Ferraris Medical Inc, Holland, NY, has purchased the assets of the medical division of Warren E. Collins Inc (Collins Cybermedic), Braintree, Mass.
“With the Collins/Cybermedic acquisition, Ferraris will now have a very strong presence in both the North American and European markets, with an enlarged line of respiratory diagnostic equipment,” said David Malys, Ferraris president and CEO. “Both the Collins and Morgan companies will be strengthened by the common Ferraris ownership in improved distribution and increased engineering research and development capabilities, and this will improve the flow of new products to cardiopulmonary and sleep diagnostic labs worldwide,” Malys said.
Ferraris Medical manufactures and markets respiratory monitoring instruments and asthma products for hospital, physician office, and home patient use.
Collins/Cybermedic is a designer, manufacturer, and marketer of cardiopulmonary diagnostic equipment for hospital and clinic use.
AVL Acquires Laboratory Data Systems
AVL Medical Instruments, Roswell, Ga, a global developer and supplier of critical care diagnostic instruments, has acquired Laboratory Data Systems (LDS), Tampa, Fla, adding proven data management capabilities to its rapidly growing critical care product portfolio.
This acquisition strengthens AVL’s ability to provide complete and integrated critical care testing solutions, enabling hospital managers to closely monitor the quality and efficiency of diagnostic testing. This capability has increased in importance as more point-of-care testing initiatives have put critical care diagnostic testing in the hands of nonlaboratory personnel.
“The LDS acquisition is an important strategic step for AVL. Data management is a key component of our goal to provide complete critical care testing solutions, from the laboratory to the point of care,” said Alfred Marek, president of AVL. “LDS is the clear leader in this field, and we are pleased to welcome LDS to AVL.”
The acquisition of LDS is the second major growth initiative taken by AVL this year. In January, the company announced a global co-operation and alliance agreement with Boehringer Mannheim (now Roche Diagnostics), the world’s largest medical diagnostic firm for research and development, manufacturing, and comarketing of products, information solutions, and services for the estimated $600 million hospital point-of-care testing equipment market.
In addition to AVL’s strategic business endeavors, it received FDA approval for the OPTIT Critical Care Analyzer, a fully automatic point-of-care analyzer. The OPTI analyzer utilizes single-use cassettes with up to eight different parameter configurations for measuring pH, total hemoglobin, oxygen saturation, blood gas, and electrolyte parameters, as well as the widest range of calculated parameters.
AVL is a leader in the development, manufacture, and marketing of AVL and private-label electrolyte analyzers and sensor technology for clinical laboratory markets worldwide. LDS is a market leader in blood gas data management software with more than 400 installations of its DataCare ABGr xsystem in the United States.
NPB 840 Ventilator Available Outside the United States
Mallinckrodt Inc, St Louis, has begun selling the new 840T Ventilator System in Europe, Latin America, and parts of the Asia Pacific Region. The system is manufactured by Nellcor Puritan Bennett, a part of Mallinckrodt’s Respiratory Group.
Designed to treat patients in intensive care units and subacute care facilities, the 840 Ventilator features high-performance pneumatics and dual microprocessor electronics that allow sensitive, precise breath delivery for critically ill infant, pediatric, and adult patients.
The product also introduces new proprietary technology to respiratory care. DualViewT touch screens display monitored data separately from ventilator settings, and the SandboxT area on the screen allows the clinician to preview selected settings before applying them to a patient. The SmartAlertT alarm system ranks alarms by urgency and helps the operator identify root causes. The system is also light and compact, and can be upgraded.
“We are very excited about this product,” said C. Ray Holman, chairman and CEO of Mallinckrodt. “It represents the next generation of top-of-the-line critical care ventilators.”
Mallinckrodt is seeking 510(k) clearance for the ventilator from the FDA.
Scandipharm Welcomes New CEO
Scandipharm Inc recently welcomed Thomas S. Stribling, president and CEO of the company. Stribling also serves on the company’s board of directors.
