Roger Stern, Founder and CEO of Stellartech (www.stellartec.com), shared medical device BARRX Inc. (www.barrx.com) success story from idea to exit, at Bio2DeviceGroup (www.bio2devicegroup.org) event. Stellartech was founded in 1988 by Roger Stern, with a goal to develop innovative electronic devices, specifically in the field of development and manufacture of complex energy delivery systems and other sophisticated medical equipment. Stellartech is responsible for the development of many “firsts” in the medical device arena. Recently, Barrx Medical (www.barrx.com), a company co-founded and incubated as a virtual company by Stellartech Research Corp., with two physician partners, was acquired by Covidien, for $325M + milestone based payments.
This venture began when Stern was approached in the year 2000, Dr. Robert Ganz, a gasteroenterologist and his colleague, with a definite clinical problem. A serious condition called Barrett’s esophagus develops after the lower esophagus is repeatedly exposed to acid reflux disease, which causes a cellular conversion to occur. Eventually about 1% of Barrett’s patients develop full fledged esophageal adenocarcinoma. What is striking however, is that the risk among Barrett’s patients of eventually developing the cancer is 30 to 125 times higher than people without this disorder. Additionally, due to changing diet and lifestyle, cancer of the esophagus is one of the fastest-growing cancers in the nation, is often fatal, and until now, Barrett’s condition was left untreated, and only monitored.
One of the early challenges was due to the fact that the lining of the esophagus is very thin and destruction of deeper tissue layers can result in stricture formation (narrowing of the esophageal lumen), in turn making it difficult or impossible to swallow food. Stellartech’s challenge was to design a system that can precisely measure the esophagus and then ablate the superficial lining, while simultaneously preserving the underlying tissue. Stellartech’s eventually developed proprietary ablation system comprises of a balloon catheter around which a band of RF electrodes is wrapped. Along with the endoscope, the catheter is inserted into the esophagus, where the balloon is inflated, so that it expands and presses against the walls. When the operator presses on a foot pedal, a generator connected to the balloon delivers a rapid burst of RF energy to the electrode band mounted on the balloon catheter. Within a few seconds, RF energy is delivered circumferentially to several centimeters of esophageal tissue, while controlling the depth of penetration to avoid deeper damage to the healthy tissue. After removal of the balloon, these treated cells slough off the walls, making way for healthy new cells to grow in their place.
This is a fascinating story of how a medical device company started with identifying and addressing an unmet patient need. Stern shared the milestones achieved, the fund raising cycles that led to further development of the product and clinical work needed to commercialize it. The procedure is now performed on an outpatient basis that allows the diseased esophageal tissue to be ablated and Barrett’s patients to be treated, at early stages. The talk was followed by Q&A.