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Initial Determination Finds ACON’s 3-1 Lipid Panels Infringe PTS Diagnostics’ Patents

Initial Determination Finds ACON’s 3-1 Lipid Panels Infringe PTS Diagnostics’ Patents

United States International Trade Commission issues initial determination finding ACON’s 3-1 Lipid Panels infringe PTS Diagnostics’ Patent Nos. 7,087,397 and 7,625,721

INDIANAPOLIS (June 6, 2019) – PTS Diagnostics announced today that an administrative law judge of the U.S. International Trade Commission (ITC) issued a notice of initial determination on June 4, 2019, in Investigation No. 337-TA-1116 finding ACON Laboratories, Inc. and ACON Biotech (Hangzhou) Co.’s (ACON) 3-1 Lipid Panels have violated Section 337 of the Tariff Act by importing devices that infringe PTS Diagnostics’ U.S. Patent Nos. 7,087,397 and 7,625,721. The ruling is an important step toward PTS Diagnostics obtaining an order excluding ACON’s 3-1 Lipid Panels from importation into the United States.

The ITC is a U.S. federal agency charged by Congress to investigate unfair trade practices that impact U.S. domestic industries. In the initial determination, the ALJ found that ACON’s 3-1 Lipid Panels infringe claims of both the ‘397 patent and the ‘721 patent. Further, the ALJ found that all of PTS Diagnostics’ patents asserted in the investigation are valid, rejecting all of ACON’s arguments to the contrary. The ALJ concluded that ACON’s importation into the U.S., sale for importation, or sale in the U.S. following the importation of the ACON 3-1 Lipid Panels violated section 337 of the Tariff Act.

The PTS Diagnostics patents asserted in the investigation cover PTS Diagnostics’ CardioChek® family of lipid analyzers and PTS Panel test strips, which are made in the U.S. PTS Diagnostics is pleased that the initial determination found that ACON 3-1 Lipid Panels infringe these patents, and the company will pursue an order from the ITC excluding all ACON infringing products from the U.S. PTS Diagnostics was represented in the ITC proceeding by Haynes and Boone, LLP.

“PTS Diagnostics appreciates the administrative law judge’s thorough consideration after extensive briefing and a hearing and the determination that ACON has infringed our patents,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “PTS Diagnostics is proud that the healthcare industry has widely embraced our CardioChek lipid measurement system, which has been used to screen more than 140 million patients worldwide. Further, this investigation demonstrates that we are committed to protecting ourselves against anyone who infringes our broad worldwide patent portfolio.”

Recognizing the strong connection between heart attack, stroke, and diabetes, CardioChek analyzers provide rapid point-of-care blood-chemistry values and measurements to help identify at-risk individuals. As one of the fastest, most cost-efficient and user-friendly analyzers on the market today, CardioChek systems accurately test lipid profile and glucose simultaneously with  one fingerstick. In as little as 90 seconds, they provide on-site results with similar accuracy to clinical laboratories.

PTS Diagnostics’ PTS Panels® lipid test strips measure total cholesterol, HDL cholesterol, and triglycerides, calculate LDL cholesterol and TC/HDL ratio, and do not require refrigeration. The accompanying meter is handheld, battery-operated, and compact and lightweight, making it easy to transport and store. CardioChek systems are CLIA-waived and meet NCEP guidelines for accuracy and precision. The CardioChek Plus analyzer offers simultaneous testing of lipid profile and glucose, has wireless communication capabilities, and is CRMLN-certified for total cholesterol and HDL cholesterol testing.

PTS Diagnostics will fully defend the ITC’s initial determination against any efforts for review or appeals.

About PTS Diagnostics
Through its People, Technology and Service, PTS Diagnostics creates health innovation that drives action and results. Since 1992, we have helped medical professionals and patients achieve better health outcomes through our accurate, precise, fast, affordable, and certified point-of-care medical devices. Healthcare professionals have used our CardioChek® products to assess cardiovascular disease risks for more than 140 million patients worldwide through lipid panel screening. And, our A1CNow® systems, which provide fast and reliable HbA1c testing, have helped physicians deliver more effective treatments to patients with diabetes. From our headquarters in the United States of America, we design, manufacture, and market our products to more than 130 countries around the globe. For more information, visit ptsdiagnostics.com.

PTS, Inc. Announces New Department for Enhanced Customer Service and Support

PTS, Inc. Announces New Department for Enhanced Customer Service and Support

Indianapolis, IN – July 6, 2012 – Polymer Technology Systems, Inc. (PTS, Inc.), the manufacturer of the CardioChek family of products, today announced the formation of a new department that will focus on customer service, technical support, customer training, internal product surveillance, complaint investigations, and the management of field evaluations and data. Known as the Regulatory and Clinical Affairs department, the group will also oversee proficiency testing and CRMLN certification.

