A Medical Device Daily

TopSpin Medical (Tel Aviv, Israel) reported that it has raised $11 million in convertible bonds from institutional investors on the Tel Aviv stock exchange.

TopSpin says it has developed a technology platform that is designed to enable MRI to be conducted with no external magnets. The company says that the ability to perform high-resolution local MRI with no external magnets is "a breakthrough in medical imaging as it enables the extension of MRI technology to a wide range of applications, in which conventional MRI cannot get to the required resolution or is simply too bulky and expensive."

The primary application developed by TopSpin is high-resolution imaging of coronary artery walls during cardiac catheterization by a single-use, IntraVascular MRI (IVMRI) catheter. It said that the IVMRI catheter has demonstrated accurate characterization of the lipid composition of atherosclerotic plaque, an important factor in determining plaque instability.

TopSpin completed its first-in-man clinical trial, which will support its application for CE-marking of the IVMRI system by the end of the year.

An additional clinical study is now ongoing in more than 10 centers in Europe, Israel and the U.S. It reports that to date about 100 patients have been enrolled in TopSpin's studies with good safety and performance results. The company said it plans to use the data to obtain FDA market clearance, expected by mid-2007.

"The $11M raised will allow us to launch our IVMRI catheter in Europe and in the US, while continuing to invest in an extensive post-marketing clinical program that would help build our market," said Erez Golan, TopSpin's president/CEO. We intend to continue working with leading cardiologists, as well as industry partners, to further demonstrate the usefulness of IVMRI in diagnosing and guiding therapy to vulnerable plaque. The successful completion of the financing will allow us to move ahead with this ambitious plan, while further developing our technology, in cardiology, urology and beyond."

Ivivi Technologies (Northvale, New Jersey) reported the closing of the sale of 250,000 shares of its common stock related to the partial exercise of the over-allotment option granted to the underwriters in connection with its initial public offering which closed on Oct. 24. These shares were sold at the initial public offering price of $6 a share, and the offering pricing occurred on Oct. 20 (Medical Device Daily, Oct. 20, 2006).

Net proceeds to the company from the exercise of the over-allotment option are expected to be about $1.35 million, which brings the total value of the offering to about $13.85 million.

During the pricing, the company reported that the underwriters of the offering had been granted an option for a period of 45 days to purchase up to 375,000 more shares of common stock from the company to cover over-allotments.

Maxim Group acted as representative of the underwriters of the offering and Brean Murray, Carret & Co. acted as co-manager of the offering.

Ivivi is an early-stage company focusing on developing electrotherapeutic technologies, those that use electric or electromagnetic signals to help relieve pain, swelling and inflammation and to promote healing processes and tissue regeneration.

In other financing activity:

• Amedisys (Baton Rouge, Louisiana) reported closing its offering of 3 million shares of its common stock at $41.50 a share for net proceeds of about $117.9 million. For a period of 30 days following the offering, the underwriters of the offering have an option to purchase another 450,000 shares of Amedisys common stock at a 5% discount to the offering price to cover over-allotments.

If exercised in full, the over-allotment will result in additional net proceeds of about $17.7 million. The share numbers in the offering do not take into account the impact of the 4-for3 stock split reported by the company on Oct. 25. The record date for the stock split will be Nov. 27.

The company said it used about $43.2 million of the proceeds from the offering to pay down and extinguish the term loan portion of its senior secured credit facility with Wachovia Bank and paid the associated accrued interest. Amedisys said it will use the remaining proceeds for working capital and possible acquisitions.

The managing underwriters of the offering were Raymond James & Associates, Wachovia Capital Markets, UBS Investment Bank, CIBC World Markets, and J.P. Morgan Securities.

Amedisys is a large home health nursing company.

• Five Star Quality Care (Newton, Massachusetts) reported that it has filed a Form S-3 with the Securities and Exchange Commission to expand the capacity under its universal shelf registration statements to $1 billion.

Five Star filed to expand its statements to accommodate the company's long term growth plan, it said, though currently reporting no plans to access the capital markets in the near future.

Five Star operates 161 healthcare and senior living communities with more than 18,000 units in 29 states.