Novel Integrated Port Closure System Zvi Peer, CEO August 2017 - - PowerPoint PPT Presentation

www.gordiansurgical.com

Novel Integrated Port Closure System

Zvi Peer, CEO August 2017

Confidential Presentation

Raised US$ 5.5 million

$5M

FDA and CE >150 surgeries (U.S., Europe, Israel & India)

$1.4B

> $1.4 billion market 5 distribution agreements More in negotiation

Snapshot of Gordian Surgical

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 Cooper Surgical Carter Thomason Teleflex Endo Fascial Closure System

Gordian’s TroClose1200™

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

Simple Secure Safe

Win-Win for Patients, Hospitals & Surgeons

TroClose1200™

Clinical Trials

• Study performed to assess efficacy & safety in the use of

the Gordian Surgical’s TroClose1200™

• Multinational trial: 3 sites

(2 in Israel & 1 in India)

• 50 patients
• 6 weeks follow-up for primary endpoint
• Study performed by 6 different

surgeons

• Intend to publish study in Peer Review journal

First-in-human with Gordian’s TroClose1200™ May 2016

• 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

PMS Surgeries: U.S and Europe

• Medical Director Bariatric Institute at Jackson

North

• Professor of Surgery in 3 Countries -

USA/Colombia/Brazil

• Previous President IFSO

“There is a high incidence of incisional & recurrent hernias following surgical procedure in the obese patient. As such , port site closure is a real clinical significance especially for bariatric surgery patients. We have used TroClose1200™ and found it to be very friendly to use, safe and an 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

• bese patient population.“
• Dr. Natan Zundel

Jackson North Medical Center Miami Beach, FL, USA

What Worldwide Surgeons say about TroClose1200™

• Director, Digestive Disease Center
• Chair, Department of Colorectal Surgery
• Affiliate Professor Florida Atlantic University College
• f Medicine
• Clinical Professor Florida International University

College of Medicine

“I was very impressed with the potential of TroClose1200™. It

• ffers several benefits including

reduced time in surgery for port site closure and more reliable secure port closure. The former advantage may save money and the latter advantage may translate to less port site hernias.”

• Dr. Steven Wexner

Cleveland Clinic Florida Weston, FL, USA

What Worldwide Surgeons say about TroClose1200™

• Head of the Bariatric and Metabolic

Surgery Unit

• Scientific Co-Director, IRCAD

Institute

What Worldwide Surgeons say about TroClose1200™

• Dr. Michal Vix

University Hospital of Strasbourg - IRCAD Strasbourg, France

“Gordian’s TroClose1200™ is a very effective system, easy to use and especially useful for younger surgeons, as the learning curve is very short. TroClose1200™ has significant advantages over other standard closure devices on the

• market. Indeed, there is definitely a

place for the Gordian Surgical product in the Worldwide market.”

KOLs are Excited and Want to be Involved, Several Invested in Gordian

Hien Nguyen, MD Johns Hopkins Edward H. Phillips, MD Cedars-Sinai Barry Salky, MD Mount Sinai Steve Schwaitzberg, MD Harvard Steven D. Wexner, MD Cleveland Clinic Florida Natan Zundel, MD Jackson North Medical Center

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

THANK YOU Zvi Peer, CEO zpeer@gordiansurgical.com

www.gordiansurgical.com