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| Accurexa's Branchpoint device as shown with a skull--Courtesy of Accurexa |
Accurexa believes it has the makings for better brain surgery with its therapeutic delivery device BranchPoint. The company has submitted it to the FDA for 510(k) clearance; it allows for the insertion of therapeutics, such as stem cells or oncology drugs, to multiple sites in the brain via a single penetration point with the radial deployment of a flexible catheter.
It could improve upon the current standard of care, which is to use a straight, rigid needle at multiple brain penetration points. Each penetration can increase the risk of bleeding, stroke and reflux of therapeutics back to the brain surface.
In early trading after the news on June 15, investors drove shares up almost 50% to about $3 each to give it a still-tiny market cap of roughly $20 million. The OTC-traded shares remain quite volatile, as are most penny stocks, and traded as high as $6 last summer.
Instead of requiring multiple injection sites, the BranchPoint device uses a flexible catheter to reach several sites from a single entry point through the skull. The company expects this could limit the risk of complications such as bleeding and stroke and could increase the amount of therapeutic that remains in the intended location. It's also expected to potentially enable real-time monitoring of therapeutic delivery via interventional MRI guidance to further improve accuracy and reduce risks.
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| Branchpoint catheter inserted in brain--Courtesy of Accurexa |
The device was invented by Dr. Daniel Lim, an associate professor of neurological surgery at the University of California at San Francisco (UCSF). BranchPoint could be used to treat conditions such as Parkinson's disease; that disease has been shown in animal studies to respond to the delivery of human dopaminergic neural stem cells directly into the brain.
"If approved by the FDA, [the BranchPoint device] would enable us to leverage this significant research investment for the clinical treatment of a wide range of diseases of the brain," Lim said in a statement.
Last August, the company changed its name to Accurexa from Cyto Wave Technologies. It also shifted its business away from the development of cancer diagnostics based on noninvasive detection of metastatic circulating tumor cells in the bloodstream.
In addition to BranchPoint, Accurexa is developing ACX-31 to deliver the chemotherapy temozolomide directly to brain cancer sites. The candidate would be used via BranchPoint, and its development is contingent upon the devices' FDA approval.
- here is the release
- and here is a San Francisco Business Times story from last August