A Carnegie Mellon University-led team has secured up to $42m from ARPA-H to develop devices that deliver patient-specific therapy and monitor disease status for conditions like hypo-and hyperthyroidism in real time.
The award is part of the ARPA-H REACT program, which supports the development of implantable bioelectronic devices to improve patient management of chronic diseases.
Burak Ozdoganlar, professor of mechanical engineering at Carnegie Mellon University (CMU), will head the Biointegrated Implantable Systems for Cell-based Sensing and Therapy (BIO-INSYNC) project as the primary investigator.
The multidisciplinary project team includes researchers from the University of Pittsburgh/UPMC, University of Florida, and University of California-Santa Cruz. Two companies, Ginkgo Bioworks and Velentium, are also in the consortium.
During the project, the team will develop and test two multi-part, pacemaker-sized system platforms that will be implanted in a patient's chest cavity through an outpatient procedure and offer real-time, adjustable, low-cost therapy and disease monitoring for up to 12 months.
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Following a ‘living pharmacy’ concept, one of the systems will use human cells to produce and release the necessary dose of a hormone or other therapeutic molecules on demand.
Utilising a ‘living sentinel’ concept, the second system will use cells that measure critical biomarkers to monitor the patient’s disease status continuously in real time. Both will feature remote interfaces to communicate key information and measurements with the patient via smart devices or directly to their healthcare provider.
While this technology can be used to treat various diseases and conditions, the team will specifically focus on its application to thyroid disorders, which impact an estimated 12 per cent of Americans.
According to CMU, BIO-INSYNC devices will enable patients to continuously monitor key hormones and deliver the right therapeutic dose as needed, eliminating current protocols like daily medications and regular blood testing. The project will conduct also a first-in-human clinical trial for patients facing thyroid conditions.
“The thyroid gland controls so many integral processes within the body, and thyroid hormone imbalances can lead to weight gain or loss, mental health issues, fertility problems, and even heart diseases,” Ozdoganlar said in a statement. “It’s important also to note that thyroid disorders disproportionally impact vulnerable populations. Our bioelectronic system offers an innovative avenue for patients to self-manage their thyroid hormone levels at a fraction of the cost. The aim is to improve patients’ quality of life by improving thyroid treatments while bridging disparities in healthcare to attain equitable care for all.”
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