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MICRO-X LIMITED — Investor Presentation 2017
Mar 21, 2017
65388_rns_2017-03-21_81fbb43d-4706-40a3-a9e2-19ee8b45a76d.pdf
Investor Presentation
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Ltd
ACN 153 273 735
Investor Update by Peter Rowland Managing Director, Micro-X Ltd. 23[rd] March, 2017
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© Micro-X Ltd 2017
Company Quality Accreditation :
ISO 13485 Accreditation Recommended 3[rd] March 2017.
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BSI Stage Two Audit successful - Certificate expected shortly
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Company-wide Quality Management System is recognised to meet Medical Device Directorate standards for all company processes operating in
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Design
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Manufacturing
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Quality
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Supply chain management
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Necessary for CE Marking
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Regulatory Approvals:
‘K’ Number received from FDA: 15[th] March 2017.
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FDA acknowledge receipt of a complete & valid 510(k) submission
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Product marketing can now commence
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• Approval time normally 90 days
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Health Canada Licence Application submitted to Therapeutic Products Directorate
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Declaration of Conformity (for CE Marking) data preparation well advanced
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Reliability Growth Testing:
Achieved RG Target 8[th] March 2017.
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Normal Operation:
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60 x-ray shots/day = 22,000 per annum
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Target for Mean Time Between Failures is 11,000 cycles
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RGT Program
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3 carts, 50 circuits/shift, 3 shifts/day
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Reliability Target set at 130,000 cycles
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Currently at 180,000 cycles (8 years life)
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- Continuing to add 1500 cycles per day
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Generating Strong Market Interest
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Enthusiastic customer interest shown at recent Trade Shows
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Carestream regional sales offices requesting additional units for demo/sale
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Pre-launch stocking order now planned for 2.5x earlier guidance with increasing momentum
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European Congress of Radiology, Vienna, 2[nd] March 2017
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Arab Health, Dubai, 30[th] January 2017
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Pathway to Launch :
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Service Training under way at Carestream HQ
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Hospital Trade Trials in Canada on receipt of TPD Licence
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Nano featured in more major Trade Shows:
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Genoa, Italy, 6[th] April
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Sao Paulo, Brazil, 4[th] May
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Leipzig, Germany, 24[th] May
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Manchester, UK, 12[th] June
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Nano production rate increases for Carestream:
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Reliability demonstration
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International Service & End-User Training
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QA Evaluation
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Internal Trials
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Market Development
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Regulatory Approvals
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© Micro-X Ltd 2017
Thank You; Any questions?
© Micro-X Ltd 2017