Blog Tag: Cancer Therapy

FDA Breakthrough Device Designation for Biology-Guided Radiotherapy (“BgRT”) Device

On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has granted the company breakthrough device designation for its biology-guided radiotherapy (“BgRT”) for lung tumors.

The FDA breakthrough devices program:

is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Further details regarding the breakthrough devices program can be found here and here.

According to RefleXion, “the breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors.  It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery” and “aims to remove the uncertainty of guiding radiation delivery using images taken days before treatment.” Many patients with stage four cancer cannot use current forms of radiotherapy because existing technology is unable to efficiently track and treat multiple tumors.  “The unmet need in lung cancer is staggering,” said Todd Powell, president and CEO of RefleXion.  According to Cancer.Org, “[l]ung cancer is the most common cause of cancer-related death,” accounting for 25% of all cancer deaths in the United States.

As RefleXion explains, the use of PET emissions in BgRT to guide treatment makes the “cancer itself act as a fast, biological fiducial continuously signaling its locations even during motion.”  As the PET tracer collects in the tumor, “a series of positron annihilation events occur resulting in the emission of two photons almost 180 degrees to each other.”  The detector in the RefleXion X1 device finds these emissions and outputs images in real time.  A video of RefleXion’s X1 Machine (shown below), used for BgRT, can be seen here.

 

Gilead to Acquire Kite Pharma for $11.9 Billion

Gilead to Acquire Kite Pharma for $11.9 Billion

Gilead Sciences, Inc. recently announced an agreement to acquire Kite Pharma, Inc. for $11.9 billion.  According to the announcement, Kite Pharma focuses on cell therapy treatment for cancer, which involves the genetic engineering and reintroduction of a patient’s own cells to better identify and combat cancers.

(Graphic from Kite Pharma website)

With the announcement, Gilead’s President and CEO stated that “cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients[,]” and the acquisition “establishes Gilead as a leader in cellular therapy[.]”  The announcement notes that Kite Pharma’s treatment for non-Hodgkin lymphoma is currently under review by the FDA, with a target action date of November 29, 2017.

Kite Pharma, Inc. is based in Santa Monica, CA and Gilead Sciences, Inc. has its U.S. headquarters in Foster City, CA.

FDA Clearance for Monteris Medical Ablation System

Today’s Medical Developments reports that Monteris Medical‘s second generation MRI-guided ablation device, the “NeuroBlate System,” has just received FDA 510(k) clearance.

According to the press release, the NeuroBlate System combines updated, active MRI visualization and a surgical laser to selectively ablate diseased brain tissue.  Monteris Medical’s first generation system has been available in U.S. hospitals since 2010.  Regarding its new system, John Schellhorn, President and CEO of Monteris Medical, states that:

Monteris invested significant resources to develop a laser ablation system that is faster and adapts to contemporary clinical workflow.  The NeuroBlate System provides neurosurgeons controlled, three-dimensional ablation via a powerful software platform.  It supports surgical decision making during brain operations as well as providing post-procedure confirmation of the effects of the thermal therapy.

The press release also indicates that the Cleveland Clinic will soon be adopting Monteris Medical’s second generation NeuroBlate System to treat patients who seek minimally invasive options or are not candidates for traditional surgery.