Sole source contract to continue studies into developing a FDA-approved synthetic platelet to treat hemorrhage

The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR 6.302-1 to Case Western Reserve University (CWRU), 10900 Euclid Avenue, Cleveland, Ohio, 44106 to continue the Navy’s studies into developing a FDA-approved synthetic platelet to treat hemorrhage. The proposed research is a continuation of a previous study performed by a CWRU laboratory and funded by the Defense Health Program (DHP). Previous work has completed the research and development to demonstrate that the synthetic platelet is effective in significantly decreasing bleeding in a rat major femoral artery injury. Thus, the lab has already assembled an extensive team of trained scientists and technical staff capable of performing this important research. The study will perform testing of the synthetic platelets in a large animal model of trauma that mimics human trauma. The model used will mimic non-compressible injuries sustained by military personnel and permits direct comparison to other hemostatic interventional studies. The estimated value of the contract is $162,121.00. No other vendors are capable of performing this work because only the laboratory of Dr. Erin Lavik’s at CWRU has the synthetic platelets. They are the sole manufacturer of this product and have a patent pending. The proprietary nature of the platelets means that there are no other companies who have or could obtain the platelets. This Notice of Intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All capability statements received by 9:00 AM Eastern Time, 5 JULY 2012 will be considered by the Government. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to contact@example.gov.