News
Elixir Medical Corporation Announces Excellent Nine Month Safety and Efficacy Results from the EXCELLA II Randomized Clinical Trial
Results from the EXCELLA II Randomized Clinical Trial using Elixir Medical’s DESyne Novolimus-Eluting Coronary Stent System to Be Featured In the Late Breaking Clinical Trial Presentation at EuroPCR10
Elixir Announces Positive First-In-Man Results for Three Drug Eluting Coronary Stent Systems with Durable and Bioabsorable Polymers during TCT 2009
Elixir Medical Announces Activities at Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference
SurModics Licenses Hydrophilic Coating for Elixir's Drug-Eluting and Bare Metal Stent Delivery Systems
Elixir Medical Corporation Announced Positive First-In-Man Results from Three Drug Eluting Coronary Stent Systems
Elixir Medical Corporation Licenses Myolimus™ from Novartis Pharma AG for site specific drug delivery applications
Elixir Medical Announces Positive Clinical Results for the Company's First Drug Eluting Coronary Stent
Events
Presentations at Transcatheter Cardiovascular Therapeutics 2007, Washington DC
Session: First-in-Man Experiences with Drug-Eluting Stents: Passive and Active Stent Coatings
Elixir Medical Announces Positive Clinical Results for the Company's First Drug Eluting Coronary Stent
Novolimus Eluting Stent System Demonstrates Promising Safety and Efficacy Clinical Profile
Washington, D.C. and Sunnyvale, Calif.—Oct. 21, 2007—Elixir Medical, a developer of innovative drug eluting stent platforms for the treatment of cardiovascular disease, announced four-month results for EXCELLA, a first-in-man clinical trial of the company's Novolimus™ Eluting Coronary Stent. Results were presented at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., by Alexandre Abizaid, M.D., Ph.D., chief of Coronary Interventions at the Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil.
Elixir Medical's Novolimus Eluting Coronary Stent system was effective in reducing lumen loss and neointimal hyperplasia formation at four-month angiographic follow-up after undergoing interventional procedure, with an in-stent late lumen loss of 0.15 ± 0.29 mm and a neointimal volume obstruction as measured by intravascular ultrasound (IVUS) of 2.7 ± 2.7 percent. There were no MACE events or incidents of stent thombosis reported through the four-month follow-up period. Acute device success was achieved in all patients.
"Elixir's Novolimus Eluting Stent looks promising as a next-generation drug eluting stent system for the treatment of cardiovascular disease," said Professor Abizaid. "I look forward to long-term data in more complex patient groups to confirm these excellent results."
The trial enrolled 15 patients with ischemic heart disease in Brazil having single de novo native coronary artery lesions. The primary endpoint of the study was in-stent late lumen loss at four months. Secondary endpoints include major adverse cardiac events (MACE). In addition, serial IVUS was performed on all patients at baseline and four-month follow-up.
"The clinical results of the EXCELLA trial validate the safety and effectiveness profile of the Novolimus Coronary Stent system in preclinical studies," said Guy Leclerc, M.D., chief of Interventional Cardiology at the University of Montreal, Canada, who presented extensive preclinical data on Elixir's Novolimus Eluting Stent System at TCT.
"The positive EXCELLA results mark a significant milestone for our company," said Motasim Sirhan, chief executive officer, Elixir Medical Corporation. "We are excited about the opportunity to participate in this dynamic industry and bring forward innovative DES product platforms."
About Elixir Medical's Novolimus Eluting Coronary Stent System
Novolimus is a proprietary pharmacologic compound with anti-proliferative and immunosuppressive properties developed for drug eluting stent therapy. The stent is coated with a durable polymer coating technology to control the release of Novolimus. Elixir Medical's Novlimus Eluting Coronary Stent System is designed to provide safety and efficacy with a substantially lower polymer load and lower drug dose than currently commercially available drug eluting stent systems.
About Elixir Medical
Elixir Medical Corporation develops state-of-the-art drug eluting stent platforms for the treatment of cardiovascular disease. The company has a strong pipeline of drug eluting stent platforms with durable and biodegradable polymer release technologies and fully biodegradable stent platforms. Privately held, Elixir Medical is based in the San Francisco Bay Area.
