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Distrubuted in the UK by Haddenham Healthcare Ltd

An innovative solution for night bandaging

SETTLEMENT Nett 30 days. Accounts payable monthly. We reserve the right to charge interest on amounts outstanding over 30 days at the current bank rate + 3% on a daily basis.

DELIVERY/HANDLING Standard charge of £3.90 ex VAT applies to each requested delivery. Additional charge may be levied for courier service. Delivery times are approximate and are dependent on the order being received and complete. Haddenham Healthcare Ltd cannot be held responsible for a courier’s failure to deliver to the specified time due to adverse weather conditions or other exceptional circumstances.

PRICES Subject to change without notice. Exclude VAT.

RETURNS Customer liability returns for Credit Note are subject to a £5.00 handling charge per item. Returned goods must be in a saleable condition and have a minimum of 18 months shelf life remaining.

NON DELIVERY Non receipt of goods must be notified, in writing, within 21 days of the date on the despatch note/invoice.

WARRANTY Products are guaranteed against defects in material and manufacture. Specific warranty terms vary per product. Please consult each individual product’s ‘Instructions for Use’ for details.

LIABILITY Responsibility for the selection and application of products rests with the professional staff treating the patient.

Haddenham is a registered trademark of Haddenham Healthcare Ltd, UK; Mobiderm is a registered trademark of Thuasne, France. Images on pages 2, 3, 5, 6 and front cover are reprinted with permission from Thuasne, France.

© 2016 Haddenham Healthcare Ltd.

CONTENTS

INTRODUCING MOBIDERM AUTOFIT 2

ABOUT AND CARE INSTRUCTIONS 3

SIZING AND ORDER CODES 4

CLINICAL TRIAL INFORMATION 5

TERMS & CONDITIONS

Semi-open garment:Easy to put on, easy to take off!

Sleeve with attached retractable mitten: limits the risk of œdema migration; the hand can be freed for usual tasks

Velcro fasteners: instant setup and high performance

Several tightening notches:adaptation to each patient’s individual morphology.Adjustment marks: precise and repeatable application, control of the œdema volume variation

The standard, self-adjustable sleeve, to adapt to each patient’s individual morphology and evolution overtime!

Description :Self-adjustable sleeve, with mitten and thumb for the upper limb lymphoedema

For which patients?• For all stages of the lymphoedema• To be used during the maintenance phase or at the end of the reduction phase• For patients presenting dysmorphims or progressive oedema• For patients who wish autonomous control of their oedema• For patients who need a product immediately

2

In order to maintain results obtained during the intensive phase of bandage application, the patient must have access, during the maintenance phase, to a permanent, efficient and comfortable treatment. His/her autonomy will contribute to observance of the treatment prescribed and can guarantee its long-term success.

Taking over from day-time compression and as a genuine alternative to self-bandage, garments have been developed to continue mobilising the oedema during the night, and thereby reinforce the effects of the day-time treatment.

These garments are made of a soft elastic material designed to deliver a soft pressure, well-accepted by patients in the night-time phase. They are fitted with the device on the inside, which helps promote lymphatic circulation with micro-massages.

A unique night-time treatment:Helps preserve effects achieved by day-time compressionand continue the night-time treatment without interruption.

An unintrusive and discreet treatment: Works during sleep without disturbing it.

Rapid application:A single garment to put on.

Care instructions

Close the velcro fasteners prior to washing.

Two wash options are possible:

Hand wash:Soak the device in cold soapy water, rub with a clean sponge and squeeze the water out by pressing.

Machine wash:Use the wool cycle, at cold temperature, and use a laundry net. Hand squeeze the water out by pressing.In both cases, let dry at room temperature away from any direct source of heat.When not used, the sleeve should be kept flat, with the velcro fasteners closed.If it must be folded, position the hooks pointing outward.

