NEW-FILL

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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 protocol
• 1 scan of treatment area before treatment
• 1 scan ..day 90
• 1 scan.. day 180
• 1 scanyear 1
• 1 scanyear 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.