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IMPEDIMED LIMITED — Investor Presentation 2012
Feb 27, 2012
65135_rns_2012-02-27_64e3a464-f429-4623-9a8f-c61c7f0d16d3.pdf
Investor Presentation
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ASX : IPD
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28 February 2012
ImpediMed Company Presentation
Brisbane, Australia. – ImpediMed Limited (ASX: IPD) refers shareholders to the attached Company presentation being given today at the Citi, 2012 Global Health Care Conference in New York.
For more information: Greg Brown CEO & Director
T: +61(7) 3860-3700
M: +61408281127
About ImpediMed
ImpediMed Limited is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed’s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphoedema. Pre-operative clinical assessment in cancer survivors, before the onset of symptoms, may prevent the condition from becoming a lifelong management issue and thus improve the quality of life of the cancer survivor. ImpediMed has the first medical device with an FDA clearance in the United States to aid health care professionals, clinically assess secondary unilateral lymphoedema of the arm and leg in women and the leg in men. For more information, visit: www.impedimed.com.au
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ImpediMed Limited
Company Presentation
February 2012
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Disclaimer
This presentation has been produced by ImpediMed Limited (“ImpediMed”) only and may contain forward-looking statements that are based on management’s current expectations, beliefs and assumptions and are subject to a number of risks and uncertainties. The forward-looking statements contained in this presentation (which may include words such as “expects”, “anticipates”, “plans”, “believes”, “scheduled” or “estimates”) include statements about future financial and operating results, status of our regulatory submissions, coverage, possible or assumed future growth opportunities and risks and uncertainties that could affect ImpediMed’s product and products under development. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from those described. In any forward-looking statement in which ImpediMed expresses an expectation or belief, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished. We are not under any duty to update forward-looking statements unless required by law.
This investor presentation update is not an offer of securities.
ImpediMed and its directors, employees, associates, affiliates and agents, make no:
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(a) representations or warranties, expressed or implied, in relation to this presentation or the accuracy, reliability or completeness of any information in it or the performance of ImpediMed; and
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(b) accept no responsibility for the accuracy or completeness of this presentation and the information contained in it.
This presentation is intended to provide background information only and does not constitute or form part of an offer of securities or a solicitation or invitation to buy or apply for securities, nor may it or any part of it form the basis of, or be relied on in any connection with any contract or commitment whatsoever. The information in this presentation does not take into account the objectives, financial situation or particular needs of any person. Nothing contained in this presentation constitutes investment, legal, tax or other advice. This presentation does not, and does not purport to, contain all the information prospective investors in ImpediMed would desire or require in reaching an investment decision.
To the maximum extent permitted by law, none of ImpediMed, its officers, directors, employees, associates, affiliates or agents, nor any other person accepts any liability for any loss, claim, damages, costs or expenses of any nature (whether or not foreseeable), including, without limitation, any liability arising from fault or negligence on the part of any of them or any other person, for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it or any errors or omissions in it.
The distribution of this presentation in jurisdictions outside Australia may be restricted by law and you should observe any such restrictions. This presentation has not been filed, lodged, registered or approved in any jurisdiction and recipients of this presentation should keep themselves informed of and comply with and observe all applicable legal and regulatory requirements. In Australia this presentation is made only to sophisticated or professional investors under the Corporations Act.
Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended.
Please review financial releases on ImpediMed’s website (www.impedimed.com) for a complete listing of risk factors.
