Paralysis News
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Eikonoklastes Therapeutics and Forge Biologics Announce Viral Vector Contract Development and AAV Manufacturing Partnership
Eikonoklastes Therapeutics, a preclinical biotech company developing treatments for today’s most challenging diseases, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership that will advance Eikonoklastes’ AAV-based gene therapy, ET-101, into clinical trials for the treatment of patients with ...
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Synchron Announces First Human U.S. Brain-Computer Interface Implant
Synchron, an endovascular brain-computer interface (BCI) company, today announced the first human BCI implant in the United States. This procedure represents a significant technological milestone for scalable BCI devices and is the first to occur in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery. The procedure was performed at Mount Sinai West in ...
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Synchron Appoints Kurt Haggstrom as Chief Commercial Officer
Synchron, an endovascular brain-computer (BCI) interface company, today announced the appointment of Kurt Haggstrom as Chief Commercial Officer. Haggstrom brings an extensive background in medical device commercialization and product launches, with a technical background in R&D engineering, holding over 20 U.S. patents. “I am honored and excited to join the Synchron team and be part of ...
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Team Gleason Partners with Synchron to Redefine Accessibility
Team Gleason and Synchron, an endovascular brain computer interface company, today announced a partnership agreement to provide patient-focused feedback on their platform to transform daily life for patients with physical and speech disabilities like ALS, muscular dystrophy, and cerebral palsy. The partnership will enable Synchron to collaborate with Team Gleason’s expert committees and an ...
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Citrine Medicine Announces Approval of Wakix (pitolisant) for Named Patient Program in China
The narcolepsy drug Wakix can now be prescribed to patients in China with urgent unmet medical needs BOSTON, Mass., and Boao, Hainan, China, May 07, 2021 – Citrine Medicine, a China-based rare disease therapeutics company, today announced that the narcolepsy therapy Wakix® (pitolisant) has been approved by the Health Commission and Medical Products Administration of Hainan Province ...
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Synchron Announces Enrollment of First Patient in U.S. Endovascular Brain Computer Interface Study COMMAND in Patients With Severe Paralysis
Synchron and Mount Sinai Hospital in New York Advance Industry-First FDA-Approved Clinical Trial for Brain-Computer Interface in U.S. Paralysis is a devastating condition for more than 5 million patients in the United States Synchron, an endovascular brain-computer (BCI) interface company, today announced the enrollment of the first patient in the US clinical trial, COMMAND, for patients ...
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Synchron Announces Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode for Severe Paralysis
Four Patients With ALS Who Received Stentrode™ Implant Gained Ability to Perform Daily Online Tasks No Serious Adverse Events Reported after 12 Months Synchron, a brain computer interface (BCI) company, today announced the results from a study in which four people with ALS received an implant of Synchron’s Stentrode™ device, a small mesh-like material inserted ...
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Synchron Expands Advisory Board as Brain-Computer Interface Device Stentrode Advances into Patients in US Clinical Trials
Synchron, a brain computer interface (BCI) company, today announced the expansion of its advisory board comprised of industry pioneers, to provide strategic guidance in support of the Company’s clinical development plans, corporate strategy and growth. The members of the advisory board are visionaries across the technology, neuroscience and medical device industry, which include Edward ...
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Synchron announces first direct-thought tweet, “Hello World,”using an implantable brain computer interface
Synchron, a brain computer interface company, today announced a Twitter takeover by Philip O’Keefe, one of the patients implanted with the Stentrode brain computer interface. Mr. O’Keefe is the first person to successfully message the world on social media directly through thought using an implantable brain computer interface. Mr. O’Keefe, a 62-year-old man with amyotrophic ...
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ClearPoint Neuro Congratulates Blackrock Neurotech on Receiving Breakthrough Device Designation from the FDA for the MoveAgain Brain-Computer Interface System
ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today congratulates partner Blackrock Neurotech for receiving Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its groundbreaking MoveAgain Brain Computer Interface (BCI) system. There are an estimated ...
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Flat Medical announced FDA 510(k) clearance of EpiFaith, the Epidural Safety Solution
Flat Medical Co., Ltd., the medtech company specializing in clinical safety solutions, announced it received 510(k) clearance from the U.S. Food and Drug Administration for its EpiFaith® syringe to deliver safe epidural locating solution. Based on the LOR technique, the EpiFaith® syringe is a physician-centered safeguard for epidural analgesia, which is indicated for painless labor, ...
By Flat Medical
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Synchron receives green light from FDA to begin breakthrough trial of implantable brain computer interface in US
Synchron, a venture-backed brain data transfer company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for its flagship product, the Stentrode™ motor neuroprosthesis. This early feasibility study (EFS) of the device will begin later this year at Mount Sinai Hospital, New York, and will assess the safety ...
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RepliCel Applies for Manufacturing Approval for its Collagen and Tissue Regeneration Cell Therapies
RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce it has submitted its application to Japan’s Ministry of Health, Labour, and Welfare (MHLW) for approval to manufacture the Company’s RCT-01 cell therapy for ...
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Alume Biosciences Granted FDA Fast Track Designation of ALM-488 for Surgical Nerve Visualization
Alume Biosciences, Inc., a clinical stage biotechnology company developing nerve-targeted pharmaceuticals for surgical and therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead compound ALM-488. ALM-488 is an investigational fluorescently labelled nerve targeting pharmaceutical being developed as an adjunct for the ...
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Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand
IpsiHand robotic hand-piece uniquely leverages brain-computer interface technology for chronic stroke rehabilitation IpsiHand also has been granted U.S. FDA Breakthrough Device Designation Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-computer interface (BCI) technology for upper extremity chronic stroke rehabilitation, ...
By Neurolutions
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Neurolutions IpsiHand Stroke Rehabilitation Device Authorized by FDA
Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation ...
By Neurolutions
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Neuraptive Therapeutics Announces FDA Clearance of a Second IND Application for NTX-001 in the Prevention of Postoperative Facial Paralysis and Plans to Initiate a Phase 2 Clinical Study Later This Year
NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves. Neuraptive plans to conduct a Phase 2 Multicenter, Randomized, Controlled Study Evaluating the Safety and Efficacy of NTX-001 versus Standard of Care in Treatment and Prevention of Facial Paralysis Requiring Surgical Repair. ...
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Alexion Announces Upcoming Data Presentations at the 73rd Annual Meeting of the American Academy of Neurology
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that three abstracts have been accepted for presentation at the 73rd annual meeting of the American Academy of Neurology (AAN), taking place virtually from April 17 through April 22, 2021. New real-world data will be presented evaluating SOLIRIS® (eculizumab) for the treatment of generalized myasthenia gravis (gMG) in the United ...
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APrevent and hearLIFE Group signed the exclusive distribution agreement
APrevent announced on 17TH December that APrevent and hearLIFE signed the exclusive distribution agreement for APrevent® VOIS in Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam, Cambodia, Laos, Myanmar and Brunei. We are going to provide patients with glottic insufficiency/unilateral vocal fold paralysis an innovative, safe and effective surgical treatment. hearLIFE Group has a ...
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APrevent signed the distribution agreement in Lithuania
APrevent announced on 7TH December that APrevent and Labostera signed the distribution agreement for APrevent® VOIS in Lithuania. We are going to provide patients with glottic insufficiency/unilateral vocal fold paralysis an innovative, safe and effective surgical treatment. Labostera was founded in year 2005, they are experienced in ENT surgical products including surgical voice ...
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