Elekta (Stockholm, Sweden) reported completing its acquisition of Impac Medical Systems (Mountain View, California), following approval of the transaction by Impac stockholders early last month. The purchase has been valued at about $190 million. It was first announced in mid-January.
The vote was to approve the merger of Impac with a subsidiary of Elekta. The merger became immediately effective, with Impac becoming a wholly owned subsidiary of Elekta. Under the plan of merger, Elekta paid $24 in cash for each share of Impac common stock outstanding. Impac's common stock no longer trades on the Nasdaq.
The companies have said that the merger will enable the offering of a "a fully integrated, seamless solution addressing the spectrum of cancer care, from diagnosis through treatment planning, treatment delivery and follow-up."
Elekta, founded in 1972, is an international medical-technology group, providing advanced clinical solutions for high-precision radiation treatment of cancer and for non-invasive or minimally invasive treatment of brain disorders. Its clinical solutions include the Leksell Gamma Knife for non-invasive treatment of brain surgery and Elekta Synergy for image guided radiation therapy, as well as associated software systems. Elekta's systems and solutions are used at more than 2,000 hospitals around the world to treat cancer and to diagnose and treat brain disorders, including tumors, vascular malformations and functional disorders.
Founded in 1990, Impac is a provider of oncology management software and has expanded its core system to include a complete electronic medical record for radiation and medical oncology, digital image management, full-featured practice management, laboratory information systems and cancer registry.
Impac also enables the connection to multiple healthcare information and imaging systems via the HL7 and DICOM standards. Its National Oncology Database is a longitudinal oncology databases available for cancer research today.
Rubicon Filter gets CE mark
Rubicon Medical (Salt Lake City) said it has received the CE mark for its Rubicon Filter, an embolic protection system that traps and removes debris that may be dislodged during interventional procedures. The product, which will be marketed and distributed in Europe by Boston Scientific (Natick, Massachusetts), has been cleared for commercialization in three indications saphenous vein grafts (SVG), native coronary arteries and carotid arteries as well as in three sizes: 4 mm, 5 mm and 6 mm filters.
To treat patients who have blood vessels partially or fully occluded (blocked) with plaque buildup on the vessel walls, surgeons will often utilize a small wire mesh tube known as a stent to prop open the target vein or artery. When used in conjunction with a stenting procedure, the Rubicon Filter is maneuvered into place and deployed downstream from the blockage prior to the delivery and opening of the stent, with the goal of allowing surgeons to capture and remove dislodged plaque from the blood vessel during and after the stenting procedure. Studies have identified such dislodged plaque (or embolic material) as a potential cause of heart attacks, stroke, kidney failure and death. Rubicon Medical conducted two parallel clinical trials in Europe the RULE-SVG study RULE-Carotid study in support of its CE mark filing.
"This is a big day for Rubicon Medical. We have been working diligently in preparation for this approval," said Richard Linder, president and CEO. "The Rubicon Filter performed marvelously in both native and SVG procedures, as well as in carotid applications.
Paul LaViolette, chief operating officer of Boston Scientific, termed the Rubicon Filter "a potential paradigm-shifting technology due to its low profile and ease of use."
The RULE-SVG study included 54 patients with either saphenous vein graft disease or coronary artery disease in the native coronary arteries, including a number of high-risk stenting procedures. Those procedures were performed at hospitals in Germany and Italy, with many of the studies conducted by Eberhard Grube, MD, chief of interventional cardiology at Heart Center Siegburg (Siegburg, Germany).
In the RULE-Carotid study, the Rubicon Filter was used in 60 procedures with patients suffering from significantly blocked carotid arteries, the main vessels in the neck, which feed blood directly to the brain. The procedures were performed at hospitals in Germany, with Joachim Schofer, MD, co-founder of the Center of Cardiology and Vascular Intervention (Hamburg, Germany), as the principal investigator.
HepaLife cites progress on artificial liver
HepaLife Technologies (Vancouver, British Columbia), which is focused on creating an artificial liver device and developing in vitro toxicology and preclinical drug testing platforms, reported that several of its research objectives have been achieved.
Along with measuring positive P450 activity, urea production and ammonia clearance from its PICM-19H liver cell line currently being studied for eventual use in an artificial liver device by patients suffering from acute liver failure and chronic liver disease the company reported that its research has demonstrated that PICM-19H cells can be maintained independently of STO feeder cells.
PICM-19H cell culture without the aid of STO feeder cells would allow for a more defined cell culture system and may also be important for potential FDA approval of its artificial liver device, HepaLife said. The company said its research has been further expanded to include the study of various factors that may improve and extend the length of time that PICM-19H cells can be stored at room temperature instead of heated incubators, designed to artificially mimic body temperature.
To date, HepaLife said the PICM-19H cells remain functional and viable after one week of room temperature storage. However, further extending the storage time in culture at room temperature could allow for easier long-distance transportation of these cells. Moreover, the ability to place these cells in "suspended animation" at room temperature will enable more efficient utilization of the artificial liver device in its clinic or hospital setting, the company said.
