About Artivion

Artivion, Inc. (Artivion) engages in the manufacturing, processing, and distribution of medical devices and implantable human tissues used in cardiac and vascular surgical procedures for patients with aortic disease. The company has four major product families: aortic stent grafts, surgical sealants, On-X mechanical heart valves and related surgical products (On-X products), and implantable cardiac and vascular human tissues. Aortic stent grafts include aortic arch stent grafts, abdominal stent grafts, and synthetic vascular grafts. Aortic arch stent grafts include the company's E-vita Open NEO, E-vita Open Plus, the Ascyrus Medical Dissection Stent (AMDS) hybrid prosthesis, the NEXUS endovascular stent graft system (NEXUS), the NEXUS DUO aortic arch stent graft (NEXUS DUO), and E-vita Thoracic 3G products. Abdominal stent grafts include its E-xtra Design Engineering (including Artivex), E-nside, E-tegra, E-ventus BX, and E-liac products. Surgical sealants include the company's BioGlue Surgical Adhesive products (BioGlue). In addition to these four major product families, the company sells or distributes PhotoFix bovine surgical patches (PhotoFix) and CardioGenesis cardiac laser therapy (prior to its abandonment of the business as of June 30, 2023). The company began to manufacture and supply PerClot hemostatic powder (PerClot) during the second quarter of 2023. Segments The company operates through two segments: Medical Devices and Preservation Services. The Medical Devices segment includes revenues from sales of aortic stent grafts, surgical sealants, On-X products, and other product revenues. The Preservation Services segment includes services revenues from the preservation of cardiac and vascular implantable human tissues. Strategy Artivion is committed to partnering with surgeons and cardiologists to deliver innovative technologies of unsurpassed quality that restore the health of patients with aortic disease. The company's strategic plan focuses on four growth areas that it expects to drive its business in the future. The company plans to drive growth through product development and commercialization of new and next-generation products and services focused on aortic repair; regulatory approvals in new markets and for new products, and through approvals for expanded indications for its existing products and services; entering new international markets, establishing new international direct sales territories, and developing its commercial infrastructure in new markets, including emerging markets, such as China and Brazil; and pursuing select acquisitions, licensing, and distribution opportunities that are aligned to its objectives and complement its existing products, services, and infrastructure. Examples include the company's acquisitions of JOTEC, On-X LTI, and Ascyrus Medical LLC (Ascyrus), and its distribution agreement and purchase option for NEXUS and NEXUS DUO (the NEXUS Products). To the extent that the company identifies, develops, or acquires non-core products or applications, it may dispose of these assets or pursue licensing or distribution agreements with third-party partners for development or commercialization, such as the sale of the PerClot product line. Markets, Products, Services, and Competition The company's medical devices and preservation services are primarily used by cardiac and vascular surgeons to treat patients with aortic disease, including heart valve disease, aortic aneurysms and dissections, and, to a lesser extent, other conditions in cardiac and vascular surgery. Aortic Disease Aortic Valve Disease The company markets the On-X aortic and mitral mechanical heart valves for valve replacement procedures. The company also markets its cardiac preservation services, including its CryoValve and CryoValve SG human tissues, for heart valve replacement surgeries and its CryoPatch and CryoPatch SG human tissues for cardiac repair procedures. The company's PhotoFix product is a bovine patch device used for cardiac and vascular repair. Aortic Aneurysms Following its acquisition of JOTEC GmbH (JOTEC), the company began commercialization of a broad portfolio of endovascular products for repair of aortic aneurysms. These include highly differentiated products, such as E-xtra Design Engineering, a portfolio of stent grafts tailor-made for a patient's anatomy for TAAA repair, and the E-liac for repair of aneurysms in the iliac arteries, as well as less differentiated products, including the E-vita Thoracic 3G for TAA repair and the E-tegra for AAA repair. Aortic Dissections The company sells the E-vita Open Plus, E-vita Open NEO, and AMDS as well as distribute the NEXUS Products to treat these conditions impacting the aortic arch and thoracic aorta. Other Disease States - Peripheral Vascular Disease and End Stage Renal Disease The company markets its CryoVein femoral