U.S. FDA 510(k) Submission

Jul 6, 2022 | Uncategorized




Oxford Tech Company Adaptix Submits US Regulatory Clearance for Transformational Diagnostic Product

New Medical Imaging Product Delivers Affordable 3D Imaging at the Point-Of-Care

OXFORD, U.K., Jul 06, 2022 – Medical imaging technology company Adaptix Limited (Adaptix) has submitted a 510(k) application to the U.S. Food and Drug Administration for its first medical imaging product, allowing the company to begin marketing its Point-of-Care 3D orthopedic system in the United States.

Adaptix, based at Oxford University Science Park, has developed novel technologies that allow affordable, low-dose 3D imaging at the Point-of-Care using Digital Tomosynthesis (DT), to provider quicker, more accurate diagnosis possibilities.

2D X-ray is currently the world’s dominant diagnostic modality, but frequently results in inconclusive reads due to areas of clinical interest being obscured by overlying and underlying tissues. This leads to diagnostic “misses” and delays, additional referrals for an “over-read”, and excessive and expensive escalation to Computer Tomography (CT) or MRI, as well as potentially the unnecessary immobilisation of a limb for a patient waiting diagnosis.

CT provides a more sensitive 3D image but at a far greater cost in terms of money, time and radiation dosage to the patient. Access to CT is also more limited particularly in some countries or regions, resulting in delayed diagnosis and extended travel by the patient.

Mark Evans, Adaptix’s CEO, stated, “This is the first of many innovations that Adaptix is excited about bringing to medical markets. The U.K. is the country that invented the first clinical CT and MRI scanners, and our new low-cost 3D imaging technology builds on the long-standing U.K. pedigree of innovation in medical imaging. We hope that our patent-protected technology will become even more widely deployed and that one day Adaptix’s technologies will touch the lives of everyone through medical and dental applications.”

There is a drive within healthcare systems towards a new diagnostics model where more facilities will be made available in free standing locations away from main hospital sites, to Regional Diagnostic Centres and even commercial and retail locations. This will support earlier diagnosis, greater convenience to patients and the drive to reduce health inequalities. Adaptix’s low-cost deployable 3D imaging will help change the location of service delivery within and beyond the hospital environment, and meet diagnostic needs faster and at a lower cost.

Adaptix already has active customers in the veterinary market with a low dose.

affordable 3D imaging system that is used by clinicians in first opinion practices. The orthopedic system will be offered to clinicians and payers on the ‘Pay-per-Study’ model accepted in the veterinary market. Like the veterinary system, the orthopedic system can run from a single-phase domestic power supply and requiring minimal radiation protection measures, further reducing the total cost to payers.

This is the first step in Adaptix’s mission to transform medical radiology by supplying affordable low-dose Point-of-Care 3D imaging to replace 2D X-ray and to do so using a non-standard business model. Further unmet clinical needs in the dental market (intraoral 3D) and hospital market (a portable 3D chest imaging system for Intensive Care Units, Emergency Departments and Primary Care applications) will be met by later products.

About Adaptix Limited

Adaptix Limited is transforming radiology through the development of innovative 3D imaging technologies. At the core of their patent portfolio and commercialization strategy is a distributed Flat Panel X-ray Source (FPS) system which has applications across a multitude of global markets that are currently limited to 2D X-ray imaging systems where cost, speed to diagnostic result, location or dose concerns mean CT is not optimal. Adaptix’s central mission is to transform radiology by offering affordable low-dose 3D imaging at the point-of-care and allowing “3D-first” as the standard of care.

The first of Adaptix’s medical offerings, the NeXt 3D-Ortho, enables fast, low-cost 3D imaging from a stationary source at a significantly reduced radiation dose and much lower cost than CT systems. Based in Oxford, England, Adaptix has fostered strategic partnerships in academic, medical research, and technology in support of their goal to make advanced 3D tomosynthesis more widely available to healthcare providers and their patients throughout the world. For further information, visit www.adaptix.com.

Hannah Lawrence-Lelitte (Assoc. CIPD) spent 10 years working as a senior Administrator for the University of Oxford and in HR and training roles across industries including publishing, environmental management and motorsport.

