News and Events

22

Aug. 2019

Interim report for Q3 2018/19 (no. 14)

In Q3, Ambu has achieved solid organic growth of 10% and an EBIT margin before special items of 20.1%. The pipeline has been advanced, US approval of ENT scopes secured, and Ambu is on plan for future launch of the duodenoscope, the cystoscope and next generation aView™ monitor. In terms of commercial infrastructure, Ambu has decided to further invest in and strengthen its largest market by moving to a 100% direct sales organization for pulmonary endoscopy in the US. Financial guidance is revised.

We have a unique position with our pipeline of Visualization products, and we believe there is an untapped potential to be released by further investments in a direct sales force. Therefore, we have decided to go 100% direct with our aScope products on the US market. We believe that in the years to come, our direct sales force will be able to maximise our revenue growth and our entrance into ENT and urology will benefit from having full control of the sales force. With this change, we will build the largest single-use direct organisation in our most important market globally creating a competitive advantage for Ambu. Our expansion is well under way and will be effective during H1 2019/20. As a result, our full-year guidance for 2018/19 and 2019/20 is changed. In line with our communication in June, we are committed to create significant value for our shareholders in the long-term through strategic investments,” says CEO Juan Jose Gonzalez.

Highlights for the quarter – Investing for the future

  • For Q3, revenue totalled DKK 773m (DKK 673m), with organic growth of 10% and reported growth of 15%. The gap between organic growth and reported growth is due to the strengthened USD/DKK exchange rate, and recognition of GPO fees in accordance with the accounting standard relative to the same quarter last year.
  • In Q3, Visualization contributed organic growth of 30%, Anaesthesia was flat, and PMD (Patient Monitoring & Diagnostics) delivered growth of 2%.
  • Organic growth of 15% was realised in North America, 5% in Europe and 9% in the Rest of the world. 
  • Sales of single-use endoscopes in Q3 totalled 194,000 units, up 33% relative to Q3 last year. Year to date, sales of endoscopes thus totals 525,000 units.
  • Since 2015, Ambu and Tri-anim Health Services, a leading US specialty distributor, have been in partnership to make Ambu’s single-use bronchoscopes the market leader. Today, Tri-anim covers 40% of Ambu’s revenue from sales of aScope™ products within pulmonary endoscopy in the US market. As part of the ongoing initiative to ex-pand our direct sales force, Ambu and Tri-anim have mutually agreed to fully transition the sales of aScope™ products to Ambu and the agreement has effect from 1 October 2019. We are confident that with our pipeline of new endoscope products in markets including ENT and urology, we will be able to maximise revenue growth and cross-sales effects by going direct. This is an attractive investment for Ambu as transition effects will be outweighed by higher long-term growth.

    Furthermore, pricing policies towards distributors in the US will be changed with the purpose of optimizing prices. These important investments will have a one-off effect in Q4 and will cause significant changes to the guidance for the full year 2018/19 and 2019/20 and to the expected number of endoscopes sold.

A conference call is being held today, 22 August 2019, at 10.00 (CEST). The conference will be held in English and can be followed online at www.ambu.com/webcastQ32019.

Download
You can download the entire Q3 company announcement (pdf).

15

Apr. 2020

Researchers Warn About Contaminated Bronchoscopes for COVID-19 Patients

Researchers Warn That Contaminated Reusable Bronchoscopes Could Cause Secondary Infections and Higher Mortality Rates in COVID-19 Patients

As the coronavirus pandemic continues to spread, researchers have flagged a new potential threat: Patients and healthcare staff may be at risk of infection from contaminated bronchoscopes, the devices used to look inside patients’ lungs. They warn that these devices, which are also used to obtain samples and wash out patients’ lungs, could spread other microbes that may cause secondary infections.

The authors shared these views in a newly released manuscript. The paper was published on April 2 in a special coronavirus edition of the journal Infection Control & Hospital Epidemiology.

Exposure to COVID-19 or other pathogens
It is not clear how often COVID-19 patients are receiving bronchoscopies. But it is not uncommon for patients with severe lung ailments to have this procedure, either for diagnosis or as part of their treatment.

“It is possible that contaminated bronchoscopes could infect COVID-19 patients with other infectious diseases,” said Cori L. Ofstead, MSPH, one of the authors. “It’s also possible that contaminated devices could expose health care workers to the virus when they are cleaning and disinfecting them between patients. Given what we’ve learned about the overall level of bronchoscope contamination, we urgently need to know whether healthcare personnel are getting exposed to the virus or other pathogens on bronchoscopes due to the lack of PPE and other supplies.”

A possible solution
The authors note that sterile, disposable bronchoscopes would “substantially reduce the risks” to patients and hospital staff, and also point out that disposable devices are recommended by the American Association for Bronchology and Interventional Pulmonology. In addition, many tests for COVID-19 result in false negatives, while a bronchoscopy is the most accurate way to confirm that a patient has the virus, Ofstead states.

Ofstead and her colleagues, however, report that single-use bronchoscopes are not available everywhere, and also may not be effective for some bronchoscopy uses.

“This study adds to the mounting evidence that single-use bronchoscopes would be a better option for protecting patients and hospital staff from infection,” said Juan Jose Gonzalez, CEO of Ambu A/S, a medical device maker that has pioneered single-use bronchoscopes.

Based on previous research
The manuscript was authored by Ofstead, Krystina M. Hopkins, MPH, Matthew J. Binnicker, PhD, and Gregory A. Poland, MD. Ofstead is an epidemiologist with 25 years of research experience. She has conducted studies of the risks associated with bronchoscope contamination. The results of her studies have been cited in guidelines published by the Centers for Disease Control and Prevention, The Joint Commission, and the Infectious Diseases Society of America. Poland is the director of the Vaccine Research Group at the Mayo Clinic and an expert in vaccine-preventable infections including pandemic influenza and coronaviruses.

The manuscript, which was independently funded, bases its views on the authors’ previous research on bronchoscope contamination and vaccine-preventable infections. A 2018 study, which was peer-reviewed and published in Chest Journal, looked at bronchoscope use at three U.S. hospitals and discovered microbial and fungal growth on 58% percent of the devices.

The manuscript notes that clinicians have reported that some COVID-19 patients are also suffering from other bacterial and fungal lung infections, and that patients with multiple infections tend to fare significantly worse. The fact that such patients are especially vulnerable makes it even more important to ensure that bronchoscopes are not spreading such co-infections to COVID-19 patients, the authors say.

Reprocessing effectiveness
Currently, most bronchoscopes are reusable, and are cleaned and disinfected after each procedure. Ofstead and her colleagues argue that cleaning and disinfection are difficult to do properly and are often done incorrectly even under normal circumstances.

The authors acknowledge that reprocessing effectiveness has not been evaluated in epidemic settings and research is needed to confirm that COVID-19, influenza viruses, and other pathogens are eliminated in these settings.

“No patient should suffer from preventable nosocomial infections due to bronchoscopy,” Ofstead said. “Using bronchoscopes that have physical defects and harbor viruses, bacteria, or fungi puts vulnerable patients at risk and could have adverse effects on public health. Institutions are obligated to protect both patients and reprocessing personnel and ensure bronchoscope reprocessing practices adhere to guidelines and manufacturer instructions.”

Download
You can download this press release (pdf).

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