Implantica AG, a medtech company pioneering advanced technology inside the body, has unveiled its strategy to manufacture 10,000 RefluxStop devices in preparation for substantial demand from the United States, following FDA pre-market approval. RefluxStop is an innovative treatment for acid reflux, a condition affecting over one billion people worldwide.

The company is taking decisive steps to accelerate the global expansion of RefluxStop, focusing on commercial readiness, scalability, and timely delivery. By building infrastructure, securing inventory, and strengthening resources and specialist teams, Implantica aims to support a rapid and efficient rollout in the US and other key international markets, pending regulatory approvals.

A core part of the strategy is to establish robust inventory levels in advance of launch. This proactive manufacturing investment is designed to mitigate common bottlenecks caused by production scale-up during early market entry. The move positions Implantica to respond swiftly to anticipated high demand and drive sustainable growth for the RefluxStop business.

Dr Peter Forsell, founder and CEO of Implantica, commented: “The US GERD market presents a significant opportunity, with around 20% of adults affected by the condition and limited effective treatment options available. RefluxStop, supported by its unique mechanism of action and strong clinical outcomes, has the potential to transform care. By investing early in manufacturing and launch preparedness, we are ensuring the scalability and speed required to deliver value both to patients and stakeholders.”

RefluxStop is the only anti-reflux device that restores and maintains the lower oesophageal sphincter in its natural position without encircling or compressing the food passageway, a key differentiator from existing surgical solutions that are often linked with swallowing difficulties and other side effects. This innovative approach allows the body to restore its natural anti-reflux barrier, addressing the root cause of acid reflux.

Implantica, headquartered in Europe, is committed to transforming patient outcomes through advanced in-body medical technologies. RefluxStop, already CE-marked in Europe, is set to become a paradigm-shifting treatment option in gastroesophageal reflux disease once FDA approval is secured.