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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……….