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Thursday, March 07, 2019 2:04:15 AM
I am not at all surprised that they are having trouble generating sales. In medical devices 510k clearance means nothing, it only means that you can market your product but that by no means equals that sales will be generated.
Medical device reimbursement is a real tough game especially for 510k products.
ADM does not need to make tons of devices when they only sell like 20 units per month. There will not be any big orders because it is a prescription device not a disposable medical device like a catheter, sutures, stents, etc. Their business model per their press release is that an independent salesman will get an order from a doctor and then send it to ADM to be fulfilled. Really bad business model. In general companies like chronic diseases because your patient pool (customers) are already there to be marketed to rather than having to wait for them to come in (i.e. waiting for someone to have a surgery scheduled) as is in acute conditions. That is why so many companies are drooling over NASH.
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