{"64054":{"#nid":"64054","#data":{"type":"news","title":"Atlanta Company Pioneers Medical Devices with Georgia Tech Help","body":[{"value":"\u003Cp\u003ECardioMEMS, a graduate of Georgia Tech\u0027s ATDC startup accelerator, is a rising star in the medical device industry. Pioneering a new class of monitoring devices for heart patients, the company completed a successful clinical trial in May 2010 for its second product, which resulted in a $60 million equity investment and purchase option from St. Jude Medical Inc., a large medical device company based in St. Paul, Minn.\u003C\/p\u003E\n\u003Cp\u003EThat investment earned the company a 2011 \u0022Deal of the Year\u0022 award from Georgia Bio, a nonprofit association that represents Georgia\u0027s pharmaceutical, biotech and medical device community.\n\u003C\/p\u003E\n\u003Cp\u003ECardioMEMS, which has more than 65 employees, grew out of Georgia Tech research. The company\u0027s products combine wireless communications technology with microelectromechanical systems (MEMS) fabrication, providing doctors with more information while making monitoring less invasive for patients. \n\u003C\/p\u003E\n\u003Cp\u003EMEMS uses micro-machining fabrication to build electrical and mechanical systems at the micron scale -- one-millionth of a meter. Using technology originally developed for the integrated circuit industry, MEMS is an attractive platform for medical devices because mechanical, sensing and computational functions can be placed on a single chip.\n\u003C\/p\u003E\n\u003Cp\u003ECardioMEMS began marketing its first product in 2006: the EndoSure sensor, which measures blood pressure inside a repaired abdominal aortic aneurysm. Implanted along with a stent graft during endovascular repair, this tiny sensor may allow doctors to monitor post-surgery patients more effectively than the CT scans that had previously been used. The EndoSure sensor is also less expensive and more convenient. \n\u003C\/p\u003E\n\u003Cp\u003ENow the company\u0027s second product, a sensor that measures intracardiac pressure in people who suffer from congestive heart failure, is moving closer to FDA approval.\n\u003C\/p\u003E\n\u003Cp\u003EImplanted in the pulmonary artery, CardioMEMS\u0027 new heart sensor enables Class III heart-failure patients (considered to be in the moderate stage of heart failure) to take daily intracardiac pressure readings at home. This information is transmitted to a website, which enables physicians to monitor patients more effectively and alter medications when necessary. In fact, results from the recent clinical study showed a 40 percent reduction in hospitalizations when doctors used data from CardioMEMS\u0027 system to treat patients.\n\u003C\/p\u003E\n\u003Cp\u003ELaunched in 2001, CardioMEMS was co-founded by Dr. Jay Yadav, a cardiologist and director at the Cleveland Clinic Foundation at the time, and Mark Allen, a professor in Georgia Tech\u0027s School of Electrical and Computer Engineering and director of the school\u0027s MEMS research group. \n\u003C\/p\u003E\n\u003Cp\u003EDue to the unique nature of its technology, CardioMEMS elected to locate in Atlanta to be close to Allen and his students. ATDC accepted CardioMEMS into its incubator program shortly after the startup\u0027s formation.  The Georgia Research Alliance assisted with an industry partnership grant early in the company\u0027s development.\n\u003C\/p\u003E\n\u003Cp\u003E\u0022ATDC has played an important role in CardioMEMS\u0027 success, especially during our early years,\u0022 said David Stern, CardioMEMS\u0027 senior vice president for scientific affairs and one of the company\u0027s first full-time employees. \n\u003C\/p\u003E\n\u003Cp\u003EBioscience companies face unique challenges, Stern explained: They have greater needs for capital, face higher technical risks and typically need FDA or other regulatory approval before they can market their products or services. And unlike many entrepreneurs that can start their companies in a garage or home office, bioscience companies require special facilities. \n\u003C\/p\u003E\n\u003Cp\u003ECardioMEMS was among the first tenants in ATDC\u0027s Biosciences Center, located within Georgia Tech\u0027s Environmental Science \u0026amp; Technology (ES\u0026amp;T) research center, which enabled the company to access wet labs equipped with special ventilation and purified water systems. CardioMEMS was also able to use Georgia Tech clean rooms for micromachining.