vein and CryoArtery femoral artery vascular preservation services for vascular access. The company markets its vascular preservation services, including its CryoVein and CryoArtery tissues, and a synthetic surgical graft portfolio for peripheral vascular reconstruction surgeries. Product Categories and Products On-X Mechanical Heart Valves The On-X product line includes the On-X prosthetic aortic and mitral heart valves and the On-X ascending aortic prosthesis (AAP). The company also distributes CarbonAid CO2 diffusion catheters and sells Chord-X ePTFE sutures for mitral chordal replacement, and it offers pyrolytic carbon coating services to other medical device manufacturers as part of the On-X family of products. On-X heart valves are bileaflet mechanical valves composed of a graphite substrate coated with the company's silicon-free pyrolytic carbon coating that provides a smooth microstructure surface. The company holds a Conformite Europeene Mark product certification (CE Mark) for On-X heart valves. Competition: On-X heart valves compete primarily with mechanical valves from Abbott Laboratories, Medtronic, plc. (Medtronic), and Corcym S.r.l. (who completed acquisition of the LivaNova heart valve business in June 2021) (Corcym). The company began selling On-X heart valves in January 2016 following its acquisition of On-X Life Technologies, Inc. (On-X LTI). The company sells On-X heart valves throughout the world including North America, Europe, the Middle East, and Africa (collectively, EMEA), Asia Pacific (APAC), and Latin America (LATAM). Aortic Stent Grafts Hybrid stent grafts, surgical grafts, and endovascular stent grafts can be used in the treatment of complex thoracic and abdominal aortic disease, such as aortic dissections and aortic aneurysms, as well as in other aortic and peripheral procedures. Thoracic Stents and Stent Grafts E-vita Open NEO The E-vita Open NEO is the next generation of the E-vita Open Plus hybrid stent graft, with an updated delivery system and improved handling. The company obtained a CE Mark for E-vita Open NEO in the first quarter of 2020 and began limited distribution of E-vita Open NEO in the second quarter of 2020 with full product launch in the fourth quarter of 2020. The company obtained marketing approvals in addition to the CE Mark for the E-vita Open NEO in other countries throughout the world. Competition: The E-vita Open NEO competes outside the U.S. with products from Terumo Medical Corporation and two smaller companies. AMDS The company acquired Ascyrus in 2020. Ascyrus developed the AMDS hybrid prosthesis, the world's first aortic arch remodeling device for use in the treatment of acute Type A aortic dissection. Hemi-arch reconstruction is the standard of care for the treatment of acute Type A aortic dissection. AMDS is used as a complement to, and in conjunction with, hemi-arch reconstruction without adding technical complexity to this life-saving procedure. The design of the AMDS allows for rapid deployment of the graft in the aortic arch during a standard replacement of the ascending aorta, adding on average fifteen minutes to the procedure time. The deployment of the AMDS preserves the native arch, potentially allowing for minimally invasive re-interventions as needed, including the repair of additional entry tears, rather than an invasive arch repair. In the Dissected Aorta Repair Through Stent clinical trial supporting its CE Mark and Health Canada approvals, the AMDS was shown to reduce mortality, complications, and reoperations compared to the standard of care, thereby improving the care of patients and offering significant cost savings for the health care system. The company began selling AMDS in 2020 following the acquisition of Ascyrus. The company sells AMDS outside of the U.S., including in EMEA, Canada, APAC, and LATAM. Enrollment for the PERSEVERE clinical trial to gain the U.S. approval was completed in November of 2023. The company anticipates receiving a Premarket Approval (PMA) from the FDA for the AMDS in late 2025. NEXUS Products The company distributes the NEXUS Products in certain countries in Europe under an exclusive distribution agreement with Endospan Ltd. (Endospan), an Israeli corporation. Endospan holds a CE Mark for NEXUS which is the only endovascular stent graft system approved for the repair of both aneurysms and dissections in the aortic arch and markets the NEXUS DUO as a custom-made alternative for flexible aortic arch repair. NEXUS DUO is a low profile, custom made aortic arch system designed to treat a range of aortic arch pathologies including chronic dissection, aortic aneurysm, penetrating aortic ulcer, as well as intramural hematoma. Unlike the NEXUS off-the-shelf device, NEXUS DUO includes a secondary branch designed to minimize surgical preparation for patients undergoing endovascular repair of the aortic arch. While