879682--3/28/2008--PLC_SYSTEMS

related topics

{product, candidate, development}

{product, liability, claim}

{customer, product, revenue}

{stock, price, share}

{product, market, service}

{property, intellectual, protect}

{stock, price, operating}

{interest, director, officer}

{personnel, key, retain}

{control, financial, internal}

{operation, international, foreign}

{acquisition, growth, future}

We expect to incur significant operating losses in the near future. Our company may be unable to raise needed capital. If we are unable to raise additional capital during 2008, our common stock could be delisted from AMEX. Our company is currently dependent on one principal customer. We are dependent on Novadaq in the U.S. to attempt to increase our TMR revenues. Our company is currently dependent on one principal product line to generate revenues. Our company is dependent on certain suppliers. We are dependent upon our key personnel and will need to hire additional key personnel in the near future. In order to compete effectively, our current and future products need to gain commercial acceptance. Our newest product, RenalGuard, has only had limited testing in a clinical setting and we may need to modify it in the future to be commercially acceptable. Our planned future U.S. pivotal clinical trial to study the safety and effectiveness of RenalGuard in preventing contrast-induced nephropathy will take us a significant amount of time to complete, if we can complete it at all, and the results of this clinical trial may not show sufficient safety and efficacy for us to either obtain FDA approval or otherwise be able to successfully market and sell the product. We will need to build a direct sales and marketing organization or otherwise enter into one or more distribution arrangements in order to market our RenalGuard System in the U.S, if and when it is approved for sale, and in the EU, as we prepare for a sales launch in this market in 2009. Our primary competitor in TMR may obtain FDA approval to market a new device, the impact of which is uncertain on the future adoption rate of TMR. Rapid technological changes in our industry could make our products obsolete. We must receive and maintain government clearances or approvals in order to market our products. Changes in third party reimbursement for TMR procedures or our inability to obtain third party reimbursement for RenalGuard could materially affect future demand for our products. Securing intellectual property rights for our RenalGuard System is critical to our future business plans, but may prove to be difficult or impossible for us to obtain. Asserting and defending intellectual property rights may impact our results of operations. We may be subject to product liability lawsuits; our insurance may not be sufficient to cover damages. We are subject to risks associated with international operations. Because we are incorporated in Canada, you may not be able to enforce judgments against us and our Canadian directors. Our stock price has historically fluctuated and may continue to fluctuate significantly in the future which may result in losses for our investors. The market price of our stock may fall if shareholders sell their stock.

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879682--3/28/2008--PLC_SYSTEMS_INC