MR-guided, Focused Ultrasound Therapy Company Receives US Approval to Treat Bone Pain

Physicians use the MRI to plan and guide the therapy and track treatment outcome. The focused ultrasound acoustic energy kills the nerves causing the pain from bone metastases, resulting in a fast drop in pain.

InSightec, Ltd. (Tirat Carmel, Israel) reported that it has received US Food and Drug Administration (FDA) approval for the ExAblate MRI-guided focused ultrasound for treatment of painful bone metastases in patients who are not candidates for or refuse to undergo radiation treatment.

This is the second FDA approval for ExAblate, which received FDA approval in 2004 as a noninvasive, outpatient therapy for uterine fibroids. GE Healthcare (Chalfont St. Giles, UK) is a minority shareholder of Insightec, Ltd. and is a distributor of ExAblate in many countries worldwide.

InSightec’s ExAblate system is exclusively compatible with GE Healthcare’s normal and wide-bore MRI systems, including Signa HDxt 1.5T, Signa HDxt 3.0T, Optima MR450 & 450w, and Discovery MR750 & 750w. It combines therapeutic acoustic ultrasound waves with continuous guidance and treatment monitoring by MRI.

“The FDA approval of ExAblate is an exciting next step in GE’s investment in InSightec,” said Tom Gentile, president and CEO of GE Healthcare Systems and InSightec board member. “Pain is the most common and most severe symptom for patients suffering from bone cancer; we believe that ExAblate can help significantly improve the quality of life for patients. This is the first approved oncology application of ExAblate and we are excited that InSightec will continue researching in this area to expand the applications of this product.”

Bone metastases ensue when cancer cells move from their primary site and spread to other parts of the body. According to the American Cancer Society, more than two-thirds of breast and prostate cancers that metastasize spread to the bones. This also happens in up to 30% of bladder, metastatic lung, and thyroid cancers.

Pain is the most common and severe symptom of bone metastases and is usually treated with radiation therapy. However, up to 30% of patients either do not respond to radiation therapy or are unable to undergo radiation for pain relief. The clinical study findings to support the premarket approval (PMA) approval showed that ExAblate therapy offers these patients considerably less pain and also improves patient well-being and function. Patients also reported reduced use of medications.

“The new FDA approval of ExAblate for pain palliation offers new options for cancer patients with crippling bone pain who are seeking pain-management options but are no longer eligible for radiation treatment,” said Dr. Kobi Vortman, president of InSightec. “This second approval represents a significant milestone in our quest to provide noninvasive treatment alternatives to improve patients’ quality of life and establish ExAblate MRI-guided focused ultrasound for new clinical uses.”

ExAblate is the only FDA-approved MRI-guided focused ultrasound system for treating uterine fibroids and bone metastases related pain management. It has also received European CE marking for uterine fibroids, bone metastases, and adenomyosis. ExAblate is a GE healthymagination-validated product and will be comarketed by GE Healthcare as InSightec’s distributor.

Related Links:
InSightec
GE Healthcare