Home News MDR certification was Enzymatica’s highlight in Q1

MDR certification was Enzymatica’s highlight in Q1


MDR certification was Enzymatica’s highlight in Q1

29 April, 2024

Enzymatica has recently published its Q1 report, where the MDR certification for ColdZyme stands out as the key milestone during the quarter.
– The MDR certification was a labor-intensive and costly process, but now that ColdZyme has been certified as one of the first cold products in Europe, it opens up great commercial opportunities.

Enzymatica develops and sells products that treat infections and alleviate symptoms in the upper respiratory tract. The products are based on a barrier technology with the company’s patented enzyme Penzyme as key component.

Enzymatica’s best-selling product is ColdZyme, a mouth spray that protects against common cold viruses and alleviates the symptoms. It has been launched in over 30 markets on four continents.

CE certification opens up opportunities

In March, ColdZyme received CE certification in accordance with the new EU regulation, MDR, for medical devices. This shows that the product meets the regulatory requirements for clinical validation and safe design.

– The MDR certification during the quarter is an acknowledgment of our solid scientific and regulatory documentation, which will contribute to creating new and exciting opportunities for Enzymatica, says Claus Egstrand in the Q1 report.

Through the CE marking, ColdZyme will have clearer and expanded health claims, which strengthens the marketing of the product. Read more here. The company has started to develop new MDR packaging.

–  We have also secured the possibility to sell in European markets for a long time to come, and MDR certification will help when seeking authorization for new markets.

Reduced sales in the first quarter

Now that the MDR certification is in place, the company hopes that sales will increase. The report for the first quarter showed net sales of SEK 9.4 million, which is a decrease of 27.7 per cent compared to the same period last year.

– Sales for the first quarter were lower than the same period last year, which in its entirety is due to the low partner sales. We are working intensively, on a broad front, to reverse this trend.

In the Swedish market, sales increased by 21 per cent compared to the same quarter last year.

Aiming for establishment in major markets

As sales to partners remain low, Enzymatica is continuing discussion with other potential partners who can take over current markets or enter new ones. The company will focus on establishing ColdZyme on the major cold remedy markets globally, such as China, Japan and the US.

– For Enzymatica it is more important that we have efficient operations in the large markets than that we have a presence in many small ones. In retrospect, I can see that historically, we have placed too much emphasis on increasing the number of markets.

Exploring business opportunities

In addition, Enzymatica is evaluating its business model to strengthen growth. Today, the company has its own production of Penzyme, which they plan to continue to do. However, the company sees an opportunity to provide Penzyme to other players.

–We should challenge ourselves when it comes to other parts of the value chain. One definite possibility would be to become a “content provider.” With “Penzyme Inside” we could broaden our business model and pave way for an international expansion.

The barrier technology has a proven effect against viruses in the upper respiratory tract, but there are also other possible applications.

  There are more potential uses in consumer health, or in other areas. This is something we will explore going forward – on our own and in collaboration with new partners and the scientific community.

Looking ahead with confidence

Claus Egstrand concludes the CEO statement in the report by saying that he expects Enzymatica to take several important steps in 2024. The company is particularly looking forward to receiving the final results from the ongoing study at the University of Kent with ColdZyme in elite athletes.

2024 has every chance of being an important and exciting year for Enzymatica. We have the MDR certification in place, we are hoping for good research results during the second quarter, and we are engaged in discussions with potential partners with great faith in our technology, our product and our capabilities.

In addition, the company has upgraded the production capacity of its manufacturing facility in Iceland, which means that they are ready for increased sales volumes. Moreover, Enzymatica’s cash position is strengthen through a rights issue of SEK 25.5 million, which means that they are financially ready to take advantage of the opportunities in 2024.

Although it is always difficult to predict the future, I expect that the many long-term shareholders who have been so patient will see Enzymatica make great strides this year.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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