Helius Medical said today it signed a $7 million strategic agreement with A&B Company Limited to develop and commercialize Helius’ Portable Neuromodulation Stimulator in China, Hong Kong, Macao, Taiwan and Singapore.
With the agreement, A&B will provide Helius with a $7 million credit facility, with $2 million drawn down and convertible promissory notes issued, the company said.
Helius said it will repay the $2 million by issuing 2.1 million shares of Helius at 96¢ per share and 1 million 3-year warrants at $1.44 per share.
With the sales and licensing transaction, A&B will assume ownership of certain Asian patents, patent applications and product support material for the PoNS device. A&B will also take over future manufacturing, clinical trials and regulatory approvals for those regions, Helius said.
“It’s a pleasure for A&B to establish a strategic relationship with Helius. There are currently no effective medical devices for the chronic neurological symptoms of traumatic brain injury. Bringing this potentially life changing technology to this significant and underserved market is an exciting prospect for A&B and fits with our vision to provide innovative solutions to those in need,” A&B owner Dr. Lam Kong said in a press release.
The PoNS device is currently being tested for safety and effectiveness in treating chronic neurological symptoms caused by disease or trauma, with an investigational registrational clinical trial being carried out in the U.S. Helius said they expect to submit the trial to the FDA for clearance sometime in 2016.
“We are very pleased to enter into this collaboration with A&B. Helius believes collaborating with an innovator in Asia will not only accelerate product evolution, but it will also provide us with a partner suited to both expand and defend intellectual property rights in these key markets” Helius CEO Philippe Deschamps said in a press release.
In August, Helius Medical said it and the U.S. Army Medical Research and Material Command have launched a phase 3 clinical trial of Helius’ portable neuromodulation stimulator.
The double-blind, randomized, sham-controlled 120-patient trial will study the safety profile and effectiveness of the PoNS device for cranial nerve noninvasive neuromodulation, Helius said. The primary endpoint at 5 weeks will be improvement in chronic balance deficit.