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Closer to Nature. Better Results.

A portfolio of natural, perforated allografts designed to meet multiple surgical needs

Closer to Nature. Better Results.

A portfolio of natural, perforated allografts designed to meet multiple surgical needs

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Designed to support natural fluid flow between planesOur SimpliDerm™ perforated portfolio provides intraoperative ease of use and optimal plane-to-plane fluid transfer upon implantation, while maintaining the regenerative performance you’ve come to expect from SimpliDerm™.

A unique proprietary processAziyo uses a proprietary, patented and gentle process to achieve a sterility assurance level (SAL) of 10-6, while preserving the key growth factors of native dermis.1,2 Due to this unique proprietary process, SimpliDerm™ offers a more pliable, intact matrix membrane that supports the angiogenic process, demonstrating a lower risk of inflammatory response, faster integration and more rapid revascularization.1

SimpliDerm™ maintains key growth factors and structural composition of human dermis, supporting robust blood vessel formation and providing similar mechanical strength, collagen integrity, and bioactive components to native dermis.1

1 Aziyo® Biologics data on file2 Instructions for Use

SimpliDerm™ Features2

Proprietary and patented gentle processing

Sterile: Sterility Assurance Level (SAL) 10-6

Ready to Use: Pre-hydrated without damage to matrix

SimpliDerm™ Advantages1

√ Closer to Human Dermis

√ Low Inflammatory Response

√ Rapid Integration

√ Enhanced Pliability

Proven to maintain key growth factors of native dermis1

SimpliDerm™ demonstrated lower inflammatory response, robust matrix regeneration and integration, greater tissue strength and suture retention, and lower fibrotic response than AlloDerm® RTU in a non-human primate model.1

Clinically proven results for an optimal immunologic response

Prior to use, physicians should become familiar with all risk information found in the Instructions for Use, which is available at http://www.aziyo.com/simpliderm/, and included in product packaging.

SimpliDerm™ Ellipse™ Medium10 x 20 cm

15 mm Suture Border2.5 mm Perforation Diameter

SimpliDerm™ Ellipse™ Large13 x 21.5 cm

15 mm Suture Border2.5 mm Perforation Diameter

SimpliDerm™ Perforated 16 x 20 cm

15 mm Suture Border2.5 mm Perforation Diameter

SimpliDerm™ Perforated 16 x 16 cm

15 mm Suture Border2.5 mm Perforation Diameter

SimpliDerm™ Perforated Portfolio

Experts in regenerative medicine. Aziyo® Biologics is excited to launch our SimpliDerm™ Perforated portfolio available

in both Ellipse™ and rectangular shapes to meet a range of surgical needs.

SimpliDermTM Perforated has two (2) distinct sides: a basement membrane and a dermal side. When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. An “Orientation Hole” has been placed in the upper right hand corner to indicate that the basement membrane is facing toward the user.

Orientation holeto assist in accurate

intraoperative placement

Orientation holeto assist in accurate

intraoperative placement

®CORPORATE HEADQUARTERS12510 Prosperity Drive, Suite 370Silver Spring, MD 20904P 240-247-1147F 510-307-9896

ALLOGRAFT PRODUCTS880 Harbour Way South, Suite 100Richmond, CA 94804P 855-416-0596

© 2019 Aziyo Biologics. SimpliDerm™ is a registered trademark of Aziyo® Biologics. All rights reserved. LT-0034Rev. 01. // Aziyo.com

SimpliDerm™ is an ambient product. SimpliDerm™ is available in a range of sizes.

Storage must be maintained at room temperature, and must not exceed 25°C.

Customer Service and Ordering 1-800-922-3100 | orders@aziyo.comHydrated

Acellular Dermal Matrix

INSTRUCTIONS FOR USE

DONATED HUMAN TISSUE FROM U.S. TISSUE BANKS. THE RECOVERY AND PROCESSING WAS PERFORMED USING ASEPTIC TECHNIQUES. THE ALLOGRAFT IS TERMINALLY STERILIZED TO A STERILITY ASSURANCE LEVEL OF 10-6 IN ITS FINAL PACKAGING.

