CryoLife, Inc. is a distributor of cryogenically preserved human tissues for cardiac and vascular transplant applications and develops medical devices. Among its products are human heart valves, which are treated to remove excess cellular material and antigens, and BioGlue surgical adhesive.CryoLife, Inc. incorporated in 1984 in Florida, was the first biomedical company to specialize in the ultra-low temperature preservation of human heart valves used for cardiac reconstruction, primarily in children born with heart defects. The Company preserves and distributes human tissues and develops, manufactures, and commercializes medical devices for cardiac and vascular transplant applications. The human tissues distributed by CryoLife include the CryoValve® SG pulmonary human heart valve and the CryoPatch® SG pulmonary cardiac patch tissue, both processed using CryoLife’s proprietary SynerGraft® technology. CryoLife’s medical devices consist primarily of surgical adhesives, sealants, and hemostats including BioGlue® Surgical Adhesive, BioFoam® Surgical Matrix, PerClot®, which the Company began distributing for Starch Medical, Inc. in October 2010.The Company preserves small diameter human saphenous vein conduits for use in peripheral vascular reconstructions and coronary bypass surgery. Failure to achieve revascularization of an obstructed vessel may result in the loss of a limb or even death of the patient. When patients require bypass surgery, the surgeon’s first choicegenerally is the patient’s own vein tissue. However, in cases of advanced vascular disease, 30% of patients have unsuitable vein tissue for transplantation, and the surgeon must consider using synthetic grafts or preserved human vascular tissue. Small diameter synthetic vascular grafts are generally not optimal for below-the-knee surgeries because they have a tendency to obstruct over time. Preserved human vascular tissues tend to remain open longer and as such are used in indications where synthetics typically fail. In addition, synthetic grafts are not suitable for use in infected areas since they may harbor bacteria and are difficult to treat with antibiotics. Preserved human vascular tissues are ideal grafts for patients with previously infected graft sites. The Company also preserves femoral veins and arteries and aortoiliac arteries for bypass orreconstruction within infected surgical areas. Wikipedia.
News Article | August 2, 2017
ATLANTA, Aug. 2, 2017 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac surgery, announced today that it will participate in the upcoming 37th Annual Canaccord Genuity Growth Conference on Thursday, August 10, 2017 at the InterContinental Boston Hotel. A live webcast of the Company's presentation is scheduled to begin at 10:00 a.m. ET and will feature an overview of the company by Pat Mackin, Chairman, President and Chief Executive Officer.
News Article | July 24, 2017
CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac surgery, announced today its results for the second quarter and first half of 2017. Pat Mackin, Chairman, President, and Chief Executive Officer, said, "We had a solid second quarter and exceeded our guidance despite facing certain headwinds in the quarter. On-X, BioGlue and tissue processing all posted revenue growth. This was highlighted by another positive quarter for On-X, particularly in North America where On-X revenue grew 19 percent excluding the OEM business. In tissue processing, we delivered our second consecutive quarter of double-digit growth in cardiac tissue. During the quarter we also initiated the transition to direct sales in Canada, Belgium, the Netherlands and Luxembourg, further expanding our direct operations in Europe. We are on track to achieve our 2017 financial guidance and remain confident our strategy will continue to transform CryoLife into a higher growth, higher margin company." Revenues for the second quarter of 2017 increased two percent to $47.8 million, compared to $47.1 million for the second quarter of 2016. The increase was primarily driven by increases in tissue processing, BioGlue, On-X and TMR revenues, partially offset by the absence of HeRO revenues. Non-GAAP revenues for the second quarter of 2017 increased four percent compared to the second quarter of 2016. A reconciliation of GAAP to non-GAAP financial metrics is included as part of this press release. Revenues for the first half of 2017 increased three percent to $92.9 million, compared to $90.1 million for the first half of 2016. The increase was primarily driven by increases in On-X, tissue processing and BioGlue revenues, partially offset by the absence of HeRO and ProCol revenues, and a decrease in TMR revenues. Non-GAAP revenues for the first half of 2017 increased four percent compared to the first half of 2016. A reconciliation of GAAP to non-GAAP financial metrics is included as part of this press release. GAAP net income for the second quarter of 2017 was $3.2 million, or $0.09 per fully diluted common share, compared to net income of $2.3 million, or $0.07 per fully diluted common share, for the second quarter of 2016. Non-GAAP net income for the second quarter of 2017 was $4.0 million, or $0.12 per fully diluted common share, compared to non-GAAP net income of $4.3 million, or $0.13 per fully diluted common share for the second quarter of 