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September 4, 2024 – BackStop Neural secured a two-year, $485k Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for the development of Thin, Softening Epidural Leads for Chronic Arm and Neck Pain. This grant will fund the continued development of a novel paddle-type epidural stimulation lead that is ten 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.
"This SBIR grant from the NIH is a testament to the groundbreaking work our team is doing,” said CEO Connie Manz excitedly. “Our novel epidural stimulation lead has the potential to significantly increase patient eligibility and improve patient experience. We are grateful for the NIH's support and look forward to advancing this promising technology."
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. 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.
Through the award, BackStop Neural will validate the mechanical and electrical stability of its softening SCS lead in benchtop tests followed by biocompatibility testing and in vivo validation in a pilot large animal study. The federal SBIR program provides non-dilutive funding to small businesses engaged in early-stage research and development. This support is crucial for startups like BackStop Neural, enabling them to bring high-impact, disruptive innovations to market. If BackStop Neural is selected to advance to Phase II of the grant, the company could receive an additional $2 to $3 million enabling the company to bring its groundbreaking technology closer to commercialization.
Chief Medical Officer Jason Carmel, MD, PhD, highlighted the technical advancements: "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. This innovation not only has the potential to reduce the risk of the surgical procedure but also enhance the overall effectiveness of the therapy. We are excited to validate its feasibility through this Phase I award."
Dr. Steven Falowski, a member of BackStop Neural's advisory board and renowned pain neurosurgeon, commented on the clinical implications: "This innovative lead technology has the potential to significantly enhance the effectiveness of SCS therapy. 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. It's an exciting development that could transform how we approach chronic pain management."
BackStop Neural's innovative approach and commitment to improving patient care have positioned the company as a leader in the field of bioelectronic medicine. This Phase I SBIR grant will enable the company to further develop and validate its novel epidural stimulation lead, bringing it one step closer to commercialization and widespread clinical use.
For more information about BackStop Neural and its groundbreaking electrode arrays, please visit www.backstopneural.com.
About BackStop Neural
BackStop Neural is a pioneering medical technology company that specializes in developing advanced spinal cord stimulation solutions for individuals suffering from chronic pain and neurological disorders. Through cutting-edge neurostimulation technology, the company strives to provide patients with a renewed sense of hope and freedom from debilitating conditions. With a team of dedicated experts and a patient-centered approach, BackStop Neural aims to transform the landscape of chronic pain relief and motor recovery.
About the SBIR Program
The Small Business Innovation Research (SBIR) program is a highly competitive program that encourages domestic small businesses to engage in federal research and development with the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization.
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Kial Gramley, Chief Product Officer
(956) 219-6752
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