Game Changer?

Today could end up being the most important day in the company's history. In October, it appears that the a group of physicians appeared before the CPT Editorial Panel requesting a code change from Category III to Category I. A Summary of Panel's Actions for the October meeting should be posted today on the AMA website.

If successful, the Category I code would become effective January 1, 2015. The next step in the process would be for the new code to go on to the RUC which ultimately determines Medicare reimbursement associated with the new code.

If unsuccessful, the company would most likely re-apply for the code change within the next year.

A Category I code is a game changer for bioimpedance spectroscopy.

July 23 2013 YE PR - stock up 16% on release.

Key highlights from the quarter:

510(k) clearance received, strengthening the L-Dex U400 franchise in the U.S.

Record number of new customers acquired globally.

Orders from new customers and expanded ordering from key multi-site customers resulted in strong growth in the U.S. lymphoedema revenue quarter over quarter, both compared to same quarter last year and 3rdquarter of financial year 2013.

Continued expansion in Australia and New Zealand through collaboration with 3M and the Australasian Lymphology Association (ALA) resulted in strong revenue growth quarter over quarter, both compared to same quarter last year and 3rd quarter of financial year 2013

It's been a rocky road and a long slide from $0.90 five years ago to $0.09 today so thought it was time to revisit this company. As far as I am aware, no new technologies have stepped up to address the issue of lymphedema, the company's major focus and strongest path toward profitability.

I've updated the iBox to reflect what I believe the current status of the company to be. They appear to have cut way back on the burn rate but still face the two major challenges of gaining coverage from health insurance companies and upgrading their CPT status which would have a positive impact on such coverage, reimbursement and payment to physicians offering the test to their patients. A breakthrough in either or both 'impediments' could have a very positive impact on the current share price.

I'm a new Mod trying to post in the iBox a live stock chart of a company listed on the ASX. It's not listed in StockCharts (which I guess iHub owns).

Any suggestions? Also tried Yahoo charts and BigCharts links without success. ImpediMed has the ticker IPD on the ASX. I can find the chart everywhere except StockCharts but something in iHub doesn't like posting the link in my iBox.

At this same confernce (Experimental Biology), the company rolled out their new product for lab animal research - the ImpediVET. The device was described as being a bioimpedance spectroscopy device, just as the SFB7 for human body comp assessment, but optimized for lab animals such as mice, rats, rabbits, and even larger species such as pigs, cattle and horses.

It looks like this could be a very attractive device for researchers for a number of reasons:
1. They don't have to sacrifice animals to assess their body composition.
2. Researchers can easily assess fat, fat-free mass, total body water, intra- and extra-cellular fluids with a relatively simple 5 minute procedure.
3. The competition are big, expensive magnet based systems that cost over $100,000 each. The service agreements alone on those instruments cost more that the ImpediVET is apparently going to sell for ($15,000).
4. The device is completely portable so it can be taking to the animals rather than the animals being brought to the lab. ImpediVET can be brought into clean rooms or out into the field and other settings. It is powered by a lithium battery and will store the results for nearly 1000 animals!
5. Results are easily uploaded into company provided software via an Ethernet port on the back of the ImpediVET. From there, they can also be downloaded to Excel or Access programs.

With the number of instituions working on metabolic syndrome and obestiy using animal models, the fact that you can dynamically monitor these body composition parameters easliy should provide researchers with lots more biologically based information during the course of a study.

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!

BCM (ATM) and ECM

In addition to body compostion parameters (FM, FFM, TBW, ECF, ICF), outside the United States, ImpediMed's DF50 also reports Body Cell Mass (BCM), also called Active Tissue Mass (ATM) and Extracellular Mass (ECM). Within the US, the company was informed by the FDA that no predicate device has been approved which reports these parameters. In order to report BCM and ECM within the US, therefore, the company will have to file for additional FDA clearence. Until then, ImpediMed has taken the position that it will not promote nor display in its devices these non-FDA cleared parameters. Other bioimpedence device reporting BCM and/or ECM are doing so off-label.

