SetPoint Medical

We are excited to share that we have filed our premarket approval (PMA) application to the FDA to advance the development of SetPoint System as potentially the first-of-its-kind neuroimmune modulation device for treatment of rheumatoid arthritis (RA). We're deeply grateful to all the SetPoint employees, RESET-RA study investigators and participants who have helped us get one step closer to offering this new treatment category to RA patients. #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're excited to announce late-breaking data from the RESET-RA study at the American College of Rheumatology’s #ACR24. New positive data through 24 weeks of follow-up support SetPoint System's potential as a first-of-its-kind neuroimmune modulation treatment for adults living with rheumatoid arthritis (RA). “The results from the RESET-RA study, highlighting improvements in disease severity and joint protection, underpin the continued positive clinical impact of neuroimmune modulation as a potential novel treatment for rheumatoid arthritis,” said John Tesser, MD, FACP, FACR, MACR of Arizona Arthritis & Rheumatology Associates, PC in Phoenix, AZ, and national rheumatologist principal investigator of the study. Learn more about the late-breaking data in today's press release: https://lnkd.in/eHeAMRkk #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're pleased to announce that Setpoint has received IDE approval from the FDA to study its proprietary neuroimmune modulation platform in people living with relapsing-remitting multiple sclerosis (RRMS). “We look forward to initiating this pilot study to advance SetPoint's platform in another therapeutic area,” said David Chernoff, M.D., Chief Medical Officer of SetPoint Medical. “The results from our studies in validated preclinical models of MS suggest that the SetPoint System has the potential to address the urgent unmet medical need for novel therapies that reduce demyelination and promote remyelination – providing new hope for people living with MS.” The pilot study will be initiated in 2025 and will enroll up to 60 patients across the United States. Dive into the details here: https://lnkd.in/g6ReKNkc #TheSetPointAdvantage #MultipleSclerosis #RRMS #MS #Autoimmune 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.

Excited to support Arthritis Foundation’s disease awareness and patient advocacy efforts again this year!

We are honored to be invited to present at Northwell Health’s Constellation Forum 2024, the premier innovation summit that unites health care pioneers, investors, and disruptors for a day of collaboration and insightful discussions. SetPoint’s CEO, Murthy Simhambhatla, will be sharing our vision for future of neuroimmune modulation and bioelectronic medicine. This year’s forum is on October 17 — you can register for free to virtually attend the forum and learn how game-changing innovations like our SetPoint System may potentially revolutionize the future of health care. Learn more and register here: www.constellationforum.com. #BioelectronicMedicine #TheSetPointAdvantage #RheumatoidArthritis #RA #Innovation

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: