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Brian Marckx, CFA

 
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  • Semler Scientific Looks To Revolutionize PAD Diagnosis
     • Thu, Jan. 8 SMLR 5 Comments

    Summary

    • Flagship product, FloChec, is a novel device for diagnosis of peripheral artery disease (PAD).
    • PAD is common in elderly population yet vastly underdiagnosed which appears to be a result of a lack of appropriate screening methods in primary care setting.
    • Flochec looks to be filling this void. Demand has been robust since its introduction in early 2011.
    • Semler exploiting shift in reimbursement from pay-for-service to pay-for-performance, particularly with Medicare Advantage plans.
    • Licensing, versus outright sales, revenue model affords lower operational risk and beefy gross margins.
  • The Viveve System Offers Better Alternative To Treat Vaginal Laxity
    Nov. 19, 2014 VIVMF Comment!

    Summary

    • Vaginal laxity is the most common physical change in women following childbirth and one that roughly 50% of women that have undergone normal vaginal delivery hold as a concern.
    • The most common methods to address vaginal laxity have significant drawbacks and include surgery, which is invasive and costly, and pelvic floor exercises such as Kegels, which often lack effectiveness.
    • Clinical studies have shown that the Viveve treatment was able to restore vaginal tightness to pre-childbirth levels in 100% of patients with statistically significant efficacy.
    • A sham-controlled study is about to commence with interim results expected in Q2 2015.
    • This marketing study, along with data from previous studies, is expected to help accelerate the roll-out of the Viveve System.
  • New Positive Clinical Data Supports Quest Towards Orphan Designations
       • Oct. 17, 2014 MDGN 1 Comment

    Summary

    • We view the new clinical data as highly promising.
    • 2nd-Gen viral vector showing more controlled delivery and longer duration of effect.
    • MDGN reveals three orphan targets, two of which could enter clinical trials in 2015.
  • LED Medical Poised To Capitalize On Growth Of Dental Digital Imaging Market
       • Sep. 26, 2014 LEDIF 1 Comment

    Summary

    • New management recently brought on to revive revenue growth.
    • Substantive changes already made including new distribution model for proprietary VELscope device and new subsidiary, LED Imaging, which is focused on products for dental imaging.
    • Management recently announced 2014 revenue guidance of at least 260% growth as fruits of new strategy are already being realized.
  • Attractive Entry Point As Biomerica Returns To Growth And Is Still Trading Cheap
    Sep. 5, 2014 BMRA 1 Comment

    Summary

    • Biomerica has been profitable eleven of the last fourteen quarters, has fairly regularly generated positive cash flow, and maintains a solid balance sheet.
    • Revenue growth had recently softened due to switch in Asian distributors but is bouncing back as new distributor gains traction.
    • We see several catalysts to drive revenue into fiscal 2015.
    • BMRA continues to trade very cheap at barely higher than book value. We see this as an attractive entry point.
  • Tiny Tribute Getting Bigger And Warranting More Attention
    Aug. 29, 2014 TBUFF 2 Comments

    Summary

    • Tribute has been overlooked and under-appreciated. Company has been aggressively in-licensing as they build out their product portfolio.
    • Recent big winner has been CAMBIA which has sparked double-digit revenue growth.
    • Company continues to look to add to growth drivers. Recent $30M capital raise will help facilitate this.
    • Recent investments in sales/marketing paying off on both the top and bottom lines.
    • As revenue and profitability continue to improve, we expect Tribute will command more attention from investors and warrant a higher valuation.
  • CombiMatrix Turns In Another Record Quarter, Stock Remains Undervalued
    Aug. 11, 2014 CBMX 6 Comments

    Summary

    • Another record quarter with fundamentals remaining very strong.
    • Stock price may be reacting negatively to litigation expense. We think investors should focus on strong operational performance.
    • Management continues to deliver on strategy focused on growth of prenatal microarray platform which generates highest revenue per test and holds most potential for long-term growth.
    • Recent investments in sales force and billing/reimbursement department are already paying dividends.
    • We think the stock remains undervalued.
  • Protea Biosciences' LAESI Technology Revolutionizing Mass Spectrometry
       • Aug. 2, 2014 PRGB 1 Comment

    Summary

    • Protea is at the initial stages of the roll-out of its LAESI technology which is used with mass spectrometry and appears to have substantive advantages over traditional ionization methods.
    • Seven units have been sold but expect the placement curve to steepen, facilitated by greater awareness of the technology in medical research and the recent hiring of key sales personnel.
    • Distribution agreement also in place with Waters Corp, additional distribution deals could be penned with other mass spec manufacturers in the near term.
    • Commercialization of the LAESI instruments is being complemented with the company’s molecular information services offerings and collaborations with leading medical institutions and industry partners.
    • These partnerships and collaborations are expected to help build awareness of LAESI and Protea’s capabilities and eventually lead to new product launches and services offerings.
  • Cardiac Surgery Rapidly Evolving As Substantial Opportunity For CytoSorbents
       • Jul. 19, 2014 CTSO 20 Comments

    Summary

    • Cardiac Surgery A New Major Focus for CytoSorbents.
    • Additional Data Supports Use of CytoSorb in Cardiac Surgery.
    • Expect Cardiac Surgery Will Be Initial U.S. Indication.
  • CombiMatrix Exploiting Growth Of Chromosomal Microarray For Prenatal Analysis
       • Jul. 10, 2014 CBMX 15 Comments

