Kurin Receives 510k from the FDA with Indication to Reduce Blood Culture Contaminations

/in ,

Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced today that the Food and Drug Administration has issued a 510(k) clearance for the Kurin product line. Kurin now has four 510(k) clearances from the FDA. The recent clearance says, in part, that Kurin reduces the frequency of blood culture contaminations*.

“We are pleased that the FDA has provided clearance to say that Kurin reduces blood culture contaminations” said Bob Rogers, CEO of Kurin, Inc. “Kurin is the market leader because our device is simple to use and requires a minimal amount of blood. Our submission to the FDA included data demonstrating dramatic decreases in contaminations while using Kurin. The new 510(k) highlights Kurin’s growing list of accomplishments and underscores why Kurin continues to be the #1 company addressing blood culture contaminations. This is yet further proof that the myth that blood must be isolated to achieve contamination reduction is simply wrong.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. 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 life-threatening C. diff. infections.

About Kurin, Inc.

Kurin Inc., 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 Lock allows the specimen of blood from the patient to be sidelined prior to the collection of the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.

Kurin Commends the CDC for Their Recent Publication on Blood Culture Contamination

/in ,

Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, commends the Centers for Disease Control and Prevention (CDC) for their just-released publication on blood culture contamination. The paper stresses the importance of reducing these preventable contaminations and highlights how devices, like Kurin, have been shown to be effective in this regard. The CDC specifically states: “There are devices that are commercially available that have shown promise in further reducing blood culture contamination rates. These devices initially divert a small amount of potentially contaminated blood and then collect blood for the blood culture.”

“We are pleased to see the CDC use their resources to address this serious clinical challenge” said Bob Rogers, CEO of Kurin, Inc. “The CDC cited the small amount of blood these devices use to prevent the initial blood from entering the blood culture bottle and thus reduce contaminations. The CDC also shared that the average contamination costs approximately $4500, showing there is a financial impact as well as negative health consequences from these contaminations. Kurin is the market leader because of its simplicity and the small amount of blood used, and we look forward to working in concert with the CDC on this important issue.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. 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 life-threatening C. diff. infections.

The new document can be found at: https://www.cdc.gov/antibiotic-use/core-elements/pdfs/fs-bloodculture-508.pdf

About Kurin, Inc.

Kurin Inc., 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.

ENA Welcomes Kurin to 2023 Corporate Engagement Council

/in ,

The Emergency Nurses Association on Tuesday announced its 2023 Corporate Engagement Council, which includes Kurin, Inc., as its newest member.

Created in 2019, the CEC brings ENA and industry leaders together with a focus on innovation and advances in emergency nursing education, advocacy and research. Council members also participate in dedicated sessions with ENA Board members and leaders centered on discussion of, and planning for, future initiatives to advance emergency nursing.

The 2023 Corporate Engagement Council includes: Bioexcel Therapeutics, BrainScope, Chamberlain University, Elsevier, HealthStream, Magnolia, Mednition, Stryker, Teleflex and now Kurin.

“ENA prides itself on having a strong relationship with industry partners who deeply value emergency nurses and the ways they provide care to patients,” said ENA President Terry Foster, MSN, RN, CEN, CPEN, CCRN, TCRN, FAEN. “Kurin’s emphasis on innovative, clinician-approved technologies makes it a great addition to the CEC.”

Kurin CEO Bob Rogers described a natural connection between Kurin and ENA, which he called a vital organization that provides leadership and a wide variety of resources to emergency department nurses.

“We are pleased to have received the invitation from the ENA to join its council,” Rogers said. “Kurin has become the market leader by providing an easy-to-use solution to reduce blood culture contamination and our goal is to work with the ENA to help their members improve clinical outcomes.”

For more information on ENA’s Corporate Engagement Council, visit ena.org/corporate-support/cec.

About Kurin, Inc.

