The Next Era in GI Surgery BioDynamixTM

AnastomosisThe Colon Ring

Clinical Training Team

PRE-CLINICAL and CLINICAL DATA

Pre-Clinical Data

Colon Ring™ vs. Stapling – Porcine

• A porcine study was conducted at Washington University in St. Louis, and included 50 pigs.

• Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.

Burst Pressure: Colon Ring™ vs. Staplers

Burst Pressure

32

151

168 167

105

192

210

96

215

112

0

25

50

75

100

125

150

175

200

225

Time "0" 2-3 Days 7-10 Days 1 Month 3 Months

POD

mmHg

Stapler CAR n=50

Colon Ring™ vs. Stapling – Porcine

• Study was conducted at Washington University in St. Louis, and included 50 pigs.

• Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.

• The circumference of the compression anastomosis grew in size by 11% compared to zero time, whereas the stapled anastomosis resulted in a 12% loss in lumen size.

Colon RingTM Preserves Natural Lumen Size

Anastomotic Index

69%

88%

90%93%

100%

87%

60%

70%

80%

90%

100%

7-10 Days 1 Month 3 Months

POD

Percent of

Maximal

Stapler CAR

Colon Ring™ vs. Stapling — Porcine

• Study was conducted at Washington University in St. Louis, and included 50 pigs.

• Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.

• The circumference of the compression anastomosis grew in size by 11% compared to zero time, whereas the stapled anastomosis resulted in a 12% loss in lumen size.

• Fewer adhesions with the compression anastomosis.

• No leaks in either type of anastomosis.

• No biochemical difference between types of anastomoses.

Clinical Data

Meta-Analysis of Human Cases

• To date more than 1050 clinical procedures were conducted.

• Clinical work is being conducted in:– The US (including Canada), – EU (Belgium, Sweden, Germany, Austria, Greece, Holland,

Italy & Turkey) – Israel– South Africa

• Over 115 Medical Centers

• Over 180 Surgeons

• Patients were 60% female, 40% male

• Average age – 62 (14 to 90)

• Overall leak rate now approximately 2%

Marketing Summary – March update

1063 procedures were recorded during 14 months of use.

USA – 525 (49%) ROW – 538 (51%)

116 Medical Centers

181 Surgeons (average 5.9 procedures per surgeon)

0

50

100

150

200

250

300525

216

81 6855 54

22 19 13 7 3

Total No. of Procedures

Demographics

Factor NMean ± SD

(range)

Age 546 62.2±13.2

(17-90)

BMI 197 28.1±6.2

(16-53)

Female60%

Male40%

Gender

I20%

II67%

III13%

ASA Status

Procedure Type

Up to 10 cm14430%

11 to 15 cm22947%

16 to 25 cm97

20%

Above 25 cm163%

Length from Anal Verge (n,%)

n=31Chemo radiated

0

100

200

300

400

500

600

Open Lap

253 272

234

304

ROW

USA

Right Extended Hemicolectomy

(End to Side)N= 83 (8%)

LeftHemicolectomy

(End to End)N= 734 (69%)

Anterior Resection(End to End)

N= 246 (23%)

Safety

• 30/973 Leaks - 3.1% (95% C.I. 1.9-4.4%)

• Right – 4; Left – 24; Low Anterior - 2

7.0%

4.0%

2.0% 2.0%

3.0%

2.0%

3.0% 3.0% 3.0%

1.4%

0%

1%

2%

3%

4%

5%

6%

7%

8%

9%

10%

0

10

20

30

40

50

60

70

80

90

100

1 to

100

(Jan-A

pr)

101 to

200

(Apr-

Jun)

201 to

300

(Jun-A

ug)

301 to

400

(Aug-

Sep

)

401 to

500

(Sep

-Oct

)

501 to

600

(Oct

-Nov

)

601 to

700

(Nov

-Dec

)

701 to

800

(Dec

-Jan)

801 to

900

(Jan-F

eb)

901 to

973

(Feb

-Mar)

Lea

kag

e R

ate (%

)

No

of P

roce

dure

s

Case No

Clinical Studies

Left-Sided Colectomy Colon Ring™ Safety Study

Purpose: Evaluation of the Colon Ring™ for the creation of end-to end colorectal anastomosis.

Number of Subjects:

30 subjectsCurrently: 35 subjects. 11 subjects with V6+18 spikes.

Patient Population:

Male or female subjects 18 years of age or older who are scheduled for laparoscopic or open sigmoid or anterior rectosigmoid resection with anastomosis > 10 cm from the anal verge with an end-to-end anastomosis.

Sites: Spectrum Health, Grand Rapids, MI PI Dr. SenagoreUniversity of California, Orange, CA PI Dr. Stamos

AE/SAE There were two device related SAE’s/AE’s at these sites.

Low Anterior Compression Anastomosis

Purpose: Evaluation of the Colon Ring™ for the creation of compression anastomosis in low anterior resections.

Number of Subjects:

15 subjects at each site, 3 months to enroll

Patient Population:

Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections.

Sites: University Hospitals of Cleveland, Cleveland, Ohio PI: Dr. DelaneyCleveland Clinic, Weston, Florida PI: Dr. Wexner

Initiation visit was scheduled for Dec 15th & Dec 16th

Phase IV Study:

• What is phase IV study?

Post marketing study is a study that is conducted after FDA approval for a product to gather additional information about a product's safety, efficacy, or optimal use.

• Prospective multi-center study of the Colon Ring for creation of circular rectal anastomosis.

• Including 20 Sites situated in Europe and the US, 300 Patients.

• Planned to start in Q’1, 2009--delayed.