Brian Marckx, CFA
Major Hurdle Cleared With ISO Certification
Verisante Technology (VRSEF) announced in late July that they obtained ISO 13485:2003 certification for manufacture of medical devices. As we have detailed in our coverage of Verisante, successfully gaining ISO certification was the most significant near-term milestone to gaining regulatory approval of Aura in Canada, Europe and Australia – the expected initial markets for their skin cancer detection device.
With the ISO certification now in-hand, Verisante can begin to finalize the required deliverables to gain Health Canada approval – which could be filed with regulators in the coming weeks. The company expects Aura to be approved for sale in Canada before the end of 2011.
Verisante has retained Emergo Group as their European representative to assist with the CE Marking process. Non-European based medical device manufacturers, such as Verisante, must appoint a European authorized representative in order for CE Marking to be valid. The CE Marking process is a little more involved than gaining Health Canada approval and requires Verisante to provide clinical data. Statistical analysis from the 1,000-lesion study is now completed which means Verisante could be in a position to complete its documentation for CE Marking in the near-term. The file will then be assessed and assuming no deficiencies, Aura can bear the CE Mark. If deficiencies are noted, Verisante will have the opportunity to remedy and the file then re-evaluated.
If all goes well Aura will be cleared for sale in Canada, Europe and Australia (once CE Marked, Australian regulatory approval should come in short-order) by year-end 2011 – hopefully we will hear more about the status of CE Mark within the next few months. While regulatory approval(s) may be in place by year-end, any sales will likely be insignificant until commercial production is under way – which will not be until 2012 (commensurate with our initial expectations).
Verisante expects to have 7 functional prototypes completed within the next couple of months and recently began their commercial manufacturing strategy. In an August 3, 2011 press release the company announced they engaged StarFish Medical, a small medical device engineering and consultancy firm, to guide their manufacturing plan. Management has been very active presenting at industry conferences and meeting with prospective customers. These efforts should help gain greater exposure of Aura to health care professionals throughout the U.S., Europe, Canada and Australia (the CEO has been circling the globe) which will hopefully pay dividends once the device is approved and ready for sale.
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