Medtronic Receives FDA Approval For Advisa MRI Pacemaker System; Peregrine Reports Results from Phase 2 Trial of Bavituximab Print E-mail
By Staff and Wire Reports   
Wednesday, 13 February 2013 18:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 13, 2013.

Showcasing its leadership position in pacing technologies, Medtronic, Inc. (NYSE: MDT) announced the U.S. FDA approval and U.S. launch of its Advisa DR MRI(TM) SureScan®  pacing system. The Advisa MRI system is Medtronic's second-generation MR-Conditional pacemaker and is the first system to combine the most advanced pacing technology with proven MRI access.

MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound or CT scans, and is critical for early detection, diagnosis and treatment. Advisa MRI was specifically tested and approved for use as labeled with MRI scanners in the U.S. Of the 156 patients scanned in the Advisa MRI Clinical Trial, none showed any MRI-related complications.  The new system includes an Advisa MRI device and two CapSureFix MRI^(TM) SureScan® leads, which must be used together.

"Your physician can implant a pacemaker with advanced options that will allow for broad access to MRI scanning," said Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tenn. "MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning often prevent the patient from having an MRI when they need it. With more than 85 percent of pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may be needed, it's key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure."

The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI environment is supported by clinical studies and extensive computer modeling, as well as real-world data. To date, more than 100,000 Medtronic SureScan devices have been sold worldwide; and, in the U.S., it is estimated that more than 10 percent of patients with SureScan pacing systems have received MRIs. These patients received Medtronic's first-generation Revo MRI® SureScan® pacing system, which was the only FDA approved (February 2011) MR-Conditional pacemaker in the U.S. before the Advisa MRI system.

Until the availability of Medtronic's SureScan pacing systems, patients with pacemakers in the U.S. have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function. According to published literature, up to 75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.


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Peregrine Pharmaceuticals (NASDAQ: PPHM)
announced results from its 70 patient open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression.

Results showed that the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). In the trial, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).

The pancreatic cancer trial is a randomized, open-label Phase II trial evaluating bavituximab with gemcitabine versus gemcitabine alone in up to 70 patients with previously untreated stage IV pancreatic cancer. The trial allowed the enrollment of patients 18 and older without any age limit, distant organ involvement and ECOG performance status of 0-2. In this trial, bavituximab was generally safe and well tolerated in combination with gemcitabine with similar adverse events occurring in both arms.



Also Wednesday:



Aldrich Corporation (NASDAQ:  SIAL)
, a leading Life Science and High Technology company (the "Company"), announced an increase of 7.5% in its quarterly cash dividend to $0.215 per share.

AMRI (NASDAQ: AMRI)
and Codexis (NASDAQ: CDXS) announced today that they have entered into a SMARTSOURCING™ partnership.

AVEO Oncology (NASDAQ: AVEO)
today reported consolidated 2012 financial results and reviewed key recent accomplishments.

Avita Medical Ltd.--Regenerative medicine company Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY) today announced that it has received formal notification of successful completion of the annual ISO Quality Recertification Audit conducted 8-9 January 2013.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, announced today that the Company will host a conference call on Wednesday, March 6th, at 4:30 p.m. Eastern Standard Time to discuss its operating results for the fourth quarter and year ended December 31, 2012, and to answer questions.

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, announced today that it has closed its previously announced direct placement to leading healthcare investor, OrbiMed Israel Partners Limited Partnership, an affiliate of OrbiMed Advisors LLC (“OrbiMed”).

BioMed Realty Trust, Inc. (NYSE: BMR)
today announced the pricing of its public offering of 12,700,000 shares of its common stock at $20.50 per share.

BrainStorm Cell Therapeutics (OTC.QB: BCLI)
, a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that it will be presenting at the 8th Annual New York Stem Cell Summit on Tuesday, February 19th at 2:00 pm EST.

CryoLife, Inc. (NYSE: CRY)
, a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that its Board of Directors has approved a quarterly cash dividend for the first quarter 2013 of $0.025 per share of common stock outstanding.

DHS Holding, Co. (PINKSHEETS: DHSM)
announced today that after months of software development, it is now ready to launch SalesKing.com with its new business-networking platform.

Discovery Laboratories, Inc. (NASDAQ: DSCO)
, a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that it has entered into a secured loan facility with Deerfield Management Company, L.P. (Deerfield) for up to $30.0 million in financing.

GTx, Inc. (NASDAQ: GTXI)
announced today that new data from two Phase II studies on the effects of Capesaris® (GTx-758), a selective estrogen receptor alpha agonist, for the treatment of advanced prostate cancer, will be detailed in presentations given by lead author, Evan Yu, MD, Associate Professor of Medicine, Fred Hutchinson Cancer Research Center, Seattle, Washington on February 14 and 15, at the 2013 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancer Symposium in Orlando, Florida.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that it will release its financial and operating results for the fourth quarter and full year ended December 31, 2012 after market close on Wednesday, February 27, 2013.

HASCO Medical, Inc. (OTCQB: HASC)
, www.HascoMed.com, a Company that conducts sales of handicap accessible vans, parts, service and rental operations in sixteen locations from Maine to Florida and sales of medical equipment and supplies in Alabama, Florida and Mississippi, announced today their fourth quarter and 2012 sales results.

Lpath, Inc. (NASDAQ: LPTN)
, the industry leader in bioactive lipid-targeted therapeutics, has promoted Leigh Hsu, Ph.D., to the new position of vice president of corporate development.

MDxHealth SA (NYSE Euronext: MDXH)
, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support the diagnosis and treatment of cancer patients, today announced that the company will present results from two important studies involving its ConfirmMDx™ for Prostate Cancer test at the ASCO Genitourinary Cancers Symposium 2013, February 14-16, Orlando, Florida, USA.

Merus Labs International Inc. (TSX:MSL) (NASDAQ:MSLI)
is pleased to announce today its financial results for the first quarter of fiscal 2013.

Nanosphere, Inc. (NASDAQ: NSPH)
, The company, a leader in the development and commercialization of advanced molecular diagnostics systems, today reported financial results for the fourth quarter and full year ended December 31, 2012.

Nektar Therapeutics (NASDAQ: NKTR)
will announce its financial results for the fourth quarter and year-ended December 31, 2012 on Thursday, February 28, 2013, after the close of U.S.-based financial markets.

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP)
announced today that it will report its 2012 financial results on Thursday, February 21, 2013 at approximately 4:00 p.m. ET.

OnPoint Medical Diagnostics (OTCQB: ONMD)
today released results from its first customer satisfaction survey which was distributed to all active users of its MRI Quality Assurance (QA) software.

PROLOR Biotech, Inc. (NYSE MKT: PBTH)
today announced that the European Commission and the European Medicines Agency (EMA) have granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone in development for the treatment of growth hormone deficiency.

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA)
today announced it has entered into a master collaboration agreement with Eli Lilly and Company (NYSE: LLY) for the development and commercialization of companion diagnostics for pairing with Lilly investigational and approved medicines across all therapeutic areas.

Sigma-Aldrich Corporation (NASDAQ:  SIAL)
, a leading Life Science and High Technology company (the "Company"), announced an increase of 7.5% in its quarterly cash dividend to $0.215 per share.

Sigma-Aldrich®Corporation (NASDAQ: SIAL)
today announced that Sigma Life Science, its innovative biological products and services business, through an exclusive collaboration with Drs. Hideo Iba and Takeshi Haraguchi at the University of Tokyo, released MISSION®Synthetic and Lentiviral microRNA Inhibitors based upon the Tough Decoy (TuD) design for the long-term suppression of any miRNA endogenous to humans or mice.



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