20.04.2005 15:18:00

Orthofix Introduces Two, Next-Generation Bone Growth Stimulators

Orthofix Introduces Two, Next-Generation Bone Growth Stimulators


    Business Editors/Medical Editors

    HUNTERSVILLE, N.C.--(BUSINESS WIRE)--April 20, 2005--

    "Always Innovating" Orthofix is the Only Company That Can Offer a Full Range of FDA-Approved Stimulation Products for Healing the Cervical and Lumbar Spine as Well as Long Bone Non-Unions

    "These new products required a stringent, 23-month pre-market approval (PMA) process and offer strong evidence that we are focused on becoming the acknowledged leader in bone growth stimulation." -- Charles Federico, Group President and CEO

    Orthofix International NV (NASDAQ: OFIX) today announced that it has begun introducing two, next-generation bone growth stimulation products--Physio-Stim(R) and Spinal-Stim(R).
    "We expect the ongoing success of our stimulation product family to be further enhanced by the launch of these next-generation products for the lumbar spine and long bone non-unions, creating additional momentum attributable to the success that our newly FDA-approved Cervical-Stim product is having. Indeed, we are very pleased with our strong first-quarter sales, fueled primarily by a significant expansion of the year-over-year growth rate of our spinal stimulation product family," said Charles Federico, Group President and Chief Executive Officer of Orthofix.
    "The spine stimulation market is estimated by orthopedic industry analysts to be about a $205 million market in 2005. With the addition of the next-generation stimulation product for the lumbar spine, along with our recently approved cervical spine product, Orthofix has significant competitive advantages in the marketplace for bone growth stimulators," added Federico. "We believe these competitive advantages will empower Orthofix to increase its current 38 percent share of the total spinal stimulation market and, consequently, we expect our 2005 growth rate to exceed the current market growth rate in this area.
    "Regarding our new Physio-Stim's potential, Frost & Sullivan estimates that there are about six million bone fractures per year in the U.S., and approximately five percent of them--or 300,000 fractures--will be non-unions and not heal without intervention. These non-unions are prime candidates for our next-generation Physio-Stim bone growth product," added Federico. (Frost & Sullivan's 2005 U.S. forecast for the 'long bone external stimulation' market is $175 million.)

    Features and Benefits of the Next-Generation Physio-Stim(R) and Spinal-Stim(R) Devices

    Rechargeable Power Source

    The next-generation Physio-Stim(R) and Spinal-Stim(R) are powered by a rechargeable 11.1 volt lithium ion battery pack rather than a disposable lithium primary 9-volt battery. The rechargeable battery pack is a convenience for the patient: a battery capacity symbol indicates a 'battery low' condition as well as a fully discharged battery. When the patient sees this symbol, he/she simply plugs the recharger unit (supplied with the device) into the control unit and then into a standard wall outlet.

    Superior User Interface

    With the Liquid Crystal Display (LCD), a patient can receive more information pertinent to his/her treatment--e.g., time remaining in the treatment session, battery capacity, specific treatment functions, call for service, etc. An audible alarm accompanies the LCD.

    Printed Circuit Assembly

    The next-generation Physio-Stim(R) and Spinal-Stim(R) devices have the drive circuit and microcontroller on a single pc board. This increases energy efficiency and enables a rechargeable battery. (From a manufacturing standpoint, this change reduces part count, assembly time and cost.)

    Customized Software Functions

    The next-generation devices can be programmed specific to patients' individual treatment protocols.
    For more information about the next-generation Physio-Stim(R) and Spinal-Stim(R) devices, as well as Cervical-Stim(R), please call Orthofix Customer Service (800-527-0404) or visit www.orthofix.com.

    About Premarket Approval (PMA)

    Pre-market approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application in order to obtain marketing clearance. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee's recommendation on whether FDA should approve the submission. (Source: U.S. Food and Drug Administration, Center for Devices and Radiological Health)

    About Orthofix International, N.V.

    Orthofix international N.V., a global diversified orthopedic products company, offers a broad line of minimally invasive surgical, as well as non-surgical, products for the spine, reconstruction, and trauma market sectors that address the lifelong bone-and-joint health needs of patients of all ages--helping them achieve a more active and mobile lifestyle. Orthofix's products are widely distributed around the world to orthopedic surgeons and patients--via Orthofix's sales representatives and its subsidiaries, including Breg, Inc., and via partnerships with other leading orthopedic product companies, such as Medtronic Sofamor Danek and Kendall Healthcare. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, the Cleveland Clinic Foundation, Innovative Spinal Technologies and National Osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com.

    Forward-Looking Statements

    This news release contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix, and are based on management's current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the integration of the businesses of Orthofix and Breg, unanticipated expenditures, changing relationship with customers, suppliers and strategic partners, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, changes to governmental regulation of medical devices, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the orthopedic industry and the economy and other factors described in the most recent report on Form 10-K and other periodic reports filed by Orthofix with the Securities and Exchange Commission.

--30--GK/bo*

CONTACT: Orthofix International, N.V. Group President and CEO Charles W. Federico, 704-948-2600 or CFO Thomas Hein, 704-948-2600

KEYWORD: NORTH CAROLINA INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL MEDICAL DEVICES PRODUCT SOURCE: Orthofix International, N.V.

Copyright Business Wire 2005

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