Actually, millions of them. Think stars colliding. Think inspiration reaching your frontal lobe. Our purpose is to advance healthcare with enhanced imaging.
Deep physics, discipline, humility. These are our super-powers, bringing Organ-Targeted PET into the clinic to improve lives.
February 12, 2024
Vivianne Freitas, M.D., discussed new research findings on PEM, its pertinent benefits, and its potential as a viable alternative in the future to conventional imaging techniques for breast cancer screening.
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February 9, 2024
Low-dose positron emission mammography (PEM) can detect invasive breast cancer in a feasible manner, according to research published February 9 in Radiology: Imaging Cancer.
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January 19, 2023
Radialis Inc. announced today that the company has received ISO 13485:2016 certification for Medical Devices - Quality Management Systems.
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July 18, 2022
Radialis Inc. today announced that it has received clearance to market the Radialis PET Imager, an organ-targeted positron emission tomography (PET) system, in the United States.
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June 21, 2022
The aim of this study is to evaluate the performance of the Radialis organ-targeted positron emission tomography (PET) Camera with standardized tests...
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May 11, 2022
Radialis today announced that it has secured financing to further grow its high-definition organ-targeted PET business through investments led by the Axion Fund of Archangel Networks.
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December 1, 2021
In this Technology Focus video, we talked to Radialis CEO Michael Waterston about the company and its technology.
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September 20, 2021
Radialis Medical today announced that it has submitted a U.S. Food & Drug Administration (FDA) 510(k) premarket notification for the Radialis PET Camera...
READ MOREFebruary 12, 2024
Vivianne Freitas, M.D., discussed new research findings on PEM, its pertinent benefits, and its potential as a viable alternative in the future to conventional imaging techniques for breast cancer screening.
READ MOREFebruary 9, 2024
Low-dose positron emission mammography (PEM) can detect invasive breast cancer in a feasible manner, according to research published February 9 in Radiology: Imaging Cancer.
READ MOREJanuary 19, 2023
Radialis Inc. announced today that the company has received ISO 13485:2016 certification for Medical Devices - Quality Management Systems.
READ MOREJuly 18, 2022
Radialis Inc. today announced that it has received clearance to market the Radialis PET Imager, an organ-targeted positron emission tomography (PET) system, in the United States.
READ MOREJune 21, 2022
The aim of this study is to evaluate the performance of the Radialis organ-targeted positron emission tomography (PET) Camera with standardized tests...
READ MOREMay 11, 2022
Radialis today announced that it has secured financing to further grow its high-definition organ-targeted PET business through investments led by the Axion Fund of Archangel Networks.
READ MOREDecember 1, 2021
In this Technology Focus video, we talked to Radialis CEO Michael Waterston about the company and its technology.
READ MORESeptember 20, 2021
Radialis Medical today announced that it has submitted a U.S. Food & Drug Administration (FDA) 510(k) premarket notification for the Radialis PET Camera...
READ MORE
Positron emission tomography (PET) imaging is a proven modality that has been in clinical practice for almost half a century. It advanced the visualization of functioning tissues, both tumors and healthy organs. In particular, PET has been instrumental in the detection of cancers metastasizing.
Organ-targeted PET builds on this progress. With thousands of modern-day silicon sensors that are placed right next to the target, our system creates high-definition images of a specific area of concern, enabling a more accurate or thorough understanding of the disease, which in turn positively impacts treatment and planning decisions.
Most importantly, our technology can play an integral role in the promise and the practice of precision medicine: the right treatment for the right patient at the right time. For instance, our images could reveal whether a breast needs to be removed or conserved. Whether a treatment is winning or losing the battle. Whether a high-risk loved one is in fact beating the odds.
When you know where to look, organ-targeted PET will give you a superior image. Organs are imaged by being positioned between the two planar detectors of the Radialis PET Imager. The detectors can be rotated and reach across the body or around the head to reach the area of interest. The detectors can also be raised or lowered for imaging seated, standing, or lying on a radio-transparent bed. Pilot study results illustrate the superiority of using planar organ-targeted imaging for many of the indications of traditional PET systems.
