SEATTLE, Sept 13, 2022 /PRNewswire/ -- Magnolia Medical Technologies, Inc. ("Magnolia Medical"), inventors of the Steripath® Initial Specimen Diversion Device® (ISDD®) family of products, today announced it filed a motion for permanent injunction in the U.S. District Court for the District of Delaware on September 9, 2022, that would prohibit Kurin, Inc. ("Kurin") from the continued sale of the infringing Kurin Lock products.
The filing follows two recent jury verdicts in Magnolia Medical's favor. The first verdict found that Kurin infringed Magnolia Medical's U.S. Patent No. 10,039,483, using the company's patented innovative technology without permission. The second verdict rejected Kurin's attempts to invalidate the asserted claims and awarded significant damages for the sale of the infringing Kurin Lock product, including a 17.7% royalty.
"We have invested over a decade in pioneering and proving the clinical value of our technology. Protecting our valuable intellectual property portfolio and the significant resources that we have dedicated to scientific research and product innovation to prevent the misdiagnosis of bloodstream infections including sepsis is important to ensure that all patients and hospitals have access to and benefit from Magnolia Medical's exclusive evidence-based technology," said Greg Bullington, CEO of Magnolia Medical.
Steripath® is the only FDA 510(k)-cleared platform specifically indicated to reduce blood culture contamination,1 and Magnolia Medical's platform offers the only all-in-one devices that meet the CDC's new guidelines to reduce blood culture contamination.2,3 A permanent injunction granted in the U.S. District Court for the District of Delaware would prohibit Kurin from continuing to infringe Magnolia Medical's patent and prevent Kurin from manufacturing, using, selling, offering for sale, and/or importing the Kurin Lock product in the United States.
"While we are gratified by the jury's unanimous infringement verdict against Kurin, we believe this enforcement action will finally put an end to Kurin's unlawful business tactics and clarify any confusion in the market," said Bullington. "We have made no agreement with Kurin that would permit Kurin to continue selling its infringing Kurin Lock. We do not license our proprietary technology and have not agreed to any license with Kurin. We will continue to vigorously defend the substantial efforts and resources that we have invested over the past decade in clinical research, product development, market development, and our intellectual property portfolio."
The Steripath® Initial Specimen Diversion Device® platform offers the only all-in-one devices that are clinically proven to meet the ENA, INS, CDC, and CLSI evidence-based best practice guidelines to reduce blood culture contamination.2,3,4,5,6 To date, 20 clinical studies have been completed supporting the clinical and cost effectiveness of Steripath. All studies reported sustained contamination rates of 1% or less using Steripath, up to a 31% reduction in vancomycin days of therapy, and as much as a 12-fold decrease in false-positive central line-associated blood stream infections (CLABSIs) over extended periods of time.7,8,9
Steripath has been adopted by hundreds of U.S. hospitals and healthcare systems to address the problem of blood culture contamination, which can lead to sepsis misdiagnosis resulting in unnecessary, prolonged, and harmful antibiotic treatment, extended length of hospital stay, false-positive CLABSIs, and wasted healthcare resources.
About Magnolia Medical Technologies
Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency, and predictability of critical laboratory tests. Magnolia Medical invented and patented the Initial Specimen Diversion Technique® (ISDT®) and Initial Specimen Diversion Device® (ISDD®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio, including more than 100 issued method, apparatus, and design patents with more than 70 additional patent applications pending. For more information, visit www.magnolia-medical.com.
Indicated to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion.
CDC. Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022.
CDC. National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022.
CLSI. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
Vanhoy MA, Horigan A, Kaiser J, et al. Emergency Nurses Association (ENA). Clinical practice guideline: prevention of blood culture contamination. 2020.
Gorski LA, Hadaway L, Hagle ME, et al. Infusion therapy standards of practice, 8th edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1): S1-S224.doi: 10.1097/NAN.0000000000000396.
Data on file.
Nielsen LE, Nguyen K, Wahl CK, et al. Initial Specimen Diversion Device® reduces blood culture contamination and vancomycin use in academic medical center. J Hosp Infect. 2021;117. doi:https://doi.org/10.1016/j.jhin.2021.10.017.
Tompkins LS, et al. Getting to zero: impact of a device to reduce blood culture contamination and false-positive central line-associated blood stream infections. Submitted to ICHE August 2022.
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SOURCE Magnolia Medical Technologies