Israeli device maker InSightec won FDA approval for its ExAblate MRI-guided focused ultrasound therapy with indication to treat pain resulting from bone metastases in patients who failed or aren’t good candidates for radiation therapy.
Bone metastases occur when cancer cells break off from the primary tumor site and spread to other parts of the body, commonly leaving patients with significant physical and emotional pain, according to a press release.
More than ⅔ of breast and prostate cancers that metastasize spread to the bones, according to the American Cancer Society, and 1 out of 3 of bone metastases patients either do no respond to radiation therapy or aren’t able to receive radiation treatment.
"Pain palliation by ExAblate can dramatically improve the quality of life for cancer patients with bone metastases," according to Dr. Mark Hurwitz, principal investigator for the clinical study that supported InSightec’s premarket approval application. "Results from the clinical study showed that ExAblate therapy significantly reduces pain caused by bone metastases. Patients also reported lasting improvement in well being and function, along with a decrease in the need for medication."
The ExAblate system uses therapeutic acoustic ultrasound in conjunction with continuous MRI guidance to plan and guide treatment with focused acoustic energy to destroy the nerves causing pain, according to a press release.
This marks the 2nd FDA win for the ExAblate system, which in 2004 won approval to treat uterine fibroids on a non-invasive, out-patient basis. The regulatory win makes the ExAblate system the only FDA-approved ultrasound-based therapy for treating uterine fibroids and bone metastases-related pain, according to the company.
"The recent FDA approval of ExAblate for pain palliation will offer new options for cancer patients with crippling bone pain who are seeking pain-management options and are no longer eligible for radiation treatment," InSightec president & CEO Dr. Kobi Vortman said in prepared remarks. "This is the second FDA approval for the ExAblate technology and represents a significant milestone in our quest to expand the applications for this innovative, non-invasive therapy."
The approval was based on clinical results from an international, multi-center, randomized clinical study comparing bone metastases patients who received ExAblate therapy to a placebo arm. Patients in the ExAblate arm of the study reported significant pain relief and quality of life improvement at 3 months of follow-up, according to a press release.
The ExAblate system also has CE Mark approval in the European Union for uterine fibroids, bone metastases, and adenomyosis, and 20 hospitals in Europe and Asia-Pacific already offer ExAblate therapy for painful bone metastases.
InSightec plans to conduct a post-marketing study of 70 U.S. patients with painful bone metastases, and the company will also establish a commercial registry, according to the press release.
The device maker is on a roll in the U.S. In August 2012 the FDA approved InSightec’ clinical trials of the ExAblate Neuro system in treatment of medication-resistant Parkinson’s disease.
The company plans to enroll 30 patients who suffer from tremors associated with the disease, randomizing them for treatment with ultrasound-based deep-lesioning of the brain.
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