Kurin Inc., 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 Announces Kurin Jet, A Quantum Leap Forward in Devices Designed to Address Blood Culture Contamination

/in

Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced today the limited commercial release of Kurin Jet™, a significant technological advance over Kurin’s own market-leading Kurin Lock®. The new ventless device is not at issue in the lawsuit with Magnolia Medical.

“We are excited to announce the introduction of Kurin Jet, a fundamentally different product that provides a new level of performance in addressing the blood culture contamination market” said Bob Rogers, CEO of Kurin, Inc. “Although our current Kurin Lock is the market leader because of its small size and passive, user-friendly design, we have leapfrogged that technology and created a much faster device with a greater level of control for clinicians. Kurin Jet can be used with direct to media, syringe draw, direct venipuncture and PIV applications.”

“Kurin Jet helps hospitals address the significant challenge of blood culture contamination with its unique design, speed, and ease of use. Based on its performance and feedback from those who have used Jet, we will limit the initial release, as demand will exceed initial production volumes. Full release will occur later this year.”

Kurin’s revolutionary approach to the contaminated blood culture problem is based on elegantly simple, intuitive designs that require no additional user steps. Like the Kurin Lock, Kurin Jet passively sidelines potential contaminants during blood culture collection. Kurin Lock and Kurin Jet both provide a better and more sustainable approach than active, conventional mechanical diversion. 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 life-threatening C. diff. infections. Kurin Lock and Kurin Jet give clinicians the tools they need to address these problems.

About Kurin, Inc.

Kurin Inc., 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 Revenue for 2022

/in

Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets announced record revenues for 2022. Revenue growth in 2022 was dramatic, increasing over 60% over 2021 revenue.

“We are pleased with Kurin’s success, as demonstrated by the impressive growth over 2021, which also saw a large revenue increase over the prior year,” said Bob Rogers, CEO of Kurin, Inc. “Our fourth quarter revenue reflected our highest sales quarter by some distance and we are very well positioned for continued strong growth in 2023.”

“In addition, we continue to roll out our proprietary Advance™ push-button needle, providing vertical integration that increases our shareholder value,” said Mr. Rogers. “We continue to build upon the company’s strong financial position and have accelerated our hiring to accommodate this growth.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. 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 Inc., 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 Successful FDA Audit

/in ,

Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, announced the results of their recent FDA inspection.

“I am pleased to announce Kurin has successfully passed an FDA inspection of our manufacturing procedures, records, and facilities,” said Bob Rogers, CEO and Inventor of Kurin. “In a recent unscheduled visit by the FDA, there were no observations of what are called a 483 non-conformance. We take pride in operating our company under Good Manufacturing Practices (GMP) and a robust Quality System. I am proud of our team for continuing to demonstrate our commitment to excellence and in consistently meeting federal requirements and our elevated expectations for quality.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Contaminated blood cultures are a significant problem, as roughly one-third of the positive results are wrong, potentially exposing these patients to unnecessary antibiotics, extending hospital stays and impacting larger community health issues, such as antimicrobial resistance and the life-threatening infections caused by C. diff.

About Kurin, Inc.

Kurin Inc., 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. Provides Update on Litigation Activity

/in

Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets, provides an update to the most recent moves by Magnolia Medical Technologies. This week, Magnolia filed a motion in the US District Court of Delaware for a permanent injunction, hoping to take Kurin off the market.

“We are disappointed, but not surprised by their attempt to create a monopoly and deprive customers of the ability to choose the most appropriate solution for them,” said Bob Rogers, CEO and Inventor of Kurin. “We will vigorously defend access to the best solution to the contaminated blood culture problem. Our experience over the past few years shows that hospitals have rejected Magnolia’s Steripath product because it is unnecessarily complex and difficult to use.  Kurin’s innovation in developing a smaller, simpler device is a demonstration of how the intellectual property system should work in America and explains why we are the market leader. We will not be bullied by a venture-backed company who continues to spend their millions on litigation in hopes of creating a monopoly. We are heartened by the support of Kurin customers, and have been told they too are upset at Magnolia’s attempts to use the legal system to reduce choice and negatively impact clinical outcomes.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. 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 infections caused by C. diff.

