|[August 25, 2014]
Nipro Diagnostics, Inc. Announces FDA Clearance of its Newest Blood Glucose Monitoring Systems, TRUE METRIX and TRUE METRIX PRO, and Expansion of Manufacturing in the USA
FORT LAUDERDALE, Fla. --(Business Wire)--
Nipro Diagnostics, Inc., today announced that the U.S. Food and Drug
Administration (FDA) has cleared its TRUE METRIX™ Self-Monitoring
blood glucose system and the TRUE METRIX™ PRO Professional
Monitoring blood glucose system.
As the diabetes store-brand leader, and largest U.S. manufacturer of
diabetes products for the store brand market, Nipro Diagnostics made the
announcement at the National Association of Chain Drug Stores (NACDS)
Total Store Expo in Boston where more than 250 retail companies,
representing over 145,000 retail outlets, were present.
Nipro Diagnostics conducted a clinical study in the United States for
submission to the FDA which was designed to assess the accuracy of the
TRUE METRIX Self-Monitoring blood glucose system and the TRUE METRIX PRO
Professional Monitoring blood glucose system when tested by lay users
and healthcare professionals, respectively. As well, the clinical data
demonstrated that the two meter systems exceeded the minimum accuracy
criteria for the new, more stringent ISO 15197:2013 performance
requirements for accuracy.
TRUE METRIX and TRUE METRIX PRO achieve a level of performance driven by
science, research and technological advancements. The meter, a complex
algorithm, test strip chemistry and electrodes, work together as part of
the TRUE METRIX system to produce accurate results. Featuring TRIPLE
SENSE TECHNOLOGY™, the systems detect, analyze and correct for
environmental and physiological variability, including hematocrit and
temperature, resulting in precise, proven accuracy.
The meters feature pre- and post-meal tags that enable patients to mark
blood glucose results to better see how food affects blood glucose.
Additionally, the products allow patients to tie notable events such as
exercise, medication, sickness, as well as other occasions, to blood
glucose readings in order to determine patterns and trends, resulting in
better decision making for diabetes management.
Manufacturing of the proprietary new blood glucose sensor technology
required signficant capital investment, which will substantially expand
manufacturing capabilities at Nipro Diagnostics' Fort Lauderdale,
Florida facility where research and development, engineering and test
strip manufacturing take place for all of the TRUE branded blood glucose
"With this investment, Nipro Diagnostics is building on its more than
25-year heritage of manufacturing blood glucose test strips in the
United States. As we invest further in the U.S., this expansion will
help us meet an ever-growing demand for blood glucose test strips as the
number of people with diabetes is expected to continue to increase. Six
consecutive years of Nipro Diagnostics' double-digit test strip growth
has brought the need for sizeable manufacturing expansion, as demand for
quality/value healthcare solutions continues to grow," said Scott
Verner, CEO and President of Nipro Diagnostics.
The high-speed, high-accuracy manufacturing line will employ the latest
innovative technologies including precision lasers that ablate
electrodes on the test strips, a machine vision system that inspects
over 100,000 characteristics on every test strip, and an advanced, ultra
high definition, state-of-the-art communications system that allows 100
percent strip quality assurance. This advanced manufacturing process
delivers a high-quality, cost effective product with proven performance.
"The launch of TRUE METRIX and TRUE METRIX PRO strengthen Nipro
Diagnostics' leadership position in blood glucose monitoring and join a
quickly expanding ecosystem of high-quality, high-value healthcare
management products including nutritional, OTC healthcare and dietary
supplements specifically designed to meet the health and wellness needs
of the diabetes patient population. TRUE METRIX is a valued addition to
our growing portfolio of healthcare management products," stated Verner.
"It is essential as the store brand leader in diabetes that we continue
to innovate from both a technology and a business perspective. The
evolving payer landscape, driven by demands of increased clinical
performance and economic accountability, has created a market energized
in disruption. The TRUE METRIX blood glucose monitoring platform
reinforces our commitment to offer an innovative, affordable solution
for diabetes patients to lead healthier lives," Verner continued.
TRUE METRIX will be made available through Retail, Mail and Distribution
channels beginning Q4, 2014 under partner brands or under Nipro
Diagnostics' own TRUE brand of products. Maintaining its core value
proposition as the quality/value manufacturer in the diabetes category,
products will be available at a value price point. Nipro Diagnostics
will work with payors and providers to add this platform to the millions
of exclusive and preferred lives currently on formulary.
About Nipro Diagnostics, Inc.: Based in Fort Lauderdale, Florida,
Nipro Diagnostics, Inc. is a leading developer, manufacturer and
marketer of diabetes monitoring and management products. The company
offers a portfolio of high-quality blood glucose monitoring systems and
diabetes management products available around the world. Nipro
Diagnostics is the exclusive supplier of blood glucose monitoring
systems, co-branded under the TRUE name, to the world's leading
pharmacies, distributors and mail service providers. For more
information, please visit: www.niprodiagnostics.com
NICO-3393 ©08/2014 Nipro Diagnostics, Inc. TRUE METRIX and TRIPLE SENSE
TECHNOLOGY are trademarks of Nipro Diagnostics, Inc.
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