have invested in the April 2018 and March 2019 private but also have bought a lot on the Seeking Alpha dip – I agree from time to time profits should be taken – I for instance sold all of my July 7.50 calls the day before the Russell Addition and half of my July 10s – both bought awhile back because of the Russell and the Seeking Alpha lies)…I did not sell my shares though – in fact I added a lot on the seeking alpha dip into the low 6’s and again at 8.78 and again on the dip back to low 8s. I would not advise a blanket statement to take sell simply because it doubled but that’s up to the individual investor. My investors who have done extensive due diligence at HRS, talking with all of the above people and on 6 separate conference calls and I see multiple catalysts this summer and yr and revenue surge next yr after some revenue this yr. I will continue to use options for trading while adding to core shares on dips, Seeking Alpha lies and misunderstandings by those who have not had those calls or visits with the above people at HRS and investor meetings.
Let me also address the one poster we did suspend and delete on this semi-private BSGM board since it was brought up as if it was a negative. As Dennis has even done on his biotech2k board, sometimes you have to make tough decisions. RealistSkeptic suddenly became a BRAND-NEW MEMBER on Investor Village one week before a series of short attacks on Seeking Alpha by White Diamond full of lies. Somehow the ONE BOARD he found to post on was the semi-private BSGM board (not in any of the top lists and not even shown when you search BSGM on IV). He asked to come to talk pros and cons....then he barraged the board with non-stop negatives including something from 20 yrs ago, did not talk about anything in my detailed HRS summary, and I ANSWERED every post (answers still posted) with facts only for him not to discuss them but to post another negative not based in facts. He jammed the board so badly 5% of the board members asked him to be removed - the next day he did it again - so the monitors banned him and deleted his post. Since then he showed up in comments section of the three SA lying BSGM bashing pieces - talking same that he posted on BSGM semi private board weeks before. He somehow found the semi-private board - joined IV and sent a barrage of negative posts to that board only - never posted on another board - deleted his profile and disappeared. We all know what this was.
I disagree with one posters view of why the stock doubled – its not a retail message board or my emails, its fundamental progress the company has made since my initial investment in April 2018 and especially since the December Investors meetings….its true I did get a lot of people to go to the various investor meetings in Houston, LA, Orlando, Miami, Boston, Conn, NY, Miami and Boca Raton – and over 20 were on 6 conference calls….But the investors who invested after I discussed BSGM with them did so after the calls and in person meetings and 10 of the smartest investors I knew and had them and others (well over 20 in total) on 6 conference calls with senior management and 10 came to the Heart Rhythm society meeting in San Fran flying from 6 states. They invested after serious diligence and given the fact the CEO and company delivered on 12 consecutive guides/promises detailed here:
The company has also met with institutional investors in Boston, NY, San Fran, Dublin, London, Zurich, Munich and other European Countries and Sam Navarro’s and CELG CMO’s additions in addition to the fundamental progress described in the link above will likely bring institutional sponsorship like this company has never seen before
And while its true the company EARNED its way into Russell 2000-3000 ETFs and indices by way of 12 straight kept promises and fundamental progress including 3 series of very successful human ablation procedures, the stock is actually about flat from when Cowen broke the news to some clients in May - so no its not a retail message board or Russell addition that has it up over 100% but the CEO and team delivering on guidance over and over again and moving past key first in human procedures, getting key patents, 2 huge board additions and continued investor and doctor education.
Which brings me to several misunderstandings about this company. Some on SA and IV say are Drs complaining about current signals….the answer to anyone who talked to them at HRS is a resounding yes…….for a decade they have been clamoring for better signals – and PURE EP delivers it….One of the reasons Mary Ann Edzards left JNJ for BSGM is because of here experience as a nurse in the EP lab…..remember her quote in my HRS detailed summary
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”
The company never promised detailed published data set at HRS – another exaggeration spread on SA that has now made its way to IV. The company promised to share results of the 22 human ablations with doctors who came to the booth at HRS – and they did that. Better than any data set IMO, doctors were shown the actual signals of the Human ablation cases with PURE EP and the signals before same patients. All 60 left with a positive impression interested in the machine. The company has more interest in machine purchase now then ever before but will continue with the rollout described in the shareholder letter above.
· It’s already cleared by the FDA for use in human actual procedures - thats how the FDA clearance process works. it’s not invasive and the current actual human procedures are nothing like a biotech clinical trial.
