Xe Derma New Generation Biologic Dressing. Xe Derma High Therapeutic Potential. ... for your patients future. Indications. Basic Characteristics

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2 Xe Derma New Generation Biologic Dressing Basic Characteristics Indications is an acellular biological dressing made of porcine dermis. After removal of all cells, an original matrix composed of a mesh of collagen 1, 2, 3 and elastic fibres is remaining. Its natural 3D structure of collagen and elastic fibres promotes cell migration into the wound, their proliferation, differentiation, and forming of high-quality, multilayered and stratified neoepidermis. 2, 4 An original manufacturing process gives it biomechanical properties similar to these of the human skin. 1 Acute and Chronic Skin Defects o Burns II a / II b degree Skin graft donor sites III grade Covering meshed autografts Temporary cover for necrectomised areas before skin grafting II a degree burns natural 3D structure of collagen and elastic fibres Courtesy of Dr. Ondrej Tolde Hydrated ready to be applied on a wound o Other acute wounds requiring reepithelisation Large surgery wounds, fasciotomy Large abrasion wounds o Chronic Wounds Leg ulcers Diabetic foot Pressure ulcers Other chronic wounds in a phase when the epithelisation process needs to be stimulated II b degree burns Skin graft donor sites is registered in the EU (CE certification). Store at room temperature, shelf life: 2 years Covering necrectomised areas before skin autografting Covering meshed autografts Chronic wounds... for your patients future

3 Xe Derma Unique Biologic Activity Unique biologic activity thanks to its natural 3D structure of collagen and elastic fibres 1, 4 Promotes cell migration into the wound and their proliferation Stimulates keratinocyte differentiation to form a multilayered, stratified neoepidermis Biomechanical properties similar to those of the human skin thanks to an original manufacturing process 1, 4 Spontaneous adherence to the wound bed by creating fine fibrin links between and the wound bed 1, 4 Resistant to shear forces on the wound during the healing process 1, 4 High elasticity making application on various body parts (face, joints,...) reliable 3, 4 Strong haemostatic effect and body fluid loss reduction 1, 2 High tensile strength 2 at minimum thickness,1 mm One-time Application Minimising primary dressing 1, 3, 4 re-applications Minimising wound infection risk 1 Reducing pain 1, 4 Reducing anaesthetics consumption and number of procedures under general anaesthesia 1 Spontaneous peeling-off after healing 1, 3 Transparency enabling wound monitoring 1 Safety Acellular tissue immunologically inert 1, 3 Sterilised by beta radiation no risk of retroviral infection 1, 3 Original 3D structure of collagen and elastic fibres stimulates keratinocyte proliferation to form a high-quality, multilayered, stratified neoepidermis. 2 In vitro Keratinocytes cultured on grew to form a multilayered epidermis differentiating into stratum basale, spinosum and granulosum. In vivo Normal skin HMWCK A1 p 63 Keratinocytes cultured on A2 Immunohistology analysis demonstrated p 63 protein expression typical for basal cells. : keratinocytes cultured using the same method on equine collagen (Biopad ) grew in a chaotic manner and no multilayered neoepidermis was formed. Note: histologic examination carried out 2 weeks after cultivation Healing of wound after necrectomy treated with A3 Healing of wound after necrectomy treated with tulle gras (Grassolind ) A4 o 1, 2, 6 High quality neoepidermis o 1, 2, 6 Speedy healing process, shortening time to healing o Safety and reduction of patient burden due o 1, 3, 4 to therapeutic procedures o Saving time of health care professionals 4 o Reducing overall healthcare costs 4 B1 B2 Keratinocyte growth and differentiation are similar in vitro and in vivo for a deep burn covered with. A covered wound shows stratified neoepidermis formation within 1 week (A3, B3). The control sample covered with tulle gras (Grassolind ) does not epithelise (A4, B4). The p 63 protein is vital to cell proliferative potential and plays a key role in keratinocyte differentiation. 5 Cells are able to grow and differentiate mainly on collagen-containing biological dressings. Nevertheless, even among these, differences have been observed, depending on the collagen fibre structure, purity, type of sterilization etc. 2 B3 B4 Expression of keratinocyte differentiation markers (HMWCK, p 63, involucrin, CD29) in a Xe-Derma-covered wound in vivo demonstrates neoepidermis stratification and confirms Xe-Derma s therapeutic potential.

