TNInvestcos lead Series B round for medical device maker
Jun 1, 2010 11:35 AM
Business focused on improving medical implant outcomes
May 25, 2010 10:32 AM
Mark Chalos from the local office of Lieff Cabraser is representing a Franklin retiree who claims the Zimmer orthopedic implant he received three years ago this month has caused a laundry list of problems.
"Zimmer’s belated suspension of sales of its defective product was too little, too late for Mr. Thomas and for countless other folks, who needed safe and effective hip implants to restore their ability to sit, stand and walk without excruciating pain," stated Chalos.
May 24, 2010 7:44 AM
BioMimetic Therapeutics, and all other companies making drug/device combination products, will face a new Food and Drug Administration hurdle on the road to product approval. On the company’s first quarter earnings call yesterday, CEO Sam Lynch said the FDA is now requiring a “Request for Designation,” or RFD, for all combination products. Through the formal process the FDA will determine whether a product is reviewed as a drug or device, based on which component is considered the "primary mode of action." Though the company believes its Augment Injectable will be categorized as a device, it plans to file the RFD in Q2 just to solidify the FDA’s position. BioMimetic currently has 65 patients enrolled in a study for the product in Canada. When asked whether the company has a “plan B” if the FDA designates the product a drug, Lynch said he believed Augment Injectable's design would be “on par with the quality of a pivotal clinical trial that the drugs people would expect,” but noted that a drug designation may require a second pivotal clinical trial.
May 11, 2010 2:20 PM
Updated with information from press conference on the Interoperability Showcase
Apr 28, 2010 8:29 AM
Venture partner targeting health care services deals
Apr 21, 2010 12:23 PM
Virginia surgeon brings clinical, business experience
Mar 4, 2010 3:38 PM
Education/innovation center to house business incubator; NMTC chief talks strategy, competition
Feb 24, 2010 11:48 AM
- ALEX B FRUIN INHERITANCE TRUST; CANDACE F STEFANSIC INHERITANCE TRUST; CANDANCE F STEFANSIC INHERITANCE TRUST; FRUIN, ALEX B TRUSTEE; FRUIN ALEX B INHERITANCE TRUST; STEFANSIC, CANDACE F TRUSTEE; STEFANSIC CANDACE F INHERITANCE TRUST; STEFANSIC CANDANCE F INHERITANCE TRUST
- ROSS, BRIDGETT D
- COOKE, ETHEN LANYARD TRUSTEE; COOKE, ETHEN LEWIS ESTATE
- JACOBS, JESSICA ALEXANDRA; JACOBS, ERIKA BESS