Golden, Colorado-April 30, 2019-Vitro Diagnostics, Inc. (OTCPK: VODG), dba Vitro Biopharma one of the world’s emerging biotechnology companies focused on allogeneic Mesenchymal Stem Cell (“MSC”) research and clinical products including AlloRx Stem Cells™, Brain Grow Technologies™ NutraVivo™ Stem Cell Activator, and the MSC-Gro™ Brand Stem Cell Culture Media has been awarded Certification to the International Organization for Standardization (ISO) Quality Standard 13485:2016 for medical devices.
This certification further strengthens Vitro Biopharma’s quality management system that is ISO 9001:2015 and CLIA certified. Regulatory certifications encompass our quality system, clinical diagnostics and cGMP manufacturing based on our commitment to attaining customer satisfaction and seeking continual improvement as a primary goal. We use risk assessment guidance, extensive control systems encompassing outside service providers, manufacturing, process & product validation, and new product development in the operation of our quality system. Vitro Biopharma is FDA-registered and operates within a broad regulatory umbrella and platform suitable for FDA-compliant drug/biologics and medical device manufacturing.
Vitro Biopharma is executing its business model based on supporting IRB-approved stem cell therapies in off-shore locations that are now yielding evidence of safety and efficacy. This goal requires compliance to internationally recognized standards such as ISO 9001 & ISO 13485 to gain clinical trial approvals in global medical tourism destinations. The recent IRB approval of our clinical trial entitled “Vitro Biopharma Allogeneic Mesenchymal Stem Cell Therapy for Musculoskeletal Conditions” in the Bahamas was facilitated by our ISO certification. Through our partner, DVC Stem, in Grand Cayman Island we provide AlloRx Stem Cells™ to support an IRB-approved trial determining the effects of MSC transplants on various inflammatory conditions. We provide our MSC-Gro™ stem cell culture medium to support clinical trials of MSC therapy for osteoarthritis (OA). These trials and several others totaling 2385 patients and pre-clinical studies in 20,000 animals provide evidence of safety and efficacy. In the US alone there are more the 30 million OA patients. The standard of care is joint replacement, but emerging evidence suggests that a single MSC injection into afflicted joints can regenerate cartilage, reduce pain, restore functionality and defer replacement at a fraction of the cost of joint replacement. We have gained preliminary evidence of safety and efficacy of AlloRx Stem Cell™ therapy of neurodegenerative diseases through clinical studies in New Zealand. Our regulatory certifications support further expansion into other medical tourism markets as well as clinical trials leading to US approvals. The FDA is in the process of adopting ISO 13485 as its quality standard for medical devices and full legal implementation is anticipated in 2020.
Dr. Jim Musick, CEO of Vitro Biopharma said, “We are extremely pleased with this milestone accomplishment as we have recently focused on achieving ISO 9001:2015, ISO 13485:2016 and CLIA certifications. This provides necessary support for our goal of suppling offshore medical tourism destinations with high quality AlloRx Stem Cells™ for various applications in regenerative medicine. AlloRx Stem Cells™ are distinctly superior to “stem cell” clinics operating in the US that are restricted to “minimally manipulated” products that contain limited stem cell content at very low purity and do not achieve international standards of stem cell definition. Adipose-derived allogeneic MSCs (Allofisel™) have been recently approved by the European Medicines Agency for treatment of a type of Crohn’s disease. These are expanded and purified stem cells that presently require pre-market FDA approval in the US as drugs. Offshore venues allow studies of expanded and purified MSCs wherein the identity, purity and potency are clearly established. Several clinical studies support the concept that adequate stem cell dosage is critical in determining therapeutic outcomes. There are variations in the known types of adult MSCs and our patent-pending AlloRx Stem Cells™ are superior to other known adult stem cells.”
About Vitro Biopharma
Vitro Biopharma, for over 10 years, has supplied major biopharmaceutical firms, elite university laboratories and clinical trials worldwide with Mesenchymal Stem Cells, MSC-Grow™ Brand of cell culture media, various stem cell derivatives and stem cell-derived differentiated cells. We also supply primary fibroblast cells and an expanding line of cancer-associated fibroblasts (CAFs) from various tumors including lung, breast, melanoma, pancreatic and colorectal tissues. Our CAFs are purchased by major pharmaceutical and biopharmaceutical firms to advance immunotherapy of cancer.
We now support clinical studies of stem cell therapies for osteoarthritis, neurodegenerative diseases including Parkinson’s disease, Multiple Sclerosis and Alzheimer’s disease while pursuing select US markets for stem cell therapies. We support high quality offshore medical tourism with the DaVinci Wellness Centre, our clinical trial partner in the Cayman Islands www.DVCStem.com.
We provide Brain Grow Technologies™ NutraVivo™ Stem Cell Activator that has been shown to induce proliferation, migration and epigenetic modification of human adult stem cells. NutraVivo™ improves overall cellular wellness and significantly increases expression of anti-aging genes.
We private label Limitless MD™ cosmetic products for topical applications in skin beautification.
About the International Organization for Standardization (ISO)
The International Organization for Standardization (ISO) (www.iso.org) is the world’s largest developer and publisher of International Standards. It is comprised of national standards bodies from 159 countries that promote high quality standards for all company processes. To meet ISO certification requirements for Quality Management Systems, companies must establish a well-tuned system of interacting processes that ensures consistent quality of the company’s products; their capacity to optimally meet customer requirements; and their fulfillment of all applicable regulatory requirements.
Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company’s auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain “forward-looking statements”. Such forward looking statements are identified by words such as “intends,” “anticipates,” “believes,” “expects” and “hopes” and include, without limitation, statements regarding the Company’s plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company’s products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company’s filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.
Dr. James Musick
Chief Executive Officer
(303) 999-2130 Ext. 1
Source: Vitro Diagnostics, Inc.