NEWTOWN SQUARE, Pa., April 21, 2017 /PRNewswire/ -- One of the world's prominent meetings in nephrology, the ISN World Congress of Nephrology is being held in Mexico City, Mexico from April 21st-25th (https://www.wcn2017.org/). Kibow has been participating at this bi-annual event since 2005 held successively in Singapore, Hong Kong, Milan, Rio De Janerio, Vancouver, Cape Town, and this year in Mexico City. Concurrently, Kibow Biotech is also attending the NKF Spring Clinical Meeting in Orlando, Florida (https://www.kidney.org/spring-clinical). Kibow Biotech will be an exhibitor at both of the events, putting its revolutionary concept of Enteric Dialysis® on display. Throughout Kibow's 20 years of operations, the company has gained an industry-leading understanding of modulating the gut microbiome to maintain healthy kidney function.
The Cleveland Clinic has recently announced its list of Top 10 Medical Innovations for 2017 (http://www.cleveland.com/healthfit/index.ssf/2016/10/cleveland_clinic_unveils_its_t.html), the #1 innovation being the utilization of the gut microbiome to prevent, diagnose, and treat disease. Kibow Biotech's flagship product Renadylä, is a dietary supplement known for its ability to target and reduce the accumulation of uremic toxins in the body, thus maintaining healthy kidney function. Recent studies have pointed out that hemodialysis or peritoneal dialysis are unable to remove several aromatic uremic toxins generated by gut dysbiosis, as these aromatic toxins are protein bound (http://www.kidney-international.org/article/S2157-1716(15)32213-9/pdf). Renadylä maintains healthy kidney function by removing dysbiosis conditions within the human gastrointestinal tract, resulting in the generation of less aromatic uremic toxins which cannot be removed with hemo/peritoneal dialysis. Such a revolutionary mechanism of action has not been widely explored by researchers and nephrologists alike.
Kibow Biotech is also proud to announce the planning of a major clinical trial (RCT) called "Hope Study," which is designed to reinforce the company's pharmaceutical-like validation with the multi-site pragmatic (logical and reasonable) randomized control trial. This trial will further document and support Renadyl'sä structure-function claim of "maintaining healthy kidney function," via a primary endpoint outlined by the NKF and FDA of reducing the decline of GFR by 30% (40% is preferred) (http://www.ajkd.org/article/S0272-6386(14)01183-4/abstract). The trial will also support the overwhelmingly positive results seen in SF-36 questionnaires assessing Renadyl'sä effect on quality of life in those taking the dietary supplement (http://www.kibowbiotech.com/pdfs/2014-Review-of-health-status-and-level-of-satisfaction-of-customers-with-CKD-using-RENADYL-results-of-a-survey.pdf). In addition to reinforcing Renadyl'sä known benefits, Kibow Biotech will be exploring Renadyl'sä impact on the reduction of the protein-bound aromatic uremic toxins which are not removed during hemo/peritoneal dialysis.
Kibow Biotech is currently exploring the option of advancing Renadylä to a prescription dietary supplement status, which could potentially qualify for medical reimbursement (similar to that of prenatal vitamins, and enteral nutrition products, etc.). By completing a large scale multi-site clinical trial with positive results and a strong statistical power, Kibow Biotech will gain higher acceptance by healthcare professionals and patients alike. As a reimbursable dietary supplement, Renadylä will have an immense business potential in the United States. Simultaneously, this product will be cost effective, convenient, and efficacious, for patients worldwide where little or no facility of hemo/peritoneal dialysis exists.
Forward-looking statements: This press release contains forward-looking statements that reflect management's current views of future events, including the status of development of the dietary supplement formulation, Renadyl™, for kidney health in the USA and the possibility of its approval as a drug in some other countries according to respective governmental authorities. Kibow Biotech is not a pharmaceutical company. Kibow products are not drugs and may not be considered as a treatment or a therapy. The dietary supplement formulation of Renadyl™ is not meant to cure, prevent or mitigate any disease. Actual results may differ significantly from the above forward-looking statements due to a number of factors including but not limited to the possibility that Renadyl™ may not prove to be safe or show evidence of clinical activity in each and every individual due to various environmental or genetic factors. Other factors that could cause or contribute to differences in actual results include, but are not limited to, whether or not the Company or any of its collaborators will be able to develop drug pathway using the technologies of the Company, whether the cash resources of the Company will be sufficient to fund operations as planned; reliance on key employees, especially senior management; the uncertainty of the Company's future access to capital; the risk that the Company may not secure or maintain relationships with collaborators, and the Company's dependence on intellectual property. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.
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