Stribling was formerly the vice chairman of Legacy Securities Corp, an investment banking firm in Atlanta. Stribling began his career in the health care industry. Prior to joining Legacy, he served as president of UCB Pharma, a company that eventually acquired Northampton Medical Inc, a company formed by Stribling.
“Having known Scandipharm since its inception, I have been very impressed with its ability to grow and innovate through challenges facing all pharmaceutical companies. It is a terrific opportunity to join an excellent group and I am excited to be a part of the team,” Stribling said.
ResMed and Invacare Sign Distribution Agreement
ResMed Corp, San Diego, has announced it has signed a 3-year distribution agreement with Invacare Corp to distribute selected ResMed CPAP and bilevel devices. The agreement forms a strategic alliance between ResMed and Invacare and marks Invacare’s formal entry into the sleep-therapy business.
Under the terms of the agreement, Invacare has been granted third-party distribution rights in the United States for ResMed’s SULLIVANr V CPAP and ComfortT bilevel devices. The company also has distribution rights for selected ResMed nasal interfaces used in conjunction with the CPAP and bilevel devices.
These products will be marketed through Invacare’s 100-plus sales force to home care providers beginning in the second calendar quarter of 1998. ResMed’s 50-plus sales force will continue to market these products, as well as its other diagnostic and therapeutic respiratory products, through its existing distribution channels.
“ResMed is pleased to enter a strategic alliance with Invacare in the sleep-disordered breathing business. The alliance adds value to both parties by allowing Invacare to augment its respiratory products line and ResMed to widen and deepen the market penetration of our excellent range of sleep products,” said Dr Peter C. Farrell, chairman and CEO of ResMed. “In addition, for an agreed-upon royalty arrangement, we have licensed to Invacare certain ResMed patents relating to sleep-disordered breathing products.”
ResMed is a leading designer, manufacturer, and distributor of medical equipment for the treatment of sleep-disordered breathing. Invacare is the world’s leading manufacturer and distributor of home health care products and mobility products for people with disabilities.
Instrumentarium Purchases Ohmeda’s Medical Equipment Businesses
Instrumentarium Corp, Helsinki, Finland, has announced the acquisition of Ohmeda’s Medical Systems and Specialty Products Divisions, formerly part of the UK-based BOC group. The final agreement is currently in effect with the exception of India, where an agreement is expected to be completed in a few months.
Instrumentarium has combined its largest division, Datex-Engstrom, with Ohmeda’s Medical Systems Division to form Datex-Ohmeda (Instrumentarium has gained the exclusive global right to the Ohmeda name). Datex-Ohmeda offers customers a significantly broader range of products than either company individually, and can combine both organizations’ efforts in continuous product development.
“Datex-Engstrom and Ohmeda share a broad range of complementary products, such as the AS/3 Anesthesia Delivery Unit and the Aestiva 3000, and a strong reputation among customers-attributes that will enable Datex-Ohmeda to draw on extensive resources and a track record of worldwide success,” said Olli Riikkala, president and CEO of Instrumentarium. “Ohmeda’s well-established US presence will enable us to become a powerful source in this very important market,” he said.
Datex-Engstrom has a global position in anesthesia monitoring and is rapidly building a significant presence in anesthesia delivery equipment and systems for intensive care and clinical information management. Ohmeda’s Medical Systems Divison is a leading supplier of anesthesia machines in the US market and a leading worldwide supplier of anesthesia machines, anesthetic agent vaporizers, respiratory monitors, and pulse oximetry products. The new entity, Datex-Ohmeda, has a presence in more than 100 countries through its subsidiaries and distributors.
The Specialty Products Division of Ohmeda is a developer, manufacturer, and marketer of infant incubators, warmers, and phototherapy systems, and suction and oxygen therapy products. It will be managed separately from Datex-Ohmeda as an independent division of Instrumentarium.
Novametrix Awarded Contract
Novametrix Medical Systems has been awarded a 3-year dual source agreement for pulse oximetry with the Defense Supply Center in Philadelphia. In addition, the company has also signed a development and manufacturing contract with a major Illinois-based pharmaceutical company.
