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SEAMVAD

BUSINESS PLAN

By David Solomon

Cukierman & Co Consulting Ltd

8 2012 ________________________________________________________________________________________________________________________ This document is the company's business plan. The plan takes into account assessments, estimates and sales forecasts for the coming years prepared by the company’s management. The plan relies on background information, market data and marketing forecasts collected primarily from published information. Changes in the economic variables, as well as additional information or various economic or business-related events, could change the basis for the underlying assumptions and, accordingly, the conclusions. Presentation of a business plan does not guarantee its implementation. Consequently, there is a possibility that the present plan will not be implemented as envisioned. CUKIERMAN & CO CONSULTING Ltd assumes no responsibility for the action or consequences of user's reliance on the valuation results expressed herein.

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Table of Contents

Part I – Executive Summary.. ......................................................................................................................................................................................... 3

Overview .............................................................................................................................................................................................................................. 4

Status and Roadmap ............................................................................................................................................................................................................. 6

Management Team............................................................................................................................................................................................................... 7

Financial Highlights ............................................................................................................................................................................................................. 7

Part II – The Products ........................................................................................................................................................................................................9

END TO SIDE [E2S - MySide] Automated Vascular Anastomosis Device ..................................................................................................................... 10

Part III – The Market .......................................................................................................................................................................................................12

The Clinical Applications and Market Landscape ............................................................................................................................................................. 13

The Global Vascular Interventional Devices Market ........................................................................................................................................................ 16

Vascular Anastomosis connectors - Competitors Comparison Table................................................................................................................................ 18

The Positioning Analysis ................................................................................................................................................................................................... 19

Part IV – The Projection ..................................................................................................................................................................................................20

The Projections .................................................................................................................................................................................................................. 21

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Part I – Executive Summary

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Overview

SeamVad offers a comprehensive solution, aiming to set a new standard and revolutionizing

the approach to vessel anastomosis without changing the basic clinical technique of

anastomosis. The Company develops unique and smart connectors for blood vessel

anastomosis, aims to tackle the major drawbacks of the old traditional suture surgical

procedure and be part of the global trends of converting the most conservative surgeon from

manual suturing to suturless devices. The company solutions are in align with the

accelerating demand for minimally invasive surgical procedures and are integrated with the

upcoming surgery robotics solutions.

The Business Opportunity

About 1.5 million bypass surgeries performed for each year among them over 0.8 million

coronary artery bypass, about 0.5 million haemodialysis vascular access [VA] bypasses and

about 0.3 million Peripheral Artery Bypass. The global vascular interventional devices market

consist of devices used in both coronary and peripheral endovascular procedures was valued

at $8.7 billion in 2011 and is poised to grow at a CAGR of 7.8% to reach $12.7 billion by 2016.

The TAM for the Company solution is above $1 billion in total.

Company Name SeamVad

Foundation 2009

Field Medical Device, Vessel Anastomosis

Products MySide (peripheral, coronary)

R&D Status Sucessful Pre clinical Trial

IP 3 Pending Patents

Regulation Class IIB / 510K, Class III / 513 (f) (2)

CEO Shahar Peled

Investors Docor, Medvest UK

Location Jerusalem, Israel

“The most challenging approach is the totally laparoscopic technique. Efforts are currently being made to facilitate the technique by providing an easier and faster method of vascular anastomosis”

Antoine Bouchard-Fortier

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Vision

To find a variety of vessel anastomosis automated applications that will replace the current manual technique in open surgeries, and will establish new horizons

for Advanced Minimally Invasive Surgeries.

The SeamVad Solution

In order to overcome the most common vascular anastomosis manual suture technique today, such as a time consuming and demanding procedure, resulting in

relatively high complication, morbidity and mortality rates and in order to align with the new demand for low cost minimal invasive procedure, SeamVad is

developing seamless vascular anastomosis devices which applied externally to the vessel, retains its natural diameter and allows future transluminal procedures.

It is simple and automated procedure that requires a short learning curve and delivers consistent results. SeamVad is aiming to approach both peripheral and

coronary markets.

Key Success Factors

Market Potential: The market is driven by the increase number of vascular related diseases, mainly due to aging population, the diabetes and the obesity.

Align with the hottest trends: The growing demand for cost saving efficient minimal invasive surgery [MIS] as well as the penetration of robotic devices to

the surgery arena is filling the demand for the Company solutions witch align with those hot trend in the medical file.