4 II a Degree Scald Burns Treatment in Children 1 Prospective Study Comparing and Treatments Epithelisation of Widely Meshed Autograft (1: 6) on III Degree Burns 6 Prospective study in adult patients with deep burns on more than 3 % of TBSA Assessment done on wound area corresponding to 2 4 % of TBSA Burned Area Healing / Epithelisation Time Pat. Sex Age % TBSA Injury Surgery Dressing % of Area Epidermis Healed / Day Quality % BSA Number of Days 1. Man Explosion Day 19 cells + 1 % / day 9 Firm 1, 8, 1 % / day 12 Firm 5 % / day 2 Fragile, Disintegrating 7, 7, 2. Woman Fire Day 24 cells + 1 % / day 12 Firm % / day 14 Firm 4 % / day 2 Fragile, Disintegrating p =.28 p = NS 3. Woman 5 3 Fire Day 2 cells + 1 % / day 11 Firm 1 % / day 13 Firm 4 % / day 2 Fragile, Disintegrating 4. Man Explosion Day 22 cells + 1 % / day 14 Firm Number of dressing re-applications Infectious Complications 1 % / day 17 Firm % of patients Number of Patients 3 % / day 2 Fragile, Disintegrating, 4 * 6, 1, Notes: Cells + : Suspension of autologous dermal cells isolated by the ReCell method was applied onto the widely meshed autograft, then the area was covered with 1 : 1.5 meshed : Widely meshed autograft covered only with 1 : 1.5 meshed : Area covered with tulle gras (Grassolind ) p <.1 p = NS The best healing result was achieved upon application of epidermal cell suspension covered with ; however, alone also stimulated epithelisation efficiently and achieved high quality healing * 17 patients in total, of these 1 patients where re-dressed two times, 6 patients three times and 1 patient four times. Main Advantages of Treatment Comparable healing time for significantly larger injured area Excellent adherence and minimised need for primary dressing re-application reduce the risk of infection, pain, analgesics consumption, and need for procedures under general anaesthesia Significantly lower material consumption per 1 cm 2 healed (p =.2) Collagen and elastic fibres in a natural 3D matrix stimulate cell migration from residual dermal adnexa to the wound area and their proliferation These results confirm conclusions of other studies regarding s positive effect on the growth, proliferation, and stratification of epidermal cells 6 Shortening epithelisation time is important for reducing early and late wound healing complications in patients with extensive burns 6 In the case of extensive burns, the use of widely meshed autografts supported with can significantly shorten the overall therapeutic process is an efficient alternative for synthetic dressings used in children. 1 Synthetic material lack biological activity typical to xenografts and biologic dressings. 2 The unique combination of properties ensures high quality of the healing process and newly formed epidermis.

5 Xe Derma New Generation Biologic Dressing II a Degree Burn Treatment on Cheek and Upper Lip Xe Derma New Generation Biologic Dressing II b Degree Burn Treatment Xe-Derma Flamazine Day : Proximal part of the wound area covered with SSD antibacterial cream (Flamazine ), distal part with Day : on admission Day : on admission Day : application Total Time to Healing: 4 Days Total Number of Applications: 1 Day 2: Dry and clean wound covered only with Day 14: Wound healed with no complications (healing complete as early as Day 4) Day 35: Detail of the cosmetic result at the location of former (left) and Flamazine contact (right) II a Degree Scald Burn Treatment in Children Day 9: Area covered with healed. Xe-Derma is spontaneously peelingoff the wound bed, the area covered with Flamazine not healed yet, showing signs of epithelisation. Total Time to Healing: 9 Days Total Number of Applications: 1 Covering Skin Graft Donor Sites in a Polymorbid Patient Day : Cranial part of the area covered with, caudal part with Day : on admission Day 3: firmly sticks to the wound bed. Under the synthetic dressing on the cranial part, exudate is accumulating. This area had to be washed and dressing replaced. Day 1: Both parts of the wound area are covered with epithelium. Total Time to Healing: 1 Days Total Number of Applications: 1 Day : Extensive wound area after harvesting medium-thick autografts from the back. Meshed used to cover the donor site. Day 14: Healing through spontaneous epithelisation, is peelingoff the wound bed Day 21: Wound healed Total Time to Healing: 21 Days Total Number of Applications: 1... for your patients future

