APLICOR 3D marketing draws FDA warning letter

The U.S. Food and Drug Administration has sent an FDA warning letter to Ties Medical, the American distribution partner of South Korea's Rokit Healthcare, over the marketing of the 3D bioprinting system APLICOR 3D. The letter, sent on Oct. 6, said the distributor was selling the product in the United States without the required marketing authorization, approval or premarket notification. The case puts aplicor 3d marketing under regulatory scrutiny.

The distributor had described the product as a liquid drug dispensing device, a Class I medical device exempt from premarket notification. The FDA disagreed. It ruled that the product's actual intended use fell outside that classification and ordered the company to stop commercially distributing it for those uses and to correct the violations.

The distinction decides what a company must file before selling a device in the United States. The distributor treated APLICOR 3D as a Class I liquid drug dispensing device, a category the FDA exempts from premarket notification. The agency ruled that the graft and wound-treatment uses in the marketing put the product outside that category, so the exemption did not apply and the required authorization was missing. The company now has to fix its marketing and its regulatory filings before it can resume sales for those uses.

Why the FDA warning letter was sent

The agency said the marketing went beyond what the Class I classification allows. The FDA warning letter pointed to promotion of the system for uses the agency had never cleared, and it required the company to fix the violations. The letter followed the agency's review of how the product was presented to American customers.

What aplicor 3d is used for

In the marketing materials, APLICOR 3D is presented as a bioprinting system that creates customized grafts from a patient's own adipose tissue and treats acute and chronic wounds, including diabetic foot ulcers, venous stasis ulcers, pressure ulcers and burns. The marketing presents the system as a way to make grafts matched to the individual patient. The FDA said those intended uses differ from the definition of a liquid drug dispensing device and therefore do not qualify for the premarket notification exemption.

Rokit Healthcare response to the aplicor 3d letter

The Korean company said the warning letter was unrelated to any quality defects in its products. "Ties Medical received the warning letter for excessive promotion exceeding FDA regulations during marketing activities, including on APLICOR 3D's brand website, and is currently implementing corrective measures within 60 days," the company said. "This warning letter does not concern any quality defects in our products."

The company said it complies with FDA medical device regulations and will keep expanding in the U.S. market with new partners. It also said it had been discussing an end to the aplicor 3d distribution agreement with the American distributor for some time, and that it is now proceeding with the termination while pursuing new contracts with major local hospital chains.

Distribution deal ends

The company said the termination talks predated the letter and were part of a search for new business cooperation with other companies. It framed the dispute as a marketing matter, not a product safety issue, and said corrective measures are underway. The bioprinting system remains the center of its push into the American wound-care market, even as it looks for a new distribution partner.