FDA Approves Xillix's Onco-LIFE'TM' PMA Supplement Thursday June 30, 11:33 pm ET
RICHMOND, British Columbia--(BUSINESS WIRE)--June 30, 2005--Xillix Technologies Corp. (TSX:XLX - News), the world leader in fluorescence endoscopy, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Company's Pre-Market Approval (PMA) Supplement for Onco-LIFE, permitting commercial distribution in the United States. Onco-LIFE is indicated for use with fluorescence imaging during bronchoscopy as an adjunct to white light imaging, to detect and localize tissue suspicious for moderate or severe dysplasia, carcinoma in situ, or invasive cancer in patients with suspected or previously treated lung cancer. ADVERTISEMENT
"FDA approval is a monumental achievement for Xillix. We were the first company to pioneer fluorescence endoscopy and achieve FDA approval in 1996, and this additional FDA approval today allows us to move forward with our exciting next generation product Onco-LIFE, which is compact, user-friendly and compatible with a wide range of endoscopes and endoscopic accessories," said Xillix President and CEO, Cynthia Roney. "We are now able to provide physicians in the United States with an effective new tool for the detection and localization of lung cancer, the leading cause of cancer death in the world."
Xillix has appointed ConMed Endoscopic Technologies, Inc., a division of ConMed Corporation (NASDAQ:CNMD - News) as the sole Onco-LIFE distributor for the lung cancer application in the United States and for both lung cancer and gastrointestinal (GI) application in Canada. ConMed Endoscopic Technologies is a recognized technological leader in the pulmonary and gastrointestinal (GI) endoscopy market. More information about ConMed is available at www.conmed.com.
Cynthia Roney added, "We would like to thank the physicians who participated in the Onco-LIFE clinical trial including: Dr. Stephen Lam (BC Cancer Agency, Vancouver), Dr. Eric Edell (Mayo Clinic, Rochester MN), Dr. Harvey Pass (Wayne State University/Karmanos Cancer, Detroit); Dr. Tom Sutedja (Vrije Universiteit Medical Center, Amsterdam), Dr. Tim Kennedy (HealthONE Presbyterian/St. Luke's Medical Center, Denver, CO), Dr. York Miller (Denver Veterans Affairs (VA) Medical Center, Denver, CO), and Dr. Greg Loewen (Roswell Park Cancer Inst, Buffalo, NY). The reference pathologist for the Onco-LIFE study was Dr. Adi Gazdar (University of Texas Southwestern Medical Center, Dallas,TX) These leading physicians all have considerable experience with fluorescence endoscopy using Xillix's earlier device, Xillix LIFE-Lung(TM). We are pleased with the feedback regarding the ease of use and clinical performance of Onco-LIFE, especially for the detection of early cancer and precancerous lesions where Onco-LIFE demonstrated a 325% per-lesion improvement in the detection of early lung cancer (moderate-severe dysplasia and carcinoma in situ) and a 250% per-patient improvement compared to white-light alone." A summary of the safety and effectiveness (SSE) of Onco-LIFE will soon be available on Xillix's website (www.xillix.com) as well as on the FDA's website (www.fda.gov).
Onco-LIFE functions in a similar manner to the Xillix LIFE-Lung Fluorescence Endoscopy System (PMA P950042) and uses native tissue fluorescence to aid in the identification of potentially precancerous and cancerous tissue. Blue light is used to illuminate the tissue and excite fluorophors naturally present in the tissue. A real-time video image of the fluorescing tissue is acquired and displayed on the video monitor. Areas suspicious for disease are displayed in red in the video image enabling biopsy and further evaluation. Compared to the results previously reported with Xillix LIFE-Lung, Onco-LIFE demonstrated a higher per-lesion improved sensitivity with the addition of fluorescence (Onco-LIFE 71%, Xillix LIFE-Lung 66%) and a considerably higher per-lesion white light sensitivity (Onco-LIFE 47%, Xillix LIFE-Lung 25%). Both devices reported comparable false positive rates (Onco-LIFE 3.56, Xillix LIFE-Lung 3.40).
About Xillix
Xillix Technologies Corp. is a Canadian medical device company and the world leader in fluorescence endoscopy for improved cancer detection. Xillix's latest device, Onco-LIFE(TM), incorporates fluorescence and white-light endoscopy in a single device that has been developed for the detection and localization of lung and gastrointestinal (GI) cancers. Onco-LIFE is approved for sale in the United States for the lung application and in Europe and Canada for both lung and GI applications. Onco-LIFE is compact, user-friendly and is compatible with a wide range of endoscopes and endoscopic accessories to help maximize global market acceptance.
