Monday, November 4, 2024

ClearMind Biomedical Clears FIM Clinical Trial for Least Invasive ICH Treatment to Date

ClearMind Biomedical’s novel neurosurgical endoscope, the Axonpen System, has completed its First in Man (FIM) clinical trial in Taiwan with outstanding results.

The Axonpen System which received US FDA 510(k) clearance in 2020 and from the Taiwan FDA in 2021, is designed to enable neurosurgeons worldwide to perform the least invasive brain surgeries for their patients. With the device requiring only a 6.5mm channel to access the intracranial space, the Axonpen System has broken ground as the least invasive treatment for intracerebral hemorrhage (ICH) in the industry. Once past the skull, the device can illuminate and visualize intracranial tissues and fluids and, typically in cases of ICH and subdural hematomas, carry out controlled aspiration and irrigation where needed.

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All 10 trial participants demonstrated speedier recovery times, spending just an average of three days in the intensive care unit. This is more than a 50% reduction in time when compared with the 10 to 14 days needed for recovery from traditional treatment methods. Patients demonstrated a full recovery of motor skills in most cases. Furthermore, post-treatment ICH blood remnants were below 15ml across the cohort. For a better prognosis, a minimum of 70% or more of the hemorrhage should be removed, with no more than 15ml of blood remnants at the injury site. Every additional 1ml of clotted blood removed enhances the chances of a good recovery by 10%.

“We set out to develop a fully integrated neurosurgical endoscope that is not only safe with minimal downtime but also optimal with every function needed by neurologists performing the procedure, which our trial has proven. While achieving this, we remain compliant of international regulations and standards to meet the needs of medical practitioners and ensuring patients’ safety during treatment,” said Carrey Yang, CEO of ClearMind Biomedical.

Prioritizing patients’ wellbeing, ClearMind Biomedical’s motto when it comes to treating ICH is “One Doctor, One Hour.” The company intended for the Axonpen System to empower doctors at regional hospitals to complete ICH surgeries in one hour, a challenge it has successfully met.

Presently, ClearMind Biomedical’s second trial for the Axonpen System is underway in Taiwan and the company is looking to conduct its next trial in the US.

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