Magnolia Medical Protects its Innovative Technology from Patent Infringement

Steripath® is the Only Technology of its Kind Supported by Independent Published Studies to Improve Sepsis Testing Accuracy

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Magnolia Medical Technologies

Mar 11, 2019, 09:21 ET

SEATTLE, March 11, 2019 /PRNewswire/ -- Magnolia Medical Technologies has asserted four patents in a patent infringement action against Kurin, Inc., asking a Federal court to enforce and protect Magnolia's intellectual property. The legal action demands that Kurin stop infringing on Magnolia's well-established patents, and respect the investments made by Magnolia to create, develop, and bring to market its groundbreaking and evidence-based technology platform that improves sepsis testing accuracy. Magnolia is the inventor and manufacturer of Steripath^®, the first-of-its-kind technology solution clinically documented to reduce blood culture contamination and false-positive results for sepsis and decrease healthcare costs.

Magnolia's history is rooted in innovation that serves patients and hospitals. For more than 40 years, Dr. Richard Patton saw first-hand as a pathologist the many problems resulting from false-positive test results for bloodstream infections, including sepsis. He filed his first patent application on Initial Specimen Diversion Technique (ISDT^™) in 2006, and co-founded Magnolia with Greg Bullington in 2008. They have invested substantial time and personal resources into the research and development underlying Magnolia's technology platform and products that increase the accuracy of testing for sepsis, which is the number one cause of death in U.S. hospitals¹. Magnolia invented and brought to market the novel and innovative Initial Specimen Diversion Device^® (ISDD^®) for blood culture collection and contamination reduction, now in its second generation called Steripath Gen2 ISDD.

Steripath — Magnolia's preassembled vein-to-bottle, closed-sterile-system to collect blood cultures — reduces contamination and false-positive results by up to 92 percent with 12-month sustained contamination rates as low as 0.2 percent.² This improvement in accuracy reduces patients' risk of sepsis misdiagnosis and the associated unnecessary use of antibiotics, while reducing hospital length of stay. Steripath has demonstrated this clinical improvement as well as reduced hospital costs in two controlled clinical studies and one cost-effectiveness study published in leading peer-reviewed medical journals, along with eight clinical abstracts presented at the major national medical society conferences.^2,3,4,5

"Magnolia uses its technology to decrease patient risk by reducing misdiagnosis and mistreatment of sepsis, which also strongly supports antibiotic stewardship," said Greg Bullington, CEO of Magnolia Medical Technologies. "Dr. Richard Patton and I have spent more than a decade developing unique medical innovations that deliver scientifically proven results, and we are committed to making sure Steripath and its future are appropriately protected, ensuring that patients and hospitals will benefit from Magnolia's technology."

On March 7, 2019, Magnolia amended its earlier Federal court complaint. Magnolia now alleges that Kurin, Inc. is infringing on four separate Magnolia patents: U.S. Patent No. 9,855,001, U.S Patent No. 10,028,689. U.S. Patent No. 10,039,483 and U.S. Patent No. 10,220,139. The four patents represent and cover years of Magnolia's research and development work to decrease patient risk and reduce healthcare costs.

While Magnolia welcomes fair and legal competition, Kurin, Inc.'s making, using, and selling of its "Kurin Lock" product wrongly exploits Magnolia's foundational technology. Magnolia will vigorously defend its technology and is seeking damages and a permanent injunction barring Kurin from making, using, selling, or offering for sale the Kurin Lock devices.

About Magnolia Medical

Magnolia Medical is a medical device company that develops, manufactures and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency and predictability of critical in vitro diagnostic (IVD) laboratory tests. Magnolia Medical invented and patented the initial specimen diversion technique (ISDT™) and device (ISDD^®) for blood culture collection and contamination prevention. The Steripath ISDD has been shown in peer-reviewed published clinical studies to reduce blood culture contamination — which in turn helps healthcare providers decrease false positive diagnostic results for sepsis and the resulting unnecessary and inappropriate antibiotic use. This reduces the risk of Clostridium difficile infections, multi-drug-resistant organisms and other antibiotic-related complications, hospital length of stay, associated healthcare-acquired infections, and hospital-wide costs^2,3,4,5. The company has amassed an Intellectual Property portfolio protecting its technology and products, including more than 60 issued method, apparatus and design patents with more than 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.

Notes to Editor:

Bios

Dr. Richard Patton, co-founder and Magnolia's Medical Director, is a board-certified pathologist with more than 40 years of experience. He was the Chief of Pathology and Medical Director of Clinical Laboratories at Northwest Hospital, Seattle, Washington for four decades, specializing in clinical microbiology, gastrointestinal pathology, and cytopathology.

Greg Bullington, co-founder and CEO of Magnolia Medical Technologies, has led all commercial aspects of company development since inception including clinical study design and execution, peer-reviewed publication, product development, manufacturing, commercial launch and overall intellectual property strategy. Bullington also has significant intellectual property expertise and is the first named inventor on more than 40 issued patents as well as more than 50 pending U.S. and international patent applications.

Fingar K (Truven Health Analytics), Washington R (AHRQ). Trends in Hospital Readmissions for Four High-Volume Conditions, 2009-2013. HCUP Statistical Brief #196. November 2015. Agency for Healthcare Research and Quality, Rockville, MD.
Rupp, M., et al. (2017). Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device. Clinical Infectious Diseases, 65(2): 201-205.
Bell, M., et al. (2018). Effectiveness of a Novel Specimen Collection System in Reducing Blood Culture Contamination Rates. Journal of Emergency Nursing, 44(6): 570-575.
Skoglund, E., et al. (2019). Estimated clinical and economic impact through use of a novel blood collection device to reduce blood culture contamination in the emergency department: A cost-benefit analysis. J. Clin. Microbiol. 57: e01015-18.
Chang, D., et al (2017). Impact of Blood Culture Diversion Device and Molecular Pathogen Identification on Vancomycin Use. Society of Healthcare Epidemiology of America (SHEA) Conference.

SOURCE Magnolia Medical Technologies