879682--3/30/2007--PLC_SYSTEMS

related topics

{product, candidate, development}

{product, liability, claim}

{customer, product, revenue}

{product, market, service}

{control, financial, internal}

{property, intellectual, protect}

{interest, director, officer}

{stock, price, operating}

{stock, price, share}

{personnel, key, retain}

{regulation, government, change}

{operation, international, foreign}

{acquisition, growth, future}

We expect to incur significant operating losses in the near future. Our new distributor for TMR products in the U.S. has only recently begun building a direct sales and marketing organization. Our company is currently dependent on one principal customer. 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. Our company may be unable to raise needed funds. In order to compete effectively, our current and future products need to gain commercial acceptance. Our newest product, RenalGuard, is still undergoing development and we have only recently begun to test it in a clinical setting as part of our initial pilot clinical study. Our planned future clinical trials 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 them at all, and the results of these clinical trials 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 if and when it is approved for sale. 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. We will soon have to comply with requirements regarding internal control over financial reporting. 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--3/30/2007--PLC_SYSTEMS_INC