German medical device company B. Braun Melsungen AG (“B. Braun”) has once again taken the lead in investing in a medical portfolio company of The Trendlines Group.
Funds raised in this round by Gordian will be used to start marketing and distribution of Gordian’s innovation in the United States and Europe.
Receiving FDA clearance is a huge milestone in Gordian’s strategic roadmap. The recent investment, led by B. Braun, allows us to move rapidly towards commercialization of our device in the U.S., Europe and other markets. Major interest in TroClose1200TM was evidenced at the recent MEDICA 2016.”
-- Zvi Pe’er, CEO of Gordian Surgical.
(NextInsight file photo)
Gordian announced it has just received Food and Drug Administration (“FDA”) regulatory clearance for its TroClose1200TM, an innovative trocar with integrated closure system for the suturing of abdominal wall incisions during laparoscopic surgical procedures.
The FDA clearance follows Gordian's receipt of the CE Mark certification, as announced on 6 September 2016.
TroClose1200TM gives surgeons “two-in-one” functionality: the device acts both as a trocar, through which surgical instruments enter the abdomen, and a device to close internal incisions made during surgery.
The sutures are inserted into the tissue at the beginning of the procedure and anchored to remain in place throughout the operation, allowing incisions to be closed easily and quickly upon removal of the device.
In the same week that Gordian received the FDA clearance, Gordian was featured at the 32nd Annual Conference of the German Association for the Study of Obesity (DAG) e.V. in Frankfurt, where a laparoscopic procedure utilizing Gordian's TroClose1200TM was performed at The Clinic for Surgery of Obesity and Metabolic Surgery at the Sana-Klinikum Offenbach a.M.
The surgery was broadcast live to surgeons from around the world gathered in an auditorium at the conference.
Gordian began human trials in 2016 to demonstrate safety and efficacy of TroClose1200TM and to date has completed all 50 laparoscopic procedures in the clinical phase. Additionally, Gordian performed the first seven cases, defined as post-marketing surveillance, in Europe, including at the prestigious institute, IRCAD in Strasbourg, France and during the live surgery in Germany.
Professor Michel Vix, Head of the Bariatric and Metabolic Surgery Unit, University Hospital of Strasbourg, France, Scientific Co-Director, IRCAD Institute, said: “Gordian’s TroClose1200TM is a very effective system, easy to use and especially useful for younger surgeons, as the learning curve is very short. TroClose1200TM has significant advantages over other gold standard closure devices on the market. Indeed, there is definitely a place for this product in the market.”
|♦ B. Braun invested US$5 m in Trendlines as a cornerstone investor in Trendlines’ Nov 2015 IPO in Singapore.
♦ B. Braun and Trendlines have executed a MOU for co-investment in Trendlines Medical Singapore, Trendlines’ first incubator outside of Israel.
Prof. Dr. Hanns-Peter Knaebel, a member of the B. Braun Management Board and CEO of their Aesculap division, added, "Our decision to lead this investment in Gordian was based on the unique design of the TroClose1200TM and the great potential we see in the global laparoscopic market for a closure/trocar integrated device. We expect the TroClose1200TM to save time for surgeons and reduce anesthesia time for patients. FDA clearance, received so shortly following receipt of CE Mark, confirms our confidence in Gordian’s management."