Medical device manufacturer ImpediMed (ASX: IPD) has provided an early insight into forthcoming results from its PREVENT trial by publishing “the first of a number of manuscripts” from its ongoing trial.
The latest results were published in ‘Lymphatic Research and Biology’ magazine, indicating that L-Dex is “very sensitive” in the assessment of sub-clinical lymphoedema in patients with a history of breast cancer. The authors also said that “frequent L-Dex measurements during that time frame are of potential clinical benefit.”
The published paper also supports the recommendation for an “aggressive measurement protocol” consisting of an L-Dex assessment every three months, especially during the first 6-12 months after patients have undergone surgery, to facilitate identification of sub-clinical lymphoedema.
“This publication significantly adds to our growing body of clinical evidence necessary to obtain payment from private payers. This publication will also be used as part of our submission to the NCCN guidelines to establish BIS as the standard of care for monitoring patients at risk of developing lymphoedema,” said Richard Carreon, managing director and CEO of ImpediMed.
Commercialising lymphoedema detection
ImpediMed specialises in designing and manufacturing medical devices using what’s known as “bioimpedance spectroscopy” (BIS) technologies and applied to deliver a variety of non-invasive clinical assessments and monitoring capabilities.
ImpediMed produces a family of “FDA-cleared” and CE-Marked medical devices, including SOZO for multiple indications including heart failure and lymphoedema.
The company also makes the L-Dex device, a means of quantifying changes in the amounts of extracellular fluid in a patient’s limbs. By taking accurate real-time readings, these changes can be documented and used to assist surgeons in clinically assessing early signs of lymphedema.
According to scientific research, recognising lymphedema early, and treating it promptly, is the best way to manage the condition. Without appropriate and timely treatment, lymphedema can lead to pain, cause recurrent infections, reduce mobility and impair bodily function.
In response, ImpediMed says it has developed a range of bioimpedance devices that measure subclinical changes in extracellular fluid which can in turn “detect lymphedema up to 10 months earlier than current methods.”
First news from ImpediMed’s keenly-anticipated trial was immediately pounced upon by investors, sending the company’s shares up 21% to $0.425 per share in late afternoon trade.