Registration Date 30 Mar 2017

PuraMatrix GMP© Clinical-Grade Gels


Medicine Tissue Engineering



PuraMatrix® has demonstrated efficacy in multiple models for hemostasis (CE Mark approved, trade name PuraStat®), tissue regeneration, acute myocardial infarction, therapeutic protein and stem cell delivery, and CNS injury. PuraMatrix® can re-hydrate and provide mechanical support for disc height collapse in degenerated IVDs, anti-adhesion, polyp resection, and bone formation. PuraMatrix® has also been used to repair and restore visual function in the CNS after damage.
Hemostasis Tissue regeneration Stem cell delivery


The advantages of using PuraMatrix® stem from the product’s simple, customizable composition: three common amino acids coupled to generate a 16-mer which is formulated into a fully transparent, ready-to-use hydrogel. PuraMatrix®‘s advantages have been validated by more than 200 publications from independent academic labs, customers, collaborators, and 3-D Matrix’s scientific founders. In both scale and function, PuraMatrix® resembles natural collagen, the most abundant protein in nature. Collagen and other similar proteins provide structural integrity to the extracellular matrix (ECM) as in vivo scaffolds for cell attachment, migration and tissue organization. Human and animal derived collagen and similar proteins present risk of infection and immune response due to their biogenic origins. As a fully synthetic, non-animal derived extracellular matrix, PuraMatrix® removes any risks associated with biogenic sources. Additionally, the ability to produce PuraMatrix®peptide hydrogel by strictly controlled and validated ISO-certified manufacturing techniques without the use of human or animal sources, or of recombination, ensures a pure, defined, always reproducible, high quality product. PuraMatrix® has passed a rigorous suite of biocompatibility and toxicity tests for medical devices, demonstrating complete resorption in less than 30 days – without problematic immune reactions or toxic breakdown products. Short-term resorbability and function as a provisional biomaterial not only contribute to enhanced usability but also mitigate concerns which plague other resorbable biomaterials (breakdown of products, foreign body response, scarring and post-operative pain). A number of animal studies by both 3-D Matrix and independent clinical researchers have demonstrated these advantages, resulting in a strong body of published literature. PuraMatrix® can be injected through fine gauge needles and catheters. PuraMatrix®gels after injection into tissue, trapping therapeutics and preventing back-leakage of injectate, thus retaining therapeutics in a tissue or defect for a longer period. The nanofiber assembly can retain and release protein therapeutics (BMP, PDFG, VEGF, etc.), drugs and cells in a controlled manner for up to 10 days, depending on the therapeutic and dynamics of the particular tissue. Together, these features serve unmet needs across a range of biomaterial applications while complementing biologics, therapeutics, medical devices and surgical procedures. Functional delivery can mean the difference between success and failure, especially for those therapies with demonstrated effectiveness in vitro. Many opportunities exist to combine PuraMatrix® with allograft biomaterials and autograft tissue. Not only does PuraMatrix® serve as a synthetic extracellular matrix, but it also acts as an injectable extender, allowing superior surgical handling and delivery while decreasing the amount of allograft or autograft needed per procedure.


Manufacturer's Description

PuraMatrix GMP© Clinical-Grade Gels are produced to meet the exacting clinical-grade quality for clinical applications.
PuraMatrix® is an ideal synthetic, transparent, biocompatible, and bioresorbable material situated at the intersection of chemical engineering and biology.
PuraMatrix® in vivo extracellular matrix has wide-ranging laboratory and clinical applications, including cell culture, drug delivery, accelerated cartilage and bone growth, and regeneration of CNS, soft tissue, and cardiac muscle.PuraMatrix® is a fully synthetic, resorbable hydrogel composed of repeating amino acid sequences of Arginine-Alanine-Aspartic Acid-Alanine prepared in an aqueous solution. PuraMatrix® self-assembles into nanofibers on a scale similar to the extracellular matrix when exposed to physiological levels of salt, forming a flowable hydrogel—users can decide exactly when to gel PuraMatrix®. PuraMatrix® nanofibers create a highly organized, 3-dimensional, porous scaffold that is very difficult, if not impossible, to produce by any manufacturing techniques. Additionally, the nanofiber density and average pore size (5-200 nm) can be controlled and customized by the concentration of peptide solution used in production.PuraMatrix® peptides are produced by well-characterized F-MOC solid-phase peptide synthesis methodology with proprietary processing modifications. The peptide is fill-finished via proprietary aseptic fill-finish and quality testing steps: formulation in liquid, sterile filtration, specification and adjustment of concentration, aseptic fill into vials or syringes, packaging, validation and documentation. Certification of fill-finish manufacturer includes ISO 90001:2000 and ISO 13485.PuraMatrix® has been tested across multiple standard animal models and in multiple tissue compartments (bone, cartilage, muscle, CNS, intracutaneous injections) – without a single negative safety outcome. This quality is due to PuraMatrix®’s low concentration of fully synthetic, short-length peptides composed of only three standard amino acids forming a biocompatible, biomimetic and bioresorbable nanofiber network structure.