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Hemcheck's Newsletter - April 2022

April has been a month when we have been traveling more extensively than previously due to international conferences starting up again along with more physical meetings with customers. One major event was EuroMedLab being held in Munich where Hemcheck exhibited. The results from the study at Sant Pau were also presented by the responsible physician, Dr Alvaro Garcia Osuna. It was a very good event for Hemcheck with a lot of interest shown in our solutions. Another conference that we exhibited at during the month was LabQuality Days in Helsinki.
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Although a smaller event than EuroMedLab, it was well worth the time being on site meeting several potential customers. We will continue to attend and exhibit at additional upcoming conferences since restrictions are now lifted in most European countries and these are valuable marketing channels.

Related to new agreements, we signed two new distributor agreements with Vingmed for the Finnish, Norwegian and Swedish markets, and with Beamed for the Qatari and Jordanian markets. We hope that we will have successful collaborations with these new partners. Another very positive event was the first evaluation order received from Sahlgrenska University hospital. Even though the order is small in economical value, it's important given the size and reputability of Sahlgrenska University hospital. Lastly we have concluded a study at Sheffield Teaching hospitals which showed very good results, which of course also is very promising.

In addition to the customer facing activities we are now also evaluating the possibility to CE-mark our technology for diagnostic use. In order to do this, we need to adhere to stricter requirements since the risk classification is higher for diagnostic use compared to our current intended use. We do this because even though the segments are clearly smaller than for our current products and usage, there is clear potential upside since the price levels are higher and the use is directly related to clinical decision making and established practice already. So as long as we can meet performance requirements and achieve the CE-mark, we believe we can have good traction in the relevant segments.

More information about the news above can be found in the newsletter!

Enjoy the reading!
Joen Averstad, CEO

Evaluating the possibility of CE-marking for diagnostic use

After Hemcheck received good feedback from the study at Liverpool Heart and Chest Hospital, as well as receiving good indications from other user tests, we have decided to evaluate the possibility of developing and CE-marking the products for diagnostic purposes, which is not the case today. There are several customer segments where hemolysis is an analysis that directly helps to diagnose a patient’s condition. The volumes are smaller in these segments compared with, for example, the broader emergency care. At the same time, the analysis is already part of the established care processes, and the price levels are clearly higher.

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Hemcheck has received a first evaluation order from

Sahlgrenska university hospital

Hemcheck has received a first evaluation order from Sahlgrenska University Hospital. The order is of smaller economic value but is potentially important as Sahlgrenska is one of the larger hospitals in northern Europe.

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Distribution agreement signed for the Finnish, Norwegian and Swedish markets

Hemcheck has signed a distributor agreement with Vingmed, one of the largest distributors in the Nordic region. The agreement entails an initial order like previous similar agreements.

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Distribution agreement signed for the Qatari and Jordanian markets

Hemcheck has signed a distributor agreement with Beamed Trading (“Beamed”) regarding the Jordanian and Qatari markets. The agreement entails an initial order like previous similar agreements.

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Clinical evaluation study completed with very good results at

Sheffield Teaching hospitals

Northern General and Royal Hallamshire hospitals, part of Sheffield Teaching hospitals, has successfully finalized a two-part evaluation study of Hemcheck’s products (v-Test) at the department of coagulation. This formal evaluation confirm that the tests does not interfere with subsequent coagulation testing and that the performance of Hemcheck’s products is very high.
The conclusions are that Hemcheck’s system does not interfere with the included subsequent analyses and has good performance and correlation with the reference method, while being quick and easy to use.

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EuroMedlab, Münich

The 24th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine, jointly hosted by IFCC, EFLM and DGKL, took place on April 10-14 in Münich. EuroMedLab was the first major IFCC/EFLM conference held following the long delay caused by the pandemic and thereby an excellent opportunity to once again bring scientists, laboratory specialists, clinicians and industry colleagues in the field of clinical chemistry and laboratory medicine from Europe and many other countries together.

Hemcheck participated in EuroMedLab as exhibitors and was represented by Peter Andersson, Sales and Marketing Manager, and Anders Hellström, Clinical Specialist. The Hemcheck team and the concept was shown great interest from the visitors at the congress. Hemcheck could register many pre-booked meetings with leading professors, physicians, specialists, distributors and scientists from all over Europe throughout the event. Future dialogues are to be expected and follow-up meetings are already being booked.
One of the highlights of this year's fair was the closing lecture performed by Dr Álvaro García-Osuna. His study concluded that Hemchecks products have similar performance compared to the laboratory reference method.
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LabQuality Days, Helsinki

On April 20-21, Labquality Days, the international congress on quality in laboratory medicine, was held at Messukeskus Expo and Convention Center In Helsinki. The event was last held in person during February 2020 before the pandemic broke out. Labquality Days is one of the largest annual international congresses in the Nordics focusing on quality in laboratory medicine and medical devices. The main theme for the 2022 congress was “Forerunner in Quality for 50+ Years”. The sub-themes consisted of Past and Future of EQA, QC & Regulation and Quality Systems in Laboratory Medicine. With an international scientific program in connection with a large number of exhibiting companies active within the clinical laboratory and healthcare technology fields, the event was highly relevant for Hemcheck.

Hemcheck was participating as an exhibitor over the two days at the congress to market our products and services and to meet relevant experts and key opinion leaders in the field. The event was well attended with many international visitors. It is one of the first congresses that Hemcheck has been able to attend in person for a long time, which is a very positive signal given the importance of meeting potential customers and stakeholders in person.

In addition to the opportunity to visit the 56 exhibitors, the conference also included several interesting lectures. The opening keynote lectures included an historical overview of quality in laboratory medicine by Dr James O. Westgard (Westgard QC), followed by Dr Sverre Sandberg (Noklus) discussing improvements in EQA through international cooperation, while Dr Mario Plebani (University of Padova) and Dr Tony Badrick (RCPAQAP) addressed questions on both internal and external quality control of clinical laboratories.

Read more about the congress here
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Transition to IVDR

In May 2022, the new IVDR regulations will come into effect, which applies to Hemcheck's products. We have been working on the transition including updating our quality management system, regulatory documentation, working procedures, etc over the last year. We have recently conducted an internal audit and we are now at the very final stages of the transition and will shortly issue our CE-documentation under the new regulations. Something that is a requirement for selling the products after May 26.



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Calendar

Upcoming events

May 4th
EuroElso
London

September 27th
5th Munich Point-of-Care Testing Symposium
Münich

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