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Semler Scientific Looks To Revolutionize PAD Diagnosis
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Righting The Ship At CryoPort
- Put Corgenix On Your Radar
- BioLife Solutions Posts Another Record Year With Revenue Up 58%
- Scrutiny Over Medical Device Safety Offers Opportunity For VeriTeQ
- Several Catalysts To Reignite Growth At LED Medical
- Zecotek, A Potential Big Winner In PET Scanner Space
- OptimizeRx CEO Resignation A Non-Event
- Pharma Bio-Serv Is Low-Risk And Trading Cheap
- PST Launch, A New Inflection Point For Interleukin Genetics
- CryoPort's Game-Changer In Frozen Biological Shipping
- Sanuwave: DermaPACE Could Be Very Competitive In $2B Diabetic Foot Ulcer Market
- Competitive Advantages, Huge Skin Cancer Market Bode Well For Aura
- OptimizeRx's SampleMD Revolutionizing Prescription Drug Sampling
- BioLife Has More Room To Run
- VolitionRx Could Be A Game Changer In Cancer Detection