Coronado Industries Enters Final Leg of Pre-FDA Approval; Six-Month Modified Study Protocol for PNT Device to Begin.FOUNTAIN HILLS, Ariz.--(BW HealthWire)--Oct. 18, 1999-- Coronado Industries Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:CDIK) (www.coronadoindustries.com) Monday announced it is currently working closely with the Food and Drug Administration to modify its Pneumatic Trabeculoplasty (PNT PNT Point PNT Paint (MacPaint graphic file format) PNT Patient PNT Pentagon (Washington, DC; US DoD) PNT Positioning, Navigation and Timing PNT Prime Number Theorem PNT Phenytoin (TM)) study protocol. The company plans to begin a six-month revised study soon and anticipates positive results during this final phase of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval process. "Of course we are excited with the progression and we are eager to move forward with the extended study. We feel this extension represents a significant milestone for our company, and for all those professionals that have played such an important role in this team effort," said Gary Smith, president of Coronado Industries. Coronado Industries, through its two wholly owned subsidiaries Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. American Glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). and Ophthalmic International, manufactures devices to treat forms of glaucoma and offers glaucoma diagnosis and treatment under an I.D.E. Study (Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and ). Pending FDA approval, Coronado will license its patented treatment procedure and equipment in the United States. Coronado's Pneumatic Trabeculoplasty (PNT(TM)) procedure uses a non-invasive, patented, low-cost pneumatic device that has proven to be an effective and safe treatment option for glaucoma. In December 1998, Coronado was granted a CE Mark from the European Commission, which serves as a "passport" to allow a manufacturer to freely sell its products within the European marketplace. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement The statements contained in this release which are not historical are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, including, but not limited to, certain delays beyond the company's control with respect to market acceptance of new technologies and products, delays in testing and evaluation of products, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. |
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