NIHSS

DiaMedica Therapeutics Provides a Business Update and Announces Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024
Health, FDA, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Epilepsy, TPA, AIS, Patient, Tissue plasminogen activator, Stroke, G&A, Investment, Therapy, Pharmacovigilance, Nektar Therapeutics, Research, KLK1, Biostatistics, NKTR, Trial of the century, DSM-IV codes, NIHSS, Amgen, Data management, Pharmacy, Food, Cubist Pharmaceuticals, Neurology, Rankine scale, Shanghai Pharmaceuticals, DMAC, Acquisition, University, Yale University, Psychiatry, MRS, ASTN, Takeda, Patent, Bangladesh Technical Education Board, Probability, Pharmaceutical industry

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the year ended December 31, 2023.

Key Points: 
  • DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the year ended December 31, 2023.
  • Management will host a conference call Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and full year 2023 financial results.
  • Other income, net, was $1.9 million for the year ended December 31, 2023 compared to $0.4 million for 2022.
  • DiaMedica Management will host a conference call and webcast to discuss its business update and full year quarter 2023 financial results on Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time:

MIVI Neuroscience™ Presents Primary Endpoint Results from the EvaQ Trial — at the 2024 International Stroke Conference

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Thursday, February 8, 2024
Technology, Radiology, Health Technology, Pharmaceutical, Neurology, Other Science, Research, Medical Devices, Infectious Diseases, Hospitals, Clinical Trials, Cardiology, Biotechnology, Health, Practice Management, General Health, Nanotechnology, Science, Medical Supplies, Software, FDA, Surgery, Other Health, Sich, CE marking, Cerebrovascular disease, LVO, NIHSS, Conference, Bangladesh Technical Education Board, Intracranial hemorrhage, Thrombectomy, Safety, Physician, ECASS, Reperfusion, IDE, Thrombus, Patient, Stroke, System, Death

MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.

Key Points: 
  • MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.
  • The data were presented yesterday at the 2024 International Stroke Conference (AZ), a premier event featuring global thought leaders and dedicated to the latest in the science and treatment of cerebrovascular disease and brain health.
  • Results of the EvaQ Trial show the Q Revascularization System to be safe and effective for thrombectomy of Large Vessel Occlusion (LVO) strokes.
  • The primary safety endpoint was symptomatic intracranial hemorrhage (sICH) which was observed at a rate of 6.5%.

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

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Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Acute coronary syndrome, Thrombolysis, Artery, Moyamoya disease, INN, Risk, ABCD2, ATC, Myocardial infarction, Bleeding, International, Blood, ASA, Brain, NIHSS, Language, Heart, TIA, Vitamin K, Vascular disease, Percutaneous coronary intervention, European Medicines Agency, VKA, Preventive healthcare, Tablet, ADP, Select, Chest pain, Aspirin, Patient, Anatomy, IIA, Atrial fibrillation, Generic drug

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Route 92 Medical Announces Impressive Clinical Results for its Tenzing® Technology.

Retrieved on: 
Tuesday, November 14, 2023
Research, Safety, SAN, NIHSS, Route, Patient, Medicine, Thrombectomy, Cooper University Hospital, Embolus, Neuroradiology, Doctor of Philosophy, Medical device, Nursing, Stroke, MD

SAN MATEO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced compelling results from a multicenter clinical study 1 on the Tenzing® 7 Delivery Catheter published in Stroke: Vascular and Interventional Neurology.

Key Points: 
  • SAN MATEO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced compelling results from a multicenter clinical study 1 on the Tenzing® 7 Delivery Catheter published in Stroke: Vascular and Interventional Neurology.
  • "Early clinical and in vitro experiences have always shown the potential of the Tenzing 7 delivery catheter.
  • "These findings underline our unwavering commitment to elevating patient outcomes through the development of best-in-class neurovascular intervention tools,” said Joey D. English, MD, PhD, Chief Medical Officer at Route 92 Medical.
  • Tenzing is a major advance.”
    For more information about Route 92 Medical and the Tenzing 7 Delivery Catheter, visit www.route92medical.com .

DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Health, FDA, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, TPA, Food, NIHSS, Investment, Clinical trial, DSM-IV codes, Patient, Research, AIS, DMAC, G&A, Stroke, Patent, Trial of the century, PPD, R, Hospital, ChromeOS, MRS, KLK1, Pharmaceutical industry, Cryptocurrency

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the quarter ended September 30, 2023.

Key Points: 
  • DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the quarter ended September 30, 2023.
  • Management will host a conference call Tuesday, November 14, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and third quarter 2023 financial results.
  • These study modifications include focusing participant eligibility to those subjects with only moderate acute ischemic strokes in the anterior circulation.
  • DiaMedica Management will host a conference call and webcast to discuss its business update and third quarter 2023 financial results on Tuesday, November 14, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time:

A Special Protocol Assessment Agreement Reached with the U.S. Food and Drug Administration for Phase 3 clinical trial of Sovateltide for the treatment of acute cerebral ischemic stroke patients

Retrieved on: 
Monday, October 2, 2023
Neuron, Therapy, Marketing, Neurogenesis, Safety, Stroke, Brain, Trial of the century, Blood, US, NIHSS, Sun Pharma, SPA, Nursing care plan, RTPA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry, Patient

The protocol is titled "The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke."

Key Points: 
  • The protocol is titled "The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke."
  • This SPA agreement by the FDA provides a clear-cut regulatory path for sovateltide, our first-in-class drug for acute cerebral ischemic stroke.
  • The narrow time window of rtPA of 4.5 hours limits its use in most patients with cerebral ischemic stroke.
  • This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke.

