CSA Medical Announces First Patient Procedures with truFreeze® Spray Cryotherapy System

CSA Medical, Inc., the leading provider of advanced spray cryotherapy technology that flash freezes and ablates unwanted tissue inside of the body, today announced the successful first patient procedures with the truFreeze® Spray Cryotherapy System. Developed based on clinical user feedback, the truFreeze System is the Company’s latest technology platform that delivers extremely cold liquid nitrogen spray through a small catheter to flash freeze a variety of unwanted tissue surfaces inside the body, including obstructive or diseased tissue in the airway or gastrointestinal tract.

“Spray cryotherapy is an important part of our clinical practice at Temple University Hospital. We are pleased to offer the new truFreeze system as it provides increased access to ablation areas as well as improved thermal and pressure control,” said Michael Smith, MD, MBA, Medical Director of the Temple Esophageal Program. “For our first truFreeze cases, we treated patients with Barrett’s esophagus and esophageal cancer. Our patients did extremely well both during and after their procedures and commented that their recovery after truFreeze was easy and comfortable. I am confident that the efficacy of truFreeze will match its tolerability, making it an attractive option to help patients with several gastrointestinal conditions.” Temple University Hospital was the first program to treat patients in the gastrointestinal tract with the new truFreeze system.

Cryotherapy, the use of extreme cold in medical applications, is a proven therapy that has been used for decades to treat diseased tissue on the skin and many parts of the body. CSA Medical’s spray cryotherapy technology was first introduced to the market in 2007 for the ablation of unwanted tissue during endoscopic procedures, and has since been used in more than 9,400 patient procedures. Spray cryotherapy is a minimally invasive and versatile ablation option because of its ability to treat inside the body with a touch-less spray application, which enables physicians to address tissue of varied shapes and sizes.

The truFreeze Spray Cryotherapy System received 510(k) clearance for use as a cryosurgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology and general surgery. The technology features a number of product enhancements that are designed to improve control and functionality of the device.

“Clinicians in a variety of medical specialties have shown significant interest in use of spray cryotherapy as a clinical intervention,” said Bill Floyd, president and CEO of CSA Medical. “With the truFreeze System, we can better address this clinical need with a versatile product that is designed to make spray cryotherapy more broadly accessible to clinicians and the patients they treat.”

CSA Medical has also sponsored the establishment of the U.S. Spray Cryotherapy Patient Registry to track clinical outcomes of patients treated with the truFreeze device. Commenting on the patient registry, Nick Shaheen, MD, registry co-principal investigator and Director of the Center for Esophageal Diseases & Swallowing at the University of North Carolina School of Medicine stated, “The information provided by the truFreeze patient registry will help us understand how to further optimize use of spray cryotherapy in pulmonary and gastrointestinal procedures with the goal of advancing clinical outcomes for patients.”

How spray cryotherapy works

Spray cryotherapy is an outpatient procedure during which a physician inserts an endoscope through the mouth to enable viewing of tissue. The physician then threads a specialized spray cryotherapy catheter through the endoscope, selects the ablation area and sprays extremely cold (-196°C) liquid nitrogen on the diseased or obstructive tissue to flash freeze and destroy it. The tissue is allowed to thaw, and the freeze-thaw cycle is typically repeated several times as determined necessary by the physician. This rapid freeze and slow thaw of tissue has been proven to destroy the targeted cells without disturbing the underlying connective tissue, providing a framework for healthy cells to regenerate. Patients are typically able to return home the same day and quickly resume normal activity.

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