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Capital Structure
Capital Structure – ASX: IPD
| Share Price4 | A$ 0.53 |
|---|---|
| Listed shares on issue (million)1 | 156.3 |
| Unlisted shares (million)2 | 0.2 |
| Listed options (million)2 | 12.5 |
| Unlisted options (million)2 | 10.2 |
| Undiluted market cap (million) | A$ 82.8 |
| Fully diluted market cap (million)3 | A$ 95.0 |
| Cash (million)1 | A$ 12.1 |
| Enterprise value (million) | A$ 82.9 |
Company listed on the ASX
12 Month Share Price Performance
Share pricing in AUD
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$0.85 1600
$0.80 1400
$0.75 1200
$0.70
1000
$0.65
800
$0.60
600
$0.55
$0.50 400
$0.45 200
$0.40 0
Thousands
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ASX: IPD - Share Pricing - Volume ASX: IPD - Share Pricing
1 Source: ImpediMed Half-Year Report ending 31 December 2011
2 Source: ImpediMed Appendix 3B issued 8 December 2011
3 Includes performance shares, listed options and unlisted options
4 As at 20 February 2012
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Executive Summary
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Medical Device Company
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Point of care testing device – razor/razor blade business model
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Intellectual Property around technology platform and applications
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First to market - targeting underserved areas in medicine
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Targeting Fluid Status Applications
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Lymphedema - direct measure of ECF differences of the limbs not total volume
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Pathophysiology shows ECF differences relevant in early stages of lymphedema
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Future targeted applications – venous insufficiency and fluid status in dialysis
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Commercial Progress - Lymphedema
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Regulatory - FDA cleared - aid in clinical assessment of unilateral lymphedema
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Clinical support – Technical performance / Diagnostic performance / Outcomes
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Reimbursement status – Category III code in place for BIS platform
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Economics – clinical based model shows strong case for prospective care
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Lymphedema - Current Diagnosis is often too late
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- Reactive model of care today
- “Lymphedema is a chronic debilitating disease that is frequently misdiagnosed, treated too late, or not treated at all” - _J Nucl Med 2003; 44:43–57_
- Often diagnosed when patient has visible symptoms – at this point patient can already have irreversible changes
- “When treated in the earliest stages, complications of this condition may be minimized” - _CA Cancer J Clin 2009;59;8-24_
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“Upper extremity lymphoedema is one of the most dreaded sequelae of breast cancer (BC) treatment”
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J Clinical Oncology, Vol 27, 2009
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The device is not intended to diagnose or predict lymphedema of the extremity
Lymphedema Incidence Rates
See reference information at end of presentation
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Armer J and Stewart B: Post Breast Cancer Lymphedema. Incidence increases from 12 to 30 to 60 months. Lymphology 43 (2010) 118-127
Conclusion: LE incidence at 5 years: Ranged from 43%-94% depending on method used
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The device is not intended to diagnose or predict lymphedema of the extremity
Bioimpedance Spectroscopy (BIS)
BIS technology directly measures the extracellular fluid
At low frequency At high frequency Cell membrane Intercellular fluid Extracellular fluid
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ImpediMed’s BIS Technique
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The device is not intended to diagnose or predict lymphedema of the extremity
ImpediMed’s L-Dex[®] U400
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Direct measure for extracellular fluid (ECF) differences of the limbs to aid in clinical assessment of unilateral lymphedema
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Pathophysiology of lymphedema shows ECF levels are relevant mainly for early changes. In chronic state ECF levels can decrease
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The device is not intended to diagnose or predict lymphedema of the extremity
Current Detection Methods - Synergistic for Different Stages of Lymphedema
| Detection Method | Direct or indirect measurement, volume or ECW |
FDA clearance for lymphedema assessment |
Reproducibility/Accuracy |
|---|---|---|---|
| Tape measure | Volumetric calculation of limb by measuring diameter at prescribed intervals along limbs |
No | Non-standardized, subjective measurement with no universal cut off Ideal for later stages |
| Water displacement | Volumetric calculation of limb using ‘Archimedes’ principal |
No | Non-standardized and subjective measurement Ideal for later stages |
| Perometer | Volumetric calculation 80% of limb using an infrared scan |
No | Standardized and objective measurement for volume only Ideal all stages |
| BIS | Direct measure of relevant compartment for early changes - the extracellular fluid differences between limbs |
Yes | Standardized and objective measurement specific for lymphedema changes Relevant mainly for early stage |
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Regulatory Status
- First FDA cleared device - Indications for use/intended use:
A bioelectrical impedance analyzer/monitor for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extra cellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.
