Gordian Surgical Completes $2.25 Million Raise and Receives FDA Clearance for TroClose1200™
Company to commence commercial activity in U.S. and Europe.
MISGAV, Israel and TUTTLINGEN, Germany, Dec. 7, 2016 /PRNewswire/ -- B. Braun Melsungen AG ("B. Braun"), The Trendlines Group Ltd. (SGX: 42T,OTCQX: TRNLY) ("Trendlines") and Gordian Surgical Ltd. ("Gordian") jointly announced B. Braun's lead position in Gordian's recent financing round of US$2.25 million; Gordian Surgical is a medical portfolio company of The Trendlines Group.
German medical device company, B. Braun Melsungen AG led the investment round with €1 million, with the remainder from current shareholders and three VC funds, two of which are Chinese funds. Funds raised in this round will be used to start marketing and distribution in U.S. and European markets.
Concurrently, with the successful fund raising round, Gordian announced it received FDA regulatory clearance for its TroClose1200™, an innovative trocar with integrated closure system for the suturing of abdominal wall incisions during laparoscopic surgical procedures. The FDA approval follows Gordian's receipt of CE Mark certification as announced on 6 September 2016.
Gordian Surgical developed TroClose1200 to give 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 self-same week as receiving 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 TroClose1200 was performed at The Clinic for Surgery of Obesity and Metabolic Surgery at the Sana-Klinikum Offenbach a.M. a nearby hospital. The surgery was broadcast live to surgeons from around the world gathered together in an auditorium at the conference.
Gordian began human trials in 2016 to demonstrate safety and efficacy of TroClose1200 and to date has completed all 50 laparoscopic procedures in the clinical phase. Additionally, the Company performed the first seven cases, defined as post-marketing surveillance, in Europe, including at the prestigious 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 stated: "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."
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 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."
Zvi Pe'er CEO of Gordian Surgical remarks, "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."
About B. Braun
With over 56,000 employees in 64 countries, B. Braun is one of the world's leading manufacturers of medical devices and pharmaceutical products and services. Through constructive dialogue, B. Braun develops high quality product systems and services that are both evolving and progressive – and, in turn, improves people's health around the world. In 2015, the group generated sales of approximately €6.13 billion.
About The Trendlines Group Ltd.
Trendlines is an innovation commercialization company that invents, discovers, invests in, and incubates innovation-based medical and agricultural technologies to fulfill its mission to improve the human condition. As intensely hands-on investors, Trendlines is involved in all aspects of its portfolio companies from technology development to business building. Trendlines's shares are traded on the Singapore Stock Exchange (SGX: 42T) and in the United States as an American Depositary Receipt (ADR) on the OTCQX (OTCQX: TRNLY).
Contact Gordian Surgical: Zvi Pe'er, CEO Gordian Surgical
E-mail: zpee[email protected]
Phone: +972.50.420.3333
Trendlines Investor Contact Information
Judith Kleinman, Director, Investor Relations & Corporate Communications
E-mail: [email protected]
Phone: +972-72-260-7000
Photo - http://photos.prnewswire.com/prnh/20161205/445646
SOURCE The Trendlines Group Ltd.; B. Braune; Gordian Surgical
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