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NEW-FILL ®

Sculpting and Filling Innovation

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History of Dermal Fillers

• Biodegradable implants

- e.g. bovine collagen, hyaluronic acid

• Synthetic non-biodegradable implants

- e.g. silicone,PMMA

• Lacking biodegradable/biocompatible implant

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Market Needs

Ideal Injectable

• Safe and effective

• Approved (CE mark)

• Biodegradable/Bioresorbable

• Non-animal origin

• Immunologically inert - no skin test

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Market Needs

Ideal Injectable

• Longer lasting

• Less expensive

• Easy to use

• Easy to store

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NEW-FILL® Product Concept

• Innovation - used in large volumes

• To fill soft tissue deficiencies/ add volume as required

• Wide range of indications

• Not cost prohibitive

• No skin test required

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NEW-FILL®

• Polylactic acid (PLA) hydrogel

• Biocompatible / biodegradable

• Immunologically inert

• No animal origin

• Manufactured to ISO standards

• Class III medical device

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NEW-FILL®

Due to its physical and chemical properties New-Fill® holds a promising position in the field of injectable fillers, not only in the treatment against natural ageing, but also in the treatment of iacterogenic lipodystrophy and trauma surgery.

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Background on P.L.A.

Used for 30 years in medicine:

• Encapsulation of vaccines

• Carrier for slow release medication - treatment of prostate cancer and infertility

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Background on P.L.A

Used for 30 years in surgery:

• Orthopaedic - resorbable implants, screws etc

• Resorbable sutures - ophthalmics, neurosurgery etc

• Skull and facial reconstructive surgery

• Tissue regeneration

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Background on P.L.A

• Safety profile well documented

• Being immunologically inert offers extra safety for immuno-suppressed patients

• Refer to brochure for additional data

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NEW-FILL® Indications

• New-Fill® can treat all parts of the face including:

- cheeks,

- eye-sockets

- temples

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NEW-FILL® Presentation

• Freeze dried sterile lyophilisate made out of a synthetic crystalline polymer of PLA in the form of slow resorbing micro-particles, scattered in a hydrocolloidal solution.

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NEW-FILL® Presentation

• 2 glass vials per pack (6cc)

• 1 set instructions for use

• 4 needles for injection

need: water for injection,1cc or 2cc syringes and 18 gauge needles

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NEW-FILL® in HIV

• Lipoatrophy caused by side effects of anti-retroviral therapy

• Characterised by loss of adipose subcutaneous tissue - mainly in the cheek area of the face

• In some cases temple and eye socket also affected

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NEW-FILL® in HIV

• Patient generally feels very well

• Patient demonstrates healthy immunological and virological state

• Appearance does not reflect this

• Can lead to non-compliance

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NEW-FILL® in HIV

• Only real treatment available - fat transfer

• Invasive operation - limited success

- short lasting results

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NEW-FILL® Presentation

• The L-PLA is in the form of microspheres whose diameter ranges from 40µ-60µ, held in a suspension in a CMC gel.The particle size is designed to avoid immediate phagocytosis and intracapillary dispersion while allowing ease of injection.

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Mechanism of Action

Dual Mechanism:

1) Immediate mechanical action - related to volume

2) Delayed reaction - formation of new collagen which persists despite resorption of pla particles

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Injection Technique

• New-Fill® is injected directly into the skin of the atrophied areas

• Causes proliferation of collagenous fibres that lead to natural dermal thickening

• The fibres make up for the absence of fat layers and the skin “rises” back to normal

• Skin is soft and supple

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Objective Measures

Echography

• patients with “ normal” skin:

dermis 1.5-4mm

fat 3-6mm

• patients on tritherapy show total absence of fat

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Objective Measures

• After each injection of New-Fill® the echography shows thickening of 2-3 mm

• At end of treatment average thickening is 10-12 mm

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Injection Technique

• Horizontal injection into the dermis

• Fine lines - superficial dermis

- threading (note blanching)

-massage

• Deep lines - deeper dermis

- layering

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Injection Technique

• Overcorrection is possible in deeper folds(cheeks,furrows)

• Overcorrection to be avoided in fine skin and lines (eyes, lips etc)

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Injection Technique

• Mix first vial with 1.5cc xylocaine 2% (without adrenaline) and water for injection 2.5cc

• Mix second vial with 1cc xylocaine and 2cc water

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Injection Technique

• Use half of first vial each side to potentiate local anaesthetic effect. Three injections at edges of lypodystrophy area.

• Use second vial (more concentrated) in deeper lipodystrophy areas

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Injection Technique

• Always inject into deep dermis using tunnelling technique

• Work quickly and keep the product well shaken

• Inject in a criss-cross fashion

• Massage whole area well afterwards

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Recommended Procedure

• Indicate areas to be treated with mirror

• Take photographs

• Explain procedure

• Use local anaesthesia if required

• Proceed area by area

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Warnings/Precautions

• Swelling or bruising may occur

• Avoid use of anti-coagulant therapy

• Temporary local erythema may occur

• Massage treated area

• Apply ice if necessary

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NEW_FILL® Clinical Study

100 patients-acceptability/safety/efficacy

• At 1 month - conjunctive,vascularized tissue capsule measuring 100µ around implant. Composed of conjunctive cells, macrophages, lymphocytes, giant cells with foreign bodies and mastocytes

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NEW_FILL® Clinical Study

• At 3 months - sharp diminution of cellular density and thickness(80µ) of capsule. Number of mastocytes remain unchanged, visible increase in deposition of collagen fibres.

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NEW-FILL® Clinical Study

• At 6 months the decline in cell number continues, capsule thickness diminishes to 60µ and is entirely composed of collagen fibres.

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NEW-FILL® Lipoatrophy Clinical Study

• Following a conclusive 12 month treatment test on 20 patients suffering from lipoatrophy of the cheek BIOTECH has launched a large study in 5 major centres in France

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NEW-FILL® Lipoatrophy Clinical Study

• 150 patients on tritherapy showing severe lipoatrophy

• 2 year retrospect

• objective echographic measures

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NEW-FILL® Lipoatrophy Clinical Study

Protocol• 1 vial per cheek per session

• 3 sessions

• 15 day intervals

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NEW-FILL® Lipoatrophy Clinical Study

Radiographic protocol1 scan of treatment area before treatment

1 scan ……………..day 90

1 scan…………….. day 180

1 scan………………year 1

1 scan………………year 2

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NEW-FILL® Lipoatrophy Clinical Study

• 4 patients to be chosen to study

- injection in the sacral area

- injection in the soles of the feet

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NEW-FILL® Lipoatrophy

• New-Fill® will be completely resorbed after 3 years

• The New-Fill ® result is that of neo-tissue which progressively diminishes

• Repeat injections every 3 years is recommended to re-stimulate neo-collagenesis

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NEW-FILL® Lipoatrophy Clinical Study

Interim data presented in Toronto

• 26 male patients aged 28-61

• 87% on combination antiretroviral therapy

• mean dermal thickness rose by4.1mm (151%) at 12 weeks

• mean dermal thickness rose by5.31 mm (196%) at 24 weeks

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NEW-FILL® Lipoatrophy Clinical Study

Interim data presented in Toronto

Data confirms the beneficial effect of intradermal New-Fill® injections while maintaining antiretroviral therapy

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NEW-FILL®

Some “before and after”

photographs……….