Today we put out our first press release and we’re pretty excited about it because it captures three critical milestones that mark the end of our “make-or-break” year:
- We now have a new partnership with Synapse Biomedical, Inc., who will serve as the manufacturer of our technology;
- We received FDA approval for our 10-patient Early Feasibility study for hand grasp and trunk stability; and
- We received significant support by the Craig H. Neilsen Foundation totaling $1.05M, which directly supports our plans for a novel business model.
In this post, and the next two, we’ll walk through each of these milestones and what they mean for the future of the IFR and for people with spinal cord injury.
Part 1. Built to Last: Our Partnership with Synapse Biomedical
Over the next three years, all the manufacturing process responsibilities for the Networked Neuroprosthesis will be handed over to our new manufacturing partner, Synapse Biomedical, Inc., who will bring them into what the FDA calls a “full Quality System.” As we go from building a few NNP systems for use in our clinical trial to full-scale production after market approval, Synapse Biomedical will oversee the expansion of our manufacturing capabilities. We signed the agreement with Synapse Biomedical earlier this week, but our partnership has been in development for more than a year, during which time they were working to engage critical partners at the University of Tokyo.
Our goal is to have Synapse Biomedical serve as the manufacturer of technology, with University of Tokyo contributing to certain manufacturing processes as well as design. We have a lot of confidence in Synapse Biomedical as our partner because they’ve already demonstrated success bringing sophisticated technology to people with SCI: their diaphragm pacing system, NeuRx®, has been used worldwide by more than a thousand people with spinal cord injury or ALS to restore respiration without a ventilator. They’ve got a strong track record marketing their system in over two dozen countries. Plus, they’re a fun, hard-working group with strong ties to Case Western Reserve University, and a mission that lines up with our own. So how has the NNP been built to date? Up to now, our engineering team at Case Western Reserve University has been the final overseer of a number of contract manufacturers who build the subassemblies and components of the NNP. (We’ll introduce them in later posts.) We’re able to do this because we have decades of experience with our earlier generation systems and have built up the expertise and facilities to do light manufacturing and testing. Within our Technical Development Laboratory (TDL), our engineering team serves as a resource for design, development, fabrication, and testing of all of our implants and external systems, instrumentation, and software. The TDL’s facilities include a cleanroom, micro- fabrication lab, machine shop, electronics lab, embedded systems lab, computer lab, and staff offices, all located on CWRU’s engineering campus.
This part of our work is supported by a $3M grant from the State of Ohio (Ohio Third Frontier Innovation Platform Program) secured by Case Western Reserve University in 2013. Through this new partnership with Synapse Biomedical, we can proceed with strengthening our manufacturing processes, putting a critical piece of the puzzle in place.
– Megan Moynahan, Executive Director, Institute for Functional Restoration