A Medical Device Daily
Artes Medical (San Diego), a specialty medical device and pharmaceutical firm, reported that the U.S. Attorney's office found that its product Artecoll was not administered by unlicensed practitioners in Beverly, California, in a case widely reported on in 2004. Artes said the ruling confirmed that a form of liquid silicone was used instead, resulting in the adverse effects alleged in the case.
"We . . . believe that it is very important to correct the public record in this regard. Artecoll has an established safety profile and has been used in over 250,000 patients outside the United States to correct a wide variety of facial wrinkles and scars," said Stefan Lemperle, president and CEO of Artes.
Lemperle added that in September 2001 the company's U.S. pivotal clinical trials for Artecoll demonstrated the safety and efficacy compared to the "gold-standard" bovine collagen control.
Artecoll, a material incorporating engineered microspheres, is being developed by Artes to correct soft tissue contour "deficiencies" and thus in potential competition with Botox.
In other legalities: Akers Biosciences (Thorofare, New Jersey) reported that a Default Final Judgment has been awarded in its favor, by the U.S. District Court, Southern District of Florida, against Tundra Management. This case resulted, Akers said, from attempted transfer of company shares by Tundra, those shares to be held as collateral for a loan to the company, some of which shares were sold without the appropriate authorization.
Akers said it has been awarded damages of more than $980,000 as a result of Tundra's breaches and has received the Default Final Judgment for set-off of the damage amount against the loan from Tundra, satisfying the debt under the loan agreements.
Akers manufactures the Biosniffer, a continuous monitoring detector designed to provide real-time information concerning airborne biowarfare agents.