“We are very pleased to have our pulse oximeters chosen by the Defense Supply Center for use in military hospitals,” said William J. Lacourciere, chairman, president, and CEO of Novametrix. “Previously, NASA chose our CO2 technology for the space shuttle program and the army chose our oximetry CO2 and flow measurement technology to be included in the L-STAT Program (Life Support for Trauma and Transport). I believe it is indicative of the quality and superior performance of Novametrix products that the US government has chosen them for these important programs,” he said.
Novametrix also has agreed to develop and manufacture a new monitor with a pharmaceutical company that will incorporate both companies proprietary technologies and will measure an entirely new medical parameter, according to Lacourciere.
“The new product line will require FDA approval. We expect a normal time frame for the FDA approval process, and shipments should begin in the late spring or early summer of next year,” he said.
Novametrix Medical Systems is a leading designer, developer, manufacturer, and marketer of medical electronic instruments and sensors that noninvasively and continuously assess a critically ill patient’s oxygen, carbon dioxide, and respiratory mechanics.
HP and NPB Announce Agreement and ISO 14001 Certification
Hewlett-Packard Company (HP) and Nellcor Puritan Bennett (NPB), a Mallinckrodt Inc business unit, have announced a new perinatal products-distribution agreement for selected world markets. NPB also announced it has received ISO 14001 Environmental Management System Standard certification-the first awarded to a medical device manufacturer in the United States.
Under the terms of the agreement, HP will sell the NPB N-400 Fetal Oxygen Saturation (FSpO2) Monitor and FS-14 Series Fetal Oxygen Sensors in Germany, Austria, Switzerland, Belgium, Netherlands, Luxembourg, Italy, and the UK. Other locations include Hong Kong, Singapore, Australia, and New Zealand. Additional locations are under consideration.
“This new distribution agreement further establishes HP’s relationship with NPB,” said David Russell, worldwide product marketing manager, patient monitors and measurements, HP patient monitoring division. “It will enable HP to interface the N-400 product to our installed base of HP 8040A and HP Series 50 family of fetal monitors, complementing our complete obstetric-monitoring product portfolio.”
“HP’s strong presence in the obstetric market and large installed base of fetal monitors will enable NPB to distribute fetal-oximetry technology more effectively to customers in Europe and Asia Pacific,” said Debra Reisenthel, senior director of NPB’s perinatal division.
NPB’s recently awarded ISO 14001 certification requires companies to establish an environmental policy statement and set measureable objectives and targets to improve their environmental operations. After receiving the certification, NPB will be audited yearly for continuous improvement toward meeting environmental goals.
“This program will benefit our employees, our customers, and our community. Our intent is for each and every employee in the Carlsbad, Calif, facility to be personally committed to, and responsible for, environmental protection,” said Donal Quinn, president, hospital business for Mallinckrodt. “Our ultimate goal is zero discharge of waste from the plant.”
Novo Nordisk and Aradigm Sign Agreement
Novo Nordisk A/S, Bagsvaerd, Denmark, and Aradigm Corporation, Hayward, Calif, have announced they have signed an agreement to jointly develop a pulmonary delivery system for administering insulin by inhalation.
The development project is expected to enter Phase 2 testing in the second half of 1998. The parties will evaluate the system for the delivery of other compounds to regulate blood glucose levels. The agreement also provides Novo Nordisk with an option to develop the technology for delivery of other compounds in two undisclosed therapeutic areas outside diabetes. Novo Nordisk holds the exclusive rights to worldwide marketing of any products resulting from the development programs.
“We are very excited to be collaborating with Aradigm on this ‘next generation’ pulmonary delivery technology. We have found that Aradigm’s comprehensive approach to making pulmonary delivery of insulin accurate and reproducible is unsurpassed,” said Lars Rebien Sorensen, corporate executive vice president and head of health care at Novo Nordisk. “We are very hopeful that this new partnership will result in important new therapeutic options for people with diabetes,” said Sorensen.
