TRANBERG™ Thermal Therapy System

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to CLINICAL LASERTHERMIA SYSTEMS AMERICAS, INC., Irvine, California 92618-2872, UEI: KU6UB56YBMP1for the Clinical Center/ National Cancer Institutes. The National Cancer Institute’s offering diagnosis and treatment of cancer.

The TRANBERG Thermal Therapy System can be configured for MR/US fusion-guided procedures using real-time tissue temperature measurements for precise therapy and ablation control. It includes a desktop mobile laser unit, innovative non-cooled laser applicators, tissue temperature probes, and procedure specific accessories. The TRANBERG system can be deployed in either a trans perineal or transrectal approach. TRANBERG™ Thermal Therapy System is used to provide laser focal therapy of localized prostate cancer.

The procedure is minimally invasive and can be performed at a urology clinic or radiology department. Side effects are minimal and typically the patient can return quickly to normal life. Image and needle guidance is used for navigating and positioning the sterile introducer and laser applicator at the correct location in the target tissue, using either the transrectal or transperineal access path.

The TRANBERG system can be seamlessly integrated with an existing ultrasound fusion system in conjunction with a (stereotactic) needle guide system and a workflow very similar to that used for targeted biopsies. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.

The total dollar value of this purchase order shall not exceed the SAT at $250,000.00. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.

Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Each response should include the following Business Information: a. UEI b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, HUBZone, veteran owned, etc.) as validated in System for Award Management (SAM).

All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Gregory Noland, Contract Specialist, gregory.noland@cc.nih.gov by the due date (02/23/2024) and time (1400) marked in this notice.