FDA has granted breakthrough designations to a set of neuromodulation products, as well as to a clutch of medical devices designed to improve outcomes in cancer and cardiovascular diseases.
Neuroelectrics secured the regulatory privileges for its Starstim neuromodulation platform in the treatment of refractory focal epilepsy. The platform is designed to personalize transcranial electrical stimulation to restore and maintain brain health. In a small pilot study, patients experienced a 44% median reduction in seizure frequency. Neuroelectrics is now preparing to start a pivotal, 190-subject study of the technology.
FDA granted breakthrough device status to Neuros Medical's High-Frequency Nerve Block system for use in the management of chronic intractable pain of the lower limbs of adult amputees. The device delivers a high-frequency electrical signal to sensory nerves in the peripheral nervous system using a nerve cuff electrode and an implantable pulse generator. In doing so, Neuros is aiming to block the chronic pain signals that affect many patients who undergo a major limb amputation.
Onward received breakthrough status for its ARC-IM platform for blood pressure and trunk control in people with spinal cord injury. The FDA designation follows the publication of a Nature paper that found epidural electrical stimulation of the spinal cord can restore haemodynamic stability in people who have injured the cord. ARC-IM uses an implantable pulse generator and a lead placed near the spinal cord to deliver the stimulation.
In cancer, FDA awarded breakthrough designation to Alpha Tau Medical. The status covers the use of the alpha-radiation cancer therapy Alpha DaRT in the treatment of squamous cell carcinoma of the skin and oral cavity. Radium-224 is inserted into the tumor, where it releases alpha particles to kill cancer cells. Alpha Tau received the FDA status after running a pilot study in which 80% of lesions showed a complete response.
Ibex Medical Analytics received its breakthrough status for a platform that uses AI algorithms to help pathologists. The platform is designed to help improve the quality and turnaround times of cancer diagnosis, implement real-time quality control and boost productivity.
AI also featured in the cardiovascular designations. Sensome secured a breakthrough designation for its AI-powered stroke guidewire. The device features sensors to provide information on the composition of a clot. By providing that information, Sensome may be able to improve the success rate of procedures to remove clots.
The other cardiovascular breakthrough designation went to VoluMetrix for its NIVAHF device. NIVAHF is a noninvasive device for monitoring the venous waveform to generate a score that corresponds to a pulmonary capillary wedge pressure (PCWP). PCWP can indicate if a patient has heart failure but it is currently only obtainable by invasive catheterization.
Finally, Bonesupport and Spino Modulation received breakthrough statuses for orthopaedic devices. The Bonesupport designation covers antibiotic-eluting product Cerament G for use in trauma patients. Bonesupport received breakthrough status for the device in bone infection last year. Spino picked up its breakthrough status for a vertebral body tethering device to treat scoliosis in young adolescents. The device is designed to help correct a curvature of the spine without spine fusion.