Hemcheck's Newsletter - November 2021

Welcome to the November Newsletter from Hemcheck

November has been an eventful month in many ways. We have participated in several live trade fairs such as Medica in Düsseldorf, RBSLM in Brussels, and Lægedage in Copenhagen, whereas EuroMedLab in Munich unfortunately was postponed to April 2022 due to the current risk of a new lock down in Bavaria.
We are at the same time making progress on several important customer user tests and trials and hope this will lead to additional positive news going forward. In late November we also extended our evaluation agreement with Hettich regarding distribution in Denmark.

On other fronts we have e.g. continued the development of our new product for the blood gas market and entered into the final validation phase during early November. This is important since when the validation is completed, we can officially CE-mark the product, which we expect to be done in early January. Several potential customers that we have had dialogues with regarding this think it is a good addition and show clear interest in the product.
In this newsletter you can read more about the industry meetings, our Q3 report, the new product for the blood gas market as well as a presentation of our new Quality assurance manager.

Joen Averstad, CEO


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Medica, Düsseldorf

Medica is the largest medical trade fair in the world and is held every year in Düsseldorf. Last year it was held digitally but this year it returned to an in-person setting. The fair covers a broad spectrum of medical related segments, e.g. laboratory medicine, imaging, health-IT, robotics, surgery, etc. Each year, thousands of exhibitors from over 50 countries attend the trade fair. Hemcheck was on site for several meetings with current and potentially new distributors/partners, as well as to participate and get information about new technologies in relevant fields. There were good days on site with productive meetings. Given that some distributor contracts have been signed during the pandemic, this was the first time we could meet some of our distributors in person which I believe is very important for our relationships going forward, says Joen Averstad, CEO of Hemcheck.

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2021 Annual RBSLM Meeting, Brüssels

2021 Annual RBSLM Meeting was arranged as a hybrid meeting by The Royal Belgian Society of Laboratory Medicine (RBSLM) in Brüssels. RBSLM aims at representing and promoting the scientific and clinical interests of laboratory medicine as well as clinical biology, biochemistry, hematology, microbiology and related new disciplines. The goal is to represent the profession as a single scientific reference group and as a group of experts with regard to the Belgian institute of Health (SCIENSANO), clinical laboratories, the medical-diagnostic and pharmaceutical sector and associations of general practitioners and medical specialists. The meeting gathered 300 participants (200 virtually) and 24 international exhibitors representing the medical laboratory and healthcare technology field onsite. There were many interesting meetings and discussions throughout the fair, especially with the university hospitals in Belgium. The next step is to follow up these dialogs in order to offer and arrange for product evaluations during 2022.

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Lægedage 2021, Copenhagen

Lægedage 2021 was held in Copenhagen and is the largest venue for practicing doctors in general medicine in Denmark. The fair, containing interesting lectures and courses, was arranged by Praktiserende Lægers Organisation (PLO) and Dansk Selskab for Almen Medicin (DSAM). There were 100 exhibitors on site representing companies, medical associations, organisations and patient associations in the area. Hemcheck and Hettich participated together in order to continue the ongoing customer processing and commercialisation journey in the Danish market. Many dialogues were started and are being followed up by Hettich in close cooperation with Hemcheck.

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Interim report Q3 2021 now available

We released our interim report for the third quarter of 2021.
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Hemcheck enters final validation phase regarding the new product for the blood gas market

Hemcheck has finalised the verification phase regarding the new product for the blood gas market and is now entering a final validation phase, where usability and performance will be evaluated in a user environment. This is the last important phase before a CE-marking can be achieved, which is needed for the product to be sold on the European market.
The new product is called the bgs-Test (bgs stand for blood gas syringe) and is a hemolysis test which can receive a significantly larger amount of blood compared to current tests and in addition function as an airtight cap while allowing for air ventilation of syringes. This allows for integration of hemolysis control in patient near tests such as blood gas analysis, including improved adaptation to current workflows. It also expands Hemcheck’s addressable market since the bgs-Test can be used in combination with more types of syringes. Lastly, it creates even better conditions for combining our product offering with other companies’ offers.

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Meet our new Quality Assurance Manager!

Michael Kissi
Can you tell our readers a little more about yourself, Michael Kissi?

I have been working with quality assurance and regulatory affairs for 15 years, starting out in the food industry. Major achievements have been building up quality management systems, implementing procedures and training to comply with quality standards and regulatory requirements. I later became a consultant and had the opportunity to work closely with product development and production in developing and producing devices for the European and American market.

After gathering experience in several markets I now look forward to working at Hemcheck to continue developing and improving the quality management system and to increase awareness in quality within the company. I also look forward to exploring new markets within blood analyses on a global level.

What is your first impression so far, a few months into your new position at Hemcheck?

My first impression is that there are clear goals, structures and commitment in how the company operates together with a very strong team working towards the same vision.

What are the most important priorities for you going forward?

Going forward my biggest priorities will be to continue preparing the company for the transition to the new medical device regulation, IVDR, as well as the quality standard for medical devices, ISO 13485.
Other priorities are to further get to know the company, products and team members and continuously improve the quality management system so we can continue to explore global markets.

I look forward to a very fun, challenging and rewarding time.

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Upcoming events

February 10th
Labquality days

March 15th
EFLM Pre-analytical phase

March 15th
5th Munich Point-of-care Testing Symposium

Contact Us
Hemcheck Sweden AB
Karlstads universitet
Universitetsgatan 2
651 88 Karlstad