I don't mean to be unduly skeptical about this exciting news, but there are a lot of nitty-gritty, ugly and practical questions from an investors' viewpoint. Here are just a few.
1 How much does the implantable heart cost to manufacture? (And who exactly will be doing the actual manufacturing of all of its parts and components?)
2. Ditto: the energy source (batteries, I believe).
3. What is the projected retail price, if any, to the patient during the trial?
4. How expensive is the implant operation expected to be during the coming FDA trial? Medical follow-ups?
5. What is the projected engineering failure rate of the device? (For example, at the very start of the program, as I recall the space shuttle was projected to have a failure rate of 1:100.) What was the actual failure rate in the cow trials?
6. Who will insure or warranty ABMD's implantable heart device against simple mechanical failure during the trial? At what premium cost? Liability to the patient may not be a big thing when you're talking about charity patients with no known relatives and a very limited life expectancy in any event, but, even so, if the device and implant operation is expensive and the device fails someone could be left holding a very expensive bag.
7. Ditto: the energy source.
8. I assume an effort will be made by ABMD to obtain patient (and known dependents') waivers of liability, but such things, at best, are only as good as the full disclosures made about known, knowable, or suspected risks. Does anyone happen to have a handle on the actual disclosure language ABMD intends to use? This could give a great deal more insight into #5 to #7, above.
9. What are the chances any health insurance company will agree to cover this experimental device during the trial? What are the costs of the actual implant operation and associated hospital care? If no insurance covers during this trial, who is picking up the tab for all this?
10. What if any agreement is expected between ABMD and patient regarding costs of care for 'related' or 'unrelated' medical complications (pneumonia, etc.) - and how is the difference delineated and who decides?
11. Can ABMD afford to pay all costs of the trial including device, operation, energy source liability costs, hospital care, and follow-ups without substantial dilution of existing shares?
12. Does anyone happen to know if the results of the earlier cow study are available somewhere? Inquiring cattle want to know. |
