Steripath Gen2, Next Generation Initial Specimen Diversion Device, Offers An Advanced Approach to Virtually Eliminating Blood Culture Contamination

Technology demonstrates significant, sustained, reproducible reduction in blood culture contamination

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Aug 30, 2018, 08:09 ET

SEATTLE, Aug. 30, 2018 /PRNewswire/ -- Magnolia Medical Technologies today announced the successful national launch and adoption of Steripath® Gen2. The next generation Initial Specimen Diversion Device®, released in early 2018, has been adopted by both existing and new hospital customer accounts as their standard approach for blood culture contamination prevention as part of their sepsis testing accuracy initiatives.

A patented one-of-a-kind technology, Steripath Gen2 integrates clinically proven mechanical initial specimen diversion with enhanced usability features. Taking input from end users, these enhancements deliver the ultimate user control and experience in a 50% smaller preassembled sterile vein-to-bottle closed system with new One-Step Diversion™. The resulting ease of use supports hospital-wide and system-wide adoption.

"Our team is very pleased with the 83 percent reduction in blood culture contamination we have achieved using Steripath," said Jessica Plante, RN, a Nurse Educator at Lee Health. "Based on this success, we are now expanding and standardizing its use throughout all Lee Health hospitals."

Developed by the inventors of the Initial Specimen Diversion Technique™ and Initial Specimen Diversion Device® technology platform for blood culture contamination prevention, Steripath Gen2 mechanically diverts and isolates the initial 1.5-2.0 mL of blood, the portion known to contain contaminants. The device then opens an independent sterile blood flow path to the culture bottles. Two controlled clinical studies published in leading peer-reviewed medical journals and seven clinical abstracts accepted and presented at major medical conferences have demonstrated sustained blood culture contamination rates as low as 0.2% in the ED¹, with hospitals then achieving positive predictive value for sepsis as high as of 97%¹, as much as a 37% reduction in vancomycin days of therapy² and an estimated average annualized hospital cost savings of $945,000 in four of the clinical trials.³

Magnolia is also working to expand the Steripath Gen2 family of products with a preassembled sterile syringe-driven collection device under development, with the goal to provide improved contamination reduction regardless of the hospital blood culture collection technique and protocol.

"At Magnolia, we are committed to eliminating blood culture contamination by empowering healthcare providers with the advanced technologies they need to significantly reduce false positive diagnostic results for sepsis, and the associated patient safety risks, global antibiotic resistance implications and avoidable costs to our healthcare system," said Greg Bullington, CEO of Magnolia Medical. "Our customers have demonstrated reproducible, sustained results in hospital settings ranging from large academic and government institutions to small community hospitals. We look forward to continued partnership and support of our hospital customers in establishing a new standard of care in sepsis testing accuracy."

About Magnolia Medical Technologies
Magnolia 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) tests. Magnolia invented and has pioneered the Initial Specimen Diversion technology platform for blood culture collection and contamination prevention. Through human factor engineering, the Steripath Initial Specimen Diversion Device^® has been clinically proven to virtually eliminate blood culture contamination, which helps healthcare providers to significantly reduce false positive diagnostic results for sepsis and reduce unnecessary and inappropriate antibiotic use. This reduces the risk of CDI, MDROs and other antibiotic-related complications, length of stay and associated HACs, and unnecessary reporting of false positive CLABSIs while significantly reducing hospital-wide costs. The company has amassed an IP portfolio protecting its technology and products, including more than 55 issued method, apparatus and design patents with over 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.

¹M. Rupp, et al; Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device. Clinical Infectious Diseases (August 2017)
²D. Chang, et al; Impact of Blood Culture Diversion Device and Molecular Pathogen Identification on Vancomycin Use. Society of Healthcare Epidemiology of America (SHEA) Conference (Spring 2017)
³Source data on file

Contact: Liz Dowling
Dowling & Dennis PR
415-388-2794
[email protected]

SOURCE Magnolia Medical Technologies