Investor Relations

The FDA clearance for the Ambu® aScope™ 5 Cysto HD marks a historic milestone as the first ever single-use cysto-nephroscope to receive such clearance in the US. It follows the CE mark in Europe earlier this year, representing an important step forward in endoscopic technology and reinforcing Ambu’s commitment to innovation and advancement in urology care.

Today, Ambu announces that the US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for the Ambu® aScope™ 5 Cysto HD, authorising the endoscope’s use in percutaneous nephrolithotomy (PCNL) procedures. It is a procedure performed in the operating room, with the purpose of removing large or complex kidney stones by creating a small passageway through the patient’s back to the kidney.

The expanded clearance marks the first time a single-use flexible cysto-nephroscope has been cleared for this specific indication in the US. With the latest indication, Ambu now provides urologists with a complete single-use endoscopy solution for kidney stone management, covering the full pathway from diagnosis to treatment.

The US urology portfolio subsequently includes three single-use endoscopes – aScope™ 4 Cysto (cystoscope), aScope™ 5 Cysto HD (cysto-nephroscope) and aScope™ 5 Uretero (ureteroscope) – all in full integration with Ambu’s aView™ 2 Advance and aBox™ 2 endoscopy systems. All endoscopes and systems leverage the same digital technology platform, offering urologists a unified, advanced and high-performance solutions portfolio that enhances procedural efficiency – in line with Ambu’s strategic focus.

Ambu’s cysto-nephroscope is designed to work in combination with the company’s ureteroscope, both of which are compatible with the Ambus’ two endoscopy systems. This integration enables simultaneous connection and dual visualization of the aScope™ 5 Uretero and the aScope™ 5 Cysto HD during combined ureteroscopy and PCNL procedures, enhancing urologists’ visualization and workflow efficiency in the operating room.

"The FDA clearance of our cysto-nephroscopy solution underpins our commitment to expanding our innovation and leadership in urology. With three single-use endoscopes integrated into one digital platform, we offer a leading portfolio that enables clinicians to efficiently perform a broad range of urology procedures, advancing the standard of care for patients."

BRITT MEELBY JENSEN
Chief Executive Officer, Ambu 
 

Read and download the full press release here.

Today, Ambu announces the launch of its new Ambu® Recircle program, teaming up with hospitals in both the US and the UK as the first key participants.

Environmental regulations in healthcare are tightening across the globe, driving the industry to address its environmental impact. The healthcare industry accounts for 4.4% of global net emissions, with medical devices contributing 71% of that total.¹  

As the market leader in single-use endoscopy, Ambu embraces its responsibility to drive sustainability initiatives in healthcare, recognising the industry’s urgent need to address environmental challenges head-on. To this end, Ambu is launching a first-of-its-kind take-back and recycling initiative for endoscopes: the Ambu “Recircle” program. This program aims to provide Ambu’s customers with an opportunity to collect and recycle used Ambu endoscopes for new non-medical purposes. Three hospitals in the US and the UK are among the first to go live with the program, specifically UCLA Health in the US and Springfield Hospital and Bodmin Community Diagnostics Centre in the UK.

"At Springfield Hospital, we’re always looking for practical ways to reduce our environmental footprint, while maintaining high standards of patient care. Taking part in the Ambu Recircle program gives us an opportunity to explore how recycling single-use Ambu endoscopes might support our waste reduction goals. We look forward to learning from the process and working closely with Ambu to understand the potential impact for our hospital and beyond."

JANIS WATTS
Outpatients Manager, Springfield Hospital, UK

REDUCING ENVIRONMENTAL IMPACT VIA RECYCLING
Ambu’s Recircle program is built on a circular approach, delivering a fully traceable and regulation-compliant recycling process for hospitals. From the moment a single-use endoscope is collected after use, it undergoes a careful process – including cleaning, shredding and material recovery – to make sure useful materials are not thrown away or burned but reused as much as possible in new non-medical products. 

This end-to-end approach reflects Ambu’s commitment to reducing environmental impact across the entire product lifecycle, from raw material sourcing to post-use recovery, aimed to help both hospitals and Ambu lower their carbon footprints. This commitment is further supported by Ambu’s pioneering efforts in integrating bioplastic materials2 into the handle of its fleet of single-use endoscopes, a milestone that Ambu achieved in late 2024 as the only endoscopy company in the world.

ROLLING OUT THE AMBU RECIRCLE PROGRAM ACROSS KEY MARKETS
Prior to going live at the three key hospitals, the Ambu Recircle program has been pilot-tested in Germany and the UK. Currently, Ambu is in the process of introducing the program to 10-20 additional hospitals across the US, UK, Germany and France.
Looking ahead to next year, the company plans to further scale its efforts in these four major markets, advancing its commitment to circularity and driving measurable sustainability initiatives across health systems.

"With the launch of our Recircle program, I’m proud that Ambu once again takes the lead in offering our customers an innovative and feasible approach to reducing their carbon footprint. Hospitals face increasing pressure to reduce emissions and operate more sustainably, and this initiative is designed to support them in that journey. By bringing circularity into healthcare, we are helping hospitals take meaningful climate action, while continuing to deliver high-quality patient care through advanced medical solutions."

BRITT MEELBY JENSEN
Chief Executive Officer, Ambu

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ABOUT AMBU’S APPROACH TO CIRCULARITY
Ambu is committed to embedding principles of the circular economy across the entire lifecycle of its solutions and packaging to support a more sustainable healthcare system. In a circular economy, the goal is to keep products, materials and resources in use for as long as possible, extract the maximum value from them while in use and then recover and regenerate products and materials at the end of their service life.

The recycling of medical devices, however, is not a straightforward prospect for hospitals. Due to medical risks, the regulations are comprehensive and complex. On top of this, the logistics, workforce and tools required make it a daunting project to embark on and requires a structured plan and open collaboration from the medical device provider.

The Ambu Recircle program ensures that the materials of used Ambu endoscopes are recycled and entered back into circularity to the maximum possible effect. Once collected, the endoscopes go through a specialised, high-quality recycling process in collaboration with trusted partners who are committed to advancing innovative recycling technologies and working closely with manufacturers to maximise material recovery and value extraction.

Ambu maintains an ongoing dialogue with partners to ensure that as recycling technologies and market demands evolve, the company remains at the forefront of material recovery. 

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¹   Trinity Life Sciences, 2023: “The pharmaceutical industry’s carbon footprint and current mitigation strategies: A literature review”: https://www.ispor.org/docs/default-source/intl2023/ispor23dehipawalaposter-pdf.pdf?sfvrsn=f2e5a6eb_0 

²   The bioplastic material that Ambu is introducing in its fleet of single-use endoscopes is derived from a mix of bio-based second-generation feedstock and fossil-based feedstock, e.g., recycled food waste. Read more about Ambu’s use of bioplastics on the company’s website.

Read and download the full press release here.

Pursuant to the Market Abuse Regulation, article 19, Ambu A/S hereby notifies receipt of information of the following transaction(s) made by persons discharging managerial responsibilities in Ambu A/S and/or their closely associated persons related to Ambu A/S’s shares admitted to trading and official listing on Nasdaq Copenhagen A/S.

The attached document discloses the data of the transactions made in Ambu shares. 

Read the company announcement here, as well as the attached documentation.