Hamilton Thorne Gets CE Mark for Its LYKOS(R) Clinical Laser System
Hamilton Thorne Ltd. (TSX-V: HTL), a leading provider of precision laser devices and advanced image analysis systems for the fertility, stem cell and developmental biology research markets, today announced that the Company has received a CE Mark for its new LYKOS® assisted clinical reproductive laser system. The CE Mark provides conformity to European Medical Device Directive 93/42/EEC, which allows a company to market and sell products in the European Economic Area (EEA).
Hamilton Thorne's best-in-class LYKOS® laser system is used for intricate clinical procedures such as laser-assisted hatching, trophectoderm biopsy and blastomere biopsy. The LYKOS® system is a powerful, yet delicate tool for advanced cellular research, providing exceptional ease of use to the clinician and a significant advance in integrated laser optics, with increased resolution, improved optics and compatibility with all major microscope models.
Also included in the CE Mark is Hamilton Thorne's Multi-Pulse software that recently received FDA clearance (K120055), which is used for performing trophectoderm biopsy in clinical settings on the LYKOS® and on Hamilton Thorne's ZILOS-tk® system.
"Our clinical lasers are precise tools that offer significant advantages to clinicians during procedures such as trophectoderm biopsy, pre-implantation genetic diagnosis (PGD) and laser-assisted hatching," said Diarmaid Douglas-Hamilton, Chief Technology Officer of Hamilton Thorne Ltd. "The CE Mark for LYKOS® in particular will enable Hamilton Thorne to increase our presence in Europe and expand our global footprint."
David Wolf, Hamilton Thorne's President and Chief Executive Officer, added, "The European market has been an important component to our global sales strategy, so we are therefore excited to receive a CE Mark for our clinical laser systems. Since its launch, the new LYKOS® laser system has had very strong sales in other regions around the world and now with full commercial European availability, we are confident that the LYKOS® will generate similar demand in the EEA."