PathMaker Neurosystems announces agreement with Proven Process Medical Devices for the development of non-invasive neuromodulation systems for treating neuromotor disorders
Boston, MA (May 20, 2015) – PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neuromodulation company developing novel non-invasive systems for the treatment of neuromotor disorders, today announced it has entered into a development agreement with Proven Process Medical Devices 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 made by PathMaker’s scientific advisors. PathMaker expects its products to bring far-reaching changes in clinical practices for treating patients with neuromotor disorders. The Company’s tsDCS-based systems use weak 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 MyoRegulator™ device 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 Chief Executive Officer of PathMaker Neurosystems. “Proven Process’ expertise and reputation with device engineering and manufacture will facilitate our efforts as we move forward our development plans for our tsDCS-based products.”
PathMaker Neurosystems Inc. was founded to commercialize recent breakthrough advances in the development and clinical application of trans-spinal direct current stimulation (tsDCS) for patients with neuromotor disorders. tsDCS is a novel modality for non-invasive neuromodulation that has only emerged within the last five years, being driven by fundamentally new understandings of spinal circuit biology made by our Company’s scientific advisors and their clinical work in treating patients with paralysis, muscle weakness and muscle tone disorders. More than 27 million patients in the US and Europe suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders, and the breakthrough non-invasive technology that PathMaker is developing promises to open up entirely new methods of treating these patients.
The MyoRegulator™ is an investigational device and is limited by United States law to investigational use only.
About PathMaker Neurosystems Inc.
PathMaker Neurosystems Inc. is a clinical-stage neuromodulation company founded to commercialize recent breakthrough advances in the development and clinical application of trans-spinal direct current stimulation (tsDCS) for patients with neuromotor disorders. More than 27 million patients in the US and Europe suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders, and the breakthrough non-invasive technology that PathMaker is developing promises to open up entirely new methods of treating these patients.
Press Contact: Don Goncalves, Tiziani Whitmyre, 781.793.9380, dgoncalves@tizinc.com
About Proven Process Medical Devices
Proven Process Medical Devices Inc. is one of the industry’s leading designers and manufacturers of Class II and Class III medical devices. The company was founded in 1994 to address the unmet need for an outsourced provider to the medical device industry with the in-depth technical, quality and regulatory knowledge needed to develop and manufacture sophisticated medical products. To ensure success, the company founders developed a “Proven Process,” which combines creative, state-of-the-art R&D, with exceptional design, process, and quality controls to achieve new product development and manufacturing success. For more information, visit http://provenprocess.com.