Interim results for six months to 31 December 2017

FDA clearance for Speedboat RS2 and CROMA platform. 

European training programme commenced for leading clinicians, with first UK patients treated.

Creo Medical Group plc (AIM: CREO) (“Creo” or the “Company”), a medical device company focused on the emerging field of surgical endoscopy, announces its unaudited half year results for the six months to 31 December 2017.

Creo is a medical device company focused on the emerging field of surgical endoscopy, having developed its ground-breaking CROMA electrosurgery advanced energy platform (“CROMA platform”) which applies microwave and bi-polar radiofrequency (“RF”) energy via its Speedboat RS2 device to cut, coagulate and ablate with precision. Early applications focus on Gastrointestinal (“GI”) surgery where Creo’s technology is expected to improve patient outcomes (shorter procedures, hospital stays and recovery times), reduce risk and make procedures easier to perform.

Operational and Recent Highlights

  • Food and Drug Administration (“FDA”) 510(K) clearance received for Speedboat RS2 and the CROMA platform in August 2017 ahead of the Board’s expectations
  • Moved into a new facility in Chepstow, providing the engineering development capability and manufacturing capacity to support the commercial phase
  • European soft launch of first product, Speedboat RS2, on track
  • Speedboat and CROMA platform installed at two NHS sites in the UK
  • Creo European Training Academy programme underway
  • A number of patients have been successfully treated with Creo’s Speedboat RS2 device, powered by the CROMA platform

Financial Highlights

  • Cash and cash equivalents of £8.6m at 31 December 2017 (H1 2016: £18.8m)
  • Operating loss of £5.1m (H1 2016: £4.7m) including £0.5m share based payments, in line with management expectations
  • Underlying operating loss of £3.4m (H1 2016: £2.6m) reflecting:
  • Accelerated investment in product development and clinical costs associated with continued progress for FDA clearance
  • New staff appointments to support scaling of business
  • Net cash outflow from operating activities of £4.4m (H1 2016: £2m) includes £0.4m of one off costs associated with office relocation
  • Net assets of £11.1m (H1 2016: £17.7m)

Craig Gulliford, Chief Executive Officer, commented:

I am pleased with the progress we have made against all our strategic objectives, not only in the first half of FY 2018, but over the last twelve months. Since we listed in December 2016, we have achieved CE marking and FDA clearance ahead of schedule for our first product, Speedboat RS2, in Europe and the US. We are executing against our training led commercialisation plan, targeting selected clinicians and key opinion leaders to drive clinical adoption. Significantly, the first patients in the UK have been treated using our Speedboat RS2 device powered by our CROMA platform. Furthermore, our technology has been deployed and utilised at a second NHS site. The advances that we have made in our pipeline positions us well to become a leading advanced energy, minimally invasive, medical device company. We remain on track for full commercial launch in 2019.

Posted 20/03/2018

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