Novel Integrated Port Closure System Zvi Peer, CEO August 2017 Confidential Presentation www.gordiansurgical.com
Snapshot of Gordian Surgical 5 distribution agreements >150 surgeries More in negotiation (U.S., Europe, Israel & India) $1.4B $5M Raised FDA and CE > $1.4 billion market US$ 5.5 million
What Is Laparoscopic Surgery? Surgeon makes small holes in the abdomen to insert instruments. To create the holes, the surgeon uses a device called a trocar. Trocar Hole
The Problem with Laparoscopic Surgery Closing the ports is difficult and takes time It is highly recommended to close the 10+ mm ports Incomplete site closure can lead to complications such as hernias
How is it Performed Today? • Manually with needle and suture Most common technique; time consuming; requires expertise • Dedicated closure devices Existing devices are complicated, expensive, and may cause tissue trauma Teleflex Endo Fascial Closure System Cooper Surgical Carter Thomason
Gordian’s TroClose 1200 ™ Gordian’s novel Integrated Port Closure System
Watch How It Works https://youtu.be/guHS75Skti hthttp://v.youku.com/v_show/id_XMTYyMTk3MTQzMg==.html File name: TroClose in Clinical use-Gordian2016 Password: gszvi2016
TroClose1200 ™ Simple Secure Safe Win-Win for Patients, Hospitals & Surgeons
Clinical Trials • Study performed to assess efficacy & safety in the use of the Gordian Surgical’s TroClose 1200 ™ • Multinational trial: 3 sites (2 in Israel & 1 in India) • 50 patients • 6 weeks follow-up for primary endpoint First-in-human with Gordian’s TroClose 1200 ™ • Study performed by 6 different May 2016 surgeons • Intend to publish study in Peer Review journal
PMS Surgeries: U.S and Europe • More than 100 surgeries performed by more than 50 surgeons as PMS cases in: Europe : IRCAD (France), Germany, Spain (Barcelona), Sweden, England and Greece USA: More than 10 different hospitals including Mount Sinai, Cleveland Clinic (Ohio and Florida), Cornell, Colombia, Montefiore and others • In all 100 plus surgeries no adverse events or safety issues • Surgeons gave positive feedback working with TroClose 1200
What Worldwide Surgeons say about TroClose1200 ™ “There is a high incidence of incisional & Dr. Natan Zundel recurrent hernias following surgical Jackson North Medical Center procedure in the obese patient. As such Miami Beach, FL, USA , port site closure is a real clinical significance especially for • Medical Director Bariatric Institute at Jackson bariatric surgery patients. We have North used TroClose1200 ™ and found it to be • Professor of Surgery in 3 Countries - very friendly to use, safe and an USA/Colombia/Brazil • Previous President IFSO excellent port closure device . To date at the 6 weeks post-op check, we have not noted any hernias or other clinically significant issues. TroClose1200 ™ provides quick full-fascial closure in obese patient population.“
What Worldwide Surgeons say about TroClose1200 ™ “I was very impressed with the Dr. Steven Wexner potential of TroClose1200 ™. It Cleveland Clinic Florida Weston, FL, USA offers several benefits including reduced time in surgery for port site closure and more reliable • Director, Digestive Disease Center secure port closure. The former • Chair, Department of Colorectal Surgery advantage may save money and • Affiliate Professor Florida Atlantic University College the latter advantage may translate of Medicine • Clinical Professor Florida International University to less port site hernias.” College of Medicine
What Worldwide Surgeons say about TroClose1200 ™ “Gordian’s TroClose 1200 ™ is a very Dr. Michal Vix effective system, easy to use and University Hospital of Strasbourg - IRCAD especially useful for younger Strasbourg, France surgeons, as the learning curve is very short. TroClose1200 ™ has • Head of the Bariatric and Metabolic significant advantages over other Surgery Unit standard closure devices on the • Scientific Co-Director, IRCAD market. Indeed, there is definitely a Institute place for the Gordian Surgical product in the Worldwide market.”
KOLs are Excited and Want to be Involved, Several Invested in Gordian Barry Salky, MD Steven D. Wexner, MD Mount Sinai Cleveland Clinic Florida Hien Nguyen, MD Steve Schwaitzberg, MD Johns Hopkins Harvard Natan Zundel, MD Edward H. Phillips, MD Jackson North Medical Center Cedars-Sinai
Strong, Experienced Team Zvi Pe’er, CEO, Is a serial entrepreneur with over 25 years ’ experience in medical devices and biotechnology. He founded and served as CEO of Romtec Electronics, which had a successful IPO and exit; biotechnology companies Fulcrum SP and BioGroup Technology; and medical device company QRay. He received an MBA from Tel Aviv University and a B.Sc. in industrial engineering from the Technion-Israel Institute of Technology. Leo Mindick, Chairman of the Board. Founder, CEO of Med-Tech Consultant Partners with years of experience in specialty medical devices, IP, regulatory, reimbursement; founder, former CEO multi-million dollar specialty medical distribution company (later acquired). Dr. Nissim Geron, Medical Director , Head of the Surgery Department at Poria Medical Center in Tiberias, Israel. He has extensive experience in laparoscopic procedures. Doni Mayerfeld, Marketing Director Over 25+ years of medical device experience with numerous senior level positions in general, cardiac & orthopedic surgical products as well as in patient monitoring equipment. He was also a US board certified New York State Physician Assistant. Amir Schvartzer, Project Manager Biomedical engineer with about 10 years’ experience in laparoscopic devices including R&D, QA/RA, training and support. Hagay Weisbrod, R&D Manager, Biomedical /mechanical engineer with over 10 years’ experience in medical devices, implants, laparoscopic equipment and surgery
Shareholders • B.Braun / Aesculap • The Trendlines Group • Several international ventures funds • Surgeons (well-known in the U.S. & Israel) • Private investors (U.S., Switzerland, Israel)
$1.4 Billion Global Market $1.4B Trocar and Closure Device Markets
Global Interest More than 140 companies from >35 countries, including major companies, asked to become Gordian’s distributors
www.gordiansurgical.com THANK YOU Zvi Peer, CEO zpeer@gordiansurgical.com
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