Covergel
About Covergel
Covergel is a thermosensitive biogel and adjuvant in endoscopic resections of large colorectal lesions in the gastrointestinal tract. It is a sterile class III medical device in hydrogel.
The objective of Covergel is to create a bioadhesive protective platform for active treatment and physiological tissue healing while providing a mechanical-protective barrier that repairs the affected mucosa. It is a biocompatible hydrogel applied using the endoscopic shielding technique (EndoSTech) for the treatment of gastrointestinal mucosal lesions alone or in combination with clips.
Covergel is a major innovation for sealing mucosal lesions and compatible with clips, and for preventing delayed bleeding. After endoscopic resection techniques, delayed, bleeding occurs in 9.1% to 12.1% of cases.
Covergel is applied in patients with large non-pedunculated colorectal lesions (LNPGT) with medium to high risk of delayed bleeding (GSEED-RE2 score ≥ 4 points).
Covergel is currently under clinical investigation and is not yet available for commercial use.
12 Characteristics to understand Covergel
How it works
After an EMR or DSE, the eschar should be covered and/or closed to prevent the development of complications.
Apply the required amount of Covergel directly to the eschar to initiate gelation and tissue adhesion.
Once the solution is applied, Covergel adheres to the tissue at a body temperature of 37°C and an elastic gelation platform is generated.
The Covergel solution will favour and initiate mucosal healing.
Covergel Ingredients
(Patent EP23382747.6)
Cellulose (C)
Biopolymer with high bioadhesive capacity and viscosity stabiliser. This active ingredient allows the hydrogel to adhere effectively to the affected mucosa by generating a primary film on the affected area by durotaxis movement.
Hyaluronic acid (HA)
The hyaluronic acid promotes tissue re-epithelialization of tissues or induced healing to remodel the extracellular matrix and heal the tissue effectively.
Rifaximin
Broad-spectrum antibiotic with minimal absorption (<0.4%) into the intestinal walls that does not generate bacterial resistance (1). Its goal is preventing bacterial degradation of the adherent INM020 against the action of the intestinal microbiota, thus increasing the effectiveness and duration of the regeneration process.
Poloxamer
This active ingredient is a rheological modifier that provides adhesive thermogelation properties. Forms gels that act as physical scaffolds that promote cell proliferation and creation of granulation tissue.
Certified Quality Assurance
The manufacturing of Covergel complies with the highest international quality standards. Our processes are certified under ISO 13485 ensuring excellence in management systems, production control, and medical device safety..
Through the implementation of these systems and the continuous auditing of our processes, we guarantee that every unit of Covergel meets the most demanding requirements for quality, safety, and traceability.
FAQ
What is the revolution of Covergel?
Covergel is the first prophylactic solution on the market to seal, protect and reparate tissue after endoscopic resection in gastrointestinal tract mucosa. Covergel formula offers a much lower cost and a much greater effective, simple and applicable than the leading options on the market.
What is Covergel suitable for?
For use alone or as a coadjuvant with clips or sutures. On its own, Covergel can be used for resections of large polyps. In complicated lesions, Covergel can be combined with clips providing a complete protection and avoiding delayed bleeding or post-surgical complications.
Why does Covergel contain antibiotic?
After endoscopic resection, an eschar is created, which can be infected by the action of intestinal flora. The Rifaximin present in Covergel aims to give the adherent gel a resistance to bacterial degradation.
How is Covergel removed from the body?
Covergel remains adhered to the body while it repares the tissues and protects the lesion. The natural regeneration of the tissues and intestinal motility promotes the detachment of Covergel until it is finally expelled through the intestinal tract.
What is a hydrogel?
It is a polyvalent three-dimensional network with flexible interlaced chains that vary between liquid and solid. This forms a mesh capable of retaining water by increasing its size without changing its shape. Covergel technology makes it possible to add some useful active substances such as moisturizers, regenerators or antibiotics to this interwoven mesh.
Why use a thermogel technology?
Thermogel technology has two objectives. The first is to make Covergel generate a perfect film and mold of the injured tissues, creating a platform that protects and initiates the healing of the injury. The second is rheological. The application of Covergel in a gel state on the lesion produces a better, faster and more efficient adhesion. Once adhered, Covergel transforms into a resistant and protective gel.
Does Covergel replace clips or sutures?
Covergel is the ideal solution to complement clips in areas where they cannot be easily applied and to prevent bleeding and infection.
How is Covergel stored?
Covergel should be stored at room temperature and should not be exposed to light. Freezing should be avoided.
