Slide 1: Investor Update
For personal use only Ltd ACN 153 273 735 Investor Update by Peter Rowland Managing Director, Micro-X Ltd. 23rd March, 2017 © Micro-X Ltd 2017 Commercial-in-Confidence
Slide 2: Company Quality Accreditation
Company Quality Accreditation : For personal use only ISO 13485 Accreditation Recommended 3rd March 2017. • BSI Stage Two Audit successful - Certificate expected shortly • Company-wide Quality Management System is recognised to meet Medical Device Directorate standards for all company processes oper
Slide 3: Regulatory Approvals
Regulatory Approvals: For personal use only ‘K’ Number received from FDA: 15th March 2017. •FDA acknowledge receipt of a complete & valid 510(k) submission •Product marketing can now commence •Approval time normally 90 days •Health Canada Licence Application submitted to Therapeutic Products Directo
Slide 4: Reliability Growth Testing
Reliability Growth Testing: For personal use only Achieved RG Target 8th March 2017. • Normal Operation: • 60 x-ray shots/day = 22,000 per annum • Target for Mean Time Between Failures is 11,000 cycles • RGT Program • 3 carts, 50 circuits/shift, 3 shifts/day • Reliability Target set at 130,000 cycle
Slide 5: Generating Strong Market Interest
Generating Strong Market Interest For personal use only • Enthusiastic customer interest shown at recent Trade Shows • Carestream regional sales offices requesting additional units for demo/sale • Pre-launch stocking order now planned for 2.5x earlier guidance with increasing momentum European Congr
Slide 6: Pathway to Launch
Pathway to Launch : For personal use only • Service Training under way at Carestream HQ • Hospital Trade Trials in Canada on receipt of TPD Licence • Nano featured in more major Trade Shows: • Genoa, Italy, 6th April • Sao Paulo, Brazil, 4th May • Leipzig, Germany, 24th May • Manchester, UK, 12th Ju
Slide 7: Thank You; Any questions?
For personal use only Thank You; Any questions? © Micro-X Ltd 2017