Paresis

Grant awards to fund novel clinical projects and scientific tools aimed at improving quality of life for individuals impacted by spinal cord injury SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation, a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million. The grants support clinical trials and research tools aimed at accelerating the therapeutic development of SCI treatments. Two grants have been awarded to .NeuroRestore, a research, innovation and treatment center that develops and applies bioengineering strategies involving neurosurgical interventions to restore neurological functions. PsychoGenics, a CNS-focused contract research organization that designs and executes preclinical drug discovery and early development programs, received the third grant. Together, the grants will fund projects designed to help catalyze and energize the field of SCI science by channeling resources for a robust clinical pipeline to rapidly increase the number of potential treatments, as well as drive progress and investment in spinal cord injury research by addressing the barriers that limit ambitious engagement. The projects include clinical trials focused on: bladder dysfunction – a major quality-of-life issue for the SCI community; and a trial to advance novel brain-spine interface (BSI) technology, which has been shown to enable thought to control movement. Finally, a preclinical study will focus on innovative techniques and technologies to provide standardized lab research resources that do not currently exist. Specifically: Brain-Spine Interface to Reverse Upper Limb Paralysis: .NeuroRestore will also receive $1.1 million over two years to support its Brain-Spinal Interface (BSI) technology to determine if thoughts, via cortical brain implants, can control not just lower extremity movement (which has been demonstrated in prior research), but also arm and hand function for those with cervical injuries. This technology is being developed by ONWARD® Medical, a medical technology company creating therapies to restore movement, function, and independence in people with SCI and movement disabilities. It is the only company currently advancing both brain-computer interface (BCI) and spinal cord stimulation technology together – a "digital bridge" connecting brain signals with movement. In late February, ONWARD Medical was awarded its 10th Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for its ARC-BCI™ System, which uses brain-BCI technology in conjunction with the company's ARC-IM® Therapy to restore thought-driven lower limb mobility after spinal cord injury (SCI). Neuroprosthetic System to Manager Lower Urinary Tract Dysfunction After Spinal Cord Injury: With a $1.5 million grant, .NeuroRestore will apply epidural stimulation implants to participants with chronic incomplete spinal cord injuries to examine if the technology can be used to assist in the functionality and control of the bladder. This proof-of-concept, safety, and feasibility study over two years will determine if epidural stimulation, which has seen success in movement and blood pressure, can be used for voiding and storage of the bladder. This early-stage study will utilize ONWARD Medical's targeted ARC Therapy stimulation, which the company is actively developing with .NeuroRestore. Standardized Testing Research InVivo Endeavor (STRIVE): A preclinical grant for $522,000 is awarded to PsychoGenics to develop an in-house standardized model for testing potential therapeutics. This project will help accelerate therapeutic development by providing a validated tool to the SCI research community. The Reeve Foundation is dedicated to developing real-world treatments for people living with spinal cord injury (SCI) and paralysis. Decade by decade, the Reeve Foundation has worked to change what was deemed possible, collaborating with equally determined scientists and labs to map a path toward progress and build a vibrant research field that delivers real improvements for people living with paralysis. Today, as 21st-century technology and cumulative scientific gains converge, we are on the cusp of a new era in spinal cord injury research. "These grants represent a fresh approach to spurring the SCI scientific arena forward through our support of high-risk-high-reward endeavors that address unmet needs of individuals living with spinal cord injury," said Marco Baptista, Ph.D., Chief Scientific Officer of the Reeve Foundation. "It is our goal to facilitate rapid scientific advancement, and these grants are an important step in ensuring that the most promising science of the day is primed for accelerated success." About the Reeve Foundation The Christopher & Dana Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Additionally, through a cooperative agreement with the Administration for Community Living, the Reeve Foundation's National Paralysis Resource Center (NPRC) promotes the health, well-being, and independence of people living with paralysis, providing comprehensive information, resources, and referral services assisting over 125,000 individuals and families since its launch in 2002. The Reeve Foundation is committed to elevating our community's voices and needs to achieve greater representation and independence. We meet all 20 of the Better Business Bureau's standards for charity accountability and hold the BBB's Charity Seal. For more information, please visit ChristopherReeve.org or call 800-225-0292. SOURCE Christopher & Dana Reeve Foundation

Fees for codes L8701 and L8702 are effective as of April 1, 2024 BOSTON--(BUSINESS WIRE)-- Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, today announced that on February 29, 2024, the Centers for Medicare & Medicaid Services (CMS) posted the final Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rates for the MyoPro®. The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67. On January 1, 2024, the MyoPro was officially classified in the brace benefit category, which enables reimbursement on a lump sum basis. These final fees become effective on April 1, 2024. “We’re extremely gratified to have reached a successful conclusion with CMS, a process that started in 2018 with the granting of the two HCPCS billing codes,” stated Paul R. Gudonis, Myomo’s Chairman and CEO. “This is an important milestone for qualified Medicare Part B beneficiaries with long-term muscular weakness or partial paralysis, and for Myomo as a company. We extend thanks to the personnel at CMS for their efforts and for appreciating the benefits that powered braces such as the MyoPro can provide to Medicare Part B beneficiaries. " About Myomo Myomo, Inc. is a wearable medical robotics company that offers improved arm and hand function for those suffering from neurological disorders and upper-limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper-limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of certain patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device in the U.S. that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Boston, Massachusetts, with sales and clinical professionals across the U.S. and representatives internationally. For more information, please visit

