Brian Buntz

March 22, 2016

2 Min Read
Indicted Ex-Acclarent CEO Opens Up in Interview

The former CEO of Acclarent, Bill Facteau shares some of his thoughts about the fraud charges he is facing and explains why is optimistic about the future.

Brian Buntz

"If you can avoid getting indicted, that would be a good thing," said Bill Facteau in an interview with Tom Salemi, content director of Healthegy from earlier in the year that is now making the rounds on the Internet.

Facteau, who is currently the chairman, president, and CEO of Earlens, says he is looking forward to having his day in court in May and that the case is going to be "a big one for our industry." The charges were filed in U.S. District Court in Massachusetts.

Following the recent acquittal of Vascular Solutions CEO Howard Root on similar charges, the Acclarent case could further help to establish how freedom of speech rules apply to off-label marketing of medical devices.

Facteau says that the indictment centered around a regulatory belief by the U.S. attorney in Boston that the 510(k) for its Relieva Stratus Microflow Spacer sinus balloon catheters were fraudulent. While the 510(k) applications was granted for delivering saline, the company is charged with promoting the device for delivering drugs--primarily steroids.

Facteau, along with former Acclarent VP of sales and marketing Patrick Fabian, is facing 18 charges, including one count of conspiracy, three counts of securities fraud, four counts of wire fraud, and ten counts of introducing adulterated or misbranded medical devices into interstate commerce.

In the interview, Facteau said that the general medtech community, as well as his friends and investors and employees at Earlens, have been "amazingly supportive."

Earlens makes a unique hearing aid that shines light onto a lens that sits on the eardrum. The company plans on marketing the device to audiologists as well as ear, nose, and throat (ENT) specialists. Facteau says that his substantial experience marketing devices to ENTs will be an asset at EarLens.

The company is the first to market a light-based hearing aid.

Facteau says that he sees reimbursement as being the potentially biggest challenge for the company because of the novelty of the technology and the uncertainty of whether it will be covered by payers.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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