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Nerve System Articles & Analysis

29 news found

Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients with Krabbe Disease

Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients with Krabbe Disease

Krabbe is a rare, genetic, neurodegenerative leukodystrophy affecting the central nervous system (CNS) and peripheral nervous system (PNS). Krabbe disease affects infants with an incidence rate of 1-2.5 in 100,000 and leads to premature death, often by 2 years of age. ...

ByForge Biologics, Inc.


Forge Reports Positive Clinical Data on Brain Development and Motor Function from the RESKUE Novel Phase 1/2 Gene Therapy Trial in Patients with Krabbe Disease at the SSIEM Annual Symposium

Forge Reports Positive Clinical Data on Brain Development and Motor Function from the RESKUE Novel Phase 1/2 Gene Therapy Trial in Patients with Krabbe Disease at the SSIEM Annual Symposium

RESKUE is the first-in-human clinical trial where subjects are administered FBX-101, an Adeno-Associated Virus (AAV) systemic gene replacement strategy, after full myeloablation and umbilical cord blood transplantation. ...

ByForge Biologics, Inc.


ReShape Lifesciences Announces 2017 Weight Loss Contest Winner

ReShape Lifesciences Announces 2017 Weight Loss Contest Winner

The FDA-approved ReShape® Integrated Dual Balloon System involves a non-surgical weight loss procedure that uses advanced interconnected balloon technology designed to take up room in the stomach to help people with a 30-40 BMI, and at least one co-morbidity, lose weight. vBloc® Neurometabolic Therapy, delivered by an FDA-approved pacemaker-like device called the vBloc ...

ByMedtimo Inc


Neuros Medical Announces Completion of QUEST Pivotal Trial 90-day Primary Endpoints

Neuros Medical Announces Completion of QUEST Pivotal Trial 90-day Primary Endpoints

Neuros Medical, a bioelectric technology company, has developed the Altius system for the treatment of chronic post-amputation pain (Phantom Limb Pain and Residual Limb Pain). Altius incorporates the Company’s patented platform technology, On-Demand Bioelectric Nerve Block. Patients initiate a 30-minute Altius treatment session as needed for targeted pain ...

ByNeuros Medical, Inc.


Kadimastem Expands R&D Program to Include Multiple Sclerosis

Kadimastem Expands R&D Program to Include Multiple Sclerosis

AstroRx® has shown to support the nerve cells in the central nervous system, including the brain and spinal cord. ...

ByKadimastem Ltd.


It All Starts With Patient Safety at Medovate

It All Starts With Patient Safety at Medovate

Mitigating for nerve damage during regional anaesthesia through innovation The concept for the SAFIRA® system was born from observations made on the clinical front line with regard to the risks inherent within the standard regional anaesthesia process around potential nerve damage in patients, and the consequences for both the patient and ...

ByMedovate


Medovate Announces Us Distribution Agreement with Mercury Medical® For Safira®

Medovate Announces Us Distribution Agreement with Mercury Medical® For Safira®

The agreement also includes the newly launched SAFIRA® Palm Operator which has been launched in the US market to offer anesthesiologists more versatility and choice when using the SAFIRA® regional anesthesia system. In California Mercury Medical® will also be distributing the SAFIRA® NRFit™ syringe, which provides an alternative to the Luer connection ...

ByMedovate


Publication of Two-Year EVOKE Double-Blind Randomized Controlled Trial Results in JAMA Neurology Demonstrate Sustained Superiority of Evoke® Closed-Loop over Open-Loop Spinal Cord Stimulation

Publication of Two-Year EVOKE Double-Blind Randomized Controlled Trial Results in JAMA Neurology Demonstrate Sustained Superiority of Evoke® Closed-Loop over Open-Loop Spinal Cord Stimulation

The limitation of open-loop SCS systems is the lack of adjustment to the broad range of electrical field strength reaching the spinal cord due to changes in distance between the stimulation electrode and the nerves. These changes in distance are caused by normal physiological activity (e.g., breathing and heartbeat) and movement, which results in variable ...

BySaluda Medical Pty Ltd.


Nalu Medical Named Best MedTech Company and Medical Device in Field of Neurology

Nalu Medical Named Best MedTech Company and Medical Device in Field of Neurology

“We believe our advanced design stands apart from other spinal cord stimulation and peripheral nerve stimulation systems and provides meaningful advantages to clinicians, patients and the healthcare ...

ByNalu Medical, Inc.


