Reperfusion

Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Thursday, March 7, 2024

TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Arch Biopartners team is currently working with hospital sites in Canada to prepare for their participation in this Phase II trial.
  • The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.

Nanoflex Robotics Installs First Remote-Ready Robotics System in North America for Vascular Interventions

Retrieved on: 
Thursday, March 7, 2024

ZURICH, Switzerland, March 07, 2024 (GLOBE NEWSWIRE) -- Nanoflex Robotics AG, a remote robotics medical startup, based in Switzerland, recently installed its first remote-ready robotics system for neurovascular procedures at The Jacobs Institute, a nonprofit medical device innovation center located in Buffalo, New York, USA.

Key Points: 
  • The Nanoflex Robotics system uses a compact magnetic field generator and a navigation control unit to guide ultra-flexible devices through the body for a range of complex vascular interventions.
  • By enabling remote mechanical thrombectomies, the Nanoflex Robotics remote robotics system reduces the need for inter-hospital transfers, thus shortening the time to reperfusion and potentially better preserving a patient’s quality of life.
  • The installation of Nanoflex Robotics first remote robotics system comes shortly after the company received its ISO 13485 certification for its quality management system in designing and manufacturing remote robotic devices for endovascular interventions.
  • Clinicians interested in learning more about the Nanoflex Robotics remote robotics system should visit www.nanoflexrobotics.com or write to info[at]nanoflexrobotics.com.

Route 92 Medical Announces Completion of Enrollment in the SUMMIT MAX Clinical Trial

Retrieved on: 
Wednesday, February 21, 2024

SAN MATEO, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial ( NCT05018650 ) evaluating the safety and effectiveness of its HiPoint™ 88 and HiPoint 70 Reperfusion Catheters as part of the MonopointⓇ Reperfusion System.

Key Points: 
  • SAN MATEO, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial ( NCT05018650 ) evaluating the safety and effectiveness of its HiPoint™ 88 and HiPoint 70 Reperfusion Catheters as part of the MonopointⓇ Reperfusion System.
  • SUMMIT MAX is the first FDA-approved aspiration thrombectomy trial which is randomized.
  • Randomized controlled trials provide the best clinical science and the SUMMIT MAX Trial compares the Route 92 Medical Monopoint System to the largest commercially available conventional aspiration system.
  • “Route 92 Medical is leading the way in neurovascular innovation technology, bringing clinicians complete solutions designed to improve endovascular thrombectomy procedure times and outcomes.

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

Retrieved on: 
Thursday, February 8, 2024

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%.

Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 10, 2024

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.
  • There is no treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

Arch Biopartners Receives Approval from the Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 3, 2024

TORONTO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received approval in Turkey from the Ministry of Health to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received approval in Turkey from the Ministry of Health to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • With the Ministry of Health (MoH) approval for the trial, Arch can now proceed to contract and activate clinical sites in Turkey.
  • Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated.

Arch Biopartners Receives Approval from Ethics Committee in Turkey to Proceed with Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Thursday, December 21, 2023

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The ethics committee approval of the trial will be followed by a final regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-January.
  • Once the trial is approved by the MoH, activation of clinical sites in Turkey will take place and patient enrollment can begin in February.
  • Quote from Richard Muruve, CEO of Arch Biopartners Inc:
    “We look forward to a positive decision from the MoH, which will permit enrollment of Turkish cardiac surgery patients into the trial.

Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Wednesday, December 13, 2023

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The FDA granted the Company permission to proceed with a Phase II trial in late June .
  • Quote from Richard Muruve, CEO of Arch Biopartners Inc:
    “The clinical trial application submitted to Health Canada is the result of clinical interest in Canada to support our Phase II trial targeting CS-AKI.
  • LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in pre-clinical models , providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

Perfuze® Announces FDA Clearances for Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment

Retrieved on: 
Wednesday, December 20, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231220858228/en/
    The Millipede 070 Aspiration Catheter is built upon a pioneering, distinctive technology that enables physicians to address critical unmet needs in ischemic stroke treatment.
  • Perfuze takes a physician-led approach to device innovation, working to advance all aspects of stroke treatment from vessel access through to thrombectomy.
  • Stroke is a critically time-sensitive disease and without appropriate diagnosis and treatment, a majority of patients suffer permanent disability or death.
  • Despite recent advances in life-saving endovascular treatment, just 10 percent of eligible stroke patients receive thrombectomy treatment today.

Rapid Medical's TIGERTRIEVER™ Delivers First-Pass Success in Challenging Ischemic Stroke Patients with ICAD

Retrieved on: 
Thursday, November 16, 2023

Rapid Medical™, a leading developer of advanced neurovascular devices, announces new data demonstrating excellent first-pass treatment success with the TIGERTRIEVER™ device in complex ischemic stroke patients with underlying intracranial atherosclerotic disease (ICAD).

Key Points: 
  • Rapid Medical™, a leading developer of advanced neurovascular devices, announces new data demonstrating excellent first-pass treatment success with the TIGERTRIEVER™ device in complex ischemic stroke patients with underlying intracranial atherosclerotic disease (ICAD).
  • “Patients with ICAD experiencing a stroke are very challenging to treat and often need rescue therapy such as stenting,” states Dr. Edgar Samaniego , Endovascular Neurologist at the University of Iowa and lead author.
  • “We achieved very high treatment success and lasting results with TIGERTRIEVER alone that we haven’t seen with other devices.
  • Moreover, TIGERTRIEVER in ICAD rivals the results only thought possible in non-ICAD patients.