Axoft Begins Commercializing its Implantable BCI Material

Neurotechnology firm Axoft is now marketing Fleuron, its ultra-soft, biocompatible material designed to improve implantable brain-computer interfaces (iBCIs).

Targeted for research and development applications, Fleuron reportedly provides superior biocompatibility and significantly reduces tissue scarring and lead migration over time. The material was recently used in Axoft’s first-in-human clinical study—Fleuron’s first authorized human use—and proved the substance passed the required ISO-10993 compatibility standards. In addition to Fleuron’s commercial launch, Axoft announced an exclusive license agreement with Stanford University to protect the technology’s core aspects.

Many iBCIs struggle to maintain a stable, long-term high-density interface with soft biological tissues due to their rigidity and limited biocompatibility. Fleuron addresses this challenge by mimicking brain tissue’s mechanical properties. Resembling a rubber-like version of Teflon, Fleuron offers both longitudinal stability as thin-film material and is compatible with high-density neural interface microfabrication, while minimizing disruption to brain tissues. The material enables new applications for biomedical micro-electromechanical systems (bioMEMS), organ-on-a-chip and implantable devices, and can be used in micro- and nano-fabrication to make high-density microelectrode arrays capable of capturing stable single-neuron electrical activity for more than a year and a half, based on preclinical models.

Dr. Jia Liu, co-founder and scientific advisor of Axoft, initiated the development of Fleuron while at Stanford during his postdoctoral training in Professor Zhenan Bao’s research group. Dr. Liu later joined Harvard University as assistant professor of Bioengineering, where he worked with Axoft co-founder and CEO Dr. Paul Le Floch to improve Fleuron’s scalability for numerous bioelectronics applications. The related intellectual property developed at Stanford was recently licensed exclusively to Axoft for applications in iBCIs for treating neurological disorders, bioMEMS, bioelectronics, and other devices.

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“Fleuron is up to 10,000x softer than the polyimide or Parylene C used by most iBCI companies and up to 1,000,000 times softer than silicon. It’s specifically designed to improve the stability of the tissue-electronics interface, reduce scar tissue and prevent implant drift within the brain over time,” Dr. Le Floch stated. “Fleuron can be used for a wide range of applications where hardware meets biology, including biohybrid devices, organ-on-a-chip, microfluidics and neural interfaces. It includes a platform of materials that are extremely biocompatible yet highly performant and capable of integrating with scalable manufacturing techniques. The broader research and industry landscape stands to benefit from Fleuron, as it has the potential to become a new standard in biomedical engineering.”

Several industrial and academic organizations are using Fleuron for their own research and development. Axoft uses custom Fleuron formulations in its iBCI devices, which have resulted in unmatched biocompatibility, long-term signal stability and a high bandwidth interface that maximizes the information exchanged between the brain and electronics.

The first Fleuron products are available for use as soft, negative photoresists for microfabrication. Axoft plans to launch more material formulations by year’s end for additional biomedical engineering applications.

Founded in 2021 and headquartered in Cambridge, Mass., Axoft is building iBCIs leveraging bio-inspired materials to create a seamless interface between the brain and electronics, and allow for measurement and stimulation at high-resolution in any brain region. Axoft aims to unlock new treatments for patients suffering from neurological disorders by producing iBCIs that answer critical unmet needs.