Boston Scientific (Natick, Massachusetts) filed a patent infringement lawsuit against Johnson & Johnson (J&J; New Brunswick, New Jersey) in an attempt to enforce its patent rights for the NIR family of stents which Boston Scientific has licensed from Medinol. Filed in the U.S. District Court for Delaware, the suit charges that J&J's BX Velocity Coronary Stent System infringes upon the Medinol patents. Boston Scientific is seeking damages as well as preliminary and permanent injunctive relief. The Medinol patents cover proprietary flexible, cellular stent designs which, the company said in a statement, enables "a flexible stent with optimized vessel wall coverage and minimal foreshortening."
Jim Tobin, Boston Scientific's president and chief executive officer, said his company had made""a major commitment" to the technology incorporated in the NIR stents. "Their innovative design is protected by U.S. patents, and Boston Scientific has the exclusive right to sell stents using that design. We have filed this suit to preserve that right from infringement by others." Boston Scientific develops a variety of products used in a various interventional medical specialties.
Battelle forms spin-off business
Battelle (Columbus, Ohio) has formed a for-profit subsidiary, Battelle Pulmonary Therapeutics, to develop and market pulmonary and drug delivery technology to treat lung and other diseases. Battelle Pulmonary Therapeutics has office and lab space in Battelle's Columbus headquarters. It currently employs 11, a staff that could reach 15 to 20 over the next year, according to Battelle.
The business has developed a new cancer treatment based on inhalation therapy which delivers anticancer drugs directly to the lungs for patients with lung cancer or tumors that have metastasized to the lung. Phase I clinical trials are under way at the Arthur G. James Cancer Hospital and Richard Solove Research Institute, the National Cancer Institute, and Memorial Sloan-Kettering Cancer Center.
Janice Beauchamp, chief financial officer for the Battelle subsidiary, predicted it would have approximately $4 million in revenue this year and $6 million to $8 million next year. Battelle Pulmonary Therapeutics has a licensing agreement with ViroPharma (Exton, Pennsylvania) to use an EHD device with ViroPharma's small molecule antiviral drug candidate for the treatment of respiratory syncytial virus disease.
Sabratek to appeal court decision
Sabratek (Skokie, Illinois) said it will appeal the dismissal of a fraud and defamation lawsuit that it brought against a financial newsletter publisher and a web site developer, saying that they had unfairly criticized the firm. The initial lawsuit was filed against Mark Roberts, publisher of Off Wall Street, and Steven Alan Keyser, who, according to Sabratek, posts messages critical of the company under the name Pluvia. The suit claimed that both men were attempting to drive down the company's stock prices, Roberts because he had shorted Sabratek and Keyser because of his Internet criticisms, along with put option purchases he had made. However, U.S. District Judge Harold Baer Jr. threw out the suit, saying that criticism of the company was simply opinion and was not necessarily an attempt to manipulate the stock price.
A Sabratek spokesperson said the company would file an appeal and would provide further backing for its charges. The company develops and sells interactive, web-enabled medical systems. Last year it filed for Chapter 11 bankruptcy protection and, since then, has been divesting a number of its assets.
Edwards recalls Lifepath graft system
Just weeks after Edwards Lifesciences (Irvine, California) was spun off by Baxter International (Deerfield, Illinois) as a separate unit, the company was forced to halt sales of its Lifepath endovascular graft system outside the U.S. and issued a product recall. The actions came after discovery of flaws in the system, reported in two patients, with those flaws resulting in what the company called a fracture of its wireform. The Lifepath system is designed to treat abdominal aortic aneurysms (AAA), a ballooning of the aorta wall that may burst and frequently results in fatality. The company said that wireform fractures produced no adverse events in the patients.
Altogether, 235 patients have undergone aneurysm repair with the system, the company said, with Chairman and CEO Michael Mussallem saying the recall was "purely precautionary." Mussallem added, "In fact, each patient's aneurysm has been shown to be shrinking -- an indication that our product continues to function as intended, helping to treat this life-threatening condition. Nevertheless, our patients' health is always our primary concern, and we felt that voluntary suspension was the appropriate decision while we complete our evaluation."
Edwards Lifesciences said it has undertaken a prompt review of all Lifepath AAA cases to determine whether any additional wireform fractures exist.
