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 ste...
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 ONE (‘NEXUS ONE’), NEXUS DUO (‘NEXUS DUO’), and NEXUS TRE (‘NEXUS TRE’) aortic arch stent graft systems (the ‘NEXUS family of products’), and E-vita Thoracic 3G products. Abdominal stent grafts include the company’s E-xtra Design Engineering (including Artivex), E-nside, E-tegra, E-ventus BX, Tuva 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 distribute 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 is focused on four growth areas that it expects to drive its business in the future as follows:
New Products – Through product development and commercialization of new and next-generation products and services focused on aortic repair;
New Indications – Through regulatory approvals in new markets and for new products, and through approvals for expanded indications for the company’s existing products and services;
Global Expansion – By entering new international markets, establishing new international direct sales territories, and developing the company’s commercial infrastructure in new markets, including emerging markets, such as China and Brazil; and
Business Development – By pursuing select acquisitions, licensing, and distribution opportunities that are aligned to the company’s objectives and complements 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 the NEXUS family of 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
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 the company’s 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 the company’s acquisition of JOTEC, it 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 (thoraco-abdominal aortic aneurysms) 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 family of 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 the company’s 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 also holds a Conformite Europeene Mark product certification (‘CE Mark’) for On-X heart valves.
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’). On-X heart valves compete with these products based on their features and benefits, such as full, 90-degree leaflet opening, pure pyrolytic carbon, flared inlet, and approved labeling claim for reduced INR for aortic valves.
The company began selling On-X heart valves in January 2016 following its acquisition of 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 full product launch in the fourth quarter of 2020.
E-vita Open NEO is a hybrid stent graft system used in the treatment of patients with either an aneurysm or dissection in the aortic arch and in the descending thoracic aorta. The E-vita Open NEO stent graft system enables a one-stage treatment to repair this condition through a combined surgical and endovascular treatment, providing a more cost-effective solution for the healthcare system and allowing the patient to avoid an additional operation.
The company obtained marketing approvals in addition to the CE Mark for the E-vita Open NEO in other countries throughout the world. he E-vita Open NEO competes outside the US with products from Terumo Medical Corporation (‘Terumo’, formerly Vascutek) and two smaller companies. The company do not sell E-vita Open NEO in the US. The E-vita Open NEO competes in Europe primarily on its proven stent graft technology and long-term clinical data. The CE Mark for the E-vita Open Plus expired in 2022 and is only sold in limited countries including Brazil.
AMDS
The company acquired Ascyrus in September 2020. Ascyrus developed the AMDS (Ascyrus Medical Dissection Stent) 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 approximately five minutes for deployment with additional time for suturing to complete the standard procedure. 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 September 2020 following the acquisition of Ascyrus. The company sells AMDS in EMEA, Canada, APAC, and LATAM. The company had minimal sales of AMDS in the US in 2023 under the investigational device exemptions (‘IDE’) and through special grants of continued access in 2024 while waiting for PMA approval in the US. Enrollment for the PERSEVERE clinical trial to gain the US approval was completed in November of 2023. In December 2024 the FDA granted a humanitarian device exemption (‘HDE’) for use of the AMDS Hybrid Prosthesis in acute DeBakey Type I dissections in the presence of malperfusion.
NEXUS Products
The company distributes the NEXUS family of 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 ONE 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 ONE 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 ability to repair the aortic arch with an endovascular approach is especially advantageous for elderly patients who are not suited for open surgery and for patients who were previously treated for a Type A dissection in an open surgical approach. The addition of the NEXUS family of 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 ONE in the fourth quarter of 2019 in EMEA. The first implant of the 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 began distribution of NEXUS TRE, the custom-made three branch graft, in the third quarter of 2024 as a limited market release.
The company also entered into a securities purchase option agreement with Endospan (‘Endospan Option’) in September 2019 and subsequent amendment (‘Endospan Option Amendment’) in July 2024 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 Endospan’s assets) up through a certain period after FDA approval of NEXUS ONE. Endospan completed patient enrollment in their US pivotal trial, TRIOMPHE in the fourth quarter of 2024.
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. Compared to its competing products, its different proximal and distal stent graft configurations, as well as straight and conical designs, enable individual treatment of the diseased aorta. 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 approximately 22 working days. 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 Artivex in EMEA and in a limited number of other countries around the world. 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 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. Most 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 the company’s portfolio of thoracic and abdominal stent grafts. 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. 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. 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 substantially depleted the remaining inventory during 2024.
