Gait Disorders, Neurologic

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

MALVERN, Pa., Aug. 15, 2024 (GLOBE NEWSWIRE) -- via IBN -- Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced financial results for the second quarter ended June 30, 2024, and provided a business update. "The recent months have been productive for our company," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. "We've completed pivotal Phase 2/3 Alzheimer's and Phase 3 Parkinson's studies, both of which revealed very encouraging data for buntanetap. Additionally, we’ve introduced a new crystalline form of buntanetap with improved properties, further strengthening our IP portfolio. These milestones position us strongly as we move closer to providing much-needed treatments to patients." Clinical Trial Updates Alzheimer’s Disease (AD) On April 29, 2024, Annovis Bio reported data from its completed Phase 2/3 AD study. The results showed that buntanetap significantly improved cognition in patients with early AD, with a 3.3-point improvement on the ADAS-Cog11 test after three months of treatment, compared to a 0.3-point improvement in the placebo group.The study also indicated a trend toward reduced plasma tau protein levels, consistent with previous findings, suggesting a potential disease-modifying effect of buntanetap.A follow-up analysis, on June 11, 2024, demonstrated that buntanetap was particularly effective in improving cognition among high-risk APOE4 carriers, showing a 3.15-point improvement.Bunetanetap was found to be equally safe in both APOE4 carriers and non-carriers, with no instances of Amyloid-Related Imaging Abnormalities (ARIA) observed. Parkinson’s Disease (PD) On July 2, 2024, Annovis Bio announced the Phase 3 PD study data, which revealed that buntanetap led to significant improvements in both the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and cognition across several PD subpopulations. Buntanetap showed a particularly strong response in individuals diagnosed with PD for more than three years as well as in those with postural instability and gait disorder (PIGD). Moreover, buntanetap halted cognitive decline in all enrolled patients and improved cognition in those with mild dementia, mirroring the positive results observed in our AD studies. Second Quarter 2024 Financial Results Annovis Bio received $7.1 million net cash from exercises of Canaccord warrants in July 2024. Cumulatively to date, Annovis Bio received $7.0 million net cash from ELOC facility announced in April 2024.The Company’s cash and cash equivalents totaled $4.0 million as of June 30, 2024, compared to $5.7 million as of December 31, 2023. The Company had 11.7 million shares of common stock outstanding as of June 30, 2024. After recent warrant exercises and ELOC share placements, as of August 14, 2024, Annovis Bio had cash and cash equivalents of $12.1 million, which we believe is sufficient to support operations through the planned AD and PD FDA meetings in Fall and continuing until the initiation of the two pivotal studies planned. Total operating expenses for the three months ended June 30, 2024, were $7.8 million, which included research and development expenses of $5.8 million and general and administrative expenses of $2.0 million. This compares to total operating expenses for the three months ended June 30, 2023, of $9.8 million, which included research and development expenses of $8.2 million and general and administrative expenses of $1.5 million. Annovis Bio reported a $0.44 basic and diluted net loss per common share for the three months ended June 30, 2024. This compares to a $1.07 basic and diluted net loss per common share for the three months ended June 30, 2023. Patents The Company filed a new composition of matter patent covering a novel crystal form of buntanetap and its use for treating and/or preventing various neurodegenerative conditions. The new crystalline form offers significant advantages over the less structured, old semi-crystalline form, including better solubility and stability as well as an additional 20 years of patent life. The Company has filed a provisional patent for the methods of manufacturing this new crystalline form, covering the entire synthesis process—from basic starting materials to finished GMP product—suitable for large-scale manufacturing at ton quantities.On July 16, 2024, Annovis Bio received FDA approval to continue the Phase 3 development with the new crystal form. Additionally, the Company was granted a U.S. patent for the use of buntanetap in the treatment of acute traumatic brain injury. Team Updates On July 9, 2024, Annovis Bio announced the expansion of its team with several key appointments: Mark White as Chief Business Officer, Alexander Morin as Director of Strategic Communications, Hilda Maibach as Senior Vice President of Statistics, and Blake Jensen as Head of Quality. Other Achievements On May 21, 2024, the Company shared a new scientific article focused on the similarities and differences in buntanetap’s pharmacokinetic behavior between several animal models and humans, summarizing years of research. On August 6, 2024, Annovis Bio revealed new preclinical data showing a synergistic improvement on cognition when combining buntanetap with the GLP-1 agonist Trulicity®. About Annovis Bio, Inc.Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor AlertsInterested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.Annovisbio.com/email-alerts. Forward-Looking StatementsThis press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Contacts Annovis Bio, Inc. 101 Lindenwood Drive Suite 225 Malvern, PA 19355 www.annovisbio.com Investor Contact Scott McGowan InvestorBrandNetwork (IBN) Phone: 310.299.1717 ‍IR@annovisbio.com Investor Website

