Permanent Vascular Repair (PVR)
The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on Permanent Vascular Repair (PVR) - the development of products that can serve as permanent arterial and/or venous grafts for reconstruction and repair of traumatic injuries.
Extremity trauma is one of the most common battlefield injuries. Through advances in early field intervention and resuscitation, such injuries have become increasingly survivable. Despite progress, extremity injuries can be devastating with complex injuries to the vasculature, bone, connective tissues, muscle, and nerves. Approximately 50% of patients with complex extremity injuries have severely impaired limb function. These injuries are commonly associated with long term complications and poor functional recovery. In fact, at the same age, military personnel have doubled the rate of post-traumatic osteoarthritis compared to individuals in the civilian population. Severe extremity trauma with initial limb salvage leads to delayed amputation in approximately 14% of patients, typically following many months of repeated surgeries and attempts at rehabilitation. Only 20% of wounded military personnel who experience severe extremity trauma are ultimately able to return to service.
The field of reconstructive surgery following extremity trauma is largely characterized at present by the need for multiple, staged reconstructive procedures, and the use of often scarce autologous tissue with frequently suboptimal results, and low rates of return to duty. In many cases, the best that can be hoped for is to prepare the damaged limb for prosthetic attachment. Optimal solutions would not only provide more durable repairs, but reduce the need autologous tissue and number of surgical procedures.
This upcoming RPP seeks proposals from entities developing products that can serve as permanent arterial and/or venous grafts for reconstruction and repair of traumatic injuries. It is recognized that products intended for other indications could be repurposed. MTEC is seeking products near FDA approval, or in development beyond Phase 1, or feasibility clinical trials (at a minimum of Technology Readiness Level 5). Prototypes must demonstrate potential to fill an identified capability gap in permanent vascular repair beginning at forward echelons of medical care. At a minimum, it is expected that interested parties will either manufacture, or be able to procure products, with sufficient clinical safety data to support proceeding into clinical trials. Proposals must aim to demonstrate significant technology advancement toward regulatory approval for a vascular reconstruction indication. Types of proposed activities that are of interest include, but are not limited to regulatory filings, manufacturing, clinical trials in trauma patients or related surrogate populations, and data needed for regulatory approval.
The initial period of performance will be 12 months, with option years to pursue follow-on clinical prototype maturation. Funding for an initial award may range from $350,000-$650,000. Initial proposed efforts must include FDA engagement on clinical and manufacturing, with follow-on efforts to be determined based on feedback received. The initial award is not intended to support basic research or research involving human subjects, but follow-on awards may require clinical trials.
The RPP will be posted to the MTEC website and FedBiz Opps to notify interested parties. MTEC membership is required for the submission of a full proposal in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. MTEC members will also have the opportunity to discuss this upcoming RPP with the Government's technical lead, LTC David Saunders, at MTEC's 2nd Annual Membership Meeting on March 30, 2017 at the Southwest Research Institute, San Antonio, TX. More information about the meeting can be found at: https://mtec-sc.org/event/mtec-membership-meeting/
To support this effort, we encourage you to also consider submitting a white paper in response to the USAMRMC's open Request for Information (RFI) entitled, "Regenerative Medicine Technology for Vascular Reconstruction for Extremity Injury", numbered, W81XWH-17-M-T401. White papers are due by April 26, 2017 4:00 P.M. EST. Details of USAMRMC's RFI can be found at: https://www.fbo.gov/index?s=opportunity&mode=form&id=9aac5e72757d055ec9c4c40e105729f2&tab=core&_cview=1. Please follow the response instructions indentified in RFI.
For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts:
• Technical questions - Dr. Lauren Palestrini, PhD, MTEC Director of Research:
lauren.palestrini@officer.mtec-sc.org
• Administrative questions - Ms. Polly Graham, MTEC Program Manager,
polly.graham@ati.org
• Membership questions - Ms. Stacey Lindbergh, MTEC Executive Director,
execdirect@mtec-sc.org
Lisa A. Fisher, Advacned Technology Interative(contractor)-- Contracts Manager, Phone 843-760-3356, Fax 843-760-3356, Email lisa.fisher@ati.org
