Medical technology company Kinetic Concepts Inc. said Thursday that Food and Drug Administration is dissatisfied with the response it has gotten from its LifeCell Corp. subsidiary following a government inspection in November of LifeCell-sponsored clinical studies.
The FDA also identified non-compliance with regulations covering the promotion of the Strattice/LTM breast implant product, Kinetic Concepts said in a filing with the Securities and Exchange Commission.
Kinetic said the FDA had conducted an inspection in November at LifeCell to determine if it complied with federal regulations related to its sponsorship of unspecified clinical studies.
Kinetic Concepts, based in San Antonio, said LifeCell responded to the regulators in December but received a letter May 9 warning that the FDA does not view "certain" responses as adequate.
A brief statement from Kinetic Concepts offered no additional details.
The company said it intends to respond fully to the FDA, and it believes the agency's concerns can be resolved without a material impact on company business.
But it said it cannot say when the issue will be resolved or give any guarantees that the FDA will be satisfied with its response.
Kinetic shares rose 30 cents to $58.97 in midday trading Thursday. Its shares have traded in a 52-week range of $31.84 to $59.59.