What’s New in Neuromodulation for Spring 2022

In the market for neuromodulation, companies are developing spinal cord stimulation (SCS), deep brain stimulation (DBS) and other stimulation devices designed to treat a vast range of indications. Current and emerging devices are addressing care gaps in the treatment of chronic pain and movement disorders as well as epilepsy, Tourette syndrome, depression, pelvic floor dysfunction, peripheral artery disease, paralysis and spinal cord injuries.

Companies competing in the market for neuromodulation include Abbott*, Boston Scientific*, Medtronic*, Nevro*, Saluda Medical*, Newronika* and Axonics, just to name a few. To keep you up to speed on what’s new in neuromodulation, SmartTRAK highlights market updates covering clinical developments, patents, new research and other top news from Spring 2022.

SmartTRAK's Anne Staylor, Executive Editor, VP &GM of Neurotherapies, is in Barcelona attending the INS 15th Congress.

The following is just a small sampling of recent neuromodulation updates from around the world compiled, reviewed and posted daily by our SmartTRAK analysts.

Clinical Developments

• Medtronic*
• • Medtronic announced the first patient implanted in its “Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop SCS System” study of its investigative, closed-loop, ECAP-responsive device to treat back and limb pain. The prospective study is enrolling 90 patients across 10 centers in Australia.
  • A University of Florida-sponsored eight patient clinical trial will evaluate DBS to treat Tourette syndrome targeting two brain regions in each hemisphere of each patient and using two leads in each hemisphere connected to two Percept PC devices. Estimated study completion is Aug 2026. clinicaltrials.gov
    
    
•  Boston Scientific*
• • Boston Scientific received FDA approval of its latest image-guided programming software, Vercise Neural Navigator with STIMVIEW XT. Developed in collaboration with Brainlab*, STIMVIEW XT provides real-time visualization of lead position and simulation modeling for Parkinson’s Disease and essential tremor treatment.
    
• Nevro*
• • A Europainclinics-sponsored 15-patient, prospective, cohort study will assess use of 10kHz SCS delivered with the Senza SCS System to treat chronic pelvic pain based on changes in pain and disability compared to baseline. Estimated study completion is May 2025. clinicaltrials.gov
    
    
•  Onward Medical
• • ONWARD Medical announced the first patient enrollment in the HemON study and first-in-human use of the Company’s ARCIM implantable pulse generator, designed to use SCS to restore movement and autonomic function for patients with spinal cord injury and other mobility-impairing conditions.
    
    
• Enrollment of First Patient in US Endovascular BCI Study
• • Synchron announced the enrollment of the first patient in the COMMAND US clinical trial of the Company’s Stentrode endovascular brain-computer interface (BCI) for patients with severe paralysis at Mount Sinai Hospital in New York. COMMAND is the first trial approved by the FDA through an investigational device exemption for a BCI in the US.
    
    
•  Activity-Specific Stimulation Restores Movement in Paralysis Patients
• • A study of 3 patients in the STIMO trial used stimulation programmed for specific activities delivered via paddle leads targeting dorsal roots involved in movement, and within a single day the treatment enabled patients with complete sensorimotor paralysis to stand, walk, cycle, swim and control trunk movements. Nat Med
    
    
•  NeuroPace
• • NeuroPace announced that the first patient was treated in the RESPONSE clinical trial to evaluate use of the Company’s RNS System to treat adolescent patients with drug-resistant focal epilepsy. The procedure took place at Westchester Medical Center in New York.
    
