A Medical Device Daily
Sound Surgical Technologies (Louisville, Kentucky) has filed a registration statement with the Securities and Exchange commission (SEC), reporting that its initial public offering (IPO) will consist of 3.3 million shares at a range of $5.50 to $7.50 per share, or potentially up to more than $24 million.
Sound Surgical said the underwriters also may purchase up to an another 450,000 shares of common stock and 45,000 shares from a selling stockholder at the public offering price.
Plans for the company’s IPO were unveiled late last year (Medical Device Daily, Dec. 29, 2004).
Sound Surgical has developed the Vaser System, an ultrasound-based device that breaks up body fat for removal in a lipoplasty (or liposuction) type of procedure and began selling it in 2001. With the Vaser, fat can be removed from any place on the body where a person has developed what the company calls “extra cushioning.”
Sound Surgical markets its systems to surgeons, surgery centers and hospitals through a direct sales force in the U.S., as well as through distribution agreements in Europe and South Korea.
Among the risk factors listed in the SEC filing are that the company has incurred losses of $4.6 million in 2003 and $4.7 million in 2004 and that at the end of 2004 it had an accumulated deficit of about $12.8 million; that its auditors have expressed doubts about the company being a “going concern” if it cannot raise additional funds; and that it competes against other lipoplasty devices from firms having greater resources.
Potential competitors under development include two non-invasive lipoplasty devices.
The filing states that the company knows of “several cases where excessive application of high ultrasonic amplitude, or the maximum absolute energy value reached by ultrasonic waves, through the Vaser System resulted in patients developing a seroma, [a] swelling from localized fluid accumulation, or experiencing skin burns. Improper application of the Vaser System can also result in damage to muscle or nerves.”
The company said that the Vaser System offers “a somewhat higher cost per procedure than traditional suction-assisted lipoplasty,” which it puts as low as $5,000 but ranging as high as $20,000.
The company has said it plans to open in the U.S. as many as four LipoSelection Centers of America.
EpiCept (Englewood Cliffs, New Jersey) also has made an IPO filing with the SEC, for 5.5 million shares in a price range from $11 to $13 a share, or up to $71 million. EpiCept first unveiled the IPO in January (MDD, Jan. 18, 2005).
The company develops topical treatments that target nerve receptors beneath the skin to alleviate moderate-to-severe pain. For delivery, it uses patches, spray-on gels and creams. Patch products in development include the LidoPain BP (for back pain) Patch designed to produce sustained topical delivery of the local anesthetic lidocaine; LidoPain SP (for surgical pain), a sterile wound bandage, or patch, providing controlled release of anesthetic to a post-surgical wound or post-traumatic wound; LidoPain TV, a topical patch for the treatment of tinnitus and vertigo, used behind the ear, releasing local anesthetics into retrograde nerve sections; and LidoPain HM, a patch applied to the forehead, for treatment of migraine.
The company has formed a strategic alliance with Adolor (Exton, Pennsylvania) for its LidoPAIN SP product candidate and with Endo (Clinton, New Jersey) for its LidoPAIN BP candidate.
The ingredients in EpiCept’s drug candidates already are approved by the FDA, and so the agency needs only to approve the firm’s formulations. Of six product candidates, half are in, or ready to enter, Phase III trials; the other half are in Phase II trials.
In other financing news:
• Bio-Rad Laboratories (Hercules, California) reported that it has begun an offer to exchange up to $200 million aggregate principal amount of its 6.125% senior subordinated notes, due 2014, which have been registered for its outstanding 6.125% senior subordinated notes, due 2014, issued in a private placement.
The exchange offer will expire at 5 p.m. EDT on May 31, unless extended. Any private notes not tendered in the offer will remain outstanding and continue to accrue interest, but will not retain any rights under the registration rights agreement except in limited circumstances. Bio-Rad is a multinational manufacturer of life science research products and clinical diagnostics, serving more than 70,000 customers through a network of more than 30 subsidiary offices.
• QLT (Vancouver, British Columbia) reported that the Toronto Stock Exchange has accepted notice of its intention to make a normal course issuer bid in the open market through the facilities of the Toronto exchange and/or the Nasdaq Stock Market, reported on April 28.
The notice provides that QLT may purchase, from May 4, 2005, to May 3, 2006, up to a maximum of 4,690,752 common shares, 5% of the number of common shares outstanding, subject to a maximum aggregate expenditure by QLT of $50 million. The actual number and timing of such purchases will be determined by QLT. The price that QLT will pay for any such shares will be the market price at the time of acquisition.
QLT reported that it has not purchased any of its common shares in the prior 12 months. There were 93,816,148 common shares outstanding as of April 28.
QLT specializes in developing treatments – including photodynamic therapies – for cancer, eye diseases and dermatological and urological conditions.
• eResearchTechnology (eRT; Philadelphia), a provider of technology and services to the medical device, biotech and pharmaceutical industries, said that its board has authorized the purchase of up to an additional 10 million shares, which extends a previously reported stock buyback program to authorize the repurchase of a total of 12.5 million shares.
eRT provides diagnostic electrocardiographic technology and services to evaluate cardiac safety in clinical development. It also provides technology and services for clinical trials processes.