Contact:
Vinayak Bhat, PhD
408-636-2006
Elixir Medical Announces Positive Nine-Month Results from the Excella Novolimus-Eluting Coronary Stent System First-In-Man Study
Lower Drug and Polymer Formulation DES Continues to Demonstrate Excellent Clinical Safety and Efficacy Outcomes
Chicago, IL and Sunnyvale, CA—April 1, 2008—Positive nine-month results from the Elixir Medical Excella™ I Trial were presented Monday at the 57th Annual Scientific Sessions of the American College of Cardiology (ACC) in Chicago by Alexandre Abizaid, M.D., PhD., FACC, Chief of Coronary Interventions at the Institute of Dante Pazzanese de Cardiologia in São Paulo, Brazil. The Excella I Trial is a fifteen patient first-in-man study of the Elixir Medical Excella Novolimus™-Eluting Coronary Stent System.
The four-month positive results from the study were presented last October at the 19th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The eight-month angiographic follow-up continued to demonstrate reduction in late lumen loss and neointimal hyperplasia formation. In-stent late lumen loss was 0.31±0.25 mm, neointimal volume obstruction was 6.0 ± 0.36 percent, and binary restenosis was zero percent. There were no MACE events or incidents of stent thrombosis through the nine-month clinical follow-up period.
“These excellent clinical results suggest that Excella may represent the next generation in drug-eluting stents by achieving the optimal clinical results using a lower drug dose and polymer load as compared to other currently available DES systems,” said Professor Abizaid.
“We believe the Excella Novolimus-Eluting Coronary Stent System will set the industry standard in achieving excellent clinical outcomes for patients,” said Motasim Sirhan, Chief Executive Officer, Elixir Medical Corporation.
Based on these sustained positive clinical results, Elixir Medical plans to initiate Excella II, a large randomized trial that will recruit patients from Europe, New Zealand, and Brazil, and will compare the Excella stent to a currently approved drug-eluting stent.
About The Excella Novolimus-Eluting Coronary Stent System
The Excella Novolimus-Eluting Coronary Stent System is designed to provide safe and effective clinical outcomes with a substantially lower drug dose and polymer load than commercially available drug-eluting stents. Novolimus, an mTOR inhibitor, is a macrocyclic lactone with anti-proliferative and immunosuppressive properties developed specifically for drug-eluting stent applications. The Elixir Medical coronary stent is covered with a thin matrix of the Novolimus drug and a proprietary durable polymer to provide controlled drug release.
About Elixir Medical
Elixir Medical Corporation develops innovative drug-eluting stent platforms for the treatment of cardiovascular disease. The company is developing a complete family of drug-eluting stent systems, with durable and bioabsorbable polymer release technologies and fully bioabsorbable stent platforms. Privately held, Elixir Medical is based in Sunnyvale, Calif. For more information, visit www.elixirmedical.com.
Contact:
Vinayak Bhat, PhD
408-636-2006
Elixir Medical Corporation Licenses Myolimus™ from Novartis Pharma AG for Site-Specific Drug Delivery Applications
Sunnyvale, CA—October 10, 2008—Elixir Medical Corporation announced today that the company entered into a co-exclusive worldwide license agreement with Novartis Pharma AG granting Elixir the rights to utilize the drug Myolimus with Elixir's vascular and other site-specific drug-delivery applications. In addition, Elixir has an exclusive worldwide license for use of Myolimus in fully biodegradable stents. “Elixir is committed to be a leader in the drug eluting stent market through the efficient development of a broad and innovative portfolio of DES products to better address physician and patient needs,” said Motasim Sirhan, chief executive officer of Elixir Medical Corporation. “The license agreement with Novartis Pharma AG for Myolimus enhances our capabilities to develop innovative product platforms for our physicians and patients.”
Myolimus, a macrocyclic lactone in the same family as Rapamycin, has demonstrated impressive versatility, stability, and a broad therapeutic index. The macrocyclic lactone drugs represent the most widely utilized drug family for drug eluting stent applications and have an established safety and efficacy profile. Elixir observed positive results from evaluating the safety and effectiveness of Myolimus for the prevention of restenosis through extensive pre-clinical testing including in vivo animal studies and in vitro testing conducted over the past several years.
Elixir has completed three separate first-in-man clinical studies evaluating the therapeutic effectiveness of the company's Myolimus-eluting coronary stent systems. These studies used the company's proprietary stent platform and three proprietary polymer technologies.
