{IMGRIGHT:85×85:http://www.massdevice.com/sites/default/files/headshots/picture-34.jpg}Here are the takeaways from the 10th annual MBA Symposium, sponsored by Boston University’s School of Management Feb. 28, at least from a medical perspective: The IPO is dead, the FDA is back from the dead and direct-to-consumer marketing is a dead end.
Latest News on MassDevice
Federal probe of Stryker ongoing in off-label promotion case
FDA to track kids’ exposure to BPA in medical devices
The federal Food and Drug Administration plans to track pediatric patients undergoing cardiopulmonary bypass and hemodialysis at two hospitals in Washington and Michigan for exposure to bisphenol-A, a chemical used to make plastics.
At issue is whether BPA in the plastics used in medical devices can be harmful to children undergoing procedures that require extended exposure to the materials, such as heart bypass operations and dialysis.
FDA hops onto Serica’s SeriScaffold
The U.S. Food and Drug Administration hopped onto Serica Technologies Inc.’s SeriScaffold product, granting the silk-based surgical mesh clearance to hit the market.
The Medford-based growth-stage device maker’s flagship product is designed to repair and remodel damaged connective tissue, avoiding the erosion and scar formation that can result from surgery.
Amicas plunges into the red, along with its share price
Amicas Inc. posted revenues of $50.4 million last year, up 9.3 percent compared with 2007, but slipped deep into the red during the fourth quarter as the value of its shares plunged.
The Boston radiology and medical image software provider said it took a $27.3 million impairment charge “primarily due to the sustained decline in the market value of the company’s equity during the fourth quarter of 2008,” adding that it doesn’t expect any material impact from the charge over the long term.
Millstone Medical Outsourcing opens second facility in Fall River
Millstone Medical Outsourcing plans to open a second inspection and clean room facility in Fall River.
The 30,000-square-foot building will include a mechanical inspection area, clean room and packaging facilities.
It’s the third location for the inspection and clean room outsourcing service provider, which operates another clean room facility and its headquarters in Fall River and a loaner kit processing and distribution center in Memphis. The new shop takes its total square footage to roughly 95,000 square feet.
Zoll to pay $12 million for Alsius Corp.
Zoll Medical Corp. agreed to buy out Alsius Corp. for $12 million, adding the Irvine, Calif.-based intravascular temperature management product maker’s operations to its line of cardiac resuscitation devices.
Chelmsford, mass. based Zoll said it will integrate the Alsius business into its operations in Sunnyvale, Calif.
HepaLife hyped over new CFO
Donna Lopolito spent 13 years as a CFO in the life sciences arena at PricewaterhouseCoopers, so she was a good pick when HepaLife Technologies Inc. tapped her to be its top financial guru.
Creganna buys Swedish polymer muscle maker
Creganna, the Irish medical device maker with operations in Marlborough, acquired Micromuscle AB and its Nobel Prize-winning artificial muscle technology for an undisclosed amount after the Swedish firm’s venture-capital backer backed out.
Linkoeping, Sweden-based Micromuscle’s electroactive polymer technology won the Nobel Prize in 2000, but the company was forced to shut down after one of its major VC investors pulled out.
NeuroMetrix posts dismal sales and earnings numbers
Hard on the heels of the plea agreement added to its miserable week by posting nearly $30 million in losses for 2008.
The Waltham-based company said sales were off 30 percent from 2007. The drop off in sales contributed to a net loss of $27.7 million for the year, compared to an 8.4 million loss reported for 2007.
The bulk of its $4.1 million fourth-quarter net loss stemmed from the $3.7 million federal settlement, with the rest due to a $274,000 writedown on the NeuroMetrix January buyout of joint-venture partner Cyberkinetics Neurotechnology Systems Inc.
NeuroMetrix pays $3.7 million in federal kickbacks case
Nerve test equipment manufacturer NeuroMetrix Inc. paid $3.7 million to settle charges in a federal kickbacks and Medicare fraud case.
Under a deferred prosecution deal with U.S. Attorney Michael Sullivan’s office in Boston and the federal Health and the Inspector General’s office of the federal Health & Human Services Dept., the Waltham-based device maker will pay $1.2 million to settle accusations of illegal kickbacks to physicians and $2.5 million to settle civil charges in that case and another alleged Medicare billing scam.
