Power Medical Interventions Inc. Chief Executive Michael Whitman doesn't let little things like product delays or lack of profitability get in the way of his plans to sell shares of the medical device company to the public.
The company's PLC 60 linear stapler, which had been expected in 2006, was delayed almost nine months because of design flaws and problems getting parts, the Langhorne, Pa.-based company said in a filing today with the Securities & Exchange Commission.
"Our ability to generate revenue from the PLC 60 staplers that we have placed in hospitals since December 2006 has been adversely affected due to the unavailability in 2007 of certain reload cartridges for the device," the filing said.
A recent FDA inspection also found instances where Power Medical failed to properly process customer complaints. Some of the FDA's "inspectional observations" had also been observed in previous inspections by the agency, the company said
"Whether the FDA will accept our response is uncertain, particularly in light of the similar nature of the current inspectional observations to the previous observations," the company said, adding that the company recently hired a senior vice president of regulatory affairs and quality assurance and has engaged a consultant who has noted that the company is making improvements.
Power Medical, which has an accumulated deficit of $150.9 million as of June 30, also has found "material weaknesses" in its financial reporting that need to be fixed. The company expects to lose money through at least next year.
