Ambu - Results for aScope Duodeno

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Ambu announces interim 60-patient clinical trial results for aScope Duodeno 1.5 showing 98.3% procedure success rate

22. november 2022

Today, Ambu shares the latest update of its clinical trial results assessing the aScope Duodeno 1.5 single-use duodenoscope for ERCP procedures. Following the launch of aScope Duodeno 1.5, Ambu re-started its multi-site clinical trial, and is sharing results from all aScope Duodeno 1.5 cases enrolled to date.

Through 60 cases across all complexity levels, the procedure success rate is 98.3%, meaning 59 of 60 cases were successfully completed using aScope Duodeno 1.5. Importantly, the one case not completed with aScope Duodeno 1.5 was also not completed with the reusable endoscope.

"These interim results add to the growing body of evidence that aScope Duodeno 1.5 meets clinical needs across all ERCP complexity grades, and performs closely in line with reusable duodenoscopes, while completely eliminating the risk of cross-contamination," says Bassel Rifai, Chief Marketing Officer of Ambu. "With these clinical results, combined with our superior economic proposition, we are confident that aScope Duodeno 1.5 will be the leading choice for health systems that would like to transition to single-use duodenoscopy."

The release today of 60-patient data comes less than two weeks after Ambu shared its 29-patient data. Based on the strong pace of recruitment, Ambu expects to share the results of 150 patients using aScope Duodeno 1.5 around our Q1 earnings release in February 2022, and showcase the results of the study at Digestive Disease Week (DDW) 2022.

With these positive clinical results, Ambu continues its worldwide commercialisation of aScope Duodeno 1.5, with the full launch currently underway across the U.S., Europe, and Australia.

The world's #1 single-use endoscopy company
Ambu launched the world's first single-use flexible bronchoscope, the Ambu aScope in 2009. A decade later, in 2021, over 1.5 million Ambu single-use endoscopes were used around the world, and Ambu has now developed scopes for a broad range of clinical areas making Ambu the largest and most innovative supplier of single-use endoscopes, with the #1 position in Pulmonology, ENT, and Urology. Ambu has announced the launch of 20 new devices for single-use endoscopy by end of financial year 2022/23 with the aim of increasing patient safety and improving healthcare workflows.

CONTACTS

Media
Mikkel Trier Wagner, Director, Corporate Communications, [email protected] / +45 4191 0830

Investors
Nicolai Thomsen, Director, Investor Relations & Strategic Financial Planning, [email protected] / +45 2620 8047

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Fra Marketwire:

"Ambus kliniske forsøg med sit endoskop Ascope Duodeno 1.5 fortsætter med at vise lovende resultater, oplyser medicoselskabet i en meddelelse mandag morgen.

Forsøgene er således blevet udvidet til 60 fra 29 ved selskabets årsregnskab for den forskudte periode 2020/21.

Af de i alt 60 procedurerer gennemført med Ascope Duodeno 1.5 var der kun i et enkelt tilfælde behov for at ty til et ikke-engangsendoskop, som heller ikke kunne gennemføre proceduren, skriver Ambu.

Det svarer samlet til en succesrate på 98,3 pct.

• De midlertidige resultater øger til de voksende beviser for, at Ascope Duodeno 1.5 lever op til de kliniske krav på tværs af alle ERCP-kompleksitetsgrader og præsterer nær niveauet for genbrugelige duodenoscoper, mens de fuldstændig fjerner risikoen for krydskontaminering, siger marketingsdirektør i Ambu, Bassel Rifai, i meddelelsen.

ERCP står meget mundret for endoskopisk retrograd kolangiopancreatikograf - også kendt som kikkertundersøgelser af galdevejene og/eller bugspytkirtlen.

Resultaterne for undersøgelserne viser ifølge Bassel Rifai, at Ascope Duodeno 1.5 vil blive det førende valg inden for sundhedsvæsner, der vil gå over til anvendelse af engangsendoskoper.

Forsøgene med endoskopet ventes udvidet til 150 i februar, når Ambu fremlægger regnskab for første kvartal af det forskudte regnskabsår 2021/22.

Det er endnu uvist, præcist hvornår efterfølgeren til Ascope Duodeno lanceres. Tidligere i november oplyste Ambu, at markedsføringen var undervejs".

.\˙ MarketWire