COLORCOM GROUP Launches New Medical-Grade Silicone Material with FDA Breakthrough Device Designation

COLORCOM GROUP has achieved a significant technological breakthrough with the launch of its proprietary KeySil™ Ultra medical-grade silicone series, which has received the U.S. FDA’s "Breakthrough Device Designation" for its revolutionary anti-calcification properties and biocompatibility. The KeySil™ Ultra material employs a dynamic molecular cross-linking design and nano-scale surface topology engineering, reducing protein adsorption by 90% while matching human tissue elasticity (0.5-20 MPa adjustable range), extending the lifespan of implantable medical devices (e.g., cardiac valves, neurostimulators) to over 15 years. Currently integrated into third-generation artificial heart projects with leading global medical device manufacturers, clinical trials show a 42% reduction in calcification-related complications. To meet growing demand, CC Group’s new Class 10000 cleanroom facility in Zhejiang will commence operations in Q4 2024, boosting annual medical silicone production capacity to 5,000 tons. The facility also houses Asia’s first Medical Material Accelerated Aging Testing Center, capable of simulating 10-year in-body degradation processes. In sustainability, the Group’s innovative Silicone-Hydrogen Co-Production System recycles byproduct hydrogen to cut annual carbon emissions by 12,000 tons, while supercritical CO₂ technology regenerates medical-grade material scraps, achieving 98% utilization efficiency. Recognized as a national green manufacturing model by China’s MIIT and awarded TÜV Rheinland’s "Zero-Carbon Factory" certification, these advancements solidify CC Group’s leadership in both medical innovation and sustainable production.