“Dr. Langston is a renowned clinical researcher of current and advanced topics in MS management and patient-centered care. His interest in PoNS Therapy has led him to be one of the first PoNS prescribers and his growing experience with this therapy, along with a long-standing commitment to improving MS patients’ condition, makes him a remarkable contributor to the PoNSTEP study,” said
“The MS patients we treat are often in the prime of their lives. At Montefiore, we believe it’s important to understand all MS treatments available in order to guide our patients in choosing their best path. We strive to help them navigate their illness by exposing them to innovative therapies as well as giving them the opportunity to participate in advanced clinical trials. I’ve been an early adopter of PoNS Therapy to help my patients improve their gait and I'm excited to join the study,” stated
About
As the academic medical center and University hospital for
Montefiore is ranked among the top hospitals nationally and regionally by
The mission of Montefiore is to heal, to teach, to discover and to advance the health of the communities it serves. From its beginning in 1884, as a facility for the care of patients with tuberculosis and other chronic illnesses, to the new millennium, Montefiore has been at the forefront of patient care, research and education and steadfast commitment to its community.
About The Madlyn Borelli Multiple Sclerosis Center
The Madlyn Borelli Multiple Sclerosis Center at
With access to the latest advances in MS care, The Madlyn Borelli Multiple Sclerosis Center offers FLAIR (Fluid-Attenuated Inversion Recovery) imaging technology for improved diagnosis. In addition to diagnosis and treatment, the center provides rehabilitation services, including physical and occupational therapy as well as support and educational programs for patients and their families.
The Madlyn Borelli Multiple Sclerosis Center is a designated
About the
Burke Rehabilitation is a not-for-profit healthcare organization devoted solely to acute physical rehabilitation. Its main campus is located in
About the PoNS Therapeutic Experience Program
The PoNS Therapeutic Experience Program (“PoNSTEP”) is a Helius-sponsored, open label observational, interventional multi-center outcome research trial designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis (MS) in a real-world clinical setting. The study will rate subjects’ adherence to PoNS therapy, which combines the PoNS device with physical therapy, to better understand the relationship between adherence to the treatment regimen and therapeutic functional outcome. The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS therapy. The secondary endpoint is improvement of gait and balance deficit over time and clinical global impression of change.
The study is currently undertaken at six site and aims to recruit up to seven or eight Centers of Excellence across
About
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative orally-applied, non-implantable medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device is indicated for use in
PoNS is also authorized for sale in
Cautionary Disclaimer Statement
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, disruptions in the banking system and financial markets, lingering impacts of the COVID-19 pandemic, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, labor shortage and supply chain risks, our ability to maintain and enforce our intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, our operating costs and use of cash, and our ability to achieve significant revenues, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
Investor Relations Contact
T: 212-452-2793
E: lwilson@insitecony.com
Source:
2023 GlobeNewswire, Inc., source