Gait Apraxia

PORTLAND, Maine, March 6, 2025 /PRNewswire/ -- MedRhythms today announced that MR-005, the company's neurorehabilitation system to support gait rehabilitation and motor function in adults with Parkinson's disease (PD), has been listed as a Class II, Rx-only medical device with the U.S. Food and Drug Administration (FDA). The company unveiled the system's brand name: Movive™. "Movive leverages the well-researched power of rhythmic auditory stimulation (RAS) for people with PD and is the second device to launch from MedRhythms' proprietary platform," said Brian Harris, Co-Founder and CEO of MedRhythms. "This is an exciting step for MedRhythms as we advance our mission to use music to address significant mobility challenges for people with neurologic injury and disease, including PD. We look forward to Movive's potential to support gait rehabilitation in PD, addressing a significant need." PD is the fastest growing neurodegenerative disease in the world. According to the Parkinson's Foundation, nearly one million Americans have PD, including 110,000 Veterans, making it the second most common neurodegenerative disease. Gait impairment and loss of motor function are defining symptoms of PD, with walking and mobility as the number one patient-reported challenge. Rhythmic auditory stimulation (RAS) and other neurologic music therapy interventions are well-established strategies for gait and motor rehabilitation in PD. However, use of RAS has been limited due to historic barriers to access. Movive is designed to expand access to individualized, progressive, and engaging RAS that is delivered autonomously in the patient's home. Movive is expected to launch in select US markets in Q2 2025. To learn more about Movive and its music-based mechanism-of-action, visit: . Join MedRhythms at the Association of VA Neurology Services (AVANS) Annual Meeting, March 7-9 About MedRhythms MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music (via a partnership with Universal Music Group) with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. The company's product for chronic stroke walking deficits received Breakthrough Device Designation in 2020, and the company raised a Series B financing round in 2021 led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine. For more information, visit . Forward-Looking Statements THIS MANAGEMENT COMMENTARY CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO THE COMPANY THAT ARE BASED ON INFORMATION AVAILABLE TO US AS OF THE DATE HEREOF. STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS ABOUT THE COMPANY'S BELIEFS, DESIGNS, ANTICIPATION, AIMS, GOALS, EXPECTATIONS AND POTENTIAL RESULTS ARE FORWARD-LOOKING STATEMENTS. IN ADDITION, THE WORDS "WILL," "MAY," "BELIEVE," "ANTICIPATE," "INTEND," "ESTIMATE," "EXPECT," "PROJECT," "PLAN," "SHOULD," "COULD," AND SIMILAR EXPRESSIONS, AND THEIR VARIATIONS AND NEGATIVES, AS THEY RELATE TO THE COMPANY OR THE FUTURE PERFORMANCE OF THE COMPANY, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH FORWARD LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES, ASSUMPTIONS AND OTHER IMPORTANT FACTORS THAT COULD CAUSE THE COMPANY'S ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF RESULTS TO DIFFER MATERIALLY FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH FORWARD LOOKING STATEMENTS. THIS MANAGEMENT COMMENTARY SPEAKS ONLY AS OF THE DATE HEREOF AND THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO UPDATE THIS COMMENTARY IN THE FUTURE. Contact [email protected] SOURCE MedRhythms WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The Centers for Medicare and Medicaid Services (CMS) assigned a new, unique Health Care Common Procedure Coding System (HCPCS) code to InTandem under Medicare's Durable Medical Equipment (DME) Benefit category E3200, as the new code, will go into effect on October 1, 2024 InTandem is indicated to improve walking and ambulation in chronic stroke and is intended to be used in the home for the physical rehabilitation of ambulatory adults. PORTLAND, Maine, Aug. 22, 2024 /PRNewswire/ -- MedRhythms, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) established a new reimbursement code for the company's flagship product, InTandem, the only clinically validated, prescription medical device that delivers rhythmic auditory stimulation (RAS) in the home to improve walking and ambulation in chronic stroke patients. Continue Reading InTandem(R) includes shoe-worn sensors, a headset, and a touchscreen control unit. In its final determination, CMS established a new HCPCS code to describe InTandem: E3200 (gait modulation system, rhythmic auditory stimulation, including restricted therapy software, all components and accessories, prescription only). CMS also determined that InTandem qualified under Medicare's durable medical equipment (DME) benefit category based on InTandem's durability and indication for home use. The CMS decision to issue a new code for InTandem underscores recognition of this significant unmet need in chronic stroke. A consistent barrier for patients with chronic stroke is a lack of access to rehabilitation once they have returned to the home. "As a clinician, I'm far too familiar with the challenges stroke patients face in accessing treatment, particularly in the chronic phase of stroke recovery," said Brian Harris, MedRhythms' Co-Founder and CEO. "The establishment of this HCPCS code offers new hope to chronic stroke patients who are battling walking deficits, and advances MedRhythms mission to bring effective care to patients who need and deserve to have access to it." InTandem delivers individualized, progressive RAS therapy in the home setting, producing gait quality and speed improvements to drive improved health outcomes and reduce the risk of adverse health events common in post-stroke patients. By leveraging wearable, clinical-grade gait sensors and a hardware control unit containing adaptive algorithms and clinically optimized music, InTandem automates the key principles of effective RAS therapy, in combination with best practices for neurorehabilitation interventions: individualization, progression, and challenge. InTandem's unique integration of advanced hardware, software, and best clinical practices enables patients to access this evidence-based intervention independently at home. "InTandem's personalized approach, grounded in the neuroscience of RAS and neuroplasticity, positions InTandem as an effective clinical intervention for chronic stroke patients seeking to improve their walking ability and overall mobility," said Dr. Alexander Pantelyat, Associate Professor of Neurology at the Johns Hopkins University School of Medicine. Jennifer Lavanture, MedRhythms' VP of Business Development and Corporate Strategy, continued: "These CMS decisions are crucial developments in the path to provide