BUFORD, Ga.--(BUSINESS WIRE)--Theragenics Corporation® (NYSE: TGX), a medical device company serving the surgical products and prostate cancer treatment markets, today announced that Galt Medical (a wholly-owned subsidiary of Theragenics) has received U.S. Food and Drug Administration 510(k) clearance to market its Galt VTI™ valved tearaway introducer. Introducers are utilized for vascular access, with the Galt VTI expected to be utilized primarily for placing catheters.
The Galt VTI is a tearaway introducer which includes an ergonomic, low-profile, patent-pending integrated valve. The Galt VTI allows surgeons the ability to introduce or provide access for other medical devices to enter into a patient’s vascular system reducing the risk of an air embolism and leakage. The Galt VTI is a less bulky and a more compact design than similar products currently available. Galt is a leader in the tearaway introducer market, and the Galt VTI is expected to open up new market opportunities.
The addressable market in the United States for the Galt VTI is estimated to be approximately $14 million of annual sales, and growing at 5% annually. The Galt VTI is expected to be launched in the second half of 2012, with revenue in the range of $300,000 expected in this calendar year based on indications of interest from our customer base. Within twelve months of launch, we expect the Galt VTI to generate annualized revenue of $1 million to $2 million, with gross profit margins higher than currently being realized in the Company's Surgical Products segment.
“Both current and potential new customers have expressed significant interest in the Galt VTI product,” said M. Christine Jacobs, Chairman and Chief Executive Officer of Theragenics Corporation. “We expect this product to be a valuable addition to our current vascular access product platform, offering important new features along with the same high quality to which our customers are accustomed.”
Ms. Jacobs added, “The Galt VTI product is the most significant internally developed product released by our Surgical Products segment to date. We intend to continue to focus on the development of new products that can utilize the FDA 510(k) clearance process in all our business units. This is an important contributor to our growth, increased profitability and increased cash flow in our Surgical Products segment.”
Galt Medical is a wholly-owned subsidiary of Theragenics. The Galt business unit manufactures and distributes vascular access products, including introducers and guidewires used in interventional radiology, interventional cardiology and vascular surgery.
Theragenics Corporation (NYSE: TGX) operates two business segments: its surgical products business and its brachytherapy seed business. The surgical products business (www.cpmedical.com, www.galtmedical.com, www.needletech.com) manufactures and distributes wound closure, vascular access, and specialty needle products. Wound closure products include sutures, needles and other surgical products. Vascular access includes introducers, guidewires and related products. Specialty needles include coaxial, biopsy, spinal and disposable veress needles, access trocars, and other needle-based products. The surgical products segment serves a number of markets and applications, including, among other areas, interventional cardiology, interventional radiology, vascular surgery, orthopedics, plastic surgery, dental surgery, urology, veterinary medicine, pain management, endoscopy, and spinal surgery. Theragenics’ brachytherapy business manufactures, markets and distributes “seeds” used primarily in the minimally invasive treatment of localized prostate cancer. The Company’s brachytherapy product line includes its palladium-103 TheraSeed® device (www.theraseed.com), and its Iodine-125 seed devices. The terms "Company", "we", "us", or "our" mean Theragenics Corporation and all entities included in our consolidated financial statements. For additional information, call our Investor Relations Department at (800) 998-8479 or visit www.theragenics.com.
This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, the accuracy of which is necessarily subject to risks and uncertainties, including, without limitation, statements regarding expected revenue, profit margins, future growth, increased profitability and cash flow, and estimated market sizes. Actual results may differ materially due to a variety of factors, including, among other things, the timing and the ability to capitalize on opportunities for investment and growth within our surgical products business, risks and uncertainties related to competition within the medical device industry, development and growth of new applications within the medical device markets, competition from other methods of treatment, new product development cycles, effectiveness and execution of marketing and sales programs, changes in product pricing, continued acceptance of and demand for our products by the markets in which we operate, introduction and/or availability of competitive products by others, potential changes in third-party reimbursement, physician training, third-party distribution agreements, legislative changes to healthcare markets and industries such as the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (including provisions such as the medical device tax), uncertainties associated with forecasting demand for a new product, the development and pricing of competing products by competitors, uncertainties and unanticipated costs in connection with the manufacturing and marketing of the Galt VTI, and other factors set forth from time to time in our filings with the Securities and Exchange Commission.
All forward looking statements and cautionary statements included in this document are made as of the date hereof based on information available to us as of the date hereof, and we assume no obligation to update any forward looking statement or cautionary statement.