open surgical repair remains the standard of care for complete aortic arch replacement, endovascular repair offers an alternative, less invasive procedure to treat the aortic arch with decreased surgical morbidity and mortality. The addition of the NEXUS Products to the company's highly differentiated aortic stent graft portfolio further strengthens its position as a leader in the aortic repair market. The company began distribution of NEXUS in 2019 in EMEA. The first implant of the next generation NEXUS DUO, the dual branch graft system in the NEXUS product line, occurred in the fourth quarter of 2022 as a limited market release. The company also entered into a securities purchase option agreement with Endospan in 2019 which provides it the option to purchase all the outstanding securities of Endospan from Endospan's securityholders at the time of acquisition (or the option to acquire all of Endospan's assets) up through a certain period of time after FDA approval of NEXUS. Endospan is enrolling patients in their U.S. pivotal trial, TRIOMPHE. E-vita Thoracic 3G The E-vita Thoracic 3G is a stent graft system that enables endovascular treatment of TAAs. Its unique spring configuration gives the stent graft flexibility, helping the stent graft adapt to the vessel's shape and ensuring a good seal at the landing zone, even in the case of complex vascular anatomy. The product line includes a wide portfolio of tapered versions from proximal to distal. The wide variety ensures the possibility of adapting the stent graft to the native course of the descending aorta. The E-vita Thoracic 3G is sometimes used in conjunction with the E-vita Open NEO and E-xtra Design Engineering. Until 2022, the company held a CE Mark for the E-vita Thoracic 3G and additional marketing approvals have been granted in several other countries throughout the world. The E-vita Thoracic 3G competes primarily with products from Medtronic, Gore, Terumo, and Cook. Thoraco-abdominal Stents and Stent Grafts E-xtra Design Engineering E-xtra Design Engineering is a comprehensive range of stent graft systems for the treatment of aortic vascular diseases that enables surgeons to quickly and efficiently respond to an individual patient's therapeutic requirements. E-xtra Design Engineering stent graft systems are tailor-made for individual patients based on imaging of the patient's own aorta. There are only limited off-the-shelf products to treat aneurysms in the thoraco-abdominal aorta due to the many side branches in this anatomy where blood flow to vital organs would be obstructed by unbranched stent grafts. The company has pioneered a service whereby it can manufacture a customized thoraco-abdominal stent graft in three weeks or less. The company's custom E-xtra Design Engineering stent graft system includes TAAA and Artivex Thoracic Extension Stent Graft System (Artivex). The company's custom TAAA is often used in conjunction with E-vita Thoracic 3G, as well as the AAA offering, the E-tegra, or in combination with both. In December 2023, the company launched Artivex as part of its E-xtra Design Engineering stent graft systems in EMEA. Artivex is indicated for use in both thoraco-abdominal aneurysms and dissections extending into the thoraco-abdominal aorta. The company sells custom TAAA, and anticipates selling Artivex during fiscal year 2024, in EMEA and in a limited number of other countries around the world. Competition: TAAA competes with customized product offerings from Cook and Terumo. Artivex competes with other thoracic extension products marketed by Medtronic, Gore, Terumo, and Cook. E-nside The E-nside TAAA multibranch stent graft system is an off-the-shelf stent graft with pre-cannulated inner branches indicated for the treatment of patients with thoraco-abdominal disease. The E-nside's pre-cannulated inner branches are designed to reduce the overall procedure time which reduces the patient's exposure to radiation. The vast majority of patients with thoraco-abdominal disease are treated with risky, invasive open surgical procedures, characterized by lengthy hospitalization periods and prolonged recuperation, or with custom-made stent grafts which can take up to 90 days to manufacture. The addition of E-nside positions the company well to capture share in the European aortic stent graft market because E-xtra Design Engineering provides patient-specific solutions, and E-nside provides an off-the-shelf solution. Further, there are synergies between E-nside and its portfolio of thoracic and abdominal stent grafts. Competition: E-nside competes with products from Cook. The company obtained a CE Mark for E-nside in the fourth quarter of 2019 and began limited selling of E-nside in the second quarter of 2020. The company fully launched E-nside in 2021. Abdominal and Peripheral Stents and Stent Grafts E-tegra The E-tegra is a AAA stent