A closer look at a microrobot that could treat a rare brain malformation

Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers.

The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation.

In 1914, neurosurgeon Walter Dandy observed a toddler with a brain cyst that led to swelling in the back of the brain. In the 1940s, another neurosurgeon, Arthur Earl Walker, identified the same type of malformation, later dubbed Dandy-Walker syndrome. While the syndrome varies in severity, children with the condition may have developmental and movement disorders, vomiting or seizures.

Treatment options for the syndrome have been limited to shunt surgery, which has a significant rate of complications. A 2015 study found more than one-quarter of Dandy-Walker syndrome patients experienced complications, including infection, shun…

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A closer look at a microrobot that could treat a rare brain malformation

Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers.

The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation.

In 1914, neurosurgeon Walter Dandy observed a toddler with a brain cyst that led to swelling in the back of the brain. In the 1940s, another neurosurgeon, Arthur Earl Walker, identified the same type of malformation, later dubbed Dandy-Walker syndrome. While the syndrome varies in severity, children with the condition may have developmental and movement disorders, vomiting or seizures.

Treatment options for the syndrome have been limited to shunt surgery, which has a significant rate of complications. A 2015 study found more than one-quarter of Dandy-Walker syndrome patients experienced complications, including infection, shun…

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Bionaut Labs wins humanitarian use device designation to treat rare pediatric brain disorder

A Bionaut prototype. The final device may undergo alteration based on FDA feedback.

The microrobotics startup Bionaut Labs has announced that FDA has granted a humanitarian use device designation for the device known as BNL-201 to treat a Dandy-Walker syndrome, a congenital brain malformation affecting the cerebellum.

According to the National Organization for Rare Disorders, the syndrome affects one out of every 25,000 to 35,000 live births.

There are currently few treatment options for the condition. A surgically-placed cerebral shunt can relieve excess fluid in the brain to relieve intracranial pressure. As Los Angeles–based Bionaut notes, invasive procedures have a risk of infections and complications.

The company says BNL-201 offers a minimally invasive option to fenestrate (puncture) the cyst that forms at the back of the brain in Dandy-Walker syndrome.

In June, FDA granted orphan…

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