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Hemcheck's Newsletter - January 2022
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After some well needed days off for the whole Hemcheck team during Christmas, we started the year with renewed energy.
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In January, we have reached a major milestone, by completing the CE-marking process of the bgs-Test. This is a project which we have worked on for a long time and the CE mark is a requirement for selling the product on the European market. Big credit to the whole team for completing this project! We are now looking forward to the coming customer trials with this new product and the related marketing and sales work.
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On other fronts we have continued our commercialisation efforts, where we have high activity of centers planning or conducting user tests or trials, which is very positive. One slightly negative trend has been the increased restrictions due to the pandemic which has lead to some planned exhibitions being postponed again, however we hope this trend is temporary.
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We also received notice during January about the intention to grant from the European patent office (EPO) regarding our filter patent application. This is very good news since this patent protects core parts of our technology. We already have the patent granted in Sweden and the US since earlier.
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In this newsletter you can read more about the news highlighted above and a presentation of our new clinical specialist.
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Intention to Grant from the European Patent Office
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Hemcheck has received a so-called “Intention to Grant” from the European Patent Office, “EPO”, regarding the patent application for our filter solution. This means that the EPO intends to approve the application after certain formal steps have been completed. The patent has previously been approved in Sweden and in the USA.
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The patent, when approved, will be of great importance as it protects a vital part of Hemcheck´s unique technology.
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Hemcheck obtains CE mark for its new product
for the blood gas market: the bgs-Test
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Hemcheck’s new product for the blood gas market is now CE marked. The bgs-Test is a hemolysis test which can receive a significantly larger amount of blood volume compared to current tests, fully functioning as an airtight cap for blood gas syringes, while allowing for air venting, which means many advantages for users.
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The CE-marking is a pre-condition for the product to be sold in the European market, and it’s the result of a series of processes and work steps including user-, technical-, regulatory- and safety requirements, user tests, etc.
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The bgs-Test from a Hemcheck perspective
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Hemcheck CTO David Melin tells us more about the work behind the bgs-Test and what to expect from future product development:
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What have been the main challenges that you wanted to solve with the bgs-Test?
We wanted to create a hemolysis test product that fits into the blood gas analysis flow, taking into consideration all work steps, as well as allowing for even greater variation in user skill levels making it very easy to use.
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What have been the main challenges of the CE marking process?
Due to the Covid-19 pandemic, getting access to health care providers for usability evaluations, product verification and similar have been quite challenging. We also changed personnel in the middle of the project which created a significant delay.
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What has been the most fun or exciting part of the development process?
Getting the first production versions of the bgs-Test and verifying that the design works as intended was a great satisfaction. One never knows if the product will really work as intended until then, so there is always some uncertainty until the functionality can be verified.
What's the next steps in product development at Hemcheck?
We will continue to improve our current products and evaluate potential broader opportunities for our technology. In parallel with this we’ll ensure our compliance with the new IVDR regulations before May 2022, when these become effective.
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Meet the new Clinical Specialist of Hemcheck
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Hemcheck has after the summer of 2021 welcomed Anders Hellström as the new Clinical Specialist for the company. Below you can read more about his priorities and focus areas for the future at Hemcheck.
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Can you tell our readers a little more about yourself?
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I have a master’s degree in chemical engineering from the Royal Institute of Technology in Stockholm. I have worked in clinical laboratories for almost two decades in Sundsvall and Stockholm (Unilabs) with things like method development, method evaluations, quality control and education. I am delighted that the opportunity to join Hemcheck arose since I know what a great problem hemolysis is in the clinical laboratory and I think Hemcheck has a really good solution for this that will benefit the patients.
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What is your first impression of Hemcheck so far?
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I encountered Hemcheck while working at Unilabs, so I already had quite good knowledge about the company and the products before I started my position. My first impression while working for Hemcheck is that there is a positive and creative environment in the company. I really enjoy working in this team. I have also been impressed by the performance of the tests in clinical environment. With a long background in clinical chemistry I know that method comparisons can be tricky when methods with different techniques are being compared. However, results in studies and user evaluations show that there is a good alignment between the Hemcheck tests and the big platforms used in clinical laboratories.
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What are the most important priorities for you when looking forward?
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There are several interesting studies and user evaluations ongoing or starting soon in different fields where hemolysis is a problem. I think it will be very interesting to follow the results.
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