Excellagen®is a new, FDA-cleared highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound care management for the management of diabetic ulcers, partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. Excellagen's unique high molecular weight bovine Type I collagen formulation is topically applied through easy to control, pre-filled, single use syringes. Excellagen is intended for physician use during debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen's viscosity optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied during debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors.Excellagen has been shown to activate human platelets, triggering the release of platelet-derived growth factor (PDGF).
Cardium's market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application - and Excellagen's unique, ready-to-use syringe-based collagen gel requires no thawing, mixing, or suturing. Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 cc of Excellagen covers wounds up to 5cm2 in size using the supplied 24-gauge sterile, single-use flexible applicator tip.
Cardium's Excellagen formulated fibrillar collagen topical gel also represents a new product platform that allows for the potential development of a portfolio of advanced wound care and therapeutic products. Cardium's Gene Activated Matrix (GAM) technology represents one extension of Cardium's FDA-cleared viscosity optimized, fibrillar collagen-based matrix for the localized topical delivery of agents that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media.
Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers.
A recent publication from a Phase 2b clinical study in diabetic neuropathic ulcers reported that application of 2.6% formulated fibrillar collagen resulted in a statistically significant 173% relative improvement in the acceleration of healing (reduction in wound radius) during the first week following a one-time application compared to patients.
EXCELLAGEN Rx
Generic Name and Formulations:
Formulated bovine type I collagen (2.6%); topical gel.
Company:
Cardium Therapeutics
Indications for EXCELLAGEN:
Management of wounds including: partial and full- thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.

Adults and Children:
See literature. Perform debridement or excision prior to application. Apply a thin layer directly to the entire wound surface and edges. May be occluded with non-adherent, gauze and foam dressings; change dressings and reeva luate weekly. If healing is incomplete, gel may be reapplied; max once weekly.

Warnings/Precautions:
Control excessive exudate, excessive bleeding, acute swelling, and/or infection before starting treatment. Discontinue or remove if infections, chronic inflammation, allergic reaction, excessive redness, pain, swelling occur. Do not freeze or reuse syringes. Avoid exposure to high temperature.

Pharmacological Class:
Wound care device.

Adverse Reactions:
Local reactions (eg, infections, inflammation, swelling).

How Supplied:
Kit—1 (4 pre-filled, single-use [0.5mL] syringes w. applicators)