Proven Process Medical Devices said yesterday it signed on to develop and manufacture a cell implant device for Giner used to administer cell therapies for indications such as liver failure, Parkinson’s disease, parathyroid disease, pancreatectomy and Type 1 diabetes.
Giner is developing a miniaturized implantable electrochemical oxygen generator to continuously supply oxygen to islets or cells in an immunoisolation cell implant device, Mansfield, Mass.-based Proven Process said.
The company hopes to use the platform in a BioArtificial Pancreas with an implantable oxygen supply to treat Type 1 diabetes.
“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. 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,” Proven Process prez Ken Fine said in a press release.
Proven Process is partnering with Giner to develop and manufacture and take the device from concept to production as Giner seeks to commercialize the implantable device.
In June, Proven Process said that it’s partnering with clinical-stage neuromodulation company PathMaker Neurosystems to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation.
Trans-spinal direct current stimulation is a novel form of non-invasive neurostim, Proven Process said. The spinal stimulation uses a direct current to stimulate spinal circuits using skin surface electrodes, the company added.
Proven Process said it plans to refine the design of Pathmaker’s prototype, as well as manage the manufacturing of the device for clinical trials, regulatory submission and commercial distribution.
