Axoft Receives Ethics Committee Approval for First-in-Human Clinical Trial in Panama
Milestone marks significant progress in developing revolutionary neural interface technology
PANAMA CITY, Panama, November 24, 2024 -- Axoft, Inc. (https://axoft.us/), a pioneer in ultra-soft neural interface technology, has received regulatory ethics committee approval to conduct its first-in-human clinical research trial in Panama. This landmark achievement paves the way for testing Axoft's groundbreaking bioinspired implant designed to provide unparalleled access to neural code. The study will take place in 2025 at The Panama Clinic. It will demonstrate the usability of Axoft’s novel soft materials that mimic the mechanical properties of brain tissue and are tailored to improve the stability of the tissue-electronics interface for implantable Brain-Computer Interfaces (iBCIs). Axoft’s study with The Panama Clinic marks the first time this bio-inspired material is authorized for human use.
The approval represents a crucial step forward in Axoft's mission to develop a seamless interface with the nervous system. The company's innovative implant mimics the soft tissues of the brain, potentially reducing implant drift and long-term damage while maintaining an ultra-high density of electrodes.
Axoft collaborates with bioaccess®, a leading Medtech contract research organization (CRO), to facilitate its clinical development plans in Latin America. This partnership ensures adherence to international standards and local regulations throughout the trial process.
"This ethics committee approval is a testament to the rigorous scientific approach and potential impact of Axoft's technology," said Julio Martinez-Clark, Chief Executive Officer (CEO) of bioaccess®. "We're excited to begin this critical phase of Axoft's research, which could revolutionize how we interact with and understand the human brain."
The upcoming clinical trial will evaluate the safety and preliminary efficacy of Axoft's neural interface, which boasts several groundbreaking features:
10,000 times softer than today's flexible electronics
1,000 times greater electrode density than soft probes currently on the market
Biocompatible design that closely mimics brain tissue properties
"This technology has the potential to provide long-term, high-resolution communication with the nervous system at the single-neuron level," explained Julio G. Martinez-Clark. "This trial is a crucial step towards realizing that potential and potentially transforming the field of neurotechnology."
Axoft's comprehensive neural interface solution includes not only the ultra-soft implant but also advanced signal processing electronics, specialized surgical implantation tools, and proprietary neural data decoding software. This integrated approach aims to overcome current limitations in brain-computer interfaces and open new possibilities in neuroscience research and therapeutic applications.
As Axoft moves forward with this pivotal clinical trial, the company remains committed to pushing the boundaries of neurotechnology while prioritizing patient safety and scientific rigor.
“Our mission is to answer unmet medical needs with iBCIs. We believe that by making iBCIs safer and more effective while also ensuring they’re user-friendly and not-overengineered, they will become a scalable solution to help millions of patients suffering from chronic neurological disorders. This includes conditions causing paralysis and for emerging indications in neuropsychiatry,” said Dr. Paul Le Floch, co-founder and CEO of Axoft. “Due to their rigidity and limited biocompatibility, many existing iBCIs fail to achieve a stable and high-resolution interface with soft biological tissues over the long term when implanted in the brain. Axoft’s brain-like polymer materials enable a seamless and stable interface with deep brain tissues. With this early feasibility study, we will generate initial safety data and demonstrate that Axoft’s BCI can decode neural signals in humans while minimizing disruption to the brain and integrating with existing surgical workflows.”
Axoft’s technology enables a high-resolution depth neural interface using minimally invasive surgery techniques. The company’s novel, patent-pending material, and device are differentiated by:
● Unmatched Biocompatibility: >10,000x softer than plastic materials used by most iBCI companies (e.g. Polyimide, Parylene C) and >1,000,000x softer than silicon, Axoft’s materials reduce scar tissue and implant drift within the brain over time.
● Long-Term Signal Stability: Axoft has already shown that its iBCI can track the electrical activity of single neurons for over a year in animal models.
● High Bandwidth Interface: With a high density of sensors/stimulators, Axoft’s iBCIs maximize the information that can be exchanged between the brain and electronics.
“It is exciting to work with a company that was thinking about the properties of the brain when they designed their implant,” said Dr. Ricardo Bermúdez, a neurosurgeon and investigator at The Panama Clinic. “The minimally invasive surgical approach and ability to be inserted anywhere in the brain enables the technology to address a wide range of unmet clinical needs.”
With the first patient planned for late January, Axoft’s study at The Panama Clinic will include up to five patients undergoing existing brain resection surgery. Study participants will be awake while testing Axoft’s iBCI, which allows for the decoding of volitional brain activity.
To enable this study, Axoft partnered with bioaccess®, the leading Medtech contract research organization (CRO) specializing in facilitating medical device clinical research in Latin America.
Axoft grew out of research from Dr. Jia Liu’s Lab of Bioelectronics at Harvard University, and the company has secured a licensing contract with the institution. This year, Axoft published papers outlining the capabilities of its novel brain implant technology in Nature Nanotechnology and Nature Neuroscience, and in 2021 Dr. Le Floch received the Forbes 30 under 30 distinction for Science. The company’s continued momentum and clinical translation recently led to an oversubscribed $10.1 million pre-Series A round from new and existing investors. To date, Axoft has raised over $18 million in funding.
About Axoft, Inc. Axoft is a neurotechnology company developing a revolutionary seamless interface with the nervous system. By combining ultra-soft materials science with advanced electronics and software, Axoft aims to create neural implants that provide unprecedented long-term stability and high-resolution neural recording. The company's mission is to enhance our understanding of the brain and develop new therapies for neurological conditions.
For more information: Sharick Rubio, Media Relations, bioaccess®
Note: This press release contains forward-looking statements about product development and clinical trials. Actual results may differ materially from those described in this press release due to various factors, including but not limited to the outcome of clinical trials, regulatory approval processes, and market acceptance.
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