Medovate and its Saudi Arabia based distributor AKSIA Healthcare have announced they have secured SFDA (Saudi Food and Drug Authority) Approval for the game-changing SAFIRA™ (SAFer Injection for Regional Anesthesia) technology.
This is the fifth regulatory approval secured by the Cambridge based medical device manufacturer which is dedicated to the development and commercialisation of innovative medical technologies from within the NHS.
Having secured SFDA Approval the company can now start selling the pioneering device in the Kingdom of Saudi Arabia, the biggest market in Middle East.
The SAFIRA™ system is a revolutionary new technology that can transform regional anesthesia into a one-person procedure and gives the anesthesiologist full control of the regional anesthesia process without the need for an assistant. It also incorporates a built-in safety system to automatically limit injection pressure, reducing the risk of nerve damage and enhancing patient safety.
The SAFIRA™ system already has FDA clearance in the US, European CE Mark certification, HSA Approval in Singapore and TGA approval in Australia.
Alan Finnerty, Technology Director at Medovate, commented: “This latest regulatory approval for SAFIRA™ is another significant step forward in bringing this revolutionary technology, developed in collaboration with clinical innovators from within the NHS, to market on a global scale. We are excited
to now be able to make the benefits of the SAFIRA™ system for safer regional anesthesia available across Saudi Arabia and we believe approvals will now soon follow in Bahrain, the UAE and Kuwait. We believe SAFIRA™ has the potential to transform the regional anaesthesia landscape and are committed to ensuring its global commercial availability working alongside our distributor partners including AKSIA Healthcare.”
Ahmed Sallam, Managing Director of AKSIA Healthcare FZC, commented: “The SAFIRA™ system is a game-changing technology for regional anesthesia which has the potential to deliver real patient safety benefits for anesthesiologists and their patients. AKSIA Healthcare is delighted to be
Medovate’s distributor partner and the whole team is excited to now be able to start full roll out of this innovative technology to hospitals throughout Saudi Arabia.”
SAFIRA™ has been exhibited at leading medtech events including a live demonstration at Arab Health 2022 by one of the co-inventors Dr Emad Fawzy, a Consultant Anesthesiologist, at the flagship Sheikh Khalifa Medical City in Abu Dhabi.
Dr Fawzy added: “There is already significant interest amongst Middle Eastern clinicians in this new technology for safer injection for regional anesthesia. I am delighted that SFDA regulatory approval has been secured enabling AKSIA Healthcare to begin activities to secure wide adoption of the
SAFIRA™ system across Saudi Arabia. This is a proud moment for myself and my co-inventors.”
The technology has received positive feedback from clinicians across the globe who have used the pioneering technology. A multi-centre Post Market Clinical Follow Up (PMCF) Study has been completed and results will be published later this year which will help to further demonstrate the
potential patient safety and cost optimisation benefits of the SAFIRA™ system.
As regional anesthesia can deliver benefits for both patients and healthcare providers, demand for such procedures continues to grow steadily, and SAFIRA™ has the potential to make a significant impact, including in the Middle East. In Saudi Arabia in 2020 there were just under 3,500 practicing
anesthesiologists (1) 1 and research conducted in 2012 showed 88% of anesthesiologists in Saudi Arabia were practising regional anesthesia on a daily basis (2). The global ultrasound guided regional anesthesia market is growing and is forecast to register a CAGR of 5.8% through to 2028 (3).