SetPoint Medical announced today that it filed with the FDA for premarket approval (PMA) of its neuroimmune modulation device. The Valencia, California-based company develops the system as a potential first-of-its-kind treatment for moderate-to-severe rheumatoid arthritis (RA). Its target population are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). SetPoint designed […]
SetPoint Medical
SetPoint Medical gets FDA IDE to study neurostimulation for MS
SetPoint Medical today announced FDA Investigational Device Exemption approval to study its proprietary neuroimmune modulation platform for people with relapsing-remitting multiple sclerosis. Valencia, California–based SetPoint plans to initiate a multicenter, randomized, double-blind, sham-controlled pilot study in 2025. The plan is to enroll 60 people across the United States. “We look forward to initiating this pilot […]
SetPoint Medical has positive data from rechargable neurostim study
SetPoint Medical today announced positive results from a clinical study of its neuroimmune modulation treatment for rheumatoid arthritis (RA). RESET-RA evaluates the SetPoint system as a potential first-of-its-kind treatment for moderate-to-severe RA. Subjects are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). The study includes 242 patients across 41 […]
FDA adds SetPoint Medical and its multiple sclerosis-treating neuromod to advisory program
SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week. With […]
SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis
SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS). Breakthrough designation enables more communication and priority regulatory review with the FDA. Plus, it supports reimbursement and patient access upon approval. This isn’t the […]
SetPoint Medical raises $80M for nerve stimulation tech that treats autoimmune disease
Autoimmune disease treatment developer SetPoint Medical announced today that it raised $80 million in a preferred stock financing. Valencia, California–based SetPoint Medical develops a novel platform for treating chronic, inflammation-mediated autoimmune diseases. Its initial focus centers around a potentially less immunosuppressive option for treating rheumatoid arthritis (RA). New investors Norwest Venture Partners and Viking Global […]
Dexcom adds COO to CFO Blackford’s title | Personnel Moves, September 19, 2019
Dexcom (NSDQ:DXCM) this week added the COO role to CFO Quentin Blackford’s title. Blackford is now in charge of Dexcom’s global supply chain, manufacturing operations and expansion into new markets, the San Diego-based company said. He’s been CFO of the continuous glucose monitor maker since 2017, when he left the chief finance spot at NuVasive (NSDQ:NUVA). […]
SetPoint Medical looks to raise $20.5 million for pivotal trial
Startup SetPoint Medical has raised $15.7 million of a total $20.5 million it is seeking in a new funding round, according to a regulatory filing. The Valencia, Calif.-based company will use the money to help it prepare for a pivotal clinical trial of its implantable bioelectronic device intended to treat rheumatoid arthritis (RA), according to […]
Report: Amazon adds MGH cardiologist Majmudar | Personnel Moves – August 21, 2018
Amazon (NSDQ:AMZN) has picked up well-known cardiologist Dr. Maulik Majmudar for a new role within the company as it looks to continue its foray into healthcare, according to a recent CNBC report. The announcement was made by Majmudar himself on Twitter, according to the report, though he did not state what his specific role within the […]
SetPoint Medical touts 2-year relief from rheumatoid arthritis
Startup SetPoint Medical has demonstrated “significant, sustained improvement” over two years in a first-in-human study using bioelectronic therapy in patients with rheumatoid arthritis (RA). Seventeen subjects with moderate to severe symptoms were implanted with a vagus nerve stimulator in the European study. At three months, the therapy was shown to have significantly reduced RA symptoms […]
OptiScan taps ex-Hansen Medical chief Vance for CEO | Personnel Moves, May 23, 2018
OptiScan taps ex-Hansen Medical chief Vance for CEO OptiScan Biomedical tapped former Myoscience and Hansen Medical chief Cary Vance to be its new CEO, replacing interim head William Mince. “I am excited to join OptiScan at this pivotal point in the company’s growth. I believe that the cutting-edge OptiScanner diagnostic system provides a unique platform […]
