SetPoint Medical Receives FDA Breakthrough Device Designation for its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

First-of-its-kind therapeutic approach targets pathways intended to promote remyelination in people with relapsing-remitting multiple sclerosis

Investigational platform technology is also in a pivotal trial as a potential treatment for adults living with rheumatoid arthritis

SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS). Breakthrough Device Designation will enable interactive communication and priority regulatory review with the FDA, and support reimbursement and patient access upon FDA approval of SetPoint’s technology.

Nearly one million people in the United States are living with multiple sclerosis (MS), an autoimmune disorder that damages the myelin sheath, the protective layer that surrounds and insulates nerve fibers. This disrupts signals to and from the brain, causing neurodegeneration and contributes to a cascade of debilitating symptoms such as visual impairment, difficulty walking, sensory disturbance, pain, cognitive difficulty, and fatigue. There is currently no cure for MS, and while the currently approved medicines can help slow down disease progression and, in some instances, ease some of the symptoms, there are no approved treatments that work by addressing the root cause of MS – damage to the myelin sheath.

“Great strides have been made over the past decade to develop drugs that can attenuate disease activity and slow the rate of development of new lesions in MS,” said Shiv Saidha, M.B.B.Ch., Professor of Neurology at Johns Hopkins University. “However, these drugs do not completely stop the development of new lesions, nor do they promote repair (remyelination) of existing lesions and damaged tissue. There is an urgent unmet medical need for therapies that can promote protection and functional restoration of damaged axons through remyelination in patients, and SetPoint's therapeutic approach could offer new hope to people living with this chronic debilitating condition.”

The FDA launched the Breakthrough Devices Program to give healthcare providers and people living with life-threatening or irreversibly debilitating conditions timely access to medical devices that could provide more effective treatment compared to existing approved treatments. This Breakthrough Device Designation is based on evidence demonstrating that SetPoint's treatment has the potential to reduce demyelination and promote remyelination.

In 2020, the FDA also granted Breakthrough Device Designation to SetPoint's device for the treatment of rheumatoid arthritis (RA). SetPoint is currently evaluating its investigational platform technology in a pivotal human clinical trial, the RESET-RA study, to treat adults living with moderate-to-severe RA. The device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat inflammation-mediated autoimmune conditions.

“This significant milestone highlights the platform potential of SetPoint's device and therapeutic approach for the treatment of multiple chronic conditions,” said Murthy V. Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical. “As next steps, we look forward to working collaboratively with the FDA to initiate the first-of-its-kind clinical trial to investigate our device for people living with RRMS.”

SetPoint's integrated neurostimulation device is placed on the vagus nerve through a small incision on the left side of the neck during an outpatient procedure. The device is then programmed to automatically deliver therapy on a preset schedule by stimulating the vagus nerve once daily to activate the inflammatory reflex for a systemic immune-restorative effect.

About SetPoint Medical

SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. SetPoint Medical’s platform technology is designed to offer patients and providers a treatment alternative for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. For more information, visit www.setpointmedical.com.

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