1100441--2/27/2008--REGENERATION_TECHNOLOGIES

related topics

{product, liability, claim}

{product, market, service}

{cost, operation, labor}

{property, intellectual, protect}

{acquisition, growth, future}

{stock, price, share}

{interest, director, officer}

{system, service, information}

{cost, regulation, environmental}

{provision, law, control}

An investment in our common stock involves a high degree of risk. You should consider each of the risks and uncertainties described in this section and all of the other information in this document before deciding to invest in our common stock. Any of the risk factors we describe below could severely harm our business, financial condition and results of operations. The market price of our common stock could decline if any of these risks or uncertainties develop into actual events. You may lose all or part of the money you paid to buy our common stock. The pending merger with Tutogen may create uncertainty for our suppliers, employees and business partners. The merger with Tutogen is subject to Shareholder approval and may not occur. The issuance of shares of our common stock to Tutogen stockholders in the merger will substantially reduce the percentage interests of our current stockholders. We will incur significant transaction and merger-related costs in connection with the merger. The merger may not provide all of the anticipated benefits. We depend heavily upon a limited number of sources of human tissue, and any failure to obtain tissue from these sources in a timely manner will interfere with our ability to process and distribute allografts. If we fail to maintain our existing strategic relationships or are unable to identify additional distributors of our implants, our revenues may decrease. If third party payers fail to provide appropriate levels of reimbursement for the use of our implants, our revenues would be adversely affected. If we fail to maintain the high processing standards that our implants require or if we are unable to develop processing capacity as required, our commercial opportunity will be reduced or eliminated. Our allograft and xenograft implants and technologies could become subject to significantly greater regulation by the FDA, which could disrupt our business. The allograft industry is subject to additional local, state, federal and international government regulations and any increased regulations of our current or future activities could significantly increase the cost of doing business, thereby reducing our profitability. Our success will depend on the continued acceptance of our allograft and xenograft implants and technologies by the medical community. Rapid technological changes will affect us and our customers, which could result in reduced demand for our products. We face intense competition, which could result in reduced acceptance and demand for our implants and technologies. If we do not manage the medical release of donor tissue into processing in an effective and efficient manner, it could affect our profitability. Negative publicity concerning methods of human tissue recovery and screening of donor tissue in our industry could reduce demand for our allografts and impact the supply of available donor tissue. If our patents and the other means we use to protect our intellectual property prove to be inadequate, our competitors could exploit our intellectual property to compete more effectively against us. Our success will depend in part on our ability to operate without infringing on or misappropriating the proprietary rights of others, and if we are unable to do so we may be liable for damages. We or our competitors may be exposed to product or professional liability claims which could cause us to be liable for damages or cause investors to think we will be liable for similar claims in the future. If we are not successful in expanding our distribution activities into international markets, we will not be able to pursue one of our strategies for increasing our revenues.

Full 10-K form ▸

1100441--2/27/2008--REGENERATION_TECHNOLOGIES_INC