graft system with special stent design for secure sealing that makes difficult vascular anatomies treatable, thus expanding endovascular treatment options for infrarenal abdominal aortic aneurysms. The design of the E-tegra enables optimal fixation and sealing. It is a proximal laser cut stent with anchors for suprarenal stent graft fixation. Its asymmetric stent design and seamless cover ensure excellent adaptation to the vessel. The product also features a low-profile delivery system with its unique squeeze-to-release mechanism supporting the user by ensuring excellent control during each phase of the implantation. The E-tegra is often used in combination with E-xtra Design Engineering and the E-liac. The company holds a CE Mark for the E-tegra and additional marketing approvals have been granted in several other countries throughout the world. Competition: The E-tegra competes with products from several companies including Medtronic, Gore, Terumo, Endologix, and Cook. E-ventus BX E-ventus BX is a balloon-expandable peripheral stent graft indicated for the endovascular treatment of renal and pelvic arteries in cases of ruptures, dissections, and aneurysms. The E-ventus BX stent grafts have a combination of high flexibility together with high radial strength through the combination of the microporous single-layer ePTFE cover and the cobalt chromium stent. The E-ventus BX stent grafts feature minimal recoil and foreshortening and enables secure fixation and positioning in the vessel. The E-ventus BX delivery system has a highly flexible catheter that allows easy advancement in the vessel and enables lesions to be reliably reached by the catheter. Radiopaque markers on the delivery system enable secure and accurate positioning of the stent graft. The E-ventus BX is often used in conjunction with E-xtra Design Engineering products, E-nside stent grafts, and the E-liac stent graft. The E-ventus BX was manufactured by Bentley, who holds a CE Mark for that product and additional marketing approvals in several other countries throughout the world. Competition: The E-ventus BX competes with products from Maquet, Gore, BD, and Bentley InnoMed. The company received the final production lots of E-ventus BX in May 2023 and it anticipates substantially depleting the remaining inventory through the first quarter of fiscal year 2024. E-liac The E-liac is a stent graft used to treat aneurysmal iliac arteries, as well as aneurysmal iliac side branches. The E-liac is a self-expanding stent graft characterized by easy and safe handling, which makes it possible to safely reach the lesion and accurately position the stent graft in the vessel. The company estimatea that 20% of patients who have an AAA also have an aneurysmal iliac artery, and as such, the E-liac is often used in conjunction with the E-tegra AAA device as well as one or two E-ventus BX devices. The company holds a CE Mark for the E-liac and additional marketing approvals have been granted in several other countries throughout the world. Competition: The E-liac competes with products from Gore and Cook. Synthetic Vascular Grafts In addition to its endovascular stent graft offerings, the company has a broad line of synthetic vascular grafts that are used in open aortic and peripheral vascular surgical procedures. The company's offerings include ePTFE grafts and both woven and knitted polyester grafts. Not only are the company is able to manufacture and sell a broad line of synthetic vascular graft offerings, but also, it is able to manufacture its own nitinol stents, given its expertise incorporating nitinol in its synthetic graft systems. The company's synthetic surgical vascular grafts have CE Marks and additional marketing approvals have been granted in several other countries throughout the world. The company's synthetic grafts compete with products from Bard, a subsidiary of BD, Gore, LeMaitre, Terumo, and Maquet. Surgical Sealants Closing internal wounds effectively following surgical procedures is critical to the restoration of the function of tissue and to the ultimate success of the surgical procedure. Failure to seal surgical wounds effectively can result in leakage of blood in cardiac surgeries, air in lung surgeries, and cerebrospinal fluid in neurosurgeries potentially resulting in prolonged hospitalization, greater post-operative pain, higher costs, and higher mortality rates. The company's proprietary BioGlue is a polymer consisting of bovine blood protein and an agent for cross-linking proteins, which was developed for use in cardiac, vascular, neurologic, and pulmonary procedures. BioGlue is stronger than other cardiovascular sealants with a tensile strength that is four to five times that of fibrin sealants. BioGlue begins to polymerize within 20 to 30 seconds, reaches its bonding strength within two minutes, and it adheres to tissues in a wet