Boston Scientific Reports Strong Performance Data for SYNERGY Stent System; Provectus Biopharmaceuticals Refutes Inaccuracies in Seeking Alpha Article Print E-mail
By Staff and Wire Reports   
Wednesday, 21 May 2014 18:58
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 21, 2014.
Boston Scientific Corporation (NYSE: BSX) reported positive three-year follow-up data for the EVOLVE clinical trial, comparing the safety and performance of the SYNERGY™ Everolimus-Eluting Bioabsorbable Polymer Platinum Chromium (PtCr) Coronary Stent System to the PROMUS Element™ Stent System.

The data were presented today at EuroPCR 2014 by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.  The primary clinical and angiographic endpoints of this non-inferiority study have already been published.

"The SYNERGY Stent three-year results from the EVOLVE trial continue to show promise with respect to safety and efficacy," said Meredith.  "Target lesion revascularization remains very low, at a rate of 1.1 percent, while there is no stent thrombosis in the SYNERGY full-dose arm at three years.  The EVOLVE clinical data support the hypothesis that this novel bioabsorbable polymer stent technology could allow for improved healing over durable polymer DES."

Boston Scientific has expanded its commercial launch of the SYNERGY Stent System in Europe and in select markets in Asia.  It features an ultrathin abluminal bioabsorbable drug/polymer coating technology which eliminates long-term polymer exposure.  In addition to reducing restenosis, the SYNERGY Stent System may also offer faster and more complete vessel healing after stent implantation, potentially reducing the duration of post-procedure dual antiplatelet therapy.

"The SYNERGY Stent System underscores our ongoing commitment to delivering meaningful innovation to the interventional cardiology community and is expected to reinforce our position as a global leader in medical devices," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific.  "The SYNERGY Stent System is uniquely designed to provide exceptional outcomes in complex cases by promoting early healing and eliminating long-term polymer exposure.

The SYNERGY Stent System is supported by a rigorous clinical program.  Beyond the EVOLVE Study three-year results, the EVOLVE II Clinical Trial, which completed enrollment in August 2013, is the pivotal trial designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the SYNERGY Stent System.  EVOLVE II is a global, multicenter, randomized, controlled pivotal trial that enrolled 1,684 patients in 125 sites worldwide, including the U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore.  Additional studies to assess outcomes, including the potential for reduced dual antiplatelet therapy, will be supported by Boston Scientific.  The SYNERGY Stent System is being investigated in multiple independent, real-world studies across the spectrum of cardiovascular disease complexity.  For more information on the SYNERGY Stent System Clinical Program, click here .

The SYNERGY Stent System is an investigational device in the U.S. and Japan, and is not available for sale in those countries.



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 It has come to the attention of Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT), a development-stage oncology and dermatology biopharmaceutical company, that an article was published on seekingalpha.com on May 21, 2104, which contains numerous inaccuracies and misstatements about the Company. Without attempting to address every false statement and inaccuracy contained in the article, the Company wishes to address some of the misinformation with the following facts:

  • The article alleges that the Company's oncology drug PV-10 "appears to have failed their Breakthrough Therapy Designation." This statement is completely false. The FDA has not reported back to the Company with respect to the Company's application for Breakthrough Therapy Designation.
  • The article indicates that Provectus is "connected to questionable stock pumpers promoting PVCT including Small-Cap Street LLC." To the contrary, Provectus is not connected in any way to Small-Cap Street LLC or any other similar promoter.
  • The article indicates that Provectus's patents begin expiring in 2016. In actuality, the most important patent with respect to PV-10 does not expire until 2031, and of the eight patents that expire in 2016, none of the patents relate to PV-10; seven of the patents relate to medical devices and one relates to dermatology.
  • The article's summary concludes by saying "PVCT appears extraordinarily overvalued with ~$750 MILLION fully diluted valuation. I believe fair value is closer to $0 and outline why in this report." Because the article is based on numerous inaccuracies, this "belief" is unfounded.

The legitimacy of any article authored by a pseudonym has to be questioned. The Company is at a loss as to why individuals would be attempting to disparage the Company, but the Company will continue to proceed with our business and plans as we have in the past.



Also Wednesday:


Abiomed, Inc. (Nasdaq:ABMD)
, a leading provider of breakthrough heart support technologies, today announced it has received approval for implementation of a Continuous Access Protocol (CAP) from the Food & Drug Administration (FDA) for RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella® RP (Right Peripheral) System.

Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO)
, an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces its consolidated financial results for the fourth quarter and fiscal year ended February 28, 2014.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
, a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, today announced that Chief Executive Officer Bob Palay will present at the Jefferies 2014 Global Healthcare Conference to be held in New York from June 2 - 5, 2014.

Hemp, Inc. (OTC:HEMP)
today announced first-quarter 2014 sales revenue of $5,490,874 resulting in a net income for the quarter of $2,606,782, surpassing previous high marks for revenue, in any one quarter, since inception.

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products announced it has secured an exclusive field of use license for the patent properties covering various uses of a plant endophyte from Brookhaven Science Associates, LLC., (BSA) manager/operator of Brookhaven National Laboratory under contract with the U.S. Department of Energy.

Nymox Pharmaceutical Corporation (Nasdaq:NYMX)
is pleased to report new positive data confirming the advantageous side effect profile of the Company's lead compound NX-1207.

Ocera Therapeutics (Nasdaq:OCRX)
, a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, announced today that company management plans to present at the Jefferies 2014 Global Healthcare Conference.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, today announced that its management is scheduled to participate in the Jefferies 2014 Global Healthcare Conference in New York.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP)
announced today that Rick Matros, the Company's Chairman and Chief Executive Officer, Harold Andrews, the Company's Chief Financial Officer, and Talya Nevo-Hacohen, the Company's Chief Investment Officer, will be participating in the NAREIT REITWeek Conference June 3-5, 2014.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
announced today that its Chief Executive Officer, Elias Vamvakas, will participate in the 11th Annual Craig-Hallum Institutional Investor Conference on Wednesday, May 28, 2014.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, announced that recent advances in its clinical programs were presented at the 17th Annual Meeting of the American Society of Gene and Cell Therapy, which is taking place in in Washington, DC, May 21 to 24.



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