Kurin, Inc. announces clinical study results of the Kurin Lock™ blood culture initial specimen diversion device at the APIC Annual Conference.

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San Diego, CA: Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today at the 2018 APIC Annual Conference in Minneapolis, MN, new clinical study data supporting the efficacy of their specimen diversion device for blood culture collection. Kurin offers the only FDA 510(k)-cleared blood culture diversion product on the market. The patented Kurin Lock™ automatically diverts approximately 0.15ml of initial blood and potential skin contaminants therein during blood culture collection. When skin microbes enter blood culture samples, false positive test results may misinform physicians and lead to unnecessary medical treatment, risk for patients, and significant costs for the hospital.

The director of infection prevention at Bayfront Health in St. Petersburg, Fla., Jared Sutton, MPH, CIC, presented data from a 9-month study of 4,200 blood cultures collected by their phlebotomy and emergency department teams. During the trial, in which Kurin was employed for only 50% of all blood culture collections, the overall contamination rate inclusive of cultures taken both with and without Kurin, dropped by 54% from 2.5% to 1.2%, a statistically significant decline. When limiting the analysis to collections for which Kurin was used, there was only one contamination, which equates to approximately a 90% decrease in the contamination rate. The hospital estimates that each false positive blood culture adds $7,500 in costs, so implementing Kurin would save the hospital over $500,000 annually, after the cost of the product.

Sutton and colleagues reported, “This study focuses on total blood culture contaminants, and not just vacutainer collections. Without stratification, the mentioned results are what a user could expect to reproduce in a “real world” scenario.”

Bob Rogers, CEO of Kurin said, “As we have seen elsewhere, this study is additional confirmation that effective diversion of skin contaminants can be accomplished with approximately 0.15ml of blood waste and without requiring clinicians to change their standard practice. The accumulating data proves that Kurin can help hospitals prevent blood culture contamination, even in fast-paced EDs.”

About Kurin, Inc.
Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. sues Magnolia Medical for misleading consumers about FDA clearance and efficacy

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San Diego, CA: Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has sued Magnolia Medical Technologies in the U.S. District Court for the Southern District of California for violations of the Lanham Act based on its false and misleading statements. In the suit, Kurin alleges that Magnolia falsely implies that its Steripath device is FDA approved/cleared, and misrepresents product performance data by selecting only the most favorable results.

“Making claims about medical product performance is under the purview of the US Food and Drug Administration. In this case, the FDA has not cleared Steripath for marketing, so making such claims is irresponsible,” said Bob Rogers, CEO of Kurin. “We have a responsibility to accurately portray the ability of medical devices to improve clinical outcomes. Magnolia has abused this principle, confusing healthcare providers.”

Kurin offers an initial specimen diversion technology that automatically and passively diverts potential contaminants during blood culture collection. When skin microbes enter into blood culture samples, false positive test results may misinform physicians and lead to unnecessary medical treatment and risk for patients and significant costs for the hospital.

Kurin’s patented automatic blood diversion product is the only FDA 510(k)-cleared blood culture diversion product on the market. The Kurin comprehensive product suite includes 21g and 23g butterfly safety needles, a PIV connector for use with IV Starts, and culture bottle holders compatible with BD Bactec®, BioMerieux BacT/Alert®, and ThermoFisher VersaTREK™ REDOX™ bottles.

“We strive to present data that accurately reflect the impact of initial specimen diversion in hospitals. Magnolia claims ‘virtual elimination of false positives’ based on studies that do not reflect actual conditions in the hospital including non-compliance due to deficiencies in their product design. In the real world, there are commonly used procedural exceptions that cannot be ignored when evaluating true product efficacy. To knowingly do so is misleading,” said Rogers.

 

About Kurin, Inc.
Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.

Kurin, Inc. Receives Allowance from United States Patent and Trademark Office for Patent on Innovative Blood Culture Collection Device

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Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that the United States Patent Office allowed its patent application and has issued U.S. Patent No. 9,820,682. The Kurin blood culture collection set is a replacement for traditional collection sets, introducing technology to divert skin contaminants while preserving the standard blood culture collection technique for clinicians.

The patent describes and claims a blood sample optimization system for reducing or eliminating contaminants in collected specimens, which are a significant factor in causing contaminated blood cultures. Like regular blood culture sets, Kurin sets include a butterfly needle for venipuncture or luer connection to a peripheral catheter and a needle for filling a culture bottle. Unique to Kurin is the Kurin Lock™ blood sequestration device, which includes a chamber for diversion of the initial aliquot of blood that often contains skin contaminants from the venipuncture site. After diversion, the Kurin Lock automatically bypasses the sequestration chamber to convey subsequent blood flow through another channel into the culture bottle.

“This patent is the first step in building intellectual property protection for our unique blood diversion technology,” said Bob Rogers, Inventor and Chief Executive Officer. “This US patent strengthens our position in the market and delineates our approach from previous diversion methods. The simplicity of this product is critical to caregiver compliance. With no need for manual manipulation, a Kurin set makes it effortless for clinicians to incorporate diversion, a proven method of lowering contaminated blood cultures, into their routine collection process.”

Blood culture diversion technology can benefit hospitals and health systems, which suffer significant financial losses due to false positive blood culture results. When sepsis is erroneously indicated, unnecessary treatment and testing may ensue. Furthermore, patients who receive false positive blood culture results may be subjected to unneeded antibiotic treatment and an extended hospital stay, putting them at risk for further adverse events.

 

About Kurin, Inc.
Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.