Market Update

Significant progress against all of the strategic objectives set

Since 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:

  • 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);
  • 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
  • Placed its CROMA advanced energy electrosurgery platform and Speedboat RS2 device with EU key opinion leaders;
  • 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
  • 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).

Following 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. Accordingly, the Board can confirm that it has instructed advisers to commence work on a proposed placing of new ordinary shares to institutional and other investors (the “Proposed Placing”). Initial Board consideration was to raise in the region of £15-20 million but given investor feedback to date the Board may choose to raise a higher amount than this. Amongst other things the net proceeds of the Proposed Placing would enable the Group to continue to extend its training programme for clinicians; complete its development of the Gastro Intestinal suite of products; continue to fund research and development into further applications of products; add distribution partners on a worldwide basis and accelerate Creo’s product roll out by scaling up the current manufacturing capabilities and accelerating a USA roll out. The Board believes that additional funds would make the Company an increasingly attractive prospect for strategic partners and allow the exploration of possible strategic M&A.

Whilst there can be no certainty that the Proposed Placing will proceed, nor as to the quantum, pricing, or timing of any such placing the Board would seek to conduct any placing as near as practicable to the Company’s closing mid price on 27 June 2018 (being the latest practicable date prior to this announcement).

Posted 06/02/18

For press enquiries please contact media@creomedical.com. For all other enquiries please visit our Contact page.

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