    

 Patents

•  Newronika*
• • Newronika was issued US Patent “Method and apparatus for treating Tourette Syndrome by brain stimulation” regarding DBS devices designed to treat motor and vocal tics, as well as involuntary movements of Tourette Syndrome by adjusting stimulation based on neural activity and local field potential oscillations while patients experience symptoms. 11,318,309
    
    
• Medtronic*
• • Medtronic’s US Patent Application “Implantable Lead Location Using ECAP” was published describing a system using sensed ECAPs to determine SCS lead placement. 20220134108
  • Medtronic’s US Patent Application “Nerve Root and Dorsal Root Ganglion Stimulation from the Lateral Epidural Space” was published disclosing implantable medical devices to stimulate spinal nerve roots and the dorsal root ganglion from the lateral epidural space without placing a lead through the foramen. 20220134109
    
    
• Abbott*
• • Advanced Neuromodulation Systems’ US Patent Application “Systems and Methods for Optimized Waveform Generation” was published describing a computerized system to analyze historical patient therapy data and suggest waveform parameters for neuromodulation treatment. 20220143410
    
    
•  Boston Scientific*
• • Boston Scientific's US Patent Application “Method and Apparatus for Adjusting Parameter Update Rates in Closed-Loop Therapy Control” was published relating to closed-loop neurostimulation systems with circuitry to adjust the sensing update rate based on one or more parameters of sensed data input. 20220134111

New Research

• Proposed Mechanism for DBS in Parkinson's Disease
• • Scientists at Boston University and The Picower Institute for Learning and Memory at MIT developed a model explaining the underlying circuit dynamics involving striatal gamma and theta oscillations that if experimentally confirmed, could further optimize DBS therapy. PNAS
    
    
• SPR Therapeutics
• • Responses of a real-world cross-sectional follow-up survey of 252 peripheral nerve stimulation patients ranging three months to two years from start of Sprint PNS system use for up to 60 days to treat pain showed 50% of patients reported sustained substantial (≥ 50%) reductions in pain and/or improvement in quality of life compared to baseline. Pain Management
    
    
• SCS to Treat End-Stage Peripheral Artery Disease (PAD)
• • A 34 patient retrospective study of SCS to treat end-stage PAD reported limb salvage was reached in 88% of participants and patients had significant improvements in walking distance and pain reduction on VAS scale from baseline (median=7.5, IQR=7-8) to two-year follow-up (median=0, IQR 0-2.75), p<0.001. Clin Hemorheol Microcirc

 Other Top News

• Saluda Medical*
• • Saluda Medical announced at the 2022 International Neuromodulation Society (INS) 15th World Congress the Company’s presence will include 18 posters, nine with oral presentations and three with late-breaking data. The research highlights the AVALON and EVOKE study results, compares the closed-loop Evoke System with open-loop and high frequency SCS and presents 12-month real world outcomes.
    
    
• Axonics
• • In its Q122 earnings call, Axonics management touted the recently cleared F15 system for incontinence and urgency treatment and disclosed plans to submit a PMA supplement to the FDA for a 4th-generation rechargeable implantable neurostimulator that will need to be recharged just once every six months for one hour. The Company expects the device to be approved by year-end 2022 and to begin shipping to customers in the Q123. AXNX Q122 Earnings Transcript on Seeking Alpha
    
    
• Welcony/Magstim Appoints New CEO
• • Welcony appointed Ronnie Stolec-Campo to succeed Lothar Krinke, PhD, who stepped down as CEO according to a press release emailed to SmartTRAK. Stolec-Campo will not continue as Welcony’s CFO. Welcony is a global neurotech company with four brands including Technomed, Neurosign, Magstim EGI and Magstim. Magstim is the maker of Transcranial Magnetic Stimulation (TMS) devices for depression treatment.
    
    
• NeuroOne
• • NeuroOne management highlighted recent accelerated five-year testing of the chronic electrodes the Company is developing for stimulation and recording, noting it is at least 12 months from commercialization, but focus will be targeting the SCS market. NMTC Q122 Earnings Transcript on Seeking Alpha
    
    
• BlueWind Medical Closes $64MM Funding Round
• • BlueWind Medical announced the closing of a $64MM Series B funding round led by ConvaTec* in anticipation of potential FDA marketing clearance for BlueWind Medical’s RENOVA iStim implantable tibial neuromodulation device, currently under investigation to treat overactive bladder.