CorNeat gPatch
Permanent periodontal regeneration membrane
Periodontal Soft Tissue Reconstruction
Gingival recession, also known as receding gums, is the exposure of the roots of teeth caused by a loss of gum tissue and/or retraction of the gingival margin from the crown of the teeth. Gum recession is a common problem in adults over the age of 40, but it may occur as early as the age of 10.
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There are many known causes for gingival recession. By far the most common are gum disease and overaggressive brushing. Due to the incremental nature of the condition, receding gums may remain unnoticed until symptoms appear, such as tooth mobility and dentin hypersensitivity (over-sensitive teeth).
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Gum recession can be addressed by a variety of gum grafting "periodontal plastic surgery" procedures. These are mainly performed due to aesthetic reasons or to address hypersensitivity and may involve repositioning of adjacent gum tissue to cover the recession (called a pedicle graft) or use of a free graft of gingival or connective tissue from the roof of the mouth (called a free gingival graft). Alternatively, a material called acellular dermal matrix (processed and donated human skin allograft) may be used instead of tissue from the patient's own palate. Success is usually determined by two measures: (1) Complete Root Coverage (CRC), which is the rate of teeth treated in which the tooth root is completely covered by gingival tissue and (2) Mean Root Coverage (MRC), which is the level of coverage.
Guided Bone Regeneration Surgery (GBR)
GBR is a dental surgical procedure aimed at increasing the volume and dimensions of the gingival bone prior to the placement of a dental implant. GBR surgeries require a membrane to prevent soft tissue from growing into the target space, allowing it to gradually be replaced with bone tissue.
CorNeat gPatch Advantages
Permanency
Provides permanent support throughout the healing process
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Does not require excision post-op
Promotes Healing
Stimulates cellular growth
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Maintains nutrient flow, better bone growth and integration
Durable/Flexible
Tear resistant
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Stretchable
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Space maintainer
Ease of Use
Easily cut, fixated and sutured to target site
CorNeat gPatch
The CorNeat gPatch is the first permanent & tissue-integrating periodontal surgical matrix for Guided Bone Regeneration (GBR) and gingival recession surgeries.
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An optimal GBR membrane
The features and benefits of the CorNeat gPatch position it as an optimal membrane for GBR, a common procedure performed to rebuild the alveolar ridge and enable it to support a tooth implant. The CorNeat gPatch combines the advantages of non-degradable membranes, such as high tensile strength, malleability, ease of handling and suturing, resulting in better bone regeneration control, together with resorbable membranes and ECMs, including better biocompatibility and bio-integration in a single surgery.
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The CorNeat gPatch is fully synthetic, hence it cannot carry or transmit disease. From a logistical perspective this allows for a long shelf life, easing regulatory hurdles related to transportation.
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The only permanent gingival reinforcement patch
Current solutions for gingival recession (around teeth or dental implants) rely on the use of autografts, allografts/xenografts, or collagen matrices, which are sutured over the exposed area and then covered by a flap of soft gingival tissue. Unlike these grafts and collagen matrices that are absorbed over time, yielding poor long-term results, the CorNeat gPatch provides, for the first time, a permanent infrastructure for gingival tissue regeneration. It is the only “scaffold” that remains in the tissue for life and, once bio-integrated, provides long lasting mechanical support to surrounding tissue. It is poised to disrupt the gingival soft tissue repair market and revolutionize current treatment.
Indications
Guided bone regeneration
Guided tissue regeneration/Gingival recession
Regulatory Path
The CorNeat gPatch has successfully completed several proofs of concepts and was proven safe and effective in subcutaneous and sub-gingival implantations. Biocompatibility tests and additional pre-clinical in vivo trials, which include a (large) animal GLP implantation study, are planned towards obtaining FDA 510(k) early in 2024.
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The plans above are subject to regulatory approvals and requirements.