RECENT PRESS RELEASES

FDA Issues Second 510(k) Clearance to C Change Surgical

January 20, 2009 – Winston-Salem, NC – In a letter dated January 13, 2009 the US Food and Drug Administration issued C Change Surgical a second 510(k) clearance to market its innovative sterile fluid control products.  C Change Surgical fluid control products improve operating room staff & procedure efficiency, patient safety and clinical outcomes and have wide application in a significant percentage of all traditional and minimally invasive surgical procedures performed worldwide each year.

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United States Patent & Trade Office Issues Significant Patents to C Change Surgical

January 8, 2009 – Winston-Salem, NC – Patrick Kammer, President and CEO of C Change Surgical announced that the United States Patent & Trade Office issued several new patents to C Change Surgical in 2008. The USPTO issued C Change Surgical two design patents in May and issued two significant utility patents in late 2008. These valuable new patents add to a rapidly growing IP portfolio that provides broad protection for C Change Surgical's™ innovative fluid control technologies and related designs.

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Impact Entrepreneur Award

February 2008 – Winston-Salem, NC –Patrick Kammer, President, CEO, C Change Surgical, Winston-Salem, was named an Impact Entrepreneur in North Carolina by Business Leader Magazine. Business Leader Media is a leading business-to-business media and information company serving business executives and entrepreneurs. Its magazines, web sites, events, and market intelligence are valuable information sources and business tools with worldwide reach

view Business Leader Media online article

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C Change Surgical Files Significant MIS Patent Application

October 25, 2007 – Winston-Salem, NC – Patrick Kammer, President and CEO of C Change Surgical announced that C Change Surgical, LLC has filed another United States Patent application. This latest application addresses innovative improvements in the use of laparoscopes and other small medical scopes used in minimally invasive surgical (MIS) procedures. “These large, rapidly expanding and lucrative growth markets are an important focus for our fluid and temperature control technologies,” said Mr. Kammer.  “Fluids are used in all MIS procedures and we are developing specific MIS fluid control products that have wide application and will significantly improve safety and efficiency in these procedures.” 

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C Change Surgical Presents at Prestigious
CED Conference

C Change CEO Lectures at Wake Forest University

September 25, 2007 – Winston-Salem, NC – C Change Surgical’s President & CEO, Patrick Kammer, served as a guest lecturer at Wake Forest University. Mr. Kammer spoke to entrepreneurial business students on opportunity analysis, corporate development, intellectual property and strategic partnerships. BusinessWeek magazine ranks Wake Forest University’s Calloway School of Business and Accountancy 17th on its list of the top 50 undergraduate business schools in the United States: http://calloway.wfu.edu. Mr. Kammer has also guest lectured on entrepreneurship at the University of North Carolina – Greensboro’s Bryan School of Business:  http://www.uncg.edu/grs/

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United States Patent & Trade Office Issues Three More Patents to C Change Surgical

July 24, 2007 – Winston-Salem, NC – Patrick Kammer, President and CEO of C Change Surgical announced that the United States Patent & Trade Office issued three more patents on C Change Surgical’s fluid control technology. “These patents create significant value for our company and our investors as they further protect our recurring revenue ThermaBasin™ product line,” Mr. Kammer said. “Over 96% of the pre-sterilized surgical packs sold to US hospitals include one or more fluid basins. Our IntraTemp™ system converts a universal, low-tech product into an efficient and precise temperature control tool in keeping with recently improved standards of care.”

Dr. Steven C. Hendrickson, a North Carolina cardiothoracic surgeon remarked, “Surgical teams are focusing on controlling identified risks and improving efficiency. This is just obviously a better way to use irrigating fluid intraoperatively. It puts precisely warmed fluid at our fingertips throughout every procedure. It’s interesting how simple, seamless improvements like this increase efficiency. We can use it to warm our scopes in minimally invasive surgeries so we don’t have those initial minutes of lens fogging.  This is a very simple way for surgical teams to properly use fluids and it will be widely adopted.” 

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Two Preeminent Business Leaders Join C Change Board of Directors

July 21, 2007 – Winston-Salem, NC – Patrick Kammer, President and CEO of C Change Surgical announced that two of North Carolina’s most prominent business executives have joined the Board of Directors at C Change Surgical. “C Change Surgical now receives guidance from a Board of Directors unsurpassed by any early stage medical device company in the world,” said Mr. Kammer. “David Norbury and Dennis Barry possess global reputations for their business accomplishments and they provide C Change with access to invaluable relationships in health care, technology and venture capital.  The value these gentlemen add to C Change is significant and we’re proud to work with them.”