Maintaining Results

Mobiderm®Pads

Epidermis

Dermis

Main components:• Outer layer of the garment: 59 % polyamide, 41 % elastane• along the arm: adhesive non-woven, polyurethane foam (15 x 15 mm cubes)• hand level: adhesive non-woven, polyethylene foam (5 x 5 mm cubes)

ABOUT MOBIDERM AUTOFIT

3

DRUG TARIFF PIP CODES

ARM 1 2 3 4 5 6 LENGTH

RIGHT 400 - 9056 400 - 9064 400 - 9072 400 - 9080 400 - 9098 400 - 9106NORMAL

LEFT 400 - 8934 400 - 8942 400 - 8959 400 - 8967 400 - 8975 400 - 8983

RIGHT 400 - 8991 400 - 9007 400 - 9015 400 - 9023 400 - 9031 400 - 9049LONG

LEFT 400 - 8876 400 - 8884 400 - 8892 400 - 8900 400 - 8918 400 - 8926

CLINIC ORDER CODES

ARM 1 2 3 4 5 6 LENGTH PRICE

RIGHT 3733-1RN 3733-2RN 3733-3RN 3733-4RN 3733-5RN 3733-6RNNORMAL

£169.00LEFT 3733-1LN 3733-2LN 3733-3LN 3733-4LN 3733-5LN 3733-6LN

RIGHT 3733-1RL 3733-2RL 3733-3RL 3733-4RL 3733-5RL 3733-6RLLONG

LEFT 3733-1LL 3733-2LL 3733-3LL 3733-4LL 3733-5LL 3733-6LL

g

c

b

d

SIZING

Circumferences 1 2 3 4 5 6

b Palm at fold of thumb 17 - 21 17 - 21 18 - 22 18 - 22 19 - 23 20 - 24

c Wrist 15 - 19 16 - 20 17 - 21 17 - 21 18 - 22 19 - 23

d Mid-point of forearm 22 - 28 24 - 30 26 - 32 28 - 34 30 - 36 31 - 37

g Axilla 25 - 32 29 - 36 33 - 40 37 - 44 41 - 48 45 - 52

Lengths

c-g Normal 40 - 45 40 - 45 40 - 45 40 - 45 40 - 45 40 - 45

c-g Long 45 - 50 45 - 50 45 - 50 45 - 50 45 - 50 45 - 50

All measurements in cm

SIZING & CODES

4

INTRODUCTION: Rebound effect of lymphedema volume is observed after Decongestive Lymphedema Therapy (DLT) in patients with Breast Cancer Secondary Lymphedema (BCSL).Successful outcomes of lymphedema long term treatments are depending on patient compliance.

OBJECTIVE: The main objective of this proof of concept study was to assess the efficacy and safety of Autofit as night treatment for maintenance phase after DLT on top of daily Thuasne Lymphology compression. Secondary objectives were to assess compliance and satisfaction of patients equipped with Mobiderm Autofit device.

Authors: Dr Mestre-Godin S1, Pasqualini M2, Dr Ben Amor C2, Pr Quéré I1

Affiliations: 1 Hôpital Saint-Eloi, Montpellier, FRANCE - 2 THUASNE, Levallois Perret, FRANCEN°ID RCB: 2014-A01008-39

METHOD/DESIGN:

Gp In = 20

Day hosiery + Night-time

Autofit

Gp IIn = 20

Day hosiery only

DLTn = 40

Stages II et III

DLTn = 40

Stages II et III

D0Randomisation

D30Primary

Outcome

D90Day hosiery + Night-time

Autofitn = 40

INTENSIVE PHASE MARILYN: MAINTENANCE PHASE

C

B

Dl

E

C

B

Dl

E

Semi-open garment:Easy to put on, easy to take off!

Sleeve with attached retractable mitten: limits the risk of œdema migration; the hand can be freed for usual tasks

Velcro fasteners: instant setup and high performance

Several tightening notches:adaptation to each patient’s individual morphology.Adjustment marks: precise and repeatable application, control of the œdema volume variation

The standard, self-adjustable sleeve, to adapt to each patient’s individual morphology and evolution overtime!

Description : self-adjustable sleeve, with mitten and thumb for the upper limb lymphœdema

For which patients?• For all stages of the lymphœdema• To be used during the maintenance phase or at the end of the reduction phase• For patients presenting dysmorphims or progressive œdema• For patients who wish autonomous control of their œdema • For patients who need a product immediately

Standard products: fast delivery!

Main components:• Outer layer of the garment: 59 % polyamide, 41 % elastane• along the arm: adhesive non-woven, polyurethane foam (15 x 15 mm cubes)• hand level: adhesive non-woven, polyethylene foam (5 x 5 mm cubes)

RIGHT ARM

LEFT ARM

Care instructionsClose the velcro fasteners prior to washing.

Two wash options are possible: • Hand wash: Soak the device in cold soapy water, rub with a clean sponge and squeeze the water out by pressing.• Machine wash: Use the wool cycle, at cold temperature, and use a laundry net. Hand squeeze the water out by pressing.

