Petil™ - Acellular Placental Tissue Particulate
Petil™ is a room temperature stable acellular allograft derived from human placental tissue collected from consenting donors. Post-decellularization and stabilization, Petil™ is packaged in a double pouch packaging system and subjected to low dose gamma irradiation. Petil™ is an acellular particulate human placental connective tissue matrix intended to replace or supplement damaged or inadequate integumental tissue. Petil™ is an allograft tissue intended for homologous use regulated by 21 CFR Part 1271 and Section 361 of the PHS Act.
Petil™ has a packaged product configuration that provides for easy rehydraton and administration of the acellular placental particulate. To preserve sterility, usable product volume, and for convenience, we load directly into a leur lock compatible syringe (3ml or 5ml volume) prior to packaging it in our double soft pouch system. This configuration reduces preparation time and product loss or contamination during preparation. By attaching any sterile leur lock needle, sterile saline can be drawn into the syringe to rehydrate the product. Post rehydration the needle can be disconnected and safely disposed of and the product can be directly administered to the surgical site or delivered via a canula by extrusion through the open leur lock bore. In contrast to currently commercially available micronized placental products, Petil™ is acellular and comprised of particles over 250 microns. This larger particle size is only available from Seed Biotech, Inc. The Petil™ design requirements were established to reduce exposed collagen fracture surface area and maximize durability (molecular weight) of the particles. These design requirements were established to reduce risks of exacerbated inflammation due to the introduction of fractured ECM to the site and potential for rapid resorption of the product.
This allograft is intended for homologous use and may be used in a variety of orthopedic, surgical, ophthalmology, spinal and wound covering applications. For specific instructions on the on the use and risks of Petil products please refer to the product insert instructions for use for information.
Clinical Advantage Overview:
Due to the novel decellularization processing of the tissue, the novel design of the product and the clinical convenience and ease of use provided by its package configuration, we believe Petil is the first acellular placental tissue particulate designed for clinical safety, use and performance.