The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated. The device is not intended to diagnose or predict lymphedema of the extremity
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The device is not intended to diagnose or predict lymphedema of the extremity
Targeting Multiple Fluid Status Markets
Lymphedema market - Arms
Today & Near Term
Lymphedema market - Legs
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Arms - female breast cancer
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Legs - pelvic cancer
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TGA, FDA, and CE cleared (Uni only)
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Estimate - US$150m+ annually
Dialysis market
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Fluid status monitoring in dialysis patients
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TGA, FDA, and CE cleared (Uni only)
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80% of market, 70% unilateral
Estimate - US$400m+annually Fluid Status Fluid Technology Status Market platform Oedema market
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Venous insufficiency
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Pelvic cancers - differentiation of lymphoedema / oedema
Future
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Business Model – Reimbursement Critical to Drive Model
Illustrative Device Economics
Assumptions (based on primary target surgeon)
Per Reading (USD) Reimbursement¹ Up to $400 Consumables¹ Up to $85 Net Clinic/Surgeon Up to $315
Target list price per reading up to US$85
Clinician enrols 8 new patients per month
Quarterly reading over the first three years Builds to annual reading volume of 1,152
¹Reimbursement and consumable amounts are targets - indicative only
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Approximately 250 surgeons treat 20% of all breast cancer patients
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Top 2,000 US surgeons treat approximately 60% of patients
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IPD est. around 800 US surgeons treat around 40% to 45% of all patients – primary target
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IPD est. up to 8,000 US surgeons operate on the breast – service through Radiation/Oncology
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Reimbursement Status
1. L-Dex reading coverage beginning in the market
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Coverage occurring sporadically– EOB’s showing reimbursement of CPT 0239T
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Examples of major private payers covering at local levels - only seen in certain states at present
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Payment is around an average of $200 presently
2. Covered lives metric - medical policy
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14.5 million covered lives announced to date
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Advancing private payers & HMO’s
3. Membership metric - managed Care
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5 PPO signed contracts in place for handling reimbursement claims
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Beech Street – Viant (BSV) – covering some claims (no contract)
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BSV is an at risk PPO with 16 million members - Covering L-Dex clients at a percentage of billed charges or contracted default percentage discount when billing CPT 0239T
4. Key obstacles for building covered lives – medical policy
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Need clinical outcomes data for L-Dex over present conventional methods – key to health economics Looking for longer term outcomes data comparing conventional intervention vs Earlier detection
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Lack of understanding to the limitations of conventional methods for early assessment
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Referenced arguments listed on website; Red Journal article in October
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The device is not intended to diagnose or predict lymphedema of the extremity
Clinical Studies – Payer Categories for Assessment
Early Dx/Treatment Improved Outcomes
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Key studies
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Campisi 2002 (RCT)
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Boccado 2009 (RCT)
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LaComba 2010 (RCT)
- Stout 2008
Reactive Care Poor outcomes
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Referred/Dx at later stage (200ml difference)
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Treatment often starts after irreversible change
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Johansson 2010
- Dini 1998
Clinical Assessment Aid for Doctors - BIS
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Technical Performance
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Van Loan 1993,1999 (RCT)
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Cornish 1996, Czerniec 2010
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Hayes 2008, Czerniec 2009
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Diagnostic performance
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Hayes 2005, 2008, 2011
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Cornish 1996, 2001
- Ward 2009
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The device is not intended to diagnose or predict lymphedema of the extremity
Prospective Care / Early Treatment – Data supporting outcomes
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1 year 2 years 5 years 10 years