Active tissue mass (Body cell mass), Extracellular mass (ECM) form part of the extended body compartment model used by some researchers and practitioners. Some practitioners have found that combinations of the basic body composition compartments can be useful when defining and documenting the change in the metabolically active areas of the body.

Active Tissue Mass or Body Cell Mass is the total mass of all the cellular elements in the body which constitute all the metabolically active tissue of the body. The ATM includes muscle tissue, organ tissue, and intracellular fluid. In the normally nourished individual, muscle tissue accounts for approximately 60% of the ATM, organ tissue accounts for 20% of ATM, with the remaining 20% made up of red cells and tissue cells. The ATM also contains the large majority (98-99%) of the body's potassium. These practitioners believe that ATM provides a way to document the nutritional status of an individual and track the calorific requirements of that person through the calculation of basil metabolic rate (BMR). BMR is a reported parameter in the DF50 Body Compostion Software.

The metabolically inactive components of body compostion then is made up of skeletal mass and extracellular fluid (ECF). A review of the literature shows that skeletal mass is generally assumed to represent about 12% of person's ideal body weight.

Practitioners within the US interested in these parameters can review published and public domain literature on these topics.

Health Fairs / Corporate Wellness

The DF50 can be operated in two different modes: Algorightm or Direct.

In the Algorithm mode, the operator chooses which of the three (3)algrorithms (General, Obese or Child) will be used on that subject and then programs the subject's height, weight, gender and age into the DF50 device. The measurement is then taken and the raw data is transformed into body composition parameters (FM, FFM, TBW, ECF and ICF) and displayed on the LCD screen of the device. All those results can then be sent to the Body Composition Analysis software provided with the DF50 for longitudinal tracking and graphing of the subject's results.

In the Direct mode, the DF50 immediately takes a reading and provides only the raw data on its LCD screen No programming of height, weight, gender and age is done on the device itself. That information can instead be entered into the Body Composition software using the computer keyboard! Many users may find this to be a faster means for processing high numbers of subjects, such as during a health fair or while in a corporate wellness event.

Two additional items add to the speed and provide a professional appearence to the report handed the subject: ImpediMed's IR Adapter and a portable printer. The writer recently acquire the Canon PIXMA iP90 portable printer. It operates in both a color and black/white mode and can be purchased for between $200 and $250.


With the DF50, IR Adapter and a portable printer, subjects can be quickly measured in the Direct mode while their demographics are typed into the Body Comp Software. The raw data can then be sent wirelessly from the DF50 to the software via the infra-red (IR)by touching the "Edit" button on the DF50. A report can be immmediately printed by going to Print\Analysis Detail in the Body Comp Software. Operated in this fashion, a single person can process subjects in as little as 2-3 minutes (20-30 subjects per hour). With two operators, one to type demographics into the software while the other prepares the subject and takes the reading, processing time can be reduced slightly further.

BTW, for those new to iHub, the Favorites menu above is a convenient place for storing links to other iHub boards of interest, to other specific posters who's input you may value, and for storing commonly used links to other internet sites. I have the Google link, for example, and several others I commonly use 'pre-programmed' into Favorite Links.

Papers on use of BIA for early detection and monitoring of Lymphedema

Cornish, BH, LC Ward, BJ Thomas and IH Bunce, Quantification of Lymphoedema using Multi-frequency Bioimpedance. Appl. Radia. Iso. Vol 49, No 5/6 pp 651-652, 1998

Cornish BH, IH Bunce, LC Ward, LC Jones and BJ Thomas. Bioelectrical impedance for Monitoring the Efficacy of Lymphoedema Treatment Programs. Breast Cancer Research and Treatment 38: 169-176, 1996

Cornish BH, M Chapman, C Hirst, B Mirolo, IH Bunce, LC Ward and BJ Thomas. Early Diagnosis of Lymphedema Using Multiple Frequency Bioimpedance. Lymphology 34 (2001) 2-11

Ward, LC; IH Bunce, BH Cornish, BR Mirolo, BJ Thomas and LC Jones. Multi-frequency Bioelectrical Impedance augments the Diagnosis and Management of Lymphoedema in post-mastectomy patients. European Journal of Clinical Investigation (1992) 22, 751-754

Cornish BH, BJ Thomas, LC Ward, C Hirst and IH Bunce. A New Technique for the Quantification of Peripheral Edema with Application in Both Unilateral and Bilateral Cases. Angiology Vol 53, No. 1, 2002

Hayes S et al. Comparison of methods to diagnose lymphoedema among breast cancer survivors: 6-month follow-up. Breast Cancer Research and Treatment. 89, 221 – 226, 2005.