In the first study, the stent platform incorporates a proprietary durable polymer coating with an established safety profile designed to have a minimal polymer load and the lowest known 'olimus' drug dose. In the second study, the stent platform incorporates a proprietary biodegradable polymer coating designed to biodegrade within three to six months. In the third study, the stent platform incorporates a different proprietary biodegradable polymer coating designed to biodegrade within six to nine months. Both biodegradable coating platforms offer the potential of achieving the desired effectiveness and resulting in a more biocompatible stent surface similar to bare metal stents (BMS).
“We also intend to utilize Myolimus in a broad range of site-specific drug delivery therapeutic applications including a fully biodegradable stent program,” commented Mr. Sirhan on the special properties and opportunities for Myolimus.
Elixir continues to make excellent progress with its proprietary macrocyclic lactone drug Novolimus. Twelve-month follow up from the Excella I first-in-man study has been successfully completed and will be presented at the upcoming TCT DES Summit. The company will initiate the Excella II multi-center randomized clinical trial in Q4' 2008. Data from Excella II will be submitted for CE mark approval of the Novolimus eluting coronary stent system.
TCT Conference Events
- Elixir will present in-vivo preclinical animal studies and early results from the first two Myolimus FIM clinical studies as well as the Novolimus FIM clinical study at the 20th annual Transcatheter Cardiovascular Therapeutics DES Summit (TCT 2008) on Monday, October 13, 2008, in Washington, D.C.
- Elixir will host a breakfast symposia on Wednesday, October 15, from 7-8 am to
present on the company's DES Programs including design, pre-clinical testing, and
FIM clinical study results.
Chair: Professor Patrick W. Serruys, MD, Ph.D. Faculty: Alexandre Abizaid, M.D., Ph.D., Peter Fitzgerald, M.D., Ph.D., Guy Leclerc, M.D., John Ormiston, M.D., Ph.D., Ch.B., Wolfgang Rutsch, M.D., Ph.D.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company's next-generation drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit www.elixirmedical.com.
Contact:
Donna Collins
Vice President, Global Marketing
Dcollins@elixirmedical.com
+1.408.636.2029
Elixir Medical Corporation Announced Positive First-In-Man Results from Three Drug Eluting Coronary Stent Systems
Results Demonstrate Excellent Feasibility and Clinical SafetySunnyvale, CA and Washington, D.C.—October 16, 2008—Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced results from three multicenter first-in-man studies of Novolimus and Myolimus eluting coronary stent systems. Findings were presented at the 20th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
"Elixir is committed to be a leader in drug eluting stents by addressing physician and patient needs through the efficient development of a broad and innovative portfolio of products," said Motasim Sirhan, chief executive officer of Elixir Medical Corporation. "We are excited about the promise of both Novolimus and Myolimus in combination with our proprietary cobalt chromium alloy stent system and polymer technologies."
"I am impressed with Elixir's broad product portfolio and the company's ability to execute on multiple programs in parallel," said Professor Patrick W. Serruys, M.D., PhD, of the Thoraxcenter, Erasmus University Hospital, Rotterdam, the Netherlands who chaired the company's breakfast symposium today at TCT. "I look forward to initiating the Novolimus EXCELLA II Randomized Clinical Trial scheduled to commence this quarter."
Novolimus Eluting Coronary Stent System with a Durable Polymer: Twelve-Month Clinical Results
Twelve-month clinical results from EXCELLA I, the first-in-man study of the Novolimus eluting coronary stent system with a durable polymer, were presented by Professor Alexandre Abizaid, M.D., Ph.D., of the Institute of Dante Pazzanese de Cardiologia in Sao Paulo, Brazil at TCT 2008.
At the twelve month clinical follow-up, the Novolimus eluting coronary stent system demonstrated sustained efficacy and clinical safety with no MACE events or incidents of stent thrombosis. Eight-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.31 ± 0.25 mm and a volume obstruction of 6.0 ± 0.36 percent.
Myolimus Eluting Coronary Stent System with a Durable Polymer: Nine-Month Clinical and Six-Month Angiographic Results
Nine-month clinical and six month angiographic and IVUS results from the first-in-man study of the Myolimus eluting coronary stent system with the lowest known dose of an 'olimus' drug and Elixir's proprietary durable polymer were presented at TCT 2008 by Professor Wolfgang Rutsch, M.D., Ph.D. of Charite Campus Mitte, Berlin, Germany. At the nine month clinical follow-up, one patient experienced a non Q-wave myocardial infarction. Six-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.15 ± 0.11 mm and a volume obstruction of 1.4 ± 1.2 percent. There were no incidents of stent thrombosis.
