Naibec's Core Biomaterial Product 'Rizenomer'... "Successful Clinical Trials in Europe"

Naibec announced on the 27th that it has confirmed the efficacy and safety of its bio collagen-based periodontal regeneration material, ‘Regenomer,’ through ongoing post-market clinical trials (PMCF) in Europe and South Korea. Since the clinical trial has proven the oral tissue regeneration efficacy and superior quality of Regenomer, the core bio material product, overseas sales, especially in Europe, are expected to grow significantly.

The clinical trials are being conducted on a total of 320 patients, including 240 at the University Hospital Frankfurt in Germany and 80 at Seoul National University Dental Hospital in South Korea. Patients are divided into four groups, with a progress rate exceeding 75% so far, and statistically significant tissue regeneration has been confirmed in the patient groups. The clinical results showed no adverse effects, and sufficient bone formation was confirmed to allow implant placement. Based on the clinical trial progress, Naibec recently received an interim report, which will be submitted to regulatory authorities including the United States, Canada, and the European Commission (CE).

Regenomer is a periodontal tissue regeneration bio material fixed by a 100% pure bio collagen-based non-chemical crosslinking method, maximizing elasticity and tissue restoration efficacy. It promotes stability and tissue regeneration of the extraction socket after tooth extraction, making it one of the essential materials used before implant procedures. Naibec received FDA approval for the marketing of Regenomer in 2015 and obtained CE certification in Europe in 2021. Through global implant companies ‘Straumann’ and ‘Nobel Biocare,’ it is already exporting core implant materials to the European and U.S. markets.

A Naibec official stated, “Since we have applied it to more than 300 actual patients and verified sufficient efficacy and safety, we expect sales expansion in the European market to accelerate. Moreover, the university hospital professors who led the clinical trials in Europe also recognized the excellent efficacy and periodontal tissue regeneration effect of Regenomer, making these clinical results reliable clinical data with academic value.”

He added, “The final clinical results will be announced at the ‘2024 EAO INDUSTRY FORUM,’ the largest implant exhibition in Europe held this October. We will actively promote the excellence of the Regenomer product in the global market. With the product lineup expanding to include Regenomer following the existing bio materials OCS-B and OCS-B Collagen, overseas sales are expected to increase significantly starting this year,” he emphasized.

Naibec is actively conducting overseas clinical trials for core dental implant materials with government support. Following OCS-B, OCS-B Collagen, and Regenomer, the new product ‘Pepticol EasyGraft’ is also planned for global clinical trials. Naibec plans to aggressively target overseas markets based on stable clinical data of high value-added bio material products.

This content was produced with the assistance of AI translation services.