Informative Papers on Lymphedema

Rockson, Stanley G; MD. Lymphoedema – A Review. The American Journal of Medicine; Volume 110; March 2001

Cornish BH, BJ Thomas, LC Ward, C Hirst and IH Bunce. A New Technique for the Quantification of Peripheral Edema with Application in Both Unilateral and Bilateral Cases. Angiology Vol 53, No. 1, 2002

Perrin M and JJ Guex . Edema and Leg Volume: Methods of Assessment. Angiology ‘The Journal of Vascular Diseases’ Vol 51 No. 1 - Jan 2000

ImpediMed's devices follow the NIH recommended guidelines for the use of bioimpedance in a clinical setting. The subject should be lying supine (on their back) so that their bodily fluids equilibreate. (When standing or sitting, gravity otherwise 'pulls' bodily fluids into the extremities.) The NIH guidelines also suggest a tetra-polar arrangement of the gel electrodes - two on the hand and two on the foot. That way the current travels through the leg, up through the torso, and through the arm - thus providing full body assessment. Scales you stand on send the BIA current up one leg and down the other. BIA machines you hold in your hands send the current up one arm and down the other. Neither method provides the accuracy of the full body, tetra-polar approach.

ImpediMed's DF50 is an excellent upgrade product for user's of the RJL System devices. Here's a brief overview:

The DF50 is a digit device so it doesn't need to be recalibrated. The RJL uses older analog technology. ImpediMed provides a test cell that allows users to verify the calibration is within range.

The DF50 uses algorithms that have been validated and published in peer-reviewed journals. The RJL uses a proprietary algorithm. Otherwise, there is a high degree of correlation between the raw data from the devices.

Results of body composition parameters (FM, FFM, TBW, ECF and ICF) are immediately available right on the LCD display on the DF50. The raw data of resistance, reactance, impedance and phase angle can also be viewed. The RJL must have the raw data run thru a software program on a computer in order to provide estimated body composition parameters.

Results can be 'beamed' into ImpediMed's Body Compostion software (provided with the device) via an infra-red (IR) port built into the device. The IR Adapter for the computer is the only option. The DF50 kit is supplied with all other components necessary to immediately begin using the device. Results can also be manually entered into the software by entering the raw data (either resistance and reactance OR the impedance and phase angle) along with the subject's weight and the algorithm of choice.

For anyone unfamiliar with iHub's Terms Of Use (TOU), the link below will bring you there:

http://www.investorshub.com/boards/complex_terms.asp

Another organization that provides very helpful information on lymphedema is The Lymphatic Research Foundation. Their website can be found at http://www.lymphaticresearch.org/main.php?content=home

From the same Wall Street Journal article:

Little-Known Risks
Here are some everyday issues than can trigger lymphedema in an arm or leg if lymph nodes have been removed or disrupted as part of cancer treatment

Carrying a heavy purse
Flying on an airplane
Excess consumption of salty foods
Sitting for long periods
Lengthy computer use
Hot tubs
Bug bites
Having your blood pressure checked

June 1, 2004

Health Journal

Efforts Mount to Combat Lymphedema,
A Devastating Side Effect of Cancer Care

By TARA PARKER-POPE
Staff Reporter of THE WALL STREET JOURNAL

A devastating side effect of cancer treatment is finally getting attention from doctors and lawmakers, but many patients still aren't aware of the risk.

