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SetPoint Medical, a medtech company based in California, is developing a neuromodulatory device that is intended to treat rheumatoid arthritis. The overlap between the nervous and immune systems is increasingly appreciated, and this technology aims to capitalize on this to create a new treatment for inflammatory disease.

The neuromodulation device is intended to be implanted on the left cervical vagus nerve in an outpatient procedure. It stimulates the nerve with electrical pulses. The idea is that this can act to calm inflammatory processes that contribute to rheumatoid arthritis, without the drawbacks of immunosuppression that can arise with classic drug treatments for the condition.

The company reports that it has recently received $145 M in financing, and is currently working on enrolling patients in the RESET-RA study, which aims to test the potential of this technology in treating rheumatoid arthritis.

Medgadget had the opportunity to speak with Dr. Murthy Simhambhatla, President and CEO at SetPoint Medical, about the company’s technology and its clinical potential.   

Conn Hastings, Medgadget: Please give us an overview of rheumatoid arthritis and how it is treated at present.

Dr. Simhambhatla, SetPoint Medical: More than 1.5 million Americans suffer from rheumatoid arthritis (RA), a condition where the body’s immune system attacks its own tissue, specifically joints, often resulting in pain, diminished function, bone erosion and joint deformity. The underlying cause of this is uncontrolled systemic inflammation.

Treatment for RA typically includes biologic drugs. There have been considerable advances in the treatment of RA over the past 20 years, with approaches focused on biologically derived immunosuppressive drugs that target specific pro-inflammatory cytokines. These treatments can however have serious adverse effects and come with “black box” warnings. Approximately, 30-40% of patients on these biologic drugs don’t adequately respond to or are intolerant of these drugs. In addition, patient compliance and treatment costs are also a challenge. There’s a significant need for new therapeutic options for patients with RA, that are less immunosuppressive and more cost-effective than current standard-of-care drugs.

Medgadget: What inspired SetPoint Medical to pursue a new type of treatment for inflammatory disease?

Dr. Simhambhatla: Current treatments for inflammatory diseases act by interfering with key aspects of the innate or adaptive immune response. This strategy can be effective in reducing damage due to inflammation but leads to immunosuppression with risks of severe infections and cancer.  

SetPoint Medical was founded with the idea of dialing down inflammation in a new way, based on the discovery of an innate neuro-immune reflex that helps the body to coordinate and control systemic inflammation. In a 2000 article, SetPoint’s co-founder, Dr. Kevin Tracey, published the finding that the vagus nerve plays an important role in how the body regulates inflammation and importantly, that electrically stimulating the vagus nerve reduces excessive immune responses and prevents tissue damage. Observing that stimulating this evolved reflex dials down inflammation by 30-70% yet doesn’t shut down the protective immunosurveillance function, it became clear that this may be a potential way to treat chronic inflammation in diseases like RA, but without the immunosuppression associated with biologics.

Since SetPoint’s founding, we have studied how best to stimulate the vagus nerve to treat chronic autoimmune disease, and we refer to this approach as “neuroimmune modulation”.

Our early preclinical and clinical research led to the development of SetPoint’s treatment platform, which is currently being evaluated in clinical trials for the treatment of RA. 

Medgadget: How do the nervous system and immune system interact? How does this create opportunities for therapeutic interventions?

Dr. Simhambhatla: The nervous system and the immune system evolved side by side and share the common language of neurotransmitters. The ability of the vagus nerve to communicate and modulate the immune system using neurotransmitters is essential to the inflammatory reflex.

The rapid onset of localized immune activity is vital to deal with an infection or injury. Also important is the coordination of a body-wide response that either recruits more resources to the fight or turns down inflammation once the immediate danger has passed. The vagus nerve innervates many of our organs and is important for this subconscious, or autonomic, coordination. The vagus nerve continuously senses what’s happening within us, including what immune cells are doing and where they are active.

The vagus nerve is not just sensory, it also relays commands to the front line. After information regarding sensed cytokines travels to the brain there is a reflexive signal that’s generated and travels down to important immunocyte-resident tissues like the spleen. The nerve releases neurotransmitters that act either directly or indirectly on immune cells through cell surface receptors that recognize those specific neurotransmitters. The affected immune cell is then reprogrammed to adopt a moderated inflammatory phenotype, through various intracellular pathways that have been well described in the literature.

This reflex is one mechanism that normally maintains immunologic homeostasis so that the body can both effectively fight off infections yet limit self-damage. By electrically stimulating the vagus nerve with our precise pulse parameters, we hope to recapitulate the typical “end of inflammation” program to coordinate the return to health in diseases characterized by chronic, damaging inflammation.

Medgadget: Beyond rheumatoid arthritis, what other inflammatory disease states could benefit from neuromodulation?

Dr. Simhambhatla: The most common chronic inflammatory diseases, like RA, all share a common feature; they are characterized by tissue damaging inflammation that does not readily resolve but instead leads to more inflammation. Our neuroimmune modulation approach is designed to break this type of vicious cycle. Other chronic inflammation-mediated diseases that may benefit from this type of treatment include Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, and multiple sclerosis.

Medgadget: Please give us an overview of your technology and how it works.

Dr. Simhambhatla: SetPoint Medical’s small, self-contained nerve stimulator generates precise electrical pulses using an integrated circuit, telemetry hardware and a rechargeable battery enclosed in a ceramic and titanium case. This device is implanted on the left cervical vagus in an outpatient procedure. Physicians determine precise, automatic dosing through an iPad application. Patients recharge the device at their convenience using a wireless charger.

Medgadget: Has the technology progressed to clinical trials or are these in the pipeline/ongoing?

Dr. Simhambhatla: We have run human feasibility studies in RA and Crohn’s disease, which showed the potential of neuroimmune modulation for the treatment of autoimmune disease. We are currently enrolling patients in our pivotal RESET-RA study to support a premarket approval (PMA) submission to the FDA. This is a multicenter, double-blind, randomized, sham-controlled, study evaluating our platform for the treatment of patients with RA, who are incomplete responders or intolerant to biologic drugs. The study will enroll up to 250 patients across various U.S. study sites.

Medgadget: Congratulations on receiving $145 M in financing recently. How does the company plan to spend this?

Dr. Simhambhatla: Thank you! We are thrilled to have the support of seasoned investors who share our passion for improving outcomes for patients with chronic medical conditions.

Proceeds from the financing will be used to complete the company’s ongoing RESET-RA trial, subsequent U.S. FDA regulatory submissions and early commercialization for the RA indication.

Here’s a link to a video introducing SetPoint Medical’s investigational implant…

Link: SetPoint Medical’s homepage…





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