BARCELONA, Spain and DÜSSELDORF, Germany, Feb. 29, 2024 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, and Minoryx Therapeutics, a late stage biotech company focused on the development of therapies for orphan central nervous system disorders, reaffirm their commitment on Rare Disease Day 2024 to finding better treatments for patients suffering from a range of rare diseases, such as leukodystrophy, including X-linked adrenoleukodystrophy (X-ALD) and more specifically cerebral adrenoleukodystrophy (cALD). This Rare Disease Day, to raise awareness of this disease, Neuraxpharm and Minoryx announce the publication of a special information film with the participation of world renowned expert Professor Fanny Mochel, the Director of the Reference Center for Leukodystrophies - La Pitié-Salpêtrière Hospital, Paris, and Karen Harrison, Support Services Manager of Alex, The Leukodystrophy Charity (Alex-TLC). In the film, Professor Mochel describes the disease and the need for regular screening to identify patients as early as possible, while Karen Harrison speaks powerfully about the patient experience and need for better treatments. The film can be found on Neuraxpharm's and Minoryx's websites, YouTube and LinkedIn channels. Watch the film here. Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, said: "The impact this disease has on patients and their families cannot be overstated. At Neuraxpharm, we are committed to bringing better treatment to patients so that we can improve the lives of those affected by this devastating disease. We hope that this film will raise awareness and understanding of the condition." Marc Martinell, Chief Executive Officer of Minoryx said: "The X-ALD community deserve all our support to help them face the extremely challenging consequences of this disease, which in the case of cALD are fatal. We want to raise awareness of the diseases and the importance of regular monitoring and early detection as these are critical factors for timely management of these patients." On 26 January 2024, Neuraxpharm and its partner Minoryx Therapeutics stated that they are seeking a re-examination of leriglitazone, Minoryx's novel brain-penetrant and selective PPAR gamma agonist, by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for conditional approval for patients with cALD. Minoryx and Neuraxpharm strongly believe that leriglitazone has a positive benefit / risk balance in patients with cALD. About X-ALD and cALD X-linked adrenoleukodystrophy (X-ALD) is an orphan neurodegenerative disease. The global incidence of X-ALD is approximately 6-8/100,000 live births. Boys and adult men with X-ALD can, at any point in their lifetime, develop cALD, which is characterized by demyelinating brain lesions that may become rapidly progressive, leading to acute neurological decline and death. These lesions can produce severe symptoms such as loss of voluntary movements, inability to swallow, loss of communication, cortical blindness and total incontinence and death with a mean survival of 3 to 4 years. Progressive cALD occurs in 31-35% of ALD patients in childhood with typical onset between the age of 2-12 and up to 60% of adult patients, with X-ALD will develop progressive cALD over time. There is currently no pharmacological treatment available for cALD. In childhood, Hematopoietic Stem Cell Transplantation (HSCT) can arrest the disease. However, it is an aggressive procedure and only available for a portion of patients; autologous HSCT is not globally available; this still requires hemo-ablation therapy with associated comorbidities and long-term safety data is being gathered. In adults, experience in HSCT is very limited and the intervention is often not recommended. In addition, all X-ALD patients reaching adulthood develop adrenomyeloneuropathy (AMN), characterized by progressive spastic paraparesis, as well as progressive deterioration of balance and sensory function, and development of incontinence. This form progresses chronically with onset of symptoms typically in adulthood, affecting both men and women, and has poor prognosis. About leriglitazone Leriglitazone is Minoryx Therapeutics's novel orally bioavailable and selective PPAR gamma agonist with a potential first-in-class and best-in-class profile for CNS diseases. It has demonstrated brain penetration and a favorable safety profile. It showed robust preclinical proof-of-concept in animal models of multiple diseases by modulating pathways leading to mitochondrial dysfunction, oxidative stress, neuroinflammation, demyelination and axonal degeneration. In clinical trials, leriglitazone showed clinical benefit in both adult X-ALD patients in ADVANCE and pediatric X-ALD patients in NEXUS. Data from ADVANCE showed that leriglitazone reduces the progression of lesions and the development of progressive cALD. Results on radiological stabilization seen in NEXUS after 24 weeks of treatment were similar to those attained with Hematopoietic Stem Cell Transplant (HSCT) or ex-vivo gene therapy, hence it is expected that leriglitazone could provide a comparable clinical benefit to cALD patients. Leriglitazone has been granted orphan drug status for X-ALD from the FDA and the EMA and Fast Track and Rare Pediatric Disease designation from the FDA for the treatment of X-ALD. About the Neuraxpharm Group Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years. Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions. The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira. Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain. For more information, please visit About Minoryx Minoryx Therapeutics is a registration stage biotech company focusing on the development of novel therapies for orphan central nervous system (CNS) diseases with high unmet medical needs. The company's lead program, leriglitazone (MIN-102), a novel, brain penetrant and selective PPAR gamma agonist, is being developed to treat X-linked adrenoleukodystrophy (X-ALD) and other orphan CNS diseases. The company is backed by a syndicate of experienced investors, which includes Columbus Venture Partners, CDTI Innvierte, Caixa Capital Risc, Fund+, Ysios Capital, Roche Venture Fund, Kurma Partners, Chiesi Ventures, S.R.I.W, Idinvest Partners / Eurazeo, SFPI-FPIM, HealthEquity, Sambrinvest and Herrecha, and has support from a network of other organizations. Minoryx was founded in 2011, is headquartered in Spain with Belgian facilities and has so far raised more than €120 million. For more information, please visit