- analyzing the market opportunity trends
- restructuring the gaps in the support of technology development
- bringing the technology position current with the regulatory bodies in Asia and the United States
- strengthening the product manufacturing options for both drug manufacturing and supplement manufacturing as well as shelf life extension
- contributing to the clinical development
- understanding where best to focus our US efforts
- building our human and financial resources in the short and medium term
- Consolidate and supplement the clinical position and initiate clinical studies for defining an FDA regulatory pathway
- Define and clarify the dietary supplement introduction and positioning for temporary marketing opportunities
- Integrity and security of manufacturing options as well as subsequent stability increases and defining a Drug Master File (DMF)
- Enhance and strengthen the proprietary and patent position
- Develop a Five Year Strategic Plan of product, technology, merger opportunities, partnering opportunities and financial planning
Dietary Supplement and Combination PlatformWe have developed the immediate commercial strategy on a limited basis and under local area specific arrangements. With pilot launch information from Asia and the US, we are planning a new corporate website presentation for BTI and a new launch of the Sugardown web site. This same approach will be leveraged in other markets in Asia and in North America with careful coordination with our regulatory compliance so we do not jeopardize our position with the FDA for future approvals. In parallel, we are evaluating the performance and capabilities of all of the current global distributors to determine the best way to support and to develop the measurement and feedback tools to ensure a common message. In addition, we are bringing resources to ensure support and feedback to and from pending sales and deliveries to our Asian collaborators. We have made our first significant shipment since corporate restructuring to Korea in November. Integrity of Manufacturing While the Korea opportunity presents immediate revenue, our focus for the past three quarters has been the manufacturing process. Specifically, we have developed procedural documentation of raw materials and the manufacturing process and have ensured the processing is compliant with the cGMP (Current Good Manufacturing Practices) rules. We have secured new patent positions. We have funded marketing material support. We completed a study and process to meet shelf life requirements. We created a convenient packaging for portability and ease of use since the greatest effectiveness is established with consumption of a tablet just prior to a food intake. In addition, the special manufacturing supply for clinical trial has been characterized with appropriate documentation and consistency and are needed prior to the start of patient enrollment. The final leg of this section is the plan for a GMP (Good Manufacturing Practices) manufacturer for the future drug product. This effort has led us to work with a new contracted partner for cost effective manufacture in China and/or India.
Patent and Proprietary PositionsWe have added to our patent portfolio in both the polysaccharide area and in the oxygen carrier positions. With the conclusion of our clinical trial and with the partnering explorations, we have worked with counsel and have advanced the proprietary positions with issued patents and with new disclosures from the clinical programs. The immediate effect on post meal blood glucose is now possible to reflect and measure by the emerging continuous blood glucose monitors reaching approval in the market from Abbott, Dexcom, Medtronics and others. Integrity of a Five Year Strategic Plan We believe the case for and agent for the immediate reduction in post meal glucose spikes has emerged as a very important aspect to the management of metabolic diseases and conditions such as pre-diabetes. The ability to reduce sugar uptake and thus reducing the system glucose blood increases in the immediate term is a superior therapeutic approach to systemic drug exposure where sugar levels are high and under constant drug reduction effects systemically. This approach and effect has opened the opportunity to a prevention scheme and thus addresses a significantly larger market with low risk of hypoglycemic events. The population of the pre-diabetics is also on the rise and is increasingly recognized as a condition to be addressed with a high level of urgency to prevent full blown diabetes. The urgency is being fueled by obesity and unhealthy lifestyle throughout the world. Prevalence is accelerating especially in large, emerging economies such as India and China with the economic burden of diabetes and pre-diabetes. Focus is shifting from treating to prevention and thereby expands the already significant market for our inclusion in the diet and exercise regimen. We have rearranged the product and the company focus to consumer-awareness and to immediate response effect so as to demonstrate a unique and early on reflection of taking self care and self management feedback.
We have taken these findings and overhaul of the organization to reframe the group and to assess and grow the relationships that contribute to a solid foundation for growth. This has allowed us to explore and advance in some activities toward the merging of technologies and to increment capital raises in preparation for the addition of staff.In conjunction with the product development, we are actively exploring strategic partnerships with third parties who can help to develop the market opportunities and provide resources to access customer segments which would otherwise be out of reach. These and many other exciting developments are being pursued in earnest, so that we fully exploit the potential of our technologies and create lasting value for our shareholders. I look forward to updating you on our progress and thank you for your on-going support. Best Regards,Carl W. RauschCEO, Boston Therapeutics Inc About Boston Therapeutics, Inc. Boston Therapeutics, headquartered in Lawrence MA, (OTCQB:BTHE) is an innovator in designing compounds using complex carbohydrate chemistry. The company's product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including: BTI-320, a non-systemic chewable therapeutic compound designed to reduce HbA1c. More information can be found on www.bostonti.com. Forward Looking StatementThis press release includes forward-looking statements. These statements may be identified by words such as "feel," "believes," expects," "estimates," "projects," "intends," "should," "is to be," or the negative of such terms, or other comparable terminology. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements contained herein. Factors that could cause actual results to differ materially include, but are not limited to: our limited operations and need to expand in the near future; risks associated with obtaining regulatory approval of our products; the ability to protect our intellectual property; the potential lack of market acceptance of our products; potential competition; our inability to retain key members of our management team; our inability to raise additional capital to fund our operations and business plan; our ability to continue as a going concern; our liquidity and other risks and uncertainties and other factors discussed from time to time in our filings with the Securities and Exchange Commission ("SEC"), including our annual report on Form 10-K filed with the SEC. Boston Therapeutics expressly disclaims any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law. Contact: Boston Therapeutics, Inc. Carl Rausch CEO Phone: 603-935-9799 Email: email@example.com www.bostonti.com