THE 1 ST MICRO TECHNOLOGY THAT ACCELERATES WOUND HEALING

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1 THE 1 ST MICRO TECHNOLOGY THAT ACCELERATES WOUND HEALING 1 st Active Technology With efficacy at cellular level, stimulates patient s cells to restart healing Accelerates healing Accelerated granulation and epithelization, regardless of wound etiology Remarkable efficacy Including in wounds with exposed bones and tendons Proven long term efficacy and safety And potential reduction in wound care and hospitalization burdens

2 ACTIVE PRODUCT THAT RESTARTS AND ACCELERATES HEALING PolyHeal Micro: PolyHeal Micro is a suspension of polystyrene Negatively Charged Microspheres -'s- in a concentration 4.5x10 6 microspheres/ml, in 22% Glycerol and water for injection. Indications: PolyHeal Micro is indicated for the treatment of ulcers of different etiologies and hard-to-heal, partial and full-thickness wounds such as: Ulcers with exposed bones, tendons, ligaments and/or foreign material; Venous and arterial leg ulcers, diabetic foot ulcers, pressure ulcers; Drainage, post-traumatic and post-surgical wounds; Hard-to-heal wounds and other ulcers in co-morbid patients. - NEGATIVELY CHARGED MICROSPHERES TECHNOLOGY - Synthetic microspheres (5μm) - Medical grade Polystyrene - Negatively charged - Biocompatible - Surface area and geometry ensure specific biophysical properties ULCER WITH EXPOSED TENDON DEEP, INTERDIGITAL, HARD-TO-HEAL WOUND DEEP SACRAL PRESSURE ULCER DEEP POST OPERATIVE DEHISCENCE WOUND WITH EXPOSED SUTURE POST-AMPUTATION FOOT WOUND WITH EXPOSED BONE VASCULAR LEG ULCER DEEP, HARD-TO-HEAL FOOT ULCER WITH EXPOSED TENDON

3 UNIQUE TECHNOLOGY WITH EFFICACY AT CELLULAR LEVEL Application of 's appears to trigger a synchronised series of events that shift the wound from the inflammatory to the proliferative phase, stimulating patient's own cells to restart the wound healing process.1,4 MECHANISM OF ACTION Cell adhesion to microspheres in the wound bed results in morphological and functional cell changes that restart healing.1, 2, 4 s provide a multi-point contact surface for cellular attachment.1 The Negative Charge in s surface improves cellular attachment and interaction.3 s restart the healing process and accelerate the formation of Granulation tissue and Epithelization4,7 s interact with the main cell lines involved in the healing process: macrophages, fibroblasts, Technology endothelial cells and keratinocytes.4, 5 Efficacy at the cellular level Cellular attachment to s results in its activation, proliferation and migration.1, 4, 5 Step 1 Chronic Wounds: Stagnation in the wound healing process s stimulate collagen synthesis and angiogenesis that Cellular results in granulation and epithelization.1, 4, 5, 7 dysfunction and a biochemical imbalance within the wound bed cause the inflammatory 1, 6, 8 In addition, s have been shown to adsorb to its surface excess processthe to stop and the wound of MMP s. becomes prone to infection Neutrophils response to infection increases release of Technology Efficacy at the cellular level pro-inflammatory cytokines and proteolytic enzymes Step 2 PolyHeal promotes the formation of granulation tissue and epithelization2 Step 1 Chronic Wounds: Stagnation in the wound healing process Cellular dysfunction and a Chronic wound biochemical imbalance within the wound bed cause the inflammatory situation process to stop and the wound becomes prone to infection without s: Neutrophils response to infection increases release of Stagnation of pro-inflammatory cytokines and proteolytic enzymes the healing process Healing wound treated with s: Restart of the healing process Step 2 PolyHeal promotes the formation of granulation tissue and epithelization2 Legend (Negatively Charged Microspheres, 5µ) (Negatively Charged Microspheres, 5μm) Legend Neutrophils Proteinases (e.g IL-1 MMPs) Pro-inflammatory cytokines (e.g IL-1, TNF) Epithelial cells Neutrophils Proteinases (e.g. MMPs) Pro-inflammatory cytokines (e.g IL-1, TNF) Endothelial Growth factors 2. Govrin J et al. Wounds 2010; 6: MediWound Ltd., Data on file cells (e.g. PDGF, VEGF) Epithelial cell Endothelial cells Growth factors (e.g. PDGF, VEGF) Macrophages Macrophages Fibroblasts Fibroblasts Collagen Collagen

