Unless the FDA approves the stapler CRDC won't have much to say.
They are like ISRG and their new stapler (which is NOT the CRDC technology). It takes about a year to slowly get the technology into the field and ensure it's being used correctly and make necessary iterations. I'm glad to see ISRG use the same verbiage that CRDC uses regarding their stapler and launch.
CRDC has stated clearly not to expect significant revenue (yet) from the micro cutter and EU sales.
CRDC has stated clearly that they think approval will be delayed until 1Q14 (although FDA could approve it within the next 30 days which closes out the 90 day timeline).
I am disappointed the market is not giving CRDC the anticipated appreciation for the microcutter and the likely approval, whether it be in 30 days or 1Q14.
The micro cutter is small and has greater articulation but is it too dainty? Will surgeons want a more robust stapler during critical surgeries. Will the microcutter be treated as a specialty stapler limiting its market potential?
Let's hope for positive input from surgeons using the stapler, CRDC needs to get the horns out and let Horton know they are in WhoVille.
Probably not a whole lot. However, this companies valuation will change significantly when the microcutter is approved. They booked $200k on 200 devices shipped to the EU. Let's say avg ASP is $2,500 per procedure in the USA and the microcutter is ideal in 850,000 procedures of the total available 1.4million stapling procedures in the USA. If they capture 20% which should be very doable with a best in class product, that's $425Million. They will need to raise money for inventory, marketing and sales. I think they will raise the money once the company is fairly valued based on the opportunity at a much higher price. This will be an entry for many large institutions similar to that of Biotech phase 3 secondary offerings. Cardica will not flounder at a mere $61Million Market valuation post approval.
I think it was $200K based on 30 devices. From their 10-K
As of June 30, 2013, over 200 MicroCutter XCHANGE 30 devices had been sold in Europe. Total product sales of our MicroCutter XCHANGE 30 devices was $0.2 million, representing 5% of total revenue for the fiscal year ended June 30, 2013.
We have heard many promises over the last few years from Bernard Hausen. Results have
been mostly delays and more dilution. That is why pps is so low compared to potential. Have
you forgotten Express 30 issues so quickly?