OCEANSIDE, CA--(Marketwire - January 07, 2013) - Therapeutic Solutions International, Inc. (OTCQB: TSOI) announced today the completion of approval of its AMPSA products with Brazil's National Health Surveillance Agency ("ANVISA") for immediate sale into the Brazilian market.
"The completion of our regulatory process with ANVISA will allow TSOI to begin product distribution in Brazil," stated Tim Dixon, CEO of Therapeutic Solutions International, Inc. "Entering the large Brazilian market is the first step in our anticipated expansion across South America."
"There are approximately 340,000 dentists in the country of Brazil. This large base of dentists will provide the company with an outstanding opportunity for distribution of our AMPSA products in Brazil contrasted to the approximate 115,000 general dentists in the United States," said Dixon.
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is a global manufacturer of the chairside anterior midpoint stop appliance (AMPSA) devices marketed internationally under the trade names Migran-X® and AMPSA CS®, which have helped countless patients prevent debilitating migraine and tension headache pain, bruxism, clenching, grinding, and TMJ disorders. The Migran-X® and AMPSA CS® devices are the most effective non-drug US FDA cleared dental method of migraine prevention on the market today. Dentists fit the AMPSA devices on patients for the treatment of medically diagnosed migraine pain, as well as migraine associated tension-type headaches, in order to reduce their migraine signs and symptoms through the reduction of trigeminally innervated muscular activity, and to prevent bruxism and TMJ syndrome through the reduction of trigeminally innervated muscular activity. In clinical trials reviewed by the US FDA, 82% of medically diagnosed migraine sufferers using the Migran-X device averaged a 77% average reduction of migraine events in the first eight weeks of use. Successful outcomes are produced by reducing head, neck and jaw muscle contraction intensity by nearly 70%.
Therapeutic Solutions International also licenses laboratories to manufacture and sell semi-custom AMPSA devices internationally. We are also a provider of continuing education programs in the United States focused on AMPSA devices. We do not sell AMPSA products in the United States. Our corporate website is www.therapeuticsolutionsint.com. Non-US dentists and physicians can order our AMPSA products at www.ordertsoi.com.
The institutional purpose of the agency is to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. The latter embraces premises and manufacturing processes, as well as the range of inputs and technologies concerned with the same. In addition, the Agency exercise's control over ports, airports and borders and also liaises with the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance.
Safe Harbor Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to the need for further financing, our exit from the US market for AMPSA products in 2013, the need to procure additional international distributors, direct competition beginning in 2013, reliance on key personnel, possible introduction of new product lines, and other specific risks set forth in our SEC filings. To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Readers are advised to review our filings with the Securities and Exchange Commission that can be accessed over the Internet at the SEC's website located at www.sec.gov.