The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)

Inclusion Criteria:

1. Subject is ≥22 years of age.

2. Subject has signed the Institutional Review Board (IRB) approved trial InformedConsent Form (ICF) prior to any trial related tests/procedures and is willing tocomply with trial procedures and required follow-up assessments.

3. Subject is diagnosed with only one (1) non-metastatic solid renal mass ≤3cmconfirmed via CT or MRI ≤30 days prior to the index procedure date.

4. Subject has had a biopsy to determine the type of tumor, ≥14 days prior to the indexprocedure.

5. Subject can tolerate general anesthesia.

6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.

7. Subject meets all the following functional criteria at ≤14 days prior to the plannedindex procedure date:

• White Blood Count (WBC) ≥3,000/mm3 (≥3 10*9/L)

• Absolute Neutrophil Count (ANC) ≥1,200/mm3 (≥1.2 10*9/L)

• Hemoglobin (Hgb) ≥9 g/dL

• Platelet count ≥100,000/mm3 (≥100 10*9/L)

8. Subject has an eGFR (Glomerular filtration rate) ≥45mL/min, ≤14 days prior to theplanned index procedure date.

9. The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.

10. Subject has an adequate acoustic window to visualize targeted tumor using theHistoSonics Edison System.

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant or nursing (lactating) during thetrial period.

2. Subject is being actively treated in another pharmaceutical or device trial ≤30 daysprior to planned index procedure date that may interfere with the primaryendpoint(s).

3. Subjects who have active cancers (not in remission for the last two years) otherthan non-melanomatous skin cancers.

4. In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s)that would cause undue risk and preclude safe use of the HistoSonics Edison System.

5. Subject is on dialysis, being considered for dialysis or has acute renal failure.

6. Subject has not recovered to Common Terminology Criteria for Adverse Events (CTCAE)grade 2 or better from any adverse effects (except alopecia and neuropathy) relatedto previous therapy.

7. Subject has an International normalized ratio (INR) >1.5 or uncorrectablecoagulopathy, (e.g., known von Willebrand disease, hemophilia, or onanticoagulants), on the planned index procedure date.

8. Subject is taking Aspirin (ASA) or NSAIDS ≤7 days prior to the planned indexprocedure date.

9. Subject has a life expectancy less than one (< 1) year.

10. In the investigator's opinion, histotripsy is not a treatment option for thesubject.

11. Subject has a concurrent condition that could jeopardize the safety of the subjector compliance with the protocol.

12. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation,embolization, radiation).

13. Subject's targeted tumor is not treatable by the HistoSonics Edison System's workingranges (refer to User Guide).

14. In the investigator's opinion, the anticipated risks of intervention outweigh thepotential benefits of the intervention.

15. Subject has bilateral kidney tumors or has a single functioning kidney.

16. Subject has a genetic predisposition to kidney cancer such as:

• Von Hippel Lindau (VHL)

• Hereditary Papillary Renal Carcinoma (HPRC)

• Birt-Hogg-Dubé Syndrome (BHD)

• Tuberous Sclerosis Complex (TSC)

• Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)

• Reed's Syndrome

• Succinate Dehydrogenase B Deficiency (SDHB)

• BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma

• MITF predisposed Renal Cell Carcinoma

17. The targeted tumor is an angiomyolipoma.

18. Subject has a known sensitivity to contrast media and cannot be adequatelypre-medicated.

19. Subject has a urinary tract infection (UTI) ≤7 days prior to the planned indexprocedure date.

20. The targeted tumor is not clearly visible with ultrasound, MRI or CT.

21. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel,ureter, organ or other vital structure.

22. The treatment of the tumor will not allow an adequate margin (as determined by theinvestigator).