A Medical Device Daily
Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and related software solutions, has signed a five-year exclusive agreement with Nihon Kohden (Tokyo) to market and sell the Zoll AutoPulse noninvasive cardiac support pump in Japan, to begin upon receipt of regulatory approval from the Japanese Ministry of Health, Labor and Welfare.
With annual revenue of about $790 million, Nihon Kohden is one of the top 100 companies worldwide selling medical equipment and one of the top 10 companies specializing in medical devices.
Richard Packer, president and CEO of Zoll, said, “Nihon Kohden sees the AutoPulse as an innovative product that can help improve patient care.” Citing Nihon Kohden's 650-person direct sale force, he said, “this exclusive agreement provides significant revenue opportunity for the AutoPulse in the world's third-largest economy.”
Commenting on the market potential of the AutoPulse, Packer continued, “Healthcare organizations in Japan are accepting of the concept of mechanical CPR because other devices that automate the CPR process have been in Japan since 1988. Consequently, more organizations understand the benefit, and are more likely to have allocated capital for such products.”
Zoll produces a comprehensive set of products for pacing, defibrillation, circulation, ventilation and fluid resuscitation that help clinicians, EMS professionals and lay rescuers resuscitate sudden cardiac arrest or trauma victims. The company also provides software that automates the documentation and management of both clinical and non-clinical information. It sells its products in more than 140 countries.
New unit to aid Bridgetech trials
Bridgetech Holdings International (San Diego), focused on maximizing emerging healthcare products and services in the U.S. and Asia, said it is collaborating with the Chinese University of Hong Kong (CUHK) to establish a new entity to manage clinical trials performed in Hong Kong and throughout China.
This new entity will oversee the State Food and Drug Administration (SFDA) application process and the requisite trials necessary to obtain regulatory approval for Bridgetech's products.
Michael Chermak, chairman and CEO of Bridgetech, termed the agreement “a concrete step in addressing the regulatory portion of Bridgetech's strategy.” He said the platform requisite clinical research organization (CRO) infrastructure already is in place, “so we are able to initiate our first trials almost immediately. CUHK is one of the institutions in Asia recognized by the U.S. FDA, which makes the data generated in these trials extremely valuable.”
Chermak said the company's domestic partners will use this information to augment their existing datasets.
Dr. Benny Zee, director of the CUHK Center for Clinical Trials, said, “We have spent several years establishing both our infrastructure and our relationships throughout China and are eager to begin taking promising products through the approval process.”
Bridgetech says it is bringing emerging devices, diagnostics and drugs to China with initial focus on oncology.
Kumars leads Applied Biosystems in Asia Pacific
Applied Biosystems (Foster City, California) has appointed TLV Kumar president for its Asia Pacific operations, based in Hong Kong.
An Applera (Norwalk, Connecticut) business, Applied Biosystems is a developer of instrument-based systems, consumables, software and services for the life sciences industry.
An executive with experience throughout the Asia Pacific region, Kumar joins Applied Biosystems from Philips Medical Systems , where he was chief operations officer for Asia Pacific.
Kumar will be responsible for executing the company's growth strategies throughout the region, with oversight of all marketing, sales, product management, customer service, supply chain, purchasing, quality, regulatory and business excellence activities.
Applied Biosystems has operations throughout Asia Pacific, including Japan, China, Hong Kong, Taiwan, South Korea, Australia, New Zealand and the 10 nations that comprise the Association of Southeast Asian Nations.
For the first nine months of the current fiscal year, the Asia Pacific region contributed $252 million or about 18% of global Applied Biosystems revenues.
pSivida expands BrachySil study scope
Global bio-nanotech company pSivida (Perth, Australia) reported that the scope of the BrachySil Phase IIb clinical trial for inoperable primary liver cancer has expanded to encompass a roll-out to further clinical centers in new Asian territories. In addition to the five centers currently active in Singapore, and centers in Vietnam and Malaysia, new centers are being negotiated in the Philippines and Taiwan.
A Phase IIb clinical trial commenced in October 2005 with BrachySil (32-P BioSilicon) as a potential new treatment for inoperable primary liver cancer (hepatocellular carcinoma or HCC).
pSivida said it also is progressing in a dialogue with the FDA relating to the U.S. program for HCC and pancreatic cancers. The study, designed in collaboration with Singapore General Hospital (SGH), is designed to determine the optimal dose of BrachySil in treating inoperable HCC. Patients will be evaluated up to 12 months after treatment. The endpoints will be based on evaluations of patient safety and target tumor responses, as well as overall survival.
A Phase IIa study conducted at SGH in 2004 on eight patients with advanced liver cancer, showed BrachySil to be both safe and well tolerated. All patients experienced a decrease in the size of their tumors, with some experiencing complete regression. To date, six of eight patients are still alive.
pSivida is a global bio-nanotech company committed to the biomedical sector and the development of drug delivery products.
MSI adds China contracts
Medical Services International (MSI; Edmonton, Alberta) said it has increased its contracts in China and is now supplying 18 separate hospitals in that country with the VScan HIV test kit in addition to pharmaceutical companies, a large industrial company and one retail chain.
This group currently using the VScan test kit just represents the Southeastern China area. The company said its distributor has started to introduce the VScan products into northeast China.