Clinician’s Report: Cellular & Bioengineered Alternative Tissue

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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.


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