Trendlines Medical portfolio company Gordian Surgical said this week it won FDA clearance for its TroClose 1200, along with announcing the closure of a $2.3 million funding round.
The Israel-based company’s TroClose 1200 trocar is designed to enable access to the abdomen during laparoscopic surgery, as well as closing the access through suturing incisions in the abdominal wall.
The device is used to open the abdomen and insert surgical tools to start a procedure, and is equipped with an integrated closure system to allow for closing incisions, the company said.
The round was led by B. Braun and joined by current shareholders and 3 venture capital funds, including 2 Chinese funds, Gordian Surgical said.
“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 USA, Europe and other markets. Major interest in TroClose was evidenced at the recent MEDICA 2016,” Gordian Surgical CEO Zvi Pe’er said in a prepared statement.
The company said it won CE Mark certification in the European Union in September, and has performed 7 cases in a post-market surveillance study so far.
“Gordian’s TroClose is a very effective system, easy to use and especially useful for younger surgeons, as the learning curve is very short. TroClose has significant advantages over other gold standard closure devices on the market. Indeed, there is definitely a place for this product in the market,” Michel Vix of France’s University Hospital of Strasbourg said in prepared remarks.
“Our decision to lead this investment in Gordian Surgical, a Trendlines’ portfolio company, was based on the unique design of the TroClose1200 and the great potential we see in the global laparoscopic market for a closure/trocar integrated device. We expect the TroClose1200 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 Surgical’s management,” B. Braun Aesculap division CEO Dr. Hanns-Peter Knaebel said in a press release.
In May, the company launched 1st-in-human trials with its TroClose 1200.
Last October, Gordian Surgical said it raised nearly $1 million in a new round of funding joined by Chinese venture capital firm Virtus Inspire Ventures. The company did not say who led the round, but said it was joined by a number of leading U.S. laparoscopic surgeons and other investors.