- ImpediMed (IPD) has rounded off its PREVENT trial, successfully meeting its primary end point in the largest recorded trial to assess lymphoedema prevention
- The findings were based on a 1,200-person trial over six and a half years, spanning 13 hospitals in the US and Australia
- The study demonstrated that intervention in patients with early detection of cancer-related lymphoedema using ImpediMed’s L-Dex technology resulted in a lower rate of progression to chronic disease, compared to patients with early detection using a tape measure
- ImpediMed says it believes these results will give clinicians the information required to begin early intervention on their patients at a stage when it’s possible to prevent the lymphoedema from advancing
- ImpediMed has come out of a trading halt up 6.67 per cent at 16 cents at 12:13 pm AEDT
ImpediMed (IPD) has rounded off its PREVENT trial, successfully meeting its primary end point.
The PREVENT study marked the largest recorded randomised controlled trial to assess lymphoedema prevention.
The primary aim of the trial was to determine if early intervention in patients with subclinical detection of extracellular fluid accumulation via bioimpedance spectroscopy resulted in a lower rate of lymphoedema progression.
The findings were based on a 1200-person trial over six and a half years, and followed up to three years, spanning across 13 hospitals in the US and Australia.
The study showed that intervention in patients with early detection of cancer-related lymphoedema using ImpediMed’s L-Dex technology resulted in a lower rate of progression to chronic disease, than patients with early detection from volume measurements using a tape measure. The results represented an absolute reduction of 11.3 per cent and relative reduction of 59 per cent.
The study also showed 92 per cent of patients with early detection of cancer-related lymphoedema using L-Dex and intervention did not progress to chronic lymphoedema.
“These results are significant, not just for ImpediMed, but for cancer patients and survivors at risk of lymphoedema,” Managing Director and CEO of ImpediMed Richard Carreon said.
“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.”
ImpediMed said it believed these results, combined with previously published data, would give clinicians the information needed to begin early intervention on their patients at a stage when it was possible to keep the lymphoedema from advancing.
The company’s paper on the study has been reviewed and, with the feedback to date, IPD remains confident it will be published in a peer-reviewed journal in the coming months.
With a preprint in the works, IPD said it could now more effectively plan its future and prepare for the next steps, including preparation of submissions to the National Comprehensive Cancer Network clinical practice guidelines and private medical insurance companies in the US.
“When the peer-reviewed paper is published, this will expand the opportunity for providers to be reimbursed for L-Dex testing, which we believe will result in a significantly wider and quicker adoption of the SOZO technology,” Mr Carreon said.
ImpediMed has come out of a trading halt and was up 6.67 per cent at 16 cents at 12:13 pm AEDT.