\n\u003C\/p\u003E\n\u003Cp\u003EIf CardioMEMS had been required to build its own clean room, it would have cost millions of dollars and delayed R\u0026amp;D for months, Stern said. In addition, Georgia Tech\u0027s clean rooms have a broad array of specialized equipment, which enabled CardioMEMS to execute its prototyping faster -- and try different equipment to see what it would ultimately need to invest in.\n\u003C\/p\u003E\n\u003Cp\u003EThe physical proximity to other entrepreneurs and researchers in ES\u0026amp;T was also a plus. \u0022At one point we were next to another medical-device company, so it was easy for our staffs to have impromptu discussions walking down the hallways,\u0022 Stern said. Being on Georgia Tech\u0027s campus gave CardioMEMS access to a deep talent pool, and enabled the company to hire professors as consultants, graduate students as permanent employees and current students as interns.\n\u003C\/p\u003E\n\u003Cp\u003EAn important aspect of being able to use Georgia Tech facilities and hire talent was the lack of red tape. \u0022With most institutions, that becomes very complicated and you can spend a lot of time negotiating contracts rather than getting work done,\u0022 Stern explained. \u0022Yet ATDC was able to make it all really easy.\u0022\n\u003C\/p\u003E\n\u003Cp\u003E\u0022This may sound like a minor point, but it\u0027s not,\u0022 said Stern, noting that startup is a crucial time for any company, but especially for a biotech firm. \u0022It\u0027s during those early years that you have the least amount of money -- and the most to accomplish. You don\u0027t want to waste time or money on anything that doesn\u0027t involve progressing R\u0026amp;D or acquiring talent.\u0022 \n\u003C\/p\u003E\n\u003Cp\u003EToday CardioMEMS is located in Technology Enterprise Park, a biobusiness complex located south of the Georgia Tech campus, and FDA approval of its heart sensor would position the company for considerable growth. The heart sensor has faced a longer road to commercialization than the company\u0027s first product, however, its market potential is dramatically larger, said Stern, citing a patient population of more than 1.5 million compared to about 30,000 for the EndoSure sensor. \n\u003C\/p\u003E\n\u003Cp\u003EAlthough CardioMEMS is already contributing to Georgia\u0027s economy by generating new high-tech jobs, the company\u0027s success has broader implications, observed Nina Sawczuk, ATDC general manager.\n\u003C\/p\u003E\n\u003Cp\u003EThe $100 billion U.S. medical device industry is made up of thousands of small and medium-sized enterprises and a few large players. \u0022Medical device companies are located throughout the country, but concentrated in specific regions known for other high-technology industries, such as microelectronics and biotechnology,\u0022 Sawczuk explained. \u0022Georgia is among the top 10 states with the highest number of medical device companies and our focus is on supporting the small, innovative companies.