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  • FluoroPharma Medical, Inc. (FPMI) Product Commercialization Plans

    FluoroPharma, a developer of specialized molecular imaging pharmaceuticals used with positron emission tomography (PET) to help detect heart disease and other problems, has stated that it intends to develop its products through the completion of phase II and/or phase III studies, at which point it will seek to partner with organizations that may facilitate the further development and distribution of its products.

    Phase I clinical trials have already been completed on the company's two lead products, CardioPET and BFPET, with pre-clinical trials completed for VasoPET, all related to cardiovascular disease (CAD) detection. The company's AZPET product for detecting amyloid deposits in the brain for Alzheimer's disease evaluation is currently in the development stage. Over 12 million patients in the U.S. alone have some degree of acute or chronic CAD, and millions of patients undergo molecular imaging studies every year, often to detect and evaluate such heart disease.

    Assuming CardioPET and BFPET are approved, their competition will be the current standard of care, and companies that are engaged in the development and commercialization of novel cardiac perfusion agents. However, FluoroPharma says it does not see competition coming from specific competitors for CardioPET and to some degree for BFPET. FluoroPharma's technologies will be competing mainly on an indication-by-indication basis with the existing or coming standards of care.

    FluoroPharma believes current experimental imaging agents are limited by their short half-lives (generally less than ½ hour), requiring faster image collection and/or an on-site cyclotron or generator to provide an additional supply. For this reason, they believe that these agents represent little or no potential competition to FluoroPharma products. In contrast, the imaging agent used in FluoroPharma products has a 110-minute half-life, and is more amenable to regional production and distribution to off-site nuclear medicine centers.

    For more information, see the company website at FluoroPharma.com

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net

    May 24 1:42 PM | Link | Comment!
  • InspireMD, Inc. (NSPR) Completes Enrollment In Acute Myocardial Infarctions Study

    Medical device maker InspireMD said this morning that it has completed enrollment in its MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial testing its stent platform technology for use in patients with Acute Myocardial Infarctions. The completion of enrollment has been achieved one month ahead of schedule, according to the company.

    The MASTER Trial is a multinational randomized controlled trial being conducted in 50 centers across nine countries (Germany, Hungary, Israel, Poland, Czech Republic, France, Ireland, Brazil, and South Africa) designed to evaluate the MGuard™ and MGuard Prime Coronary Stents compared with the standard of care, bare metal stents (BMS), or drug eluting stents (DES) for acute ST-elevation myocardial infarction (STEMI) patients. The trial has enrolled 432 patients in a two-arm, parallel design study.

    The primary endpoint is complete ST segment resolution. Clinical follow-up will continue for one year and important secondary endpoints such as TIMI (Thrombolysis In Myocardial Infarction) flow, MBG (Myocardial Blush Grade) and MACE (Major Adverse Cardiac Events) will be measured. Sub-studies include infarct size measured by cardiac MRI, as well as restenosis by invasive angiographic follow-up at 13 months.

    The company is on track to release preliminary top line results in the third quarter of 2012.

    One week ago, the InspireMD reported positive three-year results from the extended follow-up MAGICAL trial, a prospective, single arm, multi-center study conducted in 2008-09 that enrolled 60 STEMI patients, at a company-sponsored symposium at the EuroPCR conference in Paris. In that report, the company detailed that the safety and efficacy of MGuard™ observed in the trial were maintained for three years.

    Shares of the Tel Aviv, Israel-based healthcare company are continuing to search for a bottom. Trading near $3 one year ago, share value has slipped as low as 60 cents recently. A modest rise occurred in early trading today, with shares climbing 7.14% to 75 cents on today's news.

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net

    Tags: NSPR.OB
    May 24 1:41 PM | Link | Comment!
  • 2012 Vehicle Satisfaction Awards Announced By Autobytel, Inc. (ABTL) And AutoPacific

    Autobytel is an online leader offering consumer purchase requests and resources to auto dealers and manufacturers. The company also provides consumers with the information they need to purchase new and used vehicles.

    Today, the company and AutoPacific, an automotive marketing research and product consulting firm, announced the 16th annual Vehicle Satisfaction Awards. Based on the largest single-model year survey of vehicle owners, the Awards are designed to help consumers make informed vehicle purchase decisions with a true "word-of-mouth" survey.

    More than 75,000 vehicle owners across all major manufacturers took part in the survey. New vehicle owners provide input on 48 individual attributes that objectively measure the ownership experience. Some of the attributes covered by the survey include power and acceleration, interior and exterior styling, cargo capacity, quietness of the vehicle, the ease of getting in and out of the car, and driver's seat comfort.

    The survey seems to indicate that overall drivers are satisfied with the autos they purchased. The president of AutoPacific, George Peterson, summed up the survey results. He said, "In today's market, it's difficult to find a low-quality vehicle. The quality of vehicles from all manufacturers has risen to the highest level in history."

    For specific survey results and more information about the company, please visit Autobytel's website at autobytel.com

    Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net

    Tags: ABTL
    May 24 1:40 PM | Link | Comment!
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