Arian Soheili, president and CEO, said, "The benefits and cost savings of being able to ship the most important and perishable component of an artificial liver device the cells around the country without special incubator equipment would be tremendous." He added: "When it comes to developing a fully functional, therapeutically effective artificial liver device, the key is not in the hardware itself rather, it's the biological component that goes inside."
Saying that "most artificial liver systems being developed at other labs and companies have not lived up to initial expectations as a consequence of problems relating to their inability to grow liver cells quickly and safely, poor cell functionality and inconsistent results from filtering or dialysis devices," Soheili said HepaLife's cell line to date "has performed beyond our expectations."
Eucomed lauds EC's proposal
The European medical technology industry association, Eucomed (Brussels, Belgium), said that it "welcomes" a European Commission (EC) proposal for a decision of the European Parliament concerning the 7th Framework Program for Research 2007-2013, published last month. The association said it believes that what it termed "this ambitious project" will contribute to "achieving excellence in scientific and technological research in the medical technology field."
Maurice Wagner, the organization's director general, said, "We are pleased to see that a particular emphasis has been placed on the development and validation of new therapies, diagnostic tools and technologies, as well as on efficient and sustainable healthcare systems. This project will provide our industry with new opportunities to improve patient care."
Eucomed said that in its proposal, the EC "clearly recognizes the need to increase the competitiveness of European health-related industries and businesses through the creation of an environment favorable to the small- to medium-sized, research-based companies that are the main drivers of the medical technology industry.
The association said it also welcomes that special attention given to nanotechnology and emerging technologies, "as this is another area where the medical technology industry is very active today."
Eucomed said nanotechnology "offers new hopes for cancer treatment," citing the example of ongoing development of coated nanoparticles that can be injected into cancer-binding and cancer-fighting cells and then be activated by external devices, e.g. magnetically at the cancer site.
Human tissue engineering is "another fascinating medical technology with huge potential for the future," the association said. Tissue-engineered products could soon provide viable treatments for cardiovascular diseases, which cause about 50% of all deaths today.
Eucomed said research is currently under way in the field of heart-tissue regeneration, for example. With donor and mechanical heart valves encountering such problems as limited durability, shortage of supply and the inability to grow (posing a problem for childhood patients), the association said tissue-engineered valves will avoid these problems, being living replacements, capable of growing with the patient.
Research also is being undertaken to develop blood vessels capable of replacing natural vessels or to grow patches of heart muscle tissue to replace damaged tissue, Eucomed said.
Boston Sci launches 'full range' of DES sizes
Boston Scientific (Natick, Massachusetts) reported last month that it has received CE marking for three large vessel sizes (4 mm, 4.5 mm and 5 mm) of its TAXUS Express2 paclitaxel-eluting coronary stent system in Europe and other international markets. Previously, the largest drug-eluting stent (DES) system size available was 4 mm, which limited clinicians' options for treating patients with large vessels, according to the company. It said that the launch of the three large-vessel Taxus DES devices completes its line of sizes available in Europe and international markets, thus making it "the first company to offer a full range of stent sizes."
The company said it would launch the new sizes immediately and continue to supply all sizes of its Taxus systems. "With CE mark approval for large vessel sizes, we are now able to provide physicians a full complement of drug-eluting stent sizes featuring the safety, efficacy and outstanding deliverability of the Taxus system," said Paul LaViolette, Boston Scientific's chief operating officer.
The Taxus system received CE-marking in January 2003 and FDA approval in March 2004. The company said it expects to receive FDA approval for its large-vessel Taxus stent sizes in 1Q06.
In January, the company announced that it had launched its Taxus Libert paclitaxel-eluting DES, featuring the company's next-generation Libert coronary stent, in 18 countries. The company plans to launch the Taxus Libert system in Europe later this year and in the U.S. next year, subject to regulatory approval.
Xenomics files for Italian patent
Molecular diagnostics firm Xenomics (New York), a developer of next-generation medical DNA technologies, has filed a provisional patent in Italy for its technology enabling the detection of Transrenal-DNA of HIV and tuberculosis through the safe and non-invasive process of urine sampling.
"The filing of the provisional patent on our breakthrough detection of TB and HIV-DNA in the urine of AIDS patients marks a continued step in our strategy to aggressively expand the company's intellectual property portfolio and to protect that property with broad and well-enforced U.S. and international patents," said Dr. Randy White, CEO of Xenomics. "To manage this critical area, we recently established our Department of Licensing and Intellectual Property, and appointed veteran patent agent Dr. David Ladner to lead the department. Through filings such as this, Dr. Ladner is spearheading the expansion of our intellectual property portfolio."
The company said it believes the application of its patented technology platform may enable the creation of more accurate testing using urine specimens. The technology also provides the ability to simultaneously detect both HIV and tuberculosis, a common co-infection in AIDS patients, with a single urine sample, and has implications for the detection and treatment of residual HIV infections.
The discovery was made at the company's joint venture with the National Institute for Infectious Diseases (Lazzaro Spallanzani; Rome). Because the technology was developed in Italy, international patent regulations require that the patent be initially filed in that country where the discovery was made. The initial filing will lead to the filing of the broader European patent, and then to the U.S. patent.