BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007

Exclusion Criteria

• •Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years
• •Prior radical prostatectomy
• •Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
• •Prior radiotherapy to the pelvis, including brachytherapy
• •History of prior surgery involving the rectum or anus
• •Prior surgical procedure involving the peri-rectal and/or peri-prostatic area