RA Breakthrough, V.A. Study of VNS, and Patent Battle

AABM News Roundup: September 2020

Lead Stories: September 2020

The FDA has granted breakthrough designation to SetPoint Medical’s novel bioelectronic platform to treat rheumatoid arthritis. SetPoint’s CEO, Dr. Murthy V. Simhambhatla, hailed the regulatory clearance:

“This is a significant milestone for SetPoint that will enable interactive communication with the FDA, priority regulatory review for the U.S. market, as well as support reimbursement and patient access upon FDA approval.”

For more information, see: SetPoint Medical Receives FDA Breakthrough Designation for its Novel Bioelectronic Platform, Press Release, October 6, 2020

The United States Department of Veterans Affairs is funding a study of a VNS treatment that has the potential to help Iraq and Afghanistan veterans with traumatic brain injuries and post-traumatic stress:

“The study, which plans to enroll 100 veterans, is designed to assess the clinical and physiological effects of non-invasive vagal nerve stimulation (nVNS) in patients with mild traumatic brain injury (mTBI) and Post-Traumatic Stress Disorder (PTSD).”

To learn more, read the press release: electroCore Announces Department of Veterans Affairs Sponsored Study of Non-Invasive Vagal Nerve Stimulation (nVNS) in Mild Traumatic Brain Injury (mTBI) and Post-Traumatic Stress Disorder (PTSD), Press Release, September 30, 2020

Medtronic sued Axonics at the end of 2019 for IP infringement related to four patents. In March 2020, Axonics retaliated and filed patent claims against against Medtronic. Now, the United States Patent and Trademark Office has concluded that 6 of Axonics’ claims warrant review:

“The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board has decided to move forward in reviewing claims made by sacral neuromodulation specialist Axonics against Medtronic.”

Read more about the patent dispute here: Medtronic-Axonics sacral neuromod patent battle heats up, MedTech Dive, September 24, 2020

More Bioelectronic Medicine Headlines From September

Industry News

Fourth Bioelectronic Medicine Summit Showcases Broad Innovation, press release, September 28, 2020

  • Some of the most influential international experts, researchers and scientific minds, including Alliance member Valentin Pavlov, participated in the meeting which took place virtually on September 23 and 24.
  • The theme of the Summit was “Technology Targeting Molecular Mechanisms” and hosted by the Feinstein Institutes.

Corporate News

Abbott enrolls first patient in spinal cord stimulation study, Mass Device, October 1, 2020

  • The study “will compare the SCS system to medication and other non-surgical methods by evaluating improvements in pain, physical function and emotional well-being in the patients who have not had lumbar surgery or for whom surgery is not an option.”

Electromedical Technologies Inc (OTCMKTS:EMED) Pioneers New Bioelectronic Medicine Path, BioPharma Journal, September 14, 2020

  • “Electromedical Technologies Inc. may be the most interesting player in the emerging space of bioelectronic medicine…in addition to solving chronic pain, Electromedical Technologies Inc. is developing a wider research and development framework for expanding the applications of its technology.”

Boston Scientific launches Vercise Genus DBS system in Europe, MassDevice, September 10, 2020

  • “Thalamic stimulation using the Vercise Genus DBS system is indicated for suppressing tremor that isn’t adequately controlled by medications in patients who have essential tremor or PD. All indications are in Europe, as the system is not yet available for use or sale in the U.S”

Will Tibial Neuromodulation Turn the Overactive Bladder Market on Its Head?, MD+DI, September 9, 2020

  • “BlueWind Medical has launched a pivotal trial of its Renova iStim implantable tibial neuromodulation system for the treatment of overactive bladder. The device could offer a less invasive alternative to sacral nerve stimulation, a market that Medtronic and Axonics are locked in a heated battle over.”

Stocks for the Bioelectronic Medicine Revolution (NVCR, EMED, ECOR) BioPharma Journal, September 8, 2020

  • Bioelectronic medicine is starting to gain widespread attention after years of skepticism. That skepticism is now being eroded by a growing wave of peer-reviewed research overtaking the medical establishment with evidence of its efficacy.”
  • A similar story highlighting these stocks was published in Journal Transcript on September 17, 2020.

NeuroPace raises $67M for RNS system, Mass Device, August 31, 2020

  • “The company intends to use the funds raised to accelerate commercial growth and to pursue expanded indications for its RNS system, which it touts as the world’s only closed-loop brain-responsive neurostimulation system designed to prevent seizures at their source.”
  • Also covered in MD+DI

Research News

New method to observe vagal fibers activation during vagus nerve stimulation, Tech Explorist, October 2, 2020

  • One of the drawbacks of current VNS methods is that it is used bluntly, delivering energy to the vagus without targeting specific fibers…Now, a team at the Feinstein Institutes has developed an effective alternative approach.”

Spinal cord stimulation reduces pain and motor symptoms in Parkinson’s disease patients, Science Daily, September 28, 2020

  • Researchers in the U.S. and Japan reported that SCS decreased pain and reduced motor symptoms of Parkinson’s disease, both as a singular therapy and as a ‘salvage therapy’ after DBS therapies were ineffective.
  • Also covered in Parkinson’s News Today on October 2, 2020

Rapid prototyping of soft bioelectronic implants for use as neuromuscular interfaces, Nature, September 21, 2020

  • “Neuromuscular interfaces are required to translate bioelectronic technologies for application in clinical medicine…we show that soft biocompatible materials can be rapidly printed for the on-demand prototyping of customized electrode arrays…This technology might enable personalized bioelectronics for neuroprosthetic applications.”

A roadmap for advancing neurostimulation approaches for bladder and bowel function after spinal cord injury, Nature, September 7, 2020

  • Study was an anonymous survey designed to gauge patient willingness to adopt neuromodulation interventions for bladder and bowel functions. [Paywall]



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