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December 18, 2014

From interior design to medical devices, local entrepreneur secures 4th patent

Cout Jennifer Ensign, CEO of Concord-based Cristcot Inc., traded her career in interior design for medical device making, launching the company's first product, Sephure, in May.

A few years ago, Jennifer Davagian Ensign was a master seamstress, running a custom interior design business in Sudbury. Today, she’s the CEO of a Concord-based medical device company that holds patents in the U.S. and abroad, with the latest patent award coming from the Japanese Patent Office.

She’s not just running the company. She designed the chief product, Sephure. It’s a suppository applicator for people with digestive conditions and other illness, from migraine headaches to malaria, and one she designed in her own kitchen after teaching herself the basics of silicon molding.

No formal training, personal experience inspired CEO

Ensign has no engineering degree or background in medical device manufacturing. But her company, Cristcot Inc., founded in 2008, was awarded a $257,000 accelerator loan by the Massachusetts Life Sciences Center in 2012. This allowed her to build a full-scale production mold, which was pivotal in allowing her to attract investors and commercialize the product.

Since then, the Food and Drug Administration has cleared Sephure for use in the United States, and Ensign has secured two patents in the U.S., one in China, and now one in Japan. Sephure was launched in May and is now being distributed in Australia and New Zealand, and Ensign is closing in on distribution partnerships in Asia and parts of Europe. Meanwhile, consumers can purchase the product online on Amazon.com, or through Cristcot’s commercial website, www.sephure.com.

“We believe here at Cristcot that we are solving the unmet needs for the un-discussable,” Ensign said.

Ensign believes that the medical profession does recognize the importance of effective delivery methods for suppository medicine. She said there’s a level of discomfort around the subject, so it’s brushed aside.

In other countries in Asia in Europe, where Ensign says Cristcot holds the greatest opportunity, suppository medicine is viewed as “de rigor,” according to Ensign, so attitudes about a product like Sephure are more lax. But Ensign points out there’s really no product exactly like Sephure—another reason Cristcot may be poised for success. In addition, Sephure is appealing to providers in countries without modern medical systems, Ensign said, because it aids infection control.

What makes her an expert? A longtime sufferer of the digestive disorder Crohn’s Disease, Ensign actually designed Sephure to make it easier to take her medicine. She didn’t realize at the time that it would lead to a viable business model. Now, she’s used to discussing her formerly embarrassing medical problem with investors and customers without a second thought.

“My story is public and that’s OK. I live a great life because I can take my medicine and live a good life,” Ensign said.

MLSC recognizes Cristcot for growth

As a private company, Cristcot does not release financial information. But it has completed a successful round of Series A financing along with securing the MLSC accelerator loan. With six employees, Cristcot operates and manufacturers products in a 2,000-square-foot space in the Damon Mill building in Concord.

Angus McQuilken, vice president for marketing and communications at MLSC, said Ensign’s lack of medical device manufacturing experience wasn’t a concern. He said a number of peer reviewers, scientists and the MLSC’s board of directors vetted her company before issuing the loan.

The fact that Ensign has been able to hire employees and contribute to the medical device base in Massachusetts supports the MLSC’s hunch that Cristcot was a sound investment, according to McQuilken.

“These are the types of programs we look for,” McQuilken said.

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