A collaboration between IAG, Image Analysis Group, the University of Leeds, and Prof. Francesco Del Galdo brings a new AI-driven endpoint into clinical trials.

For immediate release: 21 October 2022

Digital Artery Volume Index (DAVIX©) is a novel quantitative MRI-based scoring for the assessment of the blood flow in the arteries.

DAVIX© has been validated as a predictor of the onset of Digital Ulcers in Systemic Sclerosis patients. This innovative methodology is based on the Time-of-Flight Magnetic Resonance Imaging (MRI) angiography and allows to quantitatively assess digital arterial blood flow.

Thus, predicting the onset of Digital Ulcers (DUs) in Systemic Sclerosis (SSc) patients.

The methodology was developed as part of IAG’s DYNAMIKA cloud platform and is now accessible for use in clinical trials and clinical practice for research use. DAVIX© is being deployed by biotech and pharmaceutical companies in global clinical trials as a surrogate outcome measure of SSc vascular disease activity.

This robust methodology can be delivered to clinical sites, with over 100 imaging sites around the world already acquiring the specific MRI data to allow for the assessment of SSc patients with DAVIX©.

“DAVIX© is the first MRI quantitative measure of vascular disease in Systemic Sclerosis. Building on its predictive value for active vascular disease, it is now tested in randomised clinical trials as stratification tool for vascular disease and as a surrogate endpoint for vasoactive interventions,” said Professor Francesco Del Galdo, University of Leeds.

The proprietary name of the endpoint DAVIX© has been copyrighted by the University of Leeds, with a lifetime licence assigned to IAG, Image Analysis Group.

“We look forward to seeing how this unique endpoint will help accelerating the speed of pharmaceutical R&D and most importantly improve therapeutic success for patients,“  said Dr. Olga Kubassova, CEO of IAG, Image Analysis Group.

Neointima proliferation results in vascular wall thickening and gradual loss of luminal patency and is a key pathological feature of Systemic Sclerosis. It is a recognised culprit pathological lesion in Digital Ulcers pulmonary hypertension and renal crisis.

“We are delighted with the results of this collaboration. DAVIX© fits perfectly with IAG’s suite of advanced Artificial Intelligence (AI)-supported imaging methodologies and our strategy to make DYNAMIKA™ the leading image management platform for forward thinking drug developers, “ said Simon Hart, IAG’s Bio-Partnering Director.

“IAG’s has brought technical capabilities and over 15 years of operational experience helping to optimize and standardize DAVIX© in clinical trials. This is a great compliment to all IAG’s teams involved into developing and deploying our Artificial Intelligence methodologies, across hundreds of globally distributed clinical sites, built on our DYNAMIKA™, IAG’s proprietary secure cloud based medical image management and review platform, “ added Prof. Jamshid Dehmeshki, CTO of IAG.  

About IAG, Image Analysis Group

IAG, Image Analysis Group is a unique partner to life sciences companies, leading AI-powered drug development and precision medicine. IAG leverages expertise in medical imaging and the power of DYNAMIKA™ – our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner. IAG provides early drug efficacy assessments, smart patient recruitment, and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes. IAG bio-partnering takes a broader view on asset development bringing R&D solutions, operational breadth, and radiological expertise via risk-sharing financing and partnering models.

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Image Analysis Group to Provide Imaging Strategy and Advanced Imaging Analytics in Support of MIMEDX’s Knee Osteoarthritis Clinical Trial Program

MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts and IAG, Image Analysis Group, a strategic bio-pharma imaging expert announce a partnership in the development of MIMEDX’s mdHACM.

The IAG team has significant experience in using medical imaging to support drug development.

‘We have significant evidence that mdHACM injected into the knees of people with OA provides lasting pain relief and improves function, and we believe it has potential as a DMOAD. MIMEDX has discovered how to preserve the remarkable healing properties of placental membranes when we produce mdHACM, and we have demonstrated that it contains many proteins that influence the biology of cartilage-forming cells and reduce inflammation. We believe these active proteins contribute to the striking, long-lasting benefits we have seen in patients receiving a single injection of mdHACM into their osteoarthritic knee. Following an extensive review and selection process, we are very excited to have world-class partners who are at the forefront of advancing meaningful medicines; working in collaboration accelerates our ability to gather quality data for our future Biologics License Application (BLA), and our potential to bring tremendous benefit for people living with OA.’ said Dr Robert B. Stein, M.D., Ph.D., MIMEDX President, Regenerative Medicine & Biologics Innovation.

About Image Analysis Group (IAG):

IAG, Image Analysis Group is a unique clinical development partner to life sciences companies. We broadly leverage our proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development. www.ia-grp.com

About MIMEDX: 

MIMEDX is a transformational placental biologics company, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental tissue engineering, we have both a commercial business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION^® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments.

For more information, please reach out to: imaging.experts@ia-grp.com