Myolimus Eluting Coronary Stent System with a Bioabsorbable Polymer: Six-Month Clinical and Angiographic Results
Six-month clinical, angiographic and IVUS results from the first-in-man study of the Myolimus eluting coronary stent system with Elixir's proprietary bioabsorbable polymer were presented at TCT 2008 by Dr. John Ormiston, MBChB, of Auckland City Hospital, Auckland, New Zealand. At the six month clinical follow up, one patient experienced a non Q-wave myocardial infarction and one patient experienced a target lesion revascularization. Six-month angiographic and IVUS results from the first cohort of 15 patients demonstrated an in-stent late lumen loss of 0.37 ± 0.44 mm and a volume obstruction of 14.2 ± 7.7 percent. There were no incidents of stent thrombosis.
About Novolimus and Myolimus
Novolimus and Myolimus are macrocyclic lactones in the same family as Rapamycin. The macrocyclic lactone drugs represent the most widely utilized drug family for drug eluting stent applications and have an established safety and efficacy profile.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company's next-generation drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit www.elixirmedical.com.
Contact:
Donna Collins
Vice President, Global Marketing
Dcollins@elixirmedical.com
+1.408.636.2029
SurModics Licenses Hydrophilic Coating for Elixir's Drug-Eluting and Bare Metal Stent Delivery Systems
EDEN PRAIRIE, Minnesota — October 30, 2008 — SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification and drug delivery technologies to the healthcare industry, today announced that it is providing advanced hydrophilic coating technology for Elixir Medical Corporation's drug-eluting and bare metal stent delivery systems, which are designed to optimize vessel scaffolding and localized drug delivery to provide a safe and effective treatment for cardiovascular patients.
Elixir has conducted five first-in-human clinical studies evaluating the therapeutic effectiveness of the company's Novolimus-eluting and Myolimus-eluting stent delivery systems. Novolimus and Myolimus are macrocyclic lactones in the same family as Rapamycin. The macrocyclic lactone drugs represent the most widely utilized drug family for drug eluting stent applications and have an established safety and efficacy profile.
"SurModics is pleased to license our advanced hydrophilic coating technology for Elixir's Novolimus-eluting and Myolimus-eluting stent systems," said Bruce Barclay, president and CEO of SurModics. "We believe that next generation stents, such as Elixir's, will not only improve safety and efficacy, but in the process expand the size of the overall market. Today's announcement reflects SurModics' continued drive to stay on the cutting edge of innovation in the cardiology field and highlights our ability to participate in the rapidly evolving drug-eluting stent market in multiple ways."
"We are very pleased to partner with SurModics," stated Motasim Sirhan, CEO of Elixir Medical Corporation. "We believe SurModics' hydrophilic coating technology will enhance the SurModics Licenses Hydrophilic Coating for Elixir's Drug-Eluting and Bare Metal Stent Delivery Systems deliverability of our bare metal and drug-eluting stent delivery systems, allowing us to better address physician and patient needs."
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification and drug delivery technologies to the healthcare industry. SurModics partners with the world's foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved patient outcomes. Core offerings include: drug delivery technologies (coatings, microparticles, and implants); surface modification coating technologies that impart lubricity, prohealing, and biocompatibility capabilities; and components for in vitro diagnostic test kits and specialized surfaces for cell culture and microarrays. Current efforts include a sustained drug delivery system in human trials for treatment of retinal disease and the drug delivery polymer matrix on the first-to-market drug-eluting coronary stent. SurModics is headquartered in Eden Prairie, Minnesota and its Brookwood Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the company, visit www.surmodics.com. The content of SurModics' website is not part of this release or part of any filings the company makes with the SEC.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company's next-generation drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit www.elixirmedical.com.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the following: (1) our reliance on third parties (including our customers and licensees) and their failure to successfully develop, obtain regulatory approval for, market and sell products SurModics Licenses Hydrophilic Coating for Elixir's Drug-Eluting and Bare Metal Stent Delivery Systems Page 3 incorporating our technologies may adversely affect our business operations, our ability to realize the full potential of our pipeline, and the company's ability to achieve our fiscal 2008 corporate goals; (2) costs or difficulties relating to the integration of the businesses of Brookwood Pharmaceuticals and BioFX Laboratories with SurModics' business may be greater than expected and may adversely affect the company's results of operations and financial condition; (3) developments in the regulatory environment, as well as market and economic conditions, may adversely affect our business operations and profitability; and (4) other factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2007, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at www.surmodics.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
Contact:
Phil Ankeny
Sr. VP and Chief Financial Officer
+1 (952) 829-2700
Elixir Medical Announces Activities at Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference
Sunnyvale, California.—September 17, 2009—Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals announced today that the company’s stent systems will be featured in multiple sessions at the 21st annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2009) taking place September 21 through 25, 2009, in San Francisco.
