- Medibio (MEB) has provided an update on its Sleep Analysis of Depressive Burden (SADB) study and associated MEBsleep software
- The meditech company said its SADB study has begun enrolments again after it was temporarily delayed due to COVID-19
- Whiles its MEBsleep software, which identifies different sleep stages, was also affected by COVID-19 after a meeting regarding its approval was pushed back
- The company is also in the process of having MEBsleep be approved by U.S. health officials
- Following today’s update, shares in the company closed trading down 11.1 per cent at 1.2 cents per share
Meditech company Medibio (MEB) has revealed it’s facing some setbacks due to the ongoing coronavirus pandemic.
The company provided an update on its Sleep Analysis of Depressive Burden (SADB) study and associated MEBsleep software today, with both affected by COVID-19.
Sleep study
Medibio’s SADB study began in December 2019, examining the clinical depressive burden in patients with sleep disturbance.
A number of patients were enrolled, but the study had to be delayed as sleep clinics began closing in the U.S. due to COVID-19.
The company said it has recently been able to re-enrol patients for the trial, and will update the market on its progress.
The data from the trial will be compiled with additional studies to form part of its application to the U.S. Food and Drug Administration (FDA) for eventual approval.
Medibio said on average approval can then take between six and nine months once a submission is accepted by the FDA, but with the current pandemic that timeline is likely to blow-out.
Sleep software
COVID-19 has also affected the company’s approval plans for its MEBsleep software, which essentially works to identify and track the different sleep stages.
The software was born as part of the company’s wider aim to study whether lack of sleep could be an objective sign in screening mental health issues.
Medibio is seeking FDA approval for a 510(k) application and said its discussions with the regulatory body were continuing well.
“Medibio remains positive of clearance and is actively seeking commercial collaborations and opportunities for MEBsleep in anticipation of FDA clearance,” the company said in a statement.
It’s also seeking CE Mark certification, but a recent meeting with DQS — Medibio’s regulatory body in Germany — has been delayed due to COVID-19.
That meeting is now expected to take place at the end of the month, with the company promising to release another update then.
Following today’s announcement shares in Medibio closed down 11.1 per cent, trading for 1.2 cents each on August 7.