liberDi Receives FDA Regulatory Clearance for its Digital Dialysis System
liberDi Ltd., a portfolio company of The Trendlines Group, has received FDA clearance for its Digital Dialysis Clinic, allowing patients to perform home dialysis independently with physician monitoring. This advancement aims to improve the quality of life for dialysis patients, who often spend significant time in clinics. The system has demonstrated safety and effectiveness in clinical studies involving 42 subjects and is positioned to disrupt traditional dialysis methods. The technology leverages telemedicine for enhanced patient care.
- FDA clearance enables launch of Digital Dialysis Clinic in the US, enhancing market potential.
- Clinical studies confirm safety and effectiveness, indicating a reliable product.
- Innovative system designed to improve patient independence and quality of life.
- None.
Potential to become the standard of care for home peritoneal dialysis.
MISGAV, Israel, Jan. 4, 2023 /PRNewswire/ -- liberDi Ltd., a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Digital Dialysis Clinic, which allows patients to perform dialysis at home or at the workplace, by themselves, monitored by their physician using the advanced telemedicine capabilities of the system.
liberDi CEO, Hezkiah Tsoory remarked, "Receiving FDA clearance for our state of the art Digital Dialysis Clinic technology, is a huge achievement for liberDi. This is a big step forward in liberDi's journey to improve the quality of life of people on dialysis. liberDi's system is designed to provide these patients with ease of use, freedom of movement, automatic catheter connection flush technology and patient monitoring, while performing their daily dialysis activities from the comfort of their home or workplace. liberDi frees people from spending half of their lives in dialysis centers, which is a disruptive technology in the dialysis market."
One out of ten people in the world experience kidney disease. In advanced stages of the disease, dialysis is the most common treatment. Dialysis is a life-support treatment which extends average life expectancy by 5 – 10 years[1]. Approximately
liberDi conducted two initial clinical studies to demonstrate the safety and effectiveness of the Portable Peritoneal Dialysis system on patients requiring dialysis. Forty two subjects used the system for dialysis under the supervision of three medical centers in Israel. The studies' results endorse that liberDi's Digital Dialysis Clinic is safe to use and feasible for an automatic PD exchange. liberDi also performed a human factor validation study evaluating all user groups: people requiring dialysis and their caregivers, as well as healthcare professionals such as nephrologists and dialysis nurses. The study simulated a real-world environment and proved that anyone can operate the system following a single 90 minute proper training session.
liberDi's Chairman, Mr. Caroll Neubauer, former CEO of B. Braun USA, added: "We're excited to start 2023 with FDA clearance allowing liberDi to bring its Digital Dialysis Clinic to the US market to improve treatment as well as the quality of life to dialysis patients and their families."
Professor Edwina Brown, President of the International Society for Peritoneal Dialysis and Professor of Renal Medicine, Imperial College London, said, "This represents an exciting development for peritoneal dialysis and is the first for some years. It makes at-home peritoneal dialysis easier and quicker (due to the pump in the device), and with remote monitoring available for the dialysis center it will make dialysis at home more accessible for the many people globally who develop kidney failure. The team developing liberDi should be congratulated."
About liberDi
liberDi provides mobility and freedom to people on dialysis, allowing them to continue with their normal private and professional activities while on dialysis. liberDi was founded in 2014 at the Trendlines Group Incubator in Israel and is led by a team of world-class scientists, engineers, nephrology experts and industry leaders.
[1] Dialysis | National Kidney Foundation (https://www.kidney.org/atoz/content/dialysisinfo#:~:text=Life%20expectancy%20on%20dialysis%20can%20vary%20depending%20on,care%20of%20yourself%20and%20stay%20healthy%20on%20dialysis.)
Photo - https://mma.prnewswire.com/media/1977125/liberDi_IDA_device.jpg
Contact Information
Hezkiah Tsoory, CEO liberDi
hezkiah@liberdi.com
Phone +972-4-8228090
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SOURCE liberDi
FAQ
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