[Edaily Reporter KIM SAE-MI ] #ROKIT HEALTHCARE Inc. explained that the U.S. Food and Drug Administration (FDA) warning letter regarding its product “APLICOR 3D” stemmed from “excessive promotion” by a local distributor. However, the FDA explicitly stated that the product was distributed in the U.S. without the necessary marketing authorization or approval. As it remains uncertain whether changing distributors will resolve the regulatory issues, concerns are mounting that the company’s U.S. skin regeneration business could face setbacks.

According to the biotech industry on the 26th, the FDA published a warning letter on its website on the 20th (local time) that it had sent to the U.S. medical device distributor Tides Medical. The warning letter was sent to the CEO of Tides Medical on the 6th.

In the warning letter, the FDA stated, “We have determined that Tides Medical is distributing APLICOR 3D in the United States without the required marketing authorization or approval.” The FDA demanded that the company cease activities that constitute violations of the law—including the commercial distribution of the product for the indicated uses—and take corrective action. The agency warned that failure to properly implement corrective actions could result in additional regulatory measures, such as product seizure, court injunctions, and civil monetary penalties.

News of the warning letter’s issuance on the 22nd also caused ROKIT HEALTHCARE Inc.’s stock price to fluctuate in the domestic market. In response, the company issued a statement on the same day explaining, “The FDA warning letter pertains to an issue arising from Ties Medical’s marketing activities,” and added, “We received the warning letter due to excessive promotion—beyond FDA regulations—in marketing processes such as on the brand’s website.” The company further emphasized, “This warning letter does not pertain to any quality defects in our products.”

ROKIT HEALTHCARE Inc. explained that it is also in the process of terminating its distribution agreement with Tizes Medical. The company stated that this was an issue that had been under discussion for some time as part of efforts to pursue new business partnerships, and that it is currently working on a new contract with a major U.S. hospital chain. It also revealed that Tizes Medical is implementing corrective measures within 60 days.

U.S. FDA Points Out Unauthorized Distribution for Wound Treatment… Differs from Registered Intended Use

The crux of this issue is that the

intended

use of the medical device registered with the FDA

differs from

the

intended

use as advertised and distributed in the U.S. market.

Tizes Medical argued that APLICOR 3D is a Class I “liquid medication dispenser,” a product exempt from premarket notification requirements. This classification applies to devices that dispense a specific amount of liquid medication for medical purposes.

However, according to Tizes Medical’s promotional materials cited by the FDA in its warning letter, the APLICOR 3D was introduced as a three-dimensional (3D) bioprinting system that creates customized grafts from the patient’s own adipose tissue to treat acute and chronic wounds, such as diabetic foot ulcers (diabetic foot), pressure ulcers, and burns.

The FDA determined that this therapeutic purpose differs from the intended use of conventional liquid medication dispensers and therefore exceeds the scope of the premarket notification exemption. Consequently, the agency pointed out that the required premarket notification had not been filed, and that neither a valid premarket approval nor an approved investigational medical device exemption had been obtained.

The issue is that the wound treatment function cited by the FDA is a core feature of the skin regeneration platform that ROKIT HEALTHCARE Inc. has been pursuing for commercialization in the United States. Given that Ties Medical has been distributing APLICOR 3D—manufactured and supplied by ROKIT HEALTHCARE Inc.—locally, it is questionable whether this warning letter can be viewed solely as a marketing issue specific to the distributor.

A securities registration statement submitted last June by Rokit America, ROKIT HEALTHCARE Inc.’s U.S. subsidiary, to the U.S. Securities and Exchange Commission (SEC) also explicitly states that the integrated skin regeneration platform has not received FDA authorization or approval for specific clinical indications.

This issue is also related to concerns raised by PharmDaily last May. At the time, PharmDaily reported that while ROKIT HEALTHCARE Inc.’s core 3D bioprinter and kits were registered with the FDA as liquid drug dispensers, their registered intended use did not include tissue regeneration capabilities. (Related article ☞ <ROKIT HEALTHCARE Inc., Promoting an ‘AI Organ Regeneration Platform,’ Had Different FDA Registration Details>)

Furthermore, Pharm E-Daily had previously raised questions about whether a regenerative therapy business utilizing autologous adipose tissue could be commercialized based solely on medical device registration. (Related article ☞ <ROKIT HEALTHCARE Inc.: Commercialization in the U.S. Impossible with Registration Alone... May Exceed FDA Standards>)

This warning letter is noteworthy in that it confirms, through the FDA’s official determination, the regulatory concerns raised at the time—at least regarding APLICOR 3D’s use for wound treatment.

Regulatory Issues Persist Even After Changing Distributor… Concerns Over Setbacks in U.S. Skin Regeneration Business

It is also questionable whether

regulatory issues

can be resolved simply

by changing distributors

. This is because the FDA’s concerns extend beyond the promotional activities of a specific distributor to the intended use for which APLICOR 3D is being commercially distributed. Even if a new distributor sells the product for the same therapeutic purpose, the regulatory requirements applicable to that use remain unchanged.

This issue is not limited to 3D printers; it may also affect the sale of the kits. According to the FDA’s medical device registration information, the “APLICOR 3D KIT”—a single-use product—is also registered as a Class I liquid drug dispenser under the same product code (KYX) as the printer. The FDA warning letter does not specify that the issues are limited to the printer unit itself.

The company’s explanation regarding the deadline for corrective action also requires further verification. ROKIT HEALTHCARE Inc. mentioned taking corrective action within 60 days, but the publicly released FDA warning letter specifies that the company must submit a written response detailing the corrective actions and a plan to prevent recurrence within 15 business days of receipt. If it is difficult to complete the actions within the deadline, the company must submit the reasons for the delay and a revised completion schedule. The basis for the 60-day deadline cited by the company has not been confirmed.

It is also noteworthy that the FDA has been exchanging Seohan with Tizes Medical since last February. According to a footnote in the warning letter, the FDA sent a Seohan to Tizes Medical on February 25, and Tizes Medical replied the following day. It remains unclear whether ROKIT HEALTHCARE Inc. was aware of the regulatory issues at that time or when it began discussions to terminate the distribution agreement. A ROKIT HEALTHCARE Inc. official declined to comment on when discussions regarding the termination of the agreement began, stating, “I cannot comment on that.”

As of the 26th, ROKIT HEALTHCARE Inc. has not presented any specific regulatory basis that would allow it to continue sales for therapeutic purposes, as cited by the FDA. It also remains unclear whether actual sales in the U.S. have been suspended or what impact this will have on revenue. Regardless of the change in distributor, how the company resolves the regulatory issues raised by the FDA is expected to be the key to the future of its U.S. skin regeneration business.

Nevertheless, the company believes this incident will have minimal impact on its U.S. operations. The company asserted, “This is an issue related to our former partner’s excessive marketing and promotion of medical procedures, and it has no connection to our quality or business,” adding, “We are currently in the final stages of smoothly concluding a direct sales agreement with a major U.S. healthcare partner.”

Furthermore, the company stated, “We have completed discussions regarding supply chain and inventory reviews for adoption by 28 major hospitals and approximately 1,000 other hospitals, the finalization of CPT codes for related medical procedures, and clinical demonstration plans for each hospital, and are now in the final legal review stage,” adding, “We will share updates as soon as the contract is finalized.”