FDA Approvals, Commercialization, and Ongoing Clinical Trials - Research Report on Medtronic, Hologic, St. Jude, OPKO, and Wright Editor Note: For more information about this release, please scroll to bottom. PR Newswire NEW YORK, August 20, 2013 NEW YORK, August 20, 2013 /PRNewswire/ -- Today, Analysts' Corner announced new research reports highlighting Medtronic, Inc. (NYSE: MDT), Hologic, Inc. (NASDAQ: HOLX), St. Jude Medical, Inc. (NYSE: STJ), OPKO Health, Inc. (NYSE: OPK), and Wright Medical Group, Inc. (NASDAQ: WMGI). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below. Medtronic, Inc. Research Report On August 15, 2013, Medtronic, Inc. (Medtronic) announced that it has submitted its first pre-market approval (PMA) module to the US FDA for the IN.PACT Admiral drug-eluting balloon for treatment of atherosclerotic lesions in the superficial femoral artery (SFA). Tony Semedo, President of Endovascular Therapies business at Medtronic said, "Pending FDA approval, we remain on track to launch the IN.PACT Admiral drug-eluting balloon in the United States during the second half calendar year 2015." According to the Company, the PMA application for the IN.PACT Admiral drug-eluting balloon will include clinical data from the IN.PACT SFA I and SFA II pivotal studies, the IN.PACT SFA II pharmacokinetics (PK) study, and the IN.PACT Global study, which have data of more than 1,000 enrolled patients. The Full Research Report on Medtronic, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/bc94_MDT] -- Hologic, Inc. Research Report On August 8, 2013, Hologic, Inc. (Hologic) announced that it has commenced commercialization of Horizon - a totally redesigned DXA imaging system for the assessment of three critical health problems - osteoporosis, cardiovascular disease, and obesity. The Company stated that the Horizon platform offers extended technical capabilities, workflow efficiencies and better design components in order to meet current and future clinician needs. Hologic also informed that Horizon is being launched in the US and other countries. John Jenkins, Vice President of Marketing for Specialty Imaging Products at Hologic said, "We expect the technical advancements built into our Horizon platform will set a new standard for image quality and operational efficiency." The Full Research Report on Hologic, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/d132_HOLX] -- St. Jude Medical, Inc. Research Report On August 15, 2013, St. Jude Medical, Inc. (St. Jude) announced that it has received US FDA approval and conducted first use of MediGuide Enabled Ablation Catheters for treatment of specific irregular heartbeats. The Company claimed that MediGuide technology is the first and only system that can reduce the duration of radiation exposure during catheter ablation procedures thus expanding the innovative MediGuide platform for St. Jude. St. Jude stated that ablation catheters are used to create lesions during cardiac ablation procedures while treating atrial flutter - a heart rhythm disorder. Dr. Chun Hwang, Director Cardiac Electrophysiology from Utah Valley Regional Medical Center said, "We are exposed to radiation multiple times a day, which adds up quickly. Reducing the exposure time to radiation is a huge benefit for everyone in the EP lab." The Full Research Report on St. Jude Medical, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/b338_STJ] -- OPKO Health, Inc. Research Report On August 15, 2013, OPKO Health, Inc. (OPKO) announced that it has crossed 50% enrollment in the second phase 3 trial of Rayaldy to treat patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD), and vitamin D insufficiency. According to OPKO, the endpoints of both the parallel conducted studies include vitamin D status and changes in serum calcium, serum phosphorus and plasma intact parathyroid hormone (PTH). Phillip Frost, M.D., Chairman and CEO OPKO said, "I am pleased to report that these pivotal trials with Rayaldy Capsules are progressing as planned toward completion in the first half of 2014. Top-line data are expected in mid-2014. We believe Rayaldy will prove to be superior to high monthly doses of prescription vitamin D, a common therapeutic approach which has been shown unreliable in correcting vitamin D insufficiency in patients with chronic kidney disease and generally ineffective in controlling elevated levels of parathyroid hormone." The Full Research Report on OPKO Health, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/cd43_OPK] -- Wright Medical Group, Inc. Research Report On August 8, 2013, Wright Medical Group, Inc. (Wright) announced that it has received a not approvable letter from the FDA in response to its PMA application for Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. According to Wright, in the letter FDA stated that it is "concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft." Commenting further in its letter, FDA added it believes that "it will be necessary to perform a new clinical study that evaluates the use of Augment Bone Graft as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted." Robert Palmisano, President and CEO of Wright, commented, "This is not what we expected, as we believed that all of the FDA's concerns as outlined in their previous not approvable letter from December 2011 had been fully and thoroughly addressed in the PMA amendment that BioMimetic submitted in June 2012. We are continuing to study the FDA's position and expect we will work collaboratively with the agency to determine an appropriate path forward." The Full Research Report on Wright Medical Group, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/1782_WMGI] ---- EDITOR NOTES: 1.This is not company news. We are an independent source and our views do not reflect the companies mentioned. 2.Information in this release is fact checked and produced on a best efforts basis and reviewed by a CFA. However, we are only human and are prone to make mistakes. 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NO WARRANTY OR LIABILITY ASSUMED Equity News Network is not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted by Equity News Network whatsoever for any direct, indirect or consequential loss arising from the use of this document. Equity News Network expressly disclaims any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Equity News Network does not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. AnalystsCorner.com SOURCE Analysts' Corner Contact: Joe Thomas CONTACT PHONE: +1-310-496-8071 (North America)
FDA Approvals, Commercialization, and Ongoing Clinical Trials - Research Report on Medtronic, Hologic, St. Jude, OPKO, and
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