Proven Process Medical Devices Inc. announced that it has entered into a development agreement with PathMaker Neurosystems Inc. to develop and manufacture a first-in-class non-invasive device for treating patients with muscle tone disorders using trans-spinal direct current stimulation (tsDCS) technology.
Trans-spinal direct current stimulation is a novel modality for non-invasive neuromodulation that has recently emerged, driven by fundamental new understandings of spinal circuit biology. PathMaker expects its products to bring far-reaching changes in clinical practices for treating patients with neuromotor disorders. The Company’s tsDCS technology uses subthreshold direct current to directly modulate spinal circuits in a non-invasive manner using skin surface electrodes. The Company is currently developing a family of products based on tsDCS, and its first product, the MyoRegulator, will open up a new therapeutic option for patients with muscle tone disorders.
Proven Process will refine the product design, building on PathMaker’s initial prototypes, and will create the controls needed for optimized operation and patient safety. Proven Process will apply its experience providing fully integrated contract manufacturing services for complex medical devices to build the new tsDCS products for clinical trials, regulatory submission and eventual commercial distribution.
“We are delighted to be working with Proven Process as we commercialize the first clinical products based on tsDCS,” said Nader Yaghoubi, M.D., Ph.D., President and CEO of PathMaker Neurosystems. “Proven Process’ expertise and reputation with device engineering and manufacture will facilitate our efforts as we move forward with our development plans for our tsDCS-based products.”