According to the minutes of a July meeting of the INVIMA Medical Devices and In Vitro Diagnostic Devices Expert Committee—recently released by the Colombian Institute for Food and Medicines (INVIMA)—the committee requested additional clarification, noting ambiguities in the product name, composition, and scope of application found in the review materials submitted by ROKIT HEALTHCARE Inc. regarding “Dr. INVIVO.”
This indicates that the committee intends to conduct a detailed review of how “Dr. INVIVO” is classified as a medical technology in Colombia and the scope of its use for patients.
The committee first requested clarification on the basis and source of the term “liquid dispenser” (Dispensador de líquidos)—listed as the generic name (como nombre) corresponding to the official product name in the submitted documents—as well as the current name of the product subject to the review process. This is interpreted as a request to clarify the product’s basic definition, as the level of regulation and the standards for demonstrating safety and efficacy vary depending on whether the device is merely equipment for dispensing liquids or a bioprinting system that uses patient-derived tissue to create regenerative patches.
The agency also requested clarification on whether the Daesang equipment consists of one or two units, and how many different products, models, versions, or firmware versions exist. Whether the 4D bioprinter “Dr. INVIVO 4D” is included in the ROKIT HEALTHCARE Inc. product line and what “APLICOR 3D” refers to in the materials were also raised as points requiring clarification. This is interpreted as an attempt to verify whether INVIMA is reviewing multiple products or versions under a single procedure.
The committee also requested that ROKIT HEALTHCARE Inc., the product manufacturer, issue an official statement clarifying whether Dr. INVIVO is designed for the treatment of diabetic foot ulcers, tissue engineering, and human organ regeneration. The committee further requested specific confirmation of whether the process involves harvesting a patient’s adipose tissue to create an autologous extracellular matrix (ECM)-based bioink, loading it into a printer to produce a skin patch, and then implanting it into the wound site. Additionally, the committee requested verification of the accuracy of the promotional claim “the world’s first sterile 4D organ regenerator,” as well as the submission of publicly available promotional materials and the official website.
In Colombia, 3D and 4D bioprinters that use bio-ink containing human-derived tissue or its derivatives are subject to INVIMA regulation if they produce outputs classified as medical devices or pharmaceuticals. In particular, the agency explains that products created using such equipment are generally classified as cell therapies, and technologies lacking sufficient evidence of safety, performance, and efficacy may only be used on patients in clinical trials.
The committee stated that it would maintain its previous opinion on Dr. INVIVO, issued in February 2023, until the requested safety response is submitted. At that time, INVIMA had determined that Dr. INVIVO constituted an integrated system that could not be easily classified as a simple medical device and could only be used in clinical trials approved by local regulatory authorities. The explanation states that to obtain local authorization for the use of the device, clinical studies must be submitted through the relevant procedures of the Directorate of Medical Devices and Other Medical Technologies or the Directorate of Medicines and Biological Products.
Given that local regulatory authorities have announced they will re-examine the product name, composition, intended use, and processes for utilizing patient tissue for ROKIT HEALTHCARE Inc.’s product, it has become increasingly likely that additional time will be required for local commercialization and revenue generation.
Previously, in November 2020, ROKIT HEALTHCARE Inc. signed a 10-year exclusive supply agreement for its skin regeneration platform with Elixim Biopharmaceuticals, covering Colombia, Peru, and Ecuador, and has been pursuing expansion into Latin America. According to the 2024 business report, the contract covers printers and kits, with a total order volume of 74,522 units valued at $89.5 million.
However, following recent licensing issues with its U.S. distribution partner and ongoing regulatory uncertainty in Colombia, questions are mounting regarding the company’s ability to execute its overseas business operations. In the U.S., the FDA issued a warning letter on the 6th of this month, pointing out that Tizes Medical had distributed APLICOR 3D as a medical device for wound treatment without obtaining the necessary premarket authorization or approval. ROKIT HEALTHCARE Inc. is distancing itself from the matter, stating that it arose during the distribution partner’s product promotion and sales process. The company also announced that it has begun the process of terminating its contract with Ties Medical.
A bioindustry official said, “To move toward commercialization, the product definition, treatment process, and clinical evidence must be reorganized to comply with local regulatory systems, but even that remains uncertain at present,” adding, “In Latin America as well, the timeline for generating revenue could be delayed or the project could be derailed.”
Edaily asked ROKIT HEALTHCARE Inc. for its position on the status of the local licensing process in Colombia and INVIMA’s request for additional clarification, but the company did not respond.