SimpliDerm™ Thickness: 0.90 - 1.99 MMOrder Code SizeSD.090.0307 3cm x 7cm

SD.090.0407 4cm x 7cm

SD.090.0412 4cm x 12cm

SD.090.0416 4cm x 16cm

SD.090.0510 5cm x 10cm

SD.090.0612 6cm x 12cm

SD.090.0616 6cm x 16cm

SD.090.0715 7cm x 15cm

SD.090.0812 8cm x 12cm

SD.090.0816 8cm x 16cm

SD.090.0820 8cm x 20cm

SD.090.1212 12cm x 12cm

SD.090.1620 16cm x 20cm

SimpliDerm™ PerforatedOrder Code Size

SD.090.1616P 16cm x 16cm

SD.090.1620P 16cm x 20cm

SD.090.1020ELP Ellipse™ Medium 10cm x 20cm

SD.090.1321ELP Ellipse™ Large 13cm x 21.5cmSimpliDerm™ Thickness: 2.00 - 3.50 MM

Order Code Size

SD.200.0101 1cm x 1cm

SD.200.0104 1cm x 4cm

SD.200.0307 3cm x 7cm

SD.200.0407 4cm x 7cm

SD.200.0412 4cm x 12cm

SD.200.0416 4cm x 16cm

SD.200.0510 5cm x 10cm

SD.200.0612 6cm x 12cm

SD.200.0616 6cm x 16cm

SD.200.0715 7cm x 15cm

SD.200.0812 8cm x 12cm

SD.200.0816 8cm x 16cm

SD.200.0820 8cm x 20cm

SD.200.1212 12cm x 12cm

SD.200.1620 16cm x 20cm

DESCRIPTIONSimpliDerm™ Perforated Hydrated Acellular Dermal Matrix (HADM) is a human skin allograft minimally processed to remove epidermal and dermal cells and then preserved in a gamma irra-diation protection solution. The process utilizes a proprietary and patented technology to preserve the remaining bioactive components and extracellular matrix of the dermis. The resulting acellular matrix is pre-hydrated without damage to the matrix compo-nents and is designed to be rinsed quickly in a sterile isotonic solution. The resulting allograft functions as a framework to support cellular repopulation and vascularization at the surgical site. SimpliDerm™ perforated HADM is supplied as Ellipse™ or rectan-gular shapes.

INDICATIONS FOR USESimpliDerm™ is to be used for the repair or replace-ment of damaged or insufficient integumental tissue.

It may also be used for the repair, reinforcement or supplemental support of soft tissue defects or any other homologous use of human integument. Each package of SimpliDerm™ is intended for use in one patient on a single occasion by a licensed physician.

CONTRAINDICATIONSUse of SimpliDerm™ in patients exhibiting auto-immune connective tissue disease is not recommended. SimpliDerm™ should not be used in patients with sensitivities to processing agents (see WARNINGS).

Orientation: SimpliDerm™ has two (2) distinct sides: a basement membrane and a dermal side. The basement membrane appears dull and repels blood. The dermal side appears shiny and absorbs blood. When applied as an implant, it is recom-mended that the dermal side be placed against the most vascular tissue. The allograft has an addition-al orientation hole that when oriented in the upper

right corner indicates that the basement membrane is facing toward the user.

WARNINGSPotential adverse effects that may result from place-ment of SimpliDerm™ include, but are not limited to wound or systemic infection; seroma; dehiscence; hypersensitivity; allergic or other immune response; sloughing or failure of the graft; and disease trans-mission.• Trace amounts of processing agents include,

but are not limited to: gentamicin, maltodextrin and trehalose.

• Do not re-sterilize or reuse.Extensive medical screening procedures have been used in the selection of all tissue donors (see Donor Screening and Testing). Due to limitations in test-ing technology, testing and donor screening cannot totally eliminate the risk that human source material may transmit infectious agents or diseases.