Kurin, Inc. Announces Educational Website on the Importance of Improving Value of the Blood Culture Test

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Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that it has created an educational website, www.betterbloodcultures.com, to aid clinicians in making blood culture testing more effective. Blood culture tests remain the gold standard for detecting sepsis, a bloodstream infection that is associated with significant mortality and morbidity risk.

“It might surprise many people, but 1/3 or more of all positive blood culture test results may, in fact, be wrong,” said Matt Heindel, Co-Founder and Vice President, Business Development of Kurin. “We started this business to help patients, improve antibiotic stewardship, and enable hospitals to provide better care and save money in the process. By creating a resource-rich website, we are able to have a greater positive impact on patients and hospitals alike. It is our goal to collaborate with various groups and use this website to promote best practices that improve the status quo.”

The website has several components, including reference pages providing background on the challenges related to blood cultures, an extensive bibliography to help people research the topic, and a new video created by Kurin called Cry Wolf: Consequences of a False Positive Blood Culture.

“Cry Wolf captures the problems created when a false positive blood culture occurs,” said Mr. Heindel. “The clinicians in this film effectively communicate the financial damage done to hospitals because of these erroneous results, and the negative impact on the health of the patients who receive this misdiagnosis, as they may be subjected to unneeded antibiotic treatment and an extended hospital stay, putting them at risk for further adverse events.” Additional educational content is coming in the near future and will be regularly updated. The website can be found at www.betterbloodcultures.com.

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.

Clinical results of Kurin specimen diversion technology signal a shift in the blood culture collection standard of care.

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In recent months the team at Kurin, Inc., manufacturer of the only FDA cleared blood culture diversion device, has received a wealth of clinical data from early adopter hospitals. In May, Crouse Hospital in Syracuse, NY, published a 56% overall reduction in contaminated blood cultures inclusive of all cultures drawn with or without the device. When a Kurin set was used in the blood collection, Crouse saw an 89% reduction in contaminated blood cultures. A month later, Bayfront Health presented a 54% overall reduction and a 90% reduction in contaminated cultures when Kurin was used. In both cases, the hospitals were already below the 3% national contamination rate benchmark when they began using Kurin. By addressing skin contaminants using Kurin’s passive diversion technology, the hospitals drove their overall contamination rates down to 0.8% and 1.2% respectively.

Commenting on the results, Kurin CEO Bob Rogers said, “For a decade, hospitals have been striving to achieve 3% contamination rates per industry guidance, yet it is now clear that 3% is far too lax a goal. With best practice compliance and specimen diversion for every collection, clinical data establishes that hospitals can maintain contamination rates of 1% or less, and save significantly by reducing unneeded treatment.” Indeed, Crouse and Bayfront reported annual cost savings of $185,000 and $430,000, respectively.

The founders of Kurin are familiar with what it takes to change clinical practice. As the creators of CurosTMdisinfecting port protectors, now a product and trademark of 3M, the team radically changed infusion port disinfection protocol leading to improvements in catheter related bloodstream infection rates across the country. Today passive disinfection caps have become the standard of care for hospitals to reduce their bloodstream infections.

“The parallels between Curos and Kurin are striking,” said Rogers. “In both cases, the success of the intervention comes down to caregiver compliance. If you use the technology, you will see positive results.” However, commonly used practices that deviate from the two-venipuncture standard can introduce points of contamination that compromise blood culture results. Rogers continued, “In most cases, the clinician does not know that their technique is increasing the chance of contamination, nor do they know what the downstream effects of that false positive culture might be. Therefore, Kurin is creating and sharing educational resources that raise awareness of blood culture contamination and support collection best practices.”

As part of this effort, Kurin is releasing a 5-minute documentary film entitled Cry Wolf to illuminate the prevalence of blood culture contamination, the clinical impact on patients, and the steep associated costs for hospitals. Cry Wolf debuts in partnership with CAP Today during the month of September 2018. View Cry Wolf at www.captodayonline.com starting September 18th. Additional resources may be found at www.betterbloodcultures.com, including the results described above, an annotated bibliography of studies on the topic, an educational video, blood culture contamination facts, and a listing of current industry standards.

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 CEO responds to Magnolia Medical Countersuit Press Release

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I want to take this opportunity to write to Kurin customers, the Kurin Board, employees, and our Investors. Last week, Magnolia’s CEO, Greg Bullington, issued a press release announcing counter claims Magnolia filed in early August against Kurin, Inc., and making certain inaccurate and misleading representations regarding Kurin and its products.

While we are confident in our claims and defenses in the case against Magnolia and could argue them here, we want to allow the court to make its determinations based on the facts in due course. There are a couple of items, however, that I do want to address:

1) We firmly believe in diversion as a means to reduce contamination of blood cultures. The Kurin Lock™ IS the first FDA cleared diversion device on the market. The FDA has reviewed our data and given us clearance to market with 510(k) number k162233. To our knowledge, the FDA has never reviewed Steripath to determine whether or not it is a waived device, as Magnolia contends.

2) Our customers have seen that the Kurin Lock reduces skin contaminants, allowing them to significantly decrease their number of false positives. Our customers also understand that a product’s performance is only as good as their clinician’s adherence to protocols and achieving a high level of compliance. Automatic diversion requiring no user intervention increases the likelihood of compliance, which has a direct impact on outcomes. At Kurin, we work hard to partner with our customers to develop systems to drive and monitor compliance and to achieve meaningful results.

We look forward to the adjudication of the various claims by the court. For now, we only hope all companies will abide by the rule of law and make claims that are complete and true. At Kurin we strive to do the right thing, to be truthful and transparent. After all, if we cannot serve our customers well by bringing true value, then we do not deserve to remain in business.

Bob Rogers
Chairman and CEO
Kurin, Inc.

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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San Diego, CA – 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. 10,010,282. 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.

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 sends the blood flow around the sequestration chamber through another channel into the culture bottle.

“This additional patent is the next step in building intellectual property protection for our unique blood diversion technology,” said Bob Rogers, Inventor and Chief Executive Officer. “As clinical results continue to prove the effectiveness of Kurin, this US patent further strengthens our position in the market. The simplicity of this product is critical to caregiver compliance and compliance is the key to improving clinical outcomes. 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.

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.