Start-up Uses Freezing Balloon to Treat Pre-Cancerous Esophaguses

For the 40 million Americans with acid reflux disease, treatment is often over the counter medication or a simple change in diet. However, one in five with acid reflux will likely develop Barrett’s Esophagus, a pre-cancerous condition that makes patients 30 to 125 times more likely to develop cancer of the esophagus. It was these staggering figures that caught President and CEO Peter Garcia-Meza’s attention and moved him to co-found Redwood City-based start-up C2Therapeutics.

Once a patient develops esophageal cancer, a 5-year survival rate is approximately 17 percent. To prevent this transformation of Barrett’s Esophagus into the cancer, patients must pay numerous visits to gastroenterologists for a cumbersome process of 24 steps to kill the diseased tissue. C2Therapeutics has developed technology that simplifies the procedure to 5 steps using cryotherapy, or the freezing of abnormal tissue. 

“We wanted to make the process as simple as possible for doctors,” Garcia-Meza said.

Traditionally, doctors insert an endoscope, a narrow tube-like device, down the sedated patient’s throat to take photos of the diseased tissue. Now, doctors can reduce the number of devices inserted into a patient by snaking C2Therapeutic’s 5-foot catheter down the endoscope. A two-inch balloon at the end of the catheter inflates to fill and make contact with the entire esophagus. The balloon emits gas at a temperature of -80 degrees Celsius for 10 to 15 seconds to kill any of the diseased tissue.

Their technology can cut the procedure time in half, Garcia-Meza said, from half an hour or more down to 15 minutes.

Why Barrett’s Esophagus?

Though a relatively uncommon disease affecting only 3.3 million Americans, Barrett’s Esophagus is a major concern because of the potential to become esophageal cancer, which is very deadly.

“If you get it, it’s like a death sentence,” Garcia-Meza said of the slim survival rate.

Because of the esophagus’ location between the chest and spine, surgeons have to cut deep into the body to operate, a very difficult procedure.

“So we saw this as a preventative opportunity to make a difference in a very important treatment,” he added.  

He said that gastroenterologists are often underserved in the tech realm.  So he began discussions with doctors at the Palo Alto VA Veterans Hospital to gain a better understanding of their needs and how he could deliver through technology.

The doctors were highly receptive, and even excited, to work towards better, more efficient technological devices compared to the current products, he said.

So he and co-founder Rick Williams started the company in 2006 in Williams’ basement in Emerald Hills, a typical setting for start-ups.

“It wasn’t much larger than a medium-sized room,” Williams said. But it was enough to begin the brainstorming and paperwork filing for the two co-founders.

Garcia-Meza had been a marketing consultant for several medical tech start-ups, and C2Therapeutics was Williams’ third medical start-up. Williams had extensive knowledge of cryotherapy, Garcia-Meza said.

Eventually they moved to their current location at Convention Way where they now have six employees. Though the company may purchase specific device parts from other companies, every individual product is assembled by hand in the Redwood City lab.

To date, the company has received just under $7 million in funding, and received its 510k approval from the US Food and Drug Administration (FDA), the green light to begin using the device to treat patients.

The company expects to have a final device to sell by 2013. The anticipated cost of the device, which can fit in a briefcase, is $1500 versus a traditional device that can run up towards $70,000 from all the initial set up costs. The traditional devices require a machine generator for power, while C2Therapeutic’s catheter uses a disposable 4-inch silver cylinder of energy to inflate the balloon.  

The soft balloon is much less rigid than other technology, resulting in less pain for patients.

“It’s a win-win-win in terms of efficiency, cost and patient interaction,” he said.

Future Growth

Though Barrett’s Esophagus is primarily a disease in the Western World, the technology has implications for countries in Asia as well, Garcia-Meza said. The equivalent disease of Barrett’s Esophagus is Squamous disease, which is often caused by air pollution and smoking that results in 500,000 cancer cases a year.

Garcia-Meza said the company may look towards that market once the device has become widely dispensed and used in the Western world.  

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