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May Edition 2023

Magnolia Medical Technologies – Improving the diagnostic accuracy and timeliness of sepsis test results

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Magnolia Medical Technologies is on a Mission to ZERO™. Today, the company offers healthcare institutions a solution to some of their biggest hidden problems – contamination leading to misdiagnosis of bloodstream infections, including sepsis, which can lead to unnecessary and prolonged antibiotic therapy, and false-positive CLABSIs. It aspires to create a world free of in-vitro diagnostic errors where rapid, accurate test results improve the lives of patients and providers alike.

Magnolia knows that setting new standards of care is a journey enabled by purposeful innovation, partnerships, and perseverance. As the first step of its journey, it has successfully developed and proven their evidence-based technology platform, Steripath, coupled with unparalleled support to change clinical practices and prevent unnecessary patient harm as well as system-wide costs associated with the misdiagnosis of sepsis.

Magnolia's mission is further enabled by reducing false-positive CLABSIs and leveraging its extensive intellectual property portfolio – consisting of over 100 issued method, apparatus, and design patents and 70+ patent applications pending – to address other important sources of diagnostic error that are harmful to patients and costly to hospitals.

Steripath®

Steripath is the only FDA 510(k)-cleared device specifically indicated to reduce blood culture contamination4 with an FDA-cleared labeling claim for an 83% and 88% reduction in contamination rates. Steripath comes pre-assembled and sterile to actively divert and sequester the initial 1.5-2.0mL of blood, the volume known to contain contaminants. Blood cultures are collected through an independent, second flow path, creating a closed vein-to-bottle collection system designed to prevent bypassing diversion.

Steripath Micro: It optimizes the blood culture collection process by allowing for fast, easy, and consistent diversion and test sample collection. Using an active blood culture bottle- or syringe-driven diversion method, Steripath Micro diverts the initial 0.5 to 1.0 mL of blood into the diversion chamber, preventing potential contaminants from entering the culture bottle. Once diversion is complete, simply push a button to automatically sequester the contaminants and open a second, sterile pathway for blood culture collection. Steripath’s proprietary technology and easy-to-use design help you effectively reduce blood culture contamination and false-positive test results so you can prevent patient harm, and reduce unnecessary and prolonged antibiotic usage, length of stay, and hospital costs.

An Engineered Solution for Contamination Prevention

Magnolia Medical Technologies' Training and education have long been the standard intervention, but they only show modest, unsustainable reductions in contamination rates because they cannot address potential contaminants that are viable in the keratin layer of the skin even after skin prep. Manual diversion methods to remove contaminants prior to specimen collection are impractical for busy departments and difficult to sustain and reproduce results. Passive diversion options create the potential for the contaminated blood to mix with the culture specimen, are susceptible to bypassing diversion, and do not conform to published guidelines on clinically proven diversion volumes.  

In addition to improving patient safety and quality outcomes, reducing blood culture contamination rates can also have an impact on your central line-associated blood stream infection (CLABSI) reporting. Anywhere from 30% to 45% of reported CLABSIs most likely represent contaminated blood cultures rather than true CLABSIs. These false-positive results may elevate your hospital’s standardized infection ratio (SIR), which could result in penalties and unintended economic consequences for your hospital.

Steripath is supporting the movement to a better standard for your patients. Through the use of Steripath, hospitals and health systems can reduce their blood culture contamination rates by as much as 100% with sustained results. Improving the accuracy of blood culture results directly impacts the antimicrobial stewardship efforts and the quality outcomes of your hospital.

Alternative Blood Diversion Methods

Reducing blood culture contamination, which contributes to a misdiagnosis of sepsis and unnecessary administration of antibiotics like Vancomycin, proves to be one of the most effective methods in preventing multi-drug resistant organisms (MDROs) and avoiding antibiotic-related infections like Clostridioides difficile Infection (CDI).

Blood culture results play a critical role in determining if antibiotic treatment can be de-escalated for patients in the sepsis protocol. Treatment is typically continued for patients with positive blood cultures, even when contamination is suspected. Reducing false-positive blood culture results can guide appropriate treatment and dramatically reduce unnecessary antibiotic treatment.  Clinicians rely on blood culture results for patient treatment decisions, and hospitals and healthcare systems spend considerable efforts training and educating on skin preparation and aseptic techniques. While these best practices are important, contamination caused by sources outside of the nurse or phlebotomist’s control can still occur, resulting in inaccurate or false-positive results and other negative outcomes.

About | Gregory J. Bullington

Greg Bullington, Chief Executive Officer and co-founder, has led all aspects of company development since inception including clinical trial design, execution & publication, product portfolio development and overall standard of care, commercialization and intellectual property strategy. To date, Greg has raised over $115 million in capital to drive the successful growth and development of Magnolia and the ISDD® market.

Greg has extensive experience in the healthcare industry having led product commercialization and strategy engagements for a wide variety of companies in the biotech (novel immunotherapy) as well as healthcare insurance, wellness and enterprise software sectors.

Greg began his career in professional services with Deloitte & Touche LLP. He continued his professional development as a management consultant at Lake Partners, a Seattle-based strategy consulting firm. In 2006, Greg founded Forum Ventures, a technology commercialization consultancy focused on accelerating the growth of early and mid-stage companies in a variety of sectors.

Over the past 20 years, Greg has led engagements and worked closely with senior executive teams at over 50 companies ranging from Fortune 100 corporations to venture-backed and early-stage startups as a consultant, advisor, and investor.

"We proudly partner with U.S. hospitals and healthcare providers by supporting them with best-in-class education and innovative technology designed to reduce blood culture contamination and deliver the definitive diagnostic results patients deserve."

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