Cristcot

About Cristcot

Cristcot is a clinical-stage specialty pharmaceutical company established in 2008, focusing on the development and commercialization of therapies for gastrointestinal diseases. The company was founded by Jennifer J. Davagian, who serves as CEO, and Mark C. Ensign, the COO/CSO. Davagian's personal experience as a Crohn's disease and IBS patient, and her struggles with prescribed suppository medication, directly led to the invention of the company's core technology. This personal journey into the biotech field, without a formal background, fueled the development of a patient-centric solution.

The company's foundational product is the Sephure® suppository applicator, a patented and FDA-cleared disposable device designed for the hygienic, comfortable, and rapid administration of rectal suppositories. This applicator addresses common issues such as patient discomfort, improper placement, and medication leakage by featuring a unique design that allows air to escape during insertion and withdrawal. This ensures the suppository is placed correctly, away from nerve endings that can trigger expulsion, maximizing the medication's therapeutic effect. Sephure® is sold directly to consumers globally via its website and is compatible with various over-the-counter and prescription suppositories.

Building on its device technology, Cristcot has transitioned into a clinical-stage pharmaceutical firm, developing proprietary drug-device combination products. Its lead asset is a novel hydrocortisone acetate (HCA) 90 mg suppository, administered with the Sephure® applicator, for treating ulcerative colitis (UC). This product has completed Phase 3 clinical trials, showing promising results in achieving clinical remission and mucosal healing. The company's business model leverages the 505(b)(2) regulatory pathway to develop new formulations of established drugs, targeting indications with significant unmet needs in gastroenterology. Cristcot's pipeline includes programs for ulcerative colitis, acute pancreatitis, and hemorrhoid disease. The company has successfully raised significant capital, with total funding of $37.4M over multiple rounds to advance its clinical programs toward commercialization.