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

Thursday, July 07, 2022

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.

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.

The Axonpen System is the most integrated minimally invasive neurosurgical tool, combining over eight key features including tissue visualization, a debrider and a flexible tip. Thus far, surgeons have provided feedback that the integrated functions lead to simpler operations which is key to reducing surgery time and risks. Similar devices on the market are more costly and often require pairing with other devices such as endoscopes to perform surgeries that the Axonpen System can single-handedly carry out. Involving multiple devices during surgery increases complexity while requiring more personnel in the operating theatre which can be unfeasible in regional hospitals.

With the company's steadfast focus on minimally invasive brain surgeries and successful results from the FIM clinical trial, ClearMind Biomedical has recently concluded a funding round that will help finance upcoming clinical trials for the Axonpen System, research and development for future products, and market expansion.

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