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Helius Medical Technologies, Inc. Cung cấp Cập nhật Doanh nghiệp

Ngày:

  • Fourth Quarter 2021 Revenue Projected to Range from $250,000 to $260,000
  • Unaudited Year End Cash Balance of $11 million
  • Continued Progress Toward U.S. Commercial Launch of PoNS® for Multiple Sclerosis
  • Initiation of Pivotal and Investigator Initiated Trials for Use of PoNS in Stroke Patients Targeted for First Half of 2022

NEWTOWN, Pa., Ngày 26 tháng 2022 năm XNUMX (GLOBE NEWSWIRE) - Công nghệ y tế Helius, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today provided a corporate update.

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 and Paul 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
  • Dự kiến ​​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 Dane Andreeff, President and Chief Executive Officer of Helius. “We enter 2022 poised to capitalize on our efforts and success, beginning with the U.S. commercialization of PoNS for MS, with initial prescriptions expected in the first quarter of this year. Along with achieving this significant milestone, we’ll continue to advance our study of PoNS in stroke patients, as well as open more TEP Centers of Excellence. Both initiatives will offer valuable insight into the functional outcomes of PoNS therapy in MS and stroke patients. I am very excited about what 2022 holds as we take another step closer to our goal of unlocking the full potential of neuromodulation and becoming the standard of care for gait deficit.”

Our closing procedures for our fiscal quarter and year ended December 31, 2021 are not yet complete. The preliminary financial information presented in this press release reflects our current expectations based solely on information available to us as of the date of this press release and is subject to change as a result of the completion of the Company’s financial and operating closing procedures, customary audit procedures and other developments that may occur before the completion of these procedures. Accordingly, you should not place undue reliance on this preliminary financial information, which may differ materially from actual results. See “Cautionary Disclaimer Statement” below for a discussion of certain factors that could result in differences between the estimated unaudited financial information reported in this press release and actual results.

Cuộc gọi hội nghị

Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer, will host a conference call to discuss fourth quarter and full year 2021 results and provide a business update as follows:

Ngày: Thứ hai, tháng ba 14, 2022
thời gian: 5: 00 PM ET
Toll-free (U.S.) (844) 348-4652
Quốc Tế (213) 358-0895
ID hội nghị 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 (U.S.) or (404) 537-3406 (international). The conference ID for the replay is 2995141. The webcast will be archived on the Events section of the Company’s investor relations website.

Giới thiệu về Helius Medical Technologies, Inc.

Helius Medical Technologies là công ty công nghệ thần kinh hàng đầu trong lĩnh vực thiết bị y tế tập trung vào các chứng thiếu hụt thần kinh bằng cách sử dụng các công nghệ nền tảng không thể cấy ghép nhằm khuếch đại khả năng bù đắp của não và thúc đẩy sự dẻo dai thần kinh, nhằm cải thiện cuộc sống của những người đối phó với các bệnh thần kinh. Sản phẩm thương mại đầu tiên của Công ty là Máy kích thích điều hòa thần kinh di động (PoNS). Để biết thêm thông tin, hãy truy cập www.heliusmedic.com.

Giới thiệu về Thiết bị PoNS và Liệu pháp PoNS

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 the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS therapy.

PoNS cũng được phép bán ở Canada cho hai chỉ định: (i) PoNS được phép điều trị ngắn hạn (14 tuần) thâm hụt cán cân mãn tính do chấn thương sọ não mức độ nhẹ đến trung bình (“mmTBI”) và là được sử dụng kết hợp với vật lý trị liệu; và (ii) PoNS được phép sử dụng như một phương pháp điều trị ngắn hạn (14 tuần) đối với chứng hụt chân do các triệu chứng nhẹ và trung bình của MS và được sử dụng kết hợp với vật lý trị liệu. PoNS cũng được ủy quyền để bán tại Úc cho các chuyên gia chăm sóc sức khỏe sử dụng ngắn hạn như một chất bổ trợ cho chương trình tập thể dục trị liệu để cải thiện sự cân bằng và dáng đi.

Tuyên bố từ chối trách nhiệm cảnh báo

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 U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “future,” “goal,” “target,” “milestone,” “project,” “preliminary,” “on track,” “estimate,” “continue,” “aim” and similar expressions.

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 December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

Người đọc được cảnh báo không nên tin tưởng quá mức vào bất kỳ tuyên bố hướng tới tương lai nào. Các tuyên bố hướng tới tương lai trong thông cáo tin tức này được đưa ra kể từ ngày phát hành tin tức này và Công ty không có nghĩa vụ cập nhật bất kỳ tuyên bố hướng tới tương lai nào hoặc cập nhật lý do tại sao kết quả thực tế có thể khác với các tuyên bố đó ngoại trừ mức độ yêu cầu của pháp luật.

Quan hệ nhà đầu tư Liên hệ:

Lisa M. Wilson, Truyền thông tại chỗ, Inc.
T: 212-452-2793
E: lwilson@insitecony.com


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