Five minutes at DCAT with …
Jennifer Davagian CEO of Cristcot
Jennifer Davagian is CEO of Cristcot, launched in 2008, the company that is best known for Sephure, a patented, single-use suppository applicator that is the only product of its kind. It is cleared by the US FDA for administering over-the-counter and prescription suppository medications.
PH: What is the background of Cristcot?
Davagian: Most people would have known of us as the manufacturers of the medical device, Sephure, until about eight weeks ago. In 2008, I invented the device, patented it around the globe and worked to build a full-scale production mold. It is now used with prescription and over-the-counter medication on four continents and the instructions for use are translated into 18 languages.
PH: What is different about the device?
Davagian: The applicator is narrower than a finger and offers proper placement of suppository medication. It reduces the administration time from 45 minutes while lying on the floor, to less than five seconds in any comfortable position. The applicator places the medication properly in the rectum so that the user does not feel it and can go about their daily activities. We have strong patient and nursing testimonials, saying that they have adopted the Sephure suppository applicator as the new standard of care for their treatment protocol.
PH: And recently, you moved in another direction altogether.
Davagian: We have been very confidential about our activities.; and have only recently announced that we have a unique prescription drug, entering Phase III clinical trials. This is for the remission induction of ulcerative colitis in the rectum, an incurable auto-immune disease. In addition, our first over-the-counter suppository medication will be launched commercially this summer – a laxative that will be packaged with the Sephure applicator. This is a unique drug offering with a longer shelf life intended to solve a supply chain issue. It is intended for people with GI motility problems, intermittent constipation and irregularity, and daily bowel regimes. Cristcot also has a five year federal supply contract with the US Federal Government to sell direct to government facilities such as VA hospitals that use suppository medication as part of their treatment of patients and provide mail order medical supplies to veterans.
PH: So now you are a pharma company as well as a medical device company…
Davagian: Absolutely. We develop drug delivery systems, be it with our unique formulations or with a delivery device like the Sephure applicator.
PH: Do you also offer outsourced services?
Davagian: We do. We have designed devices for other companies, for instance an applicator for vaginal use. Cristcot has developed a reputation as a leader in the design of comfortable, ergonomic, modern applicators. We have had numerous leading medical technology companies contact us with interest in our device design.
PH: Are you also developing biologics?
Davagian: No, but it is interesting to note that people taking drugs of that origin for conditions like inflammatory bowel disease typically find problems creeping up on them as a result of the treatment, like constipation. Because they don’t want to take oral treatments that affect the gastro-intestinal tract, they rely on topical stimulants, so suppository medication comes back into their treatment plan as they treat their Crohn’s or colitis with Remicade or Imuran. These patients also frequently experience acute episodes, 80% of the time this is rectal in origin and will require topical medication before reverting to their baseline treatment. So, our product complements rather than competes with biologics.