A Medical Device Daily
Aethlon Medical (San Diego) has entered into a non-exclusive agreement with Bioserv (formerly known as NextPharma Technologies; San Diego) to establish manufacturing of the Aethlon Hemopurifier under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization.
The Hemopurifier is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins from the entire circulatory system. Safety of the Hemopurifier has been demonstrated in multi-site human studies, with robust viral load reductions observed in enrolled Hepatitis-C (HCV) infected patients.
NextPharma is an outsourcing partner for the medical industry.
Market clearance of the Hemopurifier will be required by the FDA prior to mainstream commercialization in the U.S.
"While GMP may not be required for clinical studies, it will position us to export our Hemopurifier for sale as demand becomes established in India and other practitioner driven markets," said Aethlon chairman/CEO, Jim Joyce. "Additionally, the manufacturing of our Hemopurifier under GMP improves our readiness to respond to emergency and humanitarian use requests, including the sudden emergence of bioterror and pandemic threats."
In other agreements/contracts news:
• Paragon Benefits (Atlanta), a wholly owned subsidiary of the Georgia Bankers Association Insurance Trust (GBAIT), reported a partnership with North Star Health (also Atlanta), a healthcare data analytics company.
Lumina is North Star Health's cost and care management program that integrates wellness, preventive health, disease management and predictive health functionalities into one platform. Designed for both employer and employee use by separate online portals, the program provides visibility and self-directed management of healthcare costs as well as health and wellbeing.
"Our search for a system that allows maximum flexibility in reporting led us directly to the Lumina product from North Star Health," said Dan Thomason, chairman/CEO of Paragon. "Lumina's ability to link the employee health data directly to the employer through a single database platform gives us the ability to report across an entire employer base population, regardless of the number of health plans offered."
• The Sisters of Charity Health System (SCHS; Cleveland) and University Hospitals (UH; also Cleveland) have jointly reported a non-binding letter of intent to modify an existing 50/50 not-for-profit ownership structures of St. Vincent Charity Hospital (Cleveland) and Mercy Medical Center (Canton, Ohio).
An equal 50/50 joint venture between SCHS and UH will remain at St. John West Shore Hospital (Cleveland) with the addition of UH assuming operations through a new management agreement.
• Premier Purchasing Partners (San Diego) reported new agreements for steam sterilizers with Getinge USA (Rochester, New York) and Steris (Mentor, Ohio). Effective March 1, the 36-month agreements are available to acute- and continuum-of-care members of the Premier healthcare alliance.
• Greenway Medical Technologies (Carrolton, Georgia) said it will be deploying its EHR solution, PrimeSuite, into the nation's largest general pediatric practice, the 70-physician Pediatric Associates (Bellevue, Washington).
With this implementation, Pediatric Associates' eight facilities (Bellevue, Factoria, Pine Lake, Redmond, Sammamish, Totem Lake, Redmond Ridge and an administrative office located in the greater Puget Sound region of Washington) will use PrimeSuite 2008, an ambulatory EHR that includes certification in child health, to streamline its clinical, financial and administrative workflows while creating an interoperable system where patient information can be shared seamlessly within the organization.