st. george medical investor presentation

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Burke Hedges Presents Delivering Solutions Through Evolution 3700 Island Blvd Unit C–208 Aventura, FL 33160 www.stgeorgemed.com [email protected]

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St. George Medical is an innovative medical device company focused on interventional cardiology products. The company has developed proprietary medical device technology that has the potential to become the first-line treatment for patients suffering from abdominal aortic aneurysms, thoracic aortic aneurysms, mitral regurgitation, and coronary artery disease. St. George Medical’s flagship product, the Titan™AAA, was specifically developed to improve outcomes for patients diagnosed with abdominal aortic aneurysms. It received European CE Mark clearance in 2014, with US clinical trials to follow. In addition to the Titan™AAA, the company has 15 minimally invasive interventional cardiology products in the pipeline. For more information, visit www.StGeorgeMed.com.

TRANSCRIPT

Page 1: St. George Medical Investor Presentation

Burke Hedges Presents

Delivering Solutions Through Evolution

3700 Island Blvd Unit C–208Aventura, FL 33160 [email protected]

Page 2: St. George Medical Investor Presentation

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The Problem

Our Mission & Approach

The Market

Our Solutions

Our Team

Financials

Our Future

Agenda

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Page 3: St. George Medical Investor Presentation

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Abdominal aortic aneurysm (AAA) rupture is the 3rd leading cause of death in men older than 60 in the United States.

75% of AAA rupture patients bleed out before reaching the hospital.

90% of AAA rupture patients bleed out before reaching the operating table.

Current treatments have a 20% failure rate. Failure can result in AAA rupture.

Many patients don’t qualify for current treatments, or are told to wait until the risk of death from rupture exceeds the risk of surgery.

Unmet Needs in the Treatment of Abdominal Aortic Aneurysms

Death from AAA Rapture Death before reaching OR Death before reaching hospital Survivors

Page 4: St. George Medical Investor Presentation

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To create a device that would solve the 20% reoperation rate associated with conventional stent-graft technology.

To develop additional minimally invasive medical products that extend quality of life.

To form a team of world-renowned medical device experts and entrepreneurs.

To lay the groundwork for sales and distribution in Europe, the US, China, and India.

Launch 15 fully developed IP products through 2017 and become a leader in the worldwide medical device market.

Our Mission

Page 5: St. George Medical Investor Presentation

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Our Three Phase Approach

Phase I

Phase II

Phase III

Phase I Develop Products and Strategic Partnerships - 3 years (2011 – 2014) Develop solutions for the 20% reoperation

rate associated with AAA repair. Forge strategic partnerships and alliances. Get the CE Mark for products in Europe.

Phase II Manufacturing and Sales - 2 Years (2014- 2016) Manufacture and sell products in Europe,

India, and China. Develop additional products. Begin clinical trials for the US market. Earn $100 million per year in sales with 20%

profits.

Phase III Exit Strategy (2017) Sell intellectual property (IP) and cash out. Go public

Page 6: St. George Medical Investor Presentation

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Market Opportunity – AAA procedures in thousands

10 million people are diagnosed with aortic aneurysm every year, but in 2012, only 2.9% of patient were treated.

This primarily due to limitations with the current technology.

Many patients are not good candidates for the procedure.

Others are asked to wait until the risk of rupture exceeds the risk of surgery.

Addressable Market

Page 7: St. George Medical Investor Presentation

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Titan AAA Parodi

Prevents migration without barbs for solid fixation, faster healing, and reduced failure rate.

Doesn’t block access to important arteries.

Sealing ring prevents leaks and failures.

Cage-free design doesn’t interfere with normal movement.

Adapts to any anatomy, so more patients will qualify for the procedure.

Provides stability and prevents failure due to kinking. • Patent Protected

Product

• Received European CE Mark Clearance

Our Solution

Page 8: St. George Medical Investor Presentation

Additional Problems in Interventional Cardiology

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Aortic disease is a silent epidemic that kills approximately 47,000 Americans every year.

Thoracic aortic aneurysm (TAA) rupture is the 13th leading cause of death in the United States.

Mitral Regurgitation (MR) is a life threatening condition that will affect 5 million people by 2030.

Coronary heart disease is the leading cause of death worldwide.

Page 9: St. George Medical Investor Presentation

The Need for Minimally Invasive Cardiovascular

Treatments

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Studies have shown that minimally invasive procedures can:• Reduce mortality rates by as much as 67%.• Shorten hospital stays by up to 76%.• Reduce pain and scarring after surgery.

St. George Medical has developed the first minimally invasive treatments for thoracic aortic aneurysms and mitral regurgitation.

Page 10: St. George Medical Investor Presentation

Our Minimally Invasive Solutions

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Thor TAA Parodi

Prevents blog clots in the artery, a problem with existing technology.

Corstent H Atlas TMV

The first minimally invasive treatment for TAA. Patent approved in the US.