Technology : The company succeed to develop very comprehensive solution setting a new standard and revolutionizing the approach to vessel

anastomosis without changing the basic clinical technique of anastomosis

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Status and Roadmap The Company filed for a patent on the device and method in 2008. It succeeded in developing its patent protected technology as well as its End to Side first

products. The preliminary proof of concept and the first preclinical trials show good efficacy and safety results. Encouraging by the results, The Company is working

on the final product version and will be ready for the first in man trials within 12 months after conducting small additional preclinical trial. According to the

company projection, the company will have the CE MARK approval in 2014.

2015 2014 2013 2012

H2 H1 H2 H1 H2 H1 H2 H1

Peripheral Artery Bypass

Proof of Concepts

Preliminary Pre Clinical trials

Product Modification

Product DF

Second Pre Clinical

First in Man

CE Clinical trials

Sales - EU

FDA Clinical Trials

Sales – US

Coronary Artery Bypass

Pre Clinical trials

First in Man

CE Clinical trials

Sales - EU

SeamVad holds 3 patents: one on national phase, second on PCT and third is provisional.

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Management Team

Shahar Peled, BSc., MBA, CEO Shahar has over 12 years of experience in the Medical Device field. He has held senior executive positions in several early stage biomed

companies

Dr. Eldad Stelman, Founder, CMO Dr. Stelman is the chief of the vascular surgery division at the Edith Wolfson medical Center. Has over 25 year experience as a surgeon. From 1975-1982 Dr. Stelman studied at the Faculté de médicine, Université Louis Pasteur, Strasbourg France. Furthermore from 1983-1991 he was a General Surgery resident at the Beilinson Medical Center, Department of General Surgery B, directed by Professor Raphael Reiss. From 1992-1994 Dr. Stelman was involved in Vascular Surgery residencies at the Beilinson Medical Center, Department of Vascular Surgery, directed by Professor Avigdor Zelikovski.

Prof. Arie Bass (MD. PhD.), SAB Prof. Arie Bass serves is the Head of the Vascular Surgery Department in Asaf-Harofe Medical Centre, and the Chairman of the Israeli

Society for Vascular Surgery. In addition he is the Chairman of the Advisory committee for Medical Technology and Human Trials, Israeli

Ministry of Health and an Associate Professor of Surgery at Tel-Aviv University.

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Financial Highlights .

The Company is seeking $3 million in new funding. This funding will enable the company finalize the clinical trials and start sell in EU

Market

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Part II – The Products

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The connector

The multi size disposal adaptors

The applicator

END TO SIDE [E2S - MySide] Automated Vascular Anastomosis Device MySide Automated Vascular Anastomosis Device includes two parts: the Connector and the Applicator.

The Connector: The connector is a "ring" shape with anchoring members. It made of Nitinle, a Bio-grade material with super elastic characters.

The connector has a special design that allows its anchoring members to spontaneously sew the vessels to be connected. Additional unique

features enable tightening of the vessels to each other to achieve sealing of the anastomosis and eliminate blood leakage. The connector is

inserted into a disposable adaptor which allows its attachment to the applicator. The image on the right illustrates a set of multi size disposable

adaptors.

The Applicator: The applicator is "Gun-Like" structured. Its narrow and slim design is perfect for advanced minimally invasive procedures as well

as for standard open surgery approach. The trigger operation enables ideal control on the procedure and its outcomes.

The MySide Features:

Mimicking the traditional manual suture.

Automated procedure.

Allows Intim-2-Intima attachment.

Enables perfect alignment.

The MySide Advantages

The procedure is reliable and consistent.

Reduces anastomosis time by 4-5 folds as compare with manual approach.

Encourages endothelial regeneration.

Allows undisturbed blood flow.

Allows future transluminal procedures.

Compatible for large, medium and small vessel's diameter sizes.

Compatible with advanced minimal invasive surgery approaches.

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Anastomosis Work Flow- "Simple six steps to anastomosis"

Step 1 Connection of the disposable connector to the applicator

Step 2 The graft that intended to be connected is inserted into the applicator

Step 3 The graft to be connected is everted over the disposable connector

Step 4 The applicator is positioned and aligned with the target vessel

Step 5 By trigger manipulation the automated suture is spontaneously executed by the anchoring members.

