PNS 2020: What’s New in Peripheral Nerve Stimulation?

In the market for Peripheral Nerve Stimulation (PNS), companies are developing new wireless or minimally invasive technologies with novel waveforms and form factors designed to treat a wide variety of applications and unmet clinical needs, including for the treatment of intractable migraines, chronic intractable postoperative pain, suprascapular neuralgia, low back pain, tibial/ankle pain, stroke rehab, overactive bladder and tibial nerve stimulation, to name a few.

PNS Plus Rehab for Upper Extremity Deficits Post Stroke
A 9-patient study sponsored by the University of Kentucky is evaluating differences in hand/arm function in patients with severe upper extremity motor deficit after a single stroke when PNS is applied at different times in relation to motor training vs sham. The study is currently recruiting. clinicaltrials.gov

Nalu*
Nalu Medical added three senior leaders to its commercial organization: Allen Meacham, as chief business development officer; Alan Mock, as director of marketing; and Ron Kuykendall who will lead sales training. In a new role, Jon Ruais will be chief commercial and strategy officer.

PATENTS

Cala Health's Responsive PNS Device
Cala Health was issued US Patent “Systems and methods for peripheral nerve stimulation to treat tremor with detachable therapy and monitoring units” disclosing a PNS with a monitoring unit and sensors for measuring patient data and controlling stimulation in response. 10,765,856

SPRINT PNS for Refractory Axial Back Pain
A 120-patient study is assessing the effect of PNS using the SPRINT system as SOC for the treatment of refractory axial back pain (without radiculopathy) as measured by changes in pain, function, health-related quality of life and cost-effectiveness. Study completion is slated for 7/2025. clinicaltrials.gov

Nalu Stim - Nalu*

• A 250-patient, prospective, multi-center, single-arm study is evaluating the efficacy, safety, comfort and compliance of the Nalu Neurostim System for the treatment of intractable neuropathic back/leg pain. The study is recruiting and completion is expected 12/2022. clinicaltrials.gov
• Nalu Medical received 510(k) clearance 7/15/20 to expand the service life of the Nalu Neurostimulation IPG to 18 years and for a re-usable therapy disc. K201618
• Nalu Medical announced it has launched a system update that unlocks new capabilities for the Nalu Neurostimulation System, including Combination Therapies, Expanded Multi-Area, Program Scheduling and Enhanced Patient Controls. The device is FDA approved for both SCS and PNS.

SPR Therapetutics
SPR Therapeutics’ US Patent Application “SYSTEMS AND METHODS RELATED TO THE TREATMENT OF BACK PAIN” was published describing an electrical stimulation device with one or more electrodes to reduce pain and improve function long-term in persons with back pain. 20200222696

Anthem Sued for Denying PNS Coverage
Anthem illegally denied coverage for FDA-approved PNS therapy devices according to a proposed class action lawsuit filed in federal court alleging Anthem violated ERISA by saying the therapy was investigational despite evidence showing efficacy in treating chronic knee pain. Law360

ANNOUNCEMENTS

Cala Health's Improved Wrist-Worn PNS for Tremor
Cala Health’s US Patent Application “SYSTEMS AND METHODS FOR PERIPHERAL NERVE STIMULATION TO TREAT TREMOR” was published regarding a wrist/arm-worn PNS for tremor with improved algorithms to include tremor feedback, external data, predictive adaptation and long-term monitoring data. 20200179687

SPR's SPRINT PNS for Treating Post-op TKA
A 150-patient, randomized, double-blinded study is evaluating SPR Therapeutics SPRINT PNS System vs sham on post-op pain in patients who’ve had a total knee arthroplasty (TKA). The study start date is May 2020 and completion is slated for Sept 2022. clinicaltrials.gov

Cala Health
Cala Health was issued US Patent “Method for peripheral nerve stimulation” disclosing a wrist-worn PNS to treat essential tremor with an improved stimulation algorithm that incorporates tremor feedback, external data, predictive adaption and long-term monitoring. 10,549,093

CLINICAL/ REGULATORY

SPR's SPRINT PNS for Treating Post-op TKA
A 150-pt, randomized, double-blinded study is evaluating SPR Therapeutics SPRINT PNS System vs sham on post-op pain in patients who’ve had a total knee arthroplasty (TKA). The study start date is May 2020 and completion is slated for Sept 2022. clinicaltrials.gov

SPRINT PNS System for Low Back Pain
SPR Therapeutics is collaborating with the Department of Defense on a 230-patient, RCT to compare standard of care treatment to percutaneous PNS for the treatment of low back pain using the SPRINT PNS System for up to 60 days. The study starts in Feb 2020 and ends in Dec 2024. clinicaltrials.gov

Stimwave*

• Stimwave is initiating a pilot study in Q220 for a blinded RCT to evaluate StimQ PNS using subthreshold stimulation for the treatment of migraines SmartTRAK learned at NANS 2020.
  
• In 2020, Stimwave is initiating a series of 90-day studies evaluating its StimQ PNS System and subthreshold stimulation to obtain clinical data to improve reimbursement for different PNS applications, including chronic pain of the knee, shoulder, foot, low back and SI. NANS 2020

Bioness StimRouter PNS

• The biggest application for the StimRouter PNS is for tibial nerve stimulation for the treatment of foot pain Bioness CEO Todd Cushman told SmartTRAK at NANS 2020. The primary implanters are anesthesiologists, podiatrists and small bone orthopedists.
• The StimRouter PNS recently received CE mark for the treatment of OAB and fecal incontinence in Europe according to Bioness CEO Todd Cushman. NANS 2020