Inventera (0007J0) said its nano-based magnetic resonance imaging contrast agent candidate INV-002 succeeded in a Phase 3 trial in South Korea, and the company plans to file for product approval with the Ministry of Food and Drug Safety this year.
Inventera said on the 21st that it had received the final clinical study report for the Phase 3 trial and confirmed statistically significant improvement across all primary endpoints. The trial enrolled 85 patients with known or suspected shoulder joint disorders who required MR arthrography, comparing non-contrast MRI with the drug on key image-quality measures including joint distension, contrast and sharpness.
INV-002 is a next-generation contrast agent that applies nanotechnology to biocompatible materials such as iron instead of gadolinium, which carries safety concerns, to improve image quality and diagnostic accuracy. It is being developed for use in MR arthrography to diagnose musculoskeletal disorders. No contrast agent is currently approved for MR arthrography.
With the final report in hand, Inventera plans to pursue product approval and commercialization of INV-002. "Based on this final results report, we plan to file for product approval with the drug safety ministry in the fourth quarter of this year," Chief Executive Shin Tae-hyun said. "After obtaining approval, we expect meaningful revenue from INV-002 to begin next year, and we will use the commercialization of an in-house developed drug as a springboard to accelerate Inventera's growth."
South Korea's contrast agent market is estimated at about 500 billion won ($360 million), with X-ray and CT agents accounting for roughly 440 billion won and MRI agents about 66 billion won. Business Research Insights projects the global contrast agent market will expand from 13.16 trillion won in 2022 to 17.42 trillion won in 2031, growing at an average annual rate of 3.2%.