The problem is called lymphedema, a painful and debilitating swelling of an arm or leg that can occur months or even years after cancer treatment. In patients whose lymphatic systems have been damaged by radiation or the removal of lymph nodes, even minor overuse of a limb can trigger extreme swelling. Breast-cancer patients, who may have lost a dozen or more lymph nodes as part of their diagnosis and treatment, are particularly susceptible. But patients treated for prostate cancer, gynecological cancers, head and neck cancer, testicular cancer, bladder cancer, colon cancer and melanoma are also at risk.

If not treated swiftly, the condition can be irreversible. But the problem is, many patients don't even know about it. Doctors often fail to warn about lymphedema, either because they themselves aren't aware of it or because they don't want to scare patients. Some physicians even mistakenly prescribe diuretics to reduce swelling -- a treatment that can actually exacerbate the disease.

Ignorance can have serious consequences. Simple acts like carrying a heavy bag, cutting a finger or working too long at the computer can trigger the swelling. That's because the body responds to infections, injury or exertion by making extra fluid. The lymphatic system normally helps drain this fluid from body tissues, but in someone with a compromised system, even a slight increase in fluid buildup can quickly lead to overload, causing swelling in an arm or leg, depending on where the lymph nodes were removed. The limb can swell far out of proportion to the rest of the body.

While data are scarce, studies so far show from 20% to 45% of patients who are at risk for lymphedema will eventually develop it. Treatment can last for a few weeks, or for the rest of a patient's life, and involves constant care, including physical-therapy treatments, special exercises, bandages and compression garments.

"Patients usually are not educated in advance so they're not aware of some of the risk factors and the fact that they could take precautions," says Pam Massey, director of rehabilitation services at University of Texas M.D. Anderson Cancer Center in Houston. To prevent the problem, patients should avoid overuse of the arm or leg most at risk and learn to recognize symptoms so they can seek treatment quickly.

Lymphedema is beginning to get more attention in part because so many cancer patients now are living far longer, forcing doctors and researchers to focus on the long-term effects of cancer treatments. And patient advocates are pushing to improve insurance benefits for the treatments. Insurers often deny coverage because they don't have a certified lymphedema specialist in their plan, or some plans may put a cap on the amount of treatment a patient receives. In January, a Virginia law began requiring insurers to cover the costs of lymphedema treatment and supplies. Lawmakers in New York and Massachusetts also are mulling lymphedema-related legislation.

But for many patients, the biggest hurdle is getting the right diagnosis. Long Island, N.Y., shop owner Catherine Pascucci had three lymph nodes removed and a lumpectomy and radiation treatment for breast cancer three years ago. After her surgery, she returned to her fragrance shop, lifting boxes and ringing sales, never knowing that such overuse put her at risk for lymphedema.

About three months after cancer surgery, she noticed her bracelet was tight, but her breast surgeon dismissed her swollen arm as a reaction to a bug bite. Months later, another doctor told her about lymphedema, and she finally sought the right treatment. Today she must undergo regular physical-therapy treatments and wear compression bandages on both arms to control the swelling.

"My doctors never said, 'Don't lift. Don't carry,' " says Ms. Pascucci, 65 years old, who now hands out lymphedema brochures to customers. "Now I have to deal with this the rest of my life."

When lymphedema is caught early, treatment is relatively effective and the condition can be kept under control with minimal care. A physical therapist, who should have 120 to 140 hours of specialized training, uses a gentle massage that helps the fluid drain away from the painful arm or leg. The treatment, which may be needed two or more times a week for several weeks, can cost as much as $200 for an hourlong session. Custom compression garments and bandages can cost $700 or more, and most patients need two sets. The garments generally must be replaced every six months.

Delays in treatment can be disastrous. After surviving invasive cervical cancer, Folsom, Calif., resident Carolyn Chastain developed lymphedema, but her insurer wouldn't pay for visits with a trained specialist, sending her to an unqualified therapist within the plan and providing ill-fitting bandages. After finally complaining to state regulators about the inadequate treatment, the denials were reversed. But the delay in getting proper treatment left her with an irreversible form of the disease. The 43-year-old aerospace engineer was forced to quit work and now spends about eight hours a day on treatment, bandage care and exercises to cope with extensive swelling in both legs.

