Calzada completes treatment in NovoSorb trial
Calzada (ASX:CZD) subsidiary PolyNovo has announced the conclusion of treatment in the first clinical trial of its NovoSorb polymer in a surgical procedure. The biodegradable polymer has applications in treating major wounds, burns and other injuries.
The company recently launched a trial involving using NovoSorb foam dressings for topical negative pressure (TNP) in procedures involving vacuum-assisted closure of pressure sores. The trial involved 20 patients, with 10 treated with NovoSorb and the control group treated with existing product Granufoam.
Calzada announced that statistical analysis of the data from the trial is now underway and that the company aims to release the results to the market before the end of April.
A positive outcome would support PolyNovo’s application for marketing approval of NovoSorb in the US. The company plans to file a submission with the US FDA in Q3, seeking approval for the use of NovoSorb to treat pressure sores.
PolyNovo is planning to conduct a second clinical trial involving using NovoSorb as a Biodegradeable Temporising Matrix (BTM) to treat burns injuries in free flap donor site repair surgery. The trial had been scheduled to commence in Q4 last year, but PolyNovo announced in August that it was forced to push back the trial due to a slower-than-anticipated recruitment rate.
Calzada shares were trading 5.77% higher at $0.055 as of around 2 pm on Thursday.
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