Trisha Pfluger, M.S., PMP, Chief Scientific Officer, and Nicholas Totagrande, CEO, Juno Biomedical, Inc. talk medical advancement, AI, and next steps for CELLTech DBS medical technology.
ROGERS, AR / ACCESSWIRE / September 9, 2024 / CELLTech DBS is the flagship deep brain stimulation (DBS) device of Juno Biomedical, Inc. [Introduction to DBS].
CELLTech DBS leverages a unique, proprietary waveform to maximize brain tissue healing after damage.
"By integrating artificial intelligence and deep brain monitoring, CELLTech DBS offers cutting-edge personalization. Further, CELLTech DBS is both scalable and affordably manufacturable," says Trisha Pfluger, CSO.
CELLTech DBS is currently being developed in the United States in close collaboration with the FDA through the Early Feasibility Study (EFS) Program [FDA's EFS Program].
"It has been amazing to work with the FDA over the past six years to settle on how CELLTech DBS can be safely brought to and through a first-in-human clinical trial. There are quite a few components in an IDE (Investigational Device Exemption) and it takes a lot of interdisciplinary knowledge and cross-functional teamwork to get a Class III device to this point. We've discussed every aspect of moving forward with the FDA. From the device design to the full clinical design and protocol, data and safety and monitoring plans to cybersecurity, it has all been resolved and agreed upon with the FDA. Now it's time to make the accessibility of CELLTech DBS a reality through final clinical device build and testing followed by executing the planned EFS clinical trial," states Nicholas Totagrande, CEO.
The Next Generation of Evidence-Based Medicine
The first heart transplant in 1967 paved the way for numerous novel research and clinical solutions. Whether through cataract surgery, organ transplants, hip replacement surgery, or sickle cell treatment using CRISPR genetic engineering, more advanced medical technologies that can supplement pharmaceutical therapies are becoming increasingly desirable and common [Evidence-Based Medicine Overview].
"We see future medical advancements like CELLTech DBS extending quality of life for individuals who suffer loss of function from damage to brain tissue. I'd like to think that as we get older, we would all like to be able to spend our precious free time with friends and family. We should build a future that enables this freedom through more effective treatments. Our team has been working hard to bring an insurance-reimbursable solution to market to patients in need who may not otherwise have access to treatment," says Totagrande.
The CELLTech DBS waveform has been developed not only to treat damaged brain tissue after a stroke but also to potentially repair brain tissue damage or degeneration caused by other disorders and diseases.
"When CELLTech DBS therapy is turned on, the goal is to capture the correlation between brain repair and brain activity in a way never done before. We can then leverage these data with AI to further refine treatment at a truly individualized level," says Pfluger.
Artificial intelligence (AI) has already proven its value in various fields, including deep brain stimulation. Some benefits of AI include providing real-time data, saving time and resources, streamlining tasks, and reducing human error. The main goal of integrating AI into medical devices is to advance personalized treatments, a field known as 'personalized medicine' [How AI is Revolutionizing Healthcare].
"The limitations we have seen in realizing new technologies are not rooted in a lack of ability to envision or even manufacture the required components. Many are aware of this gap. You can see it in fields such as energy or food production where humanity still faces electricity shortages and hunger. Health care is no different. As the cost of living and the cost of health is ever-increasing, we are beginning to realize the burden that disease truly brings. This is avoidable. CELLTech is one of these current-day technologies that makes a substantial difference in reaching our potential as a society and human race by taking this next step," says Trisha Pfluger, CSO.
About the CELLTech DBS Program
If you're interested in collaboration opportunities or want to learn more, don't hesitate to reach out to Steve at steve@junobiomedical.com and visit our website at www.junobiomedical.com. CELLTech DBS has been developed by an extraordinary team of R&D industry leaders and subject matter experts from across the nation, including California, Northwest Arkansas, and the East Coast, among other areas; and along with international partners.
Contact Information
Steve Harvey
Executive Assistant
steve@junobiomedical.com
SOURCE: Juno Biomedical, Inc.
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