Dennis Barry – Mr. Barry is currently the CEO Emeritus and past president and CEO of Moses Cone Health System, Greensboro, N.C., Mr. Barry served on the board of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), which oversees hospital quality nationally, for five years and chaired the American Hospital Association’s Committee of Commissioners to the JCAHO for four years. Barry also was a member of the American Hospital Association’s executive committee, board of trustees and committee on nominations and served on a regional policy board. Mr. Barry’s many professional awards include the American Hospital Association Award of Honor and the North Carolina Hospital Association Distinguished Service Award. Before his tenure at the Moses Cone Health System, Mr. Barry was a general director of the North Carolina Memorial Hospital in Chapel Hill and assistant dean of the School of Medicine at the University of North Carolina at Chapel Hill. Mr. Barry earned a bachelor’s degree in pharmacy from the University of Illinois and his master’s degree in business administration from the University of Chicago, where he graduated with honors.

David Norbury – Mr. Norbury served as Chief Executive Officer of RF Micro Devices, Inc., Greensboro, NC, from September 1992 to January 2003 and as President from September 1992 to June 2002. Mr. Norbury guided the company through its early days through a period of rapid growth. RF Micro Devices, Inc. now has a market capitalization of $1.36 billion. The company engages in the design, development, manufacture, and marketing of radio frequency (RF) components and system solutions for mobile communications worldwide. It offers power amplifiers, transmit modules, cellular transceivers and transceiver modules, and system-on-chip solutions that enable mobility and provide connectivity, and support advanced functionality in mobile devices, cellular base stations, wireless local area networks and global positioning systems. Prior to overseeing the explosive growth at RF Micro Devices, Mr. Norbury served as President and Chief Executive Officer of Polylythics, Inc., a developer of semiconductor technology based in Santa Clara, California, from August 1989 to March 1991.

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October 31, 2006 – Winston-Salem, NC – Patrick Kammer, President and CEO of C Change Surgical announced that the United States Patent and Trade Office issued the first utility patent on C Change Surgical’s fluid control technology. “This patent serves as an invaluable intellectual property platform as we continue to create innovative, novel technologies that help surgical teams and their patients,” Mr. Kammer said.

“The C Change Surgical patent is for a Liquid Warming Device with Basin…this is not a tweak but a major overhaul of the process of controlling the temperature of sterile surgical fluids with precision in order to achieve better medical results.” said Kevin Flynn, C Change Surgical’s intellectual property attorney for this patent. Mr. Flynn, a principal of the Eclipse Group, LLP, went on to say, “The United States Patent and Trademark Office found all 46 claims of this application to be novel and non-obvious improvements over the prior devices,” 

The IntraTemp™ Fluid Control Stand and ThermaBasin™ procedure kit technologies make the use of sterile irrigating fluid simpler, easier and substantially more efficient for surgical teams. “Clinicians report that the IntraTemp™ technology allows surgical teams to automate and display point of use control of irrigating fluids in the sterile field during virtually all surgical procedures,” Mr. Kammer said. “Clinicians tell us that they value the IntraTemp™ system because it takes the guess work, stress and cumbersome inefficiency out of using this universal surgical tool.” http://www.eclipsegrp.com

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C Change Surgical Submits New Patent for
Fluid Control Technology

March 17, 2006 – Winston-Salem, NC – Patrick Kammer, President and CEO of C Change Surgical announced that C Change Surgical, LLC recently filed another United States Patent application for innovative improvements to equipment for use with heated sterile fluids. This most recent application discloses "access sleeves" that may be used to maintain closed containers of sterile fluid at a desired temperature. Maintaining closed containers of sterile fluid at the desired temperature and keeping them accessible in the operating room significantly improves surgical procedure efficiency. This added level of control reduces the need for clinical personnel to leave the operating room during surgery. Mark Martel, Vice President of Innovation for C Change Surgical stated, "Operating room nurses tell us that this technology is significant in that it improves control within the operating room and allows better, more consistent focus on the needs of the surgeon and the patient. It is rare that a new technology offers benefits to the patient and makes life easier for the surgical team."

"This is yet another instance where creativity by C Change Surgical has addressed a problem with the suite of prior art solutions. This C Change Surgical application joins a growing body of pending applications to obtain intellectual property rights, both foreign and domestic for novel technology and designs" noted Kevin Flynn, patent attorney at The Eclipse Group. http://www.eclipsegrp.com

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C Change Surgical receives European Community
Design Registrations

January 4, 2006 – Winston-Salem, NC – C Change Surgical, LLC has received European Community Design Registrations for the novel designs in three hospital basins compatible for use with the C Change Surgical IntraTemp™ surgical technology for use with the provision of surgical fluids. "While this is the beginning of the portfolio of issued intellectual property rights for C Change Surgical, it is only the beginning. C Change Surgical has a number of pending applications to obtain intellectual property rights, both foreign and domestic for novel technology and designs" noted Kevin Flynn, patent attorney at The Eclipse Group. Patrick Kammer, President and CEO of C Change Surgical added that "C Change Surgical believes that we have identified better ways of handling surgical fluids and we intend to protect our innovations with a portfolio of intellectual property protection."

