CSA Medical–spray cryotherapy for esophageal cancer

Project Manager:  Steven Schaefer;  Principal InvestigatorBruce D. Greenwald, M.D., UMB
Location:  Baltimore, Maryland – Baltimore City;  Project Start Date:  2/1/2012

Business Description
CSA Medical Inc. develops and manufactures a proprietary interventional spray cryotherapy technology platform comprised of a device and specialty catheters that enable delivery of spray cryogen inside the body to flash freeze and destroy diseased tissue. The company is the first to harness the power of low pressure, extremely cold (-196 o C) liquid nitrogen inside the body.

CSA Medical’s truFreeze® System is the company’s latest technology platform that is designed to deliver extremely cold liquid nitrogen spray through a small catheter to flash freeze a variety of  unwanted tissue surfaces inside the body, including obstructed or diseased tissue.

Challenge and MIPS Role
In 2006, CSA Medical was evaluating its cryospray device for treating pre-cancerous and cancerous diseases of the esophagus. Through MIPS funding, the company teamed with Dr. Greenwald in a clinical trial at the University of Maryland Medical Center. While MIPS projects typically last one year, CSA Medical’s was so successful that the company stopped the trial within nine months and decided to pursue an expanded, multi-center trial.

Patients were treated by freezing the cancers in their esophagus with CSA Medical’s Spray Cryotherapy System. After one year, 75 percent of patients with top-layer or mucosal cancer were still cancer-free.

Data from clinical trials of the Spray Cryotherapy System was published in two landmark papers in the Gastrointestinal Endoscopy Journal in April, 2010.

Results
CSA Medical’s spray cryotherapy technology was introduced to the market in 2007 for endoscopic ablation to treat esophageal disease. The technology has since been adopted by leading healthcare facilities across the country. In February 2012, the company received 510(k) clearance for the truFreeze® Spray Cryotherapy System for use as a cryosurgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology and general surgery. CSA Medical will now conduct post-market clinical studies to support new indications for the truFreeze System and the company expects to begin shipping the new system later this year.

In September 2012, CSA opened a new 8,000+ square-foot facility in Lexington, Mass., focused on product development and customer training.

Interesting Fact
CSA Medical’s technology started with an invention at the National Naval Medical Center and some Cooperative Research And Development Agreement (CRADA) work out of the National Naval Medical Center and Walter Reed Army Medical Center.

Pictured, from left to right: Richard Hughen, Vice President, Gastroenterology Business, and Steven E. Schaefer, Chief Financial Officer, CSA Medical

MIPS-Related Quote
“Years ago, CSA medical was able to attract several million dollars of investment capital. But it wasn’t until Maryland Industrial Partnerships came along, and in particular with the support of Dr. Martha Connolly, that we were able to take it to the next level and attract additional capital and do additional studies to prove the efficacy of the technology.”
–Steven E. Schaefer, Chief Financial Officer, CSA Medical

Leading up to (and beyond) the Maryland Industrial Partnerships (MIPS) 25th Anniversary Gala, we will frequently profile one (or more) of the 500+ companies that have utilized MIPS funding to bring innovations to market and create jobs in Maryland.

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