NUTH, The Netherlands, and San Diego, CA, October 10, 2016 – Fortimedix Surgical today announced the first-in-man use in the United States of 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.
Two laparoscopic cholecystectomy procedures were performed through the umbilicus with the Fortimedix Surgical system by renowned surgeon Santiago Horgan, MD, professor of surgery and chief of minimally invasive surgery at UC San Diego Health. “In my experience, the FMX314 surgical platform addresses unmet needs in minimally invasive surgery by delivering benefits to patients and physicians over more invasive, laparoscopic methods,” said Dr. Horgan. “The single-port platform allows physicians to offer patients a minimally invasive treatment option that could potentially result in fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis in comparison to conventional multi-port laparoscopic surgery.”
FMX314 emulates conventional, multi-port laparoscopy, making it easy to use and enabling surgeons to perform procedural steps ergonomically, which allows for a comfortable and secure single-port approach.
Following receipt of 510(k) Clearance and CE Mark approval in the third quarter of this year, 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., where Fortimedix Surgical will be located at booth #1139. The European commercial launch is planned for 2017.
UC San Diego Health is dedicated to delivering outstanding patient care through commitment to the community, groundbreaking research and inspired teaching. It ranked No. 1 in San Diego for the sixth consecutive year in 2016 in U.S. News & World Report’s “America’s Best Hospitals” guidebook. UC San Diego Health includes UC San Diego Medical Center in Hillcrest and Thornton Hospital, Moores Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, Altman Clinical and Translational Research Institute and Jacobs Medical Center (opening 2016), all in La Jolla, as well as other primary and specialty practices located throughout Southern California. For more information, visit health.ucsd.edu.
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 Monique Biermans via +31(0)45 544 95 20