Since receiving FDA approval in 2001, Deflux® has enabled thousands of children to receive a highly effective, minimally invasive, same-day treatment for VUR. Deflux has revolutionized the treatment algorithm for VUR over the past two decades.
SANTA BARBARA, Calif. and STOCKHOLM, Sweden, Nov. 09, 2021 (GLOBE NEWSWIRE) — Palette Life Sciences, Inc., a fully integrated life sciences company dedicated to improving patient outcomes, today announced the 20th anniversary of Deflux in the United States, the only FDA-approved minimally invasive, highly effective treatment for vesicoureteral reflux (VUR).
VUR, sometimes referred to as urinary or bladder reflux, is a serious pediatric urinary condition in which urine refluxes from the bladder through one or both ureters and back toward the kidneys. This is due to an abnormality in the region where the ureter meets the bladder. Infected urine can reflux back into the ureters and, in severe cases, into the kidneys – which may lead to long-term kidney damage. VUR is associated with increased risks of urinary tract infection (UTI), renal scarring and reflux nephropathy.
Prior to the introduction of Deflux, there were only two treatment options for VUR – antibiotic prophylaxis and surgical ureteral reimplantation.1 Antibiotic prophylaxis can reduce the incidence of UTIs but has drawbacks, such as antibiotic resistance and poor adherence. Prophylactic antibiotics can treat the UTI symptoms of VUR but do not address the root cause of the disorder. Ureteral reimplantation has a high success rate but is an invasive surgical treatment option. This requires a much longer recovery time than treatment with Deflux.2
In 2001, the FDA approved Deflux in the US to correct VUR grades II-IV in children. Deflux has been widely used as a minimally invasive treatment for VUR ever since, providing a highly effective, non-surgical treatment alternative to long-term antibiotics. Deflux has been proven effective in up to 93% of patients, with no febrile UTIs (UTI accompanied with a high-grade fever) after one injection.3
Deflux is a gel made from two biocompatible polysaccharides (types of sugars) – Non-Animal Stabilized Hyaluronic Acid (NASHA®) and dextranomer (Dx) – and is used as a tissue bulking agent via injection around the ureteral opening. Deflux administration lengthens and bulks the ureter-bladder junction to prevent urine from flowing backward from the bladder through the ureters.
Deflux has been used in more than 400,000 VUR treatments globally. Children can return to normal activities the day after Deflux treatment. Deflux has revolutionized the way that VUR is treated.
Deflux was available through Nestlé Skin Health until 2018, when Palette Life Sciences entered into an agreement with Nestlé Skin Health to license worldwide commercialization and development rights for Deflux.
In 2019, Palette launched Deflux.com as a resource for VUR patients, caregivers, and healthcare providers.
In 2020, Palette expanded access to Deflux to more than 20 countries through five distributors and direct sales initiatives.
In June 2020, Palette demonstrated its deep commitment to education and research through the creation of the Deflux Learning Center, a comprehensive VUR and Deflux-related online resource center containing information, education, training, tools and resources, including The PedSpace podcast, educational videos and webinars, clinical articles and more. The Deflux website also has an easy-to-use physician locator that helps caregivers find and connect with physicians in their area who specialize in Deflux treatments.
In early 2021, Palette expanded the Deflux Learning Center across the globe, providing caregivers, pediatric urologists and the global pediatric urology community who treat VUR with an unprecedented valuable online training and education resource.
“When I consider my 20-year journey as one of the world’s leaders in the endoscopic treatment of reflux using Deflux, I am reminded about what makes a company successful – it’s the product and it’s the people. Palette Life Sciences has been very fortunate to have both of these critical ingredients. The personnel and resources available to help physicians care for so many children around the world is commendable,” said Dr. Andrew Kirsch, MD, FAAP, Professor and Chief of Pediatric Urology at Children’s Healthcare of Atlanta, Emory University School of Medicine, and Chief Medical Officer at Georgia Urology.
“For twenty years, Deflux has offered caregivers a minimally invasive VUR treatment option for their children while fulfilling the three main goals of VUR management as provided by the AAP: prevent febrile UTIs, prevent renal injury, and minimize follow-up and morbidity,” said Per Langö, CEO and Board President, Palette Life Sciences.
Deflux is a minimally invasive, outpatient procedure that has been proven safe and effective in children with VUR. Deflux is a gel made from two polysaccharides (types of sugars) – hyaluronic acid (HA) and dextranomer (Dx) – and is used as a tissue bulking agent that is injected inside the ureteral opening to prevent urine from flowing back up from the bladder through the ureters. Learn more at Deflux.com.
About Palette Life Sciences
Palette Life Sciences is a fully integrated life sciences company. Palette Life Sciences’ products improve patient outcomes in urology and urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures. The company’s portfolio of available products includes Deflux®, Barrigel®, Solesta®, and Lidbree™. Palette Life Sciences moves rapidly to leverage novel applications of existing technologies to create breakthrough medical solutions. This focus enables the company to serve those often overlooked by traditional medical companies and improve patient quality of life. Led by experienced healthcare executives, Palette Life Sciences is headquartered in Stockholm, Sweden, with offices in Santa Barbara, California, Dallas, Texas, and Sydney, Australia. Learn more at http://www.palettelifesciences.com.
1 Läckgren G, Cooper CS, Neveus T, Kirsch AJ. Management of Vesicoureteral Reflux: What Have We Learned Over the Last 20 Years? Front Pediatr. 2021 Mar 31;9:650326. doi: 10.3389/fped.2021.650326. PMID: 33869117; PMCID: PMC8044769.
2 Beaumont Health. Vesicoureteral Reflux (VUR). Available at: https://www.beaumont.org/conditions/vesicoureteral-reflux. Accessed November 1, 2019.
3 Kalisvaart JF, Scherz HC, Cuda S, Kaye JD, Kirsch AJ. Intermediate to long-term follow-up indicates low risk of recurrence after double hit endoscopic treatment for primary vesicoureteral reflux. J Pediatr Urol. 2012;8(4):359-365.
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Deflux® and NASHA® are registered trademarks.