|Medtronic Begins US Trial for the Use of Subcutaneous Peripheral Nerve Stimulation; BIOLASE Wins FDA Clearance for EPIC 10S|
|By Staff and Wire Reports|
|Thursday, 11 April 2013 18:46|
Medtronic, Inc. (NYSE: MDT) announced the first patient enrollments in the SubQStim II pivotal clinical trial to pursue U.S. FDA approval of peripheral nerve stimulation (PNS), also known as subcutaneous nerve stimulation (SQS), for the reduction of chronic, intractable post-surgical back pain.
PNS involves an implant of electrical leads just under the skin of the lower back. These leads are connected to a stimulator which delivers mild electrical impulses to the nerves, interrupting pain signals traveling through the nervous system to the brain. Medtronic received CE (Conformité Européenne) Mark for the first 16-electrode, fully implantable system for the percutaneous delivery of PNS in the management of chronic back pain in May 2011. PNS using a fully implantable system is not currently approved by the U.S. FDA for use in the United States.
The SubQStim II pivotal study is a randomized, controlled, blinded, parallel arm, multicenter trial to assess the safety and efficacy of PNS for chronic, intractable post-surgical back pain. The study will recruit up to 323 people at 30 U.S. centers who will receive PNS using a Medtronic neurostimulation system. Subjects will be randomized to a treatment or control group for the first three months and will continue to participate in open label follow-up for up to five years.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced the U.S. FDA has cleared the EPIC 10S(TM) soft tissue diode laser for use as a surgical instrument for over 80 different indications in 19 medical markets including: ear, nose and throat, oral surgery, arthroscopy, gastroenterology, orthopedics, general surgery, dermatology, plastic surgery, podiatry, GI/GU, gynecology, neurosurgery, ophthalmology, pulmonary surgery, cardiac surgery, thoracic surgery, urology, dermatology, aesthetics, and vascular surgery (see Exhibit A for a detailed listing of medical markets and indications).
The EPIC 10S is the surgical model of the recently released, next-generation dental EPIC 10(TM).
AtheroNova Inc. (OTCBB:AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that Stephen Nicholls, M.B.B.S., PhD., Heart Disease Theme leader at the South Australia Health and Medical Research Institute (SAHMRI), has been appointed as chair of the newly renamed Clinical Advisory Board, replacing the recently retired Dr. Giorgio Zadini, one of the co-founders of AtheroNova.
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today provided a timeline of key activities and milestones related to the preclinical development of MANF (Mesencephalic-Astrocyte-derived Neurotrophic Factor).
athenahealth, Inc. (NASDAQ: ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced the Company is working with Mashery to provide new web-services-based APIs (application programming interfaces) for the health care IT developer community.
BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today the commercial launch of a new passive needle guard technology, BD UltraSafe PLUS™.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced today that the U.S. Food and Drug Administration (FDA) has cleared the EPIC 10S™ soft tissue diode laser for use as a surgical instrument for over 80 different indications in 19 medical markets including: ear, nose and throat, oral surgery, arthroscopy, gastroenterology, orthopedics, general surgery, dermatology, plastic surgery, podiatry, GI/GU, gynecology, neurosurgery, ophthalmology, pulmonary surgery, cardiac surgery, thoracic surgery, urology, dermatology, aesthetics, and vascular surgery (see Exhibit A for a detailed listing of medical markets and indications).
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will issue its first quarter 2013 financial results at 4:00 pm ET on Thursday, April 18th, 2013.
eHealth, Inc. (NASDAQ: EHTH), America's first and largest private health insurance exchange, announced today that the company plans to release first quarter 2013 financial results on April 25, 2013.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has presented data on ES210, one of its bispecific ADAPTIRTM (Modular Protein Technology) molecules, that is targeting autoimmune disease at Keystone Symposia’s Advances in the Knowledge and Treatment of Autoimmunity in Whistler, British Columbia, Canada.
Green Endeavors, Inc. (OTCQB: GRNED), a majority owned subsidiary of Nexia Holdings, Inc. (PINKSHEETS: NXHD), announced continued revenue growth in the month of March 2013 over the comparable month in 2012.
IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based topical generic drug development and manufacturing company, announced the Company will hold a conference call at 4:30 pm ET on Thursday, April 25, 2013 to discuss 1st quarter 2013 results.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics, today announced that investors, journalists and the general public are invited to listen to a live webcast of the Company’s analyst and investor community meeting on April 12, 2013.
Incyte Corporation (Nasdaq: INCY) announced today that it has scheduled its first quarter conference call for 8:30 a.m. ET on Thursday, May 2, 2013.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced the pricing of an underwritten public offering of its common stock by existing shareholders Beacon Company and Rosebay Medical Company L.P., including shares that were transferred to Beacon and Rosebay by Purdue Pharma L.P., an associated company of Beacon and Rosebay, at a public offering price of $40.00 per share.
Life Technologies Corporation (NASDAQ: LIFE) today announced the launch of Vector NTI® Express Designer, the latest advancement in its Vector NTI® software platform, which offers researchers comprehensive and streamlined custom vector and genetic construct design and synthesis.
Matrix-Bio, Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, has signed an exclusive global licensing and marketing agreement for metabolomic biomarkers with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services.
Monsanto Company (NYSE: MON) and Dow AgroSciences LLC, a subsidiary of The Dow Chemical Company (NYSE: DOW), have reached new cross-licensing agreements for creation of the next generation of advanced weed and insect control technology in corn. Monsanto will license Dow AgroSciences’ new Enlist™ Weed Control System herbicide-tolerant trait for use in field corn.
MyMedicalRecords, Inc. ("MMR"), a wholly owned subsidiary of MMRGlobal, Inc. (OTCQB: MMRF), today announced the filing of a complaint for patent infringement against Quest Diagnostics, Inc.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce their participation at the 81st American Association of Neurological Surgeons (AANS) Scientific Meeting from Saturday, April 27th, to Wednesday, May 1st, 2013, in booth #1845 at the Ernest N. Morial Convention Center in New Orleans, LA.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled Phase 2 study evaluating OGX-427 in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).
Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has submitted a new Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a sub-study on its oral insulin candidate, ORMD-0801.
Senomyx, Inc. (NASDAQ: SNMX), a company using proprietary taste science technologies to discover, develop, and commercialize novel flavor ingredients, and Firmenich, the world's largest privately-owned fragrance and flavor company, announced today that the companies have amended and restated their Sweet Taste Program collaboration agreement.
The Medicines Company (NASDAQ: MDCO) has scheduled its quarterly conference call for Wednesday, April 24 at 8:30 a.m. Eastern Time to discuss first quarter 2013 financial results, operational developments, and outlook for 2013.