A Medical Device Daily

Evalve (Menlo Park, California), a company that develops devices for the percutaneous repair of cardiac valves, said it has completed a $60 million Series D financing.

BBT Fund led the round and was joined by investors including Delphi Ventures, New Enterprise Associates, Split Rock Partners, Cutlass Capital, Integral Capital Partners, ABS Ventures, Emergent Medical Ventures and Abbott Laboratories.

The company said the financing will help it prepare for commercialization of its MitraClip in Europe and continue to move toward U.S. approval of the product by completing enrollment in its Endovascular Valve Edge-to-Edge Repair STudy (EVEREST).

The MitraClip is intended to treat mitral regurgitation (MR) by percutaneously repairing the mitral valve allowing patients to avoid the risks, trauma and costs associated with current open, arrested heart surgical treatment.

Earlier this year Evalve reported the release of data at the scientific sessions of the American College of Cardiology (ACC; Washington) that it said demonstrate that successful reduction of MR can be maintained for up to 36 months following treatment with the MitraClip. Results at 12 months also show significant reverse left ventricular (LV) remodeling, indicating improved LV function, the company said at that time.

"The strong interest from both new and existing investors indicates a high level of confidence in our clinical results to date, as well as enthusiasm for our potential to improve the continuum of care for patients suffering from structural heart disease and the expanding market this represents," said Ferolyn Powell, president/CEO of Evalve. "We are pleased that this financing will allow Evalve to progress toward commercialization of our MitraClip device for percutaneous mitral repair."

The EVEREST II study continues at more than 35 centers in North America with more than 300 patients enrolled and more than 300 MitraClip devices implanted to date. Investigators are enrolling patients in both arms of the EVEREST II study — a randomized, controlled arm and a high-risk registry arm — with the goal of completing enrollment by the end of 2008.

The EVEREST II randomized study is evaluating the safety and efficacy of the MitraClip compared to surgical mitral valve repair or replacement. This prospective, randomized, multi-center study will enroll 279 patients at up to 42 sites in the U.S. and Canada. Patients are randomized 2:1 to receive the device.

In other financing activity:

  • CardioMems (Atlanta) reported the closing of its Series E preferred stock financing for $33 million of equity funding led by Arcapita Ventures. Joining Arcapita in the round are existing investors Boston Millennia Partners, Medtronic, Easton Capital Partners, Foundation Medical Partners, and Arboretum Ventures, along with new investors Deerfield Capital Management, Vision Capital Advisors, Aperture Venture Partners and Rockport Venture Securities. The company's board of directors also reported that it has appointed Daniel Bauer CFO. CardioMems has developed a wireless sensing and communication technology for the human body. Its technology platform is designed to improve the management of severe chronic cardiovascular diseases such as aneurysms, heart failure and hypertension. According to CardioMems, its wireless sensors can be implanted and transmit cardiac output, blood pressure and heart rate data which are critical to the management of patients.
  • AxoGen (Alachua, Florida) reported raising $12.1 million in Series C funding from Accuitive Medical Ventures, Cardinal Partners, De Novo Ventures and Springboard Capital II. AxoGen said it launched its Avance nerve graft for peripheral nerve repair in July. The company raised $7.75 million in Series B financing last year (MDD, March 10, 2006).
  • Opko Health (Miami), a specialty healthcare company, reported that members of the Frost Group have made a $20 million investment in the company. Opko will issue 10,869,565 shares of its common stock at $1.84 a share, representing about a 40% discount to the five-day average trading price of the stock on the American Stock Exchange. The shares issued in the investment will be restricted securities, subject to a two-year lock-up, and no registration rights have been granted. The proceeds from the investment will be used for R&D and for general working capital. Following this investment, members of the Frost Group will collectively be deemed to beneficially own in about 62% of Opko's outstanding common stock.
  • Hologic (Bedford, Massachusetts), which specializes in diagnostic imaging products and interventional devices dedicated to serving the healthcare needs of women, reported the pricing of $1.5 billion aggregate principal amount of convertible senior notes due 2037. The convertible senior notes mature in 2037 and will pay cash interest semiannually at a rate of 2% per annum until Dec. 15, 2013, after which their principal will accrete at a rate of 2% per annum. Commencing with the interest period beginning Dec. 15, 2013, the notes will also pay contingent interest under certain circumstances based on the trading price of the notes. The notes will be convertible at an initial conversion rate of 12.9555 shares of common stock per $1,000 original principal amount of notes (equivalent to a conversion price of roughly $77.1875 a share), subject to adjustment. The initial conversion price represents a 25% premium over the closing sale price of Hologic's common stock Dec. 4. The sale of the convertible senior notes is expected to close Dec. 10. Hologic granted the underwriters an option to purchase up to an additional $225 million aggregate principal amount of the convertible notes to cover over-allotments.
  • Dynatronics (Salt Lake City) reported that its board of directors has increased its open market share repurchase program of the company's common stock by $250,000. The company said it expects to make the discretionary purchases with cash from operations and amounts available under its line of credit. Currently, increased borrowings would be required to complete the full repurchase program. At the present price of $1.13 a share, the full repurchase would comprise about 221,000 shares of stock, or about 2% of the company's issued and outstanding shares. The purchases will be made at the discretion of management over an indefinite period and the program can be terminated at any time and the company is not obligated to make any purchases under the plan.

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