\u0022 \n\u003C\/p\u003E\n\u003Cp\u003ETo this end Georgia Tech has partnered with Saint Joseph\u0027s Translational Research Institute, Piedmont Healthcare and the Georgia Research Alliance to launch the Global Center for Medical Innovation (GCMI), an initiative aimed at accelerating the development of next-generation medical devices and technology in the Southeast. \n\u003C\/p\u003E\n\u003Cp\u003E\u0022CardioMEMS is a catalyst for developing a next generation medical-device industry hub in Georgia,\u0022 Sawczuk continued. \u0022CardioMEMS marries MEMS technology with more traditional medical device technology. This is particularly exciting because the company is creating a new type of wireless product that is the future of the medical device industry. It is success stories such as CardioMEMS that the GCMI plans to replicate in the Southeast.\u0022\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EResearch News \u0026amp; Publications Office\u003Cbr \/\u003E\nGeorgia Institute of Technology\u003Cbr \/\u003E\n75 Fifth Street, N.W., Suite 314\u003Cbr \/\u003E\nAtlanta, Georgia  30308  USA\n\u003C\/strong\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EMedia Relations Contacts\u003C\/strong\u003E: John Toon (404-894-6986)(\u003Ca href=\u0022mailto:jtoon@gatech.edu\u0022\u003Ejtoon@gatech.edu\u003C\/a\u003E) or Abby Robinson (404-385-3364)(\u003Ca href=\u0022mailto:abby@innovate.gatech.edu\u0022\u003Eabby@innovate.gatech.edu\u003C\/a\u003E).\n\u003C\/p\u003E\n\u003Cp\u003E\u003Cstrong\u003EWriter\u003C\/strong\u003E: T.J. Becker\n\u003C\/p\u003E\n\u003Cp\u003E\u0026nbsp;\u003C\/p\u003E","summary":null,"format":"limited_html"}],"field_subtitle":[{"value":"CardioMEMS Produces Implantable Monitoring Devices for Heart Patients"}],"field_summary":[{"value":"\u003Cp\u003EAn Atlanta medical device company that is based on Georgia Tech research has become an industry rising star, with a new product moving toward approval -- and more than 65 employees.\u003C\/p\u003E","format":"limited_html"}],"field_summary_sentence":[{"value":"A Georgia Tech-based company is a leader in medical devices."}],"uid":"27303","created_gmt":"2011-02-03 01:00:00","changed_gmt":"2016-10-08 03:08:06","author":"John Toon","boilerplate_text":"","field_publication":"","field_article_url":"","dateline":{"date":"2011-02-03T00:00:00-05:00","iso_date":"2011-02-03T00:00:00-05:00","tz":"America\/New_York"},"extras":[],"hg_media":{"64055":{"id":"64055","type":"image","title":"CardioMEMS inspection","body":null,"created":"1449176720","gmt_created":"2015-12-03 21:05:20","changed":"1475894561","gmt_changed":"2016-10-08 02:42:41","alt":"CardioMEMS inspection","file":{"fid":"191923","name":"taf58980.jpg","image_path":"\/sites\/default\/files\/images\/taf58980_0.jpg","image_full_path":"http:\/\/hg.gatech.edu\/\/sites\/default\/files\/images\/taf58980_0.jpg","mime":"image\/jpeg","size":1381825,"path_740":"http:\/\/hg.gatech.edu\/sites\/default\/files\/styles\/740xx_scale\/public\/images\/taf58980_0.jpg?itok=iq0dpwHN"}}},"media_ids":["64055"],"related_links":[{"url":"http:\/\/www.ece.gatech.edu\/","title":"School of Electrical and Computer Engineering"},{"url":"http:\/\/www.atdc.org\/","title":"ATDC"},{"url":"http:\/\/cmmt.gatech.edu\/","title":"Center for MEMS and Microsystems Technology"}],"groups":[{"id":"1188","name":"Research Horizons"}],"categories":[{"id":"129","name":"Institute and Campus"},{"id":"139","name":"Business"},{"id":"131","name":"Economic Development and Policy"},{"id":"145","name":"Engineering"},{"id":"146","name":"Life Sciences and Biology"},{"id":"135","name":"Research"}],"keywords":[{"id":"4238","name":"atdc"},{"id":"7672","name":"CardioMEMS"},{"id":"1925","name":"Electrical and Computer Engineering"},{"id":"2313","name":"Mark Allen"},{"id":"527","name":"medical"}],"core_research_areas":[],"news_room_topics":[],"event_categories":[],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cp\u003E\u003Cstrong\u003EJohn Toon\u003C\/strong\u003E\u003Cbr \/\u003EResearch News \u0026amp; Publications Office\u003Cbr \/\u003E\u003Ca href=\u0022http:\/\/www.gatech.edu\/contact\/index.html?id=jt7\u0022\u003EContact John Toon\u003C\/a\u003E\u003Cbr \/\u003E\u003Cstrong\u003E404-894-6986\u003C\/strong\u003E\u003C\/p\u003E","format":"limited_html"}],"email":["jtoon@gatech.edu"],"slides":[],"orientation":[],"userdata":""}}}