STEWARTVILLE – A Stewartville firm, which makes medical devices to control fecal incontinence, took a major step forward this week with a deal to bring its products to European markets.

Minnesota Medical Technologies, founded in 2015 under the leadership of Jim and Philip Conway, has signed an agreement with Sweden-based Wellspect Healthcare to distribute Minnesota Medical's fecal incontinence insert throughout Europe.

The myMiracle device is made of soft silicone, with a bulb that encapsulates liquid, so the insert conforms to the patient’s body for comfort and to create a seal. A typical patient might use about 500 of the one-time-use products a year.

This deal connects Minnesota Medical’s myMiracle product with a major market. Europe approved the sale of the devices in 2020 and European patients are already using it. The FDA is expected to approve the product for sale in the US in early 2022, after Mayo Clinic completes a clinical trial in late 2021.

Minnesota Medical, which has 15 employees, is already producing myMiracle devices at its Stewartville plant.

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Minnesota Medical CEO David Jonas says the 6,500-square-foot plant in Stewartville's Schumann Business Park has the capacity to produce 6 million devices a year. However, the plan is to handle packaging and storage at a nearby Racine complex until the Stewartville facility can be expanded.

"This collaboration puts our innovative technology in the hands of one of the world's leading providers of continence care solutions,” stated Jonas in the announcement. “Wellspect has the infrastructure and relationships to immediately begin marketing and distributing this life-changing product throughout Europe. Without question, this will accelerate our growth curve."

Launching in Europe and then expanding in the US is the same path the Conways' previous Stewartville manufacturer, Rochester Medical, followed become one of the top catheter makers.

Rochester Medical grew into a major international manufacturer, with hundreds of local employees and more than $60 million in annual sales. In 2013, the Conways sold it to rival C.R. Baird for $262 million. They signed a five-year, non-compete agreement not to make urinary incontinence products. C.R. Bard closed the plant in 2016.

The Conway brothers, along with partners Lonnie Boe and Sarah Grinde, started experimenting with ideas. Minnesota Medical was born when they took their experience with catheters and urinary incontinence devices and applied it to the problem of fecal incontinence.

Jonas says it is estimated that at least 2 percent of the world’s population suffers from fecal incontinence, though most experts believe that underestimates the actual numbers of people with the condition.

“This has the potential to be much larger than Rochester Medical,” said Jonas.