Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing

Inclusion Criteria:

1. Male or female ≥ 21 years of age at Screening Visit.

2. Written informed consent obtained from subject or subject's legal representative andability for subject to comply with the requirements of the study.

3. Subject is diagnosed with colorectal cancer

4. Subject is scheduled for elective open, laparoscopic or robot assisted surgeryinvolving the creation of a circular stapled anastomosis created within 10cm from theanal verge.

5. Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.

6. Female subjects in child bearing age must be using acceptable contraception methodssuch as hormonal contraception or two forms of barrier contraception. Acceptablecontraception must be used consistently from 30 days before screening until 3 yearsfollowing surgery

Exclusion Criteria: Pre-operative exclusion criteria:

1. Female subject who is pregnant, breastfeeding, or if of child bearing potential isunwilling to practice birth control until 3 years following surgery.

2. Presence of a condition or abnormality that in the opinion of the Investigator wouldcompromise the safety of the subject or the quality of the data.

3. Subject has a history of hypersensitivity to porcine derived gelatin or collagen.

4. Subject has a history of hypersensitivity to microbial Transglutaminase.

5. Subject has a known dysfibrinogenemia, hypofibrinogenemia or a fibrinogenemia, withoutpreoperative correction of fibrinogen levels.

6. Subject participating in any other study involving an investigational (unapproved)drug or device within the past 60 days.

7. Subject participating in studies involving approved drug or device will be enrolledonly following a mutual consideration of the investigator together with the Sponsor.

8. Subject with a BMI ≥50, which may interfere with access to the surgical site andincrease overall operative risk.

9. Subject with American Society of Anesthesiology (ASA) status higher than 3.

10. Avastin use within 30 days prior to surgery.

11. Subject who has undergone a prior pelvic anastomosis.

12. Subject is scheduled for another surgery during the first 6 months following surgery (not including stoma closure ,placement of port for chemotherapy or ureter stentinsertion).

13. Subject with an active abdominal or pelvic infection at the operation site.

14. Subject has been previously treated with LifeSeal™ Surgical Sealant. Intra-operative Exclusion Criteria

15. Anastomosis or procedure (TME) was performed differently from what was defined in theinclusion criteria.

16. Subject received intra-operative sealant, glue or any buttressing material other thanthe LifeSeal™ Surgical Sealant.

17. Subject has peritoneal carcinomatosis.

18. Subject requires additional unrelated anastomosis during the surgery.

19. Subject is going through another surgical procedure (other than ileostomy oradhesiolysis) during the surgery.

20. Excessive bleeding (above 500cc) identified prior to anastomosis formation with theneed for intra-operative blood transfusion.