Fortimedix Surgical Announces CE Mark Approval for FMX314, the World’s Lowest Profile Single-Port Surgery Solution

NUTH, The Netherlands and SAN DIEGO, Oct. 03, 2016 -- Fortimedix Surgical today announced it has received CE Mark approval for FMX314, the world’s first single-port surgery solution that is compatible with a standard 15mm trocar for use in minimally invasive abdominal laparoscopic surgery. FMX314 addresses unmet needs in laparoscopic surgery by providing a platform solution that is small, simple and secure.

The FMX314, recently FDA cleared in the U.S., now receives CE Mark in Europe.

A photo accompanying this release is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/817c148c-9cb9-43d5-85ad-4d251ae94bdc

“Our company is poised for significant growth, as we continue to achieve regulatory milestones to introduce innovative surgical instruments in key markets around the world,” said Marc van de Graaf, VP Global Business Development of Fortimedix Surgical. “Following 510(k) clearance from the United States Food and Drug Administration last August, this CE Mark allows us to expand the availability of our innovative technology to patients in Europe, who will benefit from the unique advantages of FMX314.”

Because it is the first single-port platform that is compatible with a standard 15mm laparoscopic trocar, FMX314 holds the promise of fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis compared with conventional multi-port laparoscopic surgery.

FMX314 emulates conventional, multi-port laparoscopy, making it easy to use and enabling surgeons to perform procedural steps ergonomically, allowing for a comfortable and secure single-port approach.

FMX314 will be launched in the U.S. during the American College of Surgeons (ACS) Clinical Congress, taking place October 16 – 20, 2016 in Washington, D.C. at booth #1139. A European commercial launch is planned for 2017.

About Fortimedix Surgical
Fortimedix Surgical is a fast growing medical device company, aiming to challenge the status quo in minimally invasive surgery by creating novel devices that capture the claimed benefits of single-port surgery. The company is headquartered in Nuth, The Netherlands, and has a US subsidiary in San Diego, CA. With a strong history as a global market leader in contract stent manufacturing, Fortimedix has been a trusted partner in the medical device industry for over 15 years. Fortimedix Surgical is committed to driving the evolution of minimally invasive surgery through smart innovation across surgical specialties to improve the quality of life of patients throughout the world.

For more information, please visit www.fortimedixsurgical.com

Forward-Looking Statements
Certain statements herein include “forward-looking” statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally can be identified by the use of forward-looking terminology, such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “project” or “continue” or the negative thereof or other similar words. All forward looking statements involve risks and uncertainties, including, but not limited to, the protection of intellectual property, changes to governmental regulation of medical devices, the introduction of new products into the marketplace by competitors, changes to the competitive environment, the acceptance of new products in the marketplace, conditions of the surgical industry and economic and political conditions globally. Actual results may differ materially from those contemplated or implied by the forward-looking statements. The forward-looking statements speak only as of the date of this release and Fortimedix Surgical assumes no duty to update them to reflect new, changing or unanticipated events or circumstances.

For media inquiries, please contact:

Fortimedix Surgical B.V., Monique Biermans, [email protected], +31 (0)6  24 676 376
Digital press release available at: www.fortimedix.com/who-we-are/news-archive

Lazar Partners, Chantal Beaudry, [email protected], or Amy Feldman, [email protected], +1 (212) 867-1762