Axoft Successfully Completes First Four Cases of Groundbreaking Brain-Computer Interface Trial in Panama with bioaccess® Support

Apr 22

Pioneering neurotechnology company demonstrates safety and functionality of ultra-soft neural implants in milestone achievement facilitated by Latin America's only Medtech-focused CRO

The revolutionary study marks just two and a half years from seed funding to successful human implantation, showcasing the accelerated pathway possible through strategic partnerships in Latin America

Breakthrough Technology Demonstrates Clinical Success in Panama

Miami, FL – Axoft, a pioneering neurotechnology company, has completed the first four cases of its first-in-human clinical study (FINESSE) at The Panama Clinic, demonstrating both the safety and functionality of its revolutionary brain-computer interface technology2. This remarkable achievement comes just two and a half years after the company's seed funding round, highlighting the accelerated pathway to clinical validation made possible through strategic partnerships in Latin America2.

The groundbreaking study utilized Axoft's proprietary Fleuron™ material, which is 10,000 times softer than polyimide used in existing implantable brain-computer interfaces (iBCIs), providing superior biocompatibility and significantly reducing tissue scarring and lead migration over time2. This represents the first time this bio-inspired material has been authorized for human use8.

"Axoft's device has the potential to revolutionize how we collect neural data," said Dr. Ricardo Bermúdez, Brain and Spine Senior Neurosurgeon at The Panama Clinic and Principal Investigator on the FINESSE study. "I was impressed by the minimal disruption caused to the brain tissues and the data quality captured. It is a leapfrog technology compared to existing rigid electrodes that we use in monitoring and functional neurosurgery."2

bioaccess®: The Catalyst for Accelerated Clinical Development in Latin America

This landmark clinical trial was made possible through the strategic partnership between Axoft and bioaccess®, Latin America's only Medtech-focused contract research organization (CRO)4. As a US-based CRO with specialized expertise in conducting medical device clinical trials in Latin America, bioaccess® played a pivotal role in navigating the regulatory landscape and facilitating the successful implementation of this pioneering study8.

"This milestone achievement demonstrates the power of strategic partnerships in accelerating medical innovation," said Julio Martinez-Clark, CEO of bioaccess®. "By leveraging our extensive experience and specialized knowledge of conducting early feasibility and first-in-human studies in Latin America, we were able to help Axoft rapidly translate their revolutionary technology from bench to bedside, maintaining the highest standards of clinical and ethical practice while significantly reducing time-to-market."9

The successful completion of these initial cases validates bioaccess®'s unique approach to supporting Medtech startups seeking accelerated clinical study results through cost-effective and high-quality CRO services in Latin America3. The company's expertise spans regulatory navigation, site selection, and clinical operations, making it an ideal partner for innovative medical device companies looking to conduct early-stage clinical trials6.

Transformative Technology with Far-Reaching Implications

In March and April 2025, neurosurgeons at The Panama Clinic implanted Axoft's iBCIs into four patients undergoing brain tumor resection. They successfully recorded 20 minutes of brain activity through different cortical layers and subcortical regions2. This achievement is particularly notable given the revolutionary nature of Axoft's technology, which enables a high-resolution depth neural interface using minimally invasive surgical techniques7.

"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," said Dr. Paul Le Floch, co-founder and CEO of Axoft5. "With this early feasibility study, we have generated initial safety data and demonstrated that Axoft's iBCI can be used to decode neural signals in humans, while minimizing disruption to the brain and integrating with existing surgical workflows."

Axoft's innovative approach addresses a critical limitation of existing iBCIs, which often fail to achieve a stable and high-resolution interface with soft biological tissues over the long term when implanted in the brain due to their rigidity and limited biocompatibility5. By developing brain-like polymer materials that enable a seamless and stable interface with deep brain tissues, Axoft is pioneering a new generation of neural interfaces with potential applications ranging from treating paralysis to addressing emerging indications in neuropsychiatry5.

The Strategic Advantage of Clinical Trials in Latin America

The successful execution of this study in Panama highlights the strategic advantages of conducting early-stage clinical trials in Latin America. Panama offers diverse patient demographics and efficient regulatory processes, making it an ideal location for first-in-human and early feasibility studies9.

bioaccess® bridges the gap between innovative Medtech companies and the untapped potential of conducting clinical research studies in Latin America, offering a pathway to faster, more cost-effective clinical validation without compromising on quality or scientific rigor6. This approach is particularly valuable for startups seeking to accelerate their development timeline, secure additional funding, or position themselves for a successful exit6.

Looking Ahead: Continued Collaboration and Innovation

In the coming months, Axoft will continue collaborating with The Panama Clinic to conclude its first-in-human study and prepare for a second clinical trial, building on the remarkable success of these initial cases2. The data gathered from this groundbreaking study will inform future development and applications of Axoft's revolutionary technology.

This successful partnership between Axoft and bioaccess® demonstrates how strategic collaboration between innovative technology developers and specialized CROs can accelerate the translation of groundbreaking medical devices from concept to clinical application. For medical device startups looking to expedite their clinical development timeline while maintaining the highest standards of quality and scientific rigor, the pathway pioneered by Axoft and bioaccess® offers a compelling model for success.

For more information about conducting medical device clinical trials in Latin America, contact bioaccess® at www.bioaccessla.com.

Citations:

Julio G. Martinez-Clark http://www.juliomartinezclark.com/