Quickcool AB (publ) updates the time plan for the market introduction of the QuickCool® SYSTEM
QuickCool has previously assessed that the CE mark of the company's newly developed cooling system, QuickCool® SYSTEM, would be implemented during the first quarter of 2019. This is considered unlikely since both prototype 4 (4th generation) and 0 series have been delayed due to long lead times for components. The other development work, however, follows our plan. We can also note a significant uncertainty about the availability of resources and time required for the notified body to review the technical files for the CE marking. The new MDR-directive has resulted in extended processing times at certification bodies. The goal is to implement the CE mark as soon as possible. Given the uncertainties that exist, the assessment is that a CE mark cannot be issued in the first quarter of 2019, but later in 2019
The process of preparing the market introduction of the QuickCool® SYSTEM continues as planned. An important part of the introduction is to initiate talks with leading intensive care units early on. To enable this, negotiations are ongoing with selected distributors in Europe. There is considerable interest in the QuickCool® SYSTEM, as shown in already published press releases. Four distributor agreement have been signed covering seven markets in Europe, including the United Kingdom and Spain. There are ongoing discussions with distributors in most other markets in the EU, including major markets such as Germany, France and Italy. The Swedish market will be handled by its own sales representatives. In parallel, the planning of two studies is underway with Skåne University Hospital where a pilot study comprising 5 cardiac arrest patients, and one with 20 cardiac arrest patients. The pilot study, that is fully prepared, will start immediately after the CE mark has been issued. The goal of the studies is to show that the QuickCool® SYSTEM cools and is safe. The studies will be led by Dr. Hans Friberg, professor and chief physician in anesthesia and intensive care at Skåne University Hospital and chief physician at the Centre for Cardiac Arrest in the Öresund region. Dr. Friberg was instrumental in the TTM study published in the New England Journal of Medicine, 2013, entitled "Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest".
Fredrik Radencrantz, CEO of QuickCool, comments: "It is disappointing to announce that we cannot deliver in accordance with our previously assessed time plans. The work to complete the project progresses well but we have experienced long lead times on some critical components and we experience that the current workload on notified bodies makes it difficult to confirm implementation times. We feel there is a strong and genuine interest for our QuickCool® SYSTEM, which has been confirmed by the recently signed distributor agreements, as well as by all ongoing discussions with potential distributors both in Europe and other markets around the world. We do everything we can to start deliveries as soon as possible."
For additional information, please contact:
Fredrik Radencrantz, CEO
Phone: 046-286 38 40
E-mail: fredrik.radencrantz@quickcool.se
This information is such that QuickCool AB is required to make public in accordance with the EU’s market abuse regulation (MAR). The information was made publicly available by the Company’s contact person on 27 November 2018.
Quickcool is a Swedish medical technology company, whose business concept is to save lives and prevent brain damage in acute ischemia (Inadequate blood supply to the brain) by developing and providing a unique and globally patented cooling system, the Quickcool SYSTEM. Quickcool is active in the fast-growing market, Targeted Temperature Management (TTM), for brain-protective cooling treatment of patients with e.g. acute cardiac arrest and stroke. QuickCool’s solution protects the brain by cooling in the nasal cavity and thus takes advantage of the innate heat exchanger in the nose. QuickCool’s Intranasal method offers gentle and uninterrupted cooling treatment for sedated patients. Quickcool is listed on Spotlight Stock Market and conducts its business at Ideon Science Park in Lund. For more Information, please refer to: www.quickcool.se
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