SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study

Inclusion Criteria:

• Patients with painful metastatic malignant lesions involving bone;

• Patients, candidates to standard therapy, in which the RF ablation can be performedin combination with the Standard Therapy in accordance with the Investigator'sindications;

• Patients who have failed, not candidates or refuse Standard Therapy (chemotherapy orradiotherapy);

• Patients with metastatic tumor size compatible with the expected ablation dimensionsas reported for SPINERY devices in the IFU;

• Patients with localized pain resulting from not more than two sites of symptomaticmetastatic disease

• Patients that do not have evidence of impending fracture

• Patients with metastatic lesions targeted for treatment located in the thoracicand/or lumbar vertebral body(ies), peri-acetabulum, iliac crest, and/or sacrum - norestrictions on location of lesion;

• Patients with BPI-Report worst pain score ≥4/10 at the target treatment site withinthe past 24 hours

• Patients with Karnofsky score ≥ 40 at enrollment

• Patients willing and able to provide a signed and dated informed consent, complywith the study plan, follow up visits and phone calls

• Patients at least 18 years old at the time of informed consent

Exclusion Criteria:

• Patients implanted with heart pacemaker or other implanted electronic device

• Patients with previous mechanical bone stabilization in the vertebral body to betreated

• Use of SPINERY in vertebral body levels C1-C7

• Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the indexvertebra or bone.

• Active or incompletely treated local infection at the planned treatment site(s)and/or systemic infection.

• Planned treatment site(s) accompanied by objective evidence of secondaryradiculopathy or neurologic compromise.

• Planned treatment site(s) associated with spinal cord compression or canalcompromise requiring decompression.

• Fractures due to prostatic cancer or other osteoblastic metastases to the spine.Metastatic lesions originating in the prostate that are osteolytic or of mixedorigin are eligible for the study.

• Pregnant, breastfeeding, or plan to become pregnant during the study duration.

• Concurrent participation in another clinical study that may add additional safetyrisks and/or confound study results.

• Any condition that would interfere with the subject's ability to comply with studyinstructions or might confound the study interpretation.