ApaTech is touting positive results for a pair of clinical trials of its Actifuse synthetic bone graft that it says indicate the product is as good or better than iliac bone crest grafts for spinal fusion procedures.
The Food & Drug Administration cleared Etex Corp.‘s orthopedic putty for use in small-bone repairs.
The Cambridge biotech said the federal watchdog agency gave the nod to 1cc and 5cc sizes of its Beta-bsm injectable paste and Gamma-bsm moldable putty, on top of existing clearances for the 5cc and 10cc sizes.
The bone substitute materials are used to make osteo-conductive scaffolds that ape the nanocrystalline structure of human bone. The smaller sizes were developed for hand and foot/ankle surgeries. The products are used to fill voids in bone that the bone doesn’t depend on for stability.
Orthofix International NV‘s preliminary first-quarter revenues and earnings numbers indicate flat sales and a slight dip in the bottom line, compared with the same period last year.
The McKinney, Texas-based orthopedic device manufacturer, which has a presence in Boston, said it expects sales for the three-month period ended March 31 to be around $129 million, compared to $128 million for the same period last year.
Orthofix International is one of the companies named in a whistleblower lawsuit accusing the group of bone-growth stimulator manufacturers of reimbursement fraud.
It’s not the first time the Boston-based orthopedics maker has run afoul of federal authorities and the False Claims Act. In 2003, the company agreed to pony up nearly $1.6 million to settle allegations that it submitted false claims to TRICARE, the military’s healthcare program.
U.S. Attorney Michael Sullivan is making his last week on the job a busy one.
Just five days before he leaves public service for the oak-trimmed corridors of private practice, Sullivan announced a third guilty plea in the federal investigation of off-label promotion by former sales reps for Stryker Biotech.
The federal Food & Drug Administration shot down Stryker Corp.‘s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.
The watchdog agency’s panel found that bias may have influenced subjects in clinical trials for the medical device giant’s OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.
Stryker’s biotech division is headquartered in Hopkinton.
Stockholders of Orthofix International NV fought back a proxy challenge by a New York-based hedge fund.
The McKinney, Texas-based orthopedic device manufacturer said its shareholders beat back an attempt by Ramius LLC to oust four current board members and install their own people.
Orthofix also runs offices in Boston and a production facility in Springfield.
You’d be hard-pressed to argue that the past decade hasn’t been a good one for medical device companies focused on the spine (Especially with me. Full disclosure: I’m involved in two spine startups. I’m on AxioMed’s technical advisory panel and I’m a minority shareholder of Innovative Surgical Designs. At the time of this writing, I also own shares of TranS1).
Sometimes it seems like you can’t swing a pedicle screw without hitting a new spine start-up. Anthony Viscogliosi recently estimated that are 200 venture capital-backed spine companies.
ConforMIS Inc. added a pair of medical device industry veterans to its executive roster.
The Burlington orthopedic implant maker appointed Robert Phelps as SVP of sales and David Cerveny as general counsel and VP of intellectual property.
Four orthopedic device makers cleared federal criminal charges and a fifth “satisfactorily completed” its non-prosecution agreement with the U.S. Attorney’s office in Newark, the Dow Jones news service reported.