4 ACCELERATED HEALING REGARDLESS OF WOUND ETIOLOGY Treatment with PolyHeal demonstrated rapid re-epithelialization rates. 5,7 RANDOMIZED CLINICAL TRIAL PATIENTS TREATED WITH S GOT A 2.5 TIMES HIGHER STATISTICALLY SIGNIFICANT WOUND AREA REDUCTION VS. CONTROL, AT 4 WEEKS 4 Relative change in wound surface area (%), by treatment group 4 Relative change in wound size (%) Treatment duration (weeks) -14.8% p= % CLINICAL EVIDENCE 39% 21 OF 54 WOUNDS COMPLETELY CLOSED by both secondary intention or grafting 1 50% % REDUCTION IN SIZE in about half of the wounds after an average of 4.5 weeks of active treatment 1

5 RAPIDLY PRODUCES HEALTHY RED GRANULATION TISSUE In hard-to-heal wounds, the sudden development of healthy granulation tissue is an indicator measuring the initiation of the healing process. 4 RANDOMIZED CLINICAL TRIAL PATIENTS TREATED WITH S GOT A 6 TIMES HIGHER PROBABILITY OF MEETING THE PRIMARY ENDPOINT OF 75% OF LIGHT-RED GRANULATION - LRG - TISSUE AT 4 WEEKS OF TREATMENT (OR= 5.95; P<0.01) 4 Number of patients to achive 75% Light-Red Granulation tissue coverage, according to treatment group % (15/32) Percentage of patients (%) p= % (4/26) Treatment duration (weeks) x2 Almost 2 TIMES FASTER (27 VS. 49 DAYS) reaching the primary end point of 75% LRG Tissue coverage 4 59% Among the post-trauma/postoperative sub-population, after 4 weeks of treatment, 59% (n=10/17) of patients treated with s achieved 75% LRG Tissue vs. 25% (n=3/12) of control patients 4

6 REMARKABLE EFFICACY IN WOUNDS WITH EXPOSED BONES AND TENDONS Topical application of s is an effective stimulator of the wound healing process in recalcitrant lesions, especially those with exposed bones and tendons. 1 RANDOMIZED CLINICAL TRIAL 57% 57% of the patients treated with 's compared with ZERO in the control group achieved 75% of wound coverage by Light-Red Granulation Tissue 4 CLINICAL EVIDENCE ALMOST HALF OF THE WOUNDS (10 OUT OF 22) WITH EXPOSED BONES AND TENDONS ACHIEVED COMPLETE CLOSURE AFTER AN AVERAGE OF 5 WEEKS OF ACTIVE TREATMENT 1 68% 68% OF PATIENTS 15 out of 22 actively treated by 's, in average for 5.0 weeks, achieved 75% of wound coverage by Light-Red Granulation Tissue 1 COST-EFFECTIVENESS DECREASE IN HEALTH-CARE COSTS WITH 'S VS. SURGERY IN WOUNDS WITH EXPOSED BONES AND TENDONS 8 Initial management with 's instead of surgery to treat all new patients is expected to save important surgical theatre time 8 s treated patients need 0.2 surgical procedures per wound Surgically treated patients need 1.2 surgical procedures per wound

7 2-YEAR FOLLOW UP: LONG TERM EFFICACY AND SAFETY AND POTENTIAL REDUCTION IN WOUND CARE AND HOSPITALIZATION BURDENS RANDOMIZED CLINICAL TRIAL 50% more wounds that remained closed in the 's group 9 Less than half % vs. 30% respectively - of the incidence of adverse events on the 's Group vs. control 9 STATISTICALLY SIGNIFICANT REDUCTION OF 85% IN UNPLANNED HOSPITALIZATIONS IN THE 'S GROUP VS. AN INCREASE OF 55% IN THE CONTROL GROUP 9 Mean number of Hospitalizations Incidence of Hospitalizations for Wound Management 9 1,6 1,4 1,2 1 0,8 0,6 0,4 0, ± ±0.79 Hospitalizations before RCT p= ± ±2.49 Hospitalizations during RCT + long term FU STATISTICALLY SIGNIFICANT MEAN REDUCTION OF 25 HOSPITALIZATION DAYS PER PATIENT VS. AN INCREASE OF 0.91 DAYS IN THE CONTROL GROUP 9 Duration of Hospitalizations for Wound Management 9 p= Mean number of Hospitalization Days ± ±12.78 Hospitalizations before RCT 2.53± ±19.47 Hospitalizations during RCT + long term FU

