Key Points
- IMGT (IMage Guided Therapy) recently announced that its focused ultrasound system, IMD10, has been designated as a breakthrough device.
- It is the first Korean company to earn the status for a device to treat cancer.
IMGT recently announced that its IMD10 system has been granted Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA). The proposed indications for use include for use in improving overall survival in patients with locally advanced and/or borderline resectable pancreatic cancer undergoing treatment with Irinotecan hydrochloride in combination with oxaliplatin, fluorouracil, and leucovorin.
According to the company, it is the first Korean company to achieve BDD status for a device to treat cancer.
The IMD10 system uses focused ultrasound–induced cavitation to enhance tissue penetration of anticancer drugs without causing tissue damage. The device has been tested in patients with pancreatic cancer, with results presented at the September 2024 European Society for Medical Oncology Congress. Researchers are continuing to monitor patients to track long-term survival.
The Breakthrough Devices Program was established by the FDA in 2018 to allow fast-tracking of certain novel devices. Its goal is to expedite patient access to devices that provide more effective treatment or diagnosis. Devices with BDD are granted a more rapid assessment and review process, and manufacturers work directly with the FDA through the premarket review stage of the approval process.
“This designation is the result of the FDA recognizing the innovation and therapeutic value of IMD10,” said Hak Jong Lee, MD, PhD, IMGT’s CEO and founder. “This will be an opportunity to establish ourselves as a leader in the global market as we do our best to provide more effective treatment options to patients around the world.”
Six other focused or therapeutic ultrasound companies have earned BDD for their products: HistoSonics for its EdisonTM histotripsy platform, Acoustiic for its ultrasound arrays, Carthera for its SonoCloud-9 device for glioblastoma, Cordance Medical for its NeuroAccess liquid biopsy device, EDAP TMS for its Focal One platform, and SONIRE Therapeutics for its next-generation therapy system (Suizenji) for the treatment of pancreatic cancer.