DFINE Announces Full U.S. Commercial Release of STAR Tumor Ablation System

Procedure Offers New Hope for Patients Suffering from Painful Spinal Tumors

SAN JOSE, Calif.--(BUSINESS WIRE)--DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, today announced the full commercial U.S. launch of the STAR™ Tumor Ablation System. The announcement marks the nationwide release of the STAR System and percutaneous targeted Radiofrequency Ablation™ (t-RFA) therapy, which allows physicians to provide patients with rapid pain relief from metastatic spinal tumors in a single, minimally invasive treatment.

“We are encouraged by the support the STAR System has received from the interventional radiology and oncology communities, as they realize the meaningful benefits t-RFA offers patients who previously had very limited treatment options.”

“The full commercial launch represents a key milestone for DFINE, as it fulfills the vision of extending our technology platform with a second procedure to serve the large population of patients suffering from painful spinal metastases,” said Kevin Mosher, chief executive officer of DFINE. “We are encouraged by the support the STAR System has received from the interventional radiology and oncology communities, as they realize the meaningful benefits t-RFA offers patients who previously had very limited treatment options."

Since beginning its phased launch in March 2012, DFINE has experienced rapid adoption of the STAR System. More than 140 patients have been treated at 48 facilities throughout the U.S. The STAR System has performed to expectation, and procedures have resulted in excellent clinical outcomes.

“We have been extremely satisfied with the results we have achieved with the STAR System. Patients who were in severe pain have experienced significant pain relief and have been able to return to a better quality of life almost immediately following the procedure,” said Jerry Chang, MD, interventional radiologist, Eisenhower Medical Center. “Not only is it possible to achieve rapid pain relief with t-RFA, but it is also compatible with systemic therapies to treat the primary cancer, including both chemo and radiation therapies.”

Steve Booth recently experienced the benefits of t-RFA firsthand after learning his cancer had metastasized to his spine.

"I could not get out of bed one day. I had excruciating pain," he said.

After a week of using heavy painkillers and feeling no results, Dr. Chang presented the option of t-RFA for the palliative treatment of the spinal tumor, which was causing the extreme discomfort.

"I didn’t even feel the procedure, and afterwards the pain was gone - which was really amazing," Booth said. "Within days, I could swim and dance. I could do all the things I love. In my mind, it really was a miracle."

About Metastatic Spinal Tumors

Cancer is a major public health problem throughout world, with more than 1.6 million new diagnoses each year in the U.S. alone. Exceeded only by heart disease, cancer is the second most common cause of death in the U.S., accounting for nearly one of every four deaths.¹

A metastatic vertebral body tumor occurs when cancerous cells spread from a primary location in the body, such as the breast, lung, or prostate, and grow in the vertebrae of the spine. The spine is the third most common site for cancer cells to metastasize,² and it is estimated that 30 – 40 percent of cancer patients will likely develop metastatic spinal tumors.³ Metastatic spinal tumors can weaken or fracture the vertebrae, causing varying levels of pain and instability of the spine.

The STAR System was developed specifically for the palliative treatment of metastatic vertebral body tumors, which have historically been difficult to access and treat given the unique anatomy of the spine. t-RFA is typically an outpatient procedure and can be performed using local anesthesia through a small incision. A small steerable device is placed into the vertebra in a minimally invasive manner. The physician can target precisely where the device’s energy is delivered with the intent to heat and destroy the metastatic spinal tumor cells to alleviate pain while minimizing damage to surrounding tissues and vital structures. In most cases t-RFA provides pain relief in a single treatment.

About DFINE, Inc.

DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from vertebral pathologies through innovative, minimally invasive therapies. The company’s devices are built on an extensible radiofrequency (RF) platform that currently covers two procedural applications: 1. The treatment of vertebral compression fractures (VCFs) with the StabiliT^® Vertebral Augmentation System, and 2. The palliative treatment of metastatic vertebral body lesions with the STAR™ Tumor Ablation System. Both systems represent generational advancements in the minimally invasive treatment of vertebral pathologies. DFINE is based in San Jose, Calif. and is a privately held company. Stay connected with DFINE via Twitter (@DFINEinc) or YouTube, or call 1.866.963.3463.

Note: Bassem Georgy, M.D., et al. will present data regarding the first experience in t-RFA of malignant lesions of the spine using the STAR System at the European Society of Neuroradiology (ESNR) in Edinburgh, Scotland Sept, 19-23, 2012.

¹ SEER Cancer Statistics Review, National Cancer Institute, Noone, et al
² Medscape Reference: Victor Tse, MD, PhD; Chief Editor: Stephen A Berman, MD, PhD, MBA, et al.
³ Wong, et al., Spine 15:1-4, 1990; Ortiz Gómez JA. Int Orthop. 1995;19:309-311.

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