In both cases, let dry at room temperature away from any direct source of heat.

When not used, the sleeve should be kept flat, with the velcro fasteners closed. If it must be folded, position the hooks pointing outward.

RESULTS:Description of the population (Years)- Mean age : 67- Mean time since diagnosis of breast cancer: 11- Mean time since lymphedema diagnosis: 7- Lymphedema Stages: II, III

SAFETY AND EFFICACY OF AUTO-ADJUSTABLE NIGHT ARM SLEEVE (AUTOFIT) IN THE MANAGEMENT OF UPPER LIMB LYMPHEDEMA:

MARILYN TRIAL

Absolute mean volume excess variations (cm3)• Vol excess variation D0/D30 (%): 1,80 in Gp I vs 3,20 in Gp II (NS)

• At day 30, 85 % of DLT effect is maintained in Gp I vs 54 % in Gp II

-

-

-

-

-

250

200

150

100

50

0

50

100

DLT/D0 DLT/D30 DLT/D90D0/D30 D0/D90

Mea

n vo

lum

e ex

cess

var

iati

on (c

m3 )

-236.2

-205.2

-189.5

-112.3

-190.7

-112.6

92.9 92.5

45.546.7

From day 0

From initiation of DLT

Group IGroup II

Mea

n vo

lum

e ex

cess

(cm

3 )

1000

900

800

700

600

500 HR Gp I

400 HR Gp II

300

200

100

0

D0 D30 D90

DLT MAINTENANCE

Rebound EffectVolume variation

in High Responders (HR) patients (cm3)

• Autofit benefit is more pronounced among

High Rresponders DLT (Loss of 35 % during

DLT - POLIT study, JMV 2014)

82 % of the patients already wearing compression do prefer

Autofit!

10 %

90 %

Every night

4 to 6 daysper week

How often have you worn Autofit during the study? (both Gp I and II)

90 % of patients have worn Autofit every night

COMPLIANCE RESULTS*:

CONCLUSION / DISCUSSION:Results of primary criterion suggest that Autofit tends to limit rebound effect of lymphedema after DLT, especially in patients who were strongly responsive to DLT. Between D30 and D90, study period in which all 40 patients were fitted with the study medical device, a lymphedema volume stabilizing effect is observed.Results of secondary criteria show that Autofit displays favorable characteristics that increase patient's independence from specialized medical staff or relatives while keeping high level of patient's compliance in maintenance phase.

Autofit arm sleeve could offer interesting benefit to patients for self management of this chronic pathology.

10 %

90 %

Every night

4 to 6 daysper week

SATISFACTION RESULTS*:How would you rate Autofit ?Easy / Very easy to put on 70 % of patientsQuick fitting 85 % of patientsUseful self adjustement 89 % of patientsEasy / Very easy to take off 98 % of patientsComfortable 90 % of patients

EFFICACY RESULTS:

* Patient questionnaire submitted to each enrolled patient at the end of the study

AXILLARY ARM CIRCUMFERENCE

(E)

FOREARM CIRCUMFERENCE (AT

THE WIDEST POINT) (D)

WRIST CIRCUMFERENCE

(C)

HAND CIRCUMFERENCE

(B)

REFERENCE

NORMAL 40 - 45 CM LONG 45 - 50 CM

T1 25 - 32 cm 22 - 28 cm 15 - 19 cm 17 - 21 cm 37330120100261 37330120100271

T2 29 - 36 cm 24 - 30 cm 16 - 20 cm 17 - 21 cm 37330120200261 37330120200271

T3 33 - 40 cm 26 - 32 cm 17 - 21 cm 18 - 22 cm 37330120300261 37330120300271

T4 37 - 44 cm 28 - 34 cm 17 - 21 cm 18 - 22 cm 37330120400261 37330120400271

T5 41 - 48 cm 30 - 36 cm 18 - 22 cm 19 - 23 cm 37330120500261 37330120500271

T6 45 - 52 cm 31 - 37 cm 19 - 23 cm 20 - 24 cm 37330120600261 37330120600271

AXILLARY ARM CIRCUMFERENCE

(E)

FOREARM CIRCUMFERENCE (AT

THE WIDEST POINT) (D)

WRIST CIRCUMFERENCE

(C)

HAND CIRCUMFERENCE

(B)

