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Monday, 05/07/2007 11:35:03 PM

Monday, May 07, 2007 11:35:03 PM

Post# of 19
Spoke at length with a representative of the company during a recent medical/research conference.

They've apparently recently received FDA clearance on their XCA device for clinical assessment of uni-lateral lymphedema. This is a not so uncommon side effect of breast cancer surgery and radiation. Between 20-30% of women will go on to develop the disease so its not uncommon nor insignificant. Additionally, breast cancer survivors are at life long risk although the company believe they will be able to distinguish "high risk" women from "low risk" women within three to four months after surgery. Such risk stratification would allow high risk women to ultimately use a home care product while low risk women would be periodically monitored by a clinician.

The company says they've already signed a couple of the schools of lymphedema therapy as distributors. Feedback from occupational therapists (OT's) and physical therapists (PT's) in New England has been very, very positive they report. Not surprising! ImpediMed's device is probably the first new technology most of these OTs and PTs have had access to. The current standard of care is a tape measure for measuring arm circumference and estimating total volume. The only other new technology to come this way in years has been a device called the Perometer - a laser based scanner that calulates limb volume essentially by a 3-D scan. ImpediMed's XCA detects only extracellular fluid - basically lymph - and therefore is much more specific than tape measure or Perometer that only measure total limb volume. And one of the biggest advantages will be the time savings. Tape measure apparently takes 25 minutes to measure the at-risk arm and then measure the normal arm. the XCA takes less than 5 minutes.

The ImpediMed rep explained that the 20 minute time savings per patient (25 minutes vs 5 minutes) would allow OTs and PTS to schedule one extra patient for every three coming in for manual lymph drainage therapy. The device could basically pay for itself after only 5 patients per month!
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