Pharmazz Inc. and Sun Pharma enter into licensing agreement for introducing Tyvalzi™ (Sovateltide) in India

Retrieved on: 
Thursday, September 14, 2023
BSE, Reuters, Therapy, Marketing, UK India Business Council, Neurogenesis, B.I, Stroke, Quality of life, Dayanand Medical College & Hospital, Sun Pharma, NSE, Incidence, Patient, NIHSS, RTPA, MRS, Disease, Mortality, Nursing care plan, Hospital, Neuro, Death, Generic drug, Pharmaceutical industry

Developed by Pharmazz for potential global use, Sovateltide is indicated for treating cerebral ischemic stroke.

Key Points: 
  • Developed by Pharmazz for potential global use, Sovateltide is indicated for treating cerebral ischemic stroke.
  • As per agreement terms, Sun Pharma is granted rights for marketing Sovateltide in India under the brand name Tyvalzi™ (Sovateltide).
  • Pharmazz will be entitled to upfront and milestone payments, including royalties.
  • Kirti Ganorkar, CEO – India Business, Sun Pharma said, “The Phase 3 clinical trial for Tyvalzi™ conducted in India demonstrated statistically and clinically meaningful improvement in neurological outcomes in ischemic stroke.

Imperative Care Announces FDA Clearance of Zoom 88 Support, Designed to Bring the Benefits of Intracranial Access to More Stroke Patients

Retrieved on: 
Tuesday, July 25, 2023
Health, FDA, Medical Devices, Hospitals, Health Technology, General Health, Biotechnology, Stroke, Food and Drug Administration, Neuroradiology, LDP, Imperative, GM, Patient, Physician, NIHSS, TICI, Femoral artery, Erlanger Health System, National Institutes of Health Stroke Scale, Zoom, Support, Food, Pharmaceutical industry

Imperative Care has pioneered the use of large-bore .088” intracranial access paired with angled-tip aspiration catheters to enable better and faster reperfusion for stroke procedures.1,2 Zoom 88 Support expands the company’s .088” intracranial access portfolio – the only access portfolio on the market to enable large-bore intracranial access.

Key Points: 
  • Imperative Care has pioneered the use of large-bore .088” intracranial access paired with angled-tip aspiration catheters to enable better and faster reperfusion for stroke procedures.1,2 Zoom 88 Support expands the company’s .088” intracranial access portfolio – the only access portfolio on the market to enable large-bore intracranial access.
  • The portfolio also includes the existing Zoom 88 LDP and the Zoom RDL Access Platform.
  • Zoom 88 Support provides the same benefits of intracranial access found with Zoom 88 LDP, with the ability to treat more proximal or tandem occlusions,” said Ariel Sutton, GM of Imperative Care’s Stroke business.
  • “With products like Zoom 88 Support, Imperative Care continues to respond to the needs of patients with much-needed solutions to help streamline stroke procedures and treat patients quickly and effectively.”

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

Retrieved on: 
Monday, February 13, 2023
Idiopathic multicentric Castleman disease, NDA, Standard of care, BI, Therapy, III, Nursing care plan, Safety, NIHSS, Randomness, Food, MRS, Apoptosis, Investigational New Drug, Stroke, FDA, Injection, US Foods, Conference, Death, Pharmaceutical industry, Patient

WILLOWBROOK, III., Feb. 13, 2023 /PRNewswire/ -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that the US Food and Drug Administration (FDA) has issued a proceed forward letter regarding the Company's Investigational New Drug ("IND") application that includes the protocol entitled, "A Multicentric, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Study To Assess The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke." The FDA completed a safety review of the protocol and concluded that the Company could proceed with the proposed clinical investigation. Since this upcoming trial may be used as a potential pivotal efficacy study to support a future NDA, Pharmazz plans to incorporate the FDA's suggestions to the study design and update the protocol for a Special Protocol Assessment as recommended by the FDA.

Key Points: 
  • "FDA clearance of our Phase III trial is a significant milestone for Pharmazz and the potential future treatment of acute ischemic stroke patients," said Anil Gulati, M.D., Ph.D.
  • In October last year, we reported the results of our successful Phase III trial in acute cerebral ischemic stroke patients that we conducted in India.
  • The upcoming US Phase III trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of sovateltide in 444 patients with acute cerebral ischemic stroke.
  • The primary endpoint is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with the mRS of 0-2 on day 90 post-randomization.

Stemedica Initiating Phase IIb/III Clinical Trial for Patients with Chronic Ischemic Stroke

Retrieved on: 
Thursday, January 19, 2023
Health, Stem Cells, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, IND, National Institutes of Health Stroke Scale, Gene expression, MMSE, UCI, University, Mercy Gilbert Medical Center, SAFETY, AND, NIHSS, B cell, Depression, Cell proliferation, Rankine scale, Atlantic Film Festival, Rehabilitation, FDA, University of California, Horizon Fuel Cell Technologies, Patient, UCSD, Stroke, Clinical trial, Stem cell, GDS, Pharmaceutical industry, Safety

Stemedica plans to initiate a Phase IIb/III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of a single intravenous injection of allogeneic mesenchymal stem cells to subjects with ischemic stroke.

Key Points: 
  • Stemedica plans to initiate a Phase IIb/III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of a single intravenous injection of allogeneic mesenchymal stem cells to subjects with ischemic stroke.
  • Stemedica successfully completed a Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke in patients with chronic ischemic stroke and demonstrated an excellent safety profile of itMSCs.
  • We hope to bring this medication to patients with this debilitating condition,” said Dr. Lev Verkh, Chief Regulatory and Clinical Development Officer.
  • “Unlike other stroke trials using stem cells, this is the first clinical trial of its kind, evaluating Stemedica’s itMSCs.