“The products we are developing with Novo Nordisk are designed to let people with diabetes achieve tight control over their blood glucose levels, without injections,” said Richard P. Thompson, president and chief executive officer of Aradigm. “We are excited about the opportunity to work with the world leader in the insulin market and a true innovator in alternate forms of drug delivery,” said Thompson.
The joint development program is based on Aradigm’s AERxT Pulmonary Drug Delivery System, which uses proprietary technologies to create aerosols from disposable unit-dose liquid drug formulations. It also uses an “electronic inhaler” for delivering to the lung locally or systematically via the lung. The handheld system is intended to provide a very flexible way for patients to adjust their insulin dosage to precise levels.
Radiometer Announces Certification, Status of Analyzers
Radiometer Medical A/S, Copenhagen, Denmark, recently announced it has received ISO 9001 certification. The company also stated that the turn of the century will not impose unintended effects for its analyzers and monitors.
Radiometer received three certifications in one-ISO 9001, EN 46001, and CE Approval (CE approval is a special requirement of medical companies selling in the European Union (EU) of countries.
Radiometer also announced that it would be able to make the transition to the year 2000 without any impact on its performance. All analyzers and monitors were tested according to British Standard DISC PD2000-1 procedure. No unintended effects were found when all software using a built-in calendar (ABLT3 Series, ABLT5, ABLT500 Series, ABLT600 Series, BPHT5, and EMLT) were checked for possible effects in connection with the arrival of the next century.
Vitalograph Celebrates Anniversary
Vitolagraph, Lenexa, Kan, recently celebrated its 35th anniversary at the ALA/ATS conference in Chicago. To thank each visitor who stopped in the booth, the company held a drawing for the chance to win a bottle of champagne. The lucky winner was Larry Miller from New York.
Update on Spirosr Asthma Products
Dura Pharmaceuticals Inc, San Diego, and Spiros Development Corporation II, Inc, have jointly announced that patient dosing of the 1-year open-label clinical trial for Albuterol SpirosT has been completed, as well as FDA GMP preapproval inspection of Dura’s manufacturing facility for the first Spiros product. Also, enrollment in the Beclomethasone SpirosT pivotal clinical trial has been reached.
“The completion of the Albuterol Spiros open-label trial concludes our planned pre-approval clinical trial program, and we expect to submit data from this trial to the FDA early in the spring quarter,” said David S. Kabakoff, Dura’s exective vice president and chairman, president, and CEO of Spiros Corp II. “Based on the favorable results of the preapproval inspection of our manufacturing facility by the field investigators, it is still reasonable to anticipate an FDA decision on Albuterol Spiros by the end of the year and, pending approval, to launch the product in the first quarter of 1999,” said Kabakoff.
“The Spirosr technology represents an extraordinary opportunity to improve the approach to pulmonary drug delivery in the United States. Our strategy is designed to first benefit patients with asthma and chronic obstructive pulmonary disease (COPD), as we are developing, on behalf of Spiros Corp II, formulations of five of the leading therapies for these respiratory diseases for delivery in Spiros,” said Dura chairman and CEO Cam L. Garner. “We expect to commercialize these drugs over the next 4 to 5 years, pending FDA approval, which will provide physicians and patients with an alternative form, designed to be efficient and easy-to-use, of some of the most commonly prescribed respiratory medications.”
The Spiros Inhaler uses a unique, breath-activated device that is designed to deliver a consistent dose of drug to the lung independent of a patient’s ability to inhale forcefully. Spiros also does not require chlorofluorocarbon (CFC) propellants. Albuterol Spiros is expected to be the first multidose non-CFC albuterol powder inhaler product in the United States.
SleepNet Announces Promotions
Cynthia Poltack has been appointed international account manager of SleepNet Corporation, Manchester, NH. She will offer sales, technical, and promotional support to international customers. She has worked at SleepNet since 1995.
Barbara “Bobbie” Doyle has been appointed account manager, offering regional technical and sales support as well as patient awareness and education.
SleepNet Corp manufactures and distributes products for the treatment of sleep apnea, including the Phantom Nasal Mask and DPAP Stealth interactive CPAP.