|Acquisition Program: ||Medical Develop Program/BUMED, Family of Fleet Medical Equipment/MCSC|| Objective: ||Develop a completely artificial bone substitute material that mimics human bone and can replace long bones, facial bones and skull bones. This product would be used to accelerate wound healing from Improvised Explosive Device (IED) explosions and facial wounds from snipers which devastate warfighters. Naval forces presently exhibit 90% of the head and neck combats today in Iraq and Afghanistan.
|| Description: ||The proposed product will accelerate wound healing. IED destruction of long bone and facial features necessitate bone replacement. The present therapy utilizes bone harvesting or frozen demineralized freeze-dried cadaver bone when wounds are small. In larger wounds, metal or plastic forms are used. This technology will reduce long-term problems of current methods: limited availability, donor site morbidity, immune response, and disease transmission, & expense including multiple surgeries and long hospital stays & rehabilitation. The potential cost savings would be in excess of 500 million dollars to DoD and would effect a 30 billion dollar market.
|| ||PHASE I: Develop and optimize artificial bone matrix prototypes for testing in maxillofacial, orthopedic, and neurosurgical animal models. Prepare and characterize these prototypes as to osteoblastic integration and maturation in vitro.
|| ||PHASE II: Test prototypes artificial bone matrices for specific combat wound applications using FDA approved animal models
|| ||PHASE III: Transition to Phase I clinical trials.
PRIVATE SECTOR COMMERCIAL POTENTIAL/|| ||DUAL-USE APPLICATIONS: The potential cost savings would be in excess of 500 million dollars to DoD and would effect a 30 billion dollar commercial market. The artificial bone is applicable to non-war-related wounds (trauma such as car accidents, diseases such as bone cancer) and can be used in any medical setting.
|| References: ||
1. Kalorama's Implant-Based Dental Reconstruction: The Worldwide Dental Implant and Bone Graft Market, 2nd Edition
2. Collagen-Hydroxyapatite Composites for Hard Tissue Repair, Eur Cells Materials, 2006, 11:43-56 (http://www.ecmjournal.org/journal/papers/vol011/pdf/v011a06.pdf)
3. Nanoceramic Matrices: Biomedical Applications, Am J Biochem Biotech 2006, 2(2): 41-48 (http://www.scipub.org/fulltext/ajbb/ajbb2241-48.pdf)
|Keywords: ||Artificial Bone; Wound Healing; IEDs; maxillofacial; orthopedic; Accelerated Recovery|
Questions and Answers:
Q: What are the load requirements for the phase one material?
More specifically, would fabricated bone replacement need to support structural load as soon as its implanted?
A: There are no formal load requirements. As different bone types will have different load requirements (e.g., maxofacial vs extremities), this is dependent on the bone; it is foreseeable that some solutions will be appropriate for only certain types of bone types and have load bearing limits.
All bones would need some marginal load capability, but if that takes additional time to develop (e.g., one month before any load bearing) that would still be a reasonable approach.
Q: I am verifying the ONR solicitation N102-179 --
Can be either a Phase I or fast track Phase I/II The SBIR program solicitation fy10.2 clearly states ONLY PHASE I.
I am double checking. Could you please clarify?
A: The SBIR office could better answer this than the TPOC, but I believe that any SBIR/STTR topic is eligible for fast track if there is matching funding from an external investor. However, the fast tracking process is usually started at the end of Phase I (not prior to Phase I selection) and prior to Phase II selection; as such, the matching funding occurs at Phase II (not Phase I). It may be that a potential fast track would be worth mentioning as part of the commercialization strategy in a Phase I proposal, to the extent that is appropriate. (Please refer to the SBIR 10.2 Preface section for further information.)