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Cardica Inc. Message Board

  • mojo3176 mojo3176 Aug 5, 2013 5:10 PM Flag

    510k submission next week

    Worlds smallest Staple/cutter could be approved by December by FDA!
    Go CRDC GO!

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    • I want to put this out there for discussion... it seems to me from the current CC and previous calls that the mkt for the Microcutter is largely pediatric surgeries. I'm pretty good at getting to the heart of the matter - it seems to me that Hausen is over-blowing the mkt size for the Microcutter as he has done before for the C-Port and PAS-Port. Why wouldn't surgeons continue using traditional staplers they are familiar with when 12 MM trocar is acceptable (most adult surgeries), and ONLY use the Microcutter in special situations? Let's do a reality check here and look beyond the hype - how big is the mkt potential really?

      • 3 Replies to clearstone72
      • andersongordon Aug 6, 2013 1:56 PM Flag

        If the hospitals have to purchase a stapler-cutter, one which meets all needs and has greater flexibility, less force for use, uses a smaller trocar, has less incidence (95% moving higher with normal 85% for competition) at the same price as the 12 mm options, why would the hospital stock two stapler-cutters? Who will use the inferior stapler-cutter?

        It is true that the Pediatric Surgeons, which never had a stapler-cutter option will migrate to Cardica's and as these surgeons publish and talk of the new improved stapler-cutter technology others will move similarly. Just as ISRG used Prostatectomies to introduce their new technology with its ability to do surgery better and in areas previously unpenetrated, so Cardica may use this unmet and untapped area of surgery to introduce their Stapler-Cutter. This is why it is critical that the commercial introduction be as flawless and as easy to use as possible. The adoption curve will depend on it. Hausen is focusing on the most critical aspect!

        Thank you Dr. Hausen


        Sentiment: Strong Buy

      • It would be nice if Hausen could elaborate or present an argument for why the company felt that the best strategic path was to introduce the Xchange 30 first. If I remember correctly, the initial strategy was to launch the Xpress 30 & 45 first but due to “design issues” discovered in a clinical trial the Xchange 30 was swapped for the Express 30 in order to take the shortest road to qualification and profitability. The prioritization of the Xchange was supposed to help support the business while developing the Xpress. Hausen has repeatedly said the stapling market is a mature market unlike the CABG market they tried to enter. I read that as they believe they will not face the same adoption problems when they have commercial launch. However starting with the 5x30 Xchange does not really fit that strategy. If you really want to start with a product that is in a mature market and has the potential to support the business in terms of cash-flow wouldn’t you want to start with the Exchange 60 or 45? These sizes make up over 80% of the current market volume (with well-known and established procedures). Currently there is a 30mm x 12mm market out there and those devices cover 3 thickness levels. The Xchange covers vascular and medium thicknesses I believe… the market for (estabIished procedures is again reduced for the Xchange because they cannot use it for thick indications). That means the majority of the market for a 30mm line 5mm shaft device is a “new market” aka not many established procedures which means slow adoption just like the CABG products. Now why would they make the same mistake twice? Why not go after the established procedures in the 45mm and 60mm thick indications offering an 8mm or 10mm device that articulates more and has lower firing forces to establish some quick and easy volume and then go after the new markets? Now I cannot believe or hope that they wouldn’t make the same mistake twice. One possible answer is that another party may have convinced them to prioritize the 5x30 Xchange

      • This could be true but they will stillneed to purchase a microcutter or lose out on the surgeries.

        Sentiment: Strong Buy

    • Market being patient right now letting retailers sell who expected a big boom right away. Once they start taking CRDC up there's no turning back. It's the "when" and "how low" before they move it up. They have about a week before FDA submission and the more extensive Wedbush presentation.

      I hope they provide more detail into initial market potential and sales strategy at wedbush. I think they were purposely vague waiting for the FDA submission PR to make a big splash next week.

      Hausen was hedging the timing of the FDA approval by stating there's a lot that could potentially be discussed. Century might beat them to approval. It's going to be a ride.

    • Why didn't you call in Schmuck??

    • Century Medical submitting Microcutter for approval to boot!
      The world will be yours CRDC!

      • 1 Reply to mojo3176
      • Actually it will belong to whomever buys crdc...that small amount of cash in the piggy bank wont last long, Yet the big guns have waited,smartly, and let crdc's people do all the work. that's just good business except to minds in california and the former white house and any other liberal .LO@O
        we got up a pool right after the CC and put in 10 names we think may be potential buyers here, in japan, europ and isreal.
        We all put in a 100 bucks and drew slips...I GOT EDWARD SCIENCE...OH WELL EZ COME EX GO

        Sentiment: Strong Buy

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