Implantica Ag - an implant for every need in the future

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In my opinion, Implantica published a very significant FDA update regarding RefluxStop.

The company announced that it has submitted its “final response” to the FDA in the PMA process, including:

- the final additional tests

- responses to FDA questions

- processing of all 3 PMA modules

- and the successful completion of 6 pre-approval inspections (manufacturing, quality system, and BIMO)

Particularly positive:

- additional tests requested by the FDA have been completed

- no indications of new major research requirements

- inspections were passed without significant remarks

- the company’s tone is very confident.

Typically, at this stage, a decision can come within weeks or a few months, but FDA processes can always drag on. If approval is granted without major restrictions, this could be a truly massive turning point for Implantica in the US market.

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Today, RefluxStop has finally received FDA approval, and the company can officially begin its launch in the U.S. market. With this approval, one of the biggest risk factors for this investment has been removed.

Today is also the company’s Q2 earnings release, so it will be very interesting to hear management’s thoughts regarding this FDA approval and the progress of the launch in the U.S.

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Implantica receives FDA approval for RefluxStop® – Opening the U.S. market

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announced today that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for RefluxStop®, the company’s implant-based treatment for gastroesophageal reflux disease (GERD). The approval allows Implantica to begin commercial launch activities in the United States, the world’s largest medical device market.

FDA approval represents a transformational milestone for Implantica and follows the FDA’s full review of the RefluxStop® PMA application, including the long-term clinical evidence supporting the 5-year safety and effectiveness of the therapy.

RefluxStop® is designed to address the underlying cause of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction, without encircling or applying pressure on the food passageway.

Dr. Peter Forsell, CEO and founder of Implantica, says, “FDA approval of RefluxStop® is a defining landmark for Implantica and the culmination of many years of clinical development, scientific work, and rigorous regulatory review. Most importantly, it means that we can now bring RefluxStop® to the United States, where an estimated 78 million people suffer from acid reflux1.

We enter the U.S. market from a position of strength, with a substantially more mature clinical and commercial foundation than is typical for a newly approved medical device. RefluxStop® already has several years of commercial experience in Europe, close to 1,800 patients treated, more than 60 Centers of Excellence across nine European countries and published five-year clinical outcomes. Combined with our longstanding scientific engagement with many leading U.S. surgeons and experts, we believe this provides a strong foundation to launch and scale RefluxStop® in the U.S. market.

FDA approval changes our focus from preparation to execution. As the world’s largest medtech market, the United States represents a substantial commercial growth opportunity for Implantica, and we are very excited to begin the U.S. launch of RefluxStop®. The initial rollout will be targeted, focusing on selected leading U.S. centers and reflux surgeons. Commercial adoption is expected to build gradually, reflecting the physician training and site activation required to establish RefluxStop® at each center. Our focus will be on disciplined execution, high-quality surgeon training, and building a solid commercial foundation for sustainable long-term growth

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Based on Q2, Implantica’s European business is moving in the right direction, coinciding with the FDA approval that has opened up the U.S. market.

Q2 revenue grew by 66% to €0.717M, and H1 revenue by 34% to €1.574M. The starting level is still low, but the growth rate is promising. Of particular interest is the 94% gross margin, which speaks to the very strong unit economics of RefluxStop.

EBIT remained at -€4.2M, but the company had €41.7M in cash at the end of the quarter. Building the U.S. organization will likely increase costs in the near term, so cash burn is worth monitoring.

Clinical evidence also strengthened significantly: in an independent study of 602 patients across 22 centers, serious safety events and reoperations remained below 2%. In Europe, the Center of Excellence network has already grown to over 60 centers.

Implantica publishes Interim Report January – June 2026 (Q2)

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Implantica publishes Interim Report January – June 2026 (Q2)

FDA Approval of RefluxStop® – Strategic Preparation Sets the Stage for Success

Significant events in the second quarter of 2026

RefluxStop® sales increased by more than 60% compared with the prior-year period, reflecting continued commercial growth across key European markets

Largest independent RefluxStop® study to date published in Nature’s Scientific Reports, reporting mid- to long-term safety outcomes in 602 patients across 22 centers in six European countries, with serious safety events and reoperations below 2%

Clinical, health-economic and reimbursement evidence further strengthened, including new Italian cost-effectiveness data and the addition of a seventh InEK-reporting hospital in Germany supporting the reimbursement pathway

Significant events after the end of the period

FDA PMA approval secured for RefluxStop®, opening the U.S. market and enabling the start of U.S. commercial launch activities

U.S. market entry underway, with expansion of the U.S. organization and establishment of logistics and distribution infrastructure

European market presence continued to expand, including the 20th Center of Excellence in Spain at MD Anderson Madrid and new Centers in Switzerland and the UK, bringing the European network to more than 60 Centers of Excellence

Financial summary second quarter

Net sales increased by 66% to TEUR 717 (433).

Adjusted gross margin amounted to 94% (90%).

Operating loss (EBIT) decreased to TEUR 4,200 (4,525).

Loss after tax amounted to TEUR 3,987 (5,448).

Basic and diluted loss per Class A share amounted to EUR 0.06 (0.08).

Cash and cash equivalents as at the end of the period of MEUR 41.7.

Financial summary first six months

Net sales increased 34% to TEUR 1,574 (1,178).

Adjusted gross margin amounted to 94% (94%).

Operating loss (EBIT) decreased to TEUR 8,058 (8,698).

Loss after tax amounted to TEUR 8,267 (8,212).

Basic and diluted loss per Class A share amounted to EUR 0.12 (0.12).

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