DFINE, Inc. Announces Prospective Clinical Trial for Breakthrough Therapy to Treat Spinal Fractures Caused by Multiple Myeloma

SAN JOSE, Calif. and TAMPA, Fla., June 6, 2011 /PRNewswire/ -- DFINE, Inc., the developer of minimally invasive radio frequency (RF) targeted therapies for the treatment of vertebral pathologies, announced today that H. Lee Moffitt Cancer Center and Research Institute will initiate the first post-market prospective clinical trial (PCT) to evaluate the efficacy of radio frequency targeted vertebral augmentation™ (RF-TVA) using the breakthrough StabiliT® Vertebral Augmentation System for the treatment of spinal fractures caused by multiple myeloma.

Multiple myeloma is cancer of the plasma cells in bone marrow.  It is the most common primary type of bone cancer and occurs in 20,000 people in the U.S. each year.  Approximately 75 percent of patients with multiple myeloma experience back pain, with more than 50 percent of those patients suffering vertebral compression fractures (VCFs). There is currently no cure for the disease, however surgical treatment is intended to decrease pain, regain function and improve quality of life.

Participants in the trial will undergo a minimally invasive procedure using the StabiliT System - the most advanced technology for the treatment of VCFs.

During the RF-TVA procedure, a small tube is placed into the fractured vertebra and a cavity is created. StabiliT® ER(2) Bone Cement fills the cavity and permeates the surrounding bone to stabilize the fracture. With StabiliT, physicians are able to navigate within the vertebral body to target the spinal fracture with greater precision and control, while also sparing the bone - two unique benefits of RF-TVA over older, conventional therapies.  The RF-TVA procedure typically takes 30-40 minutes under local anesthesia to complete. Patients report significant and lasting back pain relief, significant improvement in mobility and quality of life, and often return to daily activities soon after the procedure (1-6).

"The study will provide detailed information about the efficacy of RF-TVA for patients who suffer from the debilitating effects of multiple myeloma," said Frank D. Vrionis, M.D., M.P.H., Ph.D., chief of neurosurgery at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla. and primary investigator of the trial.  "Based on previous research, we are encouraged by patient outcomes with RF-TVA and are optimistic about the use of the technology to effectively treat spinal fractures caused by cancer."

The prospective study will involve up to 23 evaluable patients. Participants may be male or female, 21 to 85 years of age, with pathological vertebral body fracture(s) due to multiple myeloma. The study will include three months of follow-up and key measurements include: improvement in functional status, as measured by the Oswestry Disability Index (ODI); change in quality of life; change in back pain, and change in physical disability associated with back pain.

Patient enrollment began in May 2011 and is currently ongoing. To find out if you or someone you know is a candidate for the DFINE Multiple Myeloma PCT Trial please visit http://www.moffitt.org/trials and enter MCC# 16437, or contact Moffitt Cancer Center toll-free at 1-888-MOFFITT.

"This is the first prospective study dedicated to evaluating RF-TVA technology in the treatment of VCFs caused by multiple myeloma," said Kevin Mosher, chief executive officer of DFINE.  "We look forward to working with Dr. Vrionis and the team at Moffitt, who are dedicated to advancing this field of research. It is our hope that the use of RF-TVA as a treatment option will soon become a standard of care for this patient population."

About H. Lee Moffitt Cancer Center and Research Institute

Located in Tampa, Florida, Moffitt Cancer Center is an NCI (National Center Institute) Comprehensive Cancer Center – a designation that recognizes Moffitt's excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 14 affiliates in Florida, one in Georgia, one in Pennsylvania and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report  as one of "America's Best Hospitals" for cancer. Moffitt marks a very important anniversary this year – 25 years committed to one mission: to contribute to the prevention and cure of cancer. For more information, visit http://www.moffitt.org/

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. DFINE's devices are built upon an extensible radio frequency (RF) platform that presently covers two procedural applications. The first application, the StabiliT® Vertebral Augmentation System and StabiliT® ER(2) Bone Cement, harnesses the power of radio frequency energy to repair fractured vertebrae.* The company has received FDA 510(k) clearance for a second application, the STAR™ Ablation System, for the treatment of spinal tumors. The STAR system will be commercially available later this year.  DFINE is based in San Jose, Calif. and is privately held. For more information, call 1-866-963-3463 or visit www.dfineinc.com

* As with all medical treatment options, there are risks associated with the procedure. For a complete list of potential complications and to determine if you are candidate for RF-TVA, please consult a physician. Procedure results may vary from patient to patient.

REFERENCE:

1.    Radiofrequency Kyphoplasty: A Novel Approach to Minimally Invasive Treatment of Vertebral Compression Fractures. Murphy K. In The Comprehensive Treatment of the Aging Spine: Minimally Invasive and Advanced Techniques edited by Yue, J.J., Guyer, R., Johnson, J.P., Khoo, L.T., Hochschuler, H., and Hochschuler, S.H., Elsevier. Pg 248-252.

2.    Radiofrequency Kyphoplasty for the Treatment of Osteoporotic and Neoplastic Vertebral Body Fractures: Preliminary Experience and Clinical Results after 6 Months. Elgeti, F., and Gebauer, B., J Miner Stoffwechs 2011; 18 (Supplement 1).

3. Radiofrequency kyphoplasty: a new method for the treatment of osteoporotic vertebral body compression fractures - a case report. Licht, A.W. and Kramer, W., J Miner Stoffwechs 2011; 18 (Supplement 1).

4. One year observation study upon a new augmentation procedure (Radiofrequency-Kyphoplasty) in the treatment of vertebral body compression fractures. Licht, A.W. and Kramer W. Eurospine 2011.

5. Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures As a Result of Multiple Myeloma. Erdem E., Akdol S., Amole A., Fryar K., Eberle R. American Society of Spine Radiology 2011.

6. Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. Pflugmacher, R., Bornemann, R., Randau, T., and Wirtz, D.C.. GRIBOI 2011- The 21st Interdisciplinary Research Conference On Injectable  Osteoarticular Biomaterials and Bone Augmentation Procedures.

SOURCE DFINE, Inc.