ADVENT ACCESS COMPLETES CE MARK SUBMISSION FOR av-GuardianTM

Singapore, Sept. 20, 2018 (GLOBE NEWSWIRE) --  

Singapore, 20 September 2018 – Advent Access (Advent), one of Singapore’s most innovative medtech companies, today announced that it has completed the regulatory submission and key audits for the CE Mark in the European Union (EU) for its award-winning av-Guardian^TM technology. The submission represents a significant step towards commercialisation of av-Guardian^TM.

The av-Guardian^TM is the world’s first medical implant to pioneer the concept of having a “guardian guide-door” for dialysis needles to enter a specially created dialysis vein, an arteriovenous fistula (AV fistula), without the implant being in contact with the vein. AV fistulas are widely recognised as the “lifeline” through which hemodialysis patients gain access to their blood for cleaning via a dialysis machine.

Hemodialysis is administered to patients with end stage renal disease (ESRD). In the US alone, it is estimated that nearly 500,000 patients with ESRD depend upon hemodialysis¹ with total Medicare expenditure of US$26.7 billion in 2015². Providing reliable access to the AV fistula remains one of the most stressful and challenging parts of hemodialysis. Moreover, during this usually painful procedure many complications can often arise, leading to inadequacy of the treatment or damage to the AV fistula lifeline. Advent’s av-Guardian ^TM aims to engineer a high-quality tissue track to enable reliable and less-painful vascular access to the AV fistula such that dialysis therapies can become more comfortable and effective.

Earlier in 2018, Advent completed the analysis of av-Guardian‘s first clinical study. The results have been submitted as part of the CE Mark dossier and will be presented at an internationally-renowned scientific congress later in 2018. Advent is currently conducting a second clinical study to evaluate the potential for av-Guardian^TM to assist in self-cannulation and, ultimately, to enable more patients to benefit from home or self-hemodialysis.

Peh Ruey Feng, Founder and Chief Executive Officer of Advent Access, said: “Filing for CE registration ahead of our initial schedule marks an important milestone in Advent Access’ approach to disrupting dialysis modality for patients with kidney failure globally. We are excited by the potential of av-Guardian^TM to be the solution for one of the biggest unmet needs in the provision and advancement of hemodialysis – ensuring easy and reliable use of an AV fistula to improve patient outcomes and comfort.”

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About Advent Access

Advent Access is a medical technology startup focused on end-stage renal disease management. Founded on the principles of Stanford Biodesign and as a spin-off from A*STAR, Advent Access’ mission is to pioneer innovations to significantly reduce dialysis cost and restore quality of life for kidney failure patients. Advent Access’ first product is the av-Guardian™ - an award-winning implant technology that aims to improve vascular access reliability, enable less-painful self-cannulation and in the long run, potentially reduce vascular access surgeries or hospitalizations. The av-Guardian^TM forms a key component of Advent Access’ dialysis-machine agnostic platform to transform hemodialysis to be performed independently, safely and more affordably. Centered around the patient, the av-Guardian^TM and the self-care platform seek to enable labour-light dialysis to be delivered in novel or alternative care environments. For more information on Advent Access, please visit www.adventaccess.com

¹ United States Renal Data System (USRDS). 2017 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017.

² https://www.usrds.org/2017/view/v2_09.aspx

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