Clinical results from the company’s NovolimusTM and MyolimusTM eluting stent systems with durable and bioabsorbable polymers will be discussed in the following sessions:
“Single center, first-in-man study of the Elixir Novolimus-eluting coronary stent system with durable polymer: Twenty-four-month clinical safety and efficacy results”
Alexandre Abizaid, M.D., Ph.D. 8:00 a.m. to 10:00 a.m., Poster Session Hall D, Tuesday, Sept. 22.
“The Elixir Bioabsorbable Polymer Myolimus-Eluting Stent Program”
Lecturer: Bernhard Witzenbichler, M.D. 2:16 p.m., DES Summit, Room 104, Tuesday, Sept. 22.
“The Elixir Bioabsorbable Polymer Novolimus-Eluting Stent Program”
Lecturer: Alexandre Abizaid, M.D., Ph.D. 2:23p.m., DES Summit, Room 104, Tuesday, Sept. 22.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent systems optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit www.elixirmedical.com.
Media Contact:
Donna Collins
Dcollins@elixirmedical.com
+1.408.636.2029
Elixir Medical Corporation Announces Positive First-In-Man Results for Three Drug Eluting Coronary Stent Systems with Durable and Bioabsorbable Polymers
New Bioabsorbable Polymer Results Consistent with Excellent Long Term Data from Company’s Durable Polymer Platforms Enrollment for EXCELLA II Randomized Clinical Trial Completed
Sunnyvale, Calif. and San Francisco —September 22, 2009—Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today positive results from three multicenter first-in-man studies of NovolimusTM and MyolimusTM eluting coronary stent systems with durable and bioabsorbable polymers. Findings were presented at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT 2009) scientific symposium.
Novolimus Eluting Coronary Stent System with Bioabsorbable Polymer: Nine-Month Clinical and Six-Month Angiographic Results
Nine-month clinical and six-month angiographic and IVUS results from the first-in-man study of Novolimus eluting coronary stent system with Elixir’s proprietary bioabsorbable polymer were presented at TCT 2009 by Professor Alexandre Abizaid, M.D., Ph.D. on behalf of the study investigators. At nine months, the Novolimus eluting coronary stent system demonstrated excellent efficacy and clinical safety with no MACE events or incidents of stent thrombosis. Six-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.16 ± 0.23 mm and a volume obstruction of 1.6 ± 0.9 percent.
Myolimus Eluting Coronary Stent System with Bioabsorbable Polymer: Six-Month Clinical and Angiographic Results
Six-month clinical, angiographic and IVUS results from the first-in-man study of the Myolimus eluting coronary stent system with the lowest known dose of an ‘olimus’ drug and Elixir’s proprietary bioabsorbable polymer were presented at TCT 2009 by Professor Bernard Witzenbichler, M.D., of Charite Campus Benjamin Franklin, Berlin, Germany on behalf of the study investigators. At the six-month follow-up for 30 patients, there were two non Q-wave myocardial infarctions and one target lesion revascularization. There were no incidents of stent thrombosis. Six-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.08 ± 0.16 mm and a volume obstruction of 3.2 ± 3.0 percent.
“We are excited about the excellent results of our new bioabsorbable polymer platforms with the Novolimus and Myolimus drugs. We also continue to validate the long-term safety and efficacy of our durable polymer product,” said Motasim Sirhan, chief executive officer of Elixir Medical. “Elixir continues to demonstrate its commitment to developing a broad and innovative portfolio of DES products to better address physician and patient needs.”