The initiative to enhance customer service and support gained momentum when Elsa Chi Abruzzo joined PTS, Inc. on April 16, 2012 as Vice President of Regulatory and Clinical Affairs. Before coming to PTS, Inc., she was President and CEO of Abruzzo Regulatory Affairs Consulting (ARAC) in Cincinnati, Ohio. Her company was engaged in strategic regulatory, clinical, and quality consulting for the medical device, biologic, and pharmaceutical industry. Abruzzo has a successful track record spanning 23+ years with innovative medical devices and disruptive biotechnologies; has designed, developed and managed domestic and international clinical trials; and has implemented global regulatory strategies resulting in commercialization of products in the USA and worldwide.

Leading the Clinical Affairs group at PTS, Inc. will be Michelle Evans as Director of Clinical Affairs, with Bob Murphy managing the Midwest to East Coast region and Chris Campbell managing the Midwest to West Coast region. Ryan Jesswein, who is based in Indianapolis, will assist Evans with complaint investigations, technical support calls, customer training, internal product surveillance, and field evaluations, as well as domestic and international data management. The PTS, Inc. Customer Service department will also report to Evans.

“The establishment of a Clinical Affairs department consolidates our resources and highlights our commitment for customer service and support,” said Evans. “We want to make it easier for our customers to move from the point of sale to full utilization of all we have to offer, from training and field evaluations to tech support, and our Clinical Affairs department is designed to do just that.”

Jack Rogers, based in Indianapolis, has joined the company as Director of Regulatory Affairs, also reporting to Elsa Abruzzo.

Robert Huffstodt, President and CEO of PTS, Inc., said, “It’s great to have Elsa Abruzzo on board. She understands the importance of reliably and consistently providing our customers with exceptional products and services. Putting this Clinical Affairs team in place greatly enhances our ability to meet our customers’ needs, as our sales are growing quite dramatically. Jack Rogers rounds out the team nicely, and brings yet another dimension and skill set to our global business model.”

About Polymer Technology Systems, Inc.
Polymer Technology Systems, Inc. (PTS, Inc.) is a global provider of point-ofcare diagnostic products to the healthcare industry. Headquartered in Indianapolis, Indiana, PTS, Inc. manufactures products for distribution in over 100 countries around the world. The company has sales offices in Africa, Australia, Europe, Latin America, the Middle East, and the Pacific Rim. PTS, Inc. products include the CardioChek® PA point-of-care instrument and the CardioChek® cholesterol analyzer that are marketed to the professional diagnostics industry and consumer screening market. The company offers lipid panel, LDL cholesterol, glucose, ketone, and other combination test strips for professional use with the CardioChek PA point-of-care instrument and the CardioChek Health Risk Assessment (HRA) software. For more information, visit www.cardiochek.com.

PTS, Inc. Signs Agreement to Provide Point-of-Care Lipid Testing to Life Line Screening

PTS, Inc. Signs Agreement to Provide Point-of-Care Lipid Testing to Life Line Screening

Indianapolis, IN – September 6, 2012 – Polymer Technology Systems, Inc. (PTS), the U.S.- based manufacturer of the CardioChek family of point-of-care diagnostic products, has announced the signing of a multiyear agreement to supply the CardioChek PA test system to Life Line Screening, a leading global provider of community-based preventive health screenings.

The CardioChek test system provides on-site lipid panel screening, whichincludes total cholesterol, HDL cholesterol, triglycerides, and LDL (calculated), as well as glucose, and delivers the results in less than two minutes.

According to Life Line Screening’s Laboratory Medical Director, Benjamin Gerson, MD, “PTS is an ideal partner for us. Life Line Screening is certified under the CLIA federal mandate with a Certificate of Compliance, and as such, our focus is on quality. We have 60 community-based teams throughout the U.S., conducting approximately 15,000 health screening events a year. The CardioChek system does not require a venous draw, allowing us to deliver fast results so our teams can provide clients with immediate feedback.”

Robert Huffstodt, President and CEO of PTS, Inc., is equally excited about the partnership. “Life Line Screening is a cutting-edge screening provider in the U.S. and abroad, and we are proud to have them implement our system around the world. They understand the role of preventive screening and have created a model that can deliver services on a global scale. This is very impressive and makes them a unique partner.” The ability to use this system globally is an important component of this partnership. “CardioChek is in over 120 countries, by far the most in the business,” said Kevin Luckow, Global Manager with Life Line Screening. “We are expanding our operations around the world, and they have the knowledge and experience in the intricacies of global business we need to grow.”

