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Contract Opportunity

This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Madigan Army Medical Center (MAMC), Department of Clinical Investigation and General Surgery to procure perfused medical cadavers without competition as prescribed in FAR 13.106-1(b)(1).

The perfused cadaver model is the only available model to assist in transitioning the Gastroesophageal Resuscitative Occlusion of the Aorta (GROA) device from the animal model testing phase to human models and thus brings the device closer to use in clinical practice. The GROA device is a novel balloon occlusive device that can be used as a means of obtaining temporary hemostasis in non-compressible torso hemorrhage until more advanced surgical capabilities are available. The device has shown promise in large animal model studies and proof-of-concept testing in perfused human cadaver models is the next step in device design refinement and validity testing on human anatomy. The perfused human cadaver model is the only model that allows members of the medical team with varying levels of experience to practice placing the device while simultaneously allowing for the evaluation of effective aortic occlusion without risk of injury to live human patients.

Combat Medical Systems/ SafeGuard Medical is the only source that can provide a pulsatile pump system that mimics heart and circulatory functions with oxygenated, cryopreserved bovine whole blood (US Patent 16/189657). The technology uses a proprietary flush and sealant that provides capillary sealing that extends perfusion duration while eliminating third-spacing and associated edema. These patented-cannulation techniques and pump technology provide a pulsatile-flow producing a realistic controllable heart rate, pressure, and volume. No other vendor can provide these unique characteristics necessary for this requirement.

If this justification for the sole source procurement of the Combat Medical Systems/ SafeGuard Medical perfused medical cadavers is not approved, the study cannot be conducted which is a detriment to the mission of MAMC.

This announcement fulfills the synopsis requirements under FAR 5.102 (a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source requirement.

All questions and responses concerning this notice shall be emailed to James Cheng at james.cheng1.civ@health.mil. Interested concerns must identify their capability in writing to the above email address listed above no later than 2:00 PM ET, 8 August 2023.

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