Boston Scientific Wins FDA Approval for IntellaTip MiFi XP Ablation Catheter; Incyte Issues Top-Line Results of Phase II PoC Trial of Ruxolitinib Print
By Staff and Wire Reports   
Wednesday, 21 August 2013 19:37
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 21, 2013.

Boston Scientific Corporation (NYSE: BSX) continues to expand its electrophysiology (EP) offerings with U.S. FDA approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath.  These products join the company's growing portfolio of next generation EP tools designed to redefine ablation technology.  Catheter ablation, a procedure in which localized electrical energy is delivered into the heart tissue and is aimed at restoring the continuous normal rhythm, has become a first-line treatment approach for patients with certain kinds of irregular heartbeats.

"The IntellaTip MiFi XP is a unique high resolution catheter which provides information that allows electrophysiologists to pinpoint locations for ablation, a key element needed for success," said Tom McElderry, M.D., director of Electrophysiology, University of Alabama Hospital.  "In my experience with this technology, it proved especially useful in identifying areas of interest for diagnosis and ablation.  This level of high resolution electrogram is something we have never seen before and I believe it will open a whole new array of possibilities in EP."

IntellaTip MiFi XP is indicated for ablation of atrial flutter, an arrhythmia that affects nearly one million people in the United States.  The catheter features sophisticated mini electrodes on the tip designed to provide information about tip location and help clinicians assess lesion maturation and differentiate viable from non-viable tissue.

"Following the recent FDA 510(k) clearance of our novel Rhythmia Mapping System, adding the IntellaTip MiFi XP to our portfolio further reinforces our commitment to redefining ablation and diagnostic tools for the EP physician—especially since the catheter is compatible with the Rhythmia system," said Pete Sommerness, general manager, Electrophysiology, Boston Scientific.  "We believe that the IntellaTip MiFi XP approval, combined with the introduction of our Zurpaz steerable sheath, demonstrates how we are delivering on our promise to provide electrophysiologists with meaningful innovation and complete solutions."

The Zurpaz 8.5F steerable sheath is cleared to gain access to the heart, facilitating placement of catheters for use in a variety of procedures including treatment of atrial flutter, atrial fibrillation and ventricular tachycardia.   With enhanced features, including a soft distal tip, advanced shaft construction and an intuitive ergonomic handle, Zurpaz is designed to help clinicians deliver catheters consistently and safely during electrophysiology procedures.  


Incyte Corporation (Nasdaq: INCY)
announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of ruxolitinib, its oral JAK1 and JAK2 inhibitor, in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer. The hazard ratio (HR) for overall survival (OS) in the intent to treat population was 0.79 (one-sided p=0.12), and in a pre-specified subgroup analysis conducted in patients identified prospectively as most likely to benefit from JAK pathway inhibition, the HR for OS was 0.47 (one-sided p=0.005). Within this subgroup of patients, which represented 50% of the randomized population, 6 month survival in the ruxolitinib arm was 42% vs. 11% for placebo. Durable tumor responses were only observed in patients receiving ruxolitinib, and ruxolitinib treated patients achieved a significant improvement in body weight relative to placebo.

“Results of the RECAP trial provide the first evidence that JAK inhibition is active in this disease and suggest a demonstrable survival benefit in a well-defined group of patients with refractory metastatic pancreatic cancer who can be identified without the development of a companion diagnostic test. Coupled with the overall survival benefit observed in the ongoing Phase III trials in myelofibrosis, these results solidify our belief in the therapeutic opportunity that exists for Jakafi, and provide us with an acceleration strategy to advance our JAK1 inhibitor portfolio into additional areas of unmet medical need,” stated Paul A. Friedman, M.D., Incyte's President and Chief Executive Officer.

Richard S. Levy, Incyte's Executive Vice President and Chief Drug Development and Medical Officer added, “Advanced pancreatic cancer is a devastating disease, and the RECAP study has provided us with a unique opportunity to bring ruxolitinib forward into Phase III development in a population with no attractive treatment options. We look forward to working with the FDA to define the core components of the Phase III program in pancreatic cancer as rapidly as possible, and in parallel, leveraging these results to expand our ruxolitinib and JAK1 inhibitor programs into additional solid tumor populations, including those that may benefit from selective JAK1 inhibition.”

Full results of the RECAP trial are expected to be presented at a future scientific meeting.

Safety -- Ruxolitinib in combination with capecitabine was generally well tolerated in this study. Among patients receiving ruxolitinib plus capecitabine 12% discontinued therapy for an adverse event, compared with 20% who received capecitabine alone. The rates of new onset grade 3 anemia, thrombocytopenia or neutropenia were 16%, 2% and 0%, respectively, among patients receiving ruxolitinib plus capecitabine and were 2%, 3% and 2%, respectively, among patients receiving capecitabine alone.

Also Wednesday:

Abbott (NYSE: ABT)
today announced that it has completed its acquisition of IDEV Technologies, a privately held company focused on developing next-generation medical devices for use by interventional radiologists, vascular surgeons and interventional cardiologists.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, announced today that Dr. Steven C. Quay, Chairman, CEO and President, and Mr. Kyle Guse, Chief Financial Officer & General Counsel, will present the Company's products, services and business strategy at the 15th Annual Rodman & Renshaw Global Investment Conference on Monday, September 9, 2013, at the Millennium Broadway Hotel in New York City.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the enrollment of the first patient at Academic Medical Center, Amsterdam, The Netherlands, by the Clinical Research Office of the Endourological Society (CROES) in an investigator-led, multi-center study assessing the safety, efficacy and patient satisfaction of the NanoKnife System for the ablation of prostate cancer.