    Summary

    • Molecular diagnostics company CBMX has offered a variety of genetic tests for various indications but just recently shifted the majority of its focus for growth on chromosomal microarray analysis.
    • Chromosomal microarray has gained more attention due to two recent NEJM-published studies and a recommendation from an influential trade association supporting its use in prenatal analysis.
    • CBMX is positioning itself to exploit an industry shift away from the current standard testing method towards CMA by expanding distribution, entering into key partnerships and leveraging competitive advantages.
  • LED Medical: Seasoned Executives Positioning Company For Industry Leadership
    Jul. 1, 2014 LEDIF 1 Comment

    Summary

    • LED Medical has strengthened its team with the recent appointments of Dr. David Gane and Lamar Roberts to key executive positions.
    • Gane and Roberts have led the execution of several new partnerships and initiatives for LED Medical.
    • Leadership is quickly evolving LED Medical from a product line manufacturer to a comprehensive supplier of digital imaging technologies to the North American dental market.
  • Medgenics Looking To Exploit Orphan Drug Market With Its Novel Biopump Protein Therapy Technology
       • Jun. 11, 2014 MDGN 4 Comments

    Summary

    • Biopump offers an innovative method of producing and delivering therapeutic proteins or peptides through the use of a patient's own skin.
    • Biopump offers potentially significant advantages over traditional intravenous protein therapy.
    • In September 2013, the company brought on new executive management with a specific goal of accelerating development of the Biopump technology, with a particular emphasis on orphan diseases.
    • Biopump will be further validated in just-commenced Phase I/II trial in treatment of anemia via production and delivery of erythropoietin to patients with chronic kidney disease and end-stage renal disease.
    • Game plan includes in-house development of Biopump for orphan indications and potentially partnering for further development for an ESRD/CKD indication.
  • Favorable Ruling In Markman Hearing Opens Up Options For Zecotek
    May. 15, 2014 ZMSPF 13 Comments

    Summary

    • Markman Hearing - court rules in Zecotek's favor.
    • Zecotek can now move to trial.
    • Stock reacted favorably, but we still see significant upside in the shares.
  • LED Medical: Tepid Results But Substantive Progress Being Made With Turnaround Strategy
       • May. 15, 2014 LEDIF 1 Comment

    Summary

    • New Strategy To Revive Growth Recently Implemented and Showing Early Progress.
    • Recent and Near-Term Financial Results Will Likely Remain Tepid.
    • We Think Strategy Shift Begins To Make More Meaningful Financial Impact Later in 2014.
  • Revenue Hit From Loss Of Manufacturing Customer But Recent Sell-Off Overdone
       • May. 12, 2014 BLFS 7 Comments

    Summary

    • Loss of Contract Manufacturing Customer a Surprise, Results in Big Downward Revisions to Revenue Estimates.
    • But....This Was Very Low Margin and Core Business (High Margin) Is Growing At ~30%.
    • Recent Massive Sell-Off In Stock Is Overdone.
  • Turnaround Strategy Being Implemented At Competitive Technologies
       • Mar. 13, 2014 CTTC 28 Comments

    Summary

    • New CEO brought on board to orchestrate turnaround of ugly historical financial performance.
    • First orders of business; new commercialization strategy and cost-control measures.
    • Seeking FDA approval of flagship product - will be time consuming/costly but could pay big dividends.
    • We think the game plan makes sense but legacy risks remain a big hurdle.
  • iCAD Inc: Expect 2013 Revenue Momentum To Carry Through 2014
       • Feb. 22, 2014 ICAD 1 Comment
  • Righting The Ship At CryoPort
    Editors' Pick • Feb. 21, 2014 CYRX 2 Comments
  • Put Corgenix On Your Radar
       • Feb. 19, 2014 CONX 3 Comments
  • BioLife Solutions Posts Another Record Year With Revenue Up 58%
    Feb. 18, 2014 BLFS 2 Comments
  • Scrutiny Over Medical Device Safety Offers Opportunity For VeriTeQ
    Feb. 14, 2014 VTEQ 6 Comments
  • Several Catalysts To Reignite Growth At LED Medical
       • Jan. 22, 2014 LEDIF 3 Comments
  • Zecotek, A Potential Big Winner In PET Scanner Space
       • Oct. 4, 2013 ZMSPF 3 Comments
  • OptimizeRx CEO Resignation A Non-Event
    Sep. 30, 2013 OPRX 7 Comments
  • Pharma Bio-Serv Is Low-Risk And Trading Cheap
    Sep. 16, 2013 PBSV Comment!
  • PST Launch, A New Inflection Point For Interleukin Genetics
    Editors' Pick • Jun. 21, 2013 ILIU 5 Comments
  • CryoPort's Game-Changer In Frozen Biological Shipping
       • Jun. 18, 2013 CYRX 2 Comments
  • Sanuwave: DermaPACE Could Be Very Competitive In $2B Diabetic Foot Ulcer Market
       • Jun. 12, 2013 SNWV 3 Comments
  • Competitive Advantages, Huge Skin Cancer Market Bode Well For Aura
       • Jun. 5, 2013 VRSEF 14 Comments
  • OptimizeRx's SampleMD Revolutionizing Prescription Drug Sampling
    Editors' Pick • May. 22, 2013 OPRX 3 Comments
  • BioLife Has More Room To Run
    Editors' Pick • May. 17, 2013 BLFS Comment!
  • VolitionRx Could Be A Game Changer In Cancer Detection
    Editors' Pick • May. 9, 2013 VNRX Comment!