Novolimus Eluting Coronary Stent System with Durable Polymer: Twenty-Four-Month Clinical Results
Twenty-four-month clinical results from EXCELLA I, the first-in-man study of the Novolimus eluting coronary stent system with a durable polymer, were presented by Professor Alexandre Abizaid, M.D., Ph.D., of the Institute of Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, at TCT 2009. At twenty-four months, the Novolimus eluting coronary stent system demonstrated sustained efficacy and clinical safety with no incidents of stent thrombosis.
Novolimus Eluting Coronary Stent System with Durable Polymer: EXCELLA II Randomized Clinical Trial Update
The EXCELLA II randomized clinical trial completed patient enrollment in the first quarter of 2009. The study enrolled 210 patients in Europe and Asia Pacific. Patients are currently undergoing the nine-month clinical, angiographic, and IVUS follow-up. Data from the trial will be submitted for CE Mark approval.
“The performance of Elixir’s DES system during enrollment compared well with some of the market leading stent systems,” said Professor Patrick W. Serruys, M.D., Ph.D. of the Thoraxcenter, Erasmus University Hospital, Rotterdam, The Netherlands, principal investigator for the EXCELLA II trial. “I am impressed with Elixir’s ability to successfully conduct the EXCELLA II trial while simultaneously executing the development of multiple generations of product platforms.”
About Novolimus and Myolimus
Novolimus and Myolimus are macrocyclic lactones in the same family as Rapamycin. The macrocyclic lactone drugs represent the most widely utilized drug family for drug eluting stent applications and have an established safety and efficacy profile.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit
Media Contact:
Donna Collins
Dcollins@elixirmedical.com
+1.408.636.2029
Results from the EXCELLA II Randomized Clinical Trial using Elixir Medical’s DESyne Novolimus-Eluting Coronary Stent System to Be Featured In the Late Breaking Clinical Trial Presentation at EuroPCR10
Data from the Company’s Myolimus-Eluting Coronary Stent System with Bioabsorbable Polymer Will Also Be Presented
SUNNYVALE—Elixir Medical Corporation, a developer of innovative drug eluting stent platforms for the treatment of cardiovascular disease, today announced two key presentations scheduled for the 2010 EuroPCR meeting featuring the company’s cardiovascular innovations.
Nine-month clinical, angiographic and IVUS results from the EXCELLA II Clinical Trial will be presented during the late-breaking clinical trial session. EXCELLA II is a randomized, single blinded study designed to evaluate the long-term safety and efficacy of the Elixir DESyne Novolimus-Eluting Coronary Stent System in 210 patients in Europe, New Zealand, Australia and Brazil. Also featured will be the 12-month clinical, angiographic and IVUS results from the Elixir Myolimus-Eluting Coronary Stent System with Bioabsorbable Polymer first-in-man study. Clinical results will be presented in the following sessions at EuroPCR Paris, France, May 25-28.
Tuesday, May 25
Late Breaking Clinical Trials, Main Arena: 16:31 to 16:43
- “ELIXIR EXCELLA II Randomized Clinical Trial: Nine month clinical safety, angiographic and IVUS results.” Presented by Professor Alexandre Abizaid, M.D., PhD. of the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil.
Friday, May 28
Room 252B: 10:00 to 10:09
- “Myolimus Eluting Coronary Stent System with a Bioabsorbable Polymer: Twelve-Month Clinical and Angiographic Results.” Presented by Professor Joachim Schofer, M.D., PhD. of the Hamburg University Cardiovascular Center in Hamburg, Germany.
About Novolimus and Myolimus
Elixir Medical’s pharmaceutical catalogue includes macrocyclic lactone compounds including Novolimus and Myolimus. Novolimus was developed by Elixir for site-specific drug delivery therapies. Myolimus is a Novartis Pharma AG compound. Elixir has a co-exclusive worldwide license agreement with Novartis Pharma AG granting Elixir the rights to utilize the drug Myolimus with Elixir’s vascular and other site-specific drug-delivery applications.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent systems optimize local drug delivery to provide a safe and effective treatment for cardiovascular disease. For more information, visit www.elixirmedical.com.
Media Contact: Donna Collins, +1.408.636.2029
Elixir Medical Corporation Announces Excellent Nine Month Safety and Efficacy Results from the EXCELLA II Randomized Clinical Trial Results Confirm Promise of Elixir’s Novolimus Eluting Stent Program
Sunnyvale, CA—May 26, 2010—Elixir Medical Corporation, a developer of product platforms combining state-of-the-art medical devices with advanced pharmaceuticals, announced today the superiority of the Elixir DESyne stent compared to the control Endeavor stent in the primary endpoint of the EXCELLA II randomized clinical trial.
