A Medical Device Daily

Orthofix International (McKinney, Texas) reported that it has completed the first amendment to its existing credit agreement dated Sept. 22, 2006.

The amendment, which was requested by the company, includes revisions that relax the leverage ratio and clarify the definition of consolidated EBITDA and excess cash flow, among other changes. The interest rate applicable to the loan has been amended to LIBOR plus 4.50% from LIBOR plus 1.75%, reflecting current debt market conditions. The company will continue to have flexibility to repay the loan at any time without any additional cost.

"We are very pleased to have proactively completed this amendment under the most difficult market conditions," said Alan Milinazzo, the company's president/CEO. "The changes we incorporated into the credit agreement amendment allow us sufficient flexibility to execute on our global strategies as previously outlined."

Orthofix offers a line of minimally invasive surgical, and non-surgical, products for the spine, orthopedic, and sports medicine market sectors.

PreMD (Toronto) reported that it has entered into an agreement with Midsummer Investment with respect to an offering of about C$500,000 of secured debentures. Several additional existing institutional, qualified investors and insiders have also agreed to participate, the company said. The proceeds from the private placement are to be used for general corporate purposes.

"We have been actively evaluating multiple sales and distribution options for our Prevu technology, and have been involved in several discussions. We remain focused on expanding the market for our existing products in the cosmetics industry while advancing our pipeline of cancer detection products towards the conclusions of the three pivotal clinical trials that are expected this fall," said Brent Norton, president/CEO of PreMD. "This financing should enable us to carry forward with our goals into 2009 while we implement our plans to monetize various tangible and intangible assets," he added.

The debentures mature 12 months after the date of issuance at an amount equal to C$1,100 per C$1,000 principal amount and will be secured against the assets of the company.

The company will also issue about 6.7 million common share purchase warrants, each warrant being exercisable for a period of three years into one common share at a price equal to 100% of the 5-day volume-weighted average price of the common shares on the Toronto Stock Exchange prior to closing. The sale of the debentures and warrants is expected to close on or before Oct. 3, 2008 subject to the satisfaction of certain closing conditions and any necessary regulatory approvals from the Toronto Stock Exchange.

PreMD develops rapid, non-invasive tests for the early detection of life-threatening diseases.

In other financing news:

• Clinical Data (Newton, Massachusetts) reported that it has entered into a definitive agreement with certain affiliates of Randal Kirk, Chairman of Clinical Data's board of directors, with respect to the private placement of 1,514,922 shares of newly issued common stock priced at the closing price of $16.44 per share as of Sept. 26, plus $0.0625 per share, and warrants to purchase an additional 757,461 shares of common stock at $16.44 per share, for a total purchase price of about $25 million.

The company said it intends to use the gross proceeds from the private placement, which will be paid in full to the company as no placement agent was used in the transaction, for general working capital purposes.

Clinical Data's PGxHealth division focuses on proprietary biomarker and pharmacogenetic test development as well as targeted therapeutics to help predict drug safety and efficacy. Its Cogenics division provides genomics services to both research and regulated environments.