The Giner BAPIOS™ system includes an implantable capsule with clinical testing and proven safety records
Mansfield, MA – November 17, 2015 – Proven Process Medical Devices Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today it has been selected by Giner, Inc. to manufacture its cell implant device for use in administering cell therapies for indications such as liver failure, Parkinson's disease, (para)thyroid disease, pancreatectomy and Type 1 diabetes (T1D).
Giner, a Boston-based research and development firm committed to developing and commercializing cutting-edge electrochemical technologies, has developed a miniaturized implantable electrochemical oxygen generator (EOG) that will continuously supply oxygen to islets or cells within an immunoisolation cell implant device. Oxygenation maintains cell viability and function at high cellular densities, minimizing overall implant size. The first proposed application of this platform technology is the BioArtificial Pancreas with Implantable Oxygen Supply, or BAPIOS™, a human pancreatic islet implant for the treatment of Type 1 diabetes (T1D).
In practice, this bioartificial pancreas includes a remotely powered, miniature oxygen generator that can be implanted in the body and the oxygen produced will be a critical enabler of compact cell therapy implants. The BAPIOS™ system will be fully implanted subcutaneously without infection-prone percutaneous tubes/leads.
As Giner readies its implantable device for commercialization, it sought a manufacturing partner with deep experience producing intricate, self-contained devices used in the disbursement of various cell therapies. In choosing Proven Process, Giner gains access to the technical acumen of a team well-versed in bringing innovative medical devices from Concept-to-Customer™. In addition, Proven Process holds ISO-13485 certification, covering contract services for the design and development, production and servicing of active implantable and in-vitro diagnostic medical devices.
“Giner has pioneered the next wave of innovative implantables that deliver critical cell therapies while also minimizing discomfort for patients and opening up a wide range of possibilities for those suffering from chronic ailments,” said Ken Fine, president and co-founder of Proven Process Medical Devices. “We are pleased that Giner has chosen Proven Process as its manufacturing partner to help navigate both the development and production phases as well as handling the intricacies of FDA regulatory submissions and approvals.”
About Proven Process
Proven Process Medical Devices Inc. is one of the industry’s leading designers and manufacturers of Class II and Class III medical devices. The company was founded in 1994 to address the unmet need for an outsourced provider to the medical device industry with the in-depth technical, quality and regulatory knowledge needed to develop and manufacture sophisticated medical products. To ensure success, the company founders developed a "Proven Process," which combines creative, state-of-the-art R&D, with exceptional design, process, and quality controls to achieve new product development and manufacturing success. For more information, visit http://provenprocess.com or follow us on Twitter @ProvenProcess.
For more information, contact Michael Kanis, Sales Engineer, at 508-61-0849