Notice of Intent to Sole Source – Therakos Inc.

The Department of Health and Human Services National Institutes of Health Clinical Center has issued a Notice of Intent to Sole Source for THERAKOS CELLEX Photopheresis System Procedural Kits. This special notice announces the agency's intention to procure five cases of Cellex USA Kits exclusively from Therakos Inc. for a total estimated value of $46,545.00. The procurement involves specialized medical kits required for Extracorporeal Photopheresis (ECP) procedures performed on Clinical Center patients. Each case is priced at $9,309 and contains three individual procedural kits that will be shipped together. The agency has classified this acquisition under NAICS code 325413 for In-Vitro Diagnostic Substance Manufacturing and PSC code 6515 for Medical and Surgical Instruments, Equipment, and Supplies.

The primary purpose of this sole source procurement is to obtain critical medical supplies for rare photopheresis procedures that have unpredictable demand patterns based on individual patient treatment plans. The agency justifies the sole source approach because these procedural kits are uniquely manufactured by Therakos and can only be used with the specific Therakos CellEx System already in place at the facility. The procurement falls under the Simplified Acquisition Threshold and will utilize FAR 13.106-1(b)(1) authority for single source purchasing. Due to the specialized nature of this medical equipment and the exclusive manufacturer relationship, no competitive bidding process is planned, and only Therakos Inc. is eligible to provide these specific procedural kits. The agency does not maintain large inventories of these supplies due to their high costs, short expiration dates, and recent product recall concerns.