REFERENCE

NORMAL 40 - 45 CM LONG 45 - 50 CM

T1 25 - 32 cm 22 - 28 cm 15 - 19 cm 17 - 21 cm 37330120100262 37330120100272

T2 29 - 36 cm 24 - 30 cm 16 - 20 cm 17 - 21 cm 37330120200262 37330120200272

T3 33 - 40 cm 26 - 32 cm 17 - 21 cm 18 - 22 cm 37330120300262 37330120300272

T4 37 - 44 cm 28 - 34 cm 17 - 21 cm 18 - 22 cm 37330120400262 37330120400272

T5 41 - 48 cm 30 - 36 cm 18 - 22 cm 19 - 23 cm 37330120500262 37330120500272

T6 45 - 52 cm 31 - 37 cm 19 - 23 cm 20 - 24 cm 37330120600262 37330120600272

5

INTRODUCTION: Rebound effect of lymphedema volume is observed after Decongestive Lymphedema Therapy (DLT) in patients with Breast Cancer Secondary Lymphedema (BCSL).Successful outcomes of lymphedema long term treatments are depending on patient compliance.

OBJECTIVE: The main objective of this proof of concept study was to assess the efficacy and safety of Autofit as night treatment for maintenance phase after DLT on top of daily Thuasne Lymphology compression. Secondary objectives were to assess compliance and satisfaction of patients equipped with Mobiderm Autofit device.

Authors: Dr Mestre-Godin S1, Pasqualini M2, Dr Ben Amor C2, Pr Quéré I1

Affiliations: 1 Hôpital Saint-Eloi, Montpellier, FRANCE - 2 THUASNE, Levallois Perret, FRANCEN°ID RCB: 2014-A01008-39

METHOD/DESIGN:

Gp In = 20

Day hosiery + Night-time

Autofit

Gp IIn = 20

Day hosiery only

DLTn = 40

Stages II et III

DLTn = 40

Stages II et III

D0Randomisation

D30Primary

Outcome

D90Day hosiery + Night-time

Autofitn = 40

INTENSIVE PHASE MARILYN: MAINTENANCE PHASE

C

B

Dl

E

C

B

Dl

E

Semi-open garment:Easy to put on, easy to take off!

Sleeve with attached retractable mitten: limits the risk of œdema migration; the hand can be freed for usual tasks

Velcro fasteners: instant setup and high performance

Several tightening notches:adaptation to each patient’s individual morphology.Adjustment marks: precise and repeatable application, control of the œdema volume variation

The standard, self-adjustable sleeve, to adapt to each patient’s individual morphology and evolution overtime!

Description : self-adjustable sleeve, with mitten and thumb for the upper limb lymphœdema

For which patients?• For all stages of the lymphœdema• To be used during the maintenance phase or at the end of the reduction phase• For patients presenting dysmorphims or progressive œdema• For patients who wish autonomous control of their œdema • For patients who need a product immediately

Standard products: fast delivery!

Main components:• Outer layer of the garment: 59 % polyamide, 41 % elastane• along the arm: adhesive non-woven, polyurethane foam (15 x 15 mm cubes)• hand level: adhesive non-woven, polyethylene foam (5 x 5 mm cubes)

RIGHT ARM

LEFT ARM

Care instructionsClose the velcro fasteners prior to washing.

Two wash options are possible: • Hand wash: Soak the device in cold soapy water, rub with a clean sponge and squeeze the water out by pressing.• Machine wash: Use the wool cycle, at cold temperature, and use a laundry net. Hand squeeze the water out by pressing.

In both cases, let dry at room temperature away from any direct source of heat.

When not used, the sleeve should be kept flat, with the velcro fasteners closed. If it must be folded, position the hooks pointing outward.

RESULTS:Description of the population (Years)- Mean age : 67- Mean time since diagnosis of breast cancer: 11- Mean time since lymphedema diagnosis: 7- Lymphedema Stages: II, III

SAFETY AND EFFICACY OF AUTO-ADJUSTABLE NIGHT ARM SLEEVE (AUTOFIT) IN THE MANAGEMENT OF UPPER LIMB LYMPHEDEMA:

MARILYN TRIAL

Absolute mean volume excess variations (cm3)• Vol excess variation D0/D30 (%): 1,80 in Gp I vs 3,20 in Gp II (NS)

• At day 30, 85 % of DLT effect is maintained in Gp I vs 54 % in Gp II

-

-

-

-

-

250

200

150

100

50

0

50

100

DLT/D0 DLT/D30 DLT/D90D0/D30 D0/D90

Mea

n vo

lum

e ex

cess

var

iati

on (c

m3 )

