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X1 Machine Rotates up to 60 Times Faster than Other Linear Accelerators for Precise Dose Delivery to Tumors
RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* to treat all stages of cancer today announced it has received marketing clearance from the U.S. Food & Drug Administration (FDA) for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT) for its RefleXion™ X1 machine.
“We are at the forefront of an enormous change in expanding the use of radiotherapy from a treatment solely for early-stage cancer patients to an entirely new group of patients who need it most, those with advanced stage cancer,” said Todd Powell, CEO and president of RefleXion. “This initial marketing clearance of our RefleXion X1 machine is a steppingstone on the path to our goal of providing BgRT as a novel treatment modality that will expand the overall radiotherapy market significantly.
“We have been preparing for commercial operations in the brand new factory we opened last year and expect to begin machine shipments within the next quarter,” continued Powell.
The RefleXion X1 is the only machine that combines high quality computed tomography (CT) imaging, known as fan-beam CT, with a linear accelerator to reduce motion artifacts that can inhibit accurate targeting of the radiation dose to a patient’s tumor. Its groundbreaking design rotates up to 60 times faster than other linear accelerators and modulates dose delivery from 100 points per beam station. These combined improvements may reduce the side effects of radiotherapy by allowing radiation oncologists to better localize the tumor, reduce patient setup errors and precisely deliver dose to complex tumor targets while avoiding nearby normal structures.
“Transitioning this company from a research effort to what is, as of today, a commercial entity has been a thrilling 10-year journey,” said Sam Mazin, Ph.D., founder and CTO of RefleXion. “Along the way, RefleXion has become an organization supported by dedicated and brilliant people in every corner, including our clinical partners. We will celebrate this milestone and then quickly turn our sights to bringing our biology-guided radiotherapy to market.”
BgRT, a novel treatment modality under development, uses the biological signature of a tumor to characterize its movement and to deliver a precisely tracked therapeutic radiation dose to the tumor. The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that currently restrict radiotherapy to one or two tumors. Once developed, RefleXion will scale BgRT to treat all visible tumors, even those that move rapidly due to involuntary processes such as breathing or digestion, in the same treatment session.
About RefleXion Medical
RefleXionis a privately-held company developing the first biology-guided radiotherapy system, a significant change in strategy from single tumor therapy to the ability to one day treat multiple tumors in the same treatment session in cancers that have metastasized. Currently, the RefleXion machine is cleared for the delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). The company is also developing BgRT, which incorporates positron-emission tomography (PET) imaging data to enable tumors to continuously signal their location. The BgRT technology will synchronize these data with the linear accelerator to direct radiotherapy to tumors with subsecond latency.
RefleXion is backed by premier investment firms TPG Growth/The Rise Fund, Sofinnova Partners, KCK Group, Venrock, T. Rowe Price and global pharmaceutical leaders Pfizer Venture Investments and Johnson & Johnson Innovation, JJDC Inc.
*The RefleXion X1 BgRT capability requires 510(k) clearance and is not available for sale.
One of nation’s largest, health system-run diagnostic labs receives approval to perform COVID-19 testing
After a visit to its sophisticated, 100,000-square-foot diagnostic facility by New York Governor Andrew Cuomo, Northwell Health Labs today received state and federal authorization to begin manual testing for COVID-19, the disease caused by the novel coronavirus.
Utilizing a testing process developed and approved by the New York State Department of Health (DOH), Northwell’s Lab expects to manually test 90 potential COVID-19 samples within the first full day, said Dwayne Breining, MD, executive director of the Northwell Labs. With one of North America’s largest automated testing lines, the facility processes about 20 million tests annually. Beyond the manual testing authorized today, Northwell Labs is seeking the US Food & Drug Administration’s approval to use semi-automated testing within the next week. This would give the laboratory the capability to process hundreds of tests daily, with a plan to ramp up to thousands daily in the near future.
“Over the past week, we’ve been developing the test for COVID-19, thanks to the assistance we‘ve received from New York State’s DOH Laboratory,” said Dr. Breining. “Now that the accuracy of our testing process has been validated, we can begin notifying providers and patients of their lab results and start gearing up for an automated testing process that would enable us to significantly expand the number of samples we can process.”
While the expanded ability to test patients for COVID-19 will greatly enhance Northwell’s ability to manage patients with potential infection, testing will continue to be reserved for those at risk for severe disease and who have had confirmed close contact with an infected individual.
“Only people who meet that criteria will be tested – and that testing is currently being performed at hospital emergency departments and urgent care centers,” said John D’Angelo, MD, chair of emergency medicine at Northwell, which operates 18 emergency departments throughout New York City, Long Island and Westchester County. “Even as our testing capacity increases, we will continue to screen people judiciously so we can focus our attention on those most at risk for severe COVID-19 infection who require more-immediate and intensive medical attention. All others who are concerned about exposure but who have mild or no symptoms should recuperate at home.”
Built at a cost of $60 million and opened in 2019, Northwell’s Core Lab within the health system’s Center for Advanced Medicine in Lake Success performs testing for Northwell’s 23 hospitals and 800 outpatient facilities, as well as thousands of physician offices and dozens of other hospitals, including NYC Health+Hospitals.
At a news conference Sunday morning, Governor Cuomo called on the federal government to speed up its authorization process to allow more clinical laboratories to begin testing for COVID-19. “This is one of the most technologically advanced labs in the state of New York, and one of the most sophisticated labs in the United States of America. This lab can do high-throughput automated testing, which expands exponentially the number of tests that can be done,” Governor Cuomo said. “Let’s increase as quickly as possible our testing capacity so we identify the positive people, so we can isolate them and be successful in our containment.”
Several hours after the Governor’s news conference, Northwell received approval to move forward with the manual testing.
Northwell Health President & CEO Michael Dowling praised the Governor and state Department of Health for their leadership in responding to the coronavirus epidemic. “I thank the Governor for not only giving us the support we need to begin testing for COVID-19, but also in declaring a state of emergency that will help expedite the procurement of emergency provisions, such as testing kits and cleaning supplies,” said Mr. Dowling.
To prepare its lab to begin COVID-19 testing, Northwell has invested over $2 million in recent weeks for lab supplies and equipment, part of an overall outlay of more than $5 million the health system has spent over the past seven weeks on coronavirus preparation.
Click here to see video and photos of Northwell Labs’ testing process.
About Northwell Health
Northwell Health is New York State’s largest health care provider and private employer, with 23 hospitals, about 750 outpatient facilities and more than 13,600 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 70,000 employees – 16,000-plus nurses and 4,000 employed doctors, including members of Northwell Health Physician Partners – are working to change health care for the better. We’re making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We’re training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Graduate Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook, Twitter, Instagram and LinkedIn.