Fortimedix Surgical Announces 510(k) Submission for Innovative FMX314 Surgical Platform

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Mar 24, 2016, 06:43 ET

NUTH, The Netherlands and SAN DIEGO, March 24, 2016 /PRNewswire/ --

Fortimedix Surgical announced today that it has submitted a premarket notification for its innovative FMX314 single-port surgery solution with the US Food and Drug Administration (FDA), under Section 510(k) of the Food, Drug and Cosmetic Act.

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"We are very pleased to announce our submission with the FDA, as it represents an important milestone towards market introduction of FMX314 in the United States, which is expected in the fourth quarter of this year," commented Mr. Marc van de Graaf, VP Global Business Development for Fortimedix Surgical.

FMX314 is the world's first single-port surgery solution that is compatible with a standard 15mm laparoscopic trocar, promising fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis. Closely mimicking 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.

"With its unique sizing and ease-of-use, we believe FMX314 will deliver on the promise of single-port surgery, elevating the standard of care in laparoscopy," said Mr. Van de Graaf.

Caution: The FMX314 Surgical Platform is an investigational device and not available for sale.

About Fortimedix Surgical

Fortimedix Surgical is a fast growing medical device product definition 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 continuing the evolution of minimally invasive surgery by driving technological innovation across surgical specialties to improve the quality of life of patients throughout the world.

For more information, please visit http://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.