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Brian Marckx, CFA  

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  • Turnaround Strategy Being Implemented At Competitive Technologies [View article]
    Actually PMA is also required for Class II devices for which there isn't a predicate device which is substantially equivalent. CTTC will be seeking specific indications for Calmare that are different from the intended uses listed in the 510(k). Which will require PMA.
    I specifically asked mgmt about the sham issue relative to clinical trials and, although they c/n talk specifics, I was satisfied with the answer. So wait and see.
    Yep, in an ideal world payers would have all kinds of info at their fingertips to make reimbursement decisions. Unfortunately in the real world that's not the way it works. They typically want clinical data to support efficacy.

    So please address my last comment - and disclose what your agenda is?
    Mar 25, 2014. 09:24 AM | Likes Like |Link to Comment
  • Turnaround Strategy Being Implemented At Competitive Technologies [View article]
    Yeah well despite all that scary sounding language ("breached fiduciary duties, "null and avoid", etc) the fact is that the outcome of this to CTTC could be a) detrimental b) neutral or c) positive.

    To me, more pressing near-term concerns are something that ARE known. That being that the company needs to raise add'l capital and reduce cash burn.

    Your comments re: CTTC/Calmare have an obvious negative slant with arguably limited (or no) added-value. You have zero followers and have only commented on this CTTC article under your "bearcrusher" profile - so it's obvious your profile was just set up to post negative comments about CTTC/Calmare.

    So that begs the question about whether you have an agenda. Are you short the stock? Do you sell a device that competes with Calmare? Are you a disgruntled ex-employee?

    It's unfortunate that SA allows anonymous profiles to post comments with obvious slants without disclosing their interests in doing so. Readers can decide for themselves how much value you have added with your comments and can decide whether it appears you have an agenda. I think much more value would have been provided if you had disclosed what your underlying interest was - given that you obviously just set up this profile to comment on this one article, there's a clear agenda. Of course now you can fill in information under this bearcrusher pseudonym that makes it sound as if you're a casual investor (or whoever) and have no real agenda, but I'm guessing readers may see through that.
    Mar 21, 2014. 08:23 AM | Likes Like |Link to Comment
  • Turnaround Strategy Being Implemented At Competitive Technologies [View article]
    Yep, I'd bet this is a pretty insignificant concern particularly relative to the other challenges CTTC faces. So, yep, so.....????
    Mar 19, 2014. 04:25 PM | Likes Like |Link to Comment
  • Turnaround Strategy Being Implemented At Competitive Technologies [View article]
    This is taken from the AANLCP article that you cited, "While some private insurance companies have been willing to cover treatment...." - but you imply to know that every private insurer does not pay for Calmare treatment. So either the AANLCP article is wrong, or you are. But either way it doesn't really have relevance to my article - because I state that lack of significant private insurance reimbursement has been an impediment to Calmare sales. So again, your comment adds no value.

    I did see the 8k - it's in an 8k 2 weeks prior to earnings release - so.....??? Did you expect a break-out quarter prior to this 8k? I didn't.
    Mar 18, 2014. 11:59 AM | Likes Like |Link to Comment
  • Turnaround Strategy Being Implemented At Competitive Technologies [View article]
    Again, I think I have already covered all of these topics. I do not see what value you are adding. My article explains that lack of current reimbursement and reliance on out-of-pocket payments from patients has been an issue in selling Calmare, that compelling clinical trial data from robust-designed studies will likely be necessary for eventual reimbursement and that eventual reimbursement (if it happens) will likely be years away.

    And relative to cost per treatment, a provider that uses Calmare specifically states he charges $150-$200 per treatment - which has been verified as roughly avg by mgmt.

    And that same AANLCP article you cite also states, "Several workers comp carriers and third-party administrators now cover ST (Calmare therapy). While some private insurance companies have been willing to cover treatment, other have not, and those patients presently have to pay out of pocket."
    So your statement that, "there is not a single insurer in the entire USA whose medical policy statement says anything other than the device is considered "experimental" and, hence, does not qualify for reimbursement" is clearly shot down according to this AANLCP article.
    Mar 18, 2014. 10:21 AM | Likes Like |Link to Comment
  • Turnaround Strategy Being Implemented At Competitive Technologies [View article]
    I don't have proof that he has a PhD. I don't regularly verify the educations of developers of technologies that I cover and I don't see the relevance of your statement. Whether he does or does not (and I have no reason to believe that he does not), I don't think that has any relevance as to "proving" or "disproving" the efficacy of Calmare - I certainly do not ascribe any potential for Calmare to Marineo. Efficacy will be evaluated in clinical studies.
    Mar 14, 2014. 09:25 AM | Likes Like |Link to Comment
  • Turnaround Strategy Being Implemented At Competitive Technologies [View article]
    Yes I have read the latest 10-Q and I am very familiar with their financial situation - which I mention is not good. And I also mention that their financial performance has been bad - so both those points I've already made.

