LANGHORNE, Pa., May 27, 2009 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (OTCBB:PMII), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that the U.S. Food and Drug Administration (FDA) has cleared its 510(k) application for marketing its iDrive Intelligent Power Unit(tm), detachable Intelligent Surgical Instruments and iConsole(tm). Based on the marketing clearance by the FDA, Power Medical Interventions (PMI) intends to launch the iDrive, Intelligent Surgical Instruments and iConsole products for commercial sale, effective immediately.
A first-of-its-kind breakthrough in operating room instrumentation, the iDrive is designed to support a variety of minimally invasive procedures by offering surgeons a broad range of cutting and stapling configurations combined with increased flexibility, access and precision. The iDrive is a novel hand-held, computer-controlled power unit to which any of the company's Intelligent Surgical Instruments can be attached. This innovation allows all of PMI's Intelligent Surgical Instruments to be driven by a single power unit. As a result, hospitals will be able to acquire PMI's advanced technology platform at less than half of the current cost, which may lead to significant savings for hospitals. The potential now exists for a comprehensive surgical solution that may be significantly less expensive than manual surgical stapling devices. In addition, the iDrive is reusable, easy to use, cost effective, and less wasteful, potentially leading to savings for hospitals and health networks.
The iConsole is a proprietary wireless device that communicates directly with the iDrive 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.
The iDrive and iConsole combination represents a dynamic technology solution which is designed to enable the incorporation of important functional enhancements. PMI intends to aggressively pursue and implement a variety of key enhancements, which ultimately could lead to offering surgeons the world's first wireless computer mediated platform with unprecedented capabilities such as wireless video processing, Internet access, a patient record interface and controlled tissue compression software.
"The iDrive and iConsole are the latest examples of Power Medical Interventions' commitment to pioneering continued innovation in the surgical arena. These instruments will deliver critical advantages to surgeons offering single handed use, flexibility, and access to remote anatomical sites. PMI's Intelligent Surgical Instruments have applications in open surgery, minimally invasive surgery and the emerging field of natural orifice translumenal endoscopic surgery (NOTES)," said Michael Whitman, president and chief executive officer of PMI. "At the same time, these new instruments are designed to reduce healthcare costs and improve hospitals' operational efficiency. Our hospital customers will now be able to acquire PMI's advanced stapling technology at a greatly reduced cost. The iDrive/iConsole combination offers a single power unit to drive all of our Intelligent Surgical Instruments, eliminating the need to purchase multiple power units. The cost savings is passed along to our hospital customers. Furthermore, the reusable and autoclavable nature of these instruments plays a key role in helping to reduce medical waste, offering additional meaningful benefits to our hospital customers."
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, the ability of the Company's products, including the iDrive Intelligent Power Unit(tm), detachable Intelligent Surgical Instruments and iConsole, to achieve broad market acceptance; the Company's ability to raise additional capital; the Company's ability to restructure its debt; the possibility of incurring additional losses in the foreseeable future; 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 comply with the covenants of its 7% Senior Convertible Secured Notes; the Company's inability to satisfy the requirements of the FDA 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 Report on Form 10-Q for the quarterly period ended March 31, 2009 and Annual Report on Form 10-K 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.