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- ImpediMed (IPD) announces clinical trial agreement for its SOZO platform, which helps patients with end stage renal disease by assisting with removing fluid during dialysis
- The company has entered into the agreement with Balboa Research and Frenova Renal Research, which will both conduct an initial observational trial
- The observation trial will enrol approximately 70 patients who will be followed over four weeks and 12 dialysis sessions
- Following the observation trial the company intends to commence discussions with the FDA to determine an interventional trial clinical evidence plan
- Shares last traded on February 10 at 19 cents
ImpediMed (IPD) has announced a clinical trial agreement for its SOZO platform, which helps patients with end-stage renal disease by assisting with removing fluid during dialysis.
The company has entered into the agreement with Balboa Research and Frenova Renal Research, which will both conduct an initial observational trial.
Dr Mark Boiskin and Dr Dylan Steer have agreed to serve as principal investigators for both the observational trial and a pivotal interventional trial, which will be used to support an FDA clearance for renal failure.
The observation trial will enrol approximately 70 patients who will be followed over four weeks and 12 dialysis sessions.
The observational trial will be conducted across three Balboa Nephology and Fresenius Medical Care joint venture dialysis centres.
The company expects the trial to commence upon IRB approval, in late February, and to be completed in Q4 FY22.
Following the observation trial, the company intends to commence discussions with the FDA to determine an interventional trial clinical evidence plan.
These discussions will reportedly involve a breakthrough device designation process, which it said would position SOZO for market clearance.
Shares last traded on February 10 at 19 cents.
