Kurin Inc. Responds to Allegations Published by Magnolia Medical Regarding Patent Infringement

Kurin Inc., manufacturer of Kurin® blood culture collection sets, responds to comments made by Greg Bullington, CEO of Magnolia Medical, in a letter Magnolia published regarding their patent-infringement lawsuit against Kurin.

“Magnolia’s unusual tactic to email blast their allegations of patent infringement has created confusion for healthcare providers, and we are compelled to address this action,” said Bob Rogers, CEO of Kurin and inventor of the Kurin Lock®. “Kurin reassures our customers and potential customers that these allegations are false. Kurin is here solely to serve our customers, and we will continue to do so with disruptive technological innovations like the elegantly simple, FDA 510(k) cleared, Kurin Lock. In contrast, Magnolia Medical could be a study on mismanagement. Steripath has been on the market for years, but its poor design makes it bulky, awkward, and difficult to operate. Their response to address these product deficiencies was to launch virtually the same device: Steripath Gen. 2.”

Continuing Rogers said, “Magnolia has engaged in a pattern of deception, marketing a device it claims does not require FDA 510(k) clearance (Kurin has been issued two 510(k) clearances), and misleading customers with selective use of clinical performance data. Since we launched the Kurin Lock, Magnolia has continuously told customers that Kurin does not work. Magnolia, now desperate, really wants everyone to believe that they invented the Kurin Lock! If this were true, Magnolia would never have chosen its Rube Goldberg Steripath design.”

“When you compare the two devices it is clear, the Kurin Lock is unrelated to anything Magnolia ever conceived. In fact, the U.S. Patent Office has repeatedly found the design of the Kurin Lock to be novel compared to Magnolia’s patents, and has already issued three patents on the Kurin Lock concept,” said Mr. Rogers. “The Kurin Lock does not infringe any Magnolia patent and we are confident that this position will be proven in court.”

“In closing,” said Rogers, “we are quite familiar with this situation. At our last company, Ivera Medical, makers of the green Curos Port Protector, we prevailed over a host of similar patent related attacks. As with Curos, the Kurin Lock is, and will remain, on the market throughout this process, as long as it takes.”

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. CEO Addresses Patent Infringement Lawsuit Brought by Magnolia Medical

We have had interested parties asking for clarification regarding the patent infringement case Magnolia has filed against Kurin. The short answer is: we are very comfortable with our position and, if the concern is regarding Kurin and its availability in your facilities, you should have no concerns.

First, the timing of the suit is not a coincidence. For the first year, Magnolia harshly attacked the Kurin Lock design, claiming that the diversion volume was too low to reduce contaminations and that because the Kurin Lock does not completely isolate blood it cannot work. With our continued clinical success these arguments have been proven false, and now they are undermining Magnolia’s reputation. Several Steripath hospitals, across the country, have recently switched to Kurin because they are getting the same or better clinical results and clinicians are much happier with the simplicity of Kurin. Unable to compete successfully in the market, Magnolia has turned to desperate allegations of patent infringement.

At Kurin, we respect the intellectual property rights of others. This is apparent in the design of the Kurin Lock, which is fundamentally different from Steripath in concept and operation, and which Magnolia previously claimed would not work.  The groundbreaking design of the Kurin Lock has itself been found novel compared to Magnolia’s patents and worthy of its own patent protection by the U.S. Patent Office. We firmly believe that the Kurin Lock does not infringe any Magnolia patent, and we remain confident that this position will be proven out in the courts.

Our team at Kurin has a great deal of patent litigation experience. At our last company, Ivera Medical (the Curos green cap designed to decrease bloodstream infections) we created a whole new class of medical devices and with our success many tried to copy us. We were involved in multiple infringement cases (both on offense and defense) and when the dust settled, we prevailed. We understand patent litigation and how to manage it, and we are confident that our patent team will serve us as well with Kurin as they did with Curos.

Based on our experience, we expect this case to take years to work through the system and candidly, it will cost a lot of money. With the good fortune of selling our last company, we have plenty of financial resources to follow this case through to the end. We see no impact on product availability, during or after the case, so please take comfort in that. If there is further information you need, please let me know and I will do what I can to help.

Bob Rogers,
CEO, Kurin, Inc.
bobrogers@kurin.com

Kurin, Inc. receives FDA 510k clearance for its novel Kurin Lock with peripheral IV infusion set.

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has received a second 510(k) clearance (K181895) for its new Kurin® PIV18 peripheral IV configuration with an extension set, which can be used for infusion.

“We are pleased to receive clearance from the FDA, the governing body for the medical products and processes we have developed,” said Bob Rogers, CEO of Kurin. “Our Kurin PIV18 product was developed at the request of our customers, who, after using the single-use Kurin Lock® for blood culture collection, wanted to expand their use to include draws from infusion lines.”

The majority of blood cultures are taken via direct venipuncture, but there are times in busy Emergency Departments when a culture is taken from a freshly placed IV. By adding an extension set to the previously-available PIV product, nurses can leave the set in the vein after the culture is taken, saving time and sparing the patient another needlestick.

Kurin developed 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, as well as significant costs for the hospital. Kurin’s patented automatic blood diversion product is the only FDA 510k cleared blood culture diversion product on the market.

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 results on Kurin® efficacy from Central Texas Veterans Health Care System

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that the Temple VA Hospital in Temple, TX, presented their findings comparing results of Kurin and Magnolia Medical’s Steripath at the recent Southwest Association of Clinical Microbiology. They are the first hospital to report on results comparing Kurin®, a passive low-volume diversion technology to Steripath®, a mechanical diversion device. They concluded that both products were effective. When they used Kurin, they had a blood culture contamination rate of 0.2%. The authors concluded that there was no difference in rates of specimen contamination, despite the fact that Kurin diverts significantly less blood than Steripath.
“We applaud the VA Temple for providing the first comparative study of these two products,” said Bob Rogers, Inventor and CEO of Kurin. “Although our clinical results from several hospitals have been similar to published results regarding Steripath, having both products tested by the same hospital offers a greater level of credibility to this conclusion.”

Kurin is the only diversion device with 510(k) clearance from the FDA and is the first device to allow for passive blood diversion, providing clinicians a seamless path to compliance. Outcomes are driven by compliance and compliance is a function of how simple technology is integrated into practice, which can be particularly challenging in the busy Emergency Department.

“Although it is not stated in the clinical publication, after the study concluded, the facility allowed the nurses to decide which product to use and we are pleased they chose Kurin,” said Mr. Rogers. “Our goal is to significantly improve patient outcomes while saving hospitals large sums of money and, given the importance of the Department of Veterans Affairs to our country, there is no group we are more pleased to assist than our veterans and those providing their care.”

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 Agreement with Premier for Kurin Lock® to help impact contaminated blood cultures

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, announced today that it has been awarded a Med/Surg Group agreement in the Safety Phlebotomy Category with Premier. Effective December 1, 2018 the new three-year agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the Kurin blood culture products.

“Premier and Kurin share patient safety values by providing innovative solutions designed to address a common source of contaminated blood cultures and in doing so reducing overall healthcare costs,” said Bob Rogers, Inventor and CEO of Kurin. “We are pleased to be the only blood diversion product on contract with Premier and are already engaged with Premier hospitals to help impact patient care and positively impact hospitals financially.”

Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,000 U.S. hospitals and 165,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost.

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 Educational Website on the Importance of Improving Value of the Blood Culture Test

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.

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

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

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.

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.