First-of-its-Kind Medical Device Sephure® Ensures Proper Placement of Suppositories and Improves Patient Quality of Life

Jennifer Davagian Ensign, Founder & CEO of Cristcot Inc. today announced that Sephure®, a first-of-its-kind disposable suppository applicator, is now available to the millions of people who require suppository medication therapy. Although suppositories have been around for hundreds of years, there is no standard of care for their administration.

Concord, MA (PRWEB) April 03, 2014

Jennifer Davagian Ensign, Founder & CEO of Cristcot Inc. today announced that Sephure®, a first-of-its-kind disposable suppository applicator, is now available to the millions of people who require suppository medication therapy. Although suppositories have been around for hundreds of years, there is no standard of care for their administration.

Necessity was the mother of invention for Ensign who was diagnosed with Inflammatory Bowel Disease, more than 20 years ago and lived with infrequent flares before her first hospitalization seven years ago. She was prescribed a combination of oral and topical rectal suppository medication for the maintenance of remission. In the beginning, Ensign followed her doctors’ instructions that included lying on the floor for 30-45 minutes twice a day, administering a suppository with a finger and resisting the urgency to expel the medication. Upon standing, she needed to wear a protective undergarment because the medicine leaked outside her body. The time and impact on her quality of life was too burdensome for the young mother and business owner and within three months Ensign completely abandoned her prescribed treatment.

A year-to-the-day from her first hospitalization, Ensign landed back in intensive care where she faced the medical consequences of her non-compliance and the reality of her declining health. Upon leaving the hospital a second time, she was committed to taking her medication as prescribed, but dedicated to living a better quality of life.

A master seamstress by trade, Ensign understands how things fit together. Armed with that knowledge and some supplies from her local grocery store and Home Depot, she set to work teaching herself plastic and silicone molding to create a unique suppository applicator.

Using her own invention, Ensign was steadfast in taking her medication and found that the new device offered freedom from the burdensome process she was used to. With the new applicator, administering medicine took less than five seconds, she didn’t have to schedule her life around it, and protective undergarments were no longer necessary.

In the beginning, Ensign secured intellectual property and planned to license the technology. But she soon discovered that a medical device like Sephure would need a champion to guarantee that it would be available to the millions of patients who need it.

"I knew that licensing would not ensure the commercialization of the product,” Ensign said. “I learned that there are millions of other patients, like me, who are unable to take oral medication, or require topical treatment. It would take a strong advocate to talk about the difficulties of suppository treatment and pave the way for marketing a product that dramatically improves patient quality of life while changing the value proposition for staying compliant with prescribed treatment.”

With patent protection filed in the US and around the globe, Ensign hired engineers to build a full scale production mold for manufacturing in an ISO-13485 facility, filed and received FDA clearance for marketing and distribution in the US and conducted four market research studies. While Ensign’s company Cristcot Inc. is launching the product this year, her company and Sephure have attracted significant industry attention along the pathway to market readiness. In 2012, Cristcot was named as one of five promising emerging life science companies and was awarded an Accelerator Loan by the Massachusetts Life Sciences Center. In 2013, Ensign was invited to give the keynote address and co-chair the International Conference on Gastroenterology and Urology and she was a recipient of Boston’s 2013 "Invented Here" award.

“At first, when I began to share my story, it was difficult talking about something so private in a public forum,” Ensign said. “The response I received was overwhelming. The fact of the matter is that it’s an uncomfortable topic and most patients are suffering in silence, not sharing their struggle even with those closest to them. There is no shame in pain and by telling my story I hope to improve the quality of life for people I don’t know so that they can maintain their privacy yet stay compliant with their treatment.”

About the Device:
Sephure works, in part, because of Boyle's law of physics. The patented device technology, not seen in other applicators, allows air to escape the body during the administration of the suppository and withdrawal of the device. Because the medicine is properly placed, it does not leak outside the body and overall administration time is reduced from 45 minutes to less than 5 seconds. Patients do not feel the medication, and therefore can immediately resume daily activities. Because patients do not feel an urgency to expel the medication, laxative suppositories may stay in the body longer to complete their therapeutic effect. For patients taking suppositories for treatment of disease, the medication does not leak outside the body and therefore the need for protective undergarments is minimized or eliminated.

Non-adherence to prescribed, long-term medical therapy in the US is estimated to cost up to $100 million each year and accounts for 10% of all hospital admissions.

Suppository medication, both prescription and over-the-counter, is used to treat a variety of symptoms and diseases including, but not limited to; Crohn’s Disease, ulcerative colitis, irritable bowel syndrome, hemorrhoids, chronic constipation, mental health disorders, migraine headaches, fever, nausea, and complications related to spinal cord injury. Elderly residents in nursing and long term care facilities customarily receive medications in suppository form and the use of suppository medication will likely increase with our aging population.

Sephure applicators are for one time use, are available in two sizes to fit current suppository shapes, and can be ordered in quantities of 10, 30 or 90. A pediatric suppository applicator is expected to be available in late 2014.

To order a trial pack of Sephure or for additional information, please visit http://www.sephure.com.


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