Step 6 Disconnection of the applicator from the connected vessel

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Part III – The Market

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The Clinical Applications and Market Landscape The vascular surgery is necessary in various cases such as a significant reduction of blood flow (caused by narrowing of the caliber of an artery) that results in pain

and functional limitation. The surgical treatment consists of the exclusion of the restricted section of the artery and the construction of a detour-bridge (bypass) in

order to restore the blood flow. The bypasses are made usually by using, as conduits, a segment of vein or prosthesis.

Three main circumstances require creation of an artificial connection or reconnection of blood vessels:

The obstruction of a major artery usually due to arteriosclerosis, a disease where deposits of fats and calcium at the vessel's wall gradually obstruct it;

The creation of direct connection between an artery and a vein for haemodialysis patients;

The tear or transection of major artery.

The anastomosis market potential for SeamVad products is constructed of three main fields:

Coronary Artery Bypass Graft [Heart attack];

Peripheral Artery Bypass and Transplantations;

Arteriovenous Fistula or Graft Bypass.

50%

31%

19%

Coronary artery bypass Peripheral artery bypass Vascular Access [VA] bypass

About 1.6 Milion bypass a year

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Coronary artery bypass graft (CABG) surgery

Coronary artery bypass grafting (CABG) is a type of surgery that improves blood flow to the heart. Surgeons use CABG to treat people who have severe coronary heart disease (CHD). According to the American Heart Association 500,000 coronary artery bypass graft (CABG) surgeries were performed in

the United States each year, making it one of the most commonly performed major operations.

CABG surgery is advised for selected groups of patients with significant narrowing and blockages of the heart arteries

(coronary artery disease). CABG surgery creates new routes around narrowed and blocked arteries, allowing sufficient

blood flow to deliver oxygen and nutrients to the heart muscle. The surgeons can bypass multiple coronary arteries

during one surgery.

Peripheral Artery Disease [PAD] procedures and trends

According to the TASC report, PAD affects more than 27 million patients in North America and Europe. These people are at high risk of arterial occlusion, and are

candidates for peripheral vascular bypass surgery. The prevalence of PAD has been evaluated in several epidemiologic studies and is in the range of 3–10%,

increasing to 15–20% in people aged over 70 years old. Patients with peripheral vascular disease can suffer from

decreased blood flow which can lead to disability and amputation, stroke or blood clots, and death.

Peripheral artery bypass surgery is a procedure to treat PAD and restore blood flow to the legs by redirecting

blood around the blocked or narrowed artery. Peripheral artery bypass surgery is similar to coronary artery

bypass surgery (CABG), a treatment for disease in the arteries that supply blood to the heart. During the surgery,

a healthy vein from another part of the body (usually the saphenous vein that runs from the ankle to the thigh) is

used to re-route blood around the diseased artery. 0

100000

200000

300000

400000

500000

600000

EU US ASIA

1 milion patients are treated for their symptoms of pain, or to save their legs each

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Arteriovenous Fistula or Graft Bypass

More than 1 in 1,000 patients in the U.S. has end-stage renal disease, and most patients who require renal-replacement

therapy undergo haemodialysis.

By the year 2020, more than 750,000 patients are expected to have end-stage renal disease, and over 500,000 will

require haemodialysis.

A vascular access process should be prepared weeks or months before the patient start dialysis. The early preparation of

the vascular access will allow easier and more efficient removal and replacement of its blood with fewer complications.

The three basic kinds of vascular access for haemodialysis are an arteriovenous (AV) fistula, an AV graft, and a venous

catheter.

Arteriovenous fistula: A surgeon creates an AV fistula by connecting an artery directly to a vein, frequently in the forearm. Connecting the artery to the vein causes more blood to flow into the vein. As a result, the vein grows larger and stronger, making repeated needle insertions for haemodialysis treatments easier. For the surgery, only a local aesthetic is needed. In most cases, the procedure can be performed on an outpatient basis.

Arteriovenous graft: Used mainly for small veins that won’t develop properly into a fistula, the patient can get a vascular access that connects an artery to a vein using a synthetic tube, or graft, implanted under the skin in its arm. The graft becomes an artificial vein that can be used repeatedly for needle placement and blood access during haemodialysis.

Venous Catheter: The catheter is placed into a large vein in the neck, chest or groin. It is used to administer medication or fluids, obtain blood tests and directly obtain cardiovascular measurements such as the central venous pressure. A hollow needle is advanced through the skin until blood is aspirated.