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| Stout 2008 • Prospective 5 year observational trial 196 breast cancer patients • Tested preoperative, baseline, 1, 3, 6, 9, and 12 month assessment post surgery with Perometry • 22% (43 pts) developed • Used 3% cut off for subclinical lymphedema definition • Compression sleeve LaComba 2010 • RCT comparing prophylactic treatment v. education only • 120 patients • 1 year follow up • > 2cm arm difference defined lymphedema • Control 25% develop, treated arm 7% • Difference statistically significant at 1 yr • 72% prevention 1yr Boccado 2009 • 2year follow up– 55pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline & 6mth • Followed up for 3 years by water displacement – 200ml difference defn • Control 33% develop, early dx/treatment arm 8% • 76% prevention 2yrs Campisi 2002 • 5 year follow up– 50pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline 1,3,6mths, 1,2,3yrs • Followed up for 5 years by water displacement – 200ml difference defn • Control 36% develop, early dx/treatment arm 8% • 79% 5yr prevention Johansson 2010 • 10 year treatment F/U • 292 patients at risk – 111 cases develop (ave. - 8% cut off) – 38.2% incidence over study • Treatment after recognition by water displacement - no patient returned to baseline – only slowed further progression • All remained stage II or greater Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients - 1 year 22% (developed subclinical) All returned to near baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated 111 patients developed 38% Dx (111pts) /no return |
Stout 2008 • Prospective 5 year observational trial 196 breast cancer patients • Tested preoperative, baseline, 1, 3, 6, 9, and 12 month assessment post surgery with Perometry • 22% (43 pts) developed • Used 3% cut off for subclinical lymphedema definition • Compression sleeve LaComba 2010 • RCT comparing prophylactic treatment v. education only • 120 patients • 1 year follow up • > 2cm arm difference defined lymphedema • Control 25% develop, treated arm 7% • Difference statistically significant at 1 yr • 72% prevention 1yr Boccado 2009 • 2year follow up– 55pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline & 6mth • Followed up for 3 years by water displacement – 200ml difference defn • Control 33% develop, early dx/treatment arm 8% • 76% prevention 2yrs Campisi 2002 • 5 year follow up– 50pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline 1,3,6mths, 1,2,3yrs • Followed up for 5 years by water displacement – 200ml difference defn • Control 36% develop, early dx/treatment arm 8% • 79% 5yr prevention Johansson 2010 • 10 year treatment F/U • 292 patients at risk – 111 cases develop (ave. - 8% cut off) – 38.2% incidence over study • Treatment after recognition by water displacement - no patient returned to baseline – only slowed further progression • All remained stage II or greater Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients - 1 year 22% (developed subclinical) All returned to near baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated 111 patients developed 38% Dx (111pts) /no return |
Stout 2008 • Prospective 5 year observational trial 196 breast cancer patients • Tested preoperative, baseline, 1, 3, 6, 9, and 12 month assessment post surgery with Perometry • 22% (43 pts) developed • Used 3% cut off for subclinical lymphedema definition • Compression sleeve LaComba 2010 • RCT comparing prophylactic treatment v. education only • 120 patients • 1 year follow up • > 2cm arm difference defined lymphedema • Control 25% develop, treated arm 7% • Difference statistically significant at 1 yr • 72% prevention 1yr Boccado 2009 • 2year follow up– 55pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline & 6mth • Followed up for 3 years by water displacement – 200ml difference defn • Control 33% develop, early dx/treatment arm 8% • 76% prevention 2yrs Campisi 2002 • 5 year follow up– 50pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline 1,3,6mths, 1,2,3yrs • Followed up for 5 years by water displacement – 200ml difference defn • Control 36% develop, early dx/treatment arm 8% • 79% 5yr prevention Johansson 2010 • 10 year treatment F/U • 292 patients at risk – 111 cases develop (ave. - 8% cut off) – 38.2% incidence over study • Treatment after recognition by water displacement - no patient returned to baseline – only slowed further progression • All remained stage II or greater Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients - 1 year 22% (developed subclinical) All returned to near baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated 111 patients developed 38% Dx (111pts) /no return |
Stout 2008 • Prospective 5 year observational trial 196 breast cancer patients • Tested preoperative, baseline, 1, 3, 6, 9, and 12 month assessment post surgery with Perometry • 22% (43 pts) developed • Used 3% cut off for subclinical lymphedema definition • Compression sleeve LaComba 2010 • RCT comparing prophylactic treatment v. education only • 120 patients • 1 year follow up • > 2cm arm difference defined lymphedema • Control 25% develop, treated arm 7% • Difference statistically significant at 1 yr • 72% prevention 1yr Boccado 2009 • 2year follow up– 55pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline & 6mth • Followed up for 3 years by water displacement – 200ml difference defn • Control 33% develop, early dx/treatment arm 8% • 76% prevention 2yrs Campisi 2002 • 5 year follow up– 50pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline 1,3,6mths, 1,2,3yrs • Followed up for 5 years by water displacement – 200ml difference defn • Control 36% develop, early dx/treatment arm 8% • 79% 5yr prevention Johansson 2010 • 10 year treatment F/U • 292 patients at risk – 111 cases develop (ave. - 8% cut off) – 38.2% incidence over study • Treatment after recognition by water displacement - no patient returned to baseline – only slowed further progression • All remained stage II or greater Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients - 1 year 22% (developed subclinical) All returned to near baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated 111 patients developed 38% Dx (111pts) /no return |
