Business
Adaptix secures 510(k) clearance from FDA
Adaptix secures 510(k) clearance from FDA.
About this update from Avingtrans Plc
30 January 2023 Avingtrans Plc ("Avingtrans" or the "Group") Adaptix secures 510(k) clearance from FDA Avingtrans PLC (AIM: AVG), which designs, manufactures and supplies critical components, modules, systems and associated services to the energy, medical and industrial sectors, announces that medical imaging technology associate company Adaptix Limited (Adaptix) has received 510(k) clearance from the U.S. Food and Drug Administration for its first orthopaedic medical imaging product. In 2021, Avingtrans invested £4m in Adaptix, for an 11.9% stake in the business and in December 2022 announced a further investment of £2m by means of a Convertible Loan. The Board of Adaptix has made the following announcement: Adaptix, based at Oxford University Science Park, has received 510(k) clearance for its first medical imaging product. The first Adaptix medical product is a Digital Tomosynthesis Orthopaedic imaging system. It is a portable, low-dose imaging system capable of delivering fast, lower-cost, X-ray imaging at the point of patient care. Developed specifically to offer 3D X-ray imaging of hands, elbows and feet at a fraction of the radiation dose and per-study price of traditional CT systems, the system provides clinicians with clearer images than 2D X-ray systems, offering advantages in terms of fewer acquisitions, accelerated patient workflow and enhanced diagnostic accuracy. Adaptix is already serving veterinary and industrial (Non-Destructive Evaluation) markets using its novel and patent-protected technologies. Receiving the 510(k) clearance is important as it is the first step in Adaptix delivering its mission to transform radiology through provision of innovative truly-portable 3D imaging technologies into healthcare providers. Mark Evans, CEO of Adaptix, commented: "We are delighted to receive the 510(k) clearance which allows this innovative technology, and our first medical product, to be marketed in the world's largest healthcare market. The team are energized by achieving this milestone, and we look forward to delivering enhanced orthopaedic DT imaging systems; a dental DT imaging system; and a chest DT imaging system for Intensive Care and Emergency Department use. We see a future where 3D travels to the patient at the point-of-care throughout hospitals, clinics and primary care transforming patient pathways, improving patient experience, and reducing the cost of care delivery." Enquiries: Avingtrans plc Roger McDowell, Chairman Steve McQuillan, Chief Executive Officer Stephen King, Chief Financial Officer 01354 692391 Singer Capital Markets (Nominated Adviser and Broker) Shaun Dobson Alex Bond Oliver Platts 02074 963000 IFC Advisory (Financial PR) Graham Herring Tim Metcalfe Zach Cohen 020 3934 6630 About Avingtrans plc: Avingtrans designs, manufactures and supplies original equipment, systems and associated aftermarket services to the energy, medical and industrial markets worldwide. Business units Hayward Tyler - Luton & East Kilbride, UK and USA, China and India Specialises in the design, manufacture and servicing of performance-critical motors and pumps for challenging environments. Energy Steel, Inc - Rochester Hills, Michigan, USA Energy Steel, part of the Engineered Pumps and Motors Division of Avingtrans plc, has been serving the nuclear power industry since 1982 with capabilities in equipment fabrication, material supply, precision machining, engineering, and repair services. Through strategic OEM partnerships, it also provides solutions for obsolete nuclear components and support for the most complex projects. Stainless Metalcraft Ltd - Chatteris, UK and Chengdu, China Provider of safety-critical equipment for the energy, medical, science and research communities, worldwide, specialising in precision pressure and vacuum vessels and associated fabrications, sub-assemblies and systems. Booth Industries - Bolton, UK Designs, manufactures, installs and services doors and walls which can be tailored to be: blast &explosion proof; fireproof; acoustically shielded; high security/safety; or combinations of the above Ormandy Group, Bradford, UK Design, manufactures and servicing of off-site plant, heat exchangers and other HVAC (heating, ventilation and air conditioning) products Composite Products Ltd - Buckingham, UK Centre for composite technology, parts and assemblies, serving customers in industrial markets. Magnetica Ltd - Brisbane, Australia Magnetica Limited specialises in the development of next generation MRI technologies, including dedicated extremity MRI systems and MRI system components. Magnetica has successfully built and tested a compact, integrated 3 Tesla orthopaedic MRI system, demonstrating clinical-quality imaging. Commercialisation of this system (and others) is on-going. Magnetica's structure now includes two other business units: Scientific Magnetics - Abingdon, UK Designs and manufactures superconducting magnet systems and associated cryogenics for a variety of markets including MRI and provides services for Nuclear Magnetic Resonance instruments. Tecmag Inc, Houston, USA Designs, manufactures and installs instrumentation, including consoles, system upgrades, and probes, mainly for Magnetic Resonance Imaging (MRI) and Nuclear Magnetic Resonance (NMR) systems.