13:11:44 EDT Fri 26 Apr 2024
Enter Symbol
or Name
USA
CA



Helius Medical Technologies Inc (2)
Symbol HSM
Shares Issued 23,377,491
Close 2018-09-19 C$ 12.63
Market Cap C$ 295,257,711
Recent Sedar Documents

Helius to create PoNS clinical experience program

2018-09-19 08:37 ET - News Release

Mr. Philippe Deschamps reports

HELIUS ANNOUNCES FIRST PARTNERSHIP TO IMPLEMENT CLINICAL EXPERIENCE PROGRAMS WITH THE INVESTIGATIONAL PONS THERAPY IN THE UNITED STATES

Helius Medical Technologies Inc. has partnered with The Ohio State University Wexner Medical Centre, a leading U.S. neurorehabilitation centre located in Columbus, Ohio, to establish the company's first clinical experience program for the company's portable neuromodulation stimulator (PoNS), an investigational medical device.

Helius's clinical experience programs (CEPs) are being sponsored by the company to be implemented in partnership with leading, early-adopter, neurorehabilitation centres in the United States, including academic and research institutions, hospital systems, and high-volume independent neurorehabilitation centres. CEPs will allow the company to offer an open-label clinical study of PoNS therapy in patients suffering from chronic balance deficit due to mild- to moderate-traumatic brain injury (TBI).

"We expect our clinical experience programs will be an important component of the company's preregulatory clearance activities because they will enable us to build relationships with leading, early-adopter, neurorehabilitation centres and key opinion leaders in the area of TBI, generate clinical evidence, and gain real-world experience in the use of our PoNS device," said Philippe Deschamps, Helius's chief executive officer. "Our clinical experience programs are open-label clinical studies that enable us to treat patients in a real-world clinical setting in advance of a 510(k) clearance for our PoNS device from the U.S. Food and Drug Administration."

Mr. Deschamps continued: "After we contract with a neurorehabilitation centre to implement a new CEP, we will obtain institutional review board approval, train the CEP site's physical therapists and then begin patient recruitment. We believe these CEPs will allow us to validate our proposed commercial model for use of the PoNS in the clinical setting after we receive 510(k) clearance. Importantly, Helius's CEPs will generate health outcomes data which we intend to use to support the value proposition of use of the PoNS device in coverage discussions with payers. Looking ahead, we expect to begin patient recruitment and enrollment at The Ohio State University Wexner Medical Centre during the fourth quarter of 2018 and we look forward to announcing additional CEP partnerships later this year."

About Helius Medical Technologies Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The company's purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain's ability to heal itself. The company's first product in development is the portable neuromodulation stimulator (PoNS).

About the PoNS device and PoNS treatment

The portable neuromodulation stimulator (PoNS) is an investigational, non-invasive, medical device.

PoNS treatment is being developed as the first and only tongue-delivered neuromodulation that combines stimulation of cranial nerves with physical and cognitive therapy to restore lost neurological function. The company's trials investigating the PoNS in traumatic brain injury are more fully discussed in the company's disclosure materials, including its annual report on Form 10-K and other filings with the United States Securities and Exchange Commission.

We seek Safe Harbor.

© 2024 Canjex Publishing Ltd. All rights reserved.