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High-growth company with focus on becoming a single-use pure player within all main endoscopy markets.

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17

Jul. 2020

Ambu receives FDA clearance for its sterile, single-use duodenoscope (no. 12)

Ambu is ready to launch single-use solution to help increase patient safety and prevent duodenoscope infections. Further devices for GI in development.

The Ambu® aScope™ Duodeno received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on 17 July 2020 and is now ready for commercial launch as planned.

At Ambu, we are determined to advance patient safety through innovative design of single-use devices, and we are excited to improve safety for the two million patients each year, who need an ERCP procedure,” says Juan Jose Gonzalez, CEO of Ambu. “It’s no longer necessary to balance the necessity of the procedure against the risk of infection from a reusable endoscope. Now, both doctor and patient can focus on diagnosis and treatment by using a sterile, single-use duodenoscope.

Reusable duodenoscopes have been under increasing critique from FDA in recent years because there have been cases of device-related infections and patient fatalities. In August 2019, FDA recommended duodenoscope manufacturers and health care facilities to transition to duodenoscopes that are partially or completely single-use.

The aScope Duodeno is sterile, seamlessly integrates into existing hospital systems and offers an intuitive, lightweight design with similar functionality to reusable duodenoscopes,” says Greg Swanson, SVP, Chief Marketing Officer at Ambu. “Over the past six months, we have expanded our sales organization and built a dedicated commercial infrastructure for gastroenterology. After today’s FDA clearance, we will now approach our customers to arrange product demonstrations, set up evaluations and promote what Ambu has to offer within the field of GI.

A single-use duodenoscope system
Ambu’s duodenoscope solution consists of a single-use endoscope – Ambu® aScope™ Duodeno – and a reusable processor unit – Ambu® aBox™ Duodeno. The FDA clearance covers both devices. Duodenoscopes are used for visual examination of the duodenum and play a key role in diagnosis and treatment of conditions like gallstones, pancreatitis, tumors or cancer in the bile duct and pancreas.

Initiating post-market study
As part of the regulatory approval of the aScope™ Duodeno, a small-scale performance test was carried out in which 13 gastroenterologists evaluated the device in in-vitro and in-vivo test models. The aScope™ Duodeno performed on par with the market-leading reusable duodenoscope control and was evaluated positively regarding image quality, scope navigation and ergonomics in post-test interviews.

Having obtained FDA approval, Ambu will as planned initiate a 500-patient post-market study at multiple centers in the U.S. A sub-set of the study will be made public during Q1 of Ambu’s financial year 2020/21 when data from a minimum of 60 procedures is available.

Over the next three years, Ambu is introducing 15 new devices across all major areas of endoscopy including GI, the largest endoscopy market globally. This includes three additional single-use devices: A colonoscope, a gastroscope and a cholangioscope.

Built on a decade of experience 
Ambu launched the world’s first single-use flexible bronchoscope, the Ambu® aScope™ in 2009. Ten years later, in 2019, over 600,000 Ambu single-use endoscopes were used in more than 6,000 hospitals making Ambu the world’s largest supplier of single-use endoscopes. The aScope™ Duodeno was designed with input from a global gastroenterologist consultant board along with engineering expertise from the team of Invendo Medical acquired by Ambu in 2017.

Download
You can download this company announcement (pdf).

15

May. 2020

Ambu is now part of UN Global Compact

When Holger Hesse founded Ambu in 1937, it was with a desire to have a positive impact on the world. A positive impact on healthcare and a positive impact on business practises.

Through the years, different words have been used to describe these efforts in our company: Decency, morals, professional pride, social responsibility, CSR and now ESG or sustainability.

A formal commitment 
In our CSR efforts in recent years, Ambu has been inspired by the principles of UN Global Compact and the 17 Sustainable Development Goals. However, now we have made a formal commitment and joined the UN Global Compact.

This means that we are committed to making the UN Global Compact and its principles part of the strategy, culture and day-to-day operations of our company.