"The last thing a person should have to do after battling for their life with cancer," she says, "is to fight for every pittance of health care related to lymphedema."

The National Lymphedema Network, www.lymphnet.org, provides extensive information on the disease.

E-mail healthjournal@wsj.com.

Single frequency, multi-freqency and bioimpedance spectroscopy

Bioimpedance is often referred to generically as BIA (Bioelectrical Impedance Analysis) but a variety of different approaches exist. For the purpose of standardization, I would like to suggest the following definitions:

Bioimpedance - generically includes any of the methods defined below.

Single-frequency bioimpedance - uses only one frequency of current.

Multiple- or multi-frequency bioimpedance - generally use 2 to 10 different frequencies of current.

Bioimpedance Spectroscopy or BIS - use a spectrum of 256 different frequencies when taking readings. Devices using BIS most often will employ a Cole-Cole plot of resistance (R) versus Reactance (Xc) to determine Rinf, or the theoretical resistance at infinity and Rnaught or Rzero (Ro), the theoretical resistance at a zero frequency. Rinf provides a measure of Total Body Water (TBW) while Ro provides a measure of Extra-cellular fluid (ECF). The level of fluids lying inside the body's cells, or Intra-cellular fluid (ICF) can be derived by subtracting ECF from TBW.


Single frequency devices rely on the use of algorithms to estimate body composition parameters. Algortihms, also called prediction equations, are mathematically derived by studying a population while using both bioimpedance and the reference method for the parameter of interest, TBW for example. The basic assumption when using a single frequency bioimpedance device is that the subject or patient is similar that those that made up the population from which the prediction equation was derived. Since body composition can vary by gender, ethnicity and race, matching the subject to a proper algorithm is critical. ImpediMed's single frequency device, the DF50, provides the choice of three agrorithms. (#msg-9790870)

Bioimpedance spectroscopy or BIS is a direct measure and does not rely on the use of algorithms to determine the subject's TBW and ECF. This makes BIS more robust across different genders, ethnic groups and races.

DF50 algorithms

ImpediMed's DF50 is an FDA cleared medical device. It uses a single 50 kHz frequency and algorithms to provide assessments of body composition. As of this date (February 19, 2006), ImpediMed's DF50 provides three (3) algorithm that the user of the device can choose from. All three have been published in peer-reviewed medical journals. Here are the citations on the three algorithms:

General Population - Lukaski, et al
Lukaski HC, Johnson PE, Bolonchuk WW, Lykken GI. Assessment of fat-free mass using bioelectrical impedance measurements of the human body. American Journal of Clinical Nutrition, 41: April 1985, pp 810-817

Obese Population - Segal, et al
Segal K, van Loan M, Fitzgerald PI, Hodgdon J, Van Itallie T. Lean body mass estimation by bioelectrical impedance analysis; a four-site cross-validation study. American Journal of Clinical Nutrition, 47: 1988, pp 7-14

Pediatric Population - Cordain, et al
Cordain L, Whicker R, Johnson J. Body composition determination in children using bioelectrical impedance. Growth Development & Aging, 52:1988 pp 37-40

Welcome to the ImpediMed board on Investors Hub! This board has been created for the benefit of not only potential investors but also those using ImpediMed's devices, those interested in learning more about the clinical utility of bioimpedance, and those already knowledgable about the technology wishing to contribute to the discussion.

As menioned in the Board Information area (iBox), ImpediMed is an Australian biotech with offices in Brisbane. (Brisbane lies within the State of Queensland.) The company is currently privately held but may have an IPO on either the Australian Stock Exchange or NASDAQ one day.

I'm forewarned that newcomers should familiarize themselves with iHub's Terms of Use or (TOU) as they refer to them. Basically, they call for civil posting, no spam and no verbal attacks on other posters. Probably best if you take a few moments to read them yourself if you haven't done so already.

Beyond that, we're open for business!! Welcome!

How does this company's product measure blood flow? I assume it is non-invasive.

26th of Feb at 10;30 AM EST