St. Jude Announces First US Patient Implant Cardiac Pacemaker; Xerox Expands Healthcare Research in India, New York Print E-mail
By Mary Davila   
Thursday, 06 February 2014 20:50
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 6, 2014.

St. Jude Medical, Inc. (NYSE:STJ)
, a global medical device company, today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for U.S. Food and Drug Administration (FDA) approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy.

The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.

“This clinical research trial will be testing the latest innovative, non-surgical pacemaker option for U.S. patients experiencing heart rhythm issues,” said the study’s co-investigator Dr. Vivek Reddy, Director of Electrophysiology Services at The Mount Sinai Hospital and Chairman of the Steering Committee of the study. “This new-age, tiny pacemaker may ultimately be safer for patients because it doesn’t have leads or have to be inserted under the skin of a patient’s chest, like a traditional cardiac pacemaker. I believe this pioneering, compact device, which is placed directly inside the heart, may be a true game-changing technology in cardiovascular medicine and may help revolutionize care for patients with arrhythmias. I look forward to the results of the LEADLESS II clinical trial.”

The Nanostim leadless pacemaker is less than 10 percent the size of a conventional pacemaker and is the least invasive pacing technology available today. The small size of the device and lack of a surgical pocket, coupled with the exclusion of a lead, improves patient comfort and may reduce complications, including device pocket-related infection and lead failure. The elimination of the visible lump and scar at a conventional pacemaker’s implant site, in addition to the removal of patient activity restrictions that are routinely put in place in an attempt to prevent dislodgement or damage to a conventional lead, will potentially improve the quality of life for patients with this technology by allowing most to continue living active, uninhibited lifestyles. The device is supported by the St. Jude Medical Merlin™ Programmer, which is also used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs).

“Since the introduction of the first implantable pacemaker in 1958, pacemaker technology has continued to evolve into smaller, more efficient devices,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “Despite this evolution, pacing technology has, until now, required surgery in addition to leads that connect the pacemaker to the heart. The Nanostim leadless pacemaker is the first miniaturized device that removes the need for leads, thus offering less invasive and less complicated procedures for physicians and patients around the world. We believe the innovative nature of this technology will change the future landscape of cardiac rhythm management devices by revolutionizing the delivery methods and design of these life-saving technologies.”

Cardiac pacemakers are used to treat bradycardia, which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements. More than 4 million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.


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Chronic illnesses such as cardiovascular and respiratory diseases require continuous monitoring, which can be expensive and difficult, especially in remote areas and homes. The Xerox (NYSE:XRX) Innovation Group today announced a suite of healthcare research projects being conducted in India by Xerox Research Centre India (XRCI) and Xerox Research Center Webster (XRCW) in New York that use video cameras and data analytics to monitor a patient’s condition without wires, discomfort or risk of infection.

Scientists believe the contact-free approach will make it less intrusive to patients in India and across the globe for doctors to monitor the condition of their patients.

Working closely with the Manipal University Hospital in Manipal, India, Xerox researchers have been testing the feasibility of using video cameras to develop technologies that continuously monitor the condition of patients. Using patented software algorithms, Xerox scientists have been able to convert data collected by the cameras into vital signs. When a heart pumps, for example, freshly oxygenated blood makes the skin appear redder. A video camera documents these subtle changes that are imperceptible to the human eye, and a computer then calculates a heart rate. Because the cameras can scan skin from a distance, patients can – in theory – be free from wires, sensors and other devices that typically are used today.

“Our initial work at Manipal was in the neonatal unit, evaluating the algorithms to monitor infant vital signs with cameras, but that has quickly expanded into other areas,” said Lalit Mestha, research fellow at the Xerox research center in New York and project leader.

Using cameras to track a patient’s condition can improve comfort levels and decrease the risk of infection. Cameras can open up the possibility of diagnosing patients at their homes, clinics and in locations that may be far from a specialist.

Mestha’s team also is working with the University of Rochester Medical Center in New York on a project that uses cameras to detect occurrence of atrial fibrillation, a condition that can increase a person’s risk of stroke by a factor of five.

