NovoSorb BTM. A unique synthetic biodegradable wound scaffold. Regenerating tissue. Changing lives.

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1 NovoSorb BTM A unique synthetic biodegradable wound scaffold Regenerating tissue. Changing lives.

2 Overview NovoSorb BTM is a unique synthetic biodegradable wound scaffold that delivers good cosmetic and functional outcomes through regeneration of the dermis. No Proteins. Biodegradable. NovoSorb BTM is a biodegradable tissue scaffold developed for the treatment of full-thickness wounds where the dermal structure has been lost to trauma or surgical debridement. Unlike other tissue scaffolds NovoSorb BTM does not contain any sensitizing proteins. It is designed to reduce shrinking, contraction of the wound and scar formation. Comprising a wound-facing biodegradable foam (NovoSorb) bonded to a non-biodegradable transparent sealing membrane, the matrix can be implanted into surgically debrided wounds and is designed to deliver a more aesthetic outcome than that currently achieved by immediate split thickness skin grafting. This improved aesthetic is achieved as, over a short period of weeks, the dermis regenerates within the polyurethane foam matrix. This dermal regeneration reduces the pie dish effect,reduces the scar and improves functional outcomes. Indications for use Deep Dermal Burns (not FDA approved for full thickness burns. PMA trials are in progress in the US) Trauma and reconstructive surgery Wide excision surgical wounds Large wound closure Scar Revision Venous Leg Ulcers (VLU) Diabetic related foot ulcers (DRFU) Pressure injuries (PI)

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4 Composition The BTM Wound Dressing is composed of three layers Foam A wound-facing, 2mm thick, white, open cell foam with a high degree of porosity (>90%) designed to subsequently biodegrade. The foam is a biocompatible, biodegradable polyurethane material. Bonding layer A polyurethane adhesive layer which bonds the Foam and Sealing Membrane together. Sealing Membrane A temporary, transparent polyurethane membrane designed to physiologically close the wound and limit evaporative water loss. The sealing membrane is designed to remain attached to the dermal foam, if required, for at least 30 days in vivo. Implantation of BTM 1 The BTM is designed to be surgically implanted into a fully debrided, clean, surgical wound. All necrotic and non-viable tissue must be removed before the BTM is implanted. Ensure the edge of the BTM abuts the wound margin but does not overlap the surrounding skin. Staple or suture into place. The BTM should be tailored to fit the wound and body contours with a gentle tension to avoid pleats and wrinkles. 2 Full integration of the dermal layer into the BTM can be assessed by blanching the BTM area with your fingers. Once you have a rapid re-profusion of the area you have blanched the BTM can be delaminated. 3 When ready to delaminate remove the sutures/staples and lift a corner of the seal using a forcep. Maintain a 30 degree angle to the dermal area and peel the film away in a smooth motion. 4 Small to medium Wounds: can be closed through secondary intention using moist wound healing products to cover and protect the new dermis. Large surgical wounds or Burns: may require closure with split skin graft (SSG).

5 Application in operating rooms Customise the cut of the BTM to the contour of the area and ensure no overlap. Held in place with staples; note the contouring. Note the contouring, firm fit to all areas including the axilla and joints. The areas over the trunk have been covered with an antimicrobial and elastic netting.

6 Secondary dressing of the BTM Whilst dressing protocols might be decided by the operating surgeon, it is recommended to cover the BTM with a low-adherent protective dressing, overdressed with an antibacterial dressing. Compression may then be afforded with crepe bandages, and is important where swelling is likely. Splinting may be desirable if placement has been into a wound over a highly mobile area. This dressing should be changed every three days. Other dressing regimes may need to be changed more frequently depending on their duration of antibacterial action. The BTM Wound Dressing is synthetic but it has no intrinsic antibacterial properties. Splints can be discontinued at Day 7 post-placement. Application and rapid integration Day 2 Day 4

7 Staged grafting Day 31 Day 9 pt 5 Day 38 post BTM

8 Outcomes pt 1 Day 536 pt 1 Day 368

9 pt 1 Day 194 pt 1 Day 171 pt 1 Day 312

10 Necrotizing Fasciitis Neck Free flap application Current standard of care Non-BTM Note the scarring and the tendons in this example of the traditional approach. BTM - Innovates the standard Note the lack of scar/contracture and topography. Day 0 Open

11 Note the full range of movement and lack of contraction. Day 180

12 Published use over bone Various publications of BTM use can be found on our website and within the online peer review journal eplasty. This particular case demonstrates the use of BTM over a calvaria (skull). This case study demonstrates the robust nature of BTM in a challenging clinical application. Day 40 Day 43

13 Day 47 Day 89 Day 40 Day days post-grafting

14 Packaging BTM comes sterilized in a multilayer packaging. A cardboard envelope contains a white aluminized peel-able pouch which encloses a sterile transparent peel-able pouch containing the BTM. Labels are affixed to the white aluminized pouch and the outer cardboard envelope, and carry details such as date of manufacture, product batch number and expiry date. Each pouch is nitrogen filled. Sterilisation: Gamma irradiation. Catalogue number Description Pack sizes PS BTM Wound Dressing 10cm x 10cm 1 PS BTM Wound Dressing 10cm x 10cm 5 PS BTM Wound Dressing 10cm x 10cm 25 PS BTM Wound Dressing 10cm x 20cm 1 PS BTM Wound Dressing 10cm x 20cm 5 PS BTM Wound Dressing 10cm x 20cm 25 PS BTM Wound Dressing 20cm x 40cm 1 PS BTM Wound Dressing 20cm x 40cm 5 PS BTM Wound Dressing 20cm x 40cm 25

15 Estimate of pieces required Application Site BTM size Surface area ~No: Sheets Neck 10x20cm 200cm Anterior Trunk 20x40cm 800cm Posterior Trunk 20x40cm 800cm Buttocks 20x40cm 800cm 2 2 Arms Legs 10x20cm 20x40cm 10x20cm 20x40cm 200cm 2 800cm 2 200cm 2 800cm 2 Melanoma/wide excisions 10x10cm 100cm x20cm 200cm 2 1 DRFU 10x10 cm 100cm 2 1 VLU 10x10 cm 100cm 2 1 A mix of sizes is advised to tailor to contours A mix of sizes is advised to tailor to contours Contraindications BTM application is contraindicated in wounds where necrotic/devitalized tissue is present, such wounds must be surgically debrided to viable tissue pre-application. BTM should not be applied into overtly infected wounds, such wounds should be debrided of non-vital tissue and be topically treated with antimicrobial dressings +/- systemic antibiotics before application is considered. BTM should only be applied into surgically debrided chronic wounds where underlying pathology capable of potentiating the wound has been addressed (e.g. meticulous blood sugar control in diabetic ulceration, compression hosiery/dressings in venous ulceration to combat sustained venous hypertension, etc). BTM should be applied into wounds only after effective hemostasis has been afforded. Warnings The following complications are possible with the use of wound dressings. If any of the following conditions occur, the device should be removed: chronic inflammation, allergic reaction, excessive redness, pain or swelling. Precautions BTM is sterile if the package is unopened and undamaged. Do not use if the package has been perforated or the seal is broken or any other contamination is suspected. Opened and Unused BTM cannot be resterilized and must be discarded. BTM should not be applied until excessive exudate, bleeding, acute swelling and infection are controlled. Debridement or excision must be meticulous and remove any remaining necrotic tissue that may cause infection.

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