Who we are

About Fortimedix Surgical

Fortimedix Surgical is a fast growing medical device company with the ambition to inspire a new wave of technological advancement in the field of minimally invasive 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.

Building on our established position as a stent industry leader with state-of-the-art manufacturing capabilities, we have in-house control over the manufacturing of key components of our products, including the symphonX™ Surgical Platform. Thanks to our network within the medical device industry, we are able to work with various professional service providers for the supply of other platform components and services. This allows us to outsource cost by leveraging their expertise and infrastructure.

Our Mission

Drive the evolution of minimally invasive surgery through smart innovation across surgical specialties to improve the quality of life of patients throughout the world.

In close collaboration with our Scientific Advisory Board, we target clear unmet needs in various surgical specialties, including general surgery, gynecology and colorectal surgery. We combine device development expertise and manufacturing know-how to create solutions that enable surgeons to easily adopt novel technologies and provide better care and offer patients the potential for improved health outcomes.

Our Vision 2020

Challenge the status quo in minimally invasive surgery by creating novel devices that capture the claimed benefits of single-port surgery. 

Reducing the number of incisions and minimizing abdominal wall trauma is the next logical step in the evolution of laparoscopic surgery as it has the potential to offer significant benefits over traditional laparoscopy. General adoption of single-port methods has been hindered by ease-of-use and sizing limitations associated with the inability to achieve adequate triangulation for optimal surgical manipulation, retraction and exposure. We have developed an innovative surgical platform to overcome these limitations and deliver on the promise of single-port surgery, including fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis.

Company Milestones

Since 2008 we have been developing solutions for minimally invasive surgery. Fortimedix Surgical originally emerged as a business unit of Fortimedix Manufacturing B.V., a global leader in the field of endovascular stents since 1999. Fortimedix Surgical quickly grew into an independent medical technology company in 2012, leveraging the strong heritage of innovation and operational excellence of the Fortimedix family. Below is an overview of our most important milestones since 2008.

Note: FMX314 is the engineering code name for symphonX™ used during the pre-commercial phase.

 

MARCH 2008
Filing of priority IP

AUGUST 2012
Incorporation of Fortimedix Surgical B.V.

MARCH 2013
First successful pre-clinical lap-chole

DECEMBER 2013
Phase I Clinical Trial (First-in-Man)

APRIL 2014
SAGES Emerging Technology Session on FIM results

AUGUST 2014
FIM study results published in Surgical Endoscopy

DECEMBER 2014
Phase II clinical trial (safety & efficacy)

APRIL 2015
SAGES Emerging Technology Session on phase II study results

JUNE 2015
Phase II study results published in Surgical Endoscopy

NOVEMBER 2015
Phase I Inguinal Hernia Repair clinical trial

JANUARY 2016
First Pre-clinical transanal colon resection (TaCR) study (cadaver)

MARCH 2016
SAGES Emerging Technology Session on Initial study results Colorectal surgery

MARCH 2016
FMX314 FDA 510(k) & CE mark submission

MAY 2016
Phase I Tubal Sterilization clinical trial

AUGUST 2016
FDA 510(k) clearance

SEPTEMBER 2016
CE mark approval

OCTOBER 2016
First-In-Man USA
Market launch symphonX™ at ACS Clinical Congress

DECEMBER 2016
First-In-Man Europe at University of Cologne

JUNE 2017
EAES Amazing Technologies Session on pre-clinical TaCR studies

JULY 2017
NOSCAR summit presentation on pre-clinical TaCR studies

AUGUST 2017
Launch symphonX™ Instruments short

Fortimedix Surgical Milestones

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