For millions suffering from chronic pain, relief often comes with a host of complications. But a new generation of spinal cord stimulators aims to change that.

BackStop Neural is developing thin, softening epidural leads for chronic arm and neck pain and won a two-year, $485k Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support continued development.

A softer touch for spinal cord stimulation

Founded in 2018, BackStop Neural specializes in spinal cord stimulation systems. The company’s recent NIH funding will back the development of stimulators that use tiny electrodes to interrupt pain signals before they hit the brain. The company’s website describes them as “stable, high charge-injection capacity titanium nitride electrodes.”

One novel element in the design is the lead, the component that delivers the electrical stimulation. The company said its paddle-type epidural stimulation lead is 10 times thinner than commercially available products.

“This lead is made with a proprietary polymer that is stiff for implantation but softens once implanted, ensuring close contact with the spinal cord for stable and efficient stimulation and insertion into the narrower cervical space,” the company said in a news release.

“Spinal cord stimulation (SCS) is effective in the treatment of chronic, intractable pain of the trunk and/or limbs due to a variety of neuropathic pain conditions including failed back surgery syndrome, complex regional pain syndrome, and painful diabetic neuropathy,” the company later continued. “However, it is still underutilized as a therapy partly due to SCS leads not being well suited to placement in the cervical epidural space. BackStop Neural’s softening lead may improve the risk profile of placement in regions with less epidural space, such as the cervical region, to increase patient eligibility and expand the use of SCS in the current standard of care for chronic pain patients.”

Balancing rigidity and flexibility

“Our team has worked tirelessly to develop a lead that combines the best of both worlds—rigidity for implantation and flexibility for long-term use,” Chief Medical Officer Dr. Jason Carmel said in the news release, adding that the lead has “the potential to reduce the risk of the surgical procedure but also enhances the overall effectiveness of the therapy.”

Neurosurgeon Dr. Steven Falowski, a member of BackStop Neural’s advisory board, said the technology “could transform how we approach chronic pain management.”

“The ability to maintain consistent contact with the spinal cord could lead to more reliable pain relief and potentially reduce the need for repeated adjustments or revisions,” he said in the release.

The NIH grant will enable BackStop Neural to conduct testing of the new lead, including evaluating its mechanical and electrical stability, biocompatibility, and effectiveness in a pre-clinical animal study.

BackStop is eligible for Phase II of the grant, which would provide an additional $2 to $3 million if granted.

The company was founded by experts with diverse backgrounds. CEO Connie Manz previously conducted research at MIT, Draper and UT Dallas. President Walter Voit is a serial entrepreneur and tenured professor at UT Dallas. Carmel is a neurologist and motor systems neuroscientist at Columbia University.