Spectranetics Announces FDA Clearance for Mechanical Lead Extraction Devices; Celladon Receives Breakthrough Therapy Designation for MYDICAR Print E-mail
By Staff and Wire Reports   
Thursday, 10 April 2014 20:01
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 10, 2014.
The Spectranetics Corporation (Nasdaq: SPNC) announced FDA clearance of two new mechanical lead extraction platforms that expand physicians' options for safe removal of cardiac leads. Each incorporates innovative designs for mechanical extraction aimed at providing total lead management solutions.

The TightRail™ rotating mechanical sheath platform combines unprecedented shaft flexibility and column strength to help physicians safely navigate the vasculature during cardiac lead extraction procedures. An advanced forward-facing dilating blade remains shielded until activated. The tip feature rotates in both directions for efficient dilation. The physician controls when the blade is exposed, for procedural safety.

The SightRail™ manual dilator sheath platform features visual indicators that show bevel orientation and tip alignment, supplementing fluoroscopy as a means to determine position and orientation. A longer inner sheath gives physicians improved ability to grip and manipulate the device, especially when advancing and rotating. The SightRail sheath set has also received CE mark approval for use in Europe.

These new platforms represent Spectranetics' entry into the mechanical extraction device market and complement the laser-based technology that established the company's leading position in lead extraction.

Charles Love, M.D., Professor of Medicine and Director of Cardiac Rhythm Device Services at New York University Langone Medical Center, has been performing extractions since 1988. "In my experience, removing cardiac leads requires skill, patience and the right tools," said Love.

"Identifying bevel orientation can be challenging with fluoroscopy alone, so the visual direction offered by the SightRail sheath helps ensure proper sheath positioning and tip orientation when working in the superior vena cava (SVC)."

Love pointed out the utility of the TightRail mechanical sheath in aligning with the curves and bends characteristic of the SVC. "Leads rarely take a straight course through the vasculature," he said. "Having a flexible sheath that follows the curvature of the lead and maintains alignment with the lead is critical to successful extraction."

Spectranetics CEO Scott Drake sees the next-generation mechanical extraction devices as a welcome addition to the company's portfolio of lead extraction solutions. "Physicians consistently emphasize the need for the right tool at the right time for lead management. By providing a broader range of clinical solutions, our goal is to continue to enable safe, predictable outcomes in lead management," said Drake. "Our confidence in the long-term strength of this business continues to be driven by the launch of our mechanical tools portfolio and increasing contribution from our sales force expansion."

There are over seven million implanted cardiac devices globally. Each year, about 750,000 additional patients are implanted with these devices worldwide, translating to 1.5 million leads. It is estimated that in 2014, roughly 400,000 patients will meet indications for a lead extraction procedure.



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Celladon Corporation (Nasdaq: CLDN),
a clinical-stage biotechnology company developing novel therapies for patients with heart failure and other diseases characterized by SERCA enzyme deficiencies, today announced that its lead product candidate, MYDICAR®, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for reducing hospitalizations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative. This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions and where preliminary clinical evidence suggests it provides a substantial improvement over existing therapies. Celladon is developing MYDICAR as a novel, first-in-class therapy for patients with chronic heart failure due to systolic dysfunction. MYDICAR uses genetic enzyme replacement therapy to correct the deficiency in the enzyme SERCA2a, which is an enzyme that becomes deficient in heart failure patients and results in inadequate pumping of the heart. Celladon has developed a companion diagnostic to identify the patients who are AAV1 NAb negative and therefore eligible for MYDICAR treatment.

"We are looking forward to working with the senior staff at the FDA to determine the most expeditious path to bring MYDICAR to patients with advanced heart failure. This breakthrough therapy designation validates MYDICAR's unique characteristics and clinical data to date and underscores the urgent need for new treatments for heart failure," said Krisztina Zsebo, Ph.D., president and CEO of Celladon. "MYDICAR has the potential to provide transformative disease-modifying effects with long-term benefits in heart failure patients with a single administration. Our goal is to bring MYDICAR to market as quickly as possible in the United States, where we estimate approximately 350,000 heart failure patients with currently limited remaining treatment options could be eligible for therapy."

Celladon is currently evaluating MYDICAR in the Phase 2b CUPID 2 trial to determine its efficacy in reducing the frequency of and/or delaying heart failure-related hospitalizations. This randomized, double-blind, placebo-controlled, multinational trial is evaluating a single intracoronary infusion of MYDICAR versus placebo added to a maximal, optimized heart failure regimen in patients with NYHA class III or IV symptoms of chronic heart failure due to systolic dysfunction. Patient enrollment has been completed and 250 patients have been randomized in this trial. The Company expects to report results in April 2015.



