Dec 1 2009
Stem Cell Therapy International Inc. (/exchange>/exchange>>/>OTCBB/exchange>>/>>/>>/>: SCII) announced that it has signed an agreement with Histostem Ltd. of South Korea ("Histostem"), for the exclusive, worldwide rights to the distribution of the Company's existing SteMixx line of stem cell based cosmetic products, as well as future products under development. Previously available for purchase only in Korea, SteMixx received approval last month from the Korean FDA as an effective cosmetic for the treatment of aging skin.
Stem Cell Therapy International will seek similar product validations from regulatory agencies in the United States and Europe and expects to begin distributing SteMixx products in the United States in early 2010.
David Stark, President and CEO of SCII, commented, "This distribution agreement, combined with the Korean FDA's approval of product labeling, is an extremely favorable development in our Business Plan. This is an important building block that enables Stem Cell and Histostem to confidently move forward with international opportunities to grow the business in advance of the final closing of our merger. The worldwide cosmeceutical market is estimated at $21 billion, and SteMixx is an established cosmetic product now validated by the Korean FDA for an extremely lucrative segment of that market. We look forward to introducing SteMixx in other markets around the world."
Andrew J. Norstrud, Chief Financial Officer of Stem Cell, added, "This agreement provides us with the opportunity to validate the effectiveness of SteMixx according to accepted international standards and we believe our team's combined 30 years experience in international regulatory affairs positions us well to create protocols for the study of this product that will meet the rigorous certification criteria of the U.S. and European regulatory agencies. We intend to study the active ingredients of SteMixx with the goal of developing a line of products that best utilizes its proprietary agents. Our involvement as the exclusive distributor of SteMixx adds to the momentum created by the recent approval of Histostem patents in the U.S. and E.U. and we expect to finalize our merger in the near term."
In October of this year, Histostem received a U.S. patent for the isolation of stem cells for therapy, a method central to obtaining one of the primary ingredients for the development and manufacturing of the SteMixx facial cream, as well as for previous and anticipated future clinical trials of stem cell therapies. Histostem also received an E.U. patent for the isolation of stem cells from live media, the first patent ever awarded for this unique method. The patented method is used to isolate stem cells directly from a freshly donated cord blood sample, greatly enhancing the immediacy and point-of-care possibilities for patients seeking treatment with stem cells derived from a non-controversial source.
David Stark added, "We are currently evaluating the optimal distributing partners for SteMixx, which is expected to be a high-end luxury brand sold through department stores and other superior retail venues."
Source:
Stem Cell Therapy International, Inc.