· There is little risk at all that the computer can measure the electrical impulses in the heart and show it on a screen - thats what this is. Its cleared to be used in humans because its non-invasive and not risky at all.
· It now has been proven by the Top Dr ablation Dr in the world on multiple patients - not a trial it is approved and these are real procedures – all three doctors who performed them were, as promised at HRS, and discussed the “results” as promised.
So those who came saw the visibly obvious HUGE advantage of doing an ablation with PURE EP over the same patients signals before PURE EP. As for published data sets, which IMO will likely come later this yr after TCAI, maybe U Penn, Mayo and others use the second-generation machines distributed this quarter, there is this misconception that published data on time saved, etc. is needed for sales for the first tier sales. I disagree.
While data is being gathered and will be during the 90 day under contract further human ablation procedures and that data will help spur the second wave of buying - Kowalski is clear its not needed for the initial surge of sales - supply will be the problem not demand when the company enters commercialization phase later this yr.
1) Because Dr Brenyo himself told me: 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 in April 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. I asked him what would be needed for EP labs to buy this machine would they need detailed data sets – he again said he will help put such together and that would certainly help accelerate the second wave of buying but what was shown at HRS is so visibly obvious – and that and comments from top tier guys like Dr Natale already has the machine in demand.
2) And again because John Kowalski believes strongly, he could sell many machines right now if he had inventory to sell – there is demand coming out of HRS already…remember John Kowalski at JNJ created the sales model of cardiac devices, has sold many machines before full data sets come out, left JNJ taking a pay cut and publicly said he was buying a LOT of stock all the way into the 8’s. He told us he could sell the machine now. He and Amy Scott helped create this industry and sales model. Remember their backgrounds when someone unfamiliar with the sales model says.
Also don’t underestimate the relationship with Dr Natale of TCAI – most at HRS including Dr Brenyo called him the number one AFib and ablation influencer in the industry. Remember TCAI is in process of opening what many believe will be one of the most forward-thinking state of the art EP labs in the world - “opening a new, state-of-the-art Electrophysiology Center dedicated to treating patients with cardiac arrhythmias”
· “The newly expanded space will allow us to better serve our patients who come from all across North America, in addition to a growing number of people traveling to Austin from Asia, Europe, Latin America and the Middle East seeking care at TCAI.”
· “We are committed to providing the highest level of care for patients with cardiac arrhythmias,” Todd Steward, chief executive officer of St. David’s Medical Center, said. “The expanded space also features an international training center, which will allow TCAI to continue to share with physicians around the world the latest advances in interventional cardiac electrophysiology, improving outcomes for patients worldwide.
BioSig believes they will want not only multiple commerical units but also some simulators as this new center evolves in the coming yr.
Remember Dr Natale was chosen to do the First in Human ablation procedures earlier this yr….
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.
Also do not forget the Mayo 10 yr collaboration with 9 yrs to go….
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.
Based on recent SEC filing last month and Dr Asirvatham’s comments and excitement during the last BioSig working session in MN, most believe Mayo will exercise their option and invest $1 million in BioSig stock this quarter, likely soon. While very excited about the PURE EP ability to deliver game changing signals during ablation, they are equally excited with respect to neurology and other areas. This reminds me of the BSGM CEO comments in December in the LA investor meeting, fully expecting some time in the future to have multiple medical device companies to be interested in acquiring BSGM – he might have to give them cardiac but he said they can’t have the neurology and other assets – I believe investors will get some updates on this pipeline later this yr.
Could you - like one guy suggests - sell half your shares if you listened to my initial posts and have a double – sure its not a bad strategy if you want a riskless investment and take all your original investment off, I would not argue with that. (as long as the sale is not based on listening to erroneous requirements posted for first tier sales of PURE EP). Me I continue to add in my IRA, Roth IRA and regular accounts on dips like the Fake Diamond articles into multiple catalyst coming – and play the swings with calls so far very successfully. I am in this investment for yrs and not just for cardiac but for neurology and the continued pipeline being developed with Mayo in the 10 yr collaboration with 9 yrs to go. Remember - But don’t do it because of uniformed posters or SA comments. Anyone who wants to learn about company and be on next call with CEO or the new board member former CELG CMO just let me know. Also keep an eye on the BSGM semi-private board for more updates and keep next May 6-9 open for trip to San Diego and the HRS meeting I suspect 20 top tier investors will be going there this time. (Clearly our group is holding long term and buying dips).