Image of the Sonalleve MR-HIFU system created to treat osteoid osteomas from https://profoundmedical.com/

In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 


“Osteoid Osteomas” may sound like a hipster band your Gen Z kid listens to, but in fact they are small, non-cancerous bone tumors that tend to be less than 1.5 cm in size. Definitely not cool.

While the tumors can occur in any bone in the body at any age, they are generally found in the long bones, including the femur and tibia, of children and young adults. Osteoid osteomas typically cause pain, which often escalates to severe at night. In addition to generally having a negative impact on sleep quality, the tumors can also cause muscle atrophy, swelling, and changes in bone growth.

In most cases, tumors are treated symptomatically with nonsteroidal anti-inflammatory drugs. However, if the pain is severe or the location of the tumor poses additional health risks, surgery may be recommended to resect the tumor. Surgical resection has many potential complications and does not necessarily provide a long-term solution, so since its introduction almost 30 years ago, computerized tomography (CT) guided radiofrequency ablation has been used as an alternative to surgical resection. During the radiofrequency ablation procedure, a probe is introduced into the tumor under CT guidance, and then heat is applied locally to destroy tumor cells. While the technique is less invasive and less destructive, tumor recurrence is often reported.

In 2014, it was reported that an incisionless technique, utilizing magnetic resonance imaging (MRI) to guide high-intensity ultrasound waves, destroyed a benign bone tumor in the leg of a child. Fast-forward six years, and at the end of 2020, FDA approved a Humanitarian Device Exemption (HDE) marketing application for the Sonalleve MR-HIFU. The device uses MRI-guided, high-intensity focused ultrasound to destroy osteoid osteomas in the extremities. The device can also perform real-time monitoring of the temperature change occurring inside the tumor during the sonication procedure.

The clinical results provided as part of the HDE application support the probable benefit of using the Sonalleve MR-HIFU system for the ablation of painful osteoid osteoma. Effectiveness of the MR-HIFU treatment was evaluated in a study of nine patients, and there were no reports of technical difficulties or serious adverse events. There was however, a statistically significant decrease in the patient’s pain scores within 4 weeks of treatment. After 4 weeks, eight of the nine patients no longer required any pain medication.

On their website, Profound Medical Inc. states that the Sonalleve MR-HIFU system is able “to concentrate ultrasound waves from outside the body into a target deep beneath the intact skin, thermally ablating the lesion without an incision and without affecting nearby tissue.” We think the use of the technology to treat osteoid osteoma in children and young adults is exciting, and look forward to learning about other ways the technology could be used safely and effectively to treat other diseases or conditions! I’m pretty sure ‘Osteoid Osteoma Ablation’ is a band name we can all rock out to.

Further Reading

  1. Profound Medical Inc.

  2. FDA Announcement

  3. HDE Approval Order

  4. Summary of Safety and Probable Benefit (SSPB)

  5. Humanitarian Device Exemption

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