Action Potential Venture Capital

Reimbursement News: Today the American Medical Association CPT Editorial Panel accepted new CPT Category I codes for #Barostim.   “The Category I code designation represents an important milestone for the company and is a testament to the increased adoption, safety, and effectiveness of Barostim as an important option for patients suffering from the debilitating symptoms of heart failure. We greatly appreciate the support and guidance that the Society of Vascular Surgery and American College of Cardiology provided throughout this process,” said Kevin Hykes, President and CEO of CVRx.   The codes are expected to be implemented on January 1, 2026.   Read the full press release: https://barost.im/3Agzdum

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.

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.

https://lnkd.in/g45DKpKk

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:

I want to thank my excellent panelists Sara Shnider, Martin Dieck, and Suraj Mudichintala for their candid discussion about investing in neurotech at the Neurotech Reports Neurotech Leaders Forum. Phenomenal insights and I'm looking forward to a strong 2024 in neurotech investing.