BRINGING MEDICAL INSIGHT INTO FOCUS

Our story, like the story, starts with a bang.

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.

VERSATILE

TARGETED

PRECISE

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July 18, 2022

Radialis PET Imager Receives FDA Clearance

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

Technical evaluation of Radialis PET Imager published in the journal Sensors

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 Inc. Secures Financing for Growth

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

Aunt Minnie Technology Focus: Radialis develops organ-based PET scanner

In this Technology Focus video, we talked to Radialis CEO Michael Waterston about the company and its technology.

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July 18, 2022

Radialis PET Imager Receives FDA Clearance

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 MORE

June 21, 2022

Technical evaluation of Radialis PET Imager published in the journal Sensors

The aim of this study is to evaluate the performance of the Radialis organ-targeted positron emission tomography (PET) Camera with standardized tests...

READ MORE

May 11, 2022

Radialis Inc. Secures Financing for Growth

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 MORE

December 1, 2021

Aunt Minnie Technology Focus: Radialis develops organ-based PET scanner

In this Technology Focus video, we talked to Radialis CEO Michael Waterston about the company and its technology.

READ MORE

LOREM IPSUM

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Is the mass cancerous?
Are there other smaller masses of concern?
What is the extent of the tumor?
Is a more conservative/less invasive treatment appropriate?
Are nearby lymph nodes involved?
Is the disease responding to treatment?

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.

VERSATILE

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.

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HIGH DEFINITION

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.

WHOLE BODY PET

RADIALIS

Single patient imaged on the same day with one standard injection of FDG radiotracer

EASY TO DEPLOY

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.

TARGETED EARLY DETECTION

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.

  1. Soriano et al.. "Performance evaluation of the Dual Ring Mammi breast PET", IEEE NSS/MIC, 2013.
  2. Luo et al., "Performance Evaluation of a PEM Scanner Using the NEMA NU-4 2008 Small Animal PET Standards", IEEE Trans. on Nuc. Sci., 2010.
  3. Pan et al., "Performance evaluation of the 5-Ring GE discovery MI PET/CT system using the NEMA NU 2–2012 standard", Med. Phys., 2019.
  4. Miller, "Vereos PET/CT: Focusing on high performance", Philips Healthcare, Advanced Molecular Imaging, 2016.
  5. van Sluis et al., "Performance characteristics of the digital Biograph Vision PET/CT system", J Nucl Med, 2019.
  6. Prenosil et al., "Performance Characteristics of the Biograph Vision Quadra PET/CT system with long axial field of view using the NEMA NU 2-2018 Standard", J Nucl Med 2021

WHO WE ARE

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.

Michael Waterston, MA, MSc
President and CEO
Alla Reznik, PhD
Chief Scientific Officer
Oleksandr Bubon, PhD
Chief Technology Officer
Kenneth Olsen, MBA
Director of Operations
I am proud to have been associated with the Radialis team, which has significantly improved performance for breast imaging as compared to prior dedicated-breast functional imaging systems. Clinical studies with this new system have demonstrated remarkable results in providing information critical for treatment planning.
- Irving Weinberg MD PhD, Organ-Targeted PET Pioneer
Brandon Baldassi
President and CEO
Borys Komarov
President and CEO
Shayna Parker
President and CEO
Targeted early detection of cancer in high-risk populations is proven to save lives and the versatility of low-dose PET makes this an exciting platform to be working on.
- Steven Laken PhD, Colorectal Cancer Screening Innovator
Christopher Gillespie
President and CEO
Edward Anashkin
President and CEO
Sergey Reznik
President and CEO
Brett Belcher
President and CEO
Marina Mukha
President and CEO
We have seen the ability of the system to detect small lesions of breast cancer with low doses of radiation. This may represent an alternative screening tool in high-risk populations and a way to address overtreatment due to false-positive MRI imaging.
- Vivianne Freitas MD MSc, Princess Margaret Cancer Centre, Breast Imaging Research Lead

BOARD OF DIRECTORS

Andrew Dean PhD
James Peotto CPA CA
Aaron Rezaei PEng MBA      
Carmel Shields MBA JD        
Michael Waterston MA MSc

Keith Jobbitt LLB
Michael Polonsky
Wayne Schnarr PhD MBA
Irving Weinberg MD PhD