Instrumentation Laboratory Achieves Record Worldwide Sales in 2016

Banner Year Attributed to Innovation, New Product Launches and Acquisitions

Bedford, MA - April 4, 2017

Instrumentation Laboratory (IL) today announced record total worldwide sales in 2016 of $792 M (€716 M). In its two major business segments, Hemostasis and Critical Care Diagnostics, IL achieved worldwide growth in local currencies of 6.2% and 5.5%, respectively. Drivers for this success include the introduction of innovative products and continued growth within core product lines.

IL launched its new GEM® Premier™ 5000 system with Intelligent Quality Management 2 (iQM®2) for Critical Care testing, as well as several novel HemosIL® reagents for Hemostasis testing in 2016. During the same period, the Company expanded worldwide commercialization of its new ACL TOP® Family 50 Series Systems, HemoCell™ Specialized Lab Automation, and HemoHub™ Intelligent Data Manager; while also shipping a record number of its flagship GEM Premier systems for Critical Care and ACL TOP Hemostasis Testing Systems to customers worldwide.

In September, IL and parent company Werfen, acquired CA Casyso AG and its TEM subsidiaries, a global leader in IVD testing for Patient Blood Management, with their leading ROTEM® product line for viscoelastic testing. In December, IL and Werfen initiated the acquisition of Accriva Diagnostics, allowing IL to establish a market-leading position in hospitalbased point-of-care (POC) Hemostasis testing, expand its position in POC Critical Care testing, and complement its leadership of the Hemostasis laboratory segment. Key Accriva products include Hemochon® and VerifyNow® systems.

“2016 was a remarkable year for IL. Not only did we continue to grow our core products lines, we also introduced new breakthrough products developed internally and integrated key products obtained through strategic acquisitions into our portfolio. As a result, our leadership in Hemostasis and Critical Care IVD and expertise in point-of-care testing have been catalyzed,” said Ramon Benet, CEO at IL. “Collectively, these achievements assure continued healthy growth and contribute to enhancing efficiency, reducing costs and improving the quality of patient care in hospitals around the world.”

As sales of the Company’s flagship GEM Premier 4000 system for Critical Care continued aggressive growth in 2016, its new GEM Premier 5000 system with iQM2 received 510(k) clearance from the US FDA. Designed for use at the hospital point-of-care, this system represents a true breakthrough in quality management and simplicity. Measuring critical parameters, including blood gases, electrolytes, metabolites, and a full CO-Oximetry panel, from heparinized wholeblood samples, the GEM Premier 5000 system provides accurate results in seconds, allowing faster patient management decisions in acute care settings, while saving time and cost. Integral to the system, iQM2 provides a complete picture of quality for each sample—continuously and in real-time—ensuring the quality of every test result. No competitive system offers such assurance of sample quality and compliance.

Several new innovations in Hemostasis were also introduced by IL in 2016. The new ACL TOP Family 50 Series Systems was launched in North America, representing a true breakthrough in routine and specialty testing, and offering unprecedented pre-analytical quality assurance, risk-management and laboratory accreditation benefits. HemoCell Specialized Lab Automation, a unique Hemostasis workcell, was 510(k)-cleared by the US FDA, allowing Hemostasis labs to standardize their testing processes. And, HemoHub Intelligent Data Manager, a specialized information technology solution centralizing oversight and access to an unlimited number of ACL testing systems for operational performance, quality management and clinical-decision support, was launched worldwide during the same period.

Adding to the comprehensive HemosIL portfolio of automated assays, the HemosIL HIT-Ab(PF-H) assay was 510(k)-cleared by the US FDA, providing the first, liquid, ready-to-use, fully automated, on-demand assay for Heparin-Induced Thrombocytopenia (HIT) on a Hemostasis testing system. Additionally, HemosIL ReadiPlasTin®, a new liquid, ready-touse PT reagent, was commercialized in global markets, while HemosIL Apixaban Testing Solution was commercialized in Europe. Finally, the HemosIL AcuStar VWF:CB assay, a fully automated chemiluminescent immunoassay for the ACL AcuStar® System, to aid in the investigation of von Willebrand Disease, was commercialized in Europe and other international markets.*

*Not currently 510(k)-cleared.


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