helping repair nerve damage in patients
Peripheral nerve injury results in more than 700,000 surgical procedures each year. Of these, more than 40 percent involve the placement of either a nerve allograft (a section of nerve tissue for transplant), or a device to guide nerve re-growth and healing. There are currently several nerve guidance implants on the market, but patients only show modest benefit and regain relatively little function.
University of Michigan team Jeff Sakamoto, Ph.D., and Kendell Pawelec, Ph.D., has developed novel synthetic multi-channel scaffolds, which have demonstrated greatly improved neural regeneration. Consisting of discrete microchannels packed into an outer sheath, the scaffolding has the ability to be secured to one end of a severed nerve, and guide growth and reconnection to the transected end of the nerve.
The device consists of hierarchical porosity; at the macro scale, high-aspect ratio microchannels linearly guide bundles of axons, and at the micro scale, pores within the walls allow for flexibility and diffusion of nutrients. The device also has been shown effective in regeneration of peripheral nerves in vivo and maintaining the orientation to reduce misalignment of nerves.
The microchannel scaffold technology is a culmination of 18 years of collaboration between Sakamoto and his colleagues Mark H. Tuszynski, M.D., Ph.D., professor of neurosciences and director of the University of California San Diego (UCSD) Translational Neuroscience Institute; and UCSD research scientist Kobi Koffler, Ph.D. UCSD has contributed to the latest study by providing the critical efficacy testing, interpretation of in vivo data, and input into scaffold design and function.
Significant Need
There are more than 700,000 surgical procedures annually to correct peripheral nerve injury. Currently, there is no single nerve repair implant technology that is effective in regenerating nerves with gaps beyond 20mm, and without the need for an auto or allograft.
Compelling Science
To recapitulate damaged nerve tracts, physical guidance is required to linearly guide regenerating axons. The multi-channel scaffold technology consists of discrete microchannel arrays that mimic the native nerve architecture and dimensions. To enable implantation, the microchannels are packed into an outer sheath, with the ability to be secured to one end of a severed nerve and guide growth and reconnection.
Competitive Advantage
The nerve regeneration technology is synthetic and multi-channel, and circumvents the issues that are associated with current state-of-the-art technology. It is effective in linearly guiding nerves and consists of low cost, FDA-approved materials. Current treatments are often complex and recovery is modest with limited benefits, while the multi-channel scaffolds have shown clinically meaningful regeneration.
Overall Commercialization
- Commercialization Strategy: Establish clinical proof-of-concept and manufacturing process prior to licensing
- Intellectual Property: Contributors to University of Michigan-owned IP that involves the design and fabrication of current generation synthetic polymer scaffolds
- Regulatory Pathway: Fabrication process to be used in a 510(k) submission. Currently preparing for pre-Investigational Device Exemption (IDE) approval
- Product Launch Strategy: To be determined by licensee
Milestones
- Refinement of manufacturing processes begin with a medical device development firm to achieve >80% open lumen volume, repeatability of embossed features, and cutting cross-sections to allow greater axon penetration
- Scale up the scaffold prototypes to achieve dimensions suitable for clinical application
- Prototypes will be characterized via mechanical testing and advanced microscopy to determine kink resistance, homogeneity, and open lumen volume
- Assess clinical feasibility/efficacy in preclinical model with 25mm nerve gap
- Continue with customer discovery and create a business plan
