ClariCore System Used in Transperineal Prostate Biopsy

The overall objective of this study is to acquire ultrasound images, spectral data and
prostate tissue biopsy cores using the ClariCore System via a transperineal approach.
Ultrasound images corresponding to each needle insertion will be saved for the purpose of
further algorithm development that will provide physicians with real time tissue
classification in conjunction with location information from the ultrasound imaging.

Inclusion Criteria:

1. Males per Investigator assessment appropriate for transperineal prostate biopsy

2. Patient scheduled for transperineal prostate biopsy based on standard of care urologic
requirements to assess for tissue malignancy

3. Prostate volume > 20cc and length at least 22mm as verified by ultrasound or prostate
MRI prior to the procedure

4. Patient must be able to provide legal consent and signs an IRB (Institutional Review
Board)/EC (Ethics Committee) approved Informed Consent form to participate in the
study prior to any study mandated determinations or procedure

Exclusion Criteria:

1. Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or
transperineal prostate mapping biopsy

2. Acute painful perianal disorder (i.e. rectal abscess)

3. Symptomatic, acute prostatitis

4. Surgical absence of a rectum or the presence of a rectal fistula

5. Patient has systemic infection or evidence of any surgical site infection (superficial
or organ space), including active urinary tract infection

6. Previous prostate intervention [TURP (bipolar, monopolar, laser)] TUMT, HIFU, Cryo,
Rezum, Urolift], not including previous prostate biopsy

7. Current required use of blood thinning agents for medical comorbidity which prohibits
the cessation of use as typically required per standard of care (SOC) prior to a
medical procedure; or history of a bleeding disorder (e.g. coagulopathy)

8. Prior pelvic irradiation

9. Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha
reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)

10. Actively receiving intravesical therapy or within 6 months of treatment for bladder
cancer

11. Patient has compromised immune system

12. Active inflammatory bowel disease within the last 6 months

13. Any condition, or history of illness or surgery that, in the opinion of the
Investigator, might confound the results of the study or pose additional risks to the
patient (e.g.

significant cardiovascular conditions or allergies)

14. Patient is not likely to comply with the protocol or follow up evaluation

15. Patient is participating in a clinical trial of another investigational drug or device
that may impact participation in this clinical study