2016. GAAP net income for the first half of 2017 was $5.4 million, or $0.16 per fully diluted common share, compared to net income of $4.9 million, or $0.15 per fully diluted common share, for the first half of 2016. Non-GAAP net income for the first half of 2017 was $7.2 million, or $0.21 per fully diluted common share, compared to non-GAAP net income of $7.6 million, or $0.23 per fully diluted common share for the first half of 2016. With the exception of the income tax rate, the Company is reiterating its full year 2017 financial guidance, as summarized below, and expects revenues in the third quarter of 2017 to be between $46.5 million and $47.5 million. All numbers in the table above are GAAP except where expressly referenced as non-GAAP. The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. The Company's financial guidance for 2017 is subject to the risks identified below. This press release contains non-GAAP financial measures. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company's non-GAAP revenues include (as applicable) On-X revenues for the period in 2016 prior to the closing of the acquisition and excludes revenues for the HeRO Graft and ProCol product lines for 2016. The Company's other non-GAAP results exclude (as applicable) business development expenses; gain on sale of business components; amortization expenses; and inventory basis step-up expense. The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions and the operating expense structure of the Company's existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses and the transaction and integration expenses incurred in connection with recently acquired and divested product lines. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as new acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company does, however, expect to incur similar types of expenses in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur. The Company will hold a teleconference call and live webcast tomorrow at 8:00 a.m. Eastern Time to discuss the results followed by a question and answer session hosted by Mr. Mackin. To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 8:00 a.m. A replay of the teleconference will be available July 25 through July 31, and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13665887. The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations. Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac surgical procedures. CryoLife markets and sells products in more than 80 countries worldwide. For additional information about CryoLife, visit our website, www.cryolife.com. 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. These statements include those regarding our financial guidance for 2017 and our ability to keep on track to achieve our 2017 financial guidance and to continue to build CryoLife into a higher growth, higher margin company. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These risks and uncertainties include that the expected benefits of our focus on certain key initiatives may be incorrect or may not be achieved; we may not achieve the growth in core products that we expect; we may not continue to make progress at all or as quickly as we would like on certain items that negatively impacted the fourth quarter of 2016; we may not achieve the financial benefits of moving to direct sales channels in Canada, Belgium, the Netherlands, and Luxembourg and expanding our direct sales operations in Europe; and our business development efforts may not be successful. 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, 2016, and our subsequent filings with the SEC. CryoLife does not undertake to update its forward-looking statements.
News Article | July 10, 2017
To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 8:00 a.m. A replay of the teleconference will be available July 25 through July 31 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13665887. The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations. In addition, a copy of the earnings press release, which will contain financial and statistical information for the completed quarter, can be accessed on the Investor Relations section of the CryoLife website. Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of implantable tissues and medical devices used in cardiac surgical procedures. CryoLife markets and sells products in more than 80 countries worldwide. For additional information about CryoLife, visit our website, www.cryolife.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cryolife-announces-release-date-and-teleconference-call-details-for-2017-second-quarter-financial-results-300484889.html
CryoLife | Date: 2015-02-18
Methods are provided that include applying to a surgical field in the patient following a lymphadenectomy or other procedure in which a lymph node or lymphatic vessel is dissected, a bioresorbable and biocompatible material in an amount effective to control oozing of lymphatic fluid. The material may be a hydrophilic polysaccharide material which, in contact with tissues in the surgical field, produces a gelled matrix that adheres to and forms a mechanical barrier with tissues in the surgical field to control oozing of lymphatic fluid. The hydrophilic polysaccharide material may include a modified starch such as a cross-linked carboxymethyl polysaccharide.
