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Envol Biomedical Obtains ClearPoint Neuro Capabilities to Investigate Gene Transport in the Brain Using MRI-Guided Neurosurgical Capabilities

January 31, 2025

At Envol Biomedical, innovation is at the core of our mission, and we are thrilled to announce expansion of our offerings to include ClearPoint Neuro technology for industry-leading neuro navigation and drug delivery devices. We hope that this will lead to cutting-edge translational research that will not only enhance our capabilities, but also provide clients with highly sophisticated tools for precision delivery of therapeutics to the brain.

A Leap Forward in Neuroscience

For years, Envol Biomedical has been investing heavily in advancing its neuroscience capabilities, building on a foundation of expertise from leading clinical neurosurgeons. Our team has worked diligently with clients who seek to explore and access the central nervous system, performing specialized surgeries, dosing studies, and providing critical brain tissue samples. However, when it comes to delivering treatments to specific areas of the brain, precision is paramount.

In traditional stereotactic procedures, where surgeons rely on a standard brain atlas as guidance, precision can be limited, especially when targeting very specific regions of the brain. To address these challenges, we have added ClearPoint Neuro Navigation to our toolkit, an FDA-cleared platform that enables delivery of therapeutics to target regions in the brain with sub-millimetric accuracy.

ClearPoint Neuro’s Pioneering Technology

ClearPoint provides image-guided navigation for the delivery of therapeutics to the nervous system, thus allowing scientists and clinical neurosurgeons to focus on drug discovery and surgical efforts that maximize therapeutic efficacy. Accurate delivery is crucial for advancing therapies from preclinical studies to successful IND applications, as well as successful clinical trials. Image guidance may allow sponsors to customize their drug delivery approach to minimize therapeutic waste, confirm target accuracy, maximize target coverage.

This system offers a level of accuracy and translational continuity that enables a highly targeted approach for delivering novel drugs and gene therapies to the brain. The ability of being able to conduct these procedures during intraprocedural MR imaging provides the neurosurgeon with important feedback regarding cannula placement within the target, therapeutic coverage of the anatomy, and ability to make adjustments in near real-time following cannula insertion – all of which are not possible during standard stereotactic procedures conducted in the operating room without imaging.

Paving the Way for the Future of Gene Therapy

Envol has recently conducted a pilot study in which we delivered an adeno-associated viral vector intraparenchymally into a pre-selected region of the brain (the thalamus). This viral vector expressed a green fluorescent protein specifically in neurons that facilitate tracking of the therapeutic payload distal from the site of infusion using advanced imaging techniques, such as cryo-focused tomography and fluorescence microscopy.

By imaging brain slices, we can create detailed, three-dimensional reconstructions that pinpoint exactly where the drug has been delivered and where it has been transported to. This breakthrough in 3D neuro-imaging will not only enhance our understanding of how therapies interact with the anatomy in situ, but may also improve the ability to track and refine drug delivery processes in future clinical applications.

Cutting-Edge Imaging Capabilities

We have also collaborated with a local imaging company that provides access to a 3 Tesla magnet that enables us to see and analyze brain activity at a high resolution. This collaboration extends to other imaging modalities, including PET, CT, SPECT, and DEXA scans, ensuring that our research capabilities are among the best in the world.

By combining these technologies, Envol is positioning itself as a leader in the neuroscience space, offering clients a full spectrum of imaging and neuro-surgical services that are clinically translatable. Our ability to work with nonhuman primates, alongside these advanced imaging capabilities, ensures that we can deliver highly valuable insights for preclinical and clinical research.

What’s Next?

As we finalize the results of our pilot study, Envol will look to present these findings at the upcoming American Society of Gene & Cell Therapy (ASGCT) conference.  We are also looking to publish the data. If anyone is interested in more information, please feel free to contact us. 

Empowering Our Clients

Through these collaborations, Envol Biomedical is not just keeping pace with the rapidly evolving field of neuroscience but leading it. Our clients will benefit from our growing suite of capabilities in neuroscience and imaging, which will help drive advancements in clinical treatments and research. With our investment in precision techniques, including MRI-guided drug delivery and cutting-edge 3D imaging, Envol is poised to offer clients the tools they need to succeed in the increasingly complex field of neuroscience.

Stay tuned for more updates on this groundbreaking research and our upcoming white paper and be sure to connect with us for more information on how our collaborations are pushing the boundaries of scientific discovery.


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