-- Fourth Quarter 2021 Revenue Projected to Range from
-- Unaudited Year End Cash Balance of
-- Continued Progress Toward
-- Initiation of Pivotal and Investigator Initiated Trials for Use of PoNS in Stroke Patients Targeted for First Half of 2022 --
2021 Corporate Highlights and Achievements
- Received marketing authorization from the
U.S. Food and Drug Administration (“FDA”) for use of PoNS for short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) - Granted a second FDA Breakthrough Designation for PoNS for the treatment of dynamic gait and balance deficits resulting from a stroke
- Received authorization from the
Australian Therapeutic Goods Administration (“TGA”) for the sale of PoNS as a Class IIa medical device to improve balance and gait - Contracted with
NYU-Langone Health , the first of a targeted ten to twelve Centers of Excellence in a multi-center, company-sponsored Therapeutic Experience Program (“TEP”), an open label observational interventional trial designed to evaluate the impact of subjects’ adherence to PoNS therapy - Launched collaboration with the
Medical University of South Carolina (“MUSC”) in an Investigator Initiated Trial (“IIT”) to evaluate the effects of PoNS therapy on the recovery of gait and postural stability in chronic stroke survivors - Appointed several highly qualified individuals to restructure senior leadership team including President & Chief Executive Officer, Chief Financial Officer, Chief Medical Officer, and Vice President of Sales & Marketing,
North America - Enhanced the Board of Directors with the appointment of industry veterans
Sherrie Perkins andPaul Buckman - Raised
$24.0 million gross proceeds from equity financings to fund Company through several critical milestones including the US commercial launch of PoNS for the treatment of gait deficit due to MS
Canadian Commercial Activities
- Total of 37 authorized PoNS clinics at the end of 2021, up from 31 at the end of 2020, despite the impact of COVID-19
- Expected 4th quarter 2021 revenue increased more than 30% year over year compared to Q4 2020, and more than doubled compared to Q3 2021
- Revenue uncertainty due to COVID-19 will continue into 2022, due in part to the potential impact of the recent reinstatement of some COVID-19 restrictions in certain parts of
Canada
Key 2022 Targeted Milestones
- Initial prescriptions for PoNS for the treatment of gait deficit due to MS related to the
U.S. commercial launch projected in the first quarter 2022 - Conduct IIT stroke trial at MUSC, which will allow for observation of PoNS therapy in a real-world clinical setting; expect to enroll twelve participants during the first half of 2022
- Full expansion of TEP, with the goal of enrolling ten to twelve Centers of Excellence and fifty to sixty MS patients by mid-2022
- Initiation of pivotal clinical trial in stroke patients in the first half of 2022
Year End 2021 Financial Updates
- Unaudited 2021 year-end cash balance of
$11.0 million - Estimated unaudited fourth quarter 2021 revenues between
$250 thousand and$260 thousand
“The past year was a period of great transformation for Helius and validation of the PoNS therapy,” said
Our closing procedures for our fiscal quarter and year ended
Conference Call
Date: | |
Time: | |
Toll-free ( | (844) 348-4652 |
International | (213) 358-0895 |
Conference ID | 2995141 |
A live webcast of the call will also be provided on the Events section of the Company's investor relations website at:
https://edge.media-server.com/mmc/p/mtbio3ko.
A replay of the call will be available for one week at (855) 859-2056 (
About
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue 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, the impact of the COVID-19 pandemic, inflation, supply chain disruptions and labor shortages, 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, future clinical trials and the clinical development process, manufacturing and supply chain risks, the product development process and FDA regulatory submission review and approval process, other development activities, 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
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