Life Line Screening intends to deploy the CardioChek test system immediately. “PTS has the products, operational efficiencies, training, and distribution in place that we were looking for,” continued Luckow. “Their system is accurate and easy to use. It doesn’t require refrigeration and is battery-operated, which are important operational benefits for our teams. We look forward to a long and mutually beneficial partnership.”

The CardioChek test system, FDA-cleared for marketing in the U.S., in accordance with pre-market notification requirements set forth by the FDA, are CE-marked for marketing in the European Union and are licensed or registered as required for marketing globally.

About Life Line Screening
Life Line Screening was established in 1993, and has since become the nation’s leading provider of preventive health screenings. Highly trained clinical teams are on staff across the nation to bring affordable screenings to convenient, neighborhood locations. These non-invasive, painless tests help people identify their risk for stroke, vascular diseases or osteoporosis early enough that they and their physicians can begin preventive procedures. Visit the website at www.lifelinescreening.com or call 1-800-697-9177.

About Polymer Technology Systems, Inc. (PTS, Inc.)
Polymer Technology Systems, Inc. (PTS, Inc.) is a global provider of point-of-care diagnostic products to the healthcare industry. Headquartered in Indianapolis, Indiana, PTS, Inc. manufactures products for distribution in over 120 countries around the world. The company has sales offices in Africa, Australia, Europe, Latin America, the Middle East and the Pacific Rim. PTS, Inc. products include the CardioChek® PA point-of-care instrument and the CardioChek® cholesterol analyzer that are marketed to the professional diagnostics industry and consumer screening market. The company offers tests for a Lipid Panel, LDL  Cholesterol, Glucose, Ketone, and other single and combination test strips for professional use with the CardioChek PA point-of-care instrument and the CardioChek Health Risk Assessment (HRA) software. For more information, visit www.cardiochek.com

All trademarks used or mentioned in this release are protected by law.

For further information, please contact:
Kathleen Sutton
Director, US Marketing
Polymer Technology Systems, Inc.
Indianapolis, IN
317-870-5610

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CardioChek Test System Accepted by HEART UK for Use in Nationwide Program​

CardioChek Test System Accepted by HEART UK for Use in Nationwide Program

Indianapolis, IN – September 20, 2012 – Polymer Technology Systems, Inc. (PTS, Inc.), the U.S.-based manufacturer of the CardioChek family of point-of-care diagnostic products, announced today that HEART UK has accepted CardioChek as a point-of-care system for lipid testing in a nationwide health screening program. HEART UK, the United Kingdom’s (cholesterol) charity, works with the public and healthcare professionals to promote healthier lifestyles. HEART UK’s acceptance of CardioChek as a screening tool is a significant milestone, as PTS continues to expand its presence in global markets.

The CardioChek test system provides on-site lipid panel screening tests and delivers readings for total cholesterol, HDL cholesterol, triglycerides, LDL (calculated), and glucose in less than two minutes. CardioChek is represented in the UK by BHR Pharmaceuticals Ltd., a specialty distributor of point-of-care medical diagnostics.

Andrew Greaves, Sales Director for BHR, said he is delighted that HEART UK has approved CardioChek as a screening tool in the national “Health-Check” program, and he is confident that HEART UK’s acknowledgment will generate great interest within primary care organizations. Greaves continued, “As the Department of Health (UK) positions for greater awareness of the ‘Health-Check’ program, the drive to reduce the incidence of heart disease, and the need for reliable lipid testing in primary care, grows.”

Robert Huffstodt, President and CEO of PTS, Inc. said, “We are honored by this important acknowledgement by HEART UK. Their organization is very much respected for the work they do in cholesterol awareness and testing, and HEART UK’s recognition of the CardioChek system as a useful point-of-care screening tool is significant to our organization. With HEART UK’s dedication to healthcare and our proficiency in providing fast, reliable test results, I am confident our partnership will effectively detect and help to moderate the risk factors for heart disease in the United Kingdom.”

About HEART UK
HEART UK is registered as a charity with the Charity Commission (registered charity number 1003904) and as a company limited by guarantee with the Registrar of Companies (registered company number 02631049). HEART UK is an acronym, standing for Hyperlipidemia, Education, Atherosclerosis, and Research Trust UK. Visit the website at www.heartuk.org.uk.

