How it works.Collymer represents a polymerizable collagen protein that is free from cellular and other immunogenic components. It capitalizes on the unique self-assembly and structural signaling properties of naturally occurring collagen that your body produces. Preclinical studies indicate that the surrounding tissue cells recognize scaffolds and materials formed from Collymer, allowing the process of cellularization, vascularization and innervation to begin. The proprietary fabrication techniques developed by GeniPhys allow the creation of custom materials for multiple applications.
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What is Collagen?
Collagen, in its fibrillar scaffold form, provides the fundamental infrastructure of the body's tissues, including skin, muscle fat, tendon, bone, and blood vessels. This scaffold is the primary determinant of tissue structure and functional properties and also engages cells and other biomolecules when orchestrating complex processes associated with tissue development, homeostasis, and healing. Collagen also represents the body's natural polymer from which tissues are built when damaged or injured. Within the body, collagen protein polymerizes (self-assembles) to form the fibrillar scaffold of tissues.
The Problem
When tissues are damaged due to injury, disease, or surgical procedure, the healing response is initiated. Our body has limited capacity for tissue regeneration in part because of our cells' inability to efficiently produce sufficient collagen tissue building materials. Without the key structural scaffold, scarring and fibrosis are common.
Collymer Advantages
Collymer technology has captured essential features of collagen and it's scaffold forming capacity, allowing customization of a broad array of materials that are noninflammatory and support accelerated and improved regenerative healing.
Compared to conventional collagens and collagen biomaterials, differentiating features of Collymer include:
Compared to conventional collagens and collagen biomaterials, differentiating features of Collymer include:
- Patented polymerizable collagen protein that is highly purified and free from cellular and other immunogenic components
- Capacity to transition from liquid to physically stable fibrillar scaffold when mixed with buffer to physiologic pH; scaffold recreates structural and biological signaling features of collagen found naturally within tissues
- Amenability to engineering design and biofabrication methods, enabling custom manufacturing of a wide variety of material formats. Examples include:
- In-situ scaffold-forming collagens for restoration of soft tissue defects and voids (e.g., fat, breast, skin, muscle)
- High-strength materials (i.e., sheets, tubes) of various thicknesses that can be sutured into place
- Materials with gradients in fibril densities for restoration of tissue interfaces
- Uncommon mode of action marked by noninflammatory, regenerative healing validated by preclinical studies; and
- Robust and low-cost manufacturing process (ASTM F3089-14).
Collymer Possibilities
GeniPhys plans to pursue a wound management indication for its first product, Collymer SAS™, and will follow with clinical studies to support soft tissue restoration. Collymer SAS has potential additional applications in areas such as bone filler, soft tissue filler (aesthetic), vocal fold medialization and therapeutic cell or drug delivery. Due to the versatility of Collymer and the ability to leverage proprietary biofabrication techniques, applications such as cartilage replacement, vascular grafts, and heart valve replacement, among others, all present compelling opportunities. GeniPhys will pursue strategic alliances with global innovative companies in order to achieve the full potential of Collymer and therefore deliver improved regenerative and restoration solutions to patients.
Magnified view of Collymer Fibrillar Scaffold
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Video of in-situ scaffold formation (polymerization) by Collymer SAS
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Collymer High Strength Sheet
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Collymer is an investigational device and has not yet been cleared by the FDA.