Atossa Genetics Inc. (NASDAQ: ATOS)
and its subsidiary The National Reference Laboratory for Breast Health (NRLBH), will display their products and services at the Georgia Obstetrical and Gynecological Society 2013 Annual Meeting, August 22-25, in Greensboro, Georgia, and at the inaugural National Women's Survivors Convention, August 22-24, in Nashville, Tennessee.

today announced that the Netherlands Institute for Pigment Disorders (Stichting Nederlands Instituut voor Pigmentstoornissen or SNIP) has reached the target enrollment in a pilot randomized clinical trial evaluating ReCell® Spray-on Skin® in patients with skin pigmentation disorders including vitiligo.

Bacterin International Holdings, Inc. (NYSE MKT: BONE)
, a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced an inducement grant to the Company’s new Chief Executive Officer, Daniel Goldberger, as an inducement material to entering into employment with the Company pursuant to Section 711(a) of the NYSE MKT Company Guide.

Bioanalytical Systems, Inc. (NASDAQ:BASI)
announced today that on August 15, 2013, the Company received a letter from the Nasdaq Listing Qualifications Department stating that the Company no longer complies with the Listing Rules for continued listing of the Company's common shares on the Nasdaq Capital Market since the Company has not yet filed its Form 10-Q for the period ended June 30, 2013 with the Securities and Exchange Commission.

BioTime, Inc. (NYSE MKT: BTX)
, a biotechnology company that develops and markets products in the field of regenerative medicine, today announced the expansion of its senior management team with the appointment of Lesley Stolz, Ph.D. as Executive Vice President, Corporate Development.

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 third quarter 2013 of $0.0275 per share of common stock outstanding.

DelMar Pharmaceuticals, Inc. (OTCQB: DMPI)
today announced that the company has received a notice of allowance from the United States Food and Drug Administration (FDA) that will enable the company to accelerate the dose-escalation of its ongoing Phase I/II of VAL-083 in refractory glioblastoma multiforme (GBM) patients.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW) expert review panel to provide reimbursement for the Edwards SAPIEN XT transcatheter aortic heart valve.

eHealth, Inc. (NASDAQ: EHTH)
, the nation's first and largest private online health insurance exchange, released answers to a series of frequently asked questions designed to introduce consumers to the newly established health insurance open enrollment period.

Galena Biopharma (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the European Patent Office notified the Company of an intention to grant a Pharmaceutical Use Patent for NeuVax™ (nelipepimut-S).

AsthmaSense® Cloud, a mobile app that essentially turns a smartphone into an easy-to-use, personal monitoring device for people with asthma, has earned its creator and medical technology company, iSonea Ltd. (ASX: ISN) (OTCQX: ISOAY), the 2013 North American Frost & Sullivan Award for New Product Innovation Leadership.

Incyte Corporation (Nasdaq: INCY)
announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of ruxolitinib, its oral JAK1 and JAK2 inhibitor, in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
today announced that Michael Hall, MB. BCh., has joined the company as senior vice president of clinical development. Dr. Hall will lead Ironwood’s clinical research, clinical development, clinical operations, biostatistics and pharmacovigilance teams.

Galectin Therapeutics Inc. (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced completion of a $3 million private placement of 500,000 shares of unregistered common stock to a single investor.

Life Technologies Corporation (NASDAQ: LIFE)
today announced that its stockholders voted to adopt the previously announced merger agreement providing for the acquisition of Life Technologies by Thermo Fisher Scientific (NYSE: TMO) at the Special Meeting of Stockholders held earlier today.

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced it has signed an agreement with Siemens’ PETNET Solutions that grants PETNET Solutions the right to manufacture Navidea’s Fluorine-18 labeled NAV4694, an investigational beta-amyloid PET imaging agent, which is currently being evaluated in Phase 2 and 3 clinical trials evaluating subjects with signs or symptoms of cognitive impairment such as Mild Cognitive Impairment and Alzheimer’s disease.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
, a developer of oral drug delivery systems, announced today that it has initiated patient recruitment for a new clinical trial of its orally ingestible insulin capsule, ORMD-0801 for patients with type 1 diabetes mellitus (T1DM) in Israel.

Reliv International, Inc. (Nasdaq:RELV)
, a maker of nutritional supplements that promote optimal health, this week announced that healthy energy shot 24K™ has earned a patent from the US government.

Simulations Plus, Inc. (NASDAQ:SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that it has released Version 8.5 of its industry-leading GastroPlus™ software program for the simulation of gastrointestinal absorption, pharmacokinetics, and pharmacodynamics.

Targeted Medical Pharma, Inc. (OTCQB: TRGM)
, a biotechnology company that develops and distributes prescription medical foods, convenience kits and generic pharmaceuticals to physicians and pharmacies, today announced the appointment of William B. Horne as the company’s Chief Financial Officer.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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