- Medibio (MEB) has suffered a regulatory hurdle after the U.S. Food and Drug Administration (FDA) deflected a product approval
- The healthcare stock’s MEBsleep device failed to meet the requirements for a marketing clearance which indicates the product is safe and effective
- The company’s diagnostic software suffered a similar setback earlier this month after the FDA barred it from Breakthrough Device Designation
- Now, Medibio will meet with the regulatory body to discuss ways to reframe its application for MEBsleep
- Shares in the company are back in the grey in intraday trade, trading at 0.9 cents each
Medibio (MEB) has suffered a regulatory hurdle after the U.S. Food and Drug Administration (FDA) deflected a product approval.
The company’s MEBsleep device, which detects sleep stages in patients, was being prepared for a 510(k) clearance, which essentially means a product can be marketed as safe and effective.
To gain this approval, Medibio took its medical technology to the FDA in the hopes it would lead to early revenue generation.
However, the FDA has since knocked back the application, explaining it needs more clinical data and information on MEBsleep’s eligible patients to give it the green light.
All is not lost, however — the regulatory body has allegedly provided a detailed roadmap to support Medibio as it reframes its submission.
As a result, MEB has flagged a future meeting with the FDA to figure out the next steps for its sleep software.
Speaking to the regulatory setback, Medibio Managing Director Claude Solitario says this isn’t the company’s only option.
“We are also exploring other avenues for the commercialization of MEBsleep that do not require regulatory approval, such as the pharmaceutical research market pursuant to Investigational Device Exemptions (IDE) regulations; and other partnership opportunities,” he stated today.
“It is important to note that this program has not affected the progress of the depressive burden trial, which is Medibio’s primary objective and from which we will not deviate,” Claude concluded.
However, Medibio’s depression diagnostic software suffered a similar setback earlier this month after the FDA barred it from Breakthrough Device Designation.
Despite the hurdle, the company is persisting with the software’s clinical trial and said it would meet with the regulator to discuss the decision.
Overall, the company’s mission is to identify links between measurable human characteristics, known as biomarkers, and mental health conditions.
It’s hoped Medibio’s software can help patients quickly and accurately detect conditions so they can better understand their mental wellness.
Currently, the healthcare stock is developing products which promote corporate wellness, as well as solutions for clinicians in the mental health sector.
Shares are back in the grey in intraday trade, trading at 0.9 cents at 1:22 pm AEDT.