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Saturday, September 22, 2012 1:42:59 AM
Neuromics.....
During the current fiscal quarter ending July 31, 2012, the Company announced expanded business opportunities with Neuromics, Inc., a current distributor of the Company’s products. The additional opportunities include expanded sales of Vitro’s stem cell products as well as additional products that are perceived to enhance the competitive advantage of the Company’s existing MSC product line by combination with other third party products providing enhanced opportunities for customers, including clinical development of adult stem cell technology. Through evaluations that are ongoing, additional complementary products are being added to the Neuromics, Inc. product line. We anticipate further additional activities leading to expansion of revenue generation through our distribution agreement with Neuromics, Inc.
StemGenesis.....
We are also attended the International Society for Cellular Therapy during the present fiscal quarter and the business opportunities resulting from this have yielded another, separate agreement for distribution of the Company’s entire product line into certain Chinese provinces through StemGenesis, Inc, a stem cell company located in Qingdao, Shandong Province, China and with operations in the USA as well.
Vitropin......
The Company now has out-licensed two of its patents covering technology for the generation and purification of FSH, a hormone used to treat infertility. Management of the Company maintains close association with the licensee and is assisting the licensee to develop this business through establishment of distribution channels and related activities. We received a license fee in 2011 and are entitled to royalty payments from product sales. These activities are being accelerated since there has been substantial progress during the early portion of 2012 in the establishment of global distribution channels. Furthermore, the regulatory process of gaining approval to market these products has been advanced through the location of a manufacturing partner. This activity has led to the drafting of registration filings seeking marketing approval for Vitropin™, the Company’s highly purified urofollitropin product and related products in certain foreign countries by the licensee. Since the market for pharmaceutical treatment of infertility is estimated to be quite substantial, capture of even a small portion of the total market can have a positive impact to the Company’s financial position since royalty income is largely transferred to net income because of minimal associated expenses.
Differentiated cells.....
Product improvements during the present quarter have focused on our clinical grade MSC-Gro™ media and the addition of new stem-cell derived products including differentiated cells derived from the Company’s adult MSC cell lines. The latter products may be utilized for high throughput screening applications in new drug discovery & development and represent a consumable product since the differentiated cells are not capable of further proliferation. We have now introduced human MSC-derived chondrocytes and plan related additional line extensions during the fourth fiscal quarter of 2012. These cells are useful in the development of new drugs for the treatment of arthritis and osteo-arthritis.
510-K related......
The Company has defined and prioritized its stem cell product pipeline that is primarily designed to yield products for clinical testing of adult stem cells for various applications in injury/disease treatment and regenerative medicine. The products being developed are primarily medical devices and animal therapeutic products that have shorter and less expensive pathways to regulatory approval than new drugs or biologics. Medical devices receive FDA authorization by filing a request for marketing approval known as a 510K filing. This filing requires laboratory testing comparing the performance a new product with another similar product that has already received US FDA 510K approval without the necessity of clinical trials. The Company is presently focused on the development and 510K-filing of its clinical grade MSC-Gro™ media products. Management believes that there is a substantial market for such products in clinical development programs focused on human MSCs both in the US and abroad, including China where the Company now has an alliance partner, StemGenesis, Inc. The regulatory approval of medical devices in China is accelerated by prior FDA approval of a 510K filing, as the Company is planning.
Pipeline products under development......
Additional pipeline products include tools for in-vivo imaging of human MSCs and animal MSCs, including equine MSCs that are now in early stage development by the Company.
New patent application filed.....
The Company also filed a new US patent application covering its intellectual property related to the development of its MSC-based clinical products.
http://knobias.10kwizard.com/filing.php?param=&ipage=8478230&DSEQ=1&SEQ=&SQDESC=SECTION_BODY&exp=
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