Francis R. Amato is Chief Executive Officer of electroCore, Inc. Prior to being the Chief Executive Officer and joining electroCore in 2012, Mr. Amato spent 22 years in the pharmaceutical industry, most recently at Merck, where he served as Vice President of the Specialty Commercial Operations Group within Global Human Health. Mr. Amato has extensive commercial experience in health care, serving previously as Executive Director, Global Business Operations at Schering-Plough; Business Unit Lead, Oncology at Ligand Pharmaceuticals; National Sales Director, Specialty Managed Markets at Pfizer Inc.; and National Sales Director, Hospitals at Pharmacia Corporation.
In this 3,389 word interview, exclusively in the Wall Street Transcript, Mr. Amato makes a case for his medical device company with investors:
“We are dedicated to improving patient outcomes through patient-administered noninvasive vagus nerve stimulation — nVNS — therapy as provided by the gammaCore device that is placed on either side of your neck, next to your trachea. You stimulate the nerve for two minutes at a time. When you say direct competition, we look at our primary competition being medication.”
The global business development of electroCore is being managed directly by the company:
“In Europe, basically, you can get your CE mark first, then you run your clinical and pivotal studies, and then you apply for reimbursement in the single-payer health care systems.
Whereas in the United States, you go to the FDA, get an agreement, or what is called an IDE — investigational device exemption — to run a study, and then you take that data, bring it back to the FDA, and they consider your therapy for approval.
Once you get that approval, then you can go out and start to petition the commercial health care and the government-covered health care in the United States for reimbursement. That is the big difference between the two systems there.
You can get a CE mark pretty easily if your therapy is safe. A lot of companies do that for the purposes of running their clinical trials. It is really a clinical trial strategy more than anything else.”
See what comes next for electroCore under Mr. Amato’s guidance in the complete 3,389 word interview, exclusively in the Wall Street Transcript.
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