Glysure CEO Discusses Real-Time Glucose Monitoring Technology, ISO 13485 Certification and CE Mark

March 18, 2013 OneMedPlace Team 0

As part of our expert series on the state of the industry, OneMedRadio spoke with Glysure CEO Chris Jones to discuss this recent news and learn about this unique technology. Jones also discussed trends in the industry affecting company growth and investment strategy, including reimbursement issues, evolving exit strategy, and the move away from normative medicine.

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Amedisys Shares Are Too Pricey For A Declining Business: Looking for Single Digits

March 15, 2013 Jake King 0

Amedisys, Inc. (AMED) reported 4Q and year-end earnings Tuesday, March 12, and the key highlight was the company’s 2013 EPS guidance range of $0.60-$0.70, substantially below the Street’s $0.77 estimate. Analysts EPS estimates were lowered when the company reported its third quarter 2012 earnings miss (2013 EPS forecasts back then called for $0.93 a share), hence, the business continues to deteriorate and the earnings trough has not yet been reached.

Acadia Forges Forward With Pimavanserin

March 14, 2013 Jason Napodano 0

On March 12, 2013, Acadia Pharmaceuticals (ACAD) reported financial results for the fourth quarter and full year 2012. Total revenues in the quarter were $0.4 million, essentially in-line with our estimate of $0.3 million. Revenues consisted of collaborative payments from Allergan, Inc. (AGN) and other collaboration partners. For the full year 2012, total revenues were $4.9 million.

PDUFA: Kadcyla, Immunogen – Metastasized Breast Cancer

March 12, 2013 OneMedPlace Team 0

Metastasized breast cancer now has a new therapy on the market, though it remains to be seen whether noticeably dangerous side effects may prevent widespread use. Trastuzumab emtansine (T-DM1) or Kadcyla, produced by Immunogen [Nasdaq: IMGN], is a treatment that targets the HER2 protein.

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Meaningful Use, The Affordable Care Act, Sequestration, and Medical Devices

March 11, 2013 Chelli Miller 0

The Healthcare ecosystem in the United States is changing dramatically due to significant regulations and legislation. Though Obamacare gets the most attention for its impact on patient care and healthcare coverage, legislation such as the Meaningful Use Regulations passed in 2009, followed by the passage of the Affordable Care Act in 2010, and the most recent Sequestration may have a profound impact on the opportunities for developing medical devices and medical device investors.

RELEASE: Glysure Earns ISO 13485 Certification

March 6, 2013 OneMedPlace Team 0

GlySure Limited, developer of in-hospital continuous blood glucose monitoring systems, today announced that it has achieved ISO 13485 certification, the global standard for the requirements of a quality management system for the design, manufacture and distribution of medical devices. By establishing a quality management system that meets international regulatory and customer requirements, GlySure has set the foundation for its European clinical trials.

Word on the Street:The Buy-Side View for 2013

February 21, 2013 Lisa Sher 0

The BIO CEO Investor Conference remains one of the most important events for companies, investors and industry executives to explore partnerships, raise capital, network or simply gain some useful, fresh insight from industry experts. Monday’s opening Plenary Session, Word on the Street–Buy Side View for 2013, was informative and featured some of the industry’s most respected names.