Kurin, Inc. receives FDA 510k clearance for its push-button needle

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has received 510(k) clearance (k191832) for its novel push-button needle.

“The FDA clearance of our push-button needle is another important step in the continued growth of our company,” said Bob Rogers, CEO of Kurin. “Development of our proprietary needle provides us vertical integration and also allows us to offer superior options to our customers. We are experiencing exponential growth and milestones like this one position Kurin well for our rapid expansion plans,” said Mr. Rogers.

Kurin developed initial specimen discard technology that automatically and passively sidelines 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 discard product is the only FDA 510(k) cleared blood culture product in its class.

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 Hire of EVP Operations Amid Record Growth

Kurin Inc., the inventor and manufacturer of 510(k)-cleared and patented Kurin® blood culture collection sets announced the hiring of Don Canal to the newly created position of Executive Vice President, Operations. 

“Bringing Mr. Canal into Kurin is an important addition to our company,” said Bob Rogers, CEO of Kurin, Inc. “Demand for Kurin’s products is growing at a torrid rate. The addition of Mr. Canal demonstrates our commitment to excellence. Mr. Canal’s extensive medical device manufacturing, operations, and regulatory experience, including most recently our work together at Ivera Medical, builds on our ability to handle the rapidly increasing demand for Kurin.”                                                

Kurin’s Initial Specimen Discard (KISD) technology is superior to currently marketed diversion technologies, requiring no user interaction with complicated manual manipulations. The Kurin Lock® automatically and passively corrals potential contaminants during blood culture collection. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays, and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection.

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. Reports Record Third Quarter Revenues

Kurin Inc., the inventor and manufacturer of 510(k)-cleared and patented Kurin® blood culture collection sets announced third quarter revenues increased 4.5 times over the revenue of the same period in 2018. Kurin also reports third quarter sales exceeded their total revenues for 2018.

“We want to thank our customers for their support and trust in Kurin. These forward thinking, quality driven organizations saw the value of Kurin, clinically, financially, and as part of the important fight against growing antimicrobial resistance. Since the close of 2018, we have seen strong sequential quarter over quarter growth,” said Bob Rogers, CEO of Kurin, Inc. “Kurin’s elegantly simple, intuitive design requires no additional user steps. Kurin coupled with adherence to policy is helping customers to achieve higher compliance and delivering significant reductions in false positive blood cultures. Our customer results combined with an extraordinary team of people are driving our success.”

Kurin’s revolutionary and disruptive approach to the initial specimen diversion technique, automatically and passively corrals potential contaminants during blood culture collection. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing patients to unnecessary antibiotics, extending hospital stays, and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection.

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 CE Mark for its novel Kurin Lock®

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has received its CE Mark that allows product distribution into the European Economic Area (EEA) and European Union (EU) Candidate Member States (i.e. Iceland and Turkey).

“We are pleased to receive the CE Mark, the clearance needed for medical products to be marketed in this important region,” said Bob Rogers, CEO of Kurin. “The family of Kurin products was developed to help hospitals improve their blood culture samples and we look forward to helping hospitals in the EEA and EU Candidate States in their efforts to lower their contamination rates.”

Kurin developed initial specimen diversion technology that automatically and passively diverts potential contaminants during blood culture collection. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and the life-threatening C. diff. infection.

Kurin’s patented automatic blood diversion product is the only FDA 510k-cleared blood culture diversion product in the US and now holds that same distinction for the European 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. 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.