Maryland Technology Enterprise Institute

Mtech Press Releases

FOR IMMEDIATE RELEASE
October 16, 2007

Potential Breakthrough Cancer Treatment Emerges from MIPS-Funded Clinical Trial Teaming CSA Medical Inc. and University of Maryland Researchers
Results presented today at American College of Gastroenterology’s Annual Meeting

COLLEGE PARK, Md.— A clinical trial conducted by University of Maryland School of Medicine researchers and CSA Medical Inc. may yield a breakthrough treatment for pre-cancerous and cancerous diseases of the esophagus.

Results of the trial, supported by the Maryland Industrial Partnerships Program (MIPS), show that a technique called CryoSpray Ablation (CSA) can reduce and often eliminate pre-cancerous and cancerous lesions in patients, including those with Barrett's esophagus, a precursor to cancer involving esophageal lesions created by chronic acid reflux.

Trial results will be presented today at the American College of Gastroenterology's Annual Scientific Meeting in Philadelphia by Bruce Greenwald, M.D., associate professor of medicine at the University of Maryland School of Medicine, who was principal investigator of the study. The trial was conducted at the University of Maryland Medical Center in Baltimore.

"Esophageal cancer is as lethal as lung cancer and is one of the fastest growing cancers in the Western world right now," says Tim Askew, president and CEO of CSA Medical. "More than 6 million people in the U.S. have Barrett's esophagus, while 65 million people suffer from GastroEsophageal Reflux Disease (GERD), also called "acid reflux" or "heartburn". Approximately 350,000 persons with GERD develop more dangerous lesions, while 15,000 develop cancer annually, according to Askew.

CSA Medical's CryoSpray Ablation platform sprays liquid nitrogen on pre-cancerous or cancerous tissue, freezing and killing the malignant cells. Malignant cells die and slough off harmlessly, while normal tissue grows back.

"Most patients don't feel any significant pain and say it is a non-event," says Askew. "One patient said that finding parking was more difficult than the procedure. No other therapy for this type of cancer allows tissue to grow back naturally without the potential for scarring," Askew added.

Current treatments can be invasive, can require a hospital stay, and may produce severe side effects, including pain and a narrowing of the esophagus. CryoSpray Ablation is an outpatient procedure, with patients generally resuming normal activities the same or next day.

MIPS funding enabled CSA Medical to team 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.

In the past 18 months, CSA Medical has grown from one to 16 employees, raised $12 million in financing, acquired FDA clearance for its product, obtained certification to market its product in Europe, began a national, 20-center clinical trial, and commercially launched its CryoSpray Ablation product.

"The MIPS funding allowed us to validate our early clinical trial data in a major university hospital with a prominent physician," said Askew. "It was also a catalyst for our commercialization process."

More than 60 physicians around the country have been trained on CryoSpray Ablation, while 16 leading hospitals are currently treating patients using the device. CSA Medical plans to add about 30 additional treatment centers in the next six months.

"I think CryoSpray Ablation will gain a firm foothold in gastroenterology for the destruction of cancer and precancerous lesions in the GI tract," says Dr. Greenwald. "It holds a unique position in its ability to treat non-flat lesions that other technologies are lacking."

CSA Medical plans to investigate CryoSpray Ablation for treating other diseases.

About MIPS (www.mips.umd.edu)
The MTECH Maryland Industrial Partnerships Program, an initiative of the A. James Clark School of Engineering's Maryland Technology Enterprise Institute, brings university innovation to the commercial sector by supporting university-based research projects to help Maryland companies develop technology-based products.

About CSA Medical (www.csamedical.com)
CSA Medical Inc. is a privately held medical technology company dedicated to pioneering CryoSpray Ablation of pre-cancerous and cancerous lesions in the gastrointestinal tract. The company's mission is to design, develop and distribute a highly versatile platform of affordable CryoSpray Ablation (CSA) products that are considered safe and effective by patients, providers and payers, worldwide.

About the University of Maryland School of Medicine (www.medschool.umaryland.edu)
Established in 1807, the University of Maryland School of Medicine is the fifth oldest - and first public - medical school in the nation. The School of Medicine is dedicated to providing excellence in biomedical education, basic and clinical research, quality patient care and service.

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Watch CSA Medical's Computer Simulation of Cryo Spray Ablation Treatment (link goes to CSA's web site)