What’s New in Neuromodulation? News to Know Before NANS 2024

The North American Neuromodulation Society (NANS) is celebrating its 30^th anniversary in 2024 and is once again bringing together the leading clinicians, researchers and manufacturers to Caesar’s Palace in Las Vegas for the NANS 2024 Annual Meeting, to be held January 18-21. To get you up to speed before the meeting, SmartTRAK has put together highlights of recent neuromodulation news. The following is just a small sampling of recent Neuromodulation-related news and updates from around the world compiled, reviewed and posted in real-time every day by the expert analysts at SmartTRAK.

SmartTRAK will be attending NANS 2024 from January 18-21. If you'd like to meet with us in person, please reach out to Anne Staylor, SmartTRAK’s Executive Editor and VP & GM, Neuro Therapies, at anne.staylor@smarttrak.com, or just click the button below.
Market Updates

• YTD, factors that appear to be contributing to US SCS Market Growth in 2023 include new products/players, expanded indications and advances in technologies (ECAPs, remote programming/monitoring). In Q323, performance varied by company. SmartTRAK Q323 Neuromodulation Market Recap
• Canaccord recently downgraded NVRO’s rating to HOLD noting the core SCS mkt did not recover as expected, PDN did not ramp fast enough to offset weaker SCS and new competitors (BIOTRONIK and Saluda) will likely take a disproportionate share from current NVRO users.
•  BIOTRONIK announced that a panel of SCS experts developed best clinical practices for the integration of remote device management into SCS patient care, including remote monitoring and remote programming. The recommendations were recently published in Neuromodulation.
• An article on trends in SCS utilization published in Reg Anesth Pain Med reported the SCS mkt is predicted to grow from $2.41B in 2020 to $4.12B US dollars globally by 2027.
• Nalu Medical announced the closing of a $65MM equity financing round led by a new investor, Novo Holdings. The proceeds will be used to accelerate commercial growth, expand clinical and health-economic evidence, continue product development and scale operations.
• INBRAIN Neuroelectronics announced it secured a  ~$21.6MM (€20MM) loan from the European Investment Bank (EIB) to advance the clinical development of its neurology R&D programs. LinkedIn

Revenues

• For Q323, ABT reported US Neuromodulation sales of $188MM, up +20.9% (as reported and organic) and International Neuromodulation sales of $39MM, up +7.4% as reported (+9.9% organic). ABT Q323 Earnings Release
• In Q2FY24, MDT SCS saw LSD growth, with HSD growth in the US, driven by increasing trialing and implanting rates of the Intellis platform with DTM. The 1^st European implants of Inceptiv SCS were also completed in the quarter.  MDT Q2FY24 Earnings Presentation
• For Q323, BSX reported US Neuromodulation revenue of $175MM, up +1.1% as reported vs $173MM in Q322. International revenue was $55MM, up +13.1% as reported (+11.1% operational) vs $48MM in Q322. BSX Q323 Earnings Presentation

 Patents

• MDT was issued US Patent “Dorsal Spinal Column Characterization With Evoked Potentials” describing what seems to be closed-loop SCS devices with processors to classify sensed ECAPs vs baseline ECAPS and adjust therapy parameters. 11839755
• The FDA approved MDT’s PMA supplement for its InterStim Therapy System for labeling to add MRI eligibility (full-body scans at 1.5T, 3T) criteria for lead fragments from explants and (head-only scans at 1.5T) criteria for non-functional MDT primary cell neurostimulators.
• Advanced Neuromodulation Systems’ US Patent Application “COMBINATION OF TONIC AND BURST STIMULATIONS TO TREAT NEUROLOGICAL DISORDERS” was published re combination of tonic and burst stim for tinnitus treatment, brain or spinal stim, PNS or brain stem stimulation. 20230414944
• SceneRay’s US Patent Application “Pathway Planning Apparatus, Surgical System, And Computer-readable Storage Medium” was published re surgical planning for the anterior limb of the internal capsule and nucleus accumbens stimulation to treat addiction, depression and OCD. 20230414286
• Axonics was granted US Patent “Trainer For A Neurostimulator Programmer And Associated Methods Of Use With A Neurostimulation System” disclosing a clinician training device to simulate a neurostimulator programming session or lead placement with an interactive interface. 11848090
• Epic Neuro’s US Patent Application “BRAIN STIMULATION DEVICE WITH TARGETED INJECTABLE DRUG DELIVERY,” was published re an IMD for brain stimulation and drug delivery in which the targeted stimulation increases the permeability of the blood-brain barrier. 20230390554

 Regulatory

• MDT announced it received CE Mark for its Percept RC neurostimulator for DBS. According to the Company, it is the smallest and thinnest device on the mkt, and the only rechargeable DBS system with BrainSense sensing technology to be launched in the EU.
• The FDA approved BSX’s PMA supplement for its WaveWriter Alpha SCS System for a minor labeling update to allow MR conditionality for the Precision SCS S8 and M8 adapters.
• The FDA approved MDT’s PMA supplement for its InterStim Therapy System for labeling to add MRI eligibility (full-body scans at 1.5T, 3T) criteria for lead fragments from explants and (head-only scans at 1.5T) criteria for non-functional MDT primary cell neurostimulators.
• The FDA approved ABT’s PMA supplement for its Proclaim DRG IPG for expanded 1.5T MR conditional labeling for full-body scanning using integrated whole-body RF coils with any receive coil for the Proclaim DRG IPG (Model 3664) implanted with the DRG 50 cm leads and certain accessories.
• The FDA approved Saluda Medical’s PMA supplement for its Evoke SCS System for extending the labeled shelf life of the CAP12X Lead Extension Kit, Tunneller and Epidural Needle 6.5” from 1 to 2 years and removal of the labeling disclaimer regarding biocompatibility uncertainty.

 Clinical Trials

• SPR Therapeutics announced it has completed enrollment for the RESET Clinical Trial of SPRINT PNS to treat cLBP. The multicenter RCT is comparing percutaneous PNS with standard interventional treatments for cLBP.
• A 20-patient pilot clinical trial showed that non-invasive active thoracic anodal transcutaneous spinal direct current stimulation (tsDCS) resulted in a statistically significant greater decrease in symptom severity in major depressive disorder patients vs sham treat. Mol Psychiatry
• NeuroPace announced early completion of patient enrollment in its NAUTILUS pivotal study to evaluate neuromodulation therapy in idiopathic generalized epilepsy (IGE). According to the Company, if successful, RNS could secure the first device-based indication for generalized epilepsy.
• An 80-patient clinical trial in China will use EEG-functional near-infrared spectroscopy (EEG-fNIRS) to assess the effect of STN DBS with devices from MDT, PINS Medical and SceneRay on executive function in PD patients at baseline and 1-, 6- and 12-mo post-op f/up. clinicaltrials.gov 
• Neuralace Medical announced the Safety and Efficacy of Axon Therapy Study (SEAT) of its magnetic PNS has reached the 180-day f/up, showing a 65.2% responder rate with a 55% avg reduction in pain. Dr. Leo Kapural will present the results at the upcoming NANS meeting in Jan.
• A 10-patient study will utilize the Neuromodulation eXperiment Testbed system (NEXT) with a novel 16-contact directional lead (Argyle) to stimulate and record neural activity and attempt to inform directional DBS for PD. Est study start is Jan 2024. clinicaltrials.gov