Naivec Enters Clinical Trials for Photoresponsive Peptide Tissue Regeneration Inducer

Naivek announced on the 27th that it has officially commenced clinical trials to evaluate the safety and efficacy of 'Pepticol EasyGraft,' the world's first photoresponsive peptide tissue regeneration inducer. This clinical trial, conducted with a total of 114 patients at Seoul National University Dental Hospital, Kyung Hee University Dental Hospital, and Gachon University Gil Medical Center, compares and evaluates the alveolar bone changes between Pepticol EasyGraft and absorbable periodontal tissue regeneration inducers.

This clinical trial is considered a crucial step for domestic and international market entry. By proving superior bone regeneration effects and safety compared to existing periodontal tissue regeneration inducers, it is expected to secure the quality competitiveness of Pepticol EasyGraft.

In December last year, Naivek submitted a pre-submission to the U.S. Food and Drug Administration (FDA) to obtain approval for Pepticol EasyGraft. A meeting with the FDA is scheduled for next month, during which in-depth discussions necessary for FDA product approval of Pepticol EasyGraft will take place.

Pepticol EasyGraft is a dual-functional biomaterial that combines high-purity collagen functional active substances with regenerative functional peptides. It exhibits excellent effects in suppressing periodontitis and promoting bone regeneration. Using light as a catalyst, it enhances the release and structural stability of peptides. Based on these characteristics, it is attracting market attention for its potential applications in various medical fields such as dentistry, orthopedics, surgery, and dermatology.

Naivek developed Pepticol EasyGraft as a next-generation tissue regeneration inducer with support from the Pan-Ministry Full-Cycle Medical Device Project Group. Not only has safety been proven through various toxicity tests during the development stage, but patents have also been filed for the formulation platform and anti-inflammatory peptide technology. The company explains that it is solidifying Pepticol EasyGraft’s unique position in the global market through research and development capabilities and establishing strong entry barriers.

A Naivek representative stated, "Pepticol EasyGraft is an innovative product with very high applicability due to its dual-functional biomaterial nature, and it will present a new paradigm in tissue regeneration therapy. Since efficacy and safety have been confirmed through precise preclinical studies, we expect domestic clinical trials to proceed rapidly."

He added, "We will also expedite the FDA product approval process to accelerate global market entry. We have received significant interest and partnership requests not only from existing partners but also from global pharmaceutical companies, so immediate overseas exports will be possible upon FDA product approval," emphasizing the company’s outlook.