#FDA Approval #Liechtenstein #Vaduz #Implantica #RefluxStop

Implantica's Year-End Report: Milestones for RefluxStop® Launch

Overview

Implantica, a pioneering medtech company, recently released its Year-End Report for 2025, outlining significant advancements in the development and impending launch of its innovative device, RefluxStop®. This report reflects on the past year’s successes and details crucial steps leading to FDA approval for this groundbreaking technology.

Key Highlights from Q4 2025

In the fourth quarter, the FDA completed six pre-approval inspections at various manufacturing sites and quality control systems. Thankfully, all inspections concluded without major findings, which is a crucial milestone in the Premarket Approval (PMA) review process. This positive outcome demonstrates the high standards maintained in product quality and safety by Implantica.

Additionally, during the 100-day meeting with the FDA, Implantica received constructive feedback to refine its application, indicating that the final steps towards FDA approval are promising. The first RefluxStop® procedure was successfully performed at the Careggi University Hospital in Florence, Italy, marking an exciting expansion into an esteemed medical institution.

To bolster clinical validation, over 30 scientific articles related to RefluxStop® have been published by year-end 2025, including five new entries in the fourth quarter alone. This substantial body of literature strengthens both clinical and economic evidence supporting the device and aids in facilitating reimbursement opportunities as global acceptance accelerates.

Developments After Q4

Post fourth quarter, Implantica achieved pivotal success in Italy, securing over €1.2 million in new multi-year public tender approvals. This positioning reinforces RefluxStop®'s role within the national healthcare system while paving the way for broader adoption and permanent reimbursement across Europe.

Moreover, the company announced the addition of Klinikum St. Georg in Leipzig as a new center of excellence for the RefluxStop® procedure in Germany. With a dedicated code now established in the DRG system for the procedure, the strategic objective is to conduct over 200 operations to gather crucial cost data for future reimbursement determinations.

Financial Performance Summary

Implantica’s financial performance in the fourth quarter reflected a net sales increase of 20%, totaling TEUR 530 compared to TEUR 442 in the same period last year. An impressive adjusted gross margin reached 92%, showcasing efficient operational management.

Despite these positive trends, the operating loss (EBIT) grew to TEUR 7,393, which includes an impairment expense linked to the capitalized research and development budget of TEUR 1,259. The total loss after taxes was TEUR 7,188, aligning similarly with the previous year's results.

For the full year, net sales rose by 7% to reach TEUR 2,073, with adjusted gross margin improving to 93%, demonstrating the effectiveness of Implantica’s business strategies amidst the challenges of the medtech sector.

Future Outlook

Looking ahead, Implantica plans to hold a teleconference on February 25, 2026, featuring key figures such as CEO Peter Forsell and CFO Andreas Öhrnberg. The conference will elaborate on their yearly financial performance and future endeavors concerning RefluxStop® and other innovative healthcare solutions.

As the US launch of RefluxStop® looms closer amid pending FDA approval, Implantica remains poised to make a considerable impact in the domain of gastroesophageal reflux treatment, potentially transforming patients' lives with this advanced medical technology.

For more information about Implantica and their offerings, visit www.implantica.com.