OraSure Addresses FDA Warning Letter on DNA Genotek; Stereotaxis Announces Completion of Clinical Trial of Vdrive Print E-mail
By Staff and Wire Reports   
Tuesday, 07 January 2014 20:14
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 7, 2014.

OraSure Technologies, Inc. (Nasdaq: OSUR)
announced its molecular collection systems subsidiary, DNA Genotek, received a warning letter from the U.S. Food and Drug Administration (FDA) which the FDA posted today on its website. The warning letter primarily focuses on DNA Genotek's response to two observations issued by the FDA on Form 483 as a result of a routine inspection of DNA Genotek's Ottawa, Canada facilities in September 2013.

DNA Genotek is actively engaged and working with the FDA to address the agency's observations and will continue to sell and market all of its products while responding to the warning letter. No material impact to product sales or OraSure's consolidated financial performance is expected as a result of the issues raised by the warning letter.

The warning letter requests additional documentation related to finished product acceptance testing activities for DNA Genotek's ORAcollect OC-100 collection device, a swab-like product with a small customer base that accounted for approximately one-half of one percent of OraSure's consolidated revenues in 2013. The letter notes that DNA Genotek does not currently have in place an approved premarket approval application or 510(k) clearance for its ORAcollect OC-100 device.

In addition, the warning letter indicates the need for additional documentation regarding design and development activities for DNA Genotek's products and focuses in particular on the design planning and design history file for its 510(k) cleared OrageneDx collection device, a product primarily used in commercial applications. A product similar to OrageneDx, sold under the name OrageneDiscover, is used primarily for research applications and was not specifically addressed by the warning letter.

A copy of the warning letter can be found on the FDA's website at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379997.htm.

"We take this letter from the FDA very seriously and we are working closely with the agency to ensure we fully address their concerns and observations," said Douglas A. Michels, President and CEO of OraSure Technologies. "We are committed to providing the highest quality products to our customers and to continuously enhancing our systems and processes."



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Stereotaxis, Inc. (Nasdaq: STXS)
announced it has completed the clinical trial required for FDA clearance of the Company's Vdrive™ Robotic Navigation System with V-Loop™ Circular Catheter Manipulator. Results of the 120-patient study, which was conducted at three Stereotaxis sites in the U.S. and two in Europe, will be included in a 510(k) Premarket Notification the Company intends to submit in the first quarter of 2014.

If cleared by the FDA, the Vdrive with V-Loop system will be the Company's second Vdrive product to be cleared for use in the U.S. Its Vdrive with V-Sono™ Intracardiac Echocardiography Catheter Manipulator received FDA clearance in July 2013 and has been utilized in more than 50 cardiac ablation procedures to date in the U.S.   

The Vdrive with V-Loop system, already part of the clinical routine of several European electrophysiology (EP) labs, is indicated for remotely controlling the advancement, retraction, rotation, tip deflection, and loop size of a compatible catheter. For Niobe® ES remote navigation procedures, the Vdrive with V-Loop system can improve efficiency and accuracy of loop catheter management. In the U.S., an estimated 60,000 loop catheters are used each year in complex EP procedures.   



Also Tuesday:




Accuray Incorporated (Nasdaq: ARAY)
announced today that it will report results for its second quarter of fiscal 2014, ended December 31, 2013 on Thursday, January 30, 2014 after the market closes.

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat debilitating and often fatal rare diseases, announced today that the company will participate in the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco.

Anavex Life Sciences Corp. (OTCQB:AVXL)
today announced that its President and Chief Executive Officer Christopher U. Missling, PhD, will participate in the 7th Annual OneMedForum: Investing in Healthcare 2014 ("OneMedForum") and the Noble Financial Capital Markets ("Noble") Tenth Annual Equity Conference.

Antisense Therapeutics Limited is pleased to advise that it has been selected to present at the Biotech Showcase 2014 conference to be held January 13-15, 2014, at The Parc 55 Wyndham Hotel in San Francisco, CA.  

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, and Leica Biosystems (LBS), a global leader in pathology workflow solutions and automation, announced that the companies have entered into a co-development agreement for the development of a companion diagnostic (CDx) for Arno's lead compound and personalized therapy, onapristone

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
today announced that Jean-Jacques Bienaimé, Chief Executive Officer at BioMarin, will present a company update at the 32nd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2014 at 10:30 a.m. Pacific Time.

Bridgeline Digital, Inc. (Nasdaq:BLIN)
, The Digital Engagement Company™, today announced that a worldwide leader in pediatric healthcare has selected the award-winning iAPPS Digital Engagement platform to launch its next generation, mobile-friendly mission critical website.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
, formerly Lucid, Inc., has received orders totaling $554,000 for VivaScope® systems from its Chinese distributor ConBio (Shanghai) Co., Ltd.

Cerner Corporation (Nasdaq:CERN)
invites you to listen to the live broadcast of the company's presentation at the JP Morgan Healthcare Conference in San Francisco on Jan. 14, at 9 a.m. PST.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today its K-REAL® krill oil has received "New Food Raw Material" certification in China.

