NEWTOWN SQUARE, Pa., Oct. 23, 2018 /PRNewswire/ -- Kibow Biotech is proud to announce its 21st year of operations as a pioneer with the use of Pro/Prebiotics in people with failing kidneys. Kibow has been participating and exhibiting at the annual meeting of the American Society of Nephrology being held from Oct 22–28, San Diego, CA. https://www.asn-online.org/education/kidneyweek/2018/meeting-overview.aspx. In this event, the company's personnel interact and update development with nephrology professionals on the crucial role of the gut-kidney connection, dysbiosis, and modulation of the Gut Microbiome with its innovative "Enteric Dialysis®" technology. Although marketed and sold in the USA and several other countries as a dietary supplement product, Renadyl™ is the first and only kidney health supplement with its proprietary and patented Probiotics/Prebiotics formulation researched and developed with the type of rigor applied to drug development for Kibow's revolutionary "Enteric Dialysis®" technology concept.
Recently, a new program has been initiated called "KIDNEYX". This program, established in April 2018, is a joint public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN). As per KidneyX, "approximately 17 percent of adults in the U.S. have Chronic Kidney Disease (CKD). About 700,000 of these cases have progressed to end-stage renal disease (ESRD), with over 500,000 people requiring chronic dialysis to survive, and 200,000 people have received kidney transplants. CKD and especially ESRD are debilitating, often drastically reducing the quality of life of people living with kidney diseases. Despite the high cost of dialysis treatment, these patients' 5-year life expectancy is worse than that of most cancer patients. Kidney transplantation can extend lifespan and improve quality of life, but the number of kidney donations does not come remotely close to meeting the current demand. Treatment of chronic kidney disease and end-stage renal disease is costly for the Federal government: Medicare alone spends more than $64 billion each year to care for people with CKD and an additional $34 billion to care for people with ESRD".
According to KidneyX announcement "For the past 50 years, advances in treatments for kidney diseases and kidney failure have been modest, with few significant innovations reaching people who live with kidney diseases. Several barriers may be limiting kidney health innovation, including 1) lack of capital, 2) risks associated with early-stage research and development, and 3) low levels of meaningful input from other medical, scientific, or technological fields."
For more information, please refer to the following two links - http://www.kidneyx.org/ and https://www.hhs.gov/idealab/kidneyx/rfi1/
With 21 years of R&D and clinical trial expertise, Kibow Biotech's vision is to provide an inexpensive, convenient, oral kidney health supplement that could be useful for over 300 million people suffering from CKD worldwide. Preliminary consumer 3rd biennial survey data looks promising, showing not only an arresting of the decline of GFR, but stabilization and also in majority of cases increased GFR, in all stages of kidney disease when used in conjunction with an individual's standard care of therapy (https://pdfs.semanticscholar.org/f267/4584f3257878731e71b06823c6363a8bfb53.pdf). Recently, an independent commentary by the chief R&D scientist of Kibow titled - Reality of "Enteric Dialysis ®" with Probiotics and Prebiotics to Delay the Need of Conventional Dialysis has also been published in the Journal of Nephrology and Therapeutics - https://www.omicsonline.org/open-access/reality-of-enteric-dialysis--with-probiotics-and-prebiotics-to-delay-the-need-of-conventional-dialysis-2161-0959-1000319.pdf.
For additional validation, and in order to provide evidence sufficient to justify medical reimbursement of its kidney health supplement product, the company is planning to conduct a multi-site randomized controlled clinical study for a period of two years in USA and possibly in other countries also. Slowing the progression of CKD with an inexpensive alternative technology can help reduce the healthcare cost for patients both during dialysis and before initiation of dialysis.
This kind of multi-site clinical trial that includes a well-established kidney function endpoint (https://www.kidney.org/news/new-endpoints-ckd-clinical-trials-gaining-traction-regulators) will ultimately pave the way for acceptance of the kidney health supplement by all healthcare professionals, caregivers and payers. Use of such products would significantly reduce the healthcare cost of treating CKD worldwide.
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.
About Uremic Toxin Reduction Technology – also known as "Enteric Dialysis®": Kibow's novel "uremic toxin removal technology" addresses the diffusion of various uremic toxins into the bowel as a consequence of failing kidney function. The Company's patented and proprietary dietary supplements, Renadyl™ (for humans) and Azodyl® for cats and dogs with moderate to severe kidney failure (a veterinary formulation licensed to Vetoquinol http://www.vetoquinolusa.com/) consists of a combination of three specific probiotic microbial strains and chosen prebiotics.
