Verisante Operational Update - Analyst Blog
Verisante Operational Update
Brian Marckx, CFA
Verisante Technology Inc. ( VRSEF/ V.VRS) provided an operational update last week, offering insight into progress on several fronts. Perhaps the most noteworthy of which is a meeting with the FDA, expected in Q1 2012, for initial discussions on the regulatory approval pathway for Aura. As a reminder, Aura recently was CE Marked for sale in Europe and also just received approval to be marketed and sold in Australia and Canada. As we detailed in our February 2011 initiation report on Verisante, we expect an FDA approval filing will need to be in the form of a PMA, supported with data from additional clinical testing - this pre-IDE meeting with U.S. regulators will hopefully provide guidance on the regulatory pathway as well as what the FDA will be looking for in regards to supporting data/information. Our current (as well as initial) assumptions are that Aura could be on the U.S. market by 2014.
The recent update also notes that;
- Verisante is in the process of selecting distributors and expects to launch Aura in Canada, Germany, Austria, Switzerland and Australia in the second half of 2012. This is slightly later than our early 2012 prior estimate, although given that we model only minimal sales in 2012 as a whole, the difference at this juncture is relatively immaterial
- Verisante is still awaiting publication of the analysis of the Aura trial data (i.e. - ~1,000 lesion data) and will announce the results when given the green-light
- Verisante has begun the registration process to sell Aura in Mexico and Brazil. The company hopes to obtain registration in Mexico in 2012 and Brazil possibly in late 2013
Verisante continues to present at various conferences throughout the world, raising awareness about Aura which will hopefully allow them to hit the ground running when commercial sales commence. We'll be catching up with Thomas Braun at the J.P. Morgan healthcare conference during the second week of January.
We continue to cover the company with an Outperform rating and $2.60 price target.
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