Evoke Pharma, Inc. (Nasdaq:EVOK)
, a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that its President and Chief Executive Officer, Dave Gonyer is scheduled to present at Biotech Showcase™ 2014, being held January 13-15, 2014 in San Francisco, Calif.

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 first patient has been enrolled in the Phase 2 trial for GALE-301 (Folate Binding Protein (FBP) vaccine).

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX)
announced today that Idenix management will present a corporate overview at the 32nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2014 at 11:00 a.m. Pacific Time at the Westin St. Francis Hotel in San Francisco.  

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospitalist physician group practice, today announced that Adam Singer, M.D., chairman and chief executive officer, Jeff Taylor, president and chief operating officer, and Rick Kline, chief financial officer, are scheduled to present at the 32nd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco.

Intelligent Living Inc. (OTCQB: ILIV)
has signed a Letter of Intent (LOI) to acquire the assets of Venturian Group, Inc., an enterprise Cloud and IT Solutions Architecture Company.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 32nd Annual J.P. Morgan Healthcare Conference, to be held January 13-16, 2014, in San Francisco. Mr. Bentsur's presentation will take place on Wednesday, January 15th, at 8:30 am PT.

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, announced today that Shawn Talbott, Ph.D. has accepted the role of Global Chief Science Officer for the company effective January 6, 2014.

LHC Group Inc. (Nasdaq:LHCG)
, a national provider of post-acute care services, announced today that Keith G. Myers, chief executive officer of LHC Group, and Don Stelly, president and chief operating officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, on Thursday, January 16, 2014.

The Medicines Company (NASDAQ: MDCO)
is scheduled to present at the J.P. Morgan 2014 Healthcare Conference in San Francisco, CA on January 14th at 2:00 PM Pacific Time (5:00 PM Eastern Time).

MRI Interventions, Inc. (OTCQB:MRIC)
today announced that the first real-time MRI-guided neurosurgical shunt placement using the company's ClearPoint® Neuro Intervention System has been performed at Cincinnati Children's Hospital, representing the latest application of the platform system and illustrating its utility in a wide range of neurosurgical procedures.

Myriad Genetics, Inc. (Nasdaq:MYGN)
announced today that Peter D. Meldrum, president and CEO of Myriad, is scheduled to present at the 32nd Annual J.P. Morgan Healthcare Conference, at 9:30 a.m. Pacific on January 13, 2014, at the Westin St. Francis Hotel in San Francisco, California.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
will be holding a conference call on Wednesday January 15, at 9:00 am ET to present its results for the third quarter ended November 30, 2013.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 31 countries, today introduced two new products to its U.S. family of Microcyn®-based advanced wound care products.

OraSure Technologies, Inc. (Nasdaq:OSUR)
announced that its molecular collection systems subsidiary, DNA Genotek, received a warning letter from the U.S. Food and Drug Administration (FDA) which the FDA posted today on its website.

PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, today announced that it has engaged American Capital Ventures, a boutique provider of comprehensive investor relations, financial marketing and capital advisory services to the micro- and small-cap community.

Inova Health System has expanded its strategic partnership with Premier, Inc. (Nasdaq:PINC) to drive system-wide improvements in supply chain efficiency and clinical effectiveness.

Prosensa Holding N.V. (NASDAQ: RNA)
announced today that Hans GCP Schikan, Chief Executive Officer, will present a corporate overview at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16 at 10:00AM Pacific Time at the Westin St. Francis Hotel in San Francisco.

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
, announced today that Dr. David Aviezer, the Company's President and Chief Executive Officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2014 at 12:00 PM, Pacific Time.

Regulus Therapeutics Inc. (NASDAQ: RGLS)
, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Regulus, will present a company overview at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2014 at 8:30 AM PST at the Westin St. Francis Hotel in San Francisco, CA.

Sharps Compliance Corp. (Nasdaq:SMED)
announced today that David P. Tusa, President and Chief Executive Officer, will be presenting at the Sidoti & Co. Semi Annual Micro-Cap Conference to be held at the Grand Hyatt Hotel in New York.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 32nd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2014 at 11:00 AM PT.

Stereotaxis, Inc. (Nasdaq:STXS)
announced today that it has completed the clinical trial required for FDA clearance of the Company's Vdrive™ Robotic Navigation System with V-Loop™ Circular Catheter Manipulator. Results of the 120-patient study, which was conducted at three Stereotaxis sites in the U.S. and two in Europe, will be included in a 510(k) Premarket Notification the Company intends to submit in the first quarter of 2014.

TESARO, Inc. (Nasdaq:TSRO)
announced today that Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President of TESARO, will attend the 32nd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that it will host a live webcast of its fourth quarter conference call on Tuesday, February 4th at 3:30pm CST. Vascular Solutions' Chief Executive Officer, Howard Root, Chief Financial Officer, James Hennen and VP of Corporate Development, Phil Nalbone, will discuss the company's fourth quarter results.

Zogenix, Inc. (Nasdaq:ZGNX)
, a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, reported today that it has issued inducement awards to two new non-executive employees.



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