Helius Medical Technologies, a Newtown-based medical device company, has begun exploring “strategic alternatives,” including a reverse merger and licensing deal, to enhance stockholder value, writes John George for the Philadelphia Business Journal.
According to the company, the move is linked to actions, or lack thereof, by the Center for Medicaid and Medicare Services, regarding its flagship PoNS product.
The portable neuromodulation stimulator is a non-surgical device that consists of a controller and mouthpiece, delivering mild electrical stimulation to the tongue’s surface, where thousands of nerve fibers are concentrated.
Three years ago, the Food and Drug Administration approved the use of the device for short-term treatment of gait deficit caused by mild-to-moderate symptoms from multiple sclerosis.
In documents filed with the Securities and Exchange Commission, Helius stated that CMS’s “inadequate” PoNS mouthpiece pricing, along with its deferral of a reimbursement payment determination, has limited the company’s ability to advance operations and secure traditional financing.
“We disagree with the proposed pricing for the PoNS mouthpiece and are disappointed CMS has once again mapped the controller pricing to a code for fundamentally different technology,” said Dane Andreeff, Helius’ CEO.
Read more about Helius Medical Technologies in the Philadelphia Business Journal.
