For SVG Distal embolisation No reflow High rate of restenosis

For SVGDistal embolisationNo reflowHigh rate of restenosis

For AMI / other thrombus loaded lesionsDistal embolisationNo reflow

Patients with DESLate ST due to incomplete endothelializationBleeding complications due to long term Plavix use

PCI Unmet Clinical Needs

The Evolution of Stents

Bare Metal

Drug Eluting

1st

Generation

2nd Generation

MGuard Generation3rd

While addressing the restenosis problem, today's stent technology overlooks

the adverse effects of acute embolization

• Micron Circular Knitting Technology

• Net Material: Poly Ethylene Terephthalate (PET)

• Fiber diameter: 20 μm

• Aperture size at expanded state: ~180μm X 200μm

• System profile - 1.3mm

• Net secured to the distal and proximal end of the stent

About MGuard’s Technology

About MGuard’s Technology

• The stent is wrapped with the ultra-thin polymer meshed net

• The net is designed for maximal flexibility without compromising the strength of the fiber

• The net expands seamlessly when the stent is deployed

About MGuard’s Clinical Benefits

MGuard is designed to

1. Trap thrombotic material to protect bloodstream from embolic debris

2. Reduce vessel injury and restenosis rate

3. Maintain standard procedure

Injury lowered by MGuard

About MGuard’s Clinical Benefits

MGuard Lifelong Embolic Protection

• MGuard blocks embolic showers and plaque detachment from the arterial wall, blocking debris at the source during and post procedure.

• MGuard addresses the risk of suboptimal perfusion and no-reflow in occluded lesions.

About MGuard’s Clinical Benefits

Lower arterial wall trauma

• MGuard’s net diffuses the stent pressure, creating a snow shoe effect to lower vessel trauma and injury*.

• This leads to a reduction in restenosis compared to BMS**.

About MGuard’s Clinical Benefits

Maintaining standard procedure

MGuard’s standard crossing profile and dilatationpressures make deliverability and deployment equivalent to a conventional balloon inflated stent.

MGuard Trials

• Preclinical - Coronary Porcine Study

• MGuard FIM Trial

• The GUARD Trial - Brazil Multicenter Study

• The MAGICAL Study MGuard in Acute MI Trial

• iMOS – MGuard International Registry

Animal Trials

Porcine studies by CBSET Inc. Cambridge, MA A comparison of MGuard with standard BMS

Methods9 Swine with a total of 21 stents:5 MGuard, 6 BMS (control)6 Month FU

Trial ResultsNo animal morbidity No device thrombosisLow inflammatory response (0.8 ± 0.3 on a scale of 0-3) Low Schwartz injury score (0.15 ± 0.1)Exceptionally good endothelization (4 ± 0)

Preclinical Safety Study Histology: 30 Days Post-Implantation 10X

BMS MGuard

Injury Score

Inflammation Score

Neointimal Thickness

Primary endpoint: 30 days MACE

Secondary endpoints:

Device success

Procedural success

TIMI flow post procedure

6 Months MACE

6 Months Late Lumen Loss

Participating centers:

Eberhard Grube ; Helios Heart Center, Siegburg, Germany

Karl Eugen Hauptmann ; Trier, Germany

MGuard First in Man Study

• Protocol amended to obtain long term (> 1y) results – Results expected by April 2009

FIM Clinical Results

Case Report #1 - MGuard in SVG

• 78 year old female with history of hypercholesterolemia, hypertension, smoking and diabetes.

• Coronary artery bypass surgery in 1993 and presented with progressive angina (CCS-III).

• Coronary angiography revealed subtotal occluded (99%) vein graft to the Right Coronary Artery.

• 2 MGuard stents were implanted

• Procedural success with:

• No clinical adverse events

• No CPK rise

• No no-reflow post PCI

Case Report #1 - MGuard in SVG

Pre-PCI

POSTMGuard

Case Report #2 - MGuard in SVG with IVUS

• 60 year old male• Proximal SVG (1995) lesion• 4mm lumen diameter• 80% stenosis• 4X15 MGuard stent

Baseline

No ISA;

St expansion= 98.9%

6 months

No ISA;

% St obstruction = 17%

Case Report #3 - MGuard in Acute MI

Totally Occluded LAD The Thrombus Visible

Case Report #3 - MGuard in Acute MI

Final ResultThe procedure was completed with optimal results and an absence of any angiographic complications.

Stent :

Stent material: Stainless steel 316

Stent design: Low profile

Strut thickness: 100μm, low profile stent design.

Catheter:

Rapid exchange delivery system

0.014” guide wire compatible

Guiding catheter: 6F

Nominal Pressure: 6 atm.

Rated Burst Pressure: ≤ 3.0 mm: 16 atm. ≥ 3.5 mm: 14 atm.

Radio-opaque markers: Proximal and Distal

Balloon Characteristic: Semi - compliant

Usable Catheter Length: 1420 mm ± 20 mm

MGuard Technical Data