Kidney health supplement with a pharma-like validation: Kibow Biotech is not a pharmaceutical company. Kibow products are not drugs and may not be considered as a treatment nor 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. These include but are not limited to the possibility that Renadyl™ may not reduce levels of uremic toxins in each and every individual, due to differences that exist between individuals that cannot be controlled such as genetics and lifestyle factors, as well as environmental factors that would include proper storage of the product and conditions of transport of the product in the chain of commerce. 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.
Investor & Media Contact: Terrence O. Tormey - CEO (610) 353-5130 or Email: [email protected]
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Recently, a new program has been initiated called "KIDNEYX". This program, established in April 2018, is a joint public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN). As per KidneyX, "approximately 17 percent of adults in the U.S. have Chronic Kidney Disease (CKD). About 700,000 of these cases have progressed to end-stage renal disease (ESRD), with over 500,000 people requiring chronic dialysis to survive, and 200,000 people have received kidney transplants. CKD and especially ESRD are debilitating, often drastically reducing the quality of life of people living with kidney diseases. Despite the high cost of dialysis treatment, these patients' 5-year life expectancy is worse than that of most cancer patients. Kidney transplantation can extend lifespan and improve quality of life, but the number of kidney donations does not come remotely close to meeting the current demand. Treatment of chronic kidney disease and end-stage renal disease is costly for the Federal government: Medicare alone spends more than $64 billion each year to care for people with CKD and an additional $34 billion to care for people with ESRD".
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According to KidneyX announcement "For the past 50 years, advances in treatments for kidney diseases and kidney failure have been modest, with few significant innovations reaching people who live with kidney diseases. Several barriers may be limiting kidney health innovation, including 1) lack of capital, 2) risks associated with early-stage research and development, and 3) low levels of meaningful input from other medical, scientific, or technological fields."
For more information, please refer to the following two links - http://www.kidneyx.org/ and https://www.hhs.gov/idealab/kidneyx/rfi1/
With 21 years of R&D and clinical trial expertise, Kibow Biotech's vision is to provide an inexpensive, convenient, oral kidney health supplement that could be useful for over 300 million people suffering from CKD worldwide. Preliminary consumer 3rd biennial survey data looks promising, showing not only an arresting of the decline of GFR, but stabilization and also in majority of cases increased GFR, in all stages of kidney disease when used in conjunction with an individual's standard care of therapy (https://pdfs.semanticscholar.org/f267/4584f3257878731e71b06823c6363a8bfb53.pdf). Recently, an independent commentary by the chief R&D scientist of Kibow titled - Reality of "Enteric Dialysis ®" with Probiotics and Prebiotics to Delay the Need of Conventional Dialysis has also been published in the Journal of Nephrology and Therapeutics - https://www.omicsonline.org/open-access/reality-of-enteric-dialysis--with-probiotics-and-prebiotics-to-delay-the-need-of-conventional-dialysis-2161-0959-1000319.pdf.
For additional validation, and in order to provide evidence sufficient to justify medical reimbursement of its kidney health supplement product, the company is planning to conduct a multi-site randomized controlled clinical study for a period of two years in USA and possibly in other countries also. Slowing the progression of CKD with an inexpensive alternative technology can help reduce the healthcare cost for patients both during dialysis and before initiation of dialysis.
This kind of multi-site clinical trial that includes a well-established kidney function endpoint (https://www.kidney.org/news/new-endpoints-ckd-clinical-trials-gaining-traction-regulators) will ultimately pave the way for acceptance of the kidney health supplement by all healthcare professionals, caregivers and payers. Use of such products would significantly reduce the healthcare cost of treating CKD worldwide.
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.
About Uremic Toxin Reduction Technology – also known as "Enteric Dialysis®": Kibow's novel "uremic toxin removal technology" addresses the diffusion of various uremic toxins into the bowel as a consequence of failing kidney function. The Company's patented and proprietary dietary supplements, Renadyl™ (for humans) and Azodyl® for cats and dogs with moderate to severe kidney failure (a veterinary formulation licensed to Vetoquinol http://www.vetoquinolusa.com/) consists of a combination of three specific probiotic microbial strains and chosen prebiotics.
Kidney health supplement with a pharma-like validation: Kibow Biotech is not a pharmaceutical company. Kibow products are not drugs and may not be considered as a treatment nor 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. These include but are not limited to the possibility that Renadyl™ may not reduce levels of uremic toxins in each and every individual, due to differences that exist between individuals that cannot be controlled such as genetics and lifestyle factors, as well as environmental factors that would include proper storage of the product and conditions of transport of the product in the chain of commerce. 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.
Investor & Media Contact: Terrence O. Tormey - CEO (610) 353-5130 or Email: [email protected]
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