Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC

Inclusion Criteria:

1. Patient is 21 years of age or older.
2. Patient has signed Informed Consent Form and is willing and able to abide by the protocol.
3. Naïve or recurrent low grade (LG) NMIBC tumor
4. Recurrent patients - Single or multiple tumors
5. Naive patients - 2 tumors or above
6. No prior history of HG and/or T1 in the past 5 years.
7. No prior history of Tis
8. At least one Tumor ≥ 1 mm as evaluated visually by the investigator.
9. Largest tumor diameter ≤ 30 mm as evaluated visually by the investigator
10. Cystoscopic appearance of papillary Low grade tumor
11. No active urinary tract infection as confirmed by urine culture
12. If the patient is a female of childbearing potential , she is using two acceptable \& effective methods of contraception , until 6 months post treatment
13. If the patient is a male he should use a condom during intercourse, for at least 48 hours post each instillation
14. If the patient is a male that has a partner that is a female of childbearing potential, he should be advised to use two acceptable \& effective methods of contraception until 6 months post treatment.

Exclusion Criteria:

1. Carcinoma In Situ (CIS).
2. "High Grade" urine cytology which is conclusive for HG.
3. "High Grade" tumor results in cold cup biopsy.
4. Tumor located in prostatic urethra.
5. Previous systemic chemotherapy in the last 2 years or pelvic radiotherapy.
6. Pregnant or breastfeeding patient.
7. Previous treatment with BCG within the last 12 months.
8. The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last TURBT to current tumor recurrence.
9. Treatment with full course of intravesical chemotherapy within the 3 last months.
10. The patient has/had any bladder tumor with histology other than TCC.
11. Known contraindication or hypersensitivity to MMC or gel.
12. The patient has a known history of upper urinary tract urothelial carcinoma, or Renal Cell carcinoma or other renal cancer.
13. The patient has a known urinary retention which, according to the investigator's opinion, might lead to avoid patient receiving the treatment.
14. The patient has a bleeding disorder or a screening platelet count \<50X109/L.
15. The patient has screening hemoglobin \<10 mg/dL.
16. The patient has a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g. uncontrolled diabetes, compensated congestive heart failure (NYHA III and over), myocardial infarction within 6 months of study, unstable or uncontrolled hypertension or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion.
17. The patient participated in an investigational interventional study within the past 90 days.
18. The patient has documented sever vesico-ureteral reflux or an indwelling ureteral stent.
19. The patient has the tumor in the bladder diverticulum.
20. The patient participated in a prior TheraCoat's trial with MMC and TC-3