Shares in the Stockholm Stock Exchange-listed company opened 2.5% higher than pre-announcement market close. Image credit: Shutterstock / Emily frost.

Implantica has revealed positive results for its RefluxStop implant, a device designed to treat patients with a sub-type of gastro-oesophageal reflux disease.

The results, published in Nature journal Scientific Reports earlier this month, demonstrated the device improved or completely resolved symptoms in 90% of patients.

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The investigator-initiated multi-centre study, conducted at sites in Vienna, Austria, and London, UK, investigated RefluxStop in 40 patients with ineffective oesophageal motility (IEM).

Proton pump inhibitor consumption was reduced by 84% and the Quality of Life GERD-HRQL score improved by 80%. Implantica said there were “limited side effects.”

Shares in the Stockholm Stock Exchange-listed company opened 2.5% higher than the pre-announcement market close.

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IEM is a motor disorder that causes low-amplitude contractions at the bottom of the oesophagus. It is diagnosed when most swallows are ineffective. Gastro-oesophageal reflux – the entry of stomach acid back into the oesophagus – is one of the side effects.

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Lichtenstein-headquartered Implantica said that IEM patients are usually not recommended for surgery because swallowing problems are worsened with current approaches that encircle the oesophagus.

Johnson & Johnson MedTech’s Linx reflux management system, which received CE marking in 2008 and FDA approval four years later, is one of the current technologies on the market. The system consists of magnetic titanium beads connected with titanium wires that form a ring shape. The device is surgically implanted around the lower end of the oesophagus.

While IEM is common in those with gastro-oesophageal reflux disease, interventional procedures or medication is not always needed as in some patients it neither severely impacts quality of life nor typically progresses over time.

For those who need treatment, Implantica’s RefluxStop could represent a new paradigm in anti-reflux surgery. Unlike current approaches that rely on encircling the oesophagus, the company’s device helps reconstruct all three components of the anti-reflux barrier. Upon implantation near the left side of the oesophagus above the lower oesophageal sphincter, the device restores and supports the natural anatomy in the area, reducing back-entry of acid.

RefluxStop received CE marking in August 2018, with the company now eyeing US Food and Drug Administration (FDA) approval.

Professor Sebastian Schoppmann, who led the study at the site in Vienna, said: “Given RefluxStop’s promising early results showing significant improvement in patient outcomes in gastro-oesophageal reflux disease, we are now planning additional studies to validate our findings further and hopefully establish this as an effective treatment option.”