Stout 2008 • Prospective 5 year observational trial 196 breast cancer patients • Tested preoperative, baseline, 1, 3, 6, 9, and 12 month assessment post surgery with Perometry • 22% (43 pts) developed • Used 3% cut off for subclinical lymphedema definition • Compression sleeve LaComba 2010 • RCT comparing prophylactic treatment v. education only • 120 patients • 1 year follow up • > 2cm arm difference defined lymphedema • Control 25% develop, treated arm 7% • Difference statistically significant at 1 yr • 72% prevention 1yr Boccado 2009 • 2year follow up– 55pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline & 6mth • Followed up for 3 years by water displacement – 200ml difference defn • Control 33% develop, early dx/treatment arm 8% • 76% prevention 2yrs Campisi 2002 • 5 year follow up– 50pts • Lymphoscintigraphy (LP) early diagnosis • LP at Baseline 1,3,6mths, 1,2,3yrs • Followed up for 5 years by water displacement – 200ml difference defn • Control 36% develop, early dx/treatment arm 8% • 79% 5yr prevention Johansson 2010 • 10 year treatment F/U • 292 patients at risk – 111 cases develop (ave. - 8% cut off) – 38.2% incidence over study • Treatment after recognition by water displacement - no patient returned to baseline – only slowed further progression • All remained stage II or greater Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients - 1 year 22% (developed subclinical) All returned to near baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated 111 patients developed 38% Dx (111pts) /no return |
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|---|---|---|---|---|---|
| Trials | Detection | Follow-Up | Control Arm | Treatment Arm | |
| Stout (Observational) | Perometry >3% difference | 196 patients - 1 year | 22% (developed subclinical) | All returned to near baseline | |
| Campisi (RCT) | Lymphoscintigraphy | 50 patients – 5 years | 36% | 8% | |
| Boccado (RCT) | Lymphoscintigraphy | 55 patients – 2 years | 33% | 8% | |
| LaComba (RCT) | Prophylaxis vs educate | 120 patients – 1 year | 25% | 7% | |
| Johansson (Observational) | Water displacement (8%) | 292 patients – 5 /10yrs treated | 111 patients developed | 38% Dx (111pts) /no return |
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The device is not intended to diagnose or predict lymphedema of the extremity
Support Building for Prospective care
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NAPBC clinical Standard 2.15 “Support and Rehabilitation”
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Part of the comprehensive breast cancer care program. This standard strongly recommends lymphedema management and risk reduction practices for the treatment of all breast cancer patients. The NAPBC clinical Standard was updated and published in the “2011 Breast Center Standards Manual”
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Under this standard, it recommends the National Lymphedema Network (NLN) supporting guideline document, referenced under the Center Resource section of the site – this supports baseline testing at baseline and every subsequent visit for the life of the patient.
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Avon Foundation White paper – calls for prospective care
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Clinical based Economic Model – gives clinical and economic potential benefits
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The device is not intended to diagnose or predict lymphedema of the extremity
ImpediMed’s Technology Stands to Benefit All Stakeholders
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Patients – common fear given incidence. New Prospective care model ensures education and risk reduction strategies for all patients, with prompt treatment at the earliest signs
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Providers - now have a medical device that can measure ECF differences which is reliable, easy to use; and profitable for their practices. Incentive for patient education/prevention
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Payers – lymphedema treatment is expensive and life long for chronic patients. Prospective care with earlier treatment can reduce costs significantly
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Reactive care – “the costs of managing a patient with breast cancer related lymphoedema (BCRL) were significantly higher (in the range of $US14,877 to $US 23,167) over a two year period, than those breast cancer patients without lymphoedema”
“Incidence, Treatment Costs, and Complications of Lymphedema After Breast Cancer Among Women of Working Age: A 2-Year Follow-Up Study”; Ya-Chen Tina Shih, Ying Xu, Janice N. Cormier, Sharon Giordano, Sheila H. Ridner, Thomas A. Buchholz, George H. Perkins, Linda S. Elting JCO Mar 16 2009: doi:10.1200/JCO.2008.18.3517
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Next generation technology - UB500 Uni- & Bi-Lateral arms and legs
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Summary Slide – final requirement is coverage
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First to Market Addressing large underserved medical needs – improving outcomes & Economics
Intellectual Property Patents, applications & trademarks - platform / lymphedema / edema
Regulatory leadership First FDA cleared device with a lymphedema claim - aid to clinical assessment
Reimbursement Technology specific category 3 CPT code for lymphedema
Clinical & Economic
Ten years of peer review on clinical performance for ECF plus health economics
validation
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