SBIR Phase I: Innovative actuating smart implant device of Transverse Tibial Transport technology for the treatment of Diabetic Foot Ulcers

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel implantable therapy paradigm for initiating autologous healing in patients suffering from Diabetic Foot Ulcers (DFUs). Severe DFU’s can result in amputations, resulting in loss of limb and subsequent decline in their quality of life. The novel proposed treatment paradigm of Transverse Tibia Transport (TTT) aims to stimulate soft tissue growth to offer a new treatment paradigm to current topical or pharmacological treatments. The system stimulates patients' regenerative mechanisms needed based on mechanical forces to cause neovascularization and circulation restoration to the diseased limb to heal the ulcer. This system aims to provide an invasive therapy option for approximately 967k US patients suffering from DFU equating to a total addressable market opportunity of $8Billion. If successful, the system will be used to treat patients with persistent DFU’s, with the future potential of expanding indications to treat less severe DFUs, other ischemic limb diseases, pressure sores and other common non-healing wounds. This Small Business Innovation Research Phase I project proposes a novel implantable system which leverages distraction osteogenesis as a treatment for diabetic foot ulcers. The objectives of this Phase 1 project are to complete the design and development of a low profile implantable Transverse Tibial Transport device integrating an active mechanical mechanism that is to transversely distract or retract a cut tibia bone segment in a programmable manner. The system will be driven using a novel mechanical actuation system that drives the TTT mechanism using a wireless controller. The first phase will be the feasibility development and testing of the distraction screw mechanism of the TTT implant device and the second phase is the feasibility development and testing of the actuation hardware platform for the implanted system. Upon com