Osprey Medical (ASX: OSP) 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.
May 8, 2019- Minnesota, United States and Melbourne, Australia – Osprey Medical (ASX: OSP) 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.
Dr. Jordan commented: “We are excited to be participating in the DyeMINISH Registry to help us evaluate our Contrast-Induced Acute Kidney Injury (CI-AKI) prevention protocol. Reducing the risk of kidney damage during invasive heart procedures is of the highest priority for St. Elizabeth Heart and Vascular Institute, and is one of the many areas in which we seek to achieve the highest quality care. The multifaceted prevention protocol involves individualized assessment of patient’s risk of kidney injury, detailed preparation of the patient for the procedure, and efforts to limit exposure to imaging contrast volume. The protocol includes the use of the DyeVert System, a unique device that assists in reducing the volume of potentially harmful contrast agents delivered to patients during the procedure. The registry will provide the framework and analytics we need to demonstrate improvements in patient care in our cath lab.”
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.”
- ENDS –
Contact details:
Media Investors Company
Kyahn Williamson Dr Thomas Duthy Doug Schoenberg
Buchan Consulting Investor Relations VP of Marketing
M: (61) 401 018 828 M: (61) 402 493 727 T: (952) 955 8230
kwilliamson@we-buchan.com tduthy@ospreymed.com dschoenberg@ospreymed.com
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.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions, and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our products including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. Osprey does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Osprey may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.
Foreign Ownership Restriction
Osprey’s CHESS Depositary Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 (Securities Act) for offers or sales which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities Act or the laws of any state or other jurisdiction in the US. The holders of Osprey’s CDIs are unable to sell the CDIs into the US or to a US person unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. Hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.
