AMBU OBTAINS REGULATORY CLEARANCES FOR EXPANDED GI INDICATION

Ballerup, Denmark, 25 September 2026 – Ambu, the global market leader in single-use endoscopy, today announces that its two gastrointestinal (GI) endoscopy solutions, Ambu^® aScope™ Gastro and Ambu^® aScope™ Gastro Large, have received FDA 510(k) clearance and CE mark for an expanded indication covering flexible sigmoidoscopy procedures in the lower GI tract.

Since their launches in 2022 and 2024, aScope Gastro and aScope Gastro Large have supported intraoperative endoscopy during upper GI surgery, as well as bedside procedures for diagnosis and management of upper GI bleeding. With the expanded indication, aScope Gastro and aScope Gastro Large can now also be used for flexible sigmoidoscopy procedures, including intraoperative GI endoscopy during colorectal surgery as well as lower GI bleeds in the sigmoid colon and rectum.

This expands the use of Ambu's single-use GI endoscopy solutions across both upper and lower GI care in the operating room and bedside environments in the intensive care unit. As a result, Ambu becomes the first provider of single-use GI endoscopes with dual regulatory clearance for both upper GI and lower GI procedures, while also nearly doubling the amount of procedures the Company can target.

Flexible sigmoidoscopy is a minimally invasive procedure used to examine the lower colon and rectum. During colorectal surgery specifically, it can help assess the surgical connection and identify potential complications. With the expanded indication, Ambu can offer single-use GI endoscopes that are available when needed for both upper and lower GI procedures, supporting simpler workflows and greater procedural flexibility.

GI represents the largest area of the global endoscopy market, with single-use adoption remaining in the early stages. For Ambu, GI is a long-term growth opportunity, and the expanded indication reflects Ambu’s stepwise approach to broadening its GI offering, in line with the Company’s ZOOM AHEAD strategy.

“GI is an important long-term growth opportunity for Ambu, and while single-use adoption in this area is still at an early stage, we are building our presence through a stepwise approach,” says Britt Meelby Jensen, CEO of Ambu. “With our GI endoscopy platform cleared for both upper and lower GI procedures, we are strengthening our clinical relevance, and, more broadly, taking another focused step toward our ambition to achieve global endoscopy leadership.”

Ambu expects to commercially launch its GI solutions across the U.S. and Europe in early 2027 with updated Instructions For Use (IFUs) reflecting the expanded indication.