Unmet Need:
GI bleeding can result from different pathologies, and the current treatment methods have not evolved to address the persistent clinical need for improved bleeding treatments. Current modalities to control GI bleeding have limited efficacy/application, are temporary with high recurrence rates, can be technically challenging to deploy, and are expensive. These modalities can be placed into two categories based on the therapeutic delivery method, 1) focal or 2) diffuse. Examples of Focal delivery modalities are mechanical clips or electrocautery probes and for diffuse delivery are powder-based hemostatic agents. The major issue with the current products is the longevity of effect and the risk of re-bleeding. In cases of treatment failures, the cost is high because of the need for repeat interventions, prolonging hospitalization, and referral to IR or surgery for treatment. .
Technology Overview:
Researchers at Johns Hopkins have developed two formulations of sustained-release epinephrine gels containing epinephrine nanoparticles which include a mucoadhesive and an injectable formulation. These two formulations are expected to cover a repertoire of applications in GI endoscopy including treatment of GI bleeding from ulcer (injectable), cancer (mucoadhesive), etc., and facilitate GI endoscopy applications such as the lifting of a large polyp with dissection from normal tissue (injectable) and prevent bleeding after such interventions (mucoadhesive). Epinephrine nanoparticles are released over several days providing sustained action and preventing re-bleeding.
Stage of Development:
In a porcine bleeding model with resection of large polyps from the stomach and colon, the inventors demonstrated that the injectable gel formulation outperformed other commercially available lifting gels in providing a sustained lifting of the polyp. The epinephrine-containing mucoadhesive gel when applied on the resection site instantly created a firmly adherent gel layer resulting in an immediate cessation of the bleeding, avoiding the need for hemostat clips. The injectable epinephrine containing gel also immediately stopped bleeding at ulcer sites and no bleeding was noted on follow-up. The inventors are in the process of preparing FDA 510(k) submission utilizing predicate devices for substantial equivalence and stability testing.
Publication:
Not available at this time.
