The third quarter has been characterized by continued high activity with a number of important events before market launch of our ISO-certified monitoring systems – TetraGraph, OnZurf and CliniSenz. We previously assessed that we would have CE approvals before this report, but we can only state – CE processes are challenging with significantly higher requirements for medical device approvals in our markets. We have a continuous dialogue with all parties and the biggest challenge is processing time. Our assessment is still that we will receive approvals shortly. We will report on a regular basis. However, we are pleased that despite the long CE process, we have had an active third quarter.
In the beginning of the quarter we received US patents for TetraSens disposable electrodes. With its unique design, TetraSens enables quick application with effective function. The electrodes are used in conjunction with Senzime’s monitor TetraGraph, which contributes to effective monitoring of patients receiving general anesthesia and muscle relaxation using neuromuscular blocking drugs (NMBAs). The TetraGraph makes it possible to easily and objectively determine when it is safe to allow the patient to breathe spontaneously after surgery, and ensure the correct dose of medication is administered during surgery.
We have also signed an exclusive distribution agreement with Leuag AG to enable TetraGraph’s commercialization on the Swiss market. Leuag is a leading provider of medical products within patient monitoring, diagnostics and imaging. They are a perfect partner as they have a complementary product portfolio, the network and experience required for TetraGraph to become the market leader in Switzerland.
In addition, we filed a Premarket Notification 510(k) application to the US Food and Drug Administration (FDA) for approval of TetraGraph in the United States. The FDA application is part of Senzime’s launch plan for TetraGraph in the United States, which is one of the key markets for monitoring patients undergoing surgery using both general anesthesia and neuromuscular blocking drugs. An approval from the FDA is expected within 12-15 months.
Also, it was both exciting and very positive to have been selected as one of ten companies to present at The MedTech Conference in San Jose, California, in their “Innovation Pavilion”. The interest was great and given the response, I assess we have an exciting time to look forward to the time when we have all approvals in place.
Further, we had a booth at ASA’s annual meeting in Boston in October – the largest anesthetic-related education meeting in the world – where the results of the TetraGraph study carried out at the University of Debrecen, Hungary were presented. The study shows that TetraGraph, in comparison with former market leader TOF-Watch, will provide anesthetists with precise and easy-to-use equipment that can prevent complications, avoid unnecessary patient suffering and save costs.
In summary – we are making great progress; the CE processes are challenging, but the assessment that CE approvals are imminent will remain and as soon as they are received, we will announce this, after which a broad market launch will begin.
Uppsala, November 2017
Lena Söderström, CEO of Senzime AB (publ)