Clearmind Biomedical Announces FDA Clearance and First U.S. Surgery of the Neuroblade System for Minimally Invasive Neurosurgery

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Aug 26, 2024, 10:00 ET

SAN JOSE, Calif., Aug. 26, 2024 /PRNewswire/ -- Clearmind Biomedical, a leader in medical technology focused on enhancing care for neurosurgery patients, has received FDA 510(k) clearance for its Neuroblade System. This novel neuroendoscopy system enables minimally invasive procedures with integrated features such as visualization, illumination, irrigation, suction, coagulation, and powered debridement. The company also announced the successful completion of the first U.S. surgery using the Neuroblade, performed by neurosurgeon Dr. Christopher Kellner at Mt. Sinai Hospital, New York.

The Neuroblade System is composed of three components: the Neuroblade, a single-use multifunctional neuroendoscope; the Neuropad, a reusable medical-grade tablet; and Clearpath, a disposable transparent access sheath. This system is designed to improve the efficiency and outcomes of minimally invasive neurosurgical procedures.

J. Dustin Duckett, Clearmind's Vice President and General Manager for the Americas, stated, "FDA clearance and the first U.S. surgery mark significant milestones for the Neuroblade System, which we believe will revolutionize minimally invasive neurosurgery. Developed with input from surgeons, Neuroblade's integrated features aim to enhance surgical efficiency and patient outcomes. We look forward to further developing evidence, driving adoption, and ultimately getting more patients access to desperately needed care."

In the initial U.S. case, Dr. Kellner employed the Neuroblade system during an urgent procedure to evacuate a hemorrhagic stroke. The Clearpath sheath allowed precise access to the target area, while the Neuroblade provided an all-in-one instrument with real-time visualization and integrated tools for suction, irrigation, powered debridement, and coagulation.

Dr. Kellner remarked, "The Neuroblade system offers a valuable new tool for the surgical management of intracerebral hemorrhage. Its minimally invasive design streamlines the operating room setup and integrates essential functions into a single handpiece, potentially improving patient outcomes. Neuroblade system represents a new class of technology that should simplify neurosurgical procedures and provide patients a chance at more favorable outcomes."

Clearmind Biomedical

Clearmind Biomedical is a privately held medical device company based in San Jose, California and Taipei, Taiwan. The company has rapidly developed a portfolio of minimally invasive devices aimed at improving care for neurosurgery patients. Clearmind has filed 21 patents and completed multiple studies to support the clinical value of the Neuroblade system.

https://www.clearmindbiomedicalgroup.com/

SOURCE ClearMind Biomedical Inc.