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Feedback and Inquiries.
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25841 Industrial Blvd, Suite 275
Hayward, CA 94545
Who founded RefleXion Medical?
Sam Mazin, Ph.D. and Akshay Nanduri founded RefleXion Medical in 2009.
Where does the name RefleXion come from?
The name dates back to 2008 from discussions between RefleXion’s founders, Sam Mazin, Ph.D. and Akshay Nanduri. They wanted to convey the source of the therapy as well as its capabilities. On the surface, the machine operates by “reflecting” gamma rays created by the accumulation of the PET tracer by the cancer cells back toward the tumor. It’s also the combination of the words “reflex” and “ion,” both important components of RefleXion technology. Specifically, PET emissions from cancer cells trigger immediate responses from the machine to destroy them with ionizing radiation, hence the suffix, “ion.” “Reflex” comes from the fact that the machine works in a fast, reflexive way. The capital X comes from the word X-ray, the source of the therapy.
How much money has RefleXion raised to date?
RefleXion has raised over $200M in financing from a top-tier investment syndicate that includes pharmaceutical giants Pfizer and J&J.
Who are some of the advisors and executives?
The co-founders, Sam Mazin, Ph.D. and Akshay Nanduri have assembled an impressive internal team and advisory boards comprised of KOLs and renowned industry veterans. Todd Powell assumed the roles of president and CEO in 2017 after a successful leadership tenure with Elekta, one of the industry’s largest manufacturers of radiotherapy systems. In 2018, Martyn Webster joined the team as CFO bringing specific expertise in medical device startups and fundraising. To date, the company employs over 150 people, and is growing rapidly.
What is the company’s vision statement?
To reveal cancer as never before and beat it for everyone, everywhere.
What is the company’s mission?
To create a machine that combines biotargeting with radiation and enable the first-ever systemic reach for radiotherapy for patients with any stage of cancer.
Am I able to deliver SBRT with the RefleXion X1 platform?
Yes. In addition, you can also deliver cranial SRS and IMRT.
What indications can the RefleXion X1 treat?
The RefleXion X1 is indicated for treatment planning and precise delivery of image-guided radiation therapy,
stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body.
Will the RefleXion platform fit in my existing vault?
The RefleXion X1 fits in most standard radiotherapy vaults and does not require additional shielding.
Do I need to use a special code for RefleXion IGRT treatments?
You will continue to use existing radiotherapy codes for treatment delivery and ancillary services for RefleXion X1.
Does the RefleXion X1 offer 6 DOF patient setup?
Yes. Our table offers five degrees of freedom and the additional degree of freedom is gained with our rotating gantry.
Will my existing immobilization devices work with the RefleXion X1?
Yes. The RefleXion X1 includes a premium couch top with indexing that allows for 3rd party immobilization devices.
Is my existing treatment planning system compatible with the RefleXion X1?
Your contouring tools are compatible and the RefleXion X1 treatment planning system handles plan optimization and dose calculation.
Can the RefleXion X1 deliver biology-guided radiotherapy or BgRT?
The RefleXion X1 is equipped with BgRT components, but is currently cleared to deliver SBRT, SRS and IMRT. The RefleXion™ BgRT capability requires 510(k) clearance; this feature is not available for sale.
What is RefleXion BgRT?
RefleXion BgRT (Biology-guided Radiotherapy) is the first machine designed to utilize the cancer itself to guide radiation delivery – even in tumors that are moving – to enable a leap forward in the ongoing goal of managing motion, reducing margins and diminishing toxicity, so that multiple tumors can be treated in the same session.
How does the RefleXion system with BgRT work?
RefleXion’s BgRT uses PET – the gold standard in cancer imaging – in a novel way to solve the conundrum of tumor tracking. By transforming the use of PET from gradual image formation to instantaneous emission detection, BgRT aims to remove the uncertainty of guiding radiation delivery using images taken minutes, hours or even days before treatment. With PET emissions guiding treatment, the cancer itself acts as a fast, biological fiducial continuously signaling its location even during motion.
As the PET tracer accumulates in the tumor, a series of positron annihilation events occur resulting in the emission of two photons almost 180 degrees to each other. Their source – the tumor – can be localized along this straight line of coincidence, called a line of response, or LOR. The PET arcs on the RefleXion X1 machine detect the LORs and using that location information, immediately deliver a beamlet of radiation to the tumor to destroy it. This real-time response by the LINAC to detected PET emissions is the fundamental principle of BgRT.
What are the challenges in treating cancer with radiotherapy today?
There are two major hurdles in radiotherapy today. The first is that tumors move with natural processes like breathing. This means that radiotherapy must meet the challenge of hitting a moving target accurately. The second obstacle is that normal tissues and organs are often located near tumors, which puts them at risk for bystander injury if the radiation is not delivered with millimeter precision.
To address these issues, complex plans and devices – including implanted fiducials — are often required to locate and deliver treatment to just one tumor with acceptable certainty. Therefore, in a patient with multiple tumors, the amount of time and effort required to treat the entire disease can become too burdensome to even attempt. This is one of the reasons that oncologists have not fully explored the use of radiotherapy in later stages of cancer, when tumors have spread to multiple locations in the body.
When will RefleXion therapy be available to patients?
RefleXion is pending 510(k) clearance from the U.S. Food & Drug Administration (FDA). When we’re notified by the FDA that our machine has received 510(k) clearance, we will issue a public announcement.