Note: Certain of the statements contained in this press release contain forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The Company does not expect to update forward-looking statements continually as conditions change. Investors are referred to the full discussion of risk factors associated with the Company's business contained in the Company's Annual Information Form filed with securities regulatory authorities dated March 31, 2005. Further, Xillix notes that this press release contains forward-looking statements with respect to ConMed Corporation made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 relating to ConMed's performance on a going-forward basis. These forward looking statements involve risks and uncertainties which could cause actual results, performance or trends to differ materially for ConMed from those expressed in the forward looking statements herein or in previous disclosures. With respect to ConMed, please refer to the comments and risks relating to forward-looking statements discussed in ConMed's annual report on Form 10-K for the year ended December 31, 2004.
Xillix Announces Onco-LIFE'TM' Sales Management Team Friday July 8, 9:05 am ET
RICHMOND, BRITISH COLUMBIA--(CCNMatthews - July 8, 2005) - Xillix Technologies Corp. (TSX:XLX - News), the world leader in fluorescence endoscopy for the early detection of cancer, today announced its Onco-LIFE(TM) Sales Management team responsible for global sales. Joining Patrick du Monceaux, Vice President Sales & Marketing and David Marsh, Director North American Sales are David Vogt - Western Region US Sales Manager, Victor Marone - Eastern Region US Sales Manager, David Phillips - European Business Manager, Northern Region, and Martine Forissier - European Business Manager, Southern Region. As announced on May 17, 2005, Xillix's North American Sales Management team will be working with ConMed Endoscopic Technologies (www.conmed.com), the sole distributor of Onco-LIFE in the United States (for the lung application) and in Canada (for both lung and GI applications). ADVERTISEMENT
"We are pleased to have assembled such a highly seasoned sales management team with medical device experience," said Patrick du Monceaux, Vice President, Sales & Marketing. "All of our sales managers have strong relationships in the medical community and a wealth of industry-specific expertise which is invaluable as we move forward with sales in Europe, Canada and globally, particularly now with the launch of Onco-LIFE in the U.S., the world's largest medical device market."
In North America, David Marsh, Director of North American Sales, who joined Xillix in the first quarter of 2004, has more than 20 years of sales and marketing experience in the medical device industry, including managing the U.S. sales force for Bard Endoscopic Technologies, a division of CR Bard (now ConMed Endoscopic Technologies). David Vogt, Western Region US Sales Manager, has more than 20 years of progressive sales management experience in the medical device and critical care markets, as both a division and regional manager for several large multi-national corporations. Victor Marone, Eastern Region US Sales Manager, brings more than 10 years of sales and marketing experience to Xillix. During his time at Bard Endoscopic Technologies and GE Healthcare, Victor gained valuable experience introducing new technologies to the medical community and managing capital equipment purchases. David Vogt and Victor Marone have responsibility for driving sales opportunities, sales su! pport and training as well assisting ConMed in their respective regions; both report to David Marsh.
In Europe, David Phillips and Martine Forissier have responsibility for driving sales opportunities, sales support and training, as well as managing Xillix's network of European distributors; both report to Patrick du Monceaux. David Phillips, European Business Manager, Northern Region, brings 17 years experience in implementing and managing successful direct sales operations and distributor networks. In his most recent position with Medtronic Europe, David was Senior Business Manager for the Emergency Response Systems business in the Emerging Markets segment, comprised of Eastern Europe, Middle East, Africa and India. Martine Forissier, European Business Manager, Southern Region, comes to Xillix with extensive experience in the medical device and clinical applications business. In her most recent position with Medtronic Europe, Martine was the European Director of Commercial Business for the Emergency Response Systems, comprised of Western Europe and supporting other areas ! in Europe and the Emerging Markets. Sales opportunities in other global markets including Asia, are currently being managed directly by Mr. du Monceaux.
About Xillix
Xillix Technologies Corp. is a Canadian medical device company and the world leader in fluorescence endoscopy for improved cancer detection. Xillix's latest device, Onco-LIFE(TM), incorporates fluorescence and white-light endoscopy in a single device that has been developed for the detection and localization of lung and gastrointestinal (GI) cancers. An international multicenter lung cancer clinical trial of Onco-LIFE demonstrated a 325% per-lesion improvement in the detection of early lung cancer (moderate-severe dysplasia and carcinoma in situ) and a 250% per-patient improvement compared to white-light alone. Onco-LIFE is approved for sale in the United States for the lung application and in Europe and Canada for both lung and GI applications. Onco-LIFE is compact, user-friendly and is compatible with a wide range of endoscopes and endoscopic accessories to help maximize global market acceptance
Note: Certain of the statements contained in this press release contain forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The Company does not expect to update forward-looking statements continually as conditions change. Investors are referred to the full discussion of risk factors associated with the Company's business contained in the Company's Annual Information Form filed with securities regulatory authorities dated March 31, 2005.
The Company is listed on the Toronto Stock Exchange under the trading symbol "XLX".
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