DFINE® Announces First Patients Enrolled in the STARRT Clinical Study on Spinal Tumor Ablation with the STAR Tumor Ablation System

Prospective multi-center trial enrolling patients in USA

San Jose, Calif. January 23, 2015 — DFINE, Inc.,announced today that the first two patients have been enrolled in the STARRT Clinical Trial at Providence Sacred Heart Medical Center, Spokane WA. The multi-center trial is the first prospective study to evaluate the treatment of painful metastatic lesions with STAR Targeted Radiofrequency Ablation (t-RFA) and Radiofrequency Targeted Vertebral Augmentation (RF-TVA) prior to or following radiation therapy.

The principal investigator for the study, Jack Jennings, M.D., Ph.D., Director of Spine and Musculoskeletal Intervention at Washington University School of Medicine (St. Louis, MO), commented, “The protocol for this study is designed to clarify t-RFA as part of the treatment algorithm for metastatic spinal tumors and is the result of the collaboration of a multi-disciplinary working group on metastatic spine disease.”

DFINE will enroll 64 patients presenting with painful metastatic spinal lesions at up to 20 centers in the United States. The trial will evaluate the degree and durability of the palliative effect of t-RFA and vertebral augmentation combined therapy. Patients that have either failed or refuse further radiation therapy, or have yet to receive radiation therapy are eligible to be enrolled. Patients will be evaluated through a six month follow up period. The primary outcome is reduction of their pain. Secondary outcomes being evaluated are changes in quality of life, reduction of pain medications and the time to achieve adequate pain relief. Tumor control will also be evaluated.

“We’ve had very promising results with targeted radiofrequency ablation (t-RFA) to ablate localized metastatic spine tumors and augment the fractured vertebrae that is often associated with the disease. This procedure allows me to give patients rapid pain relief that dramatically improves their quality of life,” said Dr. Jayson Brower, the principal investigator at Providence Sacred Heart Medical Center where the first two patients were treated.

Cancer is a major public health problem throughout the world, and when cancer is not found early, it can metastasize (spread) to other parts of the body. A metastatic spinal tumor is a growth of cells (mass) in or around the vertebra of the spine. Over five million Americans are living with cancer that was diagnosed in the last five years and more than 1.67 million new cancer cases were expected to be diagnosed in the US in 2014 1 It is estimated that 30-40% of late-stage cancer patients will likely develop metastatic spinal tumors.2

“t-RFA and RF-TVA provide an innovative new treatment option for the many patients worldwide who suffer from the debilitating effects of metastatic spinal tumors,” said Greg Barrett, Chief Executive Officer of DFINE.

“As a company, we are committed to building a body of scientific evidence supporting the therapy and are excited to partner with several leading medical centers in the United States on this landmark trial.”

To learn more about the STARRT clinical trial, go to Clinical trials.gov/ study ID # NCT02225223.

STAR™ Tumor Ablation System

Indications for Use

The STAR Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Risks & Contraindications

Like all surgical procedures, radiofrequency ablation procedures using the STAR System involve risks, and some patients are not good candidates for the procedure. For detailed description of risks and contraindications, please review the product Instructions for Use.