Functional imaging of primary tumors including mamographic views
Functional imaging of primary tumors including mamographic views
Functional imaging of primary tumors including mamographic views
Functional imaging of primary tumors including mamographic views
Functional imaging of primary tumors including mamographic views
Functional imaging of primary tumors including mamographic views
Proximal lymph node imaging to inform treatment planning
3D brain volumes are being developed by combining coronal and sagittal scans
Cardiac radiotracers are available for the visualization of both viable tissue and blood perfusion
Inflammation detailed could be used to monitor response to treatment
Functional imaging of primary tumors including mamographic views
Proximal lymph node imaging to inform treatment planning
3D brain volumes are being developed by combining coronal and sagittal scans
Cardiac radiotracers are available for the visualization of both viable tissue and blood perfusion
Inflammation detailed could be used to monitor response to treatment
The Radialis PET Imager is able to resolve objects as small as 1.3mm. With more available data, the Radialis PET Imager can reveal clinically-relevant details not visible in traditional PET. By placing the proprietary detector surfaces close to the area of interest, the Radialis PET Imager maximizes the resolution of the image acquired. The system also has excellent contrast sensitivity, differentiating between adjacent areas of relatively similar radiotracer uptake.
Single patient imaged on the same day with one standard injection of FDG radiotracer
The Radialis PET Imager integrates smoothly into existing PET facilities with a small system footprint. Adding a Radialis PET Imager leverages existing investment in nuclear medicine infrastructure and staffing. The system can be easily sited with a size of 2.5 feet wide, 6 feet long, and 4.5 feet tall, and requiring only standard 120V 15A electrical service. The system itself is passive and its room requires only the standard radiation safety procedures for patients who have been administered radiotracer.
FDA 510K CLEARANCE CONFIRMS BROAD CLINICAL UTILITY
Radialis has been cleared to commercialize the Radialis PET Imager across the United States. Radialis’ comprehensive submission detailing the innovative system’s design and verified performance capabilities, along with medical images from clinical cases satisfied all FDA requirements. Outside of the United States, the system is available for research use only at this time.
INDICATION FOR USE
The Radialis PET Imager is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
Our roots lie in deep, fundamental physics to solve medical imaging problems. For instance, the founding inspiration for Radialis: to replace vacuum tubes with silicon photomultipliers in planar detectors to make PET imaging more sensitive. We believed we could fill the medical need to image tissues that were problematic for physicians, such as dense breasts. We can now enhance the visualization of traditional radiotracer injections. However, it is clear that a broader, more powerful application for organ-targeted PET remains: TARGETED-EARLY DETECTION. This opportunity has become the focus of our development efforts.
The practice of medicine is rapidly evolving, with innovative treatments and advanced knowledge of disease risk fueling a real-time transformation of healthcare.
Think monoclonal antibodies, immune therapies, new and safer surgical tools. Advanced therapies are often even more effective when administered early in disease progression. At the same time, advances in genetics make us better-informed today with respect to whom of us is most at risk for certain diseases. The contribution of age, genetic disposition, family history, and behavioral habits are all better understood.
On the one hand we know how to treat disease better and on the other hand we also know who is at risk. What is missing is the obvious bridge – the targeted detection from those at risk of who actually have early onset of a given disease. Organ-Targeted PET has the potential to be that bridge for many patients, a platform for targeted early detection across a broad range of diseases. With the unlocking power of safer, low-dose tracers, combined with high-definition imaging, physicians can spot issues before they become problems. This is a large, impactful idea, think big bang.
At peak detection concentrations of radiotracer, the Radialis PET Imager collects ten times more useful imaging data than state-of-the-art traditional PET scanners. The system also collects more useful events from the area of interest than other organ-targeted systems and even new whole-body PET scanners with their extended axial field of view. This has the potential to enable imaging with doses of radiotracer that are low enough to be appropriate for detecting treatable disease in high-risk populations.
Radialis is advancing precision medicine by providing the next generation of organ-targeted precision imaging. Our team includes industry leaders with a track-record of breaking new ground in medical imaging. Please contact us if you are interested in learning more.
Andrew Dean PhD
Keith Jobbitt LLB
Aaron Rezaei PEng MBA
Carmel Shields MBA JD
Michael Waterston MA MSc