The first minimally invasive alternative treatment for Mitral Regurgitation.

Page 11: St. George Medical Investor Presentation

Our Competitive Advantage

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Medtronic, Cook, Gore, Endologix, and other current market leaders use antiquated self-expanding stent technology. St. George Medical is the first to offer a balloon-expandable stent that offers the following advantages:

Current TechnologySelf Expanding

• Lack of adjustability with 13+ sizes.

• Once deployed, the stent is not adjustable.

• Low radial strength makes it prone to migration.

• Uses anchoring barbs that damage the artery

wall.

• No sealing ring.

• Fully-caged body with metal stent.

• Not suitable for difficult anatomies with short and

angled necks, so many patients don’t qualify for

the procedure.

• Prone to kinking.

Our TechnologyBalloon Expanding

• Adjustable sizing that only requires 2 sizes.

• Adjustable and accurate deployment.

• High radial strength keeps the stent in place.

• Doesn’t require barbs for anchoring.

• Sealing ring to prevent leaks.

• Cage-free body doesn’t limit normal movement.

• Suitable for difficult anatomies because of the

adjustability, secure fixation, sealing ring, and

cage-free body.

• Increased stability prevents kinking.

Page 12: St. George Medical Investor Presentation

Regulatory Strategy

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Obtain European CE Mark clearance for each product.• Done for Titan AAA in Q1 2014, Thor in 2015.

Sell and distribute approved products in Europe and emerging markets.

At the same time, complete US clinical trials and prepare for sales and distribution.

Set up manufacturing in the United States.

Page 13: St. George Medical Investor Presentation

Intellectual Property

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Our intellectual property includes 23 international and US patents with 9 additional pending patent applications.

Page 14: St. George Medical Investor Presentation

Our Founder

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Dr. George L. de GoicoecheaCEO and Founder of St. George Medical, Inc.

• Inventor and entrepreneur in the cardiovascular device industry.

• Excels at making early-stage businesses profitable.

• Pioneered work on on the pacemaker, vascular grafts for surgical bypass, and the first minimally invasive aortic aneurysm treatment.

• Previously launched 3 successful startups – Mintec sold to Boston Scientific for $72 million.

• Father of the $2 billion per year aortic stent graft market.

Page 15: St. George Medical Investor Presentation

Medical Advisory Board

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Dr. Juan Carlos Parodi – Chairman of the Board• Co-Inventor of the first endovascular stent graft to treat AAA.• Revolutionized interventional cardiology.• Holds key patents related to Titan AAA and Thor TAA.

Dr. Joseph Lamelas – Medical Board• Chief of Cardiac Surgery at Mt. Sinai Medical Center in Miami.• Performed more than 7000 open-heart procedures.• Developing Atlas TMV – the first minimally invasive treatment for MR.

Dr. Eduardo de Marchena– Medical Board• Professor of Medicine and Surgery at the University of Miami.• Four-time recipient of the Best Cardiology Attending Award.• Developing Corstent H - next generation coronary stent technology.

Dr. Claude Mialhe– Medical Board• Inventor of the Introducer System for large caliber aortic stents.• Two-time recipient of the Innovation Award in London.• Developing the Mialhe Introducer System for the Titan AAA.

Page 16: St. George Medical Investor Presentation

Management Team

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Guro Bjornstad – Vice President of Clinical Development• 20 years of experience bringing cardiovascular products to market.• Oversees clinical development for all products at St. George Medical.

Gerald North, Esq. – Antitrust Litigation and Patent Lawsuits• Experience and success in legal disputes related to AT&T, Gore, and Mintec.• Oversees patent and legal matters for St. George Medical.

Burke Hedges – Vice President of Corporate Development• 30 years of business experience with over 20 successful startups.• Oversees business development for St. George Medical.

Bernhard Neuwirth – Vice President of Sales (Europe)• Sales experience with prominent companies, including Boston Scientific and J&J.• Oversees sales for St. George Medical in the European market.

Doug Berkoff – Chief Financial Officer• 20 years of experience in financial operations management.• Oversees financial matters for St. George Medical.

Frank Avellanet – Consultant• 36 years of management experience in the medical device industry.• Oversees worldwide manufacturing for St. George Medical.

Page 17: St. George Medical Investor Presentation

Financials

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5-Year Financial Projections

Page 18: St. George Medical Investor Presentation

The Future of St. George Medical

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St. George Medical recently entered Phase II of its three stage development plan.

The company has initiated the second round of equity funding to support manufacturing and sales efforts.

With a strong IP portfolio and family of 15 medical device products, St. George Medical is positioned to become a major player in the medical device industry.

We hope you enjoyed the presentation.

If you’re interested in learning more about St. George Medical, check out: www.StGeorgeMed.com

If you’re interested in getting involved with the company in its early stages, check out:www.stgeorgemed.com/investor-contact

A member of our team will get back to your shortly.