CryoLife Receives CE Mark For HeRo® Graft
First European Cases Anticipated in July, Followed by Controlled Market Introduction in the Second Half of 2013
ATLANTA, June 10, 2013 /PRNewswire/ — CryoLife, Inc. (NYSE:CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today achievement of a CE (Conformite Europeenne) Mark for the HeRO (Hemodialysis Reliable Outflow) Graft system produced at the Company’s new manufacturing facility in Atlanta. The HeRO Graft is a proprietary graft-based solution for end-stage renal disease (ESRD) hemodialysis patients with limited access options and central venous stenosis.
The first HeRO Graft clinical cases in Europe are expected to be performed in July 2013. The surgeons performing these initial cases will establish the first HeRO Graft training center in Europe, which will support the Company’s controlled market introduction of the product during the second half of 2013, followed by a broader European launch in 2014. The Company estimates the European market opportunity for the HeRO Graft to be approximately $30 million.
“We have received positive feedback on the HeRO Graft from European physicians at medical meetings in Europe and the United States,” noted Steven G. Anderson, chairman, president and CEO of CryoLife. “We believe it will be well received in Europe because it is clinically proven to reduce infection rates by 69 percent as compared to tunneled dialysis catheters, which is a benefit for patients and government payors. Following the initial European cases, we will gradually train physicians and roll out the product to additional centers in order to ensure positive clinical outcomes ahead of a broader launch in 2014. We will also evaluate our early HeRO Graft experience in Europe, which we expect will further demonstrate the clinical utility of the product.”
About the HeRO Graft
The HeRO Graft received its initial FDA 510(k) clearance in 2008 and initial CE Mark approval in 2011. It is indicated for catheter dependent ESRD patients on long-term hemodialysis who have exhausted all other access options, such as AV fistulas and grafts (AVFs and AVGs). Prior to the introduction of the HeRO Graft, the only option for these patients was access through percutaneous tunneled dialysis catheters (TDCs), which are higher cost, have high infection rates, limit a patient’s lifestyle, and foster central venous stenosis, or narrowing. The HeRO Graft overcomes the limitations of TDCs by providing a completely subcutaneous graft that functions like a regular access graft during dialysis and provides superior blood flow and a 69 percent reduction in bacteremia (bacteria in the blood) compared with TDCs. HeRO Graft is the only subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis patients with central venous stenosis.
The HeRO Graft has been implanted in more than 6,000 patients to date and is supported by nearly 130 published clinical studies and presentations. The product has established and expanding reimbursement rates in the U.S., with reimbursement codes that are endorsed by the Society for Vascular Surgery and the American Medical Association. Hemosphere has 6 issued patents on the product in the U.S., Europe and Japan and 12 patents pending.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S., certain countries in Europe, and Canada. CryoLife’s CryoValve® SG pulmonary heart valve, processed using CryoLife’s proprietary SynerGraft® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. CryoLife’s CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair or reconstruction of congenital heart defects. CryoLife’s BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community for use in soft tissue repair and approved in Japan for use in the repair of aortic dissections. Additional marketing approvals for BioGlue have been granted in several other countries throughout the world. CryoLife, through its subsidiary Cardiogenesis Corporation, specializes in the treatment of coronary artery disease for severe angina using a laser console system and single use, fiber-optic handpieces to perform a surgical procedure known as Transmyocardial Revascularization (TMR). In addition, CryoLife and its subsidiary Hemosphere, Inc. market the HeRO® Graft, which is a solution for end-stage renal disease in certain hemodialysis patients. CryoLife distributes PerClot®, an absorbable powdered hemostat, in the European Community and other select international countries. CryoLife’s BioFoam® Surgical Matrix is CE marked in the European Community for use as an adjunct to hemostasis in cardiovascular surgery and on abdominal parenchymal tissues (liver and spleen) when control of bleeding by ligature or conventional methods is ineffective or impractical.
Statements made in this press release that look forward in time or that express management’s beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These statements include those regarding our plans related to and the expected timing of the first HeRO Graft clinical cases in Europe, the HeRO Graft’s controlled market introduction, and its broader European launch. These statements also include those regarding the planned training of physicians and the establishment of training centers, the estimated European market opportunity for the HeRO Graft, the belief that the HeRO Graft will be well received in Europe, the medical benefits associated with the HeRO Graft, our expectations related to our early HeRO Graft experience in Europe, and our expectations re expansion of reimbursement rates in the U.S. Applicable risks and uncertainties include that the estimated European market opportunity for HeRO Graft may be incorrect and the market opportunity may shrink due to factors beyond our control, including general economic conditions and government regulations. Competitors may be able to develop and successfully market competing products. To the degree that the estimated European market opportunity is correct, there is no guarantee that we will successfully penetrate and grow sales within this market. HeRO Graft sales are dependent on physician and patient acceptance, and we may experience currently unforeseen difficulties related to the HeRO Graft product, and to physician training and patient acceptance. HeRO Graft may not continue to provide the anticipated medical benefits, including the reduction of infections in patients, or HeRO Graft may not be perceived in Europe as a safe and effective product. If the medical profession and patients do not perceive HeRO Graft to be a safe and effective product, our sales would be materially impacted and we may experience lawsuits or regulatory scrutiny as a result. Our plans, and the expected timing of such plans, regarding physician training and the introduction and distribution of the HeRO Graft in Europe may be impeded or delayed by factors beyond our control, including general economic conditions, or changed based on management’s assessment of the overall business needs of our company at the time. Reimbursement rates are subject to insurance requirements that are subject to change at any time. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2012, and our Form 10-Q for the quarter ended March 31, 2013. CryoLife does not undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife’s Web site:
The Ruth Group
D. Ashley Lee
Nick Laudico / Zack Kubow
Executive Vice President, Chief Financial Officer
646-536-7030 / 7020
and Chief Operating Officer
SOURCE CryoLife, Inc.