DyeMINISH Multi-Centre Global Patient Registry Launched
May 8, 2019- Minnesota, United States and Melbourne, Australia – Osprey Medical is pleased to announce the launch of DyeMINISH™; a global patient registry to evaluate the ongoing safety and performance of the DyeVert™ Contrast Reduction System during standard clinical use in a real-world patient population. The DyeMINISH registry is a retrospective, large-scale, multi-centre study with the first patient included on May 7, 2019. The registry is designed to enrol up to 10,000 participants and is expected to complete in late 2023.
The first patient was included in the DyeMINISH registry at St. Elizabeth Healthcare in Edgewood, Kentucky by Dr. Mark Jordan, an Interventional Cardiologist. St. Elizabeth Healthcare operates five facilities throughout Northern Kentucky and more than 115 primary care and specialty office locations in Kentucky, Indiana and Ohio. A member of the Mayo Clinic Care Network, St. Elizabeth is a mission-based organization committed to improving the health of the communities it serves, providing more than $117 million in uncompensated care and benefit to the community in 2017.
The DyeMINISH Registry includes two study cohorts. The Core Study cohort is comprised of patients who underwent coronary or peripheral angiography imaging procedure with the DyeVert System. The Comparative Health Outcomes Sub-Study includes patients undergoing the same procedures without DyeVert that can be matched to a DyeVert Group patient via propensity score matching.
The Core Study aims to evaluate the use of imaging dye thresholds, actual imaging dye delivered to the patient and imaging dye saved. The Core Study also aims to evaluate the incidence of adverse events, such as the incidence of CI-AKI, the relationship between imaging dye and CI-AKI and other variables through to 120 days post-procedure. The Comparative Health Outcomes Sub-Study will compare the difference in health outcomes between those patients who received DyeVert versus the no DyeVert control via measures which include kidney function, imaging dye use, and incidence of major cardiac and renal adverse events.
Osprey Medical’s President and CEO, Mike McCormick commented: “Real-world evidence plays an increasingly critical role in health care and regulatory decision-making, payor coverage, policy development and clinical guideline revisions. Through collaboration with our customers and medical advisors, Osprey Medical’s significant investment in the DyeMINISH Registry will provide a scalable platform for real-world data acquisition, management, and analysis that will support peer reviewed publications of improved outcomes for Chronic Kidney Disease patients. Data generated by the registry will directly support our mission of improving clinical care for Chronic Kidney Disease patients undergoing angiography procedures.”
About Osprey Medical (ASX: OSP)
Osprey Medical’s vision is to make heart imaging procedures safer for patients with poor kidney function. The amount of dye (contrast) used during angiographic imaging procedures increases the patient's risk for dye-related kidney damage known as Contrast-Induced Acute Kidney Injury (CI-AKI). The Company’s core technologies originated from research conducted by Dr David Kaye at Melbourne’s Baker Institute. Its proprietary dye reduction and monitoring technologies are designed to help physicians minimize dye usage and monitor the dose of dye real time throughout the procedure. The Company’s DyeVert™ System reduces contrast while maintaining image quality in a self-adjusting easy-to-use design that monitors dye usage. Osprey Medical’s Board and Management are comprised of experienced and successful personnel with established track records covering medical device development, regulatory approvals, sales and marketing, and mergers-acquisitions. Osprey Medical’s advisory board comprises world-recognised experts in heart and kidney diseases.
