Together with Sunnybrook Research Institute, the Foundation recently co-hosted a workshop in Toronto to create a roadmap of studies leading to new treatments of psychiatric conditions using focused ultrasound. The group discussed the state of the technology, past studies, current challenges, and future preclinical and clinical research directions for using focused ultrasound to treat or modulate psychiatric disorders such as obsessive-compulsive disorder (OCD) and depression.
As a key component of the Foundation’s partnership with the Cancer Research Institute, we have established a grant program to jointly fund research projects that will help move the field toward new focused ultrasound and cancer immunotherapy combination treatments. This first request for proposals seeks preclinical projects relating to how different “modes” of focused ultrasound compare in terms of the immune response generated, and how this immune response correlates with biological, acoustic, and imaging metrics.
In conjunction with National Pet Cancer Awareness Month, the Foundation recently announced its veterinary program to study the use of focused ultrasound for the treatment of animals. The initiative could ultimately enable veterinarians to offer state-of-the-art therapies, while collecting data necessary to accelerate the technology for human applications. The program’s first study at the Virginia-Maryland College of Veterinary Medicine will use focused ultrasound to treat soft tissue tumors in dogs.
In January, bestselling author and Foundation Board member John Grisham will join Foundation Chairman Neal F. Kassell, MD, at CES 2018 (Consumer Electronics Show)®. The pair will discuss The TumorwithGary Shapiro, the president and CEO of the Consumer Technology Association. Called “The Global Stage for Innovation,” CES convenes 170,000 industry professionals and features more than 4,000 exhibits.
The latest post examines recent activities by the FDA and others to promote the inclusion of patient input into regulatory decisions and clinical trial design. Could this new patient-centered approach be beneficial for non-invasive treatment options like focused ultrasound?
Just 10 weeks after Kimberly Spletter underwent focused ultrasound treatment for the dyskinesia – or involuntary movements and shaking – associated with her Parkinson’s disease, she bravely shared her experience at TEDx Charlottesville. She recalled going from a wheelchair to running a 5K race in just a few short weeks. Since then, more than 55,000 people have watched Kimberly’s inspiring talk. Now, two years later, Kimberly talks about that experience and her life today.
Researchers have achieved two milestones in clinical studies testing focused ultrasound to reduce either the tremors or dyskinesia associated with Parkinson’s disease.
Tremor: Preliminary Pilot Study Results Published Investigators have published encouraging preliminary results from a pilot study using focused ultrasound to treat patients with tremor-dominant Parkinson’s disease in JAMA Neurology. READ MORE >
Focused ultrasound was FDA approved to treat essential tremor in July 2016. To improve the procedure, treatment teams are evaluating the effectiveness of current techniques and studying new methods for choosing, targeting, and confirming ablation sites. Meanwhile, researchers in Italy explore how often focused ultrasound can be safely and effectively repeated for glaucoma. Also, Seattle-based Kona Medical’s phase II, randomized, sham-controlled clinical trial for hypertension failed to find effective parameters.
To test the feasibility of using focused ultrasound to provide targeted delivery of doxorubicin to liver tumors, Constantin C. Coussios, PhD, and researchers at the University of Oxford and Oxford University Hospitals have designed a clinical trial using focused ultrasound hyperthermia to trigger release of the encapsulated chemotherapy agent. Patients will receive a cycle of ThermoDox followed by ultrasound-mediated hyperthermia, in hopes of increasing the medication’s concentration in the tumor. Patients are currently being enrolled.
Insightec’s Exablate Neuro was named Best Medical Technology at the 2017 Prix Galien USA Awards. The Galien Foundation annually honors outstanding biomedical and technology products designed to improve human condition. Products had to have earned FDA approval within the last five years before being judged by the selection committee, which included four Nobel Laureates. In 2016, another focused ultrasound device, EDAP’s Focal One, received the Prix Galien.
French company Eye Tech Care recently received approval from the China Food and Drug Administration to market its EyeOP1 glaucoma treatment there. Having treated more than 5,000 patients, the focused ultrasound system is the first non-invasive device approved to treat the more than 22 million people affected by glaucoma in China, where it is the second most common cause of blindness.
Profound Medical’s TULSA-PRO device is now being investigated to treat benign prostatic hyperplasia (BPH) in Germany. The technology combines MR imaging with directional (inside-out) and focused (outside-in) ultrasound technology, and could offer a significant improvement over traditional BPH treatments. The Canadian company’s device already has the CE Mark, and a clinical trial is underway, which if successful, is expected to support its application for FDA approval.
December 26 is the deadline for submitting public comments on the FDA’s recently published draft guidance on Breakthrough Devices. The draft guidance document describes the policies the agency intends to use to implement the Breakthrough Devices Program, a part of the 21st Century Cures Act that expands the Expedited Access Pathways (EAP) program by making future 510(k) applications eligible along with Premarket Approval applications and De Novo device submissions. All participants previously granted EAP designation will have designation as Breakthrough Devices.