SetPoint Medical

Major news: We are thrilled to announce that the RESET-RA study has successfully met its primary endpoint!  👏🎉 This morning, we announced positive topline results from this landmark clinical study highlighting that neuroimmune modulation using the SetPoint System demonstrates a clinical benefit in adults living with moderate-to-severe rheumatoid arthritis (RA). “We are thrilled with these results from the RESET-RA study as they highlight the potential of the SetPoint System for providing rheumatologists and their patients a safe and effective treatment alternative to current RA therapies,” said Murthy Simhambhatla, Ph.D., Chief Executive Officer of SetPoint Medical. “As next steps, we look forward to submitting the data for presentation at upcoming rheumatology and neurosurgical medical meetings and completing our premarket approval submission to the FDA.” Read the full announcement from today’s release: https://lnkd.in/eizkT-4t #TheSetPointAdvantage #RheumatoidArthritis #RA This communication contains information about a device not yet approved in the United States for commercial use. The Setpoint System is limited by United States law to investigational use only.

We are excited to share that SetPoint’s groundbreaking multiple sclerosis (MS) preclinical research in the gold-standard rodent EAE model was published in the prestigious PNAS journal.     This publication, led by our Vice President of Research, Yaakov Levine, and our senior scientist, Chandramohan Natarajan, MS., Ph.D, highlights that neuroimmune modulation may be a promising approach to treat MS as it not only reduces inflammation and ameliorates symptoms, but potentially also promotes myelin repair (remyelination). https://lnkd.in/gyHfAR6A

🎉 Join us at the Congress of Clinical Rheumatology West 2024 in San Diego from September 26th to 29th! 🌟 Don't miss Dr. David N. Chernoff's groundbreaking talk on Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis. This is a unique opportunity to learn about the latest advancements in RA treatment from an esteemed expert in the field. 📅 Mark your calendars and register now to elevate your practice with cutting-edge insights, network with peers, and earn CME credits. 📍 Hilton San Diego Bayfront 🔗 Register Here: https://lnkd.in/eGjnh_hh #CCRWest #Rheumatology #MedicalConference #SanDiego

We're happy to share that, following the recent Breakthrough Device Designation, Setpoint's neuroimmune modulation platform for the treatment of multiple sclerosis (MS) has now been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot! “We’re excited to be included in the TAP Pilot as the program will help streamline collaboration with the FDA - from initiating the first-of-its-kind clinical trial evaluating this approach for people living with RRMS, to accelerating access to this breakthrough therapy upon approval,” said Alexis Dineen, Vice President of Regulatory Affairs at SetPoint Medical. “Ultimately, this program highlights the FDA's commitment to spur development and widespread access of safe and effective treatment options to the people that need them most.” #TheSetPointAdvantage Learn more about this big week for Setpoint in our latest press release: https://lnkd.in/dhigu3NK

In the spirit of #MSAwarenessWeek, we are thrilled to announce that SetPoint’s neuroimmune modulation platform has received Breakthrough Device Designation from the FDA for the treatment of multiple sclerosis (MS). This designation from the FDA recognizes the potential of our therapeutic approach to meet a critical and unmet medical need: promoting remyelination in individuals living with relapsing-remitting multiple sclerosis (RRMS), which no currently approved treatment achieves. “This significant milestone highlights the platform potential of Setpoint’s device and therapeutic approach for the treatment of multiple chronic conditions,” said Murthy Simhambhatla, 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.” #TheSetPointAdvantage Learn more about this important milestone and its implications for MS treatment in the full press release:

In an insightful interview with Katie Couric, SetPoint Medical’s co-founder Dr. Kevin Tracey discusses the link between the vagus nerve and chronic inflammation, the innovative field of neuroimmune modulation, and our ongoing RESET-RA trial investigating this novel treatment option for RA patients. We look forward to reporting on the outcomes of our study and learning more about the therapeutic potential of this technology. Stay tuned!

This holiday season, we want to take a moment to extend our gratitude to all the SetPoint employees who worked so hard to make this year special. Your passion and dedication to developing this novel therapy to help RA patients is deeply inspiring! We celebrated this year’s numerous achievements with some great food and holiday cheer. Wishing each of you and your loved ones a holiday season brimming with joy, peace, and good health.

This #Thanksgiving, we want to extend our profound gratitude to all the incredible people who make the RESET-RA study possible. We deeply appreciate the dedication and hard work of our partners, investigators, and staff. And to our RA study participants, your resilience and strength are truly inspiring. You are appreciated immensely! We look forward to our continued collaboration with you as we evaluate the therapeutic potential of this technology. Wishing our entire community a warm and joyful Thanksgiving!

Congratulations to our co-founder, Dr. Kevin Tracey, on this well deserved recognition! His foundational discovery of the inflammatory reflex is the basis for SetPoint's therapeutic approach, and has the potential to improve lives of millions of people living with autoimmune diseases. #TheSetpointAdvantage

🧟♀️ 🧛♂️ #HappyHalloween2023 🧛♀️ 🧟♂️ Each year, we are amazed at the ingenuity and creativity of our team! #TheSetPointAdvantage