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:
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
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:
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’ 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 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:
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
Clinical/Regulatory:
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 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 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
Revenues:
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.
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 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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