Welcome!

News Feed Item

CryoLife Acquires Distribution Rights and Purchase Option for Genesee BioMedical's PhotoFix™ Bovine Pericardial Patch

Anticipates U.S. Commercial Launch in October 2014

ATLANTA, Aug. 7, 2014 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has acquired the distribution rights to PhotoFix, a bovine pericardial patch stabilized using a dye-mediated photo-fixation process that requires no glutaraldehyde from Genesee BioMedical, Inc., a Denver, Colorado-based manufacturer of cardiac surgery instruments and devices.  CryoLife expects to launch PhotoFix through its U.S. sales force in October 2014.

Cryolife logo

Under terms of the agreement, CryoLife acquired the distribution rights to PhotoFix for an upfront cash payment.  Genesee will manufacture PhotoFix and is expected to begin providing inventory to CryoLife in the fourth quarter of 2014.  CryoLife also obtained an option to acquire the PhotoFix product line at a predetermined price beginning in March 2015.

PhotoFix, which was last commercially available in 2010, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and is indicated for use in intracardiac repair, including ventricular repair and atrial repair; great vessel repair and suture line buttressing; and pericardial closure.  PhotoFix is complementary to CryoLife's portfolio of implantable living human tissues for use in cardiac and vascular surgeries.

Pedro del Nido, MD, chief of cardiac surgery at Boston Children's Hospital, said, "I am pleased that PhotoFix will once again be available as an option to treat my patients.  I've used PhotoFix and was very impressed with the results.  I believe it should be a primary option for cardiac surgeons for reconstruction and repair in pediatric and congenital heart patients when native tissues are not available."

Steven G. Anderson, chairman, president, and CEO of CryoLife, said, "We believe that Genesee's PhotoFix bovine pericardial patch has the potential to become the product of choice for pediatric cardiac surgeons, as it already had impressive levels of use at leading U.S. institutions.  PhotoFix's unique photo-fixation process does not use glutaraldehyde, which is used in competitive products and has been associated with calcification and mechanical degradation of the tissue in patients.  PhotoFix is a strong addition to our existing product offerings, and we can see it becoming a leading option in the market as we build adoption with our anticipated October 2014 U.S. commercial launch."

Woody Mathison, president and CEO of Genesee BioMedical, said, "It's a pleasure to announce our distribution agreement with CryoLife.  We believe that the experienced CryoLife sales force is the best partner for PhotoFix, and we look forward to seeing commercial progress through the remainder of the year, with further expansion in 2015."

Based on public information available on competitive products, CryoLife estimates that the U.S. market for biological patches, such as PhotoFix, used in cardiac and vascular surgical procedures is currently between $30 million and $40 million per year.

About CryoLife

CryoLife, Inc. is a leader in medical device manufacturing and distribution and in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries.  It operates throughout the U.S. and internationally.  CryoLife manufactures and distributes BioGlue® Surgical Adhesive, an FDA-approved adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels.  BioGlue is also CE marked in Europe for use in soft tissue repair and has received additional marketing approvals in several other countries throughout the world.  CryoLife's BioFoam® Surgical Matrix is CE marked in Europe 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.  CryoLife distributes PerClot®, a powdered hemostat, in Europe and other select international countries.  CryoLife has received FDA 510(k) clearance for a topical version of PerClot and is conducting a pivotal clinical trial in the U.S. for potential FDA approval of the surgical version of PerClot.  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).  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 ProCol®, a natural biological graft derived from a bovine mesenteric vein that provides vascular access for end-stage renal disease hemodialysis patients, which is approved for sale in the U.S.  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 the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects.

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: the ability of Genesee BioMedical to manufacture PhotoFix per FDA regulations, anticipated timing of our receipt of PhotoFix inventory and our commercial launch of PhotoFix, the levels of acceptance and adoption of PhotoFix by surgeons, and estimates regarding the size of the U.S. market for biological patches.  The risks and uncertainties affecting these statements include that the success of our efforts related to PhotoFix is subject to factors beyond our control, including general economic conditions, physician and patient acceptance, the potential inability to maintain reimbursement approvals and maintain and expand reimbursement rates, and regulatory approvals and scrutiny.  Competing products -- those already in the market and those that may be introduced in the future -- may materially affect sales growth of PhotoFix.  We are relying on Genesee Biomedical to provide our PhotoFix inventory; therefore, we may experience delays, shortages, or outages of product, or quality issues with respect to such product, if Genesee experiences financial, operational, regulatory, or other challenges with its business.  Any such events could have a significant adverse effect on our sales of PhotoFix and our ability to establish and grow it as a product offering.  We may experience currently unforeseen difficulties related to our ability to successfully market and distribute PhotoFix.  Our beliefs regarding the market opportunity for PhotoFix may be incorrect, and even if correct, there is no guarantee that we will successfully grow PhotoFix sales or fully realize the potential benefits of any clinical advantages of the product.  Also, our profits from PhotoFix sales could be lower than anticipated if we are not able to achieve our desired pricing levels.  For a discussion of additional factors impacting CryoLife's business, see our Form 10-K for the year ended December 31, 2013, as filed with the SEC, and subsequent filings with the SEC.  CryoLife does not undertake to update its forward-looking statements.

For additional information about the company, visit CryoLife's Web site: http://www.cryolife.com.

CONTACT:


CryoLife

The Ruth Group

D. Ashley Lee

Nick Laudico / Zack Kubow

Executive Vice President, Chief Financial Officer
and Chief Operating Officer

646-536-7030 / 7020

[email protected]

Phone: 770-419-3355

[email protected]

Logo - http://photos.prnewswire.com/prnh/20140319/MM86518LOGO

SOURCE CryoLife, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, will discuss some of the security challenges of the IoT infrastructure and relate how these aspects impact Smart Living. The material will be delivered i...
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
Historically, some banking activities such as trading have been relying heavily on analytics and cutting edge algorithmic tools. The coming of age of powerful data analytics solutions combined with the development of intelligent algorithms have created new opportunities for financial institutions. In his session at 20th Cloud Expo, Sebastien Meunier, Head of Digital for North America at Chappuis Halder & Co., will discuss how these tools can be leveraged to develop a lasting competitive advanta...
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, will provide a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services ...
VeriStor Systems has announced that CRN has named VeriStor to its 2017 Managed Service Provider (MSP) 500 list in the Elite 150 category. This annual list recognizes North American solution providers with cutting-edge approaches to delivering managed services. Their offerings help companies navigate the complex and ever-changing landscape of IT, improve operational efficiencies, and maximize their return on IT investments. In today’s fast-paced business environments, MSPs play an important role...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
SYS-CON Events announced today that Ocean9will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.