The company’s patent attorney, Kevin Flynn of Durham, NC is a frequent speaker and commentator on intellectual property issues, especially those issues of particular relevance to entrepreneurial companies. In 2004 and again in 2005, Mr. Flynn was chosen by a poll of North Carolina attorneys as belonging to the legal Elite for the category of Intellectual Property/Patent attorneys. http://www.eclipsegrp.com

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Medical Device Executive Nominated for
National SBA Award

December 15, 2005 – Winston Salem, NC – Patrick Kammer, President & CEO of the Winston-Salem medical device company, C Change Surgical, was officially nominated for the Small Business Administration Small Business Person of the Year Award. Kammer has headed the company as it researched & developed a surgical technology that now has six patents pending. C Change Surgical received official FDA clearance to market its IntraTemp surgical technology just 14 months after forming its company. The company is now in the early stages of production for its IntraTemp surgical fluid control technology.
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The company estimates that its IntraTemp device could be used in over 20 million surgical procedures worldwide each year. C Change Surgical will earn revenue by selling hospitals and surgery centers a pre-sterilized surgical kit needed for use with the IntraTemp for each surgery.

C Change Surgical, LLC, was founded in July 2004. The privately held company operates from a 27,000 square foot FDA audited GMP facility located in the Piedmont Triad Research Park in Winston-Salem, NC. C Change Surgical is focused on developing and commercializing technologies that improve operating room staff & procedure efficiency, patient safety and clinical outcomes in millions of surgical procedures worldwide.

The company regularly consults with a carefully selected group of senior nurse and physician advisors about creating cost effective, easily adopted solutions to serious surgical complications. C Change is now developing additional technologies that seamlessly assist the surgical staff and aid in patient safety. Our advisors include experts in minimally invasive, plastic, vascular, cardiac, thoracic, general, colorectal, OB-GYN, urology and other surgical specialties.

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C Change Surgical Participates in Invitation-Only
MedAssets New Technology Forum

October 10, 2005 – Winston Salem, NC – C Change Surgical, LLC, exhibited the IntraTemp product line, its new surgical device technology, at the prestigious MedAssets New Technology Forum held in St. Louis, Missouri in October, 2005. MedAssets annually invites 100 senior clinical and administrative executives from across the US to inspect potential “breakthrough technologies.” MedAssets, headquartered in Atlanta, Georgia operates the fastest growing group purchasing organization and supply chain services company in the U.S. MedAssets Supply Chain Systems builds customized procurement solutions for common medical supplies, pharmaceuticals, physician preference supplies, food and nutrition items, and capital equipment. It serves more than 22,000 healthcare providers nationwide including The University of North Carolina Health Care System, Charleston Area Medical Center (West Virginia), Inova Health System (Virginia), Bon Secours Health System (Maryland), Christiana Care Health System (Delaware), University of Pittsburgh Medical Center (Pennsylvania), Atlantic Health System (New Jersey), Banner Health (Arizona), Main Line Health (Pennsylvania), North Mississippi Health Services, Rush System for Health (Illinois), St. Joseph Health System (California), Saint Barnabas Health Care System (New Jersey), University of Rochester Medical Center (New York), and many others.

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C Change Surgical Starts First Production Run of IntraTemp Machines

September 14, 2005 – Winston Salem, NC – C Change Surgical, LLC, an early stage medical device company located in the Piedmont Triad Research Park in Winston-Salem, NC began initial production of the IntraTemp product line. The IntraTemp is C Change Surgical’s patent pending, surgical technology that has usage potential in over 20 million surgical procedures performed globally each year. “We’re pleased to be producing a sophisticated surgical technology in the Piedmont Triad area of North Carolina. This region has a long tradition of manufacturing excellence. Folks here can be proud to make a technology that has the potential to help surgical staffs in millions of operations each year,” said Todd Cassidy, C Change Surgical’s Senior Vice President for Operations.

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The FDA Officially Notifies of 510(k) Approval and Clears C Change Surgical to Market Surgical Device Technology

August 24, 2005 – Winston Salem, NC – C Change Surgical, LLC, announced that the US Food and Drug Administration informed the company of official 510(k) clearance to market its IntraTemp surgical control technology to US hospitals. “The official FDA clearance came on August 15, just six weeks after our FDA submission – a record time for our executive team. We’re proud of our execution as a management team. We achieved this milestone just after our first birthday as a company,” said Bob Kelly, Vice President for Regulatory Affairs & Quality Assurance at C Change Surgical. Mr. Kelly earned an undergraduate electrical engineering degree from the University of Virginia, his MBA from Indiana and holds his RAC Certification by the Regulatory Affairs Professional Society. He has over 20 years of regulatory, engineering and manufacturing experience in the medical device industry.

