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Category: CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Clinical trial, studies, and data updates reported in Medical Device News Magazine.

Coya Therapeutics Presents Updated ALS...

April 26, 2024

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or...

Sedana Medical Completes Patient Recruitment...

April 25, 2024

Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025".

Coya Therapeutics Presents Updated ALS Biomarker Data at the 2nd Annual Johnson Center Symposium

April 26, 2024

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board, and Dr. David Beers, Ph.D., Associate Research Professor of Neurology, Houston Methodist Hospital (HMH), will present biomarker data today as part of a presentation at the 2nd Annual Johnson Center Symposium in Houston, TX. The data presented highlights the strong predictive value of oxidative stress biomarker (4-HNE) levels with the rate of disease progression and...

Insulet Presents Omnipod Virtual Care Experience and Pre-Pivotal Study Results at the American Diabetes Association 80th Scientific Sessions

Omnipod 5 Automated Glucose Control System, Powered by Horizon™ (Omnipod 5), formerly known as the Omnipod Horizon System, is the first tubeless smartphone-controlled automated insulin delivery system for people living with diabetes.

June 11, 2020

Reflow Medical Enrolls First Patients in the DEEPER LIMUS Study of the Temporary Spur Stent System

Reflow Medical notes the OUS single-center clinical trial (NCT04162418) is expected to enroll up to 30 participants and last approximately six months.

June 10, 2020

Insulet Resumes Pivotal Study of its Next-Generation Product – Omnipod, Powered by Horizon™

Insulet expects to commercialize Omnipod, Powered by Horizon, in the U.S. in the first half of 2021, pending clearance by the FDA.

June 5, 2020

The Annals of Thoracic Surgery Published In Vivo Study Concludes Hemovent’s MOBYBOX ECLS Device Provides “Excellent (Long-Term) Safety and Physiologic Efficacy”

Hemovent reports the study concluded that Hemovent’s MOBYBOX ECLS device “provides excellent safety and physiologic efficacy in a 7-day (long-term) sheep experiment without visible clotting, hemolysis, or sustained reductions in fibrinogen or platelets.”

June 5, 2020

The Journal of Bone and Joint Surgery Published Article Shows Smith+Nephew’s OXINIUM on XLPE for Total Hip Arthroplasty as Best Performing Bearing Beyond 10 Years

Total hip arthroplasty using a bearing combination of OXINIUM on XLPE versus traditional ceramic or metal constructs results in greatly improved survivorship and significantly reduced the need for revision. Read more.

June 3, 2020

IMPACT Study Found a 25% Reduction in Total Healthcare Costs Associated with Earlier Prosthetic Care

The IMPACT study utilized the IBM Watson Truven Health Marketscan, a national commercial claims database, and analyzed data on 510 patients with lower limb amputations.

June 2, 2020

Non-Pharmaceutical Clinical Trial Starts Using Photobiomodulation to Treat Intubated COVID-19 Patients

Approved by the Ministry of Health in Brazil, a group of international physicians and scientists are in the early stages of data collection utilizing Multi Radiance Medical’s handheld super pulsed laser therapy devices to improve the condition of patients.

May 27, 2020

First Patient Enrolled in Phase 1 Natural Vascular Scaffolding Clinical Trial

The therapy is designed to open vessels and keep them open without the use of permanent implants in the treatment of peripheral artery disease (PAD) of the lower extremities, a painful and debilitating condition affecting over 200 million people worldwide.

May 27, 2020

OrthogenRx Announces Response in The Journal of Bone and Joint Surgery

OrthogenRx notes the recently published response counters this position and addresses some recently reported economic and medical benefits not acknowledged within the AAOS CPGs.

May 21, 2020