nerve injury News
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Checkpoint Surgical Enrolls First Patient in Nerve Regeneration Clinical Study
Checkpoint Surgical, Inc., the leader in intraoperative nerve repair stimulation technology, today announced it has enrolled the first patient in its multi-center clinical study of the company’s breakthrough nerve regeneration technology. The patient was enrolled at The Ohio State University, one of four sites actively enrolling patients in the double-blind, randomized clinical trial. Other ...
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Neuraptive Therapeutics Announces FDA Clearance of IND Application for NTX-001, a Novel Approach for the Treatment of Patients with Peripheral Nerve Injuries
Neuraptive Therapeutics Announces FDA Clearance of IND Application for NTX-001, a Novel Approach for the Treatment of Patients with Peripheral Nerve Injuries "We are pleased to have received clearance for the company’s first IND, and are excited to initiate the trial later this year," said Evan Tzanis, Executive Vice President and Head of Research and Development. "We look forward to ...
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KLISBio to feature engineered silk innovation at AAHS 2022
With the profound impact on patients’ quality of life, peripheral nerve injuries remain at the forefront of treatment challenges for orthopedic surgeons. That’s a driving force behind KLISBio’s SILKBridge®, a first-to-market solution for peripheral nerve repair. KLISBio will introduce SILKBridge® to attendees at the American Association for Hand Surgeons Annual Meeting ...
By KLISBio
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Medovate Industry Partner for Esra Residents & Trainees Workshop Event in Portugal
Medovate is delighted to be sponsoring the European Society for the 4th ESRA Residents & Trainees Workshop event, taking place at the Hospital das Forças Armadas on the 1st and 2nd April in Porto, Portugal. As well as being an Industry Partner, Medovate will also be showcasing the SAFIRA® system (SAFer Injection for Regional Anaesthesia) – a pioneering device which is ...
By Medovate
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KLISBio to share its leading-edge silk-based technology platform at 2022 AAOS Annual Meeting
Milan, Italy (March 23, 2022) – Today, KLISBio, a MedTech company challenging the status quo in regenerative medicine by leveraging a silk-based multidisciplinary technology platform, announced its attendance 2022 American Academy of Orthopaedic Surgeons Annual Meeting. The event will be held March 22-26 in Chicago -IL. KLISBio’s designated attendee to 2022 AAOS Congress is Jason ...
By KLISBio
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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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It All Starts With Patient Safety at Medovate
When Medovate was spun out of the National Health Service (NHS) in 2017, one of the key priorities was to ensure that each medical device the company developed added real value to patient safety. The company mission is to “improve patient care and safety by supplying innovative Medtech solutions inspired by clinicians and developed in partnership with the NHS.” Through a unique ...
By Medovate
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Alafair Biosciences Receives 510(k) Clearance for VersaWrap Nerve Protector
Alafair Biosciences, Inc., a commercial-stage medical device company, announced that it has received 510(k) clearance from the FDA for VersaWrap Nerve Protector (VersaWrap). Similar to VersaWrap Tendon Protector indicated for tendon, VersaWrap Nerve Protector is an ultrathin, sutureless, bioresorbable hydrogel implant ideally suited for covering and protecting peripheral nerves. By forming a ...
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Silk Road Medical Announces FDA Approval of Expanded Indications for the ENROUTE Transcarotid Stent System
Silk Road Medical, Inc.?(Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that that the U.S. Food and Drug Administration (FDA) approved expanded indications for the ENROUTE stent to include patients at standard risk for adverse events from carotid endarterectomy (CEA). Previously, the stent was approved for use only in patients with ...
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Checkpoint Surgical’s Next-Generation Guardian Nerve Stimulator and Intraoperative Lead Accessory Provide Next Level Intraoperative Nerve Assessment
Checkpoint Surgical announces the full commercial release of the Checkpoint Guardian Nerve Stimulator, the next generation of its classic intraoperative nerve stimulation technology. The new Checkpoint Guardian optimizes intraoperative nerve assessment capability, particularly for nerve repair procedures, providing more precise controls and information to take nerve assessment to the next level. ...
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KLISBio to participate at 2022 IFSSH, IFSHT & FESSH Combined Congress With an abstract presentation on SILKBridge
Milan, Italy (June 1st, 2022) – Today, KLISBio, a MedTech company challenging the status quo in regenerative medicine by leveraging a silk-based multidisciplinary technology platform, announced its attendance to 2022 IFSSH, IFSHT & FESSH Combined Congress organized by the International Federation of Societies for Surgery of the Hand and International Federation of Societies for Hand ...
By KLISBio
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FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval
FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial ...
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Neuraptive Therapeutics Appoints Robert S. Radie as Chief Executive Officer and Chairman of the Board
Experienced healthcare industry executive with 35 years of experience Additions to the board of directors to support the company's advancing its lead program, NTX-001, along with its pipeline products Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve ...
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Axogen, Inc. to Report Fourth Quarter and Full-Year 2021 Financial Results and Host Conference Call on February 22, 2022
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will report fourth quarter and full-year 2021 financial results on Tuesday, February 22, 2022 after the market closes. Axogen management will host an investment-community conference call and webcast following the release at 4:30 p.m. ET. ...
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Axogen, Inc. to Participate at Jefferies London Healthcare Conference
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, chairman, CEO and president, will present at the Jefferies London Healthcare Conference. The presentation is scheduled for Wednesday, November 17, 2021 at 4:25 p.m. (11:25 a.m. ET). The presentation will be webcast live and ...
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Neuraptive Therapeutics Announces FDA has Granted Fast Track Designation to NTX-001 Clinical Development Program for Treatment of Patients with Peripheral Nerve Injuries
Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve ...
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Axogen, Inc. to Participate at Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, chairman, CEO, and president, will present at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum. The presentation is scheduled for Thursday, November 18, 2021 at 10:00 a.m. ET. The ...
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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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OnLume Surgical Participates in Clinical Trial Combining Fluorescence-Guided Surgery Imaging Device with Alume’s Novel Nerve-Targeting Agent
OnLume Inc., a Madison, Wisconsin-based medical imaging company with unique technology for improving surgical precision in the operating room, has announced the start of participation in a clinical trial combining its fluorescence-guided surgery (FGS) imaging device with a novel nerve-targeting agent. OnLume has unique FGS imaging technology to illuminate critical anatomy in real time during ...
By OnLume Inc.
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Axogen to Participate at Upcoming Investor Conferences
Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced it will participate in two investor conferences in February. Karen Zaderej, chairman, CEO, and president will participate in a fireside discussion at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on ...
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