Precision Data.
Perfusion Insights.
WHY PERFUSION MATTERS
Tissue perfusion is the continuous flow of blood cells through microvascular blood vessels that feed oxygen and nutrients directly to every cell in our bodies.
A healthy level of tissue perfusion is needed for wound healing. In patients with Peripheral Arterial Disease ("PAD"), foot tissue perfusion levels can fall significantly as a result of atherosclerotic plaque buildup in blood vessels in our legs.
The narrowing of these blood vessels causes a condition called "ischemia", or insufficient blood flow. Critical limb threatening ischemia ("CLTI") represents the end-stage of this disease.
When patients with CLTI suffer an open wound on the foot, that typically becomes an ischemic chronic wound that cannot heal for months, sometimes years. The longer the wound remains open, the more likely the chance of infection, which in turn greatly increases the likelihood of tissue necrosis and consequent amputation. Time is of the essence in restoring higher levels of foot tissue perfusion.
The Problem With Current Standard of Care
Limited Angio Suite Guidance
In the angio suite, it's always a fine balance between avoiding unnecessary risk, versus being aggressive enough to achieve adequate increase in foot tissue perfusion for wound healing to take place.
Doctors need real-time quantitative perfusion feedback to finetune that balance, and make the right judgment calls while the patient is on-table.
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In angioplasty procedures to improve blood flow to ischemic feet, patients present with lesions/occlusions in multiple blood vessels, requiring the doctor to make on-table decisions that balance benefit vs risk.
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X-ray angiographic imaging is useful to locate the precise location of the lesions, but were never designed for, and cannot provide a quantitative perfusion readout. It cannot confirm that the opening of a lesion has led to a rise in foot tissue perfusion at the wound site.
Our PEDRA Xauron Perfusion System
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The first device to achieve real-time, deep-tissue perfusion monitoring on a quantitative index.*
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Granted Breakthrough Device Designation by FDA for treatment of critical limb ischemia.
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* Pre-approval product in clinical studies.
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Real-time perfusion feedback in <10 seconds.
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Up to 4 channels to assess perfusion changes across foot angiosomes.
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Portable, and VESA-compatible for use with rolling cart or pole platforms.
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Radiolucent sensors integrate seamlessly with angiographic imaging.
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Simple user interface approved by physicians and angio suite staff.
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Built-in battery permits continuous monitoring from angio suite to recovery room.
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Completely non-invasive; no need for contrast or other dye fluids.
Demonstrated Sensitivity To Periprocedural Perfusion Changes
For the first time, with advanced laser technology, we are able to give physicians real-time perfusion feedback that enables them to make the right decisions in the angio suite, for greater success in limb salvage.
Diagnosis: ABI
Intervention: X-Ray
Post-op Monitoring: ABI
ABOUT US
Our Management
Kareen Looi, CEO
MBA (Darden), LLB (NUS)
Kareen is a serial entrepreneur with over twenty years of startup leadership in vascular devices, raising over SGD20 million in startup funding from venture firms and angels. She was previously CEO-founder of Setagon, a US coronary stent company acquired by Medtronic. She has spoken on medtech entrepreneurship at Darden (University of Virginia), Singapore-Stanford Biodesign, INSEAD Singapore, National University of Singapore and Singapore Management University.
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Whye-Kei Lye, CTO
BSc, Physics (Caltech), MSc/PhD (Yale)
Whye-Kei is a serial inventor and entrepreneur, and previously CTO-founder of Setagon, a US coronary stent startup. He is Director of the SingHealth Intellectual Property Office, managing the IP portfolio of the largest chain of public hospitals and specialty clinical centers in Singapore. Previously, he served as the Director of Business Devt (Future Health Care) at Nanyang Technological University, to drive the translational development of drugs/therapeutics and medical devices. He has been an invited speaker and panel member on the topic of entrepreneurship and innovation at Singapore-Stanford Biodesign, National Healthcare Group, and Singapore General Hospital. He is an author of 13 publications and book chapters, and is an inventor on 31 patents and patent applications.
