The Swedish Medical Product Agency (Läkemedelsverket) has approved an application from Inhalation Sciences (ISAB) for a clinical trial of its PreciseInhale aerosol generation system, the company said. ISAB expects to initiate the trial in June 2021 and to complete the study by the end of the year.
Inhalation Sciences first announced its intentions to validate PreciseInhale for clinical use in 2019. ISAB also recently announced the formation of a scientific advisory board to advise it on the potential use of PreciseInhale when the system becomes available for human studies.
ISAB CEO Manoush Masarrat commented, “This is a huge milestone for us. Successful clinical validation could be transformational for ISAB, unlocking new markets valued at several billion SEK, and opening up a wide range of new growth avenues. We are confident that the clinical validation of PreciseInhale will significantly increase the size of our market, reducing the cost and time for pharmaceutical companies and making PreciseInhale the leading, low-risk, high-precision aerosol delivery system on the market. I am proud of the team at ISAB who have worked so hard to make this study happen. This is a major landmark.”
Read the ISAB press release.
