Intellectual property & regulatory
Aclara's commercial position rests on two pillars: a patent estate over the multilayer photoreactive fabric media and its manufacturing method, issued in the U.S. and advancing internationally, and an exclusive worldwide license from the universities that invented it. On the regulatory side, the company has completed two FDA Q-Submissions and is preparing a 510(k) premarket notification for its antimicrobial surgical mask program.
Patent estate
| Territory | Reference | Status |
|---|---|---|
| United States | U.S. Patent No. 11,975,221, “Anti-Microbial Multilayer Fabric Media And Method For Making Same” | Issued |
| Canada | Canadian application No. 3,205,374 | Allowed (2026) |
| European Union | International application chain | In process |
| United Kingdom | International application chain | In process |
The issued claims cover the multilayer fabric media and the method of making it: the media architecture and its manufacturing process.
License position
Plum Spun Inc. holds exclusive worldwide commercialization rights to the patented technology under licenses from the George Washington University and UC Riverside. The inventors’ rights are assigned; the ownership chain is documented; and the company’s license is the commercial foundation beneath every product and partnership.
Regulatory program
Aclara has engaged the FDA directly, twice, through the Q-Submission process and used that feedback to shape its regulatory strategy. The current program is a 510(k) premarket notification for an antimicrobial-treated surgical mask, a defined Class II pathway with cleared predicate devices and an established special-controls framework.
Pre-Submission feedback from the FDA has informed the predicate strategy, the claim architecture, and the testing plan, which reduces program risk before the filing.
The submission package is in active preparation, with university high-containment laboratories performing the supporting performance testing. See Research.
Antimicrobial surgical masks are a recognized Class II device category with cleared predicate devices. This pathway has precedent.
Status: the 510(k) has not been filed and no Aclara product is cleared. What a partner gets is a mapped pathway with two rounds of FDA feedback behind it, not a promise of its outcome.