SenoRx (Aliso Viejo, California) has filed an amended registration statement with the Securities and Exchange Commission for an initial public offering (IPO) of its stock, which it plans to register under the symbol SENO.
The company, which manufactures biopsy systems and breast tissue markers used in the diagnosis and treatment of breast cancer, has filed to sell 5.5 million shares at $11-$13 per share. The company said net proceeds of about $59.4 million will be used to repay debt, expand product development, regulatory and clinical initiatives.
The company also granted the underwriters of the offering the right to purchase up to 825,000 additional shares of common stock to cover any over-allotments. The underwriters can exercise this right at any time within 30 days after the closing of this offering.
If all the shares are exercised, the company expects to net up to $68.6 million, assuming the shares price out at the $12 midpoint.
The company said it specifically planned to use $36 million of the IPO proceeds for sales and marketing initiatives to support the ongoing commercialization of its EnCor system and other products under development; and $9 million for research and development activities, including support of product development, regulatory and clinical initiatives.
The company’s primary diagnostic product, EnCor, is a vacuum-assisted breast biopsy probe system with which a doctor may collect tissue samples and biopsies through a transparent tissue collection chamber. The system allows the doctor to examine the quality of the specimen mid-probe, rather than performing numerous biopsies. The system can also be used in conjunction with other imaging equipment such as MRIs and ultrasounds.
In 2004, the company received 510(k) clearance from the FDA to market the EnCor system in 2004. Over the subsequent period ending in October 2005, the company began selling the product on a limited basis while it focused on enhancing certain elements of the product to optimize its performance, and subsequently progressed with a full commercial launch of the system in November 2005.
SenoRx said it expects to apply for 510(k) clearance for another product, its Radiation Balloon, in the second half of 2007. It is also developing breast surgery and breast reconstruction devices, its Single Step, Shape Select and GED, for which it respectively expects to enter limited launch phases in late 2008.
The company, founded in 1998, incurred net losses of $6.8 million in 2004, $8.6 million in 2005 and $15.4 million in 2006 and, as of that date, had an accumulated deficit of about $65.5 million.
The company underwent an inspection of its facilities by the FDA in April 2005, which resulted in the issuance in July 2005 of a warning letter related to, among other things, its failure to adequately validate manufacturing changes it undertook to prevent the tip of the Gel Mark Ultra Biopsy Site Marker from shearing off in the patient’s breast during the biopsy procedure, which it had experienced. The company said it responded with a corrective plan and believes it is in compliance.
• InSight Health Services (Lake Forest, California), a provider of diagnostic imaging, has launched an offer to exchange shares of its common stock for up to $194.5 million aggregate principal amount of 9-7/8% senior subordinated notes, due 2011, issued by the company’s subsidiary, InSight Health Services.
For each $1,000 of aggregate principal amount of notes tendered, noteholders will receive 40 shares of common stock after giving effect to a 4.70424-for-1 reverse split.
The company is soliciting votes to accept or reject a pre-packaged plan of reorganization, which will attempt to accomplish the restructuring on the same terms as the out-of-court exchange offer.
The exchange offer and consent solicitation will expire on April 19, unless extended.
• Laboratory Corporation of America (LabCorp; Burlington, North Carolina) reported that for the period March 12-Sept. 11, its zero coupon subordinated liquid yield option notes (LYON), due 2021, and zero coupon convertible subordinated notes, due 2021, will accrue contingent cash interest at no less than 0.125% of the average market price of a LYON or zero coupon note, as applicable, for the five trading days ended March 7, in addition to the continued accrual of the original issue discount.
Contingent cash interest, which the company has determined to be roughly $1.22 a note, will be payable to holders of the LYONs or zero coupon notes as of Aug. 27. The payment of contingent cash interest is expected to be made Sept. 11.
• EarlyDetect (Irvine, California) reported retaining MidSouth Capital (Atlanta) as its exclusive investment banker. EarlyDetect makes in vitro diagnostic health test kits for in-home, hospital and small-test site use.
EarlyDetect’s two wholly owned subsidiaries, Pan-Probe Biotech and Sherman Biotech, are working on the R&D of diverse formulations and testing of vaccines for the H1N5 Bird Flu, off-patent drug SB-15, a formulation targeted toward reducing anxiety in Fragile X patients, autism and other related illnesses.