Tuva BX
Tuva BX is a balloon-expandable peripheral stent graft indicated for the endovascular treatment of arterial ruptures, aneurysms and other peripheral vascular system pathologies. The Tuva BX stents are manufactured using a cobalt chromium alloy which is covered internally and externally with ePTFE so that the stent is completely encapsulated. The Tuva BX stent is designed for different artery diameters by adapting its open cell design with alternating connection bridges. The device also has enhanced visibility due to three radiopaque markers at each stent end that facilitate accurate placement in implantation and post-dilation. The Tuva BX is often used in conjunction with E-xtra Design Engineering products, E-nside stent grafts, and E-liac stent grafts.
The Tuva BX is manufactured by LVD Biotech SL, who hold a CE Mark for that product and additional marketing approvals in several other countries throughout the world. The Tuva BX competes with products from Maquet, Gore, BD, and Bentley InnoMed.
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 estimates 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. The E-liac competes with products from Gore and Cook.
Synthetic Vascular Grafts
In addition to the company’s endovascular stent graft offerings, it 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 the company’s 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
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. The company received regulatory approval to commercialize BioGlue in China during the third quarter of fiscal year 2024.
BioGlue competes primarily with surgical sealants from Baxter, Ethicon, Grena Ltd, Integra LifeSciences, and Bard, a subsidiary of BD. BioGlue competes with these products based on its features and benefits, such as its strength and ease of use.
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 the company’s proprietary SynerGraft SGPV valves (83%) compared with patients receiving standard allografts (58%).
Two other domestic tissue processors, LifeNet Health (‘LifeNet’) and LeMaitre Vascular (‘LeMaitre’), offer preserved human heart valves and patches in competition with the company. The company competes favorably on the basis of surgeon preference, documented clinical data, technology, and customer service, particularly with respect to the capabilities of its field representatives. 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 US. 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. The human tissues the company distributes offer specific advantages over synthetic and bioprosthesis alternatives, particularly for the treatment of infection in hemodialysis and peripheral bypass patients.
Two other domestic human tissue processors, LifeNet and LeMaitre, offer preserved vascular tissue in competition with the company. There are also a number of providers of synthetic and bioprosthetic alternatives to vascular tissues preserved by the company and those alternatives are available primarily in medium and large diameters. The company’s vascular tissues compete with products from Gore, BD, LeMaitre, LifeNet, 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 the company’s 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 US in May 2011 when the company 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 does not require additional operating room preparation or special storage conditions and is easy to apply. 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 US, which it transferred to Baxter, and began manufacturing and supplying PerClot for Baxter.
Marketing and Distribution
In the US and Canada, the company markets its products and preservation services primarily to physicians and sell the company’s 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 the company’s field representatives and its 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 the company’s subsidiaries through approximately 50 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 the company, including virtual and remote programs. The company sponsors programs, and work 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 coordinate peer-to-peer training at various medical institutions.
The company’s human tissues are obtained in the US 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 family of products are solely manufactured by Endospan in Herzliya, Israel.
The company maintains a facility—which contains its corporate headquarters, manufacturing, and laboratory space—and an additional off-site warehouse, in Kennesaw, Georgia. The company manufactures BioGlue, PhotoFix, and PerClot and process human tissues at this facility.
The company’s On-X facility consists of combined manufacturing, warehouse, and office space in Austin, Texas, where its On-X products, including On-X heart valves and AAPs, are manufactured.
The company’s aortic stent graft facility consists of combined manufacturing, warehousing, and office space in Hechingen, Germany and is its EMEA headquarters.
The company also maintains sales offices, some of which have distribution operations, in Brazil, Greece, Italy, Poland, Singapore, Spain, Switzerland, and the UK.
The company employs a comprehensive quality assurance program in its product manufacturing and tissue preservation activities. The company evaluates and inspects both its manufactured and distributed products to ensure conformity to product specifications. The company maintains controls over its tissue processing to ensure conformity with the company’s procedures. OPOs and tissue banks must follow the company’s procedures related to tissue recovery practices and are subject to periodic audits to confirm compliance.
Patents, Licenses, and Other Proprietary Rights
The company has also obtained rights through license and distribution agreements for additional products and technologies, including the NEXUS family of products.
Seasonality
Demand for the company’s cardiac preservation services has traditionally been seasonal, with peak demand generally occurring in the third quarter. 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 2024).
Research and Development
In 2024, the company spent approximately $28.5 million on research and development activities on new and existing products.
Government Regulation
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.
In all the company’s facilities, it is subject to regulatory standards for good manufacturing practices, including Quality System Regulations, which are the FDA regulatory requirements for medical device manufacturers, and 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.
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.
