FDA clears biology-guided radiotherapy from RefleXion

Co-founder and CTO, Sam Mazin and Todd Powell, CEO and president, with the company’s Scintix system. [Image courtesy of RefleXion]RefleXion Medical announced today that the FDA cleared its Scintix biology-guided radiotherapy treatment for cancer.

Hayward, California-based RefleXion designed the Scintix platform for use in treating both early- and late-stage cancers.

The company said Scintix is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine how much radiation to deliver. This occurs on a second-by-second basis during the actual treatment delivery.

Clearance by the FDA expands the RefleXion X1 system into a dual-treatment modality platform. It can now treat patients with indicated solid tumors of any stage. Scintix tracks tumor motion from all types of movement, including expected motion from internal processes like breathing and digestion. X1 also features a state-of-the-art anatomic modality cl…

Read more
  • 0

RefleXion expands footprint through multi-system contract with Select Healthcare

RefleXion Medical announced today that it entered into a three-system contract with Select Healthcare cancer facility developer.

The multi-year, multi-site contract was agreed upon with the aim of creating new, free-standing treatment centers using the RefleXion X1 platform for treating all stages of cancer with external beam radiotherapy (EBRT).

RefleXion said in a news release that the agreement helps to bring its novel biology-guided radiotherapy (BgRT) — a modality using emissions generated from cancer itself to direct radiotherapy — to Select Healthcare’s local communities so patients with solid tumor cancers can receive care near their home.

BgRT uses emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope, known as a PET tracer, to guide EBRT. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location.

The Ref…

Read more
  • 0

RefleXion, Mirada ink licensing deal on personalized cancer treatment

RefleXion Medical announced today that it entered into a non-exclusive, worldwide licensing agreement with Mirada Medical.

The agreement allows for the integration of Mirada’s RegEngine image registration algorithms into the RefleXion X1 treatment planning software, aligning patient anatomy between different imaging modalities or between radiotherapy treatments.

“Day-of-treatment modifications, called adaptive radiotherapy, are critical for responding to changes in patient anatomy that occur as a result of cancer treatment, and to lowering toxicity to improve outcomes,” RefleXion Chief Business Officer Thorsten Melcher said in a news release. “In challenging patients, such as those with metastatic disease where more than one tumor may be treated, adaptation requires robust tools such as Mirada’s sophisticated RegEngine software, so that clinicians can quickly assess patient anatomy and, in the future their biology, to implement changes to the treatm…

Read more
  • 0

RefleXion closes $125M debt facility

Biology-guided radiotherapy (BgRT) technology developer RefleXion Medical announced today that it closed a $125 million debt facility.

Hayward, California-based RefleXion has $55 million of the $125 million total available immediately to repay its existing $50 million in debt. The remaining $70 million will be made available upon the achievement of certain regulatory and commercial milestones.

According to a news release, RefleXion plans to use the funds to support the continued commercialization of its X1 platform and the introduction of its novel BgRT technology. The company designed BgRT to transform an injected radiotracer into a unified motion management solution that overcomes the technical limitations currently restricting radiotherapy use to one or two tumors.

BgRT has received FDA breakthrough device designation for use in lung tumors and RefleXion plans to scale the therapy to treat all visible cancer sites, creating a new treatment option for …

Read more
  • 0

RefleXion raises $80M for biology-guided radiotherapy tech

RefleXion Medical announced that it closed an $80 million equity financing to support its therapeutic oncology technology.

Hayward, California-based RefleXion develops biology-guided radiotherapy (BgRT) for all stages of cancer. The company designed BgRT to transform an injected radiotracer into a unified motion management solution that overcomes the technical limitations currently restricting radiotherapy use to one or two tumors.

BgRT recently received FDA breakthrough device designation for use in lung tumors, according to a news release. RefleXion plans to scale BgRT to treat all visible cancer sites, creating a new treatment option for patients with metastatic disease.

New investors joining the $80 million round were Ascension Ventures, Catalio Capital Management, Sixty Degree Capital and Hillenbrand Capital Partners.

Those new investors joined existing investors TPG’s The Rise Fund, KCK Group, PSP Investments, T. Rowe Price, Ally Bridg…

Read more
  • 0

RefleXion, Merck team up on late-stage cancer study

RefleXion announced today that it entered into a clinical collaboration with Merck to evaluate Merck’s (NYSE:MRK) Keytruda anti-PD-1 therapy in clinical trials.

Hayward, Calif.-based therapeutic oncology company RefleXion is joining forces with Merck to evaluate Keytruda’s safety and efficacy in combination with RefleXion’s biology-guided radiotherapy (BgRT) in multiple late-stage cancers, including non-small cell lung cancer, in two randomized controlled clinical trials.

The companies set their aim to establish whether treating multiple tumors with BgRT is safe and amplifies Keytruda’s therapeutic effect, according to a news release.

RefleXion’s X1 machine uses BgRT to deliver radiotherapy to multiple sites during the same treatment sessions, even for certain sites that move due to breathing or digestion. The company recently raised $100 million in a financing round following FDA clearance wins for its stereotactic body rad…

Read more
  • 0