Nyxoah Announces CE-Mark Indication Approval to Treat Complete Concentric Collapse (CCC) Patients

Nyxoah Announces CE-Mark Indication Approval to Treat Complete Concentric Collapse (CCC) Patients

“We are thrilled that the Notified Body has approved the Genio® system as a treatment option for the large population of CCC patients. ...

ByNyxoah SA


TISSIUM to present study results at the 76th Annual Meeting of the American Society for Surgery of the Hand

TISSIUM to present study results at the 76th Annual Meeting of the American Society for Surgery of the Hand

TISSIUM will present the latest research on its novel Sutureless Nerve Coaptation System in collaboration with surgeons from NYU Langone, Brigham & Women’s Hospital, and SUNY Downstate Medical Center. ...

ByTISSIUM


Neuros Medical Announces Completion of Enrollment in the QUEST Pivotal Clinical Study for Chronic Post-Amputation Pain

Neuros Medical Announces Completion of Enrollment in the QUEST Pivotal Clinical Study for Chronic Post-Amputation Pain

Neuros Medical, Inc., a medical device company developing innovative high-frequency nerve block technology for patients with intractable post-amputation pain, announced today the completion of enrollment in its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study. ...

ByNeuros Medical, Inc.


Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse

Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse

Food and Drug Administration (FDA) has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. ...

ByNyxoah SA


Merck and INBRAIN Neuroelectronics Collaborate to Develop the Next Generation of Bioelectronic Therapies

Merck and INBRAIN Neuroelectronics Collaborate to Develop the Next Generation of Bioelectronic Therapies

“Bioelectronic devices have the capability to directly communicate with the nervous system. Recording nerve signals and combining them with other accessible physiological datasets will lead to a better understanding of disease conditions and enable personalized treatment regimens,” said Robert Spoelgen, Head of Bioelectronics, Merck Innovation Center. ...

ByInbrain Neuroelectronics


Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius High Frequency Nerve Block System

Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius High Frequency Nerve Block System

Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable pain of the lower limb of adult amputees. ...

ByNeuros Medical, Inc.


Nalu Micro-Implantable Pulse Generator Receives Award for Implanted Medical Device Innovation and Health Benefits

Nalu Micro-Implantable Pulse Generator Receives Award for Implanted Medical Device Innovation and Health Benefits

“We believe our technology design provides a valuable neuromodulation option among the existing spinal cord and peripheral nerve stimulation systems,” said Earl Fender, President and CEO of Nalu Medical, Inc. “We greatly appreciate the MDEA for recognizing the unique and differentiating technology advancements of the Nalu System ...

ByNalu Medical, Inc.


Positive Stroke Rehabilitation Clinical Trial Results for the Vivistim Paired VNS System Published in The Lancet

Positive Stroke Rehabilitation Clinical Trial Results for the Vivistim Paired VNS System Published in The Lancet

MicroTransponder Inc., today announced that the pivotal clinical trial results for the Company's investigational Vivistim® Paired Vagus Nerve Stimulation (VNS) System have been published in The Lancet. Each year in the US, 50-60% of the 658,000 stroke survivors have upper extremity motor deficits that persist for many months to years after their stroke. The ...

ByMicroTransponder Inc. (MTI)


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

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. ...

ByNeuraptive Therapeutics, Inc.


Nyxoah announces the publication of first positive clinical data in an OSA patient suffering from Complete Concentric Collapse (CCC)

Nyxoah announces the publication of first positive clinical data in an OSA patient suffering from Complete Concentric Collapse (CCC)

For now, these patients are contra-indicated for existing Hypoglossal Nerve Stimulation OSA therapies. Nyxoah is currently conducting the BETTER SLEEP study, that aims to assess the effectiveness of the Genio® system bilateral hypoglossal nerve stimulation for Complete Concentric Collapse (CCC) patients and to build clinical evidence for a ...

ByNyxoah SA


Neuros Medical Raises $38.5M in Series BB Funding for Completion of Pivotal Clinical Study for Chronic Post-Amputation Pain

Neuros Medical Raises $38.5M in Series BB Funding for Completion of Pivotal Clinical Study for Chronic Post-Amputation Pain

QUEST is designed to assess the safety & effectiveness of the Company’s AltiusÒ High-Frequency Nerve Block system to treat intractable post-amputation pain. “We are fortunate to have the support of a strong consortium of life sciences venture capital firms and welcome Amzak Health, Sectoral Asset Management, and InCube Ventures as ...

ByNeuros Medical, Inc.

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