During the second quarter we continued to strengthen our market positions and the initial commercialization of our product portfolio.
Senzime’s quality management system was certified according to ISO 13485, which is an important step and proof that we meet the high standards of quality management for the development, manufacture and sale of medical devices. ISO certification is required by the regulatory framework and is a necessary step for CE marking of Senzime’s first three monitoring systems – OnZurf, CliniSenz and TetraGraph.
We are now in the final phase of the comprehensive process of achieving CE approvals and our assessment is that we will receive our first CE approvals in the third quarter of 2017. The CE processes have been challenging and the new, significantly higher requirements for medical device approvals well highlight how high the barriers to entry there are in our markets. Our technical files are based on long-term innovation, research, product development and clinical studies – and will be used to create long-term value in Senzime. Once CE approval is in place, we are ready to take the final step towards a broad market launch of our products in Europe, followed by Japan and the United States.
During the quarter we received a Swedish patent for Onzurf Probe and a US patent for TetraSens, which is the disposable electrode used in the TetraGraph system. Both patents are important and strategic, since they protect our single-use sensors – the products that are expected to drive the majority of sales and profitability in the long run.
We initiated a clinical study with CliniSenz for local monitoring of lactate after surgery in patients with esophageal cancer, a disease that annually affects approximately 500,000 patients globally.
Also during the quarter, clinical data from the first studies conducted at the Mayo Clinic, USA, were presented. The published results confirmed the user-friendliness of the TetraGraph system and that our now-patented design induces less discomfort from neurostimulation compared to so-called “gold standard” methods.
Demand for systems to easily and objectively determine when it is safe to wake the patient after surgery is high, and it is confirmed by the many published research studies in the field. Equally important is to ensure proper dosage of drugs during surgery and early detection of surgical complications. Our patient monitoring system makes it possible to reduce the proportion of complications and reduce costs in health care.
We are looking forward to a continued eventful and successful year!
Uppsala, August 2017
Lena Söderström, CEO of Senzime AB (publ)