Also Thursday:



Abiomed, Inc. (Nasdaq:ABMD)
announced today that on Thursday, May 1, 2014, the Company will release financial results for the fourth quarter of fiscal 2014.

Accuray Incorporated (Nasdaq:ARAY)
announced today that it will report results for its third quarter of fiscal 2014, ended March 31, 2014 on Wednesday, April 30, 2014 after the market closes.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, today announced that it has submitted a protocol to the FDA for a Phase IIb clinical trial for its MDX product candidate for the treatment of patients with Fragile X Syndrome.

American CryoStem Corporation (OTCQB:CRYO)
, a biotechnology developer, marketer and licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today announced that the Company has filed its first jointly-owned patent application with its research partners at Rutgers University titled, "Nanoparticle-Mediated Synthetic Transcription Factor for Enhanced Gene Regulation and Cell Differentiation."

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, and Phoebe Physician Group today announced that Phoebe has selected the athenaOne® suite of EHR, integrated revenue cycle management, and patient portal services for use across its growing network of employed physicians.

Baxano Surgical, Inc. (Nasdaq:BAXS)
, a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that it has received U.S. Food and Drug Administration 510(k) clearance (k133743) of its Avance™ MIS Pedicle Screw System, which may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced that the Company is a sponsor of the BioNJ International BioPartnering Conference where Panna Sharma will be moderating a panel on the topic of "Partnering for a Balanced Portfolio: Perspectives from Innovators, Partners, and Payers" today Thursday, April 10, 2014 at the Westin Princeton at Forrestal Village.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company developing novel therapies for patients with heart failure and other diseases characterized by SERCA enzyme deficiencies, today announced that its lead product candidate, MYDICAR®, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for reducing hospitalizations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative.

Cerulean Pharma Inc. (Nasdaq:CERU)
today announced the pricing of its initial public offering of 8,500,000 shares of its common stock at a public offering price of $7.00 per share, before underwriting discounts.

Coronado Biosciences, Inc. (Nasdaq:CNDO)
today announced that an Investigator-Initiated Study evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of pediatric patients with autism spectrum disorder (ASD) has initiated.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, announced that independent investigators reported non-clinical data supporting the combination potential of Cyclacel's oral sapacitabine with Bcr-Abl inhibitors, including imatinib and ponatinib, in chronic myeloid leukemia (CML) cell lines.

DS Healthcare Group, Inc. (NASDAQ:DSKX)
, a leading developer of personal care products, today announced it has signed a distribution agreement with Drogaria Iguatemi, the leading high-end retail drug store chain in Sao Paulo, Brazil.

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, announced its participation at the European Association of Urology (EAU) 2014 Annual Congress that will be held in Stockholm on April 11-15, 2014.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced today that Kessler Foundation, a global leader in rehabilitation research, has purchased a second exoskeleton, the Ekso GT, to be used in a new study examining the effectiveness of wearable robots for neuro-rehabilitation and gait training.

Fate Therapeutics, Inc. (Nasdaq:FATE),
a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that the U.S. Patent and Trademark Office (PTO) has issued Patent No. 8,691,573 entitled "Stem Cell Cultures."

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that Dr. David M. Goldenberg, Founder and Chairman of the Board, and Cynthia L. Sullivan, President and Chief Executive Officer, will ring the Opening Bell at the NASDAQ MarketSite in Times Square, New York City, on Wednesday, April 23, 2014, in honor of the Company's 30-year uninterrupted listing on the NASDAQ Stock Market.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 23 new employees.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
, announced today that it will release its first quarter 2014 financial results on April 29, 2014, after the market close.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, reported today that it has signed a Master Services Agreement with ViruSure GmbH, located in Vienna, Austria, to develop and maintain Master, Working and End of Production Cell Banks.

The Spectranetics Corporation (Nasdaq:SPNC)
today announced FDA clearance of two new mechanical lead extraction platforms that expand physicians' options for safe removal of cardiac leads.

Urologix®, Inc. (OTCQB:ULGX)
, the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today announced a strategic restructuring of its organizational infrastructure and reported preliminary financial results for its fiscal year 2014 third quarter ended March 31, 2014.

Vitacost.com, Inc. (Nasdaq:VITC)
, a leading online retailer of healthy living products, announced today that it has rebranded and expanded its line of private label health food products, replacing its "Best of All" label with the Vitacost brand.



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