A Medical Device Daily
Nexa Orthopedics (San Diego, California) reported a new multi-year distribution agreement with Smith & Nephew Endoscopy (Andover, Massachusetts), a unit of Smith & Nephew (S&N; London), giving Nexa exclusive rights to distribute certain PolyGraft products designed for forefoot surgery under Nexa’s OsteoCure biologic products brand.
Nexa will sell these products to doctors of podiatric medicine in the U.S. and orthopedic surgeons specializing in foot and ankle surgery in certain countries outside of the U.S.
The agreement extends the partnership Nexa and OsteoBiologics (OBI) formed in July 2005 (Medical Device Daily, July 15, 2005). S&N acquired OBI on July 11 (MDD, July 12, 2006). The agreement also includes the potential for more products to be developed for forefoot surgery exclusively for Nexa and will add distribution rights in several international territories.
“We are encouraged by our early success with the PolyGraft products,” said Paul Nichols, Nexa president/CEO. “We believe Smith & Nephew Endoscopy’s credibility and history of supporting innovative technologies with sound science and clinical data will help us accelerate adoption in the podiatric surgery community.”
The PolyGraft biomaterials are made with poly (D,L-lactide-co-glycolide) polymer, formed into a bi-layered cylindrical scaffold absorbed by the body in six to nine months. The material is cleared in the U.S. as bone void filler and is marketed in Europe to repair cartilage defects.
Nexa was founded in 2004 by Healthpoint Capital.
In other agreement news:
• Clinical Data (CLDA;Newton, Massachusetts)andQuintiles Transnational (Research Triangle Park, North Carolina) reported an alliance to offer Quintiles’ customers CLDA’s services related to the evaluation of drug-induced QT prolongation. The QT interval is a part of the normal heartbeat which can be prolonged as a side effect of some drugs. People with prolonged QT intervals are susceptible to abnormal heart rhythms, Janine McCargo, a spokeswoman for Clinical Data, told Medical Device Daily. Financial terms of the agreement were not disclosed.
The pharmacogenomics analyses are performed in the laboratories of Clinical Data’s service division, Cogenics (New Haven, Connecticut).
As part of the alliance, the two companies may also collaborate on the study of drug-induced QT prolongation for potential development of new products or services.
Quintiles provides services in drug development, information, financial partnering and commercialization for the pharmaceutical and biotech industries.
CLDA provides molecular and pharmacogenomics services as well as genetic tests and is organized into three worldwide divisions: PGxHealth, Cogenics and Vital Diagnostics.
The FDA approval of NexStent and Boston Scientific's pending acquisition of EndoTex could help the company end the year on a more positive note than it started on in January when it was issued a rare warning letter by the FDA. The letter was only the third such corporate-wide warning ever issued to a medical device company, the agency said (MDD, Jan. 30, 2006).
The letter cited company management for failing to properly track complaints concerning certain products, including its Taxus stent, as well as Vaxcel catheters, Leveen needle electrodes and the Enteryx device used in surgery to treat acid reflux. It said that Boston Scientific also failed to notify it about such complaints, citing three company facilities.
The FDA's concerns have served to block the agency's approval of new products from the company. The letter came just one day after Boston Scientific sealed its purchase of Guidant (Indianapolis) for about $27.2 billion, outbidding Johnson & Johnson (New Brunswick, New Jersey).