Business
Market Update
Market Update.
About this update from Creo Medical Group Plc
[{"type":"text","content":"\n \nRNS Number : 1665T Creo Medical Group PLC 02 July 2018 \n\n \nCreo Medical Group plc\n(\"Creo\" or the \"Company\")\n \nMarket Update\n \nSince the Company was admitted to trading on AIM in December 2016 (the \"IPO\") it has made significant progress against all of the strategic objectives set out at that time and continues to execute against its plans with a view to a full commercial launch in 2019. In particular, since the IPO, the Company has:\n \n· Gained FDA clearance and CE Mark for its CROMA advanced energy electrosurgery platform and Speedboat RS2 device (with FDA clearance being received ahead of schedule);\n· Trained 34 clinicians to date with some trainees being trained in collaboration with a developing global network of distribution partners ahead of commercial launch in 2019\n· Placed its CROMA advanced energy electrosurgery platform and Speedboat RS2 device with EU key opinion leaders; \n· Commenced the generation of clinical data through in-human use, with physicians utilising Creo's Speedboat device in multiple procedures with no reported complications, including procedures with patients under mild conscious sedation with same day discharge for routine follow up rather than surgery under general aesthetic and a prolonged hospital stay as would otherwise have been the case; and\n· Undertaken a FDA pre-submission meeting with the FDA for its flexible ablation device confirming that it will make a Pre-Market Notification (via the 510(k) pathway). \n \nFollowing speculation and in light of this progress and consultation with shareholders, the Board confirms that it has been considering its future funding in order to capitalise on the Company's current momentum and exploit the opportunities, it believes are, available to the Company at this time. Accor...