A Medical Device Daily

LightPath Technologies (Orlando, Florida) reported that it has raised gross proceeds of about $3.8 million through the sale of 730,000 newly issued common stock to certain institutional and private investors. The shares were sold for a price of $5.25 each.

The company said the net proceeds from the offering would be used for new product development, equipment expenditures and working capital to support the continued growth of the business.

The investors also received warrants with an exercise period of five years beginning on Sept. 20 for the future purchase of 219,000 shares of company common stock at $7.41 a share. If all of the warrants are ultimately exercised an additional $1.5 million will be raised, the company said.

This round of financing was lead by Iroquois Master Fund. Dawson James Securities acted as exclusive placement agent and financial advisor.

LightPath makes optical products including precision-molded aspheric optics, Gradium glass products, collimator assemblies, laser components utilizing automation technology, higher-level assemblies and packing solutions.

Ventiv Health becomes inVentiv

Ventiv Health (Somerset, New Jersey) reported that it is changing its corporate brand name to inVentiv Health as part of a re-branding initiative that began when it acquired inChord Communications (Westerville, Ohio) in October 2005 (Medical Device Daily, Oct. 7, 2005).

Eran Broshy, CEO of inVentiv Health said, “We have expanded and grown dramatically beyond the company we were even just two years ago and are building a unique client-focused organization. We believe our company branding must evolve to clearly communicate these changes along with our commitment to our clients' success.“

Briefly Noted

Ingen's OxyView exempt from 510(k)

Ingen Technologies (Calimesa, California), manufacturer of OxyAlert, OxyView and Secure Balance, reported that the FDA has determined its OxyView is exempt from 510(k) requirements.

The company's newest product, OxyView is a pneumatic gauge that provides visual safety warning of oxygen flow for patients in the hospital, surgical room, outpatient therapy, nursing homes and emergency response facilities, enhancing the safety and accuracy of patients being administered oxygen.

Anita Beck, president of Global Regulatory Services Associates (San Juan Capistrano, California), said she was notified that the product is exempt from 510(k) requirements, but added: “However, I was told, that you do need to register and classify the product.“

Scott Sand, CEO and chairman, said, “This is very good news. The requirement to register and classify OxyView with the FDA will be complete this month. Our tooling is under way, and our distributors are hopeful.“

Ingen Technologies is a subsidiary of holding company Ingen , which provides diagnostic and safety features to health practitioners and patients.

Edwards 10-K to include reclassification

Cardiovascular specialistEdwards Lifesciences (Irvine, California) said that its Form 10-K for the year ended Dec. 31, which the company expected to file with the SEC last week, will include a reclassification of cash flows of $14 million related to the impact of a previously announced divestiture. It said that the reclassification has no effect on the its 2005 net cash flows, any previously released balance sheets, statements of operations or statements of shareholders' equity, and no impact on its 2006 outlook.

On Feb. 2, Edwards reported 4Q05 and full-year 2005 results, including cash flows from operating activities and free cash flow. It subsequently determined that a $14 million impact from the ePTFE vascular graft business divestiture was recorded in cash flows from operating activities rather than cash flows from investing activities. As a result, the revised annual cash flow from operating activities is $136.8 million.

It said free cash flow for 2005 is $126.1 million, calculated as cash flows from operating activities, minus capital expenditures of $48.5 million, plus $37.8 million related to the company's charitable fund contribution and the restructuring of the 3F Therapeutics agreement. For the fourth quarter, revised cash flows from operating activities and free cash flow are $44.3 million and $22.4 million, respectively.

PainCare to restate financials

PainCare (Orlando, Florida), a provider of pain-focused medical and surgical solutions, reported that upon the recommendation of management, its audit committee determined that it will restate its financial statements for the years 2000-2004, and the quarters ended March 31, 2005, June 30, 2005, and Sept. 30, 2005.

Mark Szporka, CFO of PainCare, said, “As a result of this evolving interpretation of certain accounting rules, we are required to restate our historical financial results to account for certain non-cash expenses associated with our option plans, convertible debentures, warrants, and acquired practice intangibles.“

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