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The Global Vascular Interventional Devices Market The global vascular interventional devices market consist of devices used in both coronary and peripheral endovascular procedures which includes balloons,

Endovascular Aneurysm rRpair (EVAR) stent grafts, Inferior Vena Cava (IVC) filters, Intravascular ultrasound (IVUS) & angiography catheters, plaque modification

devices, hemodynamic flow alteration devices and accessory devices. This market was valued at $8.7 billion in 2011 and is poised to grow at a CAGR of 7.8% to

reach $12.7 billion by 2016. North America will be the biggest market for vascular interventional devices, followed by Europe. However, Asian countries represent

the fastest growing markets as low procedural and infrastructural costs have led to an increased drive of patients from developed regions towards Asian countries

such as India and China.

SeamVad's next generation endovascular anastomosis devises is aiming to revolutionize the intraventional market by establishing Intraluminal Bypass solution.

8,70

10,53

12,70

Global Vascular Interventional Devices Market $b

Global Vascular Interventional Devices Market

Stents Ballons Guiding Others Devices

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Major Drivers According to Research and Markets, the major driving factor for these markets would be the increasing demand for minimally invasive percutaneous endovascular

treatment. As the incidence cases of coronary and PAD continue to rise in the coming years along with increasing trends in co-morbid conditions such as obesity

and diabetes, the vascular interventional devices market for treating these diseases would show significant growth in the forecast period.

The principal advantage of minimally invasive endovascular procedures over surgery is short recovery time, short length scars, low risk of infection, bleeding, and

shorter hospital stays.

The minimally invasive surgical procedures are increasingly being used since the last decade as an alternative to vascular surgery. The coronary and PAD

market together contribute to this growth in interventional procedures. The peripheral angioplasty is expected to reach 3.3 million procedures by 2016, while

coronary angioplasty procedures are estimated to reach 4.5 million procedures by 2016.

Major Players The major players in the market include Abbott Vascular, Boston Scientific, MedtronicInc, C.R.BardInc. (U.S.), BBraunInc.(Germany), CookMedical(U.S.),

CordisCorp.(U.S.), St.JudeMedical(U.S.), TeleflexMedical(U.S.), Terumo Interventional Systems Inc.(Japan), Bayer, Edward Life sciences, and Covidien (Ireland).

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Vascular Anastomosis connectors - Competitors Comparison Table Product Company Indication Drawbacks

MySide – on PCT and

provisional phase.

End – 2 –Side anastomosis connector.

SeamVad

A private company, located in Israel, Europe and US business oriented.

Peripheral and coronary anastomosis

Externally to the vessel => intact patency

Automated => advanced minimal invasive applications

Applicable for versatile vessels diameters, allowing optimized natural blood flow through the anastomosed vessel.

ByFix – CE approved, End2-

End large-blood vessel anastomosis device (d>6mm).

HDH Medical

http://www.hdhmedical.com/ A private company, located in Israel, Europe business oriented.

Aorta-iliac / femoral bypass.

Intraluminal device => disturb vessel patency.

Not compatible for small diameter vessels.

Currently, most Aorta-iliac / femoral occlusion is treated by transcatheter (endovascular) procedure.

Optiflow – CE approved,

End-2-Side anastomosis connector for medium size diameter vessel (d=5-6mm).

Bio-connect Systems

http://www.bioconnectsystems.com/

A private company, located in the US, Europe and South America business oriented.

Large vessel E-2-S anastomosis.

Establishment of vascular access for haemodialysis.

Intraluminal device => disturb vessel patency.

Eliminate the traditional "Bio-connection" approach (Intima-2-Intima attachment and endothelial regeneration).

Practically, is not fully automated and requires manual suture to complete the procedure.

C-PORT – FDA approved,

End-2-Side anastomosis connector for small size diameter vessel (d=3-4mm).

Cardica

http://www.cardica.com/

A private company, located in the US, US business oriented. Developing several products for laparoscopic stapling and cutting devices.

Aorta-Coronary artery anastomosis.

Low patency.

Connects the "End" vessel intimae to the "Side" vessel external hence lower the potential for biological endothelial regeneration.

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The Positioning Analysis

The positioning analysis is based on two main and critical factors that show clearly that the company has a unique position in the market.

MI C

om

pat

ibili

ty

Patency

L H

H

L

My End[Seamvad]

C-PORT[Cardica]

Optiflow[Bioconnect] BYFix

[HDH]

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Part IV – The Projection

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The Projections

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