Neuro

Perfuze Announces FDA Clearance and First U.S. Clinical Use of Millipede 088 Access Catheter

Irish-based company secures first U.S. regulatory clearance for its Millipede 088 Access Catheter from the Food and Drug Administration (FDA) The company is also developing catheter-based technology for treating acute ischemic stroke GALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has secured […]

Athersys Granted Clinical Type B Meeting with FDA for MASTERS-2 Clinical Trial Protocol Discussion

CLEVELAND–(BUSINESS WIRE)–Athersys, Inc. (NASDAQ: ATHX), a cell therapy and regenerative medicine company developing MultiStem® (invimestrocel) for critical care indications, announced today that the Company has been granted a clinical Type B meeting with the U.S. Food & Drug Administration (FDA). The Company was previously granted Regenerative Medicine Advanced Therapy (RMAT) and […]

IRRAflow System Confirmed to More Effectively Remove Collected Blood and Reduce Catheter Infection Rates than Passive Drainage in Head-to-Head Analysis

Neurosurgeons from the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, published data in the March issue of Operative Neurosurgery that compared procedural and clinical outcomes when treating chronic subdural hematomas with IRRAflow against passive drainage alone. The study demonstrated that IRRAflow’s active and automated continuous irrigation […]

Pharmazz, Inc. Announces US FDA Clearance for a Phase III Clinical Trial of Sovateltide (PMZ-1620) in Acute Cerebral Ischemic Stroke Patients

The primary endpoint is the proportion of patients with a good outcome as a modified Rankin Score (mRS) of 0-2 on day 90 post-randomization Sovateltide is an endothelin-B receptor agonist that has been shown to increase blood flow, inhibit apoptosis, and induce neurovascular remodeling WILLOWBROOK, III., Feb. 13, 2023 /PRNewswire/ — Pharmazz, […]

VST-BIO Announces Successful Preclinical Trials in Ischemic Stroke

VST-Bio’s Collaborators Present Preclinical Trial Results at the American Heart Association International Stroke Conference in Dallas. SAN DIEGO, Feb. 10, 2023 /PRNewswire/ — VST-Bio Corp. a leader in the development of innovative biologics to treat acute and chronic cardiovascular disease, presented data from a recent large animal study performed by VST-Bio and Yale University demonstrating […]

Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke

LAKE FOREST, Calif., Jan. 27, 2023 Infinity Neuro announced today that its Inspira™ aspiration catheters received CE Mark approval and are now commercially available in Europe. This is the first offering from Infinity Neuro which plans to launch a full range of products for the treatment of ischemic and hemorrhagic stroke throughout 2023 […]

Athersys Provides MultiStem Clinical Update

Enrollment completed in second cohort of MATRICS-1 trial in hemorrhagic trauma Enrollment reaches halfway mark in MASTERS-2 trial in ischemic stroke CLEVELAND–(BUSINESS WIRE)–Athersys, Inc. (Nasdaq: ATHX), a regenerative medicine company developing MultiStem® (invimestrocel) for critical care indications, today provided an update on ongoing clinical trials with MultiStem for the treatment of […]

Update on Acticor Biotech’s Clinical Developments With Glenzocimab in the Treatment of Cardiovascular Emergencies

Enrollment of the 200th patient in the ACTISAVE study Initiation of patient enrollment in the GREEN Phase 2/3 study in stroke Update on the clinical evaluation of glenzocimab in stroke and myocardial infarction January 09, 2023 12:00 PM Eastern Standard Time PARIS–(BUSINESS WIRE)–Regulatory News: ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT) (Paris:ALACT), […]

Imperative Care Announces FDA Clearance and Initial Cases of Zoom RDL, the First Stroke-Specific Radial Access Platform for Mechanical Thrombectomy

– First Patient Treated with Zoom RDL at Spectrum Health – – Newest Addition to Company’s Zoom Stroke Solution Provides an Additional Option for Achieving Intracranial Access to Treat Patients for Ischemic Stroke – CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc., today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ […]

Acticor Biotech Provides an Update on the Us Regulatory Discussion with the FDA

PARIS–(BUSINESS WIRE)–Regulatory News: Acticor Biotech, (ISIN: FR0014005OJ5 – ALACT) (Paris:ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, is discussing with FDA to set up a Type C meeting for early 2023 with the same objective as for the recent meeting with the […]