Staff Report

Elekta (Atlanta) said the China Food and Drug Administration (CFDA) has approved its Flexitron brachytherapy afterloading platform for sale and marketing in China.

In China there is a high prevalence of gynecologic cancers, as well lung, breast, colorectum and esophagus cancers. Many patients with such cancers can be effectively treated with brachytherapy. With the introduction of Flexitron, hundreds of thousands of cancer patients can benefit from being treated with this new, advanced afterloading platform.

For hospitals offering brachytherapy, Flexitron can reduce workflow complexity and improve efficiency. It is revolutionizing safety and workflow in the modern brachytherapy practice. By being designed around an upgradable architecture, Flexitron represents a truly safe investment for the future.

There are about 130,000 new cervical cancer patients per year in China and about 40,000 Chinese patients are treated with brachytherapy annually.

Elekta offers complete brachytherapy solutions, including afterloading platforms, applicators and treatment planning. Elekta makes clinical solutions for treating cancer and brain disorders.

Cardio3 enrolls 240th patient in CHART-1 C-Cure study

Cardio3 BioSciences (Mont-Saint-Guibert, Belgium), a maker of regenerative, protective and reconstructive therapies, reported the enrollment of the 240th patient in its CHART-1 European trial for C-Cure, the first and only stem cell therapeutic using guided stem cells for the treatment of congestive heart failure.

With recruitment that started in mid-2013, Cardio3 BioSciences has enrolled 240 patients in less than 18 months, ahead of schedule. As usual in clinical trials targeting severe indications, the company will continue to recruit additional patients in anticipation of patient dropouts. The CHART-1 trial is currently ongoing in 12 countries in Europe and Israel.

The CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) trial represents the world's first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.

Cardio3 BioSciences' C-Cure therapy involves taking stem cells from a patient's own bone marrow and through a process called Cardiopoiesis, re-programming those cells to become heart cells. The cells, known as cardiopoietic cells, are then injected back into the patient's heart through a minimally invasive procedure, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes. C-Cure is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota) and Cardiovascular Center in Aalst (Aalst, Belgium).

The company's C-Cure is a product that is being developed for heart failure indication. C-Cure consists of a patient's own cells that are harvested from the patient's bone marrow and engineered to become new heart muscle. This process is known as Cardiopoiesis.

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