Furthermore, we are committed to reporting annually on the progress of our sustainability efforts. In practice, this reporting means that our ESG section of the annual report will be expanded and will include:

  • A description of practical actions (policies, procedures, activities) that Ambu has taken to implement the UN Global Compact principles in each of the four issue areas of human rights, labour, environment, and anti-corruption.
  • A measurement of outcomes. The degree to which targets/performance indicators were met, or other qualitative or quantitative measurements of results.

Doing the right thing
A core value of Ambu is integrity, and we aim to grow sustainably in regard to our people and the planet. In many areas, we already conduct our business according to the UN Global Compact principles, however, we need to improve the documentation of our efforts and align the measurements across our locations.

Part of a global movement
UN Global Compact is the world’s largest corporate sustainability initiative with more than 10,000 companies as members. This means that it is a global and joint effort and also a network of good practice and methods.

As UN Global Compact puts it: “Long-term business success matters – and so do your workers, communities and the planet. The UN Global Compact helps you do business right for all.”

You can read more about UN Global Compact here: UNglobalcompact.org

14

May. 2020

Capital increase in connection with exercise of warrants (no. 11)

Ambu A/S issued 2,000,000 warrants in 2014, 770,000 warrants in 2015, and 419,500 warrants in November 2016. Each warrant entitles the holder to subscribe for one Class B share with a nominal value of DKK 0.50. 22 individuals participate in the 2014 scheme, 46 individuals participate in the 2015 scheme, and 71 individuals participate in the 2016 scheme. 

For all three schemes the vesting period is three years, and all three schemes can therefore be exercised in the trading window that opened on 4 May 2020 in connection with Ambu’s interim financial report for Q2 2019/20. 

Since 4 Maj 2020, instructions have been received to exercise warrants as follows: 

  • 2014 scheme: Two individuals have issued instructions to exercise 100,000 warrants at the agreed exercise price of DKK 23.06 per share with a nominal value of DKK 0.50.
  • 2015 scheme: Five individuals have issued instructions to exercise 105,000 warrants at the agreed exercise price of DKK 39.26 per share with a nominal value of DKK 0.50.
  • 2016 scheme: Seven individuals have issued instructions to exercise a total of 20,000 warrants at the agreed exercise price of DKK 77.12 per share with a nominal value of DKK 0.50.

Today Ambu’s Board of Directors decided to carry out the capital increase relating to the exercised warrants.

As a result of the capital increase, the share capital of Ambu will be increased by a nominal amount of DKK 112,500 from DKK 125,999,800 to DKK 126,112,300 through the issue of 225,000 Class B shares.

Following this and in consideration of the employees having left the company, the following warrants remain under the said schemes:

  • 2014 scheme: 400,000 remaining warrants being held by 4 individuals.
  • 2015 scheme: 300,000 remaining warrants being held by 21 individuals.
  • 2016 scheme: 249.500 remaining warrants being held by 46 individuals.

The new B shares are expected to be admitted to trading and official listing on NASDAQ Copenhagen A/S on 20 May 2020 under the ISIN code of Ambu A/S’ existing B shares (DK0060946788).

Under section 32 of the Danish Capital Markets Act, Ambu A/S is to announce the total share capital and the total voting rights by the end of a month in which any change of the share capital was effected. The table below shows the total share capital and the total voting rights of Ambu A/S after the capital increase.

  Number of shares
(nominal value DKK 0.50)
Nominal value
(DKK)
Voting rights
A shares 34,320,000 17,160,000 343,200,000
B shares 217,904,600 108,952,300 217,904,600
Total 252,224,600 126,112,300 561,104,600


Download
You can download this announcement: Company announcement no. 11 2019/20 (pdf)

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Upcoming events

26

Aug. 2020

Report for Q3 2019/20

Follow the conference call at 10.00 (CEST). The presentation can be downloaded immediately before the conference call via the same link.

30

Sep. 2020

End of fiscal year 2019/20

27

Oct. 2020

Deadline for items for AGM 2019/20

Deadline for the inclusion of specific items on the agenda for the annual general meeting for the financial year 2019/20

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