A Medical Device Daily

Biomimetic Therapeutics (Franklin, Tennessee), a developer of “bioactive” drug/device technology, is expected to launch its initial public offering (IPO) this week. It proposes to offer more than 5 million shares at $13 a share, raising expected net of more than $60 million.

The company filed its IPO proposal with the SEC earlier this year (Medical Device Daily, Feb. 13, 2006).

BioMimetic's drug/device combinations are designed for the healing of musculoskeletal injuries and disease, including periodontal, orthopedic, spine and sports injury applications. The company's product and product candidates all combine recombinant protein therapeutics with tissue-specific scaffolds to stimulate tissue healing and regeneration.

The company in its SEC filing bills itself as focusing on “convergent” devices and predicts that the orthopedic sector will transition “from the use of traditional, passive, highly invasive metallic devices to more advanced, bio-active devices.”

BioMimetic last year received marketing approval from the FDA for its first product, GEM 21S, a synthetic regeneration system “combining a purified recombinant growth factor with a synthetic bone matrix,” calling it the first product of its type to be FDA-approved. It says its approach is to combine previously approved products to create “biologically enhanced” devices (MDD, Nov. 23, 2005).

The FDA approved it late in 2005 for the treatment of periodontal bone defects and receding gums (MDD, Dec. 12, 2005).

BioMimetic is hoping to build on the GEM technology as a treatment for various fractures, where its bone matrix can be used to repair, reinforce, or fuse broken bones.

It said it plans to use proceeds from the IPO for research and to commercialize GEM 21S.

Shares of the company will trade on the Nasdaq under the symbol BMTI.

Aurora Imaging Technology (North Andover, Massachusetts) reported the sale of $10 million of Series C preferred stock to two equity funds managed by the Pharos Capital Group (Pharos Capital Partners II and Pharos Capital Partners II-A; Dallas/Nashville, Tennessee).

Aurora said it will use the new capital to expand selling and marketing activities, both nationally and internationally, in commercialization of the Aurora 1.5T Dedicated Breast MRI System with Bilateral UltraRODEO.

Aurora says that it manufactures the only breast MRI system designed “specifically and exclusively for breast imaging optimized to detect and diagnose breast cancer.”

Olivia Ho Cheng, president & CEO of Aurora, said, “As our product gains wider acceptance, coupled with the dramatic growth the company is experiencing, we enthusiastically welcome the new equity from the Pharos Capital Group to enable us to take advantage of the many attractive business opportunities to build long term partnerships with our customers.”

Michael Devlin, managing partner of Pharos, said, “The Aurora MRI System is both innovative and timely, and we believe it should and will become the standard of care for the high-risk breast cancer population, making a significant impact in saving lives.”

The Aurora System is “optimized” specifically for breast imaging and interventional procedures, according to the company.

“Some of the proprietary and distinguishing features of the Aurora System include: a unique shimming of the magnet that changes the area of image uniformity to an ellipsoid providing the possibility of full image coverage of the breasts, the chest wall and the lymph nodes or axilla; a specially designed gradient coil with very high linearity or accuracy to meet the specific requirements of breast imaging; a patient-handling table that provides comfort for the patient and procedural utility; a fully integrated Interventional System for MRI guidance of biopsies and interventional therapy; and the user-friendly AuroraCAD computer-aided image display system designed to improve the accuracy and efficiency of radiologic interpretations.”

Its application include:

• detecting or excluding the existence of cancer in higher risk women;
• characterizing indeterminate clinical or mammographically detected abnormalities;
• determining the extent of cancer for treatment planning;
• detecting occult cancer;
• evaluating patients for residual disease following surgery;
• monitoring cancer response and the extent of residual disease after neoadjuvant chemotherapy;
• evaluating implant integrity and detecting cancer in women with breast augmentation.
• Pharos Capital Group reports about $500 million in capital under management.

In other financing news:

• Qiagen (Venlo, the Netherlands) reported the pricing of $270 million of senior convertible notes, due 2026, to be sold in minimum denominations of $100,000 to institutional investors outside the U.S. The company also granted the initial purchasers of the notes an option to acquire up to another $30 million aggregate principal amount of the notes.

The company increased the size of the convertible note issuance from the previously reported $220 million, plus a purchaser option to acquire an additional $30 million, saying that this was done “in light of the positive reception and the high level of demand for the offering on the financial markets.”

The notes will be convertible into the company's common shares at $20, subject to adjustment.

Qiagen said it plans to use the proceeds of the offering to optimize the structure of its balance sheet, to finance future acquisitions and for general corporate purposes.

The notes will be issued by a wholly-owned subsidiary of Qiagen and guaranteed by Qiagen. The settlement date of the notes is expected on or about May 16.

If the initial purchasers sell more than $270 million aggregate principal amount of the notes, the initial purchasers have an option to subscribe for up to another $30 million aggregate principal amount of the notes from the issuer to cover such sales. The initial purchasers may exercise this option for 30 days from May 9, 2006.

Qiagen reports having a portfolio of more than 320 consumable products for nucleic acid separation, purification and handling, nucleic acid amplification, automated instrumentation, synthetic nucleic acid products and related services.