Vivance, formerly AWAK Technologies, has announced the successful completion of a pre-pivotal trial for its wearable peritoneal dialysis (PD) device, Viva Kompact. The trial, conducted at Singapore General Hospital (SGH), evaluated the device's performance and safety when used independently by patients in their home environments.
The results from the trial will be presented at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, offering insights into the device's efficacy and patient experience. A/Prof. Marjorie Foo, the Principal Investigator and Senior Consultant, Department of Renal Medicine, SGH, will present the findings during oral sessions at Kidney Week.
Key Findings from the Trial
The pre-pivotal trial involved ten patients who were able to independently use the Viva Kompact device and successfully complete at least one week of dialysis in their homes. According to Vivance, no device-related serious adverse events were reported during the trial period.
"Completing this trial is a momentous achievement for our team, patients and healthcare professionals who are equally passionate about advancing kidney care to the next level," said Suresha Venkataraya, CEO of Vivance. "We are excited to share our findings, which we believe will contribute significantly to advancing the possibility of dialysis anytime, anywhere."
Viva Kompact: A Potential Game-Changer in Kidney Care
Viva Kompact is a wearable peritoneal dialysis device designed to offer patients greater flexibility and independence in managing their kidney disease. The device received US Food and Drug Administration (FDA)'s breakthrough device designation in 2019 following the completion of the First-in-Human clinical trial.
The wearable design aims to address the limitations of traditional dialysis methods, which often require patients to spend significant time in dialysis centers. By enabling dialysis to be performed at home, Viva Kompact has the potential to improve patients' quality of life and reduce the burden on healthcare systems.
Future Directions
Vivance plans to continue developing and refining Viva Kompact, with the goal of making it a widely available treatment option for patients with kidney disease. The company is also showcasing Viva Kompact along with other products at booth #829 during the ASN Kidney Week.
"We thank all collaborators, especially our clinical advisors, who made the pre-pivotal trial of this FDA-designated breakthrough device possible," said Mandar Gori, Chief Business Officer of Vivance.