CryoLife | Date: 2014-03-07
A method is provided for preparing a biological tissue for implantation. The method includes providing a biological tissue from a human or animal donor, treating the biological tissue with an antiviral treatment formulation, lysing the biological tissue, decellularizing the biological tissue with a decellularization treatment formulation, and decontaminating the biological tissue with an alkaline alcohol solution. The antiviral treatment formulation may include a solution of peracetic acid and an alcohol, wherein the peracetic acid is present in the antiviral treatment formulation at a concentration from about 0.03% to about 1.2% (v/v). The decellularization solution may include a solution of a polar aprotic solvent, such as dimethyl sulfoxide, benzyl alcohol and ethanol.
CryoLife | Date: 2013-01-30
A method is provided for preparing a tissue implant for implantation. The method includes harvesting a tissue material from a human or an animal donor, treating the tissue material in a nuclease-containing solution, and thereafter treating the tissue material with an alkaline alcohol solution. The nuclease-containing solution includes an antimicrobial. The alkaline alcohol solution comprises sodium hydroxide and ethanol.
CryoLife | Date: 2016-01-14
A connector for fluidly coupling proximal and distal tubular segments of a fluid conduit is provided. In one embodiment, the connector can include a connector body having an outer surface defining a first outer perimeter and an inner surface defining a lumen. The connector can also include a connecting device having an open configuration and a plurality of closed configurations. The connecting device can include first and second members configured to engage each other to secure the fluid conduit to the connector. The connecting device can also include a plurality of closed configurations for securing fluid conduits of different sizes.
CryoLife | Date: 2014-08-04
Systems and methods for a blood conduit for fluidly coupling a first vascular segment to a second vascular segment are disclosed herein. In one embodiment, a system for fluidly coupling proximal and distal tubular segments of a fluid conduit in a cardiovascular system is provided. The system may include a first engagement feature disposed on a distal end of the proximal tubular segment. The system also may include a second engagement feature disposed on a proximal end of the distal tubular segment. The first engagement feature may be configured to mate with the second engagement feature. In this manner, continuous flow may be provided between the proximal and distal tubular segments of the fluid conduit. In another embodiment, the proximal and distal tubular segments of the fluid conduit may collectively form a single unitary lumen without a connection device interposed between the segments.
CryoLife | Date: 2014-02-27
An apparatus and method are provided to treat a stenosis. A delivery device is provided that has an elongate tubular member coupled therewith. The elongate tubular member has an outside surface that is configured to prevent adherence of in vivo matter. The tubular member has a proximal end and a distal end and is reinforced along its length to maintain open lumen under a transverse load. The tubular member is placed in the vasculature such that the distal end of the elongate tubular member is disposed distal of a stenosis. The proximal end of the elongate tubular member is disposed inside the vessel, preferably at a location proximal of the stenosis. Thereafter, after a therapeutic period, the elongate tubular member is removed intact.
CryoLife | Date: 2014-07-15
A connector for fluidly coupling proximal and distal tubular segments of a fluid conduit is provided. In one embodiment, a system is provided for providing continuous flow of blood between two locations in a patients cardiovascular system. A first blood conduit is provided that has a distal portion and a proximal portion. The distal portion is adapted to be inserted into a blood vessel at an insertion site and to be advanced therethrough to a location spaced apart from the insertion site. The system is provided with a connector that has a distal portion adapted to be engaged with the proximal portion of the first blood conduit and a tubular body extending proximally of the distal portion. The tubular body is adapted to be inserted into and/or attached to an end of a second blood conduit, such as a vascular graft or the like.