ANEUVO Advances Bioelectronic Medicine with Pioneering Pilot Studies and an Innovative Pivotal Trial for TSSdevice, ExaStim®

ANEUVO is seeking strategic partners to join Series C financing for its ExaStim® Stimulation System, a novel neuromodulation device that has shown promise for treating individuals living with chronic SCI

Los Angeles, CA – June 14, 2024 – ANEUVO, a clinical-stage med-tech company at the forefront of bioelectronic medicine, announces significant progress in developing therapies to restore independence and enhance the quality of life for individuals with chronic conditions. ANEUVO’s flagship device, the ExaStim® Stimulation System is a portable, wireless, rechargeable device, designed to deliver targeted and selective transcutaneous spinal cord stimulation (TSS) non-invasively. ExaStim offers a new, non-surgical option for clinically paralyzed individuals due to spinal cord injury (SCI). Combining advanced semiconductor chip technology with a 16-channel, multi-electrode pad and a customizable, streamlined mobile programming interface, ExaStim aims to revolutionize SCI treatment, a profoundly untapped and underserved market.

“The ExaStim Stimulation System represents an important advancement in non-invasive spinal cord neuromodulation therapy. We are excited to lead the effort through the ASPIRE™ study before bringing this novel device to market. Upon its launch, physicians and clinicians will have direct access to new technology to treat patients suffering from spinal cord injury,” said Dr. Yi-Kai Lo, Co-founder and CEO of ANEUVO.

Past and Present Clinical Progress:
ANEUVO has successfully completed pilot studies addressing both upper and lower limb paralysis due to SCI. The nationwide, multi-center, randomized, controlled, double-blinded ASPIRE trial is also collecting valuable information spanning a diverse patient population by studying ExaStim’s impact on participants with upper limb paralysis caused by SCI. “It's changed my life in the last two months,” Ashley Dall, an ASPIRE study participant at Marquette University College of Health Sciences, told local television media outlet FOX 6 in Milwaukee. “I’m able to pick up things with a lot more stability,” said Nathan Miller, another study participant at Kennedy Krieger Institute, told local television news affiliate ABC 2 in Baltimore.

Most recently, ExaStim® has also been used to study motor improvement for pediatric cerebral palsy, with early indicators hinting at the potential for use within a new patient population.

Planned Clinical Studies
Next for ExaStim is a Home Use study for upper limb paralysis due to SCI, sub-acute treatment studies, and studies focusing on non-traumatic SCI.

ANEUVO aims to complete enrollment for the ASPIRE™ pivotal study in 2024, submit an FDA application, and bring ExaStim™ to market in 2025. For more information, please visit ANEUVO’s website.

Caution: Investigational device. Limited by United States law to investigational use.

About ANEUVO
ANEUVO is a platform and therapy development company revolutionizing bioelectronic medicine. Our commitment is to continuously innovate neuromodulation therapies that restore functional independence, improve quality of life, and create a healthier and more equitable world for people living with chronic diseases and conditions.