8 1 st Active Technology that accelerates healing, including in wounds with exposed bones and tendons 4 Easy and rapid topical application in hard-to-dress areas Efficacy at cellular level, stimulating patient s own cells to restart wound healing 1, 4 Rapidly produces healthy red granulation tissue and epithelization rates, regardless of wound etiology 1, 4 Offers the choice of wound closure by secondary intention or grafting 4 Long-term efficacy, safety and a potential reduction in wound care and hospitalization burdens 9 Product code PT-1038 Capacity 15 ml Vials / box 7 CONTRAINDICATIONS PolyHeal Micro should not be used: In patients with known sensitivity to the device s compounds. In severely infected or heavily exudating wounds. In wounds suspected of malignancy. PRECAUTIONS PolyHeal Micro is not for use in heavily infected, profusely exudating and/or necrotic wounds. There is limited experience in the use of PolyHeal Micro in deeptunnelled wounds and wounds connected to body cavities (abdomen, mediastinum and cranial cavities). PolyHeal Micro is for single use only. Reuse could lead to contamination of the wound and infection. Do not re-sterilize. PolyHeal Micro is sterile if the bottle is unopened and undamaged. Discard all opened bottles of PolyHeal Micro. Do not use after the expiry date Keep out of reach and sight of children. Do not use PolyHeal Micro in conjunction with ointments, creams, and oily products. In case the first few days of treatment with PolyHeal Micro are accompanied by pain, itching, or skin burning sensation around the wound area, a systemic medication for pain relief can be used (do not apply local or topical medication) without interrupting the treatment with PolyHeal Micro. In case of persistent or aggravated side effects, such as local infection, allergic reaction, excessive redness, pain, itching, skin burning sensation or swelling, the use of PolyHeal Micro should be interrupted until the patient consults his/her physician. Treatment should be stopped if granulation tissue protrudes over the wound s edges (over-granulation) and the wound may be topically treated to control the over-granulation. REFERENCES 1. Govrin J, et al. New method for treating hard-to-heal wounds: clinical experience with charged polystyrene microspheres. Wounds UK. 2010; 6(4); Carré A, et al. How Substrate Properties Cell Adhesion. A Physical Chemical Approach, Journal of Adhesion Science and Technology. 2010; 24:5, Khatua D, et al. Influence of Charge Densities of Randomly Sulfonated Polystyrene Surfaces on Cell Attachment and Proliferation. Journal of Nanoscience and Nanotechnology. 2011; Vol. 11, Shoham Y, et al. Wound 'dechronification' with negatively-charged polystyrene microspheres: a double-blind RCT. J Wound Care Mar; 22(3): Weissman O, et al. Treatment of wounds following breast reduction and mastopexy with subsequent wound dehiscence with charged polystyrene microspheres. Wounds. 2014; 26(2): Renò F, et al. Adsorption of matrix metalloproteinases onto biomedical polymers: a new aspect in biological acceptance. J Biomater Sci Polym Ed. 2008;19(1): Weissman O, et al. Post-facelift flap necrosis treatment using charged polystyrene microspheres. Can J Plast Surg. 2013;21(1): Guest JF, et al. Cost-effectiveness of using Polyheal compared with surgery in the management of chronic wounds with exposed bones and/or tendons due to trauma in France, Germany and the UK. Int Wound J Feb;12(1): Kaufman H, et al. Long term outcomes of a randomized controlled trial (RCT) with Negatively Charged Microspheres () technology compared to control (Poster 374). Presented in European Wound Management Association Congress (EWMA) Copenhagen May 15 th -17 th, PX-PS-1-007ABR17 Parque Empresarial San Fernando, Edificio Dublín, 2ª planta San Fernando de Henares (Spain) Tel: Fax:

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