For Immediate Release:
|Contact:||Allen & Caron Inc||CLOSURE Medical Corp|
|Joe Allen (investors)||Len Hall (media)||Benny Ward, CFO|
|(212) 691-8087||(949) 474-4300||(919) 876-7800|
RALEIGH, NC (February 22, 2005) … CLOSURE Medical Corporation (Nasdaq:CLSR), a global leader in biomaterial-based medical devices, today announced that it has received the European Union’s CE Mark approval for its proprietary OMNEX™ Surgical Sealant, the Company’s first product indicated for use inside the body. The CE Mark approval will allow the Company to market and distribute the product in EU countries and was based primarily on the positive results of the product’s biocompatibility, laboratory, animal and human clinical use data.
OMNEX™ sealant is a synthetic, biodegradable material that mechanically seals the surfaces of blood vessels and artificial grafts to prevent blood leakage after traditional suturing. The product’s clinical application under the CE Mark allows for its use as an adjunct to sutures to achieve hemostasis in peripheral vascular reconstructions, such as when bypassing an occluded blood vessel or to create a shunt for hemodialysis access in diabetic patients.
OMNEX™ sealant was developed from CLOSURE’s core cyanoacrylate
technology. Cyanoacrylates have proven to be very strong bonding agents and
OMNEX™ sealant will allow physicians in Europe the ability to use this
technology during surgery. Notably, most internal sealants other than OMNEX™
are derived from human or animal blood products; CLOSURE’s OMNEX™
sealant is entirely synthetic and will not expose patients to the risks of blood
Dr. Alan B. Lumsden, principal investigator for the OMNEX™ U. S. clinical study, stated, “I believe CLOSURE Medical's OMNEX Surgical Sealant has the opportunity to change vascular surgery. Bleeding is a byproduct of the surgeries we perform and we have found that this product controls bleeding reliably and simply, before it has a chance to begin. I do not believe there is anything else like it in terms of its effectiveness or its ease of use. I believe this sealant has the opportunity to be an enabling technology for such procedures as minimally invasive laparoscopic vascular surgery since the difficulty in suturing is currently the limiting path.” Dr. Lumsden holds positions at Baylor College of Medicine and the Methodist DeBakey Heart Center of The Methodist Hospital in Houston, Texas.
Daniel A. Pelak, President and CEO, commented, “The approval of the OMNEX Surgical Sealant is a major milestone for CLOSURE, and we believe it is the first in a series for our surgical sealant platform. Given the feedback from surgeons regarding OMNEX and the worldwide market potential for tissue sealants, we believe our unique technology will have applications in many other surgical specialties. We are encouraged by the opportunities offered by the commercialization of our technology inside the body.”
In the United States, the Company plans to seek approval for OMNEX™ sealant from the U.S. Food and Drug Administration during 2005. The Company has completed the enrollment phase of its 150-patient pivotal study for OMNEX™ sealant, which was initiated in March 2004. The study assessed the ability of the sealant to prevent leakage following reconstruction of vascular structures in patients receiving femoral bypass or arteriovenous shunt procedures for hemodialysis access. Patients were enrolled at 13 medical institutions in the U.S. and Europe with follow-up visits at four and twelve weeks.
About CLOSURE Medical Corporation
CLOSURE Medical Corporation (Nasdaq:CLSR) is a global leader in the development and manufacture of innovative biomaterial-based medical devices that fulfill the needs of healthcare practitioners, patients and consumers.
For additional information on CLOSURE Medical visit its website at www.closuremed.com or visit the “Clients” section of the Allen & Caron website at www.allencaron.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties or other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance, or other expectations implied by these forward-looking statements. These factors include, but are not limited to the early stage of commercialization of the Company’s products; the Company’s success in securing a marketing and distribution partner for its OMNEX™ product; the ability of the Company to increase the efficiencies in its manufacturing processes; the effectiveness of initiatives launched in response to the Company’s competitors’ product introductions; the progress and success of its research and development programs for future products; the success of its clinical study for its OMNEX™ product and future clinical studies; the successful enrollment of current and future clinical studies; the need for regulatory approval and effects of governmental regulation; technological uncertainties; the inventory management policies adopted by the Company’s marketing partners; end-user growth for the products sold by the Company’s marketing partners; the Company’s success in securing marketing partners for future products; the satisfactory conclusion of negotiations with, and dependence on marketing partners, and dependence on patents and trade secrets, as well as those detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission. Although the Company believes that the expectations in the forward-looking statements are reasonable, the Company cannot guarantee such results. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.