Microvisk Wins CE Approval for Blood Coagulation Meter

Microvisk Ltd. has won European CE Mark approval for its CoagMax PT/INR blood clotting analyzer that uses a micro electro mechanical (MEMS) component at the core of its sensor.

The CoagMax uses disposable strips that have a tiny built-in cantilever. By applying an electric current coming from the device, the cantilever is made to flap at a regular rate. As blood is introduced to the cantilever and is allowed to being coagulated, the CoagMax measures the frequency of the cantilever’s flapping. The changing rate indicates the speed at which blood is coagulating, providing a quick and reliable measurement that can be used by to decide whether or not to take blood thinners or other drugs that may affect the blood.

An estimated 10 million to 12 million people in the Western Hemisphere take blood thinners, according to industry statistics. In the United Kingdom, anti-coagulant prescriptions in 2013 rose by more than 10 percent.

“CE marking for CoagMax takes us close to the runway for product launch to the European healthcare professional market and beyond,” said Microvisk CEO Jim Thurlow. “The achievement of CE marking of a medical diagnostic device based on a tiny MEMS sensor is a major milestone for Microvisk — and opens up further possibilities for this technology.”

The company estimates the European market for the CoagMax product could reach $350 million by 2023, fueled partly by 7 percent annual growth in the in-vitro diagnostic sector over the next few years. The global IVD market currently is valued at $49.2 billion and is expected to rise to $69 billion by 2017, when the point-of-care PT/INR segment exceeds $1 billion.

Microvisk executives claim the company’s technology platform can potentially be used in numerous fluid viscosity testing applications.

“Bringing MEMS technology into the medical device market is a real step change, unlocking the potential of advanced technology to create smaller, simpler-to-use devices for the growing healthcare diagnostics market,” Thurlow noted.

Based in North Wales, Microvisk developz micro-electro mechanical sensors for the international medical market. It was founded in 2004 and is funded through private and venture capital investors, including Oxford Technology, Finance Wales and Porton Capital.