Enspire DBS Therapy Secures $10.3 Million for Stroke Rehabilitation Innovations

Enspire DBS Therapy Receives $10.3 Million for Innovative Stroke Rehab

Enspire DBS Therapy, Inc., a clinical-stage entity dedicated to enhancing post-stroke recovery, has announced a significant financial boost of $10.3 million through Series B1 financing. This funding round was led by Genesys Capital, an esteemed venture capital firm, and also witnessed participation from existing investors such as Cleveland Clinic and JobsOhio Ventures. The financial injection is poised to accelerate the progress of the multicenter RESTORE pivotal clinical trial, which focuses on integrating deep brain stimulation (DBS) with structured rehabilitation therapies aimed at patients suffering from chronic upper-extremity impairments following a stroke.

Purpose and Significance of the RESTORE Study

The RESTORE clinical trial is designed to evaluate the safety and efficacy of the combined approach of DBS and rehabilitation. By engaging in this trial, Enspire strives to generate crucial long-term data regarding the safety and effectiveness of this innovative therapy, which is essential for securing future marketing authorization from the FDA. The study also aims to improve patient outcomes by enhancing arm strength and overall functional recovery. Interim results from this promising study are anticipated in mid-2027, offering hope for many affected individuals.

Scott Kokones, CEO of Enspire, emphasized the importance of this funding as it represents a pivotal milestone for the company. He noted that the collaboration with Cleveland Clinic, JobsOhio Ventures, and the addition of Genesys Capital would enhance their clinical strategies and further their mission to develop effective therapies for stroke recovery.

Involvement of Genesys Capital

Jamie Stiff, the Managing Partner at Genesys Capital, will accompany Enspire's Board of Directors as part of the financing agreement. Stiff expressed excitement about Genesys Capital's role in supporting Enspire's journey, citing the company's remarkable strides in advancing DBS-enabled rehabilitation for individuals facing neurological deficits after strokes. His involvement is seen as a testament to the potential of DBS therapies to transform the lives of patients.

The Reality of Stroke

A staggering 800,000 Americans endure strokes annually, making this medical condition a leading contributor to long-term disability. Though many individuals survive the acute phase, they often contend with enduring neurological impairments that hinder their quality of life. Alarmingly, nearly half of stroke survivors require assistance with everyday tasks, highlighting the critical need for transformative treatments such as Enspire's.

The RESTORE Study in Depth

The RESTORE Stroke Pivotal Study encompasses various clinical sites and is crafted to assess the combination of DBS and rehabilitation techniques for maximizing recovery among stroke survivors. Each participant undergoes implantation with a commercially available DBS device and engages in an extensive five-month rehabilitation program. Future phases will include a comparative analysis of conventional rehabilitation against the DBS-enhanced approach. Following an initial blinded, randomized five-month period, participants from the rehabilitation-only group will switch to the DBS program for an additional five months.

This innovative study is linked to Enspire’s FDA-approved Investigational Device Exemption (IDE), allowing the company to explore new therapies to assist stroke patients. The RESTORE trial is actively recruiting candidates willing to partake in this groundbreaking research.

About Enspire DBS Therapy

Enspire DBS Therapy, based in Cleveland, Ohio, is a pioneering medical device firm dedicated to creating neuromodulation therapies tailored to restore functionality in individuals with disabilities post-stroke. Established in 2010, Enspire operates within the Cleveland Clinic ecosystem, focusing on translating cutting-edge neuroscience into practical clinical applications that can meaningfully change patient lives.

Conclusion

As Enspire DBS Therapy continues to grow and develop innovative therapies for recovery post-stroke, the future looks promising for many individuals affected by this debilitating condition. With substantial funding and ongoing research, Enspire stands at the forefront of neurological recovery advancements, striving to positively impact countless lives in the process.