field. BioGlue is dispensed through a controlled delivery system that consists of a disposable syringe and various applicator tips. BioGlue syringes are available in pre-filled 2ml, 5ml, and 10ml volumes with applicator tips suitable for various applications. BioGlue is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. The company distributes BioGlue under CE Mark for repair of soft tissues (which include cardiac, vascular, and pulmonary). The company also distributes BioGlue in Japan where it is approved for adhesion and support of hemostasis for aortotomy closure sites, suture/anastomosis sites (including aortic dissection and anastomosis sites with use of a prosthetic graft), and suture sites on the heart. Additional marketing approvals have been granted for specified applications in numerous other countries throughout the world. Competition: BioGlue competes primarily with surgical sealants from Baxter, Ethicon, Grena Ltd, Integra LifeSciences, and Bard, a subsidiary of BD. The company sells BioGlue throughout the world including North America, EMEA, APAC, and LATAM. Preservation Services Cardiac Preservation Services The company's proprietary preservation process involves its dissection, processing, preservation, and storage of donated human tissues until they are shipped to a hospital where they are implanted by physicians. The cardiac tissues the company preserves include aortic and pulmonary heart valves and cardiac patches in three primary pulmonary anatomic configurations: hemi-artery, trunk, and branch. These tissues more closely resemble in structure, and simulate the performance of, the patient's own tissue compared to non-human tissue alternatives. The company's cardiac tissues are used in a variety of valve replacement and cardiac reconstruction surgeries. The human tissues the company distributes offer specific clinical advantages over mechanical, synthetic, and bioprosthetic alternatives. Depending on the alternative, the clinical advantages of the company's heart valves include more natural blood flow properties, better results in patients who have endocarditis, no requirement for long-term drug therapy to prevent excessive blood clotting, and a reduced risk of catastrophic failure, thromboembolism, stroke, or deterioration due to calcification. The company's cardiac tissues include the CryoValve SG pulmonary heart valve (CryoValve SGPV) and the CryoPatch SG pulmonary cardiac patch (CryoPatch SG), which are both processed with its proprietary SynerGraft decellularization technology. A multi-center study showed that, at 10 years, freedom from conduit dysfunction was significantly better in patients receiving its proprietary SynerGraft SGPV valves (83%) compared with patients receiving standard allografts (58%). Competition: Two other domestic tissue processors, LifeNet Health (LifeNet) and LeMaitre Vascular (LeMaitre), offer preserved human heart valves and patches in competition with the company. Alternatives to human heart valves processed by the company include valve repair and valve replacement with bioprosthetic valves or mechanical valves. The company competes with bioprosthetic or mechanical valves from companies, including Medtronic, Edwards Lifesciences, Corcym, and Abbott Laboratories. Alternatives to the company's human cardiac patches include xenograft SIS and glutaraldehyde fixed bovine pericardial patches. The company competes with these xenograft products from companies, including Edwards Lifesciences, Anteris Technologies, Abbott Laboratories, and Baxter. The company ships human cardiac tissues to implanting institutions throughout the U.S. The company's CryoValve SGPV and CryoPatch SG are distributed under 510(k) clearance from the FDA. The company also ships limited tissues in Canada and other countries under special access programs. Vascular Preservation Services The company's proprietary preservation process involves its dissection, processing, preservation, and storage of donated human tissues until they are shipped to a hospital for implantation by a physician. The vascular tissues preserved by the company include saphenous veins, aortoiliac arteries, and femoral veins and arteries. Each of these tissues maintains a structure which more closely resembles and simulates the performance of the patient's own tissue compared to non-human tissue alternatives. The company's vascular tissues are used to treat a variety of vascular reconstructions, such as peripheral bypass, hemodialysis access, and aortic infections, which have saved the lives and limbs of patients. Competition: The company's vascular tissues compete with products from Gore, BD, LeMaitre, and Maquet. Other Products PhotoFix PhotoFix is a bovine pericardial patch fixated using a dye-mediated photo-oxidation process without the use of glutaraldehyde. The company holds FDA 510(k) clearance and previously held a