Cyclopharm has secured a significant competitive advantage in the US healthcare market after receiving the maximum allowable patent term extension of five years from the United States Patent and Trademark Office (USPTO), extending protection for its Technegas imaging kit until 2031. The extension provides uninterrupted market exclusivity for the nuclear medicine ventilation imaging agent in the world's largest healthcare market.
Technology and Clinical Applications
Technegas is a nuclear medicine ventilation imaging agent that behaves like a gas in the lungs, allowing it to reach the periphery of the lungs for better visualization. The technology is primarily used for diagnosing pulmonary embolism and is expanding into a growing number of additional indications. According to managing director James McBrayer, the FDA's thorough regulatory review and continued support during the patent extension process highlight the strong and differentiated clinical profile of Technegas, further reinforcing its position as the leading nuclear medicine agent for functional lung ventilation imaging.
Strategic Market Position
The patent extension follows an in-depth review by both the USPTO and the FDA that confirmed the patent covering Technegas qualified for a term extension. McBrayer emphasized that this outcome reflects several years of diligent and strategic work that progressed in the background while the company worked toward US Food and Drug Administration regulatory approval.
"This outcome validates our long-term commitment to protecting the value of our technology and provides a strong foundation as we accelerate our US commercialization efforts with additional business development personnel," McBrayer stated.
Commercial Impact and Future Outlook
The patent extension enables Cyclopharm to fully realize the technology's commercial and clinical potential in the US without the risk of near-term generic or biosimilar competition. The company is continuing to invest in a broader range of initiatives to extend protection for the Technegas platform, including new patent filings, next-generation developments and complementary intellectual property initiatives.
McBrayer noted that the patent extension provides a significant competitive advantage and ensures a clear runway for value creation in the US market, supporting the company's strategy to grow sales of its Technegas kit domestically.
