Quote: "On track for the 10K in March to show over $2-million in revenue for 2014! "
Also "on track" to show LARGER LOSSES from operations than in 2013, despite "revenues" and despite cutting R&D to less than $3K per month, a drop of over $400K in one yr and much more than that over subsequent yrs.
Also, what exactly are they "selling" as products/treatments for use on humans "overseas" and now per their "slide presentation" apparently at a "clinic" in Florida too?? I don't get it per their own SEC filings?
From the Bioheart 10-K, PAGE 39:
"We do not currently have product liability insurance because none of our product candidates has yet been approved for commercialization. While we plan to seek product liability insurance coverage if any of our product candidates are sold commercially, we cannot assure you that we will be able to obtain product liability insurance on commercially acceptable terms, if at all, or that we will be able to maintain such insurance at a reasonable cost or in sufficient amounts to protect against potential losses.
Claims may be made by consumers, healthcare providers, third party strategic collaborators or others selling our products if one of our products or product candidates causes, or appears to have caused, an injury. We may be subject to claims against us even if an alleged injury is due to the actions of others. For example, we rely on the expertise of physicians, nurses and other associated medical personnel to perform the medical procedures and processes related to our product candidates. If these medical personnel are not properly trained or are negligent in using our product candidates, the therapeutic effect of our product candidates may be diminished or the patient may suffer injury, which may subject us to liability. In addition, an injury resulting from the activities of our suppliers may serve as a basis for a claim against us.
We do not intend to promote, or to in any way support or encourage the promotion of, our product candidates for off-label or otherwise unapproved uses. However, if our product candidates are approved by the FDA or similar foreign regulatory authorities, we cannot prevent a physician from using them for any off-label applications. If injury to a patient results from such an inappropriate use, we may become involved in a product liability suit, which will likely be expensive to defend.
These liabilities could prevent or interfere with our clinical efforts, product development efforts and any subsequent product commercialization efforts, all of which could have a material adverse effect on our business."
I don't believe just "being overseas" frees one from liability exposure for medical products/treatments that have not been proven safe for use in humans, per the company's own SEC filings, does it?
I find that very confusing IMO.
