Page 44 - WNS 2022 Program Book-Final version

Bionaut™: Conceptually Novel, Tetherless Microrobotic Minimally Invasive
Microsurgical and Drug-Delivery Device Platform for the Treatment of CNS
William Loudon MD PhD 1,2 , Alex Kiselyov PhD 1 , Florent Cros MS 1 ,
Michael Kardosh MS 3 , Michael Shpigelmacher MS 1
1 Childrens Hospital of Orange County, Orange CA, 1 University of California
Irvine, Irvine CA, Bionaut Labs, Culver City, 2 CA/ 3 Tel Aviv, IS

Despite the most aggressive surgical and adjuvant therapeutic strategies, treat-
ment of neurological conditions remains problematic. Novel microsurgical or
therapeutic strategies including targeted biologics, immunotherapy and special-
ized delivery systems such as convection-enhanced delivery (CED) have been
proposed. While some of these novel treatments are entering phase I trials, the
field is still in need of treatment(s) that exhibits dramatically enhanced efficacy
and safety. Bionaut Labs has developed a modular microrobotic platform for
performing localized delivery of diverse therapeutics in vivo. Our proprietary
biocompatible magnetic particle(s) (the Bionaut(s)™) are specifically designed to
safely and reliably perform treatment including microsurgery or delivery of novel
therapeutics to the targeted locus in the brain. In a few representative examples,
the microsurgical Bionaut™ can be used to fenestrate cyst wall membranes to
balance the obstructed cerebrospinal outflow or to deliver therapeutics including
small molecules, biologics or engineered stem cells to treat specific CNS disor-
ders including challenging diffuse tumors or neurodegenerative diseases. Nota-
bly, the Bionauts™ are tetherlessly and remotely controlled to be accurately
navigated in 3D following predetermined trajectories using an external, low pow-
er magnetic field. The Bionauts™ are visualized in real time using conventional
imaging techniques, such as biplanar fluoroscopy image-fused with previously
acquired MRI. These particles can carry diverse diagnostic and/or therapeutic
payloads including small molecules, biologics, cells and radioisotopes. Bionaut
has secured respective orphan designations with the FDA for the device
(Humanitarian Use Device, HUD) and drug-device (orphan drug designation,
ODD) combination. These include microsurgical fenestration of the DWM cyst
and local therapeutic delivery of payload to treat malignant gliomas, respectively.
Current development status of the Bionaut platform including research and de-
velopment as well as pre-clinical regulatory considerations will be presented.
The integrated platform with examples of preclinical large animal studies will be
summarized.

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