To date, all clinical work has used experimental devices made in house by hand. The registrational clinical trials must be performed with the full commercial devices.
The PoNS is an investigational medical device that induces neuromodulation by stimulating the cranial nerves found in the tongue.
"Transitioning the PoNS from a laboratory setting to the commercial space requires collaborative input and decision making. HMT is rapidly expanding clinical trial activity and must be able to provide a full commercial grade device to complete the pivotal trials. Further to that, our Collaborative Research and Development Agreement (CRADA) with the US Army, who is funding development for Traumatic Brain Injury (TBI), requires HMT to provide a suitable number of devices to meet demand that may arise. Ximedica has this production capacity. With this milestone now complete we will be able to provide commercial devices in time for the pivotal trial program," said Philippe Deschamps, Chief Executive Officer of HMT.
"Thank you to Ximedica of Providence, RI for their expertise in the design and development of the PoNS," he added. Prototype validation and production scale-up activity is ongoing.
Helius intends to file for US Food and Drug Administration clearance for the PoNS device.
