Clinician’s Report: Cellular & Bioengineered Alternative Tissue

ACell® Inc.

Founded: 2002 Product: MatriStem® Founded: 2009 Product Description: MatriStem products maintain and support a constructive healing environment. MatriStem is comprised of urinary bladder matrix, known to promote the formation of site-specific tissue where scarring usually results. FDA Regulatory Classification: Dressing, Wound, Collagen/Mesh, Surgical. What sets product apart? It contains basement membrane and numerous collagens, provides a scaffold for natural remodeling, and complements standard of care. How does product improve patient care? MatriStem is appropriate for acute wounds, chronic wounds, and various surgical procedures to promote constructively remodeled, site-specific tissue. Contact: www.acell.com; info@acell.com, 800-826-2926.

Healthpoint® Biotherapeutics

Founded: 1992 Product: OASIS® Wound Matrix and OASIS Ultra Tri-Layer Matrix Product Description: OASIS Wound Matrix and OASIS Ultra Tri-Layer Matrix are naturally derived structures that support the body’s own healing process. Both products are intact matrices naturally derived from porcine small intestinal submucosa (SIS) indicated for the management of wounds. FDA Regulatory Classification: 510(k) Medical Device. What sets product apart? SIS technology provides a natural structure to help the body replace and repair damaged tissue. OASIS Wound Matrix is comprised of porcine-derived, acellular SIS to form a matrix-based product compatible with human tissue. OASIS Wound Matrix is a complex scaffold that provides an optimal environment for restoration of tissue structure and function. OASIS Ultra Tri-Layer Matrix is also a natural extracellular matrix derived from porcine SIS. This unique, tri-layer design incorporates three layers of natural tissue into the wound to help promote an environment conducive to healing. How does product improve patient care? OASIS Wound Matrix and OASIS Ultra Tri-Layer Matrix are natural, three-dimensional, intact SIS matrix structures that provide a natural environment for host cells and support their normal function, allowing them to repopulate and revascularize the wound. OASIS Wound Matrix and OASIS Ultra Tri-Layer Matrix promote wound closure by facilitating the body’s own tissue repair mechanisms. These products help organize and regulate multiple processes, including maintaining moisture balance and reducing elevated levels of matrix metalloproteinase activity. Contact: www.oasiswoundmatrix.com; chris.caggiano@healthpoint.com; 800-441-8227.

MiMedx®

Founded: 2008 Product: EpiFix® Founded: 2011 Product Description: EpiFix is an amniotic membrane allograft for chronic and acute wound healing. It delivers essential wound healing growth factors, enhances healing, reduces inflammation, and reduces scar tissue formation. It is available in multiple sizes. EpiFix, which can also be used for burn, oral, and cosmetic wounds, is processed through the proprietary PURION® Process that combines cleaning, dehydration, and sterilization to produce a safe, sterilized tissue allowing for storage at room temperature. FDA Regulatory Classification: Human Cells, Tissues, & Cellular and Tissue Product. What sets product apart? EpiFix is composed of multiple layers, including a single layer of epithelial cells, a basement membrane, and an avascular connective tissue matrix. The PURION Process is a patent-pending process that safely and gently separates placental tissues, cleans, and reassembles various layers before dehydrating the tissue in a way that preserves the key elements associated with healing. The sterilized tissue is packaged and stored at room temperature and has a 5-year shelf life, which negates the need for extra freezers, thawing, etc., required by other dermal substitutes. The tissue may be delivered in a dried sheet configuration using an on-lay surgical or clinical technique. Dehydrated amnion/chorion membrane allograft can also be micronized to create a powder configuration that can be administered as a topical powder or can be mixed with a saline to create an injectable solution. These options allow clinicians to select the appropriate configuration based on the patient’s wound type. With a variety of sizes available, the waste typically realized with other grafts is reduced significantly. How does product improve patient care? EpiFix has unique properties that reduce scar tissue formation, reduce inflammation, and support soft tissue regeneration. The potential medical uses of the tissue are broad, as it can be utilized in procedures where reduction in scar tissue or regeneration of a soft tissue is beneficial. Contact: www.mimedx.com; customerservice@mimedx.com; 866-477-4219.

Organogenesis Inc.

Founded: 1985 Product: Apligraf® Founded: 1998 Product Description: Apligraf contains two cell types derived from neonatal foreskin (living human keratinocytes and fibroblasts embedded in a type 1 collagen matrix). FDA Regulatory Classification: Class III Medical Device. What sets product apart? Apligraf is the only bioengineered, bilayered, living-cell-based product with FDA approval for the treatment of both diabetic foot ulcers and venous leg ulcers. How does product improve patient care? Apligraf has been shown to heal more wounds faster than conventional therapy alone. Contact: www.organogenesis.com; 888-432-5232.

Osiris Therapeutics Inc.

Founded: 1992 Product: Grafix® Product Description: Grafix is a cellular, three-dimensional matrix derived from placental membrane. It’s designed for direct application to acute and chronic wounds, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, and burns. Flexible, conforming, and immune neutral, this cellular repair matrix provides endogenous viable mesenchymal stem cells (MSCs) and growth factors to the wound site while the matrix protects the area from inflammation, scarring, and infection. FDA Regulatory Classification: Human Cells, Tissues, & Cellular and Tissue-based Product. What sets product apart?: The combination of living cells that are beneficial for wound healing, particularly mesenchymal stem cells, along with functional growth factors and matrix to provide the optimal environment. Grafix is the only wound care product containing MSCs available today. How does product improve patient care?: The presence of MSCs in normal skin and their critical role in wound healing, particularly anti-inflammatory properties of MSCs, suggest that the application of products containing MSCs is a promising solution for treatment of chronic wounds. A pilot evaluation of Grafix for treatment of recalcitrant chronic wounds showed >70% probability of wound closure at week 12. Contact: www.osiris.com; osiris@osiris.com; 443-545-1800.

Soluble Systems, LLC

Founded: 2007 Product: TheraSkin® Real Skin Wound Therapy with Living Cells Founded: 2011 Product Description: TheraSkin is an at-ready extracellular matrix to jumpstart healing on any wound, head to toe. FDA Regulatory Classification: Human Cells, Tissues, & Cellular and Tissue-based Product. What sets product apart?: TheraSkin is human skin, cryopreserved such that 98% of the dermis and epidermis cells are living at application. TheraSkin has a fully functioning extra cellular matrix with the appropriate types and ratios of collagen and a full complement of growth factors and cytokines to support healing from the very moment of application. How does product improve patient care?: TheraSkin closes a high percentage of wounds that have not responded to alternative therapies, providing the patient the best chance of healing cost effectively. Contact: www.solublesystems.com; 877-222-2681.

Shire Regenerative Medicine

Founded: 2011 Product: Dermagraft® Founded: FDA pre-market approval in 2001 Product Description: Dermagraft is a cryopreserved human fibroblast-derived dermal substitute indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved foot. Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution. FDA Regulatory Classification: Class III Medical Device. What sets product apart?: Dermagraft is composed of living human fibroblasts, an extracellular matrix, and a bioabsorbable polyglactin mesh scaffold. This cryopreserved, three-dimensional, human dermal substitute can be applied weekly for up to eight applications within a 12-week period. How does product improve patient care?: In the phase III pivotal trial, Dermagraft added to conventional therapy resulted in significantly more patients with DFUs greater than six weeks (plantar surface, including heal, forefoot, and toes) achieving complete wound closure by 12 weeks vs. conventional therapy alone (64% relative increase; 30% vs. 18%, P=0.023). Contact: www.dermagraft.com; dermagraft@shire.com; 858-754-3700.