About Kurin, Inc.

Kurin Inc., 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 Full Scale Manufacturing of Push-button Needle

/in ,

Kurin, Inc., the inventor and manufacturer of the Kurin® blood culture collection sets announced that their previously mentioned Advance Safety Needle System™ has entered full scale production on their automated machine. The Advance needle was tested in 2021, has been used in Kurin accounts since last year and is now widely available.

“We are pleased with the transition to automated manufacturing of the Advance Safety Needle, as market demand for alternative needles has been strong,” said Bob Rogers, CEO of Kurin, Inc. “Needle manufacturers have created significant stress in the supply chain with widescale backorders and unprecedented price increases. With our Advance needle, we can better control product availability for the growing Kurin customer base, as well as entertain inquiries from strategic partners looking for their own push-button needle. In addition, we are pleased that Advance shows improved performance characteristics compared to traditional, retraction-oriented products.”

Kurin’s revolutionary approach to the contaminated blood culture problem is an elegantly simple, intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection. Kurin is a simply better and more sustainable approach over conventional mechanical diversion. 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 infections caused by C. diff.

About Kurin, Inc.

Kurin Inc., 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. Statement Regarding Patent Litigation

/in

Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, today released a statement regarding results of a jury trial in the patent litigation brought by Magnolia Medical Technologies.

Magnolia Medical originally asserted four patents in the case. By the time of the trial, all of these patents were dropped, except one having only two asserted claims. The Delaware jury concluded that Kurin infringed the single Magnolia patent, and awarded a royalty on each Kurin Lock set sold during a certain time period. The verdict will not prevent Kurin from maintaining the uninterrupted supply of its market-leading Kurin Lock to hospitals – and will allow it to continue implementing its plans.

“While we strongly disagree with some aspects of the Jury’s decision, we are pleased that this chapter of the litigation has concluded and that it does not impede our ability to continue operating. The conclusion of this trial will allow us to return our focus to delivering Kurin Locks to the customers and patients who need them, and advancing this important solution to effectively address the blood culture contamination problem,” said Bob Rogers, Inventor and CEO of Kurin.

Kurin’s revolutionary and disruptive approach automatically and passively sidelines 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. Contaminated blood cultures also create a financial burden to hospitals by prolonging hospital stays.

About Kurin, Inc.

Kurin Inc., 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.

U.S. District Court Enters Judgment of No Infringement of Patent Asserted Against Kurin Inc. by Magnolia Medical Technologies, Inc.

/in

Kurin Inc., the inventor and manufacturer of Kurin® blood culture collection sets, announced that the U.S. District Court for the District of Delaware has entered a judgment that Kurin does not infringe U.S. Patent No. 9,855,001 in the patent-infringement lawsuit Magnolia brought against Kurin.  Magnolia earlier withdrew two other patents from the case, leaving just one of the four originally asserted patents for the upcoming trial.

“The fact that Magnolia has finally agreed to entry of a judgment of no infringement of this patent confirms yet again our longstanding belief that Magnolia’s case lacks merit,” said Bob Rogers, CEO of Kurin and inventor of the Kurin Lock. “As we said years ago when they filed this suit, we think Magnolia’s lawsuit reflects a belief that it cannot compete in the marketplace on the merits of its product. We look forward to defending ourselves against the last remaining patent in the upcoming trial.”

Rogers added “Kurin has quietly become the market leader by providing a simple, low cost and easy to use solution that customers prefer over other options, including Magnolia’s Steripath device.”

Kurin’s revolutionary approach to the contaminated blood culture problem is elegantly simple, an intuitive design that requires no additional user steps. Kurin passively sidelines potential contaminants during blood culture collection in contrast to conventional diversion.

About Kurin, Inc.

Kurin Inc., 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.