Golden, Colorado—April 29, 2015 —Vitro Diagnostics, Inc. (OTCQB: VODG), dba Vitro Biopharma, announced expansion of manufacturing capacity based on a recent orders for bulk quantities of its MSC-Gro™ Brand of stem cell growth media. Increased demand comes from sales to stem cell researchers and a new customer who recently qualified our media for use in its clinical testing program. We have received our initial bulk order based on extensive evaluation of Vitro Biopharma’s clinical grade MSC-Gro™. The evaluation focused on safety/efficacy parameters and showed safety in animal studies and efficacy through MSC authentication including achievement of phenotypic and functional standards following expansion of human adipose-derived MSCs in MSC-Gro™. The function of MSC-Gro™ in cell expansion was extensively examined and showed that MSC-GroTM produced superior cellular yields than previously utilized products. Vitro Biopharma anticipates regular orders at levels requiring expanded manufacturing capacity since this customer is known to consume large quantities of media.
Vitro Biopharma is expanding its production capacity 5-fold and enhancing its quality control systems to ensure compliance with regulations for manufacturing of clinical products. Expansion of production includes acquisition of needed equipment and facility improvements necessary for manufacture of clinical materials. In addition, our operating team has been expanded to include enhanced expertise in biotechnology manufacturing and regulatory affairs. Erik Van Horn, BSChE, a founder and former director of Vitro Biopharma now provides technical expertise and consultation to the Company. Erik has 12 years prior experience at Amgen, Inc. including various positions related to manufacture of numerous FDA-regulated biological products. He now provides Vitro Biopharma with expert advice related to manufacturing and regulatory issues.
Dr. Jim Musick, Vitro Biopharma’s President & CEO, said, “We are pleased to announce expansion of our manufacturing capacity to fulfill customer needs for MSC-Gro™, especially for use in clinical studies. We provide various formulations of clinical grade media optimized for expansion of MSCs. These include serum-containing and serum-free formulations together with powdered versions that reduce shipping costs to international customers. Our current growth is fueled by strategic sales of our products and services. We are very pleased to achieve recognition of the superiority of MSC-Gro™ and look forward to expansion of MSC-Gro™ sales. Several other independent laboratories have also reported superior performance of MSC-Gro™ compared to other commercially available products. The new business described here was jointly negotiated with our primary product distribution partner, Neuromics, Inc that is headed by Mr. Pete Shuster, who recently resigned from our Board of Directors. We intend to maintain a significant distribution partnership with Neuromics and Pete Shuster as we go forward. Mr. Shuster resigned to allow replacement by a director with considerable experience in clinical studies and we have established relationships with clinicians that may evolve to new Board positions.”
About Vitro Biopharma
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG; http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro Biopharma also owns a pending patent for methods and materials related to treatment of neurological conditions by activation of neural stem cells. Vitro Biopharma’s mission is “Harnessing the Power of Cells™” for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern, GMP-compliant biotechnology manufacturing and R&D facility in Golden, Colorado. Vitro Biopharma manufactures and sells “Tools for Stem Cell and Drug Development™”, including human mesenchymal stem cells and derivatives, the MSC-Gro™ Brand of optimized media for MSC self-renewal and lineage-specific differentiation. Our cell lines also include cancer-associated fibroblasts (CAFs) and MSC-derived progenitor cells, including neural stem cells as well as a growing line of terminally differentiated cells: alpha-motor neurons, osteoblasts, chondrocytes, cardiomyocytes, etc. Vitro Biopharma maintains several strategic partnerships including an alliance with Neuromics, Inc. (www.neuromics.com). Neuromics, Inc. is a primary distributor of Vitro Biopharma products and a well established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems. Through Neuromics, Vitro Biopharma has also partnered with Dr. Josef Smarda in central Europe to provide products and services related to treatment of patients with autism, autoimmunity and other conditions.
Vitro Biopharma received the Frost and Sullivan Technology Innovation Leadership Award for the industry sector: Stem Cell Tools and Technology in North America, 2014.
Safe Harbor Statement
Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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. 3
Source: Vitro Diagnostics, Inc.