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Paul Hayes, CMO
MB ChB, MD
Paul served previously as a vascular and endovascular surgeon at Addenbrookes Hospital, NHS, in Cambridge, UK, as well as a Lecturer in Surgery at Cambridge University. He has undertaken a number of first-in-man aortic endovascular implantations, and subsequently trained physicians worldwide in the use of these techniques. In addition to this he has been the Chief/Principal Investigator for many multi-center clinical trials. He sat on the Council of the British Society of Endovascular Therapy for 8 years, was also a member of the Research Committee of the UK Vascular Society Council. He is an author of over 150 papers in peer reviewed journals.
Our Clinical Advisors - Singapore
Steven Kum, MD/MBBS/M.Med(Surg)
Steven is a vascular surgeon with fellowship training in endovascular interventions at Prince of Wales Hospital in Sydney, Park Hospital in Leipzig, Germany, and Universita Vita Salute San Raffaele in Milan, and a certified wound specialist phyisican. In addition to his practice at Mount Elizabeth Novena Hospital in Singapore, Steven serves as a Clinical lecturer at both Yong Loo Lin and Lee Kong Chian Schools of Medicine, and regularly proctors physicians on endovascular procedures in Europe and Asia. He is part of the organizing committee of LINC and VERVE. As a leading expert in percutaneous deep arterialization for no-option CLI, he is the PI or co-PI on many clinical studies and has authorship on numerous articles pertaining to this technique.
Our Clinical Advisors - US
Peter Schneider, M.D.
Dr Schneider is professor of surgery at UCSF. An MD from the Johns Hopkins School of Medicine, he was the founding member and chief of the Division of Vascular Surgery at Kaiser Permanente in Hawaii from 1994-2018, where he developed a Diabetic Limb Treatment Program, and was a pioneer in the build of an endovascular practice. Dr Schneider has served as National Principal Investigator for numerous clinical trials. He is a Fellow of the American College of Surgeons, Distinguished Fellow of the Society for Vascular Surgery, Fellow of the International Society of Vascular Surgery, a past president of Western Vascular Society and has authored several textbooks including Endovascular Skills (4th edn).
Campbell Rogers, MD
Campbell is the Chief Medical Officer of Heartflow Inc which has developed FFRCT technology for non-invasive determination of fractional flow reserve in coronary arteries. From 2006 to 2012, Campbell was concurrently Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, JNJ. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital in Boston. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, and has authored numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases.
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Our Clinical Advisors - EU
Vlad Alexandrescu MD, PhD
Vlad is Head of the General, Thoracic & Vascular Surgery Dept. of the Princess Paola Hospital, Luxembourg, Belgium, and a consultant in the Cardio-Vascular and Thoracic Surgery Department of the CHU Sart-Tilman Hospital, University of Liège. He is the leading authority in the angiosome model of perfusion for diabetic neuro-ischemic foot wounds. Author of numerous publications and books, he has organized many surgical, endovascular and multi-disciplinary meetings, specialist training sessions and workshops for the professionals in his field. He is an editorial board reviewer at the Journal of Endovascular Therapy, the Journal of Diabetes and Metabolism and the Journal of Cardiovascular Surgery.
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Marco Manzi, MD
Marco is the Director of the Interventional Radiology Unit of the Foot and Ankle Clinic at Casa di Cura Abano Terme in Italy. He is a leading practitioner in the treatment of critical limb ischemia, and developed the pedal plantar-loop technique as a new method for revascularization of foot vessels. Marco has published extensively on peripheral revascularization, and is a recognized voice in major international vascular conference. He has been a member of the scientific board for Abbott Vascular and Clearstream (supplier of angioplasty devices in Ireland), as well as a proctor for Boston Scientific and EV3.
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Clinical Case Studies
An advanced prototype of the Xauron device tested in a single-center observational study in Cambridge, UK, demonstrated both safety and ease of use in the angio suite.
Case Study 1: The PEDRA Blood Perfusion Index tracks real-time changes in foot tissue perfusion attendant with balloon inflation and deflation during an angioplasty procedure.
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Case Study 2: The large increase in PEDRA Blood Perfusion Index after a successful angioplasty correlates with the observation of a healed ulcer 8 weeks after intervention.
A 50-patient CLTI study is underway at Changi General Hospital in Singapore.