Informing

It's been a long year waiting, but the medical device industry and the FDA signed off on a tentative agreement for the next 5 years of med-tech user fees.  The result is the industry's expected buy-in will nearly double; and the FDA will be expected to do more than it has prior.

MDUFMA (Medical Device User Fee & Modernization Act) tentatively raises user fees to $595 million over five years.

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Ischemic stroke is the target of a new partnership between Oxygen Biotherapeutics (NASDAQ:OXBT) and Aurum Biosciences that aims to develop a diagnostic and a treatment for the condition.

The agreement will pair the companies’ respective technologies: Aurum’s magnetic resonance imaging (MRI) technology has the potential to map salvageable tissue in the brain after a stroke and Oxygen’s technology is being studied as a way to enhance oxygen delivery to the brain. The agreement expands a research pact reached last summer when the companies decided to work together on preclinical stroke research.

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TearScience, Inc. today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its next generation product of its LipiFlow® Thermal Pulsation System , a medical device that treats evaporative dry eye by liquefying and evacuating obstructions in meibomian glands located in the eyelids.

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An Atlanta, Georgia company developing surgical imaging technology for image-guided cancer surgery is looking to add $6 million in anticipation of its European product launch.

Spectropath Inc.’s technology is a disposable, handheld, pen-like device used with an agent to make cancerous tissue turn a fluorescent color during tumor removal surgery, said President and CEO Ralph Gaskins Jr.

Complete removal of cancer is a critical predictor of patient survival, so more complete and accurate removal of tissue during surgery could reduce the need for chemotherapy and radiation treatment and improve outcomes, the company says.

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 Medical device firm Charter Medical has received European regulatory clearance for cryogenic stem cell containers.

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Diagnostics company LipoScience, which is in the midst of plans for an initial public stock offering, now has a new chief operating officer.

Timothy Fischer joined LipoScience in 2010 as the company’s vice president of research and development. Now as COO, Fischer will continue overseeing R&D as well as commercial operations and medical affairs.

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Medical device company nContact, a developer of products to treat arrhythmias, has raised close to half a million dollars.

The Morrisville, North Carolina company secured a total of $433,761 in debt financing from one investor, according to securities filings. That’s a small amount compared to the company’s venture capital haul to date; nContact has raised more than $42 million in financing, including a 2010 $16 million series D round from venture capital firms Intersouth Partners, Harbert Venture Partners, Finistere Ventures, Massey Burch Capital and ZMV Associates.

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Medline Industries has entered into a new three-year agreement with the Premier Healthcare Alliance.  The agreement will begin in April of this year and will provide savings to Premier's membership of more than 2,500 US hospitals and over 80,000 other healthcare sites.

Premier said it has also worked with the Centers for Medicare & Medicaid Services and the National Health Service North West to improve hospital performance.

In last night's State of the Union Address, President Obama implores Congress not to “gut” investments in research, so American can maintain its spot as a world leader in medical innovation.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology association (AdvaMed), released the following statement in response to the State of the Union address:

“The President is right to emphasize manufacturing, and medical technology companies support his efforts to boost manufacturing growth, especially through increased exports and lower trade barriers. Consistent with this emphasis on manufacturing, we urge President Obama to support repeal of the medical device tax, which is already causing layoffs and will make our tax system even more uncompetitive. Congress should repeal the tax this year."

Group purchasing organization Premier said it signed a raft of supply deals for a variety of medical device products.

The Charlotte-based GPO said it signed deals for endomechanical, trocar, suture and topical skin adhesives with 16 companies.

Cook Medical said it renewed a deal to provide specialty urology products to Premier. And Child Health Corp. of America said it tapped distributor Medline Industries in an exclusive deal to provide medical and surgical supplies for its network of 43 children's hospitals. The sole source, 45-month contract is worth approximately $225 million a year and is slated to begin April 9, according to a press release.

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