Apollo Endosurgery wins first EU approval

Apollo Endosurgery is making its first foray into Europe, backed by a new CE mark for two of its products that enable incision-less surgery while using a flexible endoscope.

And as it ramps up that effort, the 2012 Fierce 15 company is also gearing up to raise additional venture funding this year, CEO Dennis McWilliams confirmed to FierceMedicalDevices.

"Yes, we will be raising additional funds in 2013 [but] we haven't finalized any details or plans around that," McWilliams told us, though he declined to disclose further details. "We're very fortunate to have a large, well funded syndicate behind us."

Apollo already has 11 FDA approvals and three products marketed in the U.S.--its OverStitch endoscopic suturing system, the Apollo tissue helix, which grabs and holds onto different tissue layers inside the GI tract, and the Apollo OverTube, a device designed to protect the esophagus while delivering a flexible endoscope and surgical instruments to the GI tract. Its New CE mark covers both OverStitch and the issue helix devices, and they're meant to work with existing endoscopic technology.

Apollo's $47.6 million Series B round raised in early 2012 is helping to support Apollo's commercial rollout in Europe, though McWilliams said Apollo's reputation gained from its ramp-up in the U.S. will also help.

Similar to Apollo's U.S. rollout the company plans to market initially to key surgical centers and gastroenterologists, with an initial emphasis on European countries including Germany, France, Switzerland, Italy and Belgium. But rather than pursue direct sales in Europe as it did domestically, Apollo will work with several distributors.

McWilliams wouldn't discuss revenue for Apollo, which isn't yet profitable. But, he said, the Austin, TX, company's revenue "is growing."

- read the release

Special Report: Apollo Endosurgery – 2012 Fierce 15

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