The Impedimed Limited (ASX: IPD) share price is making good ground today, having climbed 10% from the market open to now trade at 16.5 cents.
Impedimed shares are again on the move after coming out of a trading halt that was requested before the start of trade today.
Here's what we know.
What was announced?
The company announced positive readouts from its recently completed PREVENT pivotal trial involving cancer-related lymphoedema patients across the US and Australia.
It's the end of a 6-year journey for the PREVENT trial which has been examining the effectiveness of Impedimed's L-Dex technology in reducing the onset of chronic lymphoedema.
The aim of the study was to determine if early intervention in patients with lymphoedema using "bioimpedance spectroscopy (BIS)" resulted in a lower rate of disease progression. It was compared to using a tape measure to detect the presence of excess fluid.
The study findings indicate that in patients with early detection using L-Dex, the protocol "resulted in a lower rate of progression to chronic disease than patients with early detection from volume measures using a tape measure".
This, it claims, is a result that is statistically significant. The study collected data from 1,200 patients followed for up to three years across 13 hospitals in both countries.
The results showed that in patients using L-Dex with early detection lymphoedema, the intervention resulted in a 7.9% rate of chronic lymphoedema compared to 19.2% in the tape measure group.
This represents an absolute reduction of 11.3% and a relative reduction of 59%.
In addition to these findings, "92% of patients with early detection cancer-related lymphoedema using L-Dex and intervention did not progress [to the chronic stages]".
What did Impedimed conclude from its results?
The company surmised that its methodology "should be a standard approach for prospective breast cancer-related lymphoedema (BCRL) surveillance".
It also states its process is more specific in detecting lymphoedema than a tape measure "as it had fewer triggers and longer times to intervention trigger", based on the data.
In conclusion, the company said that when compared to a tape measure, the BIS screening method results in a more precise identification of patients more likely to benefit from early compression intervention.
For reference, lymphoedema is often managed using compression garments to mobilise the excess extracellular fluid.
Speaking on the announcement, Impedimed CEO Richard Carreon said the results were "significant not just for Impedimed, but for cancer patients at risk of lymphoedema".
Touching more on the results, Carreon added:
This study is consistent with the previous studies showing regular monitoring with L-Dex and simple intervention substantially reduce the risk of developing cancer-related lymphoedema. What differentiates this study is, for the first time, we have a level I randomised controlled trial of sufficient size and duration to result in a statistically significant difference between the outcomes using L-Dex and Tape Measure.
The Impedimed share price has rallied 22% in the past week, extending its gains in the last month to over 50%.
