As a new, young doctor, Mathias Karlsson was confronted with a very sick newborn baby. He began to think about the possibility of easy testing which could be done on this newborn to give an indication of its medical needs. He started doing research and connected with Sofia Hiort af Ornäs, a talented chemist. Calmark Sweden AB was founded by Mathias and Sofia in 2008. The company had investments from private capital and business angels. During the first 9 years, extensive research was done on different biomarkers, filters and software and several patent families were filed. Prototypes were also tested with key opinion leaders in the world.
What have been the milestones so far in your company development?
Product development is proceeding according to plan – Calmark fulfilled all the milestones communicated in the listing prospectus in 2018. In October 2018, the single-use product left the prototype stage and the development of the plastic details was thus complete. An order was placed shortly thereafter on a steel tool for large-scale production of the single-use products. – Electrical safety tests of the reader were conducted during the fall of 2018 and it was approved according to standards related to the CE marking. – Chemistry development of the biomarkers LDH and glucose went according to plan and began testing at the end of 2018 on filters. – Production has been started up by collaborating with two different companies for the production lines, Note AB in Norrtälje and Frohe AB in Tyresö. Both companies have experience in medical technology products and maintain the quality level required for CE marking. – On February 8, 2019, Calmark received delivery of the first reader produced in the production environment by Note AB. – Just over a week later, on February 14, Calmark delivered the first single-use articles produced in the large-scale production environment by Frohe AB. – On January 21, 2019, the Board of Directors of Calmark Sweden AB announced that it has decided to prioritize CE-marking of the test for bilirubin separately, before the other tests, in order to get out to the market faster and receive revenue earlier. The original plan was to launch the first three tests simultaneously. The decision means that Calmark’s readers can enter the market faster and then be supplemented with more and more tests. Sales organization and procurement of distributors – On February 22, 2019, the Board of Directors of Calmark decided on a preliminary launch plan for the company’s products. In the first phase, launches are taking place in the Nordic countries, the UK and Vietnam, and then increased with more countries in Europe, as well as in Singapore, Malaysia and India. – Negotiations have started with Triolab regarding an agreement for the sales rights in the Nordic and Baltic countries. – Calmark has signed an agreement with Luctor Medical in the Netherlands, an internationally leading consulting company specialized in finding distributors for medical technology products. The agreement covers consulting services regarding distributor networks in Asia ahead of the upcoming launch. – An experienced international sales manager has been hired, Marianne Alksnis, who has long experience in international business development and sales from leading positions in life science companies. Marianne will join the company on October 15 and will be responsible for building the wide network of distributors that will provide the framework for Calmark’s sales strategy. Further capitalization – The exercise of warrants was carried out in May / June 2019 and gave the company an additional SEK 13 million to use for clinical studies, completion of production build-up and creation of a sales organization. – As previously announced, additional capitalization will be needed to reach all the way to market launch in 2020.
What are your most important markets, segments and customers?
Markets and segments – Calmark has decided on a preliminary launch plan for the products. In the first phase, launches are taking place in the Nordic countries, the UK and Vietnam, and then increased with more countries in Europe, as well as in Singapore, Malaysia and India. – For the important markets China and the USA, registration is planned, corresponding to the CE marking that is now in progress and which applies to Europe, to begin within a three-year period. Customers – Calmark plans to sell its products through a broad distributor network with the support of an international sales manager. Agreements will be signed with distributors who have similar products and have established sales and marketing channels to our end customers; hospitals and clinics. We will work together with the distributors to create various information-, marketing- and sales campaigns.
Where do you see the company five years from now?
Our vision is to become the global leader in diagnostics for newborns. Five years from now I see us well on our way towards this vision. I hope that we, by that time, have gained market share in developed countries and are able to provide decision support also in world’s poorest countries.
What are your priorities within 2019/20?
CE mark – Without CE-marked products, we cannot sell so this is the most important priority. We are now in the final phase of the development of the products according to the CE process. What remains is verification and validation which also includes clinical studies. In order to meet our technical requirements, we must show that we have good precision and accuracy, which is tested according to ISO standard protocols during verification and validation. Production capacity – When we have CE-marked products, we need production lines that can deliver enough products as we launch new markets. It is also very important that we can achieve low manufacturing costs, especially for the single-use item, in order to be able to sell at a relatively low price even in countries with low healthcare spendings. – Construction of two separate production lines is ongoing and is proceeding according to plan. Note in Norrtälje manufactures the reader. Frohe in Tyresö manufactures the single-use item, where the production line will be expanded in several steps to meet the demands. Sales organization – An important factor for our success is that we find distributors who actively sell our product in the parts of the world that we prioritize. The right strategy and the right partners are crucial to a global launch. We are pleased to have recruited a sales manager who has long experience from just this. We also take help from consulting firm Luctor Medical, specialists in finding distributors within medtech. They have lots of experience and a large network globally. In most markets, they have a local presence, which is a big advantage that we can benefit from. Registrations of the product outside the CE region, such as the US and China – We have good expertise within the company to handle complicated registrations in regions such as the US and China. We also have the help of a Dutch company – Emergo, which can assist with consulting services within QA / RA and which has a local presence in most of the countries we intend to launch. – The process of registration in the US and China will begin within a three-year period.
Why should one consider adding your company into their portfolio?
Point-of-care testing is a market with very strong growth. We have a niche product where competition is low on the world market, while the product can make a big difference for customers and patients – both financially and humanitarian.