ANEUVO Secures FDA Clearance for ExaStim Spinal Cord Stimulation System Following $22M Series C
核心洞察
ANEUVO (搜索) received FDA clearance for its ExaStim (搜索) Stimulation System, a non-invasive transcutaneous spinal cord (搜索) stimulation device for patients with incomplete spinal cord injuries.
The portable neurostimulation system is indicated to improve hand sensation and strength in adults aged 18-75 when used with functional task practice.
The company raised $22M in Series C funding led by Catcher Technology Co. Ltd. (搜索) to support manufacturing scale-up and commercial expansion.
ANEUVO (搜索), a Los Angeles-based medical technology company, has achieved a significant regulatory milestone with FDA clearance for its ExaStim (搜索) Stimulation System, a non-invasive neuromodulation device designed for patients with spinal cord (搜索) injuries. The approval comes shortly after the company secured $22 million in Series C funding to support its commercial expansion efforts.
FDA Clearance Enables U.S. Market Entry
The ExaStim (搜索) Stimulation System delivers personalized transcutaneous spinal cord (搜索) stimulation non-invasively, supporting functional neurorehabilitation for patients with paralysis (搜索) due to spinal cord injury (搜索). The device is specifically indicated to improve hand sensation and strength in individuals aged 18 to 75 with chronic, non-progressive neurological deficits (搜索) resulting from incomplete spinal cord injury, when used in conjunction with functional task practice.
"This clearance represents an important step forward for individuals living with SCI," said Dr. Yi-Kai Lo, CEO of ANEUVO (搜索). "We're providing a non-invasive solution designed for both clinic and home use, which expands access and helps patients achieve meaningful progress in their continued recovery."
Technology Platform and Design
ExaStim (搜索) is a portable neurostimulation system that delivers electrical pulses to stimulate nerves along the spinal cord (搜索) and dorsal roots (搜索) through a 16-channel, multi-electrode array. System control is managed via proprietary programming software loaded on a mobile digital device, enabling flexible treatment delivery in both clinical settings and at home.
The approval spans both clinical and home use applications, representing a significant advancement in accessibility for spinal cord injury (搜索) patients. This dual-setting capability allows for broader patient access and more flexible treatment delivery compared to traditional clinic-only approaches.
Global Market Expansion Strategy
The FDA clearance follows ExaStim (搜索)'s CE Mark certification received in April 2025, making it the first transcutaneous spinal stimulation therapy broadly approved in the European market for adult spinal cord injury (搜索). The European approval covers the full continuum of care and spans all subtypes and stages of spinal cord injury.
ANEUVO (搜索)'s operations in Europe remain fully operational following a recent decision by the Unified Patent Court (UPC) Court of Appeal, which upheld the denial of a request for preliminary injunctive relief related to the ExaStim (搜索) system.
Series C Funding Supports Commercial Scale-Up
The company's $22 million Series C funding round, led by Catcher Technology Co. Ltd. (搜索) with participation from additional new investors, provides capital to strengthen manufacturing capabilities, quality systems, and regulatory initiatives.
"This financing strengthens the operational and regulatory foundation required to responsibly scale ExaStim (搜索)," said Yi-Kai Lo, chief executive and co-founder of ANEUVO (搜索). "We are focused on building manufacturing readiness, advancing regulatory initiatives and expanding access in approved markets in a measured and sustainable manner."
Proceeds from the Series C funding will be used to execute commercial launch in approved markets and sales expansion, scale manufacturing, advance U.S. regulatory activities, and continue clinical and real-world evidence generation to drive market adoption.
Clinical Significance and Market Impact
The ExaStim (搜索) system addresses a significant unmet need in spinal cord injury (搜索) rehabilitation by providing a non-invasive alternative to traditional neuromodulation approaches. The device's portability and home-use capability represent important advances in making neurorehabilitation more accessible to patients with spinal cord (搜索) injuries.
As ANEUVO (搜索) expands its global commercial footprint, the company continues to focus on advancing its platform for non-invasive neuromodulation therapies worldwide, with emphasis on precision execution and expanding patient access to innovative rehabilitation technologies.