A Medical Device Daily
Biofield (King of Prussia, Pennsylvania), which said late last month (Medical Device Daily , July 31, 2007) that it had granted a master license to the MacKay Group Ltd. (Hong Kong), reported that MakKay has signed a memorandum of understanding to form Biofield Asia in a joint venture with United Premier Medical Group (UPMG; Hong Kong).
UPMG delivers healthcare services to China in partnership with well-known Western healthcare providers, including through its VIP ob/gyn centers in that country.
Biofield develops non-invasive diagnostic medical devices to assist in detecting breast cancer. Its Biofield Diagnostic System (BDS), a breast cancer diagnostic device, employs single-use sensors to measure and analyze changes in cellular electrical charge distributions associated with the development of epithelial cancers.
The BDS device is intended for palpable breast lesions in women under 55 years of age.
Biofield Asia will exclusively market, distribute, manufacture, and further develop and conduct R&D on the BDS in or for mainland China, Hong Kong, Macau, Taiwan, Singapore, Malaysia, the Philippines, Japan, Korea, Indonesia, India and Australia.
UPMG will seek approval from the State Food and Drug Administration in China, will purchase BDS devices and sensors, and will pay undisclosed sums to Biofield pon certain milestones related to regulatory approval, manufacture, and sales in China and certain countries.
Biofield said UPMG "has bridged the cultural, technological and medical gaps between the U.S. and China and has shown that it is capable of delivering high standards of healthcare services to China on a local and national level to meet the ever-increasing demand."
The company started with the creation and delivery of hospital consultancy services in large cities, including Beijing, Shanghai and Guangzhou, and plans to further extend its service network across China within the next five years, hoping to develop into a nationwide chain of specialized healthcare operations.
Biofield CEO Michael Antonoplos said: "This is the dawn of a new era for Biofield and we hope the beginning of a new era for women worldwide. Given its strategic partnership with leading western healthcare providers in China, we believe that there is no better institution than UPMG to bring together the best from East and West to fight cancer."
He added, "While this new partnership creates a footprint [that] extends to some of the more critical and lucrative markets in the world, more importantly, it creates an opportunity to potentially help hundreds of million of women in Asia."
Antonoplos said he believes the new partnership with UPMG "will usher in the type of joint clinical trials, R&D, advancement of Biofield's technology and other East-West government-industry collaboration, [that] will benefit women and areas outside Asia, including the U.S., and which could help the fight against other cancers."
Indian clinical trials manager named
HemoBioTech (Dallas) said it has promoted Saraswathy Swaminathan to the position of manager of foreign clinical affairs, with an initial emphasis on working to establish clinical trials of the company's HemoTech blood substitute product in India.
Prior to joining HemoBioTech, Swaminathan worked at the University of Texas Southwestern Medical Center as a research associate in the multiple sclerosis division of the Department of Neurology, conducting clinical trials for pharmacological drugs at the clinic on behalf of pharmaceutical companies and the military.
Her appointment comes on the heels of an announcement earlier this summer that HemoBioTech had engaged Paragon Biomedical (Irvine, California) to provide regulatory and clinical services in India related to HemoTech (Medical Device Daily , July 2, 2007).
Paragon will submit pre-clinical data regarding HemoTech studies that were part of a European IND and clinical data related to the HemoTech human study in Zaire to the Indian regulatory agency for review. The goal is to receive permission to commence clinical studies of HemoTech in India.
"While we are focused on establishing a U.S. clinical trial of HemoTech, [we consider] India to be an integral part of our global strategy to commercialize HemoTech," said Arthur Bollon, PhD, chairman and CEO. "With a population that exceeds 1 billion people, a significant middle class [and] a solid infrastructure for clinical trials, HemoBioTech considers India a potential stand-alone market for HemoTech."
HemoBioTech said that previous efforts by other companies to develop a human blood substitute during the past 35 years have failed because of toxicity issues, but HemoTech's apparent lack of toxicity is believed to be due to the company's proprietary chemical modification of hemoglobin.
Alberta certification for Nightingale
Nightingale Informatix (Markham, Ontario), a healthcare application service provider (ASP) of electronic medical record (EMR) and practice management solutions, said it has received confirmation from Alberta Health & Wellnet (Edmonton, Alberta) that its EMR software received Level One and Level Two re-certification under Alberta's Physician Office System Program (POSP) Vendor Conformance and Usability Requirements, placing Nightingale on the approved VCUR Product Vendor List.
Physicians in Alberta qualify for POSP funding for physician office system software when implementing products on the POSP-approved vendor list.
"Physicians within Alberta have increasingly begun to implement EMR to improve the efficiency of sharing patient data and enhance overall patient care," said Sam Chebib, president and CEO. "With the option of POSP funding for implementing products from the approved vendor list, physicians within the province are using the list as a fundamental component of their decision-making process. Being an approved vendor distinguishes Nightingale within the Alberta marketplace and strengthens our competitive position province-wide."
Nightingale's Internet-based EHR, electronic medical record and practice management solutions are designed to help physicians, health centers, hospitals and other healthcare organizations more efficiently manage their operations and patient records. The company's software offerings include Nightingale On-Demand, RidgeMark, Medical Helper, Therapist Helper, Northern Health Anesthesia, Entity and Physician WorkStation and SecureConnect.