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C Change Surgical Submits First 510(k) to the FDA for Clearance to Market New Surgical Device Technology to U.S. Hospitals

July 9, 2005 – Winston Salem, NC – C Change Surgical, LLC, an early stage Piedmont Triad Research Park medical device company, submitted its first 510(k) to the federal Food and Drug Administration (FDA) for clearance to market its new surgical device technology. Bob Kelly, Vice President for Regulatory Affairs and Quality Assurance said, “We’ve submitted for FDA clearance to market our technology because at this stage we feel that we’ve created a technology that increases efficiency for surgical teams and provides data for proof of safe surgical practice.”

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C Change Surgical Submits Additional Patents

March 15, 2005 – Winston Salem, NC – C Change Surgical, LLC, an early stage Piedmont Triad Research Park medical device company, submitted additional patents on its machine based, surgical fluid control technology system. “We’ve developed what we feel is important and valuable intellectual property. We are taking the necessary steps to protect the technology that forms the basis of our recurring revenue stream,” said Jon S. Wilson, Senior Vice President for Business Development at C Change Surgical. Successful founder or co-founder of six medical device companies, Mr. Wilson has proven expertise in medical product and patent development for key markets. Mr. Wilson's last two ventures, Wiltek and Diatek, were acquired by two Fortune 500 medical device companies.

The company’s patent attorney, Kevin Flynn of Durham, NC is a frequent speaker and commentator on intellectual property issues, especially those issues of particular relevance to entrepreneurial companies. In 2004 and again in 2005, Mr. Flynn was chosen by a poll of North Carolina attorneys as belonging to the legal Elite for the category of Intellectual Property/Patent attorneys. http://www.eclipsegrp.com

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Surgical Technology Firm Completes Prototypess

February 11, 2005 – Winston Salem, NC – C Change Surgical, LLC, an early stage medical device company located in the Piedmont Triad Research Park in Winston-Salem, NC finished engineering and design work on a fully functioning prototype of its patent pending, surgical device technology. “We’ve worked extensively with Automation Techniques, an outstanding engineering and design firm located here in the Triad, and are very pleased with how our surgical technology is developing,” said Mark Martel, Vice President for Innovation at C Change Surgical. “This project has been special to us because we’ve been able to work with C Change Surgical toward creating a surgical technology that could have a positive impact on millions of surgeries. That’s exciting,” said Automation Techniques President, Kevin Rackers.
http://www.automationtechniques.com

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The Inception Micro Angel Fund Invests in
C Change Surgical

August 16, 2004 – Winston Salem, NC – The Inception Micro Angel Fund, LLC (IMAF) has invested in C Change Surgical, LLC, an early stage medical device company located in the Piedmont Triad Research Park in Winston-Salem, NC. IMAF is a member-managed seed stage angel capital fund designed to capitalize on the growth in entrepreneurial activity and venture financing, primarily in the Piedmont Triad area of North Carolina, greater North Carolina and in selective areas of Virginia and South
Carolina. C Change Surgical represents IMAF’s largest investment to date.
http://www.inceptionmicroangelfund.com

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C Change Surgical Submits First Patents

August 6, 2004 – Winston Salem, NC – C Change Surgical, LLC, an early stage medical device company located in the Piedmont Triad Research Park, submitted its first two patent applications on its computerized surgical machine technology. Managing members at C Change Surgical indicate that their technology platform has potential application in over 20 million surgical procedures performed globally each year. “We’re excited to take this crucial step in securing broad, intellectual property protection around our surgical technology,” said Mark Martel, Senior Vice President for Innovation at C Change Surgical, LLC.

The company’s patent attorney, Kevin Flynn of Durham, NC is a frequent speaker and commentator on intellectual property issues, especially those issues of particular relevance to entrepreneurial companies. In 2004 and again in 2005, Mr. Flynn was chosen by a poll of North Carolina attorneys as belonging to the legal Elite for the category of Intellectual Property/Patent attorneys.
http://www.eclipsegrp.com

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Five Medical Device Industry Executives Form
Surgical Technology Company in the Piedmont
Triad Research Park

July 17, 2004 – Winston Salem, NC – Five medical device executives with a track record of developing both successful medical devices and the companies needed to manufacture and market them have formed a new venture located in the Piedmont Triad Research Park. The five member management team is developing a scalable, differentiating machine technology with a significant use potential in surgery to ensure optimal outcomes. “Our team has proven skills in medical device product and patent development, engineering, manufacturing, operations, medical device sales & marketing and in regulatory affairs,” said President & CEO Patrick Kammer. “We’re developing a scalable technology platform that helps surgical patients and their surgical staffs. This technology has the potential for over 20 million annual uses in a $1.75 billion segment of the global surgical supply market.” The last two companies formed by members of this management team were acquired by two Fortune 500 medical device companies.

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