Research conducted in hospital rooms provides Xerox scientists with a first-hand view of the medical field through interaction with practitioners and patients.

“Our partnership with Manipal University Hospital is helping us move the technology closer to reality,” said Manish Gupta, Xerox vice president and director of XRCI. “This research can have great implications for the future of healthcare and telemedicine in India and across the globe.”


Also Thursday:

ACETO Corporation (Nasdaq:ACET)
, a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, announced today financial results for the second quarter of fiscal 2014 ended December 31, 2013.

Amarin Corporation plc (Nasdaq:AMRN)
, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced that John F. Thero, Amarin's President and Chief Executive Officer, is scheduled to present a general company update at the 2014 Leerink Global Healthcare Conference at the Waldorf Astoria Hotel in New York City on Thursday, February 13, 2014, at 11:10 a.m. ET.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that Gerald Commissiong, President and CEO will be presenting at the 16th Annual BIO CEO & Investor Conference.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced financial and operational results for the fourth quarter and full year 2013. We will conduct a conference call tomorrow, Friday, February 7, 2014, at 8:00 a.m. Eastern Time to discuss these results and management's outlook for future financial and operational performance.

Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the first fiscal quarter ended December 31, 2013.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
announced today that Anthony Marucci, President and Chief Executive Officer, and Tom Davis, M.D., Senior Vice President and Chief Medical Officer, are scheduled to present a corporate overview at the 2014 Leerink Global Healthcare Conference on Wednesday, February 12, 2014 at 2:40 pm ET at the Waldorf Astoria in New York City.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
, today announced that Chief Executive Officer Bob Palay is scheduled to present at the Leerink Swann Global Healthcare Conference at 3:30 p.m. EST, Wednesday, February 12, in New York City.

Celsus Therapeutics Plc (Nasdaq:CLTX)
, an emerging growth, development-stage biotech company, announced today that Dr. Gur Roshwalb, Chief Executive Officer of Celsus, will present at the 2014 BIO CEO & Investor Conference on Monday, February 10, at 4:00 p.m. Eastern Standard Time at the Waldorf Astoria in New York.

The Cooper Companies, Inc. (NYSE:COO)
today announced it will release first quarter 2014 financial results on Thursday, March 6, 2014, at 4:00 PM ET.

Coronado Biosciences, Inc. (Nasdaq:CNDO),
a biopharmaceutical company involved in the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, as well as the licensing and acquisition of, and investment in, development stage compounds, biologics and companies, today announced the U.S. Patent and Trademark Office (USPTO) has granted a second key patent for CNDO-109 directed to the activated Natural Killer (NK) cell compositions employed in its NK cell therapy program, and has further issued a Notice of Allowance in an additional pending application directed to pharmaceutical compositions comprising these activated NK cells.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of minimally invasive treatments for aortic disorders, announced today details relating to the release of its fourth quarter and full year 2013 financial results, which will take place on Thursday, February 27, 2014 after the close of the market.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today that it received the title of Outstanding Exporter for 2012 from the Israeli Ministry of Economy.

Esterline Technologies (NYSE: ESL)
plans to announce financial results for its 1st quarter 2014 on Thursday, February 27, 2014. Esterline will host a conference call featuring remarks by Curtis Reusser, President and Chief Executive Officer, and Bob George, Vice President and Chief Financial Officer.

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 that Mark J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the 2014 Leerink Global Healthcare Conference.

Hyperion Therapeutics (Nasdaq:HPTX)
announced today that the company is scheduled to present at the Leerink Global Healthcare Conference on Thursday, February 13 at 2:40 p.m. ET.

IMMUNE Pharmaceuticals Inc. (OTCQX: IMNP) (NASDAQ: IMNP)
announced today that Daniel Teper, Chairman and Chief Executive Officer, will be presenting at the 16th annual BIO CEO & Investor Conference on Monday, February 10, 2014 at 11:30AM local time at the Waldorf Astoria, Room Duke of Windsor, in New York.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that it will host a conference call and live audio webcast on Tuesday, February 11, 2014 at 10:00 a.m. Eastern Time to discuss financial results for the second quarter of fiscal year 2014, and review key clinical developments and future planned activities.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the 2014 Leerink Swann Global Healthcare Conference at the Waldorf Astoria in New York City.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 16th Annual BIO CEO & Investor Conference, to be held February 10-11, 2014, at the Waldorf Astoria Hotel in New York City. Mr. Bentsur's presentation will take place on Monday, February 10th, at 4:00pm ET.