Seedling forms early-stage investment firm
Seedling Enterprises (Newton, Massachusetts) has raised more than $3 million in capital to form a company investing in medical technologies. Seedling said it will acquire technologies and internally support their development until an appropriate exit time is reached. Seedling will provide inventors with a source for research support, development engineering resources, market assessment capability, and financing to move ideas quickly from early concept to proof-of-principle.
Private funding was raised from medical device executives having ties to many of the large, local medical companies, venture capitalists with ties to the medical device industry, and several seed funds. Seedling also has entered a partnership with ACT Medical (Newton, Massachusetts/Santa Clara, California), a medical device engineering and manufacturing company. ACT will provide engineering and support services to Seedling, allowing the company to minimize start-up and infrastructure investment.
Derma Sciences restructures
Derma Sciences (Princeton, New Jersey) has implemented a restructuring which involves the consolidation of certain national accounts and direct sales functions and the elimination of four sales management and sales representative positions. Additionally, company Chairman and CEO Edward Quilty and Vice President and CFO Stephen Wills have voluntarily taken substantial reductions in pay.
The changes will produce annual savings of about $600,000, according to Wills, and the company will take restructuring charges of $100,000 over the second and third quarters of this year. "We are confident that the difficult measures comprising this restructuring will provide a solid foundation for attainment of these goals," Quilty said.
Derma Sciences is a provider of skin care, wound management and specialty securement devices used in hospitals, nursing homes and home health settings.
Nycomed, Mallinckrodt in patent settlement
Nycomed Amersham plc (Buckinghamshire, United Kingdom) and Mallinckrodt (St. Louis, Missouri) have agreed to a major intellectual property settlement between Molecular Biosystems (San Diego, California), Mallinckrodt's ultrasound contrast product development partner, and Sonus Pharmaceuticals.
The agreement covers all markets around the world, with the exception of the Pacific Rim, and resolves key intellectual property disputes between the parties, including ultrasound bubble composition.
Under terms of the settlement, Nycomed Amersham will receive from Mallinckrodt a $10 million up-front license fee, as well as royalties of an undisclosed amount on future ultrasound contrast product sales. Nycomed Amersham also will receive immediate joint access to Optison, the ultrasound contrast agent currently marketed by Mallinckrodt for diagnosis of cardiac wall abnormalities. The two companies have agreed to collaborate on further joint development and commercialization of Optison and Nycomed Amersham's Sonazoid. In return, Nycomed Amersham has granted to Mallinckrodt a non-exclusive license under the Nycomed and Sonus patents, and Mallinckrodt and Molecular Biosystems grant Nycomed Amersham and Sonus the right to practice under their ultrasound patents.
Serologicals faces stockholder lawsuit
A class-action lawsuit has been filed on behalf of purchasers of the common stock of Serologicals (Atlanta, Georgia) between April 27, 1999, and April 7, 2000, in the U.S. District Court for the Northern District of Georgia. The complaint charges Serologicals and certain of its directors and officers with issuing "materially false and misleading financial statements" overstating the company's revenue, earnings, and income. As a result, Serologicals' stock price was artificially inflated throughout the class period, according to the suit.
Companies ... in brief
Bovie Medical (Melville, New York), a maker of electrosurgical products, said that received an order, valued at more than $550,000, for one of its Bovie 300 watt operating room generators and accessories. The company said the products will be used at medical facilities in Pacific Rim countries
4-D Neuroimaging (San Diego, California), formerly Biomagnetic Technologies, reported that its stock symbol changed to FDNX May 1. The change was made "to better reflect our recent name change to 4-D Neuroimaging," said D. Scott Buchanan, president and CEO. The term 4-D is intended to suggest the company's focus on developing information "about when and where normal and abnormal functions are occurring in the brain."
Instrumentarium Imaging (Milwaukee, Wisconsin) has received ISO 9002 certification for its quality management system, covering sales and service of medical and dental X-ray equipment. Instrumentarium's three business segments are anesthesia and critical care equipment, medical equipment and supplies, and optical retail
Sterling Vision (New York) has changed its name to Emerging Vision. The company said the name change is a step toward realizing its business-to-business Internet objectives
Therapy Lasers (Houston, Texas) effected a 1-for-10 reverse stock split of its common stock. Shareholders received 1 share of common stock in exchange for and cancellation of 10 shares previously held by the owner at the April 24 trading close. The reverse split will result in approximately 1.3 million shares of common stock outstanding.