Implantica's Q3 Report Highlights Progress Towards FDA Approval

Implantica's Q3 Report Highlights Strong Advancements

Implantica is making notable strides in the medtech field, especially regarding their innovative RefluxStop® device. With strong feedback from FDA officials, the company is poised for exciting developments that could soon lead to market entry in the U.S.

Key Milestones in the Third Quarter

During this past quarter, significant progress was recorded. Implantica received commendations from the FDA for its final PMA Module 3 submission. This positive feedback is a crucial step toward gaining FDA approval.

To prepare for potential U.S. scaling, Implantica expanded its production capabilities, adding an impressive 10,000 units of RefluxStop®. The creation of two new production tools, including one positioned in the U.S., reflects the company’s commitment to local manufacturing.

RefluxStop® has generated excitement within the medical community, particularly at the 2025 American Foregut Society Annual Meeting. The event showcased a standing-room-only clinical panel, featuring leading experts on RefluxStop®, discussing remarkable five-year outcomes from pivotal studies which drew over a hundred healthcare professionals.

Furthermore, the presentation included groundbreaking real-world safety data from more than 600 patients across 22 European medical centers, which captured significant interest from surgeons in the U.S.

Updates Post Q3 and Financial Data

After the third quarter, Implantica completed a critical 100-Day FDA meeting that clarified final approval procedures. This session confirmed that the remaining PMA requirements are clearly defined and addressable.

Also, comprehensive inspections by FDA Bioresearch Monitoring (BIMO) yielded favorable results, with no major findings reported. This outcome further validates Implantica's operational integrity and adherence to quality standards, bolstering confidence in their product.

In terms of financial performance during Q3 2025, Implantica reported a 6% growth in net sales, totaling TEUR 365 compared to last year's TEUR 344. The adjusted gross margin remained strong at 93%, though it saw a slight decline from 97% in the previous year.

Implantica reduced its operating loss (EBIT) to TEUR 4,432 from TEUR 5,336 and noted a decrease in loss after tax to TEUR 4,415 from TEUR 6,444. The loss per Class A share also improved, standing at EUR 0.06 compared to EUR 0.09 last year.

For the first nine months of 2025, Implantica saw an overall 3% increase in net sales reaching TEUR 1,543. The company noted a marginal rise in adjusted gross margin to 94%, demonstrating efficiency in their business model.

Although the operating loss for the period was reported at TEUR 13,130, it showed a decrease from TEUR 18,292 year-over-year, indicating improvement in managing expenses.

Join the Upcoming Teleconference

Implantica invites interested parties to participate in a teleconference scheduled on 31 October 2025 at 15:00 CET. This call will feature key figures from the company, including Peter Forsell (CEO), Andreas Öhrnberg (CFO), and Nicole Pehrsson (Chief Corporate Affairs Officer). Details on how to join the conference will be distributed following registration.

Contact Information

For more inquiries, please reach out to Nicole Pehrsson at +41 43 505 20 57. As a leader in the medtech sector, Implantica continues to focus on advancing healthcare technology.

About Implantica

Implantica is a pioneering medtech group focused on incorporating advanced technology into healthcare. Their flagship product, RefluxStop™, is designed to prevent gastroesophageal reflux, promising to transform anti-reflux treatments through successful clinical outcomes.

The company also delves into eHealth innovations, having developed a patent-protected product pipeline that includes an eHealth platform. This platform is intended to monitor various health parameters and communicate directly with caregivers, as well as a wireless energizing platform to power implants remotely.

Implantica is publicly traded on the Nasdaq First North Premier Growth Market under the ticker IMP A SDB, marking its significant presence in the growing medtech industry.

Frequently Asked Questions

What is the main product of Implantica?

Implantica's primary product is RefluxStop™, designed to prevent gastroesophageal reflux, aiming to improve treatment options significantly.

When was the teleconference scheduled?

The teleconference is set for 31 October 2025 at 15:00 CET.

What were the net sales for Q3 2025?

For Q3 2025, net sales increased by 6% to TEUR 365, up from TEUR 344 in the previous year.

How did financial losses change in Q3?

Implantica saw a decrease in operating loss (EBIT) in Q3 2025, reducing to TEUR 4,432 from TEUR 5,336.

What is Implantica's focus in terms of technology?

Implantica concentrates on advanced technology, especially in eHealth and remote monitoring, along with its flagship anti-reflux product.

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