LifeVantage Corporation (Nasdaq:LFVN)
, a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, today reported financial results for the fiscal 2014 second quarter and six months ended December 31, 2013.

Medical Marijuana, Inc. (OTC Pink:MJNA)
would like to inform shareholders and the general public that HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. – is sponsoring, exhibiting, and representing their all-natural industrial hemp-based cannabidiol (CBD) products at the Los Angeles Medical Cannabis Cup and award competition.

The Medicines Company (NASDAQ: MDCO)
has scheduled its quarterly conference call for Wednesday, February 19 at 8:30 a.m. Eastern Time to discuss fourth quarter and full year 2013 financial results, operational developments, and outlook for 2014.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced that Bozeman Deaconess Hospital, a not-for-profit, Level III trauma organization providing a range of services throughout four hospitals in Montana, has chosen Merge for its vendor-neutral archive (VNA) and interoperability solutions.

Nature's Sunshine Products, Inc. (Nasdaq:NATR)
, a leading natural health and wellness company, today announced that the 2014 Annual Meeting of shareholders will be held on Wednesday, May 7, 2014, at the Company's principal executive offices located at 2500 West Executive Parkway, Suite 100, Lehi, Utah.

NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY)
, a clinical-stage biopharmaceutical company developing topical non-antibiotic anti-microbial products, today announced that Dr. John R. Crew, MD,FACS, Vascular Surgeon, Medical Director, Advanced Wound Care Center, Seton Medical Center in Daly City, California, will explain to medical staff at Eisenhower Medical Center in Palm Springs, California, how NeutroPhase®* wound cleanser can help manage the severely-infected wounds of patients with life-threatening 'flesh-eating' disease.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, today announced that as of January 31, 2014, Oculus has entered into certain new and amended agreements with its wholly owned subsidiary, Ruthigen Inc., which are required for Ruthigen's continued IPO process.

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that Ramesh Kumar, Ph.D., President and CEO, will present at the 16th Annual BIO CEO & Investor Conference in New York, NY.

OraSure Technologies, Inc. (Nasdaq:OSUR)
today announced that Ronald Spair, Chief Operating Officer & Chief Financial Officer, will speak to the investment community at the Leerink Swan Global Healthcare Conference in New York City.

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
, announced today that the Brazilian National Institute of Industrial Property (INPI) has approved the Company's previously-announced supply and technology transfer agreement with Fundação Oswaldo Cruz (commonly referred to as Fiocruz), an arm of the Brazilian Ministry of Health for UPLYSO™ (alfataliglicerase).

Shire plc (LSE: SHP, NASDAQ: SHPG)
  announces top-line results from two pivotal Phase 3 investigational studies evaluating the efficacy and safety of Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) versus placebo as an adjunctive treatment for major depressive disorder (MDD) in adults who inadequately responded to antidepressant monotherapy with a SSRI or SNRI.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 3:30 PM ET.

Sucampo AG, a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP), headquartered in Zug, Switzerland, announced today that all physicians in Switzerland are now able to prescribe AMITIZA® (lubiprostone) for chronic idiopathic constipation (CIC), as a result of the revision of the reimbursement limitations by the Bundesamt für Gesundheit (BAG), effective February 1, 2014.

Swisher Hygiene Inc.  (Nasdaq:SWSH) (TSX:SWI)
, a leading provider of essential hygiene and sanitizing products and services, announced today that it has entered into a Stipulation of Compromise and Settlement with the Lead Plaintiffs in the consolidated class action lawsuits filed in the U.S. against the Company.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the appointment of Clay B. Siegall, Ph.D. and Matthew Fust to the company's Board of Directors effective January 30, 2014.



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