    As far as Calmare being "approved" - it's not "approved" - it's 510(K) cleared. Will PMA approval necessarily translate into insurance reimbursement? - no, not necessarily. But it will necessitate compelling clinical evidence and reimbursement is much more likely to follow. It's obvious CMS and private payers weren't going to pay with the clinical data to-date - Mir's game plan certainly makes more sense than to try and sell in the current reimbursement environment.

    As far as the cost per treatment, it's not $500 - it's about $150 per treatment on average. Maybe some clinics are offering it for $500 but that's nowhere near the avg.

    As far as current reimbursement, Medicare does pay for Calmare treatment - granted it's spotty at best and nowhere near $150 - both of which I mention. As far as you knowing every private insurers policy towards Calmare - I doubt it. But again, I acknowledge that it's insignificant - making your point even less significant.

    As far as $8M in revenue in 2018, that's not unrealistic particularly with future compelling clinical data. As I note - a very small TENS manufacturer ramped revenue very quickly in a short period of time. That includes revenue growing from $2.6M to $8.0M in one year (then $11M, $19M, $24M, $34M...).

    Thanks for reading and all your points - although I think I already covered all of them before you made em!
    Mar 13, 2014. 04:35 PM | Likes Like |Link to Comment
  • Scrutiny Over Medical Device Safety Offers Opportunity For VeriTeQ [View article]
    One more reason there could be add'l interest in VTEQ's tech for breast implants.

    Also one more impetus for countries to implement national breast implant registries.
    Feb 24, 2014. 11:31 AM | 1 Like Like |Link to Comment
  • Put Corgenix On Your Radar [View article]
    Eric - yea just being a micro-cap keeps CONX either under the radar or off-limits of most investors. I think there has been growing interest in the company though. Just the increased participation on earnings calls is perhaps indicative of greater interest and if the financials continue to improve, there will undoubtedly be even more interest in the company.
    Feb 24, 2014. 09:19 AM | Likes Like |Link to Comment
  • BioLife Solutions Posts Another Record Year With Revenue Up 58% [View article]
    More shares will be issued with the debt conversion. As far as the RS, it's not uncommon for the share price to languish afterwards. It's an easier exit for those that were waiting to. But, BLFS did it to uplist and I think very legitimately so. This wasn't a RS so insiders could get out quick and then watch the stock tank.
    Feb 20, 2014. 11:44 AM | 2 Likes Like |Link to Comment
  • Scrutiny Over Medical Device Safety Offers Opportunity For VeriTeQ [View article]
    Thanks for the comment.
    I fully expect the company will be cash flow negative and need to raise a fairly substantial amount of add'l capital over the next few years. That doesn't necessarily mean it has to come from one investor or mean the company has to be bought for current shareholders to see a positive return. My model assumes they sell new equity on an ongoing basis. Lots of companies run in the red for years prior to becoming profitable and generating positive cash flow. Will VTEQ eventually turn cash flow positive? I don't know. There's a lot of risk that d/n happen - just as there's a lot of risks with almost any development stage or early revenue stage co.
    Feb 14, 2014. 02:09 PM | 1 Like Like |Link to Comment
  • Several Catalysts To Reignite Growth At LED Medical [View article]
    Thanks John, I appreciate the comments!!!!
    Jan 27, 2014. 10:03 AM | Likes Like |Link to Comment
  • Rockwell Steadies Itself For A Phase III Run-Up [View article]
    Slack,

    Yeah to answer that question involves a much bigger exercise and involves modeling RMTI. I don't formally cover the company anymore so I don't model it. An SFP-failure scenario doesn't require a model.

    Keep in mind though, even if the CRUISE studies hit the endpoints, there's still a lot of risk that SFP doesn't get FDA approved. I would expect the stock would react favorably though if the study results are positive - so if you're trading on the hope of positive results....
    Jun 28, 2013. 02:33 PM | Likes Like |Link to Comment
  • Rockwell Steadies Itself For A Phase III Run-Up [View article]
    Yes, link below to the Ph IIb results.

    http://1.usa.gov/16Eivw3
    Jun 28, 2013. 08:43 AM | Likes Like |Link to Comment
  • Rockwell Steadies Itself For A Phase III Run-Up [View article]
    Bite you're right about the cc. According to clinicaltrials.gov the primary endpoint was never changed (still is mean change from baseline). There's a secondary endpoint that's decrease in Hgb of >/= 1.0.

    http://1.usa.gov/1cqxmvj

    http://1.usa.gov/1cqxmvn
    Jun 27, 2013. 10:28 AM | Likes Like |Link to Comment
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