Hannah’s background is in Organisational Pyschology and she has a BSc in Psychology from the University of Surrey.

Martin Stofanko has a PhD in Immunology and MSc in Applied Genetics from University of Birmingham. Following Postdoctoral work at University of Cambridge he moved into industry in Brazil developing genetic tests for their low budget public healthcare system.

He is experienced in defining, executing and writing up quality assurance and technical documentations for IVDs and up to class IIa sterile MDs in the UK, Brazil and Germany. He has lead validation, external testing and transfer to manufacturing activities within company and outsourced abroad. He has established and extended ISO 13485 QMS from D&D to manufacturing, sales and distribution.

John has 30+ Years industry experience with a comprehensive background within Global Roles in Semiconductor, Electronics and Medical Device Industries.

Areas of expertise include, Start Up Operations, Programme and Performance Management, New Product Introduction and Product Outsource/Transfer.

Conrad Dirckx has a BA in Computer Science and PhD in MRI Imaging from Cambridge University as well as a master’s degree from the Ecole Centrale Paris in real-time computing. He has worked for GE Healthcare in their workstation, vascular x-ray and MRI business units and prior to joining Adaptix, spent 11 years working for Siemens in their molecular imaging division leading development projects for cardiology, neurology and oncology software products.

He is an APMP certified project manager who helped to pioneer the transition to lean/agile software development within Siemens MI.

Andy graduated with an Engineering Masters and boxing Blue from Oxford University, then gained Chartered Engineer status as a project manager while working for the Ministry of Defence. On the MOD Fast Stream, Andy gained corporate and leadership experience in a variety of strategic roles as well as leading counter terrorism teams in Iraq. Andy was awarded the Iraq medal and formally commended for changing the Coalition Forces campaign strategy.

Andy then went into leadership consulting & coaching (clients now diplomats & in No.10) and also moved into the commercial sector founding a film & TV company, raising finance and building relationships with the major studios. While he got the companies up and running Andy secured acting roles in Coronation Street and Emmerdale to help pay the bills.

Steve Wells spent 12 years developing medical devices for Siemens Molecular Imaging before joining Adaptix.

He has a PhD in Neuroscience, MSc in Medical Physics and a Natural Sciences degree from Cambridge. Prior to Siemens he worked as a software engineer on various commercial science projects.

Dr Siân Phillips MB,BCh MRCP FRCR is an experienced Consultant Radiologist based in South Wales.
She gained her undergraduate and postgraduate medical training in Wales. She has held several leadership roles during her career, including Associate Dean and Head of School at Health Education
and Improvement Wales; chair of Medical Imaging Sub-Committee and Imaging Essential Services Group, advising Welsh Government; and Clinical Director. As part of her active involvement in teaching and training, she has been involved in developing undergraduate curricula, been an FRCR examiner at the Royal College of Radiologists (RCR), and was instrumental in establishing and developing the National Imaging Academy, Wales. As a Fellow of the Royal College of Radiologists, she plays an active role in RCR activity.
Siân has extensive experience with Digital Tomosynthesis imaging in the general clinical setting. Her service was the first clinical department in the UK, second in Europe to introduce this innovative
technology. Her experiences with digital tomosynthesis she has shared widely, presenting at international conferences worldwide. She has sat on the Medical Advisory Board of GE Healthcare and acted as Medical Advisor to Adaptix for several years.

Adrian Crockett, BAcc, FCMA is a chartered management accountant who previously held the CFO position at Ocean Harvest Technology PLC where he helped raise £6m via an IPO, Thruvision PLC where he managed significant revenue growth towards £10m and at Venture Life PLC, an AIM listed consumer healthcare company where he was involved in the M&A of a number of businesses, participated in equity capital raises of over £25m and a revolving debt facility of similar with major UK & US banks. Before this he held senior financial management roles at Abbott Diabetes Care Ltd, a division of the US Healthcare company, Abbott, GSK & Novartis.

Sarah Small BSc, ACA is a Chartered Accountant with over 20 years’ experience of leading financial functions, including C-level experience within an AIM listed company.

Sarah has worked across a various number of industry sectors including digital marketing, retail, entertainment, education and construction. Sarah has a mathematics degree from Warwick University.