Scientists have found our visual perception dips as our feet hit the ground. Further understanding this could help develop early diagnostics for neuromuscular or psychiatric illness; understand changes in mobility as we age; or help with sports science and athletic training. For the first time, neuroscientists have established a link between shifts in our visual perception and the cadence of our steps while walking. The research, published in Nature Communications, shows that the brain processes vision in a rhythmic manner, rising and falling in sensitivity in a cycle that corresponds to the rhythm of our steps. When swinging from one step to the next, human perception is good and reactions fast. During footfall, however, our vision is not as sharp and reactions are slowed. Lead author Dr Matthew Davidson from the School of Psychology at the University of Sydney said: "This work reveals a previously unknown relationship between perception and movement. It bridges a gap between experimental psychology and our natural, everyday behaviour." The study also confirms our understanding of the visual brain sensing the environment in a strobe-like way; our perception takes regular samples of the world before stitching them together to create our seamless experience. However, the new finding that reveals shifts in our visual perception has important implications for understanding human behaviour, how we interact with our environment and make decisions. The work was conducted by Dr Matthew Davidson with colleagues Professor David Alais and Professor Frans Verstraten in the School of Psychology, University of Sydney. Dr Davidson said: "We are consciously aware of a seamless stream of vision but this is deceptive. I use the analogy of a duck swimming on a pond. Beneath the smooth motion on the surface there is a lot cycling activity beneath." This study extends earlier work from the same lab showing that perception of vision and sound is cyclic, with our brain taking around eight samples per second. Professor Alais said: "The critical new finding in this study is that these oscillations in the brain's sampling of the world slow down when walking to match the step cycle. "Humans take about two steps per second when walking and generally keep to a consistent rhythm. The reported oscillations in visual sensitivity also occur at about two cycles per second and are locked to the step cycle. In some participants these rhythmic oscillations occur at four cycles per second but these were also locked to the step cycle." This work is the first time that visual perception has been finely and continuously sampled during walking. Without virtual reality headsets and motion tracking it would not be possible. Dr Davidson said: "Thanks to VR technology we have discovered that our vision moves through a good and a bad phase on every step." It is unclear why our brain's perceptual processes are so closely linked to walking. Professor Alais said: "One possible explanation is that vision becomes secondary to motor control while your foot is grounded and the next step is planned. Once you are in the swing phase between footfalls, the brain switches back to prioritising perceptual sampling of the world, creating an ongoing perceptual rhythm that harmonises with your step rate." The findings open questions that the research team will pursue in further studies. For example, does perception of sound and touch also modulate as we walk? And what about neural activity? The research team plans to follow up these questions to further understand the implications. Dr Davidson said: "An obvious question is whether these oscillations in perception are more pronounced in the elderly given difficulties with balance and coordination as we age. "It also raises the exciting possibility that we could develop cheap and easy diagnostic tests using VR headsets, or use this information to develop tests for early onset of neuro-muscular disorders or some psychiatric illnesses, which can manifest in abnormal gaits." He said it could also be applied to further research in sports science to see if the findings could be applied to optimise decision-making and reaction times in athletes. Underlying all this research remains a persistent mystery. If the world is sampled by our brains rhythmic pulses, why is our conscious perception so seamlessly smooth? Professor Verstraten said: "This was once a question for philosophers, but with access to technology neuroscientists have been able to shed light on how the gaps get filled in. The current view is that the brain is a predictive machine that actively constructs perception and predicts what ought to be there and fills in the blanks. But clearly, we need more research to deepen our understanding." Methods Researchers tracked the walking of 45 subjects walking back and forth along a 10-metre path in a virtual environment. During each walk (lasting about 9 seconds), subjects were required to respond to between zero and eight random visual stimuli. The same stimuli were also presented in stationary trials. Eye and head movement was tracked along with gait and walking information. Of the 45 subjects, insufficient data was collected for seven subjects. In the datasets for 38 subjects, reduced perception at footfall was recorded 83 percent of the time.