CE Mark for PhotoFix which is indicated for use in intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels as well as arteriovenous access revisions). The company is transitioning its PhotoFix CE Mark to its new Notified Body, DEKRA. The company's PhotoFix product line competes with bioprosthetic and synthetic cardiac and vascular patch offerings from several other companies, including Baxter, LeMaitre, and Abbott Laboratories, based on PhotoFix's features and benefits, such as the photo-oxidation cross-linking process that does not use glutaraldehyde. The company sells PhotoFix in North America, EMEA, and APAC. CardioGenesis Cardiac Laser Therapy for Angina Treatment The CardioGenesis cardiac laser therapy product line is FDA approved for treating patients with severe angina that are not responsive to conventional therapy. The company began selling the CardioGenesis cardiac laser therapy product line in the U.S. in May 2011 when it completed the acquisition of CardioGenesis Corporation. PerClot PerClot is an absorbable powdered hemostat, consisting of plant starch modified into ultra-hydrophilic, adhesive-forming hemostatic polymers. PerClot granules are biocompatible, absorbable polysaccharides containing no animal or human components. PerClot granules have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to any further bleeding and results in the accumulation of platelets, red blood cells, and coagulation proteins (thrombin, fibrinogen, etc.) at the site of application. PerClot is readily dissolved by saline irrigation and is totally absorbed by the body within several days. In September 2010, the company entered into a distribution agreement and a license and manufacturing agreement with Starch Medical, Inc. (SMI), which allowed it to distribute PerClot, worldwide, except a few countries. In May 2023, the company obtained FDA PMA approval to commercialize PerClot in the U.S., which it transferred to Baxter, and began manufacturing and supplying PerClot for Baxter. Marketing and Distribution In the U.S. and Canada, the company markets its products and preservation services primarily to physicians and sells its products through its approximately 50-person direct sales team to hospitals and other healthcare facilities. The company also has a team of regional managers, national accounts managers, and sales and marketing management. Through its field representatives and the company's physician relations and education department, the company conducts field training for surgeons regarding the surgical applications of its products and tissues. In EMEA, the company markets its products through its European headquarters, based in Hechingen, Germany, as well as through several other subsidiaries based throughout Europe. The company employs approximately 100 direct field service representatives and distributor managers across several countries in the EMEA region. The company provides customer service, logistics, marketing, and clinical support to cardiac, vascular, thoracic, and general surgeons throughout the EMEA region. In APAC and LATAM, the company commercializes its products through its independent distributors and its subsidiaries through approximately 40 sales and clinical support specialists. The company's physician relations and education staff, clinical research staff, and field representatives assist physicians by providing educational materials, seminars, and clinics on methods for using its products and implanting tissue preserved by it, including virtual and remote programs. The company sponsors programs, and works with other companies, such as Endospan to sponsor programs, where surgeons train other surgeons in best-practice techniques. In addition, the company hosts several workshops throughout the year that provide didactic and hands-on training to surgeons. The company also produces educational videos for physicians and coordinates peer-to-peer training at various medical institutions. The company's human tissues are obtained in the U.S. through organ and tissue procurement organizations (OPOs) and tissue banks. To assist OPOs and tissue banks, the company provides educational materials and training on procurement, dissection, packaging, and shipping techniques. The company produces educational videos and coordinate laboratory sessions for OPO and tissue bank personnel to improve their recovery techniques and increase the yield of usable tissue. The company also maintains staff 24 hours per day, 365 days per year, for OPO and tissue bank support. Operations, Manufacturing, and Tissue Preservation The company conducts its internal manufacturing operations at three facilities: Austin, Texas for On-X products, Hechingen, Germany for internally manufactured aortic stent grafts, and Kennesaw, Georgia for most other products and services. Certain aortic stent graft assemblies are manufactured