access to this groundbreaking treatment to patients. MedRhythms commends CMS for their thoughtful consideration, and we greatly appreciate the time and efforts of the many patients, clinicians, and stakeholders who provided input and support throughout this process." The new code for InTandem will become effective October 1, 2024. InTandem, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2020 and was listed as a Class II medical device in July 2023, is designed to be used by people with chronic stroke gait impairment. Results of a multi-site randomized controlled trial that demonstrated the clinical benefits and safety of InTandem were published in Nature Communications earlier this year. InTandem Indication and Intended Use InTandem is indicated to improve walking and ambulation in chronic stroke, and is intended to be used in the home for the physical rehabilitation of ambulatory adults. For full prescriber information, including important safety information and Instructions for Use (IFU) visit: . About MedRhythms MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company's platform combines sensors, software, and music with advanced neuroscience to target neural circuitry. The company is developing a pipeline of products across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson's disease. In 2021, the company partnered with Universal Music Group and raised a Series B financing round led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine. For more information, visit . MedRhythms and InTandem are trademarks of MedRhythms, Inc. Forward-Looking Statements THIS MANAGEMENT COMMENTARY CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO THE COMPANY THAT ARE BASED ON INFORMATION AVAILABLE TO US AS OF THE DATE HEREOF. STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS ABOUT THE COMPANY'S BELIEFS, DESIGNS, ANTICIPATION, AIMS, GOALS, EXPECTATIONS AND POTENTIAL RESULTS ARE FORWARD-LOOKING STATEMENTS. IN ADDITION, THE WORDS "WILL," "MAY," "BELIEVE," "ANTICIPATE," "INTEND," "ESTIMATE," "EXPECT," "PROJECT," "PLAN," "SHOULD," "COULD," AND SIMILAR EXPRESSIONS, AND THEIR VARIATIONS AND NEGATIVES, AS THEY RELATE TO THE COMPANY OR THE FUTURE PERFORMANCE OF THE COMPANY, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH FORWARD LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES, ASSUMPTIONS AND OTHER IMPORTANT FACTORS THAT COULD CAUSE THE COMPANY'S ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF RESULTS TO DIFFER MATERIALLY FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH FORWARD LOOKING STATEMENTS. THIS MANAGEMENT COMMENTARY SPEAKS ONLY AS OF THE DATE HEREOF AND THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO UPDATE THIS COMMENTARY IN THE FUTURE. CONTACT [email protected] SOURCE MedRhythms

-- Significant step toward reimbursement for the only medical device approved in the U.S. for treatment of gait deficit due to multiple sclerosis (“MS”) -- -- Proceeds from recent stock issuances through the Company’s At-The-Market (“ATM”) program extends cash runway into the third quarter 2024 -- NEWTOWN, Pa., March 04, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that the Centers for Medicare & Medicaid Services (“CMS”) has assigned Healthcare Common Procedure Coding System (“HCPCS”) Level II codes A4593, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime” to describe the PoNS controller and A4594, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, mouthpiece each” to describe the PoNS mouthpiece. The new HCPCS codes will be effective April 1, 2024. “PoNS Therapy® is life-changing for people who suffer gait impairment due to MS and we’re pleased that CMS understood the benefits of this innovative treatment by establishing HCPCS codes for both the PoNS mouthpiece and controller. This marks a critical reimbursement and access milestone and provides Helius the ability to begin negotiating reimbursement with third-party payers using these unique HCPCS codes. We believe there is a reasonable likelihood that at the public meetings this summer CMS will determine a reimbursement amount for each of the PoNS controller and mouthpiece to take effect on October 1, 2024,” stated Helius’ President and Chief Executive Officer, Dane Andreeff. “As we pursue widespread reimbursement for PoNS Therapy, we have continued to manage our cash burn. With the recently announced $1.5 million of net proceeds from the sale of shares of our common stock under our ATM program at an average share price of $9.17 per share, our cash runway has been extended into the third quarter of this year. Once we establish reimbursement for PoNS, we believe we will be able to expand reimbursement across third-party payers and have a pathway to positive cash flow as we continue to pursue authorization for stroke in the U.S.,” concluded Andreeff. PoNS is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program. The Company is also seeking marketing authorization under PoNS’s breakthrough designation for stroke in the United States, where over five million stroke survivors are affected by walking and balance disability. In Canada, PoNS is authorized to treat balance impairment due to MS, stroke and mild-to-moderate traumatic brain injury. About Helius Medical Technologies, Inc. Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information visit www.heliusmedical.com. About the PoNS Device and PoNS Therapy The Portable Neuromodulation Stimulator (PoNS) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, 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. PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com. 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 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,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s plans to provide CMS additional information to support reimbursement economics ahead of the public meetings expected early this summer and the expectation that CMS will then determine a reimbursement amount for each of the PoNS controller and mouthpiece to be effective October 1, 2024, the success of the Company’s developmental, regulatory and commercialization efforts, the impact of HCPCS codes on the Company’s commercialization efforts, the sufficiency of the Company’s future cash position, future decisions and approvals from applicable regulatory entities in the U.S. and Canada, and the uses and effectiveness of PoNS and PoNS Therapy. 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, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to continue to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure additional 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 December 31, 2022, 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. 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 ContactLisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com