-236.2

-205.2

-189.5

-112.3

-190.7

-112.6

92.9 92.5

45.546.7

From day 0

From initiation of DLT

Group IGroup II

Mea

n vo

lum

e ex

cess

(cm

3 )

1000

900

800

700

600

500 HR Gp I

400 HR Gp II

300

200

100

0

D0 D30 D90

DLT MAINTENANCE

Rebound EffectVolume variation

in High Responders (HR) patients (cm3)

• Autofit benefit is more pronounced among

High Rresponders DLT (Loss of 35 % during

DLT - POLIT study, JMV 2014)

82 % of the patients already wearing compression do prefer

Autofit!

10 %

90 %

Every night

4 to 6 daysper week

How often have you worn Autofit during the study? (both Gp I and II)

90 % of patients have worn Autofit every night

COMPLIANCE RESULTS*:

CONCLUSION / DISCUSSION:Results of primary criterion suggest that Autofit tends to limit rebound effect of lymphedema after DLT, especially in patients who were strongly responsive to DLT. Between D30 and D90, study period in which all 40 patients were fitted with the study medical device, a lymphedema volume stabilizing effect is observed.Results of secondary criteria show that Autofit displays favorable characteristics that increase patient's independence from specialized medical staff or relatives while keeping high level of patient's compliance in maintenance phase.

Autofit arm sleeve could offer interesting benefit to patients for self management of this chronic pathology.

10 %

90 %

Every night

4 to 6 daysper week

SATISFACTION RESULTS*:How would you rate Autofit ?Easy / Very easy to put on 70 % of patientsQuick fitting 85 % of patientsUseful self adjustement 89 % of patientsEasy / Very easy to take off 98 % of patientsComfortable 90 % of patients

EFFICACY RESULTS:

* Patient questionnaire submitted to each enrolled patient at the end of the study

AXILLARY ARM CIRCUMFERENCE

(E)

FOREARM CIRCUMFERENCE (AT

THE WIDEST POINT) (D)

WRIST CIRCUMFERENCE

(C)

HAND CIRCUMFERENCE

(B)

REFERENCE

NORMAL 40 - 45 CM LONG 45 - 50 CM

T1 25 - 32 cm 22 - 28 cm 15 - 19 cm 17 - 21 cm 37330120100261 37330120100271

T2 29 - 36 cm 24 - 30 cm 16 - 20 cm 17 - 21 cm 37330120200261 37330120200271

T3 33 - 40 cm 26 - 32 cm 17 - 21 cm 18 - 22 cm 37330120300261 37330120300271

T4 37 - 44 cm 28 - 34 cm 17 - 21 cm 18 - 22 cm 37330120400261 37330120400271

T5 41 - 48 cm 30 - 36 cm 18 - 22 cm 19 - 23 cm 37330120500261 37330120500271

T6 45 - 52 cm 31 - 37 cm 19 - 23 cm 20 - 24 cm 37330120600261 37330120600271

AXILLARY ARM CIRCUMFERENCE

(E)

FOREARM CIRCUMFERENCE (AT

THE WIDEST POINT) (D)

WRIST CIRCUMFERENCE

(C)

HAND CIRCUMFERENCE

(B)

REFERENCE

NORMAL 40 - 45 CM LONG 45 - 50 CM

T1 25 - 32 cm 22 - 28 cm 15 - 19 cm 17 - 21 cm 37330120100262 37330120100272

T2 29 - 36 cm 24 - 30 cm 16 - 20 cm 17 - 21 cm 37330120200262 37330120200272

T3 33 - 40 cm 26 - 32 cm 17 - 21 cm 18 - 22 cm 37330120300262 37330120300272

T4 37 - 44 cm 28 - 34 cm 17 - 21 cm 18 - 22 cm 37330120400262 37330120400272

T5 41 - 48 cm 30 - 36 cm 18 - 22 cm 19 - 23 cm 37330120500262 37330120500272

T6 45 - 52 cm 31 - 37 cm 19 - 23 cm 20 - 24 cm 37330120600262 37330120600272

6

Haddenham Healthcare Ltd, Crendon House, Crendon Industrial Park, Long Crendon, Bucks HP18 9BB

Tel: 01844 208842 Fax: 01844 208843

Email: sales@hadhealth.com

Website: www.hadhealth.com