A Medical Device Daily
Power Medical Interventions (PMI; Langhorne, Pennsylvania) has filed a registration statement with the Securities and Exchange Commission for a proposed initial public offering of up to $100 million, though the per-share price and number of shares to be offered have not yet been disclosed.
The company, which makes cutting and stapling products used in open and endoscopic procedures, including bariatric surgery, colorectal and thoracic surgery, said it intends to use the funds for working capital, expansion of sales and marketing, continuation of R&D, expanded manufacturing, capital equipment and possible acquisitions.
PMI has developed the micro-robotic, computer-assisted SurgASSIST system used to cut tissue, close wounds and reconnect anatomical structures, which the company calls "a preferable alternative to hand suturing."
The company said in its filing that it has sustained losses since its 1999 launch, including a net loss of $28.3 million for the year ended Dec. 31, 2006. As of that date, it had an accumulated deficit of $137.1 million.
Among risks listed by the company, it said it is involved in two appeal proceedings in Germany in connection with two patent-infringement lawsuits against it. The lawsuits allege that certain of the company's products infringe three European patents held by Ethicon Endo-Surgery (Cincinnati).
Between May 2002 and June 2005, the company noted that the FDA has conducted three inspections of its facilities, and each of those inspections resulted in the issuance of a Notice of Inspectional Observations, or Form 483. Certain observations regarding its processes to handle customer complaints, submit medical device reports, initiate corrective and preventive actions, and to conduct internal quality audits were identified by the FDA as areas of possible non-compliance with FDA regulations.
From Feb. 13 to April 26, 2007, the FDA conducted an additional inspection of the company's facility in Langhorne, Pennsylvania. A Form 483 from that inspection generated 24 inspectional observations, including the failure to properly process customer complaints, failure to submit to the FDA medical device reports or to submit them within regulatory timeframes, and the lack of reporting a field action.
The company has applied for the listing of its common shares on the NASDAQ Global Market under the symbol PMII.
In other financing news:
• Pluristem Life Systems (Haifa, Israel), a biotherapeutics company developing products for malignant, degenerative and auto-immune indications, reported closing on a private investment in the company of about $13.5 million.
The financing, which is a continuation of the investment disclosed in February, included as investors the Technion-Israel Institute of Technology (Haifa) and inventors who collaborated on the technology and whose patents were acquired by Pluristem.
"The response to this capital raise was extraordinary and provides us with the financing we need to complete the development of our first product, PLX-I, and explore the use of our placental expanded mesenchymal stem [PLX] cells for other clinical indications," said Zami Aberman, CEO of Pluristem.
Pluristem is developing PLX-I as an alternative to bone marrow transplantation. PLX-I is an allogeneic product, based on supplementing hematopoietic stem cells contained in umbilical cord blood to improve the effectiveness of HSCs engraftment and shorten recovery times. PLX-I mesenchymal stem cells were proven to increase the engraftment of HSCs from CB by up to five fold in a pre-clinical study.
• Atlantis Components (Cambridge, Massachusetts), a maker of dental implants, said it has completed a $9.8 million Series D convertible preferred stock financing.
This financing included new investor Signet Healthcare Partners. Previous shareholders ABV Holding, CID Equity Capital, Heron Capital Venture Fund I, Ironwood Equity Fund, Massachusetts Technology Development, and VIMAC Early Stage Fund also participated in the D round.
The company said that proceeds of the financing will be used to increase market penetration of its products in the dental implant marketplace.
Atlantis produces what it calls "patient-specific" components using 3-D optical scanning, advanced software-based systems and integrated manufacturing methods. "These products are highly customized to the needs of each patient and clinician," it said.
• InSight Health Services Holdings (Lake Forest, California) reported that the offer to exchange shares of its common stock for up to $194.5 million principal amount of 9 7/8% senior subordinated notes, due 2011, of InSight's wholly owned subsidiary, InSight Health Services Corp., has been extended and will expire on May 25, unless further extended.
InSight initiated the exchange offer on March 21. As of May 21, it said that about $163.5 million of notes had been tendered.
InSight is a provider of diagnostic imaging services serving managed care entities, hospitals and others in more than 30 states.