HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
New Data Presented at CHEST 2023 Demonstrate the Clinical Utility of Veracyte’s Envisia Genomic Classifier for Patients with Interstitial Lung Disease
The studies presented at the CHEST Annual Meeting show that adding the Envisia Genomic Classifier to the diagnostic process can improve the ability to detect UIP.
Owlstone Medical Recruits First Patient in Phase 2 Clinical Trial for the Early Detection of Lung Cancer through Breath Biopsy
Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Results from Phase 1 of the EVOLUTION trial demonstrated the relevance of the molecular pathway targeted by D5-EthGlu and provided crucial evidence to support further test development. With the recruitment of the first patient into Phase 2, we are excited to continue to progress a test that has the potential to transform lung cancer diagnosis by substantially increasing the uptake of testing, leading to more cases of lung cancer being caught early and significantly reducing mortality and costs. Our nodule management test also holds the potential for more effective identification of benign nodules, reducing unnecessary biopsies and surgery.”
Salubris Biotherapeutics Presents Positive 6-Month Data from Phase 1b Clinical Trial of JK07 in Late-Breaking Session at The Heart Failure Society of America Annual...
The data were presented in a late breaking oral session during the Heart Failure Society of America Annual Scientific Meeting 2023. JK07 is the first investigational antibody fusion protein and first selective ErbB4 agonist to enter clinical development for heart failure. Heart failure is a leading cause of morbidity and mortality globally, with estimates of more than 6 million patients affected by HFrEF and HFpEF in the US.
Neoadjuvant Study with LTX-315 In Early-stage Melanoma Patients to be Presented at the 15th Nordic Melanoma Meeting
The title of the presentation is: Neoadjuvant LTX-315 in combination with pembrolizumab in resectable stage III/IV melanoma (NeoLIPA trial): Protocol for a single center phase II open label study.
Amber Implants Announces Start of Clinical Trial with VCFix® Spinal System
This first-in-human clinical trial will assess the safety and effectiveness of the VCFix® Spinal System implant for patients suffering from vertebral compression fractures. The implant is provided with a user-friendly, single-use sterile surgical kit, ensuring perfect traceability and reducing the risk of infection.
Theradaptive Awarded DOD Clinical Trial Award of up to $7.4 Million
Commenting on the award, Theradaptive CEO and founder, Luis Alvarez, Ph.D. said, "The CDMRP Clinical Trial Award comes at a pivotal time for our company as we prepare for first in human clinical trials. Veterans and service members are disproportionally likely to suffer from traumatic extremity injuries or spinal degeneration and disc injury, and currently lack efficacious treatments with very few options. We have already demonstrated superior outcomes in preclinical studies, showing the promise of our technology. With this CTA award we are one step closer to providing new and improved therapies to patients and aligning with CDMRP's strategic goal of trying to increase post-injury quality of life by halting or slowing orthopedic disease progression in servicemembers and veterans."
Lipogems® Announces 140 Independent Peer Reviewed Publications with 5 Years of Follow up in Orthopaedics
Giorgio Ninzoli, President of Lipogems International. "The gold standard for evidence is 1 year follow up and we are excited to report 5 years follow up with positive results after a single injection of MicroFat."
Study Outcomes Could Provide Insights Into New Targeted Treatments to Manage this Challenging Disease
The study aims to determine if immediate biological preservation of patient-derived chordoma tumor tissue, collected intraoperatively and implanted for serial sampling in translational research, will provide new insights into the biological weakness of the disease and contribute to developing improved treatment therapies reports NICO.
Study Validates Lunit AI as a Game-Changer, Poised to Replace One Human Reader in Breast Cancer Screening
Utilizing Lunit INSIGHT MMG, an FDA-cleared and CE-marked AI solution for mammography analysis, this research backs AI's potential to replace one human reader under Europe's double reading guideline and underscores its capacity to alleviate the strain on radiologists.