About BHR Pharmaceuticals, LTD
BHR Pharmaceuticals Limited specializes in point-of-care (POC) medical diagnostics in six major fields; allergy, cardiovascular, diabetes, female health, gastro-intestinal and hematology. BHR works with the leading diagnostic manufacturers of the world to bring quality products to the UK market. The products and services offered by BHR have proven to be of great value to healthcare teams. With active support from BHR, PCT’s, GP’s and pharmacies achieve service framework objectives in a meaningful, timely and cost-effective manner. Visit the website at www.bhr.co.uk.

About Polymer Technology Systems, Inc. (PTS, Inc.)
Polymer Technology Systems, Inc. (PTS, Inc.) is a global provider of point-of-care diagnostic products to the healthcare industry. Headquartered in Indianapolis, Indiana, PTS, Inc. manufactures products for distribution in over 120 countries around the world. The company has sales offices in Europe, Latin America, and the Pacific Rim. 

PTS, Inc. products include the CardioChek® PA point-of-care device and the CardioChek Health Risk Assessment (HRA) software, that are marketed to the professional diagnostics industry and the consumer screening market. The company offers tests for a Lipid Panel, LDL Cholesterol, Glucose, Ketone, and other single and combination test strips for professional use with the CardioChek point-of-care device. Visit the website at www.cardiochek.com.

For further information, please contact:
Kathleen Sutton
Director of Marketing
Polymer Technology Systems, Inc.
Indianapolis, IN
317-870-5610

All trademarks used or mentioned in this release are protected by law.

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PTS, Inc. Signs Agreement with Fisher HealthCare to Distribute CardioChek® Products

PTS, Inc. Signs Agreement with Fisher HealthCare to Distribute CardioChek® Products

Indianapolis, IN – October 25, 2012 – Polymer Technology Systems, Inc. (PTS, Inc.), the U.S.-based manufacturer of CardioChek point-of-care diagnostic products, has announced the signing of a multiyear distribution agreement with Fisher HealthCare (Fisher). Fisher HealthCare is part of Thermo Fisher Scientific Inc., an international company that serves customers within the pharmaceutical and biotech industries.

Per this agreement, Fisher will have access to the CardioChek test system, which provides on-site ketone, glucose, and lipid panel readings in less than two minutes.

The CardioChek system does not require a venous draw or refrigeration, allowing healthcare providers to offer fast results to patients in a variety of settings.

This new agreement with PTS, Inc. fits with Fisher’s strategic plan to expand its presence within the Point-of-Care Testing (POCT) market.

According to Joyce Trost, Director of National Distribution for PTS, Inc., the agreement grew out of discussions with Fisher in response to an unmet need within the Point of Care Testing market. “Throughout our discussions, it became increasingly apparent that Fisher HealthCare’s expansion into the POCT market and PTS, Inc.’s targeted strategy were in full alignment, thereby significantly enhancing PTS, Inc.’s access to the clinical diagnostic market segments of the IDN and Health System in general.”

Robert Huffstodt, President and CEO of PTS, Inc. said, “We have invested our resources in the design and manufacturing of products to serve the clinical diagnostic market, and our agreement with Fisher HealthCare not only validates our investment, it also solidifies our presence in this market. PTS is proud to be positioned as a global partner for improving health and enhancing wellness, and we are very pleased to be partnering with Fisher HealthCare to improve patient diagnostics.”

The CardioChek test system is FDA-cleared for marketing in the U.S., in accordance with pre-market notification requirements as set forth by the FDA, as well as CLIA-waived. It is also CE-marked for marketing in the European Union.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Their mission is to enable their customers to make the world healthier, cleaner, and safer. With revenues of $12 billion, Fisher has approximately 39,000 employees and serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies, as well as in environmental and process control industries. Their products and services help their customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com for more information.

About Polymer Technology Systems, Inc. (PTS, Inc.)
Polymer Technology Systems, Inc. (PTS, Inc.) is a global provider of point-of-care diagnostic products to the healthcare industry. Headquartered in Indianapolis, Indiana, PTS, Inc. manufactures products for distribution in over 120 countries around the world with sales offices in Europe, Latin America, and the Pacific Rim.

PTS, Inc. products include the CardioChek® PA point-of-care device and the CardioChek Health Risk Assessment (HRA) software, that are marketed to the professional diagnostics industry and the healthcare screening market. The company offers tests for a Lipid Panel, LDL Cholesterol, Glucose, Ketone, and other single and combination test strips for professional use with the CardioChek point-of-care device. Visit the website at www.cardiochek.com.

Media contact:
Kathleen Sutton
Director of U.S. Product Management
Polymer Technology Systems, Inc.
Indianapolis, IN
317-870-5610

All trademarks used or mentioned in this release are protected by law.

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