Press Release –11 August 2011
Microvisk introduces World’
s First Diagnostic smart strip system in the US
® and CoagLite
® devices set for trials in major US medical centres
Microvisk Technologies has introduced its unique handheld devices which monitor the blood clotting
status of patients to the US market. Showcased at the prestigious American Association for Clinical
Chemistry annual conference, the Microvisk devices attracted strong interest from distributors and
potential partners ahead of clinical trials in major US medical centres this autumn and product
CoagLite®’are a point of care test and a home use test
respectively that clinicians and patients can use to establish the correct dosage of anti-coagulation
medication such as Warfarin and to monitor treatment. The devices are set to be trialled with 250
patients in three major cardiac centres in Florida from October with product launches scheduled for
Both devices incorporate a disposable SmartStrip® that uses embedded sensors to measure the
clotting speed of blood from a drop of the patient’
s blood taken by a finger prick, with the results
displayed on a handheld reader. SmartStrip is the world’
s first medical diagnostic strip to be based
on a Micro-Electro-Mechanical System (MEMS) with an on-board memory chip and was originally
created as a movement system for nano-robots. MEMS technology is used in the computer
projector, iPhone and Nintendo Wii as well other technology based applications. Existing devices
deploy optical analysis or measure chemical reactions, requiring a patient to provide more blood
and producing a less accurate and less robust result.
Multicentre European clinical trials of CoagMax® and CoagLite® are already well under way in the
UK and Germany. The devices will be introduced to the German market in November at Medica, the
s leading medical trade fair which attracts over 137,000 visitors. Product launches in both
countries are scheduled for early 2012.
John Curtis, chief executive officer of Microvisk, said: “We are delighted at the overwhelming
interest shown by US distributors and potential partners in our CoagMax® and CoagLite® devices –
it is extremely encouraging. We remain on track to commence US clinical trials this autumn and are
gearing up for product launch there in summer 2012.
“We are also continuing to make excellent progress with patient trials in the UK and Germany. We
have been expanding our UK manufacturing facilities and are recruiting additional staff as we
prepare for European product launches in early 2012.”
Microvisk has established a US operation at Florida and recently appointed medical industry
veteran, Bill Moffitt, as company chairman. Mr Moffitt has over 30 years experience in the
diagnostics and medical device industry and is the president and CEO of Nanosphere in the US and
Bill Moffitt said: “The reaction to our introduction of the CoagMax® and CoagLite® devices to the
US market was all that we could have wished for. These innovative devices will transform the way
that blood testing is carried out and Microvisk now has the opportunity to capture a substantial
s office and home tests for Warfarin patients.”
Seven million people in the western world use Warfarin and the Food and Drug Administration
(FDA) estimates that over one million new patients start taking the drug every year. Patients must
have regular blood tests at their doctor’
s surgery or hospital clinic to ensure they receive the correct
dose. Warfarin is affected by food and exercise and if the dose is too low there is a risk of blood
clots forming which can result in a stroke or heart attack, while too high a dose can lead to a life
The Microvisk devices enable patients to test their blood clotting ability at home, in the same way
that people with diabetes test for glucose.
John Curtis added: “Our significant market opportunity in the US and Germany is driven by their
healthcare systems, which have introduced payments to all at-risk Warfarin users to do weekly
home blood tests, rather than having to go to the doctor or hospital clinic.”
To date, only three companies have developed a test system for blood coagulation that can be used
s surgery and although certified for home use, market research shows that doctors feel
that they are insufficiently robust and too complex for home use.
The Microvisk SmartStrip® is unique in the blood clotting diagnostic world as a solid state system
that is robust and simple to use at home. It also requires far less blood than other systems, which
The coagulation status (clotting speed) of the patient is measured by tiny multi-layered paddles on
the surface of the strip and a memory chip ensures the device is calibrated to provide the highest
levels of accuracy, while the MEMS technology means that high volumes of the device can be
Press enquiries to: Margaret Henry, PR Consultant.
Tel: +44 (0) 1865 261491
Photo available on request
s CoagMax® device which will enable patients on Warfarin to carry out blood tests at home.
s exhibition stand at the American Association for Clinical Chemistry conference, where the
company showcased its unique handheld devices which monitor the blood clotting status of patients.
About Microvisk Technologies
Founded in 2004, Microvisk Ltd is developing medical testing devices based on Micro ElectroMechanical Sensors for the international medical market.
Initial research was carried out at the Rutherford Appleton Laboratories facility in Oxfordshire, managedby the Science and Technology Facilities Council (STFC). Microvisk was spun of STFC and is owned byprivate and venture capital investors who include Porton Capital, Oxford Technology Management, NewHill (Boston, USA), Midven, the Rainbow Seed Fund and Finance Wales.
Many people suffer from coagulation (blood clotting) disorders and the Microvisk technology is designedto enable patients and clinicians to monitor blood clotting ability and assist in the correct dosage ofanti-coagulation medication such as Warfarin.
s first products are the CoagMax® device, a point-of-care test and the CoagLite® device, a
home use test. The devices conduct the internationally recognised Prothrombin Time or INR test byusing a drop of the patient’
s blood taken by a finger prick. Each device is simple to use with a large
display and buttons, and sized to be discreet as it can be held in the palm of a hand.
Microvisk's technology uses a different approach to the other devices and tests on the market, which useoptical analysis or chemical reactions. Microvisk uses Micro Electro Mechanical Sensors (MEMS) on adisposable strip which incorporates a small cantilever to measure viscosity. The devices can test a smallvolume of whole blood making the test less intrusive and effectively removing the need for a laboratory.
In addition, the strip has its own on-board memory to inform the handheld instrument of allmanufacturing variables and under what conditions the strip has been kept since the day of itsmanufacture.
The Prothrombin Time or INR test works by introducing tissue factor to begin the clotting cascade whichis the same series of reactions that occur when a blood vessel is ruptured. The clot changes the bloodfrom a free flowing solution to a gel-like substance and it is this change that the sensors monitor anddetect.
s manufacturing and INR application specific research facility is located at St Asaph Business
Park in North Wales. The company also has a non-application specific technology research laboratory inChipping Warden, Northamptonshire and an operation in Florida, USA.
The Microvisk board includes: Bill Moffitt (Chairman); Fred Hallsworth (Deputy Chairman); John Curtis(CEO); Peter Whitehouse (CFO); John Mihell (NED, also Investment Executive at Finance Wales);Matthew Frohn (NED, also a Director of Oxford Technology Management Ltd) and Terry Swainbank(NED, also Investment Director at Synergis Technologies).
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