A Medical Device Daily
BioForm Medical (San Mateo) a company that develops injectable implant products for soft-tissue augmentation, including Radiesse and Coaptite said it has filed a registration statement with the Securities and Exchange Commission (SEC) for a proposed initial public offering (IPO) of shares of its common stock.
In its filing the company said it planned to raise up to $115 million, and said all shares of the common stock to be sold in this offering will be sold by the company. The number of shares to be offered and the price range have not yet been determined.
The company said it plans to use a yet undetermined amount of the proceeds from the IPO to further develop Radiesse; and an undetermined amount for the development of Aethoxysklerol and BioGlue, and other product development activities.
It also said that it might use a portion of the net proceeds to acquire complementary products, technologies or businesses.
The company said it has incurred losses and generated negative annual cash flows from operation activities in all but one year since its inception in 2000 and had an accumulated deficit of $47.5 million as of June 30, 2007.
Previously BioForm settled a patent infringement suit with Artes Medical (San Diego, California) and Martin Lemperle, MD, one of Artes’ founders regarding Radiesse and Coaptite (Medical Device Daily, Nov. 2, 2005). Artes granted BioForm an exclusive license under certain Artes patents to make and sell implant products containing calcium hydoxylapatite particles, including BioForm’s Coaptite and Radiesse products and a non-exclusive license under the same patents to make and sell certain other non-polymeric implant products.
Radiesse, is an injectable implant used to restore or correct signs of facial lipidatrophy or fat. Coaptite is a tissue bulking agent, which is marketed through the company’s distribution agreement with Boston Scientific (Natick, Massachusetts) for use in the treatment of stress urinary incontinence in adult females.
The company said sales of Radiesse generated most of its revenue in the fiscal years 2005, 2006 and 2007. Other revenue consists primarily of the sale of Coaptite. Total net sales reached $47.4 million in fiscal 2007, up 109% from $22.7 million in fiscal 2006.
The company presented results of a clinical study confirming the long-term efficacy of Radiesse for the treatment of vocal fold insufficiency.
Study data showing that 73% of study patients reported their voice was greatly or significantly improved 12 months after Radiesse treatment were presented during the Combined Otolaryngology Spring Meetings in Chicago (MDD, June 6, 2006). Radiesse demonstrated success in improving the voice of patients for 12 months without surgery. The company said this investigation is the largest multicenter, open-label, prospective clinical study of its kind in the field of voice disorders.
CIBC World Markets, Jefferies & Company, Piper Jaffray & Co., and JP Morgan Securities are acting as joint book-running managers of the offering and, along with CIBC World Markets. and Jefferies & Co. as representatives of the underwriters.
Seno Medical Instruments (San Antonio) reported receiving a $2 million award from the Texas Emerging Technology Fund (TETF). The company said this funding will allow it to develop its lifesaving technology for cancer imaging and detection and move it closer to the global market place.
The patented functional imaging technology will be commercialized to produce real-time color images, which differentiates benign and malignant tumors, for all solid tumors, such as in breast cancer. Seno’s intent is to provide the most advanced, high-quality products for cancer screening, diagnosis and therapeutic treatment that are more humane than existing technologies.
The TETF is a $200 million program created by the Texas Legislature in 2005. A 17-member advisory committee of high-tech leaders, entrepreneurs and research experts reviews potential TETF projects and recommends funding for projects to the Governor, Lieutenant Governor and Speaker of the House. To date, the TETF has allocated $94.1 million in grant funds to Texas companies and universities across the state.
Seno Medical Instruments was founded in 2005 and is focused on the earliest detection of cancer through the use of its patented opto-acoustic technology.
In other financing news: Healthnostics (Bethesda, Maryland), a medical and biotechnology analytics company, reported that the March 12, 2007 Special Stock Distribution for shareholders of record will be delivered to those shareholders beginning on Aug. 30, 2007 through the company’s transfer agent.
This special restricted stock distribution consisted of one share of Healthnostics’ common stock for each 10 shares of Healthnostics common stock held by shareholders of record as of the March 12, 2007 date.