PriMatrix™

PriMatrix™Dermal Repair Scaffold
PriMatrix is an EBM technology product cleared by the FDA for use in the management of wounds.
DescriptionPriMatrix is an acellular collagen dermal tissue matrix derived from fetal bovine skin. The device is supplied sterile, stored dry at room temperature, and hydrates in seconds for hassle free use. It has shelf life greater than one year.
IndicationsPriMatrix is intended for the management of wounds that include:
· Partial and full thickness wounds
· Pressure, diabetic, and venous ulcers
· Second degree burns
· Surgical wounds: donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence
· Trauma wounds: abrasions, lacerations, and skin tears
· Tunneled/undermined wounds
· Draining wounds
Contraindications
· PriMatrix is not designed, sold, or intended for use except as indicated.
· PriMatrix should not be used for patients with a known history of hypersensitivity to collagen or bovine products.
· PriMatrix should be used with caution in regions where an infection exists.
· PriMatrix is not indicated for use in third degree burns.
EBM is a strong, animal-derived, highly biocompatible, remodelable collagen membrane for use as a surgical mesh covering a broad spectrum of tissue repair applications including rotator cuff, dura, pelvic floor reconstruction, skin wounds, and urogynecological conditions. EBM is distinguished by its ability to be remodeled over time by the body into a functional tissue. EBM is processed by a patented method that results in a strong matrix that retains essential biological properties. It has sites for rapid and specific cell attachment and for binding cell-secreted products, such as signaling molecules with the ability to stimulate and direct tissue regeneration. It is also readily vascularized, thus becoming a living tissue shortly following implantation.

When hydrated, EBM is a soft and drapable membrane that conforms to complex geometries. It has high tensile and suture pullout strength without requiring a crosslinking step, therefore it is free of harmful chemical crosslinkers. Crosslinking with chemical agents destroys molecular recognition sites along the collagen biopolymer. When the recognition sites are destroyed; resulting in inadequate vascularization, cell migration, and cell attachment, tissue remodeling can be seriously compromised.
Over time, EBM remodels into a native tissue, providing a permanent repair of the target site. In contrast, synthetic polymer implants and crosslinked biopolymers remain in the patient as foreign bodies and are not remodeled. Synthetic biodegradable polymer implants, on the other hand, lack the biological information necessary for successful remodeling.

Most surgeons who use EBM prefer it to competing products because of its attractive pliable texture, handling, and suturing characteristics, as well as its rapid hydration rate, all features that save time in the operating room. EBM is manufactured through a series of effective microbial, fungal, viral, and prion inactivation steps, and is biocompatible per FDA and ISO 10993 requirements, exhibiting no acute or chronic foreign body response. EBM can serve as a "delivery device" when enriched with signaling molecules, cells, antibiotics, drugs, and other agents. It forms the basis for our first commercial products, TissueMend and Durepair. Further, because of its superior biocompatibility and strength, EBM may be used to build many types of medical devices, including vascular, orthopedic, and other tissues that require substantial strength.