2 History of Dermal Fillers Biodegradable implants - e.g. bovine collagen, hyaluronic acid Synthetic non-biodegradable implants - e.g. silicone,PMMA Lacking biodegradable/biocompatible implant
3 Market Needs Ideal Injectable Safe and effective Approved (CE mark) Biodegradable/Bioresorbable Non-animal origin Immunologically inert - no skin test
4 Market Needs Ideal Injectable Longer lasting Less expensive Easy to use Easy to store
5 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
6 NEW-FILL® Polylactic acid (PLA) hydrogel Biocompatible / biodegradable Immunologically inert No animal origin Manufactured to ISO standards Class III medical device
7 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.
8 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
9 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
10 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
11 NEW-FILL® Indications New-Fill® can treat all parts of the face including: - cheeks, - eye-sockets - temples
12 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.
13 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
14 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
15 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
16 NEW-FILL® in HIV Only real treatment available - fat transfer Invasive operation - limited success - short lasting results
17 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.
18 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
19 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
20 Objective Measures Echography patients with “ normal” skin: dermis 1.5-4mm fat 3-6mm patients on tritherapy show total absence of fat
21 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
22 Injection Technique Horizontal injection into the dermis Fine lines - superficial dermis - threading (note blanching) -massage Deep lines - deeper dermis - layering
23 Injection Technique Overcorrection is possible in deeper folds(cheeks,furrows) Overcorrection to be avoided in fine skin and lines (eyes, lips etc)
24 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
25 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
26 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
27 Recommended Procedure Indicate areas to be treated with mirror Take photographs Explain procedure Use local anaesthesia if required Proceed area by area
28 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
29 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
30 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.
31 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.
32 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
33 NEW-FILL® Lipoatrophy Clinical Study 150 patients on tritherapy showing severe lipoatrophy 2 year retrospect objective echographic measures
34 NEW-FILL® Lipoatrophy Clinical Study Protocol 1 vial per cheek per session 3 sessions 15 day intervals
35 NEW-FILL® Lipoatrophy Clinical Study Radiographic protocol 1 scan of treatment area before treatment 1 scan ……………..day 90 1 scan…………….. day 180 1 scan………………year 1 1 scan………………year 2
36 NEW-FILL® Lipoatrophy Clinical Study 4 patients to be chosen to study - injection in the sacral area - injection in the soles of the feet
37 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
38 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
39 NEW-FILL® Lipoatrophy Clinical Study Interim data presented in Toronto Data confirms the beneficial effect of intradermal New-Fill® injections while maintaining antiretroviral therapy
40 NEW-FILL® Some “before and after” photographs……….