reply

Hi Robert,

I have no problems with you posting the reply as these are. Things I have mentioned before publicly. I agree with your comments and welcome any comments positive or negative.

All the best,

Dave


6 Mar


Hi Robert,

Thank you for reaching out. Regarding Midcity news, I do not know who they are nor do I have any recollection of doing an interview with them. What I have said is that there is a lack of awareness regarding our technology with patients and physicians which is not only true for us but for LVAD technologies. The difference is that LVAD technologies have been around for many years. On Bloomberg, I never got the chance to bring up results and yes I would have said that. I was told they were going to ask me about specific results but never did.

On your suggestion, we have already hired a PR company and you will hear next week on our quarterly call we are doing what you suggest with one exception. We are not allowed to interview nor approach any patient that is in an FDA trial which the weaned patients are. They remain in follow up for a total of 5 years. Otherwise, I would have them at our booth at trade shows as well. We can't but the doctors that are taking care of them can. The FDA also has strict guidelines for "promotion or advertising" of a clinical trial which impacts us as well. If we were commercial, none of these would come into play. Again, stay tuned for next week to hear what we are doing.

I appreciate people that are more direct as opposed to those that appear to have unclear agendas so no need to apologize. On recruitment, Heartware had trouble getting their sites up and running in their follow on destination therapy trial due to sites taking longer to get IRB approval. Thoratec has not announces any enrollments in their. Class III trial and I am told they have had massive delays in getting sites activated. Our number one priority is enrollment and many of the experts in this space tell me are doing more than what other companies are and to be patient. Easier said than done