6 Xe Derma Application Protocol Xe Derma Bibliography 4 Simple Steps 1. Clean and prepare the wound area using standard methods, so that the wound is clean of all impurities and / or necrotic tissue. If necessary, collect a sample for microbiological examination. 2. If necessary adjust the dressing size using sterile scissors in a manner to make it exceed slightly the wound edges. 3. Hydrate for 1 3 minutes prior to application (e. g., in saline, water for injection or Ringer solution). Apply hydrated Xe-Derma on the wound. For large wound areas, use several pieces as necessary, and make their edges slightly overlap. 4. Over, apply secondary dressing such as you normally use (e. g., tulle gras and Furantoin- or 3 % boric-acid-soaked gauze, then outer dry gauze dressing). Note: 1. Do not use in the case of high wound-infection risk. 2. Make sure to remove all necrotic tissue prior to applying. If this is not properly done, may not adhere to the wound, and the treatment may not be successful. 3. Poor patient compliance (excessive movement, etc.) during the first 24 hours may negatively impact adherence to the wound bed. Post-Application Assessment Perform secondary dressing replacement as usual. If sticks firmly to the wound, replace carefully only the secondary dressing. will peel-off on its own when the wound will have healed. If the patient is febrile, inspect the wound. If Xe-Derma adheres to the wound, replace only the secondary dressing. If exudate is accumulating under, remove (if necessary, hydrate it with saline) and collect a sample for microbiological examination. In case of wound infection or deterioration remove and replace it with another type of treatment. List of Pre-Clinical Publications: Matoušková E. et al: Necrobiotic Process Causing Burn Wound Conversion May Be Prevented by Allogenic Keratinocytes Delivered by the Recombined Human/Pig Skin. Folia Biol (Praha). 21; 47(4): Pokorná E. et al: Y Chromosome and Vimentin Used to Trace the Fate of Allogenic Keratinocytes Delivered to the Wound by the Recombined Human/Pig Skin. Folia Biol (Praha). 21; 47(4): Matoušková E. et al: Prevention of burn wound conversion by allogenic keratinocytes cultured on acellular xenodermis. Cell Tissue Bank. 22; 3(1): Matoušková E. et al: Human allogeneic keratinocytes cultured on acellular xenodermis: The use in healing of burns and other skin defects. Biomed Mater Eng. 26; 16 (4 Suppl): S Matoušková E. et al: Treatment of burns with tissue engineered human/pig skin. Poster Matoušková E. et al.: Growth and differentiation of keratinocytes on acellular xenodermis Xe-Derma used as biological cover for acute and chronic wounds. Poster Zajíček R. et al: Human keratinocyte growth and differentiation on acellular porcine dermis. The Scientific World Journal, 212, List of Clinical Publications: Matoušková E. et al: Prevention of burn wound conversion by allogenic keratinocytes cultured on acellular xenodermis. Cell Tissue Bank. 22; 3(1): Matoušková E. et al: Human allogeneic keratinocytes cultured on acellular xenodermis: The use in healing of burns and other skin defects. Biomed Mater Eng. 26; 16 (4 Suppl): S Matoušková E. et al: Treatment of burns with tissue engineered human/pig skin. Poster Brychta P. et al: Acellular porcine dermis its characterization and use in burn medicine. Poster 12 th EBA Congress, Budapest, September 27 Zajíček R. et al: Xe-Derma : a new biological cover for treatment of acute and chronic wounds. Hojení ran 2, (28) Řezaninová L. et al: Úloha sestry při aplikaci nových metod v léčbě ulcerací syndromu diabetické nohy. Med. Pro Praxi 28; 5 (11): Dubský M. et al:comparison of healing capacity between acellular porcine dermis and porcine xenografts in diabetic foot disease. Abstract EWMA 29 Helsinki Pospíšilová A.: Léčba chronických ran moderními krycími prostředky. Prakt. Lékaren. 21; 6(6): Zajíček R. et al: New biological temporary skin cover Xe-Derma in the treatment of superficial scald burns in children. Burns 37 (211): Königová R. et al: Burn wound coverage and burn wound closure. Acta Chir Plast. 2; 42(2): Wosková V. et al: Hlavní zásady léčby syndromu diabetické nohy. Med. Pro Praxi 21; supplementum: Dubský M. et al:assessment of Acellular porcine dermis as a new local treatment of diabetic foot ulcers. Diabetic Foot Study Group 28, Lucca, Italy Zajíček R. et al: Hojení široce síťovaných autotransplantátů pomocí autologních epidermálních buněk a bezbuněčné xenodermis Xe-Derma. Hojení ran 6, 2: 12 18, 212 References: 1. Zajicek, R. et al: New biological temporary skin cover Xe-Derma in the treatment of superficial scald burns in children. Burns, 211; 37(2): Zajicek, R. et al: Human Keratinocyte Growth and Differentiation on Acellular Porcine Dermal Matrix in relation to Wound Healing Potential. The Scientific World Journal 212, Xe-Derma Návod k použití. 4. Zajíček, R. et al: Xe-Derma : A new biological cover for treatment of acute and chronic wounds. Hojení ran 2, 12 28, Koster, M. I., Roop, D., R.: The role of p63 in development and differentiation of the epidermis, Journal of Dermatological Science, vol. 34, no. 1, pp. 3 9, Zajíček, R. et al: Healing of widely meshed autografts with autologous epidermal cells and acellular xenodermis Xe-Derma. Hojení ran 6, 2: 12 18, 212. Note: If the wound is infected, exudate may accumulate under, may shift on the wound, or begin to dissolve. In such cases, remove and replace it with another type of treatment. Should this occur only in a limited area, while firmly sticks to the wound everywhere else, use scissors to remove carefully only the relevant part on the spot concerned while leaving in place on all other parts of the wound.... for your patients future

7 Treatment of acute and chronic skin defects... for your patients future Promotes systematic epithelisation process resulting in high quality of newly formed skin 1, 2, 6 Stimulates speedy healing and shortens time to healing 1, 2, 6 Guarantees safety and reduces patient burden due to therapeutic procedures Through minimising dressing replacements, it significantly reduces wound infection risk, pain, anaesthetics consumption, and need for procedures under total anaesthesia 1, 3, 4 Saves time of health care professionals 4 Reduces overall healthcare costs 4 MEDICEM International GmbH, Baarerstrasse 8, 63 Zug, Switzerland M/BUR/TTT/SEP212/INT2 Thanks to unique biologic activity and original manufacturing process, Xe-Derma :