What's New in Interventional Pain Management? News to Know Before ASPN in Miami

Meet with SmartTRAK in Miami!

The American Society of Pain and Neuroscience (ASPN) will be holding
its 6th Annual Conference in Miami Beach from July 11-14, 2024, which
will feature the latest research, cutting-edge updates and discussion on
topics in pain and neuroscience.

SmartTRAK has put together highlights of recent news in SCS, PNS and
minimally invasive spine to catch you up on the “news to know” before
going to ASPN 2024. The following is just a small sampling of recent
news and SmartTRAK updates from around the world compiled,
reviewed and posted in real-time every day by the expert analysts
at SmartTRAK.

SmartTRAK’s Anne Staylor will be getting the scoop on what’s new at
ASPN, and will be available to meet in person at the meeting. If you or
your company have important news you’d like to share, please reach out
to Anne Staylor, SmartTRAK’s Executive Editor and VP & GM, Neuro
Therapies, at anne.staylor@smarttrak.com,

New Products:

• SPR Therapeutics' SPRINT extensa XT System with Bimodal PNS
  

  BSX was issued a US Patent, “Stimulation Modes To Adapt Customized Stimulation Parameters For Use In A Spinal Cord Stimulation System,” describing a graphical user interface to allow a pt to select a stimulation mode and predict optimal SCS parameters for personalized SCS. 12017061

•  SiLO TFX* - Aurora Spine*

   Aurora Spine Corp. announced the successful use of SiLO TFX MIS Sacroiliac Joint Fixation Device in over a dozen patients, providing a minimally invasive surgical option for SI joint pain. Aurora estimates market opportunity > $2.3B/yr in the US and expects full launch by mid-year.

•  Inceptiv SCS: Offering Options in a Closed-Loop Device
  

  David Carr, Medtronic’s (MDT) VP and GM of Pain Interventions, discusses the company’s new Inceptiv SCS, what differentiates it from other SCS devices and what it means for MDT and the SCS market in an interview with SmartTRAK. Inceptiv SCS: Offering Options in a Closed-Loop Device

Patents:

• Nevro*

  NVRO’s US Patent Application, "Selective High-Frequency Spinal Cord Modulation For Inhibiting Pain With Reduced Side Effects, And Associated Systems And Methods," was published from 1.5 KHz to ~50 KHz SCS to treat LBP with reduced side effects.20240181258

• INBRAIN Neuroelectronics

  INBRAIN Neuroelectronics’ US Patent Application “SYSTEM FOR NEUROMODULATION APPLICATIONS” was published describing implantable and non-invasive wearable sensor-driven closed-loop neuromodulation systems that allow patient monitoring for PNS, VNS, DBS and SCS therapy. 20240207618

• SPR Therapeutics

  SPR Therapeutics was granted US Patent “Systems And Methods For Treating Shoulder Pain Related To Subacromial Impingement Syndrome” re one-time, continued or periodic PNS to neurological motor points of the posterior and middle deltoid muscles to mediate shoulder pain. 11944809

Studies:

• Long Term Reductions in Opioid Medication Use After SCS
  A claims analysis using the Merative MarketScan Commercial Database on the effect of SCS on longer-term opioid and non-opioid pain med use reported during follow-up, 60% of 2,669 SCS patients either discontinued opioid use or reduced opioid daily dose by ≥ 20% from baseline. J Pain Res
  
  

• Freedom* - Curonix*
  A 21-patient study on the Freedom PNS System to treat chronic pain in the lower extremities observed 100% of patients reported more than 50% pain relief, with mean pain scores reducing from 7.29 to 2.81. Fourteen of 19 patients with long-term follow-up experienced ≥ 50% improvement in pain. Pain Physician
  

• TAK1 Alleviates Inflammatory Joint Pain in OA and Gouty Arthritis
  Preclinical study results showed that TAK1 is a critical signaling node in inflammatory joint diseases and gouty arthritis. Selective pharmacological inhibition with HS-276 significantly attenuated several aspects of the disease, including joint degeneration and pain. J Pain Res