for the company by a contract manufacturer in Slovakia. The AMDS product is solely manufactured by a supplier in Charlotte, North Carolina, and the NEXUS Products are solely manufactured by Endospan in Herzliya, Israel. The company maintains sales offices, some of which have distribution operations, in Brazil, Greece, Italy, Poland, Singapore, Spain, Switzerland, and the U.K. In all of its facilities, the company is subject to regulatory standards for good manufacturing practices, including current Quality System Regulations, which are the FDA regulatory requirements for medical device manufacturers, and current Good Tissue Practices (cGTPs), which are the FDA regulatory requirements for the processing of human tissue. The company also operates according to International Organization for Standardization (ISO) 13485 Quality System Requirements, an internationally recognized voluntary system of quality management for companies that design, develop, manufacture, distribute, and service medical devices. The company maintains a Certification of Approval to ISO 13485. Patents, Licenses, and Other Proprietary Rights The company owns rights to numerous U.S. and foreign patents and pending patent applications relating to its technology for various product lines. The main patent for BioGlue expired in mid-2012 in the U.S. and expired in mid-2013 in the majority of the rest of the world. Although the patents for BioGlue have expired, this technology is still protected by trade secrets and manufacturing know-how, as well as the time and expense to obtain regulatory approvals. Seasonality Historically, the demand for most of the company's aortic stent grafts is seasonal, with a decline in demand generally occurring in the third quarter due to the summer holiday season in Europe. The company is uncertain whether the demand for AMDS and the NEXUS Products is seasonal, as these products have not fully penetrated many markets and, therefore, the nature of any seasonal trends may not yet be obvious. Historically, the demand for BioGlue products is seasonal, with a decline in demand generally occurring in the third quarter followed by stronger demand in the fourth quarter. Demand for the company's cardiac preservation services has traditionally been seasonal, with peak demand generally occurring in the third quarter. This trend for cardiac preservation services is primarily due to the high number of surgeries scheduled during the summer months for school-aged patients. Based on experience in recent years, this trend is lessening as the company is distributing a higher percentage of its tissues for use in adult populations. Demand for the company's vascular preservation services has also traditionally been seasonal, with lowest demand generally occurring in the fourth quarter (year ended December 31, 2023). This trend for vascular preservation services is primarily due to fewer vascular surgeries being scheduled during the winter holiday months. Research and Development In 2023, the company spent approximately $28.7 million on research and development activities on new and existing products. Government Regulation In all of its facilities, the company is subject to regulatory standards for good manufacturing practices, including current Quality System Regulations, which are the FDA regulatory requirements for medical device manufacturers, and current Good Tissue Practices (cGTPs), which are the FDA regulatory requirements for the processing of human tissue. The company also operates according to International Organization for Standardization (ISO) 13485 Quality System Requirements, an internationally recognized voluntary system of quality management for companies that design, develop, manufacture, distribute, and service medical devices. The company maintains a Certification of Approval to ISO 13485. The FDA periodically inspects the company's facilities to review the company's compliance with these and other regulations and has authority to seize non-complying medical devices, enjoin and/or impose civil penalties on manufacturers and distributors marketing non-complying medical devices, criminally prosecute violators, and order recalls in certain instances. The company's activities in preserving and transporting human hearts and certain other organs are also subject to federal regulation under the National Organ Transplant Act (NOTA), which makes it unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce. The FDA periodically audits the company's tissue preservation facilities for compliance with its requirements and has the authority to enjoin the distribution, force a recall, or require the destruction of tissues that do not meet its requirements. History The company was founded in 1984. The company was incorporated in 1984 in Delaware. It was formerly known as CryoLife, Inc. and changed its name to Artivion, Inc. in 2022.