Exhibit 99.1
CARDIOTECH
AMEX:CTE
Forward Looking Statement
CardioTech believes that this Release contains forward-looking statements that are subject to risks and uncertainties. Such statements are based on management’s current expectations and are subject to factors that could cause results to differ materially from the forward-looking statements. Please refer to CardioTech’s SEC filings.
CV Disease
• 60 million patients in US
• 1 million deaths yearly
• 5 million diagnosed with CHF
• A coronary event every 29 secs
• Primary cause of hospitalization in US
• 500,000 open heart surgeries (CABG + valves)
• 850,000 open heart surgeries worldwide
• Treatment: diet, lifestyle changes, drugs, angioplasty, stents, CABG
Corporate Organization
Markets: $500 million surgical disposables
$350 million OEM products
$300 million wound dressings
$1.5 billion for CABG
Strategy
• Target medical devices for late-stage cardiovascular disease.
Leverage established sales organization
Leverage manufacturing expertise
Introduce FDA approved products
1. Manufacture and distribute products for open heart surgery
2. OEM producer of state of the art disposable products
3. Clinical trials for CABG
CardioPass
Coronary Artery Bypass
4 mm ID
Picture showing heart and arteries with a typical triple coronary artery bypass.
Pre heparinized
Compliant
CT Biomaterials
• Premium biomaterials
• $50 million market
• Hydrophylic/hydrophobic PU
• Licensing/royalty streams
• Recognized world leaders (SBIR)
Cardiopass Microporosity
Picture of a cross-sectional view of a Cardiopass synthetic graft exhibiting graded microporosity.
Pulsatility/Compliance
Picture of a longitudinal sectional view of a Cardiopass synthetic graft exhibiting internal pulsatility and compliance.
36 months implant
Picture of cross sectional view of Cardiopass synthetic graft showing collagen formation within the graft |
| Picture of Cardiopass synthetic graft showing neovascularization of the graft wall |
Healing
Picture of natural coronary artery showing normal blood vessel anatomy |
| Picture of Cardiopass synthetic artery prior to implantation |
| Picture of Cardiopass synthetic artery after implantation showing tissue ingrowth |
Saphenous vein harvest
Picture of surgical team performing a saphenous vein harvest procedure.
Clinical Milestones
Graph of clinical milestones reflecting the following milestones achieved or to be achieved (all quarters refer to calendar quarters):
• Animal trials: Begin in 1st quarter 2001 and completed 1st quarter 2002
• Clinical trials: Begin in 4th quarter 2001 and estimated completion in 2005
• CE Mark: Begin in 2nd quarter 2003 and estimated completion in 2nd quarter 2004
• FDA Clearance: Estimated beginning of FDA Clearance in 3rd quarter of 2004 and completed in 4th quarter 2006
Clinical endpoints
• Primary Outcomes
• MACE
• Myocardial infarction
• Death
• Urgent or elective intervention
• Secondary Outcomes
• Patency rate
• Quality of life
• Freedom from Angina
Competitors (CABG)
• Thoratec
Aria CABG
Polyurethane (Thoralon)
2, 3 and 4 mm ID
FDA Clinical trials Phase I
• Possis
Silicone-covered PTFE
Gish Acquisition
• Accretive, synergistic
• $17 million sales; cash flow positive
• Critical mass
• Sales, manufacturing, regulatory
• CABG Manufacturing
• Products for myocardial protection
• Close: April 4, 2003
Oxygenators
Picture of typical oxygenator schematic
Oxygenator/cardioplegia
Most efficient oxygenator
Heparin coated
Picture of Gish Biomedical VISIONTM Oxygenator
Maintains heart at 2 C
Maintains body at 37 C
FINANCIAL HIGHLIGHTS
UNAUDITED
(In 000’s)
|
| 2003 |
| 2002 |
| ||
Current Assets |
| $ | 10,758 |
| $ | 4,728 |
|
Total Assets |
| 17,191 |
| 6,554 |
| ||
Working Capital |
| 6,720 |
| 3,608 |
| ||
Total Liabilities |
| 4,183 |
| 1,120 |
| ||
Stockholders’ Equity |
| 13,008 |
| 5,434 |
| ||
Investment Merits
• Established markets
• Differentiated products
• Vertically integrated
• Reimbursement-approved products
• Experienced team
• Biomedical engineers
• Production professionals
• Sales/marketing specialists
• Regulatory experts
Products for Life TM
Picture of Gish Biomedical headquarters in Rancho Santa Margarita, California
Picture of perfusionist utilizing oxygenator equipment during coronary bypass surgical procedure |
| Picture of Gish Biomedical product sampling |