The Elixir DESyne Stent is the first drug eluting stent with the thinnest durable polymer coating and a low drug dose to achieve excellent clinical outcomes as compared to the leading commercially available drug eluting stent systems. The DESyne stent elutes a novel macrocyclic lactone compound Novolimus.
Nine-month clinical, angiographic and IVUS results from the EXCELLA II randomized clinical trial evaluating the Elixir DESyne Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System was presented on behalf of the EXCELLA II investigators at EuroPCR by Alexandre Abizaid, M.D., Ph.D., from the Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, and co-principal investigator for the trial. The study was designed to enroll 210 patients in Europe, Australia, New Zealand and Brazil.
At nine months, the Elixir DESyne Stent demonstrated superiority (p<0.001) to the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.11 ± 0.32 and 0.63 ± 0.42 respectively). In a subset of patients who underwent intravascular ultrasound (IVUS), the Elixir DESyne Stent demonstrated a statistically significant reduction in neointimal inhibition with a percentage volume obstruction of 4.5% ± 5.1 compared to 20.9% ± 11.3 for the Endeavor Stent (p <0.001). Clinical events measured using the device oriented composite endpoint (DoCE) were lower for the DESyne stent compared to the Endeavor stent (2.9% and 5.6% respectively).
“The EXCELLA II study confirms the excellent 2-year results from the EXCELLA I trial and positions the Elixir DESyne Stent as a strong next generation DES product,” said Professor Alexandre Abizaid.
In addition, the Elixir DESyne stent demonstrated a statistically significant reduction in restenosis, a re-blockage in the stent, at nine months compared to Endeavor (1.4% and 7.6% respectively (p=0.037).
“The Elixir DESyne Coronary Stent System will be competitive with the best in class drug eluting stent systems” added Professor Patrick W. Serruys, M.D., Ph.D. of the Thoraxcenter, Erasmus University Hospital, Rotterdam, The Netherlands, and principal investigator for the EXCELLA II trial.
“The excellent results from the EXCELLA II trial reinforces our enthusiasm for the Novolimus compound and the effectiveness of the Novolimus eluting coronary stent programs,” said Motasim Sirhan, chief executive officer of Elixir Medical. “These results also confirm that excellent clinical outcomes can be achieved with a design incorporating an ultra thin durable polymer and low drug dose” continued Mr. Sirhan.
Elixir Medical Files for CE mark
Elixir Medical announced that the company submitted a CE mark application for the Elixir DESyne Novolimus Eluting Coronary Stent System in the first quarter of 2010.
About the EXCELLA II Clinical Trial
The EXCELLA II trial is a multi center, randomized, single blind, evaluation of the Elixir DESyne Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System. The study was designed to enroll 210 patients from Europe, Australia, New Zealand and Brazil. The primary endpoint was in- stent late lumen loss assessed by quantitative coronary angiography (QCA) at nine months. Secondary endpoints of the study include: device-orientated composite endpoints and stent thrombosis rates at 30 days; 6, 9, 12, and 24 months; with annual clinical follow-up to 5 years. A subset of patients underwent intravascular ultrasound (IVUS) evaluation at 9 months.
About Elixir Medical’s Product Pipeline
Elixir Medical is developing a wide range of drug and device platforms for vascular therapies. These include drug eluting stent systems with durable and bioabsorbable polymers, and fully bioabsorbable drug eluting stent systems.
The company utilizes the powerful macrocyclic lactone class of drugs, which have established safety and efficacy profiles. This family of drugs is the most widely used for drug eluting stent applications.
Novolimus, a metabolite of sirolimus, was developed internally by Elixir for use in site- specific therapies.
Elixir also has a license to Myolimus, a Novartis Pharma AG compound. The co-exclusive license grants Elixir worldwide rights to utilize the drug Myolimus with Elixir’s vascular as well as other site-specific drug-delivery applications. In addition, Elixir has an exclusive worldwide license for use of Myolimus in fully biodegradable stents. The company is developing Myolimus-eluting systems with both durable and bioabsorbable polymers.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent systems are designed to optimize local drug delivery to provide a safe and effective treatment for cardiovascular disease. For more information, visit http://www.elixirmedical.com.
Media Contact:
Donna Collins
Dcollins@elixirmedical.com
+1.408.636.2029
