Escalon(R) Announces FDA 510(k) Clearance For Sonomed MASTER-VU(TM) B-Scan System

Main Category: MRI / PET / Ultrasound
Also Included In: IT / Internet / E-mail;  Eye Health / Blindness;  Regulatory Affairs / Drug Approvals
Article Date: 04 Jan 2008 - 0:00 PDT

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Escalon Medical Corp. (Nasdaq Capital Market: ESMC) announced that its Sonomed, Inc. subsidiary received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MASTER-VU(TM) ophthalmic B scan ultrasound system. The MASTER-VU(TM) System consists of a B scan probe that can be interfaced to a standard personal computer (via a USB cable connection) using Sonomed's proprietary software, thereby converting the personal computer into an ophthalmic ultrasound system. Sonomed plans to commence shipments of the product in the United States immediately.

Barry Durante, Sonomed's President stated: "The FDA clearance, along with the previously received CE certification, will allow Sonomed to market this new breakthrough instrumentation worldwide. With computers becoming standard in most ophthalmic physician offices, purchasing the probe and software offers complete portability for use in multiple locations. Loading the software in computers in multiple offices allows the physician to carry only the probe from office to office. We expect that the MASTER-VU(TM) will be a valuable addition to our product line in both the U.S. and international marketplace."

The MASTER-VU(TM) System adds to Escalon's wide range of top quality and market leading ultrasound systems. This flexible and easy-to-use instrument offers simple installation, low maintenance and immediate user productivity. The MASTER-VU features include:

-- Measurement calipers for multiple intraocular measurements.

-- Ability to save both 30-second "clips" as well as individual frames on a scrolling frame manager.

-- On-screen annotation capability, including text and graphics.

-- Easy installation and low maintenance.

Sonomed, Inc. is a diagnostic ultrasound company specializing in the design, manufacture and distribution of instruments for ophthalmology. Sonomed is focused on providing quality instrumentation for ophthalmic physicians' offices, clinics and hospitals.

Founded in 1987, Escalon develops markets and distributes ophthalmic diagnostic, surgical and pharmaceutical products as well as vascular access devices. Drew Scientific, which operates as a separate business unit, provides instrumentation and consumables for the diagnosis and monitoring of medical disorders in the areas of diabetes, cardiovascular diseases and hematology, as well as veterinary hematology and blood chemistry. Escalon seeks to utilize strategic partnerships to help finance its development programs and is also seeking acquisitions to further diversify its product line to achieve critical mass in sales and take better advantage of Escalon's distribution capabilities, although any such partnerships or acquisitions may not occur. Escalon has headquarters in Wayne, Pennsylvania and manufacturing operations in Long Island, New York, New Berlin, Wisconsin, Dallas, Texas, Waterbury, Connecticut and Barrow-in-Furness, U.K.

This press release contains statements that are considered forward- looking under the Private Securities Litigation Reform Act of 1995, including statements about Escalon's future prospects. They are based on Escalon's current expectations and are subject to a number of uncertainties and risks, and actual results may differ materially. The uncertainties and risks include whether the Company is able to:

-- implement its growth and marketing strategies, improve upon the operations of Escalon's business units, including the integration of Drew's and MRP's operations, the reorganization of the Drew business and the integration of any acquisitions Escalon may undertake, if any, of which there can be no assurance

-- implement cost reductions

-- generate cash

-- identify, finance and enter into business relationships and acquisitions.

Other factors include uncertainties and risks related to:

-- new product development, commercialization, manufacturing and market acceptance of new products,

-- marketing acceptance of existing products in new markets

-- research and development activities, including failure to demonstrate -- clinical efficacy

-- delays by regulatory authorities, scientific and technical advances by Escalon or third parties

-- introduction of competitive products

-- third party reimbursement and physician training, and -- general economic conditions.

Further information about these and other relevant risks and uncertainties may be found in Escalon's report on Form 10- K, and its other filings with the Securities and Exchange Commission, all of which are available from the Commission as well as other sources.

Escalon Medical Corp.
http://www.sonomedinc.com