Implantica is ramping production of its acid reflux treatment device ahead of its expected approval by the FDA.
RefluxStop, which has already earned pre-market approval, is a non-active implant that is placed on the upper part of the stomach through laparoscopic surgery. It's designed to treat acid reflux without affecting the food passageway.
The company said it will produce 10,000 RefluxStop devices to meet "substantial demand from the U.S. market."
"The U.S. GERD market represents a tremendous business opportunity, with an estimated 20% of adults affected by this unforgiving disease – a population that remains severely underserved by current treatment options. The urgent clinical need, combined with the scalability of RefluxStop® and our solid preparedness for launch, enables us to quickly monetize a huge market opportunity and create long-term value for our stakeholders. Implantica is not only innovating at the product level—we are also executing a commercialization strategy designed for speed, scalability, and impact," said Dr. Peter Forsell, founder and CEO of Implantica, in a statement.
Last month, Implantica said that it had completed development and initial testing on two new multi-cavity production tools for manufacturing larger quantities of the RefluxStop device. It said one tool will help support manufacturing ramp-up in Europe and one tool will be used to setup a new manufacturing site in the U.S.
