• Jessica Foley, PhD, recently gave the keynote address at the Pediatric Device Innovators Forum. .
  • Clinical, regulatory and reimbursement experts convened to discuss focused ultrasound for pediatric indications.
  • The event was hosted by the National Capital Consortium for Pediatric Device Innovation, a collaboration between Children’s National Hospital and the University of Maryland.

Key Points

  • Jessica Foley, PhD, recently gave the keynote address at the Pediatric Device Innovators Forum.
  • Clinical, regulatory, and reimbursement experts convened to discuss focused ultrasound for pediatric indications.
  • The event was hosted by the National Capital Consortium for Pediatric Device Innovation, a collaboration between Children’s National Hospital and the University of Maryland.

Pediatric Device Innovators Forum screenshot with iconOn July 22, 2021, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) held the third Pediatric Device Innovators Forum where clinical, regulatory, and reimbursement experts discussed “Focused Ultrasound for Pediatric Indications.” The Foundation’s Chief Scientific Officer, Jessica Foley, PhD, participated in a keynote fireside chat alongside Michael Anderson, MD, Senior Advisor of the US Department of Health and Human Services and Children’s National Hospital (CNH) (begins at 4:15 mark). The two discussed how focused ultrasound offers unique advantages to the pediatric patient population and conjectured ways in which the technology will impact patients in the next few years.

The rest of the program featured case studies on osteoid osteoma (begins at 16:22 mark) and diffuse intrinsic pontine glioma (DIPG) (begins at 47:48 mark) as well as a discussion of reimbursement strategies and clinical trial design for novel technologies (begins at 58:50 mark).

The NCC-PDI is a collaboration between CNH and University of Maryland Fischell Institute for Biomedical Devices. It is one of five consortia funded by the US Food and Drug Administration (FDA) to support pediatric device innovators in making medical devices available for young patients.

The field of focused ultrasound for pediatrics celebrated three milestones in the past year:

  • In September 2020, the Foundation designated Children’s National Hospital as its first pediatric Center of Excellence.
  • The FDA approved Profound Medical’s Sonalleve® focused ultrasound system to treat the first pediatric condition – osteoid osteoma – in November 2020.
  • In June 2021, Sonalleve® received the CE mark in Europe for the treatment of desmoid tumors.

The advantages of focused ultrasound over other treatment modalities are advantageous in the pediatric population. Focused ultrasound is noninvasive and thus has the potential to reduce stress and trauma from surgery. It also avoids ionizing radiation, which is especially appealing for pediatric patients. Focused ultrasound may also lead to improved efficacy by increasing targeted drug delivery of various medications to diseases – such as brain tumors, sarcomas, desmoid tumors, and bone tumors – and potentially decrease systemic side effects.

Pediatric focused ultrasound clinical trials that are ongoing or have recently completed enrollment use thermal ablation for bone metastases, benign brain tumors, and pediatric solid tumors, such as sarcomas, neuroblastomas, and Wilms’ tumors. There is also a first-in-human clinical trial ongoing at Columbia University using focused ultrasound to facilitate the delivery of chemotherapy to DIPGs. Additionally, there is a clinical trial that is exploring a different focused ultrasound mechanism of action involving drug delivery of thermosensitive doxorubicin in pediatric solid tumors that have been refractory to traditional treatment.

“In pediatric care, there are many conditions that are considered ‘rare diseases’ because the number of patients affected by them are low,” explains Dr. Foley. “It is challenging to get companies, policymakers, and others to invest time and resources into investigating innovative treatments for these conditions. The Foundation is dedicated to advancing focused ultrasound for patient care, and we believe that this technology can offer better outcomes for many of these diseases. To this end, we have in place a strong advocacy initiative to educate all stakeholders on behalf of the technology and patients.”

The next Pediatric Device Innovators Forum will be hosted by the University of California San Francisco (UCSF)-Stanford Pediatric Device Consortium. The meeting will take place September 23, 2021, and it will address “Using Real World Evidence to Accelerate Pediatric Device Development: Challenges and Future Directions.”

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