Fortimedix Surgical Announces 510(k) Clearance for Innovative Single-port Surgical Platform

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Aug 29, 2016, 09:00 ET

NUTH, the Netherlands and SAN DIEGO, August 29, 2016 /PRNewswire/ --

Fortimedix Surgical today announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for FMX314, an innovative single-port platform for use in minimally invasive abdominal laparoscopic surgery.

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"We are very pleased to announce we have secured 510(k) clearance for our platform, as it signifies an important milestone in our quest to deliver on the promise of single-port surgery," commented Mr. Wout Bijker, CEO of Fortimedix Surgical.

FMX314 is the world's first single-port surgery solution compatible with a standard 15mm laparoscopic trocar, promising fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis. Emulating conventional, multi-port laparoscopy makes FMX314 easy to use and enables surgeons to perform procedural steps ergonomically, allowing for a comfortable and secure single-port approach.

Market introduction in the United States is scheduled during the upcoming ACS Clinical Congress 2016 (October 16 - 20) in Washington, DC.

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.