LANGHORNE, Pa., April 28, 2009 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (Nasdaq:PMII), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that it has filed a 510(k) application with the United States Food and Drug Administration (FDA) requesting marketing clearance for the company's iDrive Intelligent Power Unit (IPU)(tm), detachable Intelligent Surgical Instruments and iConsole(tm) monitor. The company plans to launch the iDrive and iConsole products once 510(k) clearance is received from the FDA.
The iDrive IPU, a first-of-its-kind breakthrough in operating room instrumentation, is designed to support a variety of minimally invasive procedures. The iDrive IPU is a novel hand-held, computer-controlled power unit to which any of the company's Intelligent Surgical Instruments can be attached, offering surgeons a broad range of cutting and stapling configurations by providing increased flexibility, access and precision. In addition, the iDrive IPU is reusable, providing important efficiencies and cost savings for hospitals and health networks.
The iConsole is a proprietary wireless device that communicates directly with the iDrive IPU during surgical procedures to output specific auditory and visual reference information via its speaker and liquid crystal display. Outputs provide surgeons with important information regarding calibration, firing, and instrument and reload type, allowing surgeons to make real-time, critical decisions that may ultimately lead to an improved patient outcome. Furthermore, the iConsole can serve as a valuable data collection and reporting system with the potential to be integrated with inventory management systems and electronic medical records to improve operational performance for health care organizations, surgery centers and hospitals.
"We believe that the iDrive IPU and iConsole are two of the most powerful and sophisticated surgical instruments to be developed worldwide. Once commercially available, we expect these instruments to contribute significantly to the company's sales growth as they offer unique capabilities to support minimally invasive surgical procedures that are currently difficult, or not possible, with existing instruments. Additionally, we are excited about the potential role that the iDrive IPU, Intelligent Surgical Instruments and iConsole may play in enabling the emergence of natural orifice translumenal endoscopic surgeries (NOTES) which are conducted through the body's natural openings, minimizing incisions, pain and recovery time," said Michael Whitman, president and chief executive officer of Power Medical Interventions (PMI). "At PMI, we are dedicated to continuous innovation aimed at anticipating and addressing the evolving needs of today's surgeons. Today's milestones with regard to the iDrive IPU and iConsole are the latest demonstrations of PMI's leadership as a developer of the world's most advanced surgical instruments."
About PMI's Intelligent Surgical Instruments(tm)
PMI has developed a suite of state-of-the-art wireless Intelligent Surgical Instruments(tm) that are used by surgeons for cutting, stapling and tissue manipulation in a variety of procedures in open surgery, minimally invasive surgery (MIS) and in the emerging field of natural orifice translumenal endoscopic surgery (NOTES). PMI designed these first-of-their-kind devices to improve medical outcomes by offering superior consistency, repeatability, compressive force, access to anatomical sites, ergonomics and ease of use compared to conventional endomechanical devices. As a result, Intelligent Surgical Instruments have the potential to become the standard of care in an increasing number of procedures.
About Power Medical Interventions, Inc.
Power Medical Interventions is the world's only provider of computer-assisted, power-actuated surgical cutting and stapling products. PMI's state-of-the-art wireless Intelligent Surgical Instruments(tm) are revolutionizing and expanding minimally invasive surgery applications and enabling novel surgical procedures to benefit surgeons, patients, hospitals and healthcare networks. To learn more about Power Medical Interventions, Inc. and its products, please visit www.pmi2.com.
Safe Harbor Statement
Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements relating to the future financial performance of the Company are subject to many factors including, but not limited to, approval by the FDA of the Company's 510(k) application requesting marketing clearance for the Company's iDrive Intelligent Power Unit(tm), detachable Intelligent Surgical Instruments and iConsole, the Company's inability to raise additional capital; the possibility of incurring additional losses in the foreseeable future; the inability of the Company's products to achieve broad market acceptance; the Company's inability to further identify, develop and achieve commercial success for new products and technologies; the Company's difficulty in increasing production to provide customers with adequate supply; the Company's inability to improve gross margins; loss of the Company's key suppliers; the Company's inability to manage continued growth; inability to remediate the Company's internal weakness over financial reporting and achieve and maintain effective internal control over financial reporting; failure in the Company's training efforts; the risk of product liability claims connected with the use of the Company's products; adverse effects or risks relating to the Company's sales in international markets; the Company's inability to meet the requirements for continued listing on the NASDAQ Capital Market; the Company's inability to comply with the covenants of its 7% Senior Convertible Secured Notes; the Company's inability to satisfy the requirements of the U.S. Food and Drug Administration and other regulatory agencies; loss of key personnel; lack of third party coverage and reimbursement for the Company's products; risk of loss of the Company's key manufacturing facility, and other risks detailed in the Company's Securities and Exchange Commission filings, including the Company's Annual Report on Form 10-K, as amended, for the year ended December 31, 2008.
Such statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. When used in this press release the terms "anticipate," "believe," "estimate," "expect," "may," "objective," "plan," "possible," "potential," "project," "will" and similar expressions identify forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise.