A Medical Device Daily

National Dentex (Natick, Massachusetts), an owner/ operator of dental laboratories in the U.S., said it amended its credit facility with Bank of America. The company said the amendment to its $50 million credit facility extends the maturity date of the revolving line of credit to Nov. 7, 2011, amends certain interest rate terms and definitions, and amends and restates certain financial covenants.

"We are very pleased to enter into this amendment with Bank of America, with which we have had a long standing beneficial relationship, especially given the current difficulties in the credit markets," said David Brown, president/ CEO of National Dentex. "By extending the maturity date of our revolving facility for an additional two years, making it coterminous with our term loan, we believe that we will have sufficient liquidity to meet our needs for the foreseeable future at a reasonable cost."

National Dentex's dental laboratories provide a full range of custom-made dental prosthetic appliances, including dentures, crowns, and fixed bridges, and other dental specialties.

In other financing activity:

Orthofix (Boston) said it has given notice to its lenders that in addition to its regularly scheduled payments it intends to make a $10 million debt pre-payment on Dec. 29 in advance of the scheduled maturity, permanently reducing its current credit facility by that amount.

"This is a good time to begin deleveraging our balance sheet," said Bob Vaters, executive VP/CFO of Orthofix. "The improving outlook at Blackstone along with more normalized capital expenditures and the completion of purchases of Trinity inventory under the current distribution agreement with NuVasive contributed to our decision to make a prepayment. With expected continued cash flow improvements we will look for additional opportunities to pay down debt early, increasing the company's flexibility to execute its operating plan."

Following recent leadership changes at the company's Blackstone business, Orthofix said it has implemented a number of initiatives intended to rationalize expenditures and improve the supply chain. The company also has begun the limited market release of two new products, the Firebird pedicle screw system and the PILLAR SA interbody device, which the company expects to launch in the U.S. during 1Q09.

Earlier this week Orthofix and the Musculoskeletal Transplant Foundation (Edison, New Jersey) reported the completion of a major development milestone related to Trinity Evolution, a new stem cell-based allograft, and accelerated the expected launch date of this new product to the first half of 2009.

Orthofix offers a broad line of minimally invasive surgical, and non-surgical, products for the spine, orthopedic, and sports medicine market sectors that address the lifelong bone-and-joint health needs of patients of all ages.

OmniComm Systems (Fort Lauderdale, Florida), a provider of integrated electronic data capture solutions for clinical trials, said it has completed a $5.1 million convertible debt financing. OmniComm will use the capital to finance ongoing R&D and to provide working capital for planned growth in operations.

Investors in this financing include members of the company's executive management team including CEO Cornelis Wit, CTO/chairman Randall Smith, COO Stephen Johnson and CFO Ronald Linares. Additionally, two members of the company's board, Matthew Veatch and Guus van Kesteren and one of the company's strategic partners, Noesis Capital, were investors.

"We are pleased to close on this round of financing and excited at the unprecedented level of confidence and commitment shown by our senior management team and directors," Wit said. "Particularly in a time that funding is scarce for many industries, it is very satisfying to see that there is a lot of confidence in the future of OmniComm Systems. This capital will allow us to continue to evaluate and implement opportunities that create value for our shareholders."

The new $5.1 million financing, which carries more favorable covenants than the prior financing, is comprised of a two-year term loan bearing a fixed interest rate of 12%, the company said. Proceeds will be used to repay roughly $800,000 in principal amounts owed on secured convertible debentures that were originally issued in February.

OmniComm provides Internet solutions to pharmaceutical, biotechnology, research and medical device organizations that conduct clinical trial research.