Rokit Healthcare (376900.KQ) said it is terminating its distribution contract with Tides Medical, its U.S. partner. The company said a recent warning letter the U.S. Food and Drug Administration sent to Tides Medical arose from local marketing practices and was unrelated to any defect in the product's quality.
In a statement on the 22nd, Rokit Healthcare said the distribution contract with Tides Medical "is currently in the process of being terminated," adding that the termination had been under discussion for some time as the company pursued new business partnerships with other firms. The company said it is also seeking a new contract with a large local hospital chain to expand in the U.S. market.
The statement follows the FDA's issuance of a warning letter to Tides Medical on the 6th over the three-dimensional bioprinting system APLICOR 3D. In the letter, the FDA said Tides Medical failed to meet applicable clearance and approval requirements in selling Rokit Healthcare's APLICOR 3D in the United States.
According to the FDA, Tides Medical described the product as a liquid medication dispensing device, a Class I medical device exempt from premarket notification, but the agency determined that the intended use promoted in marketing materials fell outside the scope of that classification. Tides Medical had presented APLICOR 3D as a system that uses a patient's own adipose tissue to create customized grafts for treating acute and chronic wounds, including diabetic foot ulcers, pressure ulcers and burns.
The FDA concluded that such an intended use differs from the scope of use for a liquid medication dispensing device and therefore does not qualify for the premarket notification exemption. It called for the company to stop commercially distributing the product for that purpose and to correct the related violations.
Rokit Healthcare said the warning letter resulted from "overstated promotion that went beyond the scope of FDA regulations during the marketing process," adding that it is carrying out corrective measures within 60 days and that the matter is unrelated to any defect in product quality.
The company said it complies with all FDA medical device regulations and plans to pursue more transparent and aggressive market expansion with new partners on that basis. It added that it would share details of the process going forward in a transparent manner.