• Prospera SCS System* - BIOTRONIK*
  Russo, MD, et al.’s 12-month interim outcomes of the BIOTRONIK-sponsored BENEFIT-03 study reported* that clinicians est that between implant and 12 mos, remote SCS device mgmt prevented 3.0 visits on avg for all patients, with up to 8-visit savings for high-need patients. INS 2024 Abstract 828

• NXTSTIM
  NXTSTIM announced results of a 550-pt real-world study with a remote pt monitoring (RPM) platform and EcoAI transcutaneous nerve and electromyographic stim reported at 18 mos, 92% of patients had pain improvement vs baseline. Of all patients, 66% had ≥ 40% improvement in VAS scores.

Clinical/Regulatory:

• PNS to Treat Postherpetic Neuralgia 
  

  A 60-pt study in China will evaluate the safety and efficacy of percutaneous PNS to treat patients with postherpetic neuralgia by comparing pain scores from patients receiving active vs placebo stimulation. The estimated study completion is June 2025. clinicaltrials.gov

• Spinal Simplicity*
  

  Spinal Simplicity announced its FDA 510(k) clearance for the Patriot-SI Posterior Implant System. This system must be used with a Liberty SI Lateral System device and implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

• Intellis* - Medtronic*
  A 115-pt MedtronicNeuro-sponsored RCT will evaluate DTM SCS plus conventional medical management (CMM) vs CMM alone to treat intractable back pain in patients without prior history of spine surgery based on VAS scores and responder rates. The study was completed in Oct 2023. clinicaltrials.gov

Markets:

• Saluda Medical*
  

  Saluda Medical announced that the Washington State Healthcare Authority’s Health Technology Assessment resulted in a new coverage determination of SCS that enables access to SCS for state employees, Medicaid recipients and patients with worker’s compensation coverage. LinkedIn

• Spinal Cord Stimulators - US Spinal Stimulators*
  For Q124, the WW Market for Spinal Cord Stimulation (SCS) was up +7.5% YoY in Q123. ABT led with a 29.4% share (including DRG), followed by MDT (26.6%), BSX (24.7%), NVRO (16.0%) and Other (3.3%) share. SmartTRAK Financial Dashboard*
  
  
• Nevro
  For Q124, the decrease in US trialing procedures was driven by softness in US trialing and physicians taking time out of their practice to attend NVRO’s SI joint fusion training (220 have been trained to date on Nevro1, one of three SI joint products). NVRO Q124 Earnings Release
  
  
• Curonix
  Curonix announced it trained 65 healthcare providers in Feb 2024 via hands-on learning and discussions on PNS to treat chronic pain. The training events took place in Nashville, TN, Miami, FL and Pittsburgh, PA. LinkedIn

 Revenues:

• Aurora Spine*

  For Q124, Aurora reported revenues of $4.0MM, +35.7% YoY, attributed to increased activity in the pain market with increased SI joint implant sales due to SiLO TFX* and continued growth in Zip* implants.

• Boston Scientific* 
  

  For Q124, BSX’ Pain franchise grew in the low double digits but declined mid-single digits organically, with continued pressure on the US SCS business. BSX Q124 Earnings Transcript on Seeking Alpha

• WW SCS Revenue in Q423/FY23
  SCS WW revenue was up +7.9% YoY in Q423 and up +7.1% sequentially. ABT led the WW market with 29.3% share (including DRG), followed by BSX (26.7%), MDT (23.7%), NVRO (17.3%) and Other (3.0%). SmartTRAK Q423/FY23 Neuromodulation Market Recap*

Other:

• Former Stimwave CEO Sentenced to Six Years in Prison
  

  Former Stimwave CEO Laura Perryman was sentenced to 6 yrs in prison after being found guilty of healthcare/wire fraud for creating and selling an inert, non-functioning component of the Stim-Q PNS System, the White Stylet “receiver,” so implanters could bill Medicare/payers $18K.

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