About LeMaitre Vascular

LeMaitre Vascular, Inc. provides medical devices and human tissue cryopreservation services largely used in the treatment of peripheral vascular disease, end-stage renal disease, and to a lesser extent cardiovascular disease worldwide. The company develops, manufactures, and markets vascular devices to address the needs of vascular surgeons and, to a lesser degree, other specialties, such as cardiac surgeons, general surgeons and neurosurgeons. The company’s diversified portfolio of devices consists of brand name products that are used in arteries and veins and are well known to vascular surgeons. The company’s principal product offerings are sold globally, primarily in the United States, Europe, Canada and the Asia Pacific. The company sells its products and services primarily through a direct sales force. The company’s worldwide headquarters is located in Burlington, Massachusetts, and it also has North American sales offices in Chandler, Arizona and Vaughan, Canada. The company’s European headquarters is located in Sulzbach, Germany, and it also has European sales offices in Milan, Italy; Madrid, Spain; and Hereford, England. The company’s Asia Pacific headquarters is located in Singapore, and it also has Asia-Pacific sales offices in Tokyo, Japan; Shanghai, China; Kensington, Australia; and Seoul, Korea. The company also sells its products in other countries through distributors. Products and Services The company has a portfolio of 16 product lines, which include 13 different product types, most of which are used to treat vascular disease, and most of which are used in open vascular surgery and dialysis access. The company also offers human vascular tissue cryopreservation services. The company’s 13 product offerings include a suite of biologic products. These offerings include the XenoSure patch (bovine pericardium), CardioCel and VascuCel patches (bovine pericardium), ProCol graft (bovine mesenteric vein), Artegraft (bovine carotid artery), Omniflow II biosynthetic graft (ovine tissue and synthetic mesh) and RestoreFlow Allograft cryopreservation services (human cadaveric tissue). Allografts Through its RestoreFlow allograft business, the company provides human cadaver tissue cryopreservation services, in particular the processing and cryopreservation of veins and arteries. The company’s RestoreFlow allografts are cryopreserved human tissue grafts, including saphenous veins, femoral veins and arteries, aortic and iliac arteries, aortic and pulmonary valved conduits and pulmonary patches. These allografts are used in a variety of vascular reconstructions, such as peripheral bypass, hemodialysis access, and aortic infections, as well as in cardiac repair and reconstruction. Angioscopes The PeriVu Disposable Angioscope is a fiberoptic catheter used for viewing the lumen of a blood vessel. PeriVu also provides direct visualization of valves during in-situ bypass procedures. Balloon Catheters for Embolectomy and Thrombectomy The company’s TufTex and Syntel lines of embolectomy catheters are used to remove blood clots from arteries. It sells single-lumen latex and latex-free embolectomy catheters, as well as dual-lumen latex and latex-free embolectomy catheters. The dual-lumen embolectomy catheters enable clot removal and simultaneous irrigation or guide-wire trackability. The company’s Syntel thrombectomy catheter features a silicone balloon and is designed for removing thrombi in the venous system. Balloon Catheters for Occlusion and Perfusion Occlusion catheters temporarily occlude blood flow to allow the surgeon time and space to complete a procedure. Perfusion catheters perfuse blood and other fluids into the vasculature. The company’s Pruitt line of occlusion and perfusion catheters reduces vessel trauma by using internal balloon fixation rather than traditional external clamp fixation. Bovine Grafts The company’s Artegraft biologic graft is a bovine carotid artery used for dialysis access in patients with or without a previously-failed synthetic graft. Its biological fibrous matrix is processed to enhance long-term patency and provide a tightly woven, cross-linked conduit that is flexible and compliant. Artegraft (Artegraft, Inc.) is also indicated for lower extremity bypass. Vascular and Cardiac Patches The company’s XenoSure biologic patches are made from bovine pericardium and are used primarily for closure of vessels after surgical intervention. The company’s VascuCel and CardioCel biologic patches are acellular, collagen bioscaffolds with optimized biocompatibility and zero aldehyde toxicity. These bovine pericardium patches are used in vessel repair, as well as heart repair and reconstruction, including neonatal repairs. Carotid Shunts The company’s Pruitt F3 and Flexcel carotid shunts are used to temporarily shunt blood to the brain while the surgeon removes plaque in a carotid endarterectomy surgery. Its Pruitt F3 shunt features internal balloon fixation. The company’s Flexcel shunt is a non-balloon shunt offered for surgeons who prefer external fixation. Closure Systems The company’s AnastoClip AC and AnastoClip GC closure systems attach vessels to one another with titanium clips instead of sutures. These closure systems create an interrupted anastomosis that expands and contracts as the vessel pulses, which improves the durability of the anastomosis. The AnastoClip AC and AnastoClip GC closure systems also enable dura closure in neuro applications. Ovine Vascular Grafts The company’s Omniflow II biosynthetic vascular graft is a composite of cross-linked ovine collagen with a polyester mesh endoskeleton. It is indicated for lower extremity bypass and dialysis access. This device is not available in the United States. Polyester Vascular Grafts The company’s AlboGraft, Wovex and Dialine II vascular grafts are collagen-impregnated polyester grafts used to bypass or replace diseased arteries. These prostheses are available in straight tube and bifurcated versions. ePTFE Vascular Grafts The company’s LifeSpan ePTFE vascular graft is an expanded polytetrafluoroethylene (ePTFE) graft used to bypass or replace diseased arteries and to create dialysis access sites. LifeSpan is available in both regular and thin wall options with optional full or partial external spiral support. The company’s stepped and tapered LifeSpan grafts are designed to reduce the risk of steal syndrome and high cardiac output, complications that sometimes arise in dialysis access grafts. Radiopaque Tape The company’s VascuTape radiopaque tape is a flexible, medical-grade tape with centimeter or millimeter markings printed with a proprietary radiopaque ink which is visible to the eye and an x-ray machine or fluoroscope. VascuTape is applied to the skin and provides interventionalists with a simple way to cross-reference between the inside and the outside of a patient’s body, allowing them to locate tributaries or lesions beneath the skin. Valvulotomes The company’s valvulotomes cut or disrupt valves in the saphenous vein, a vein that runs from the foot to the groin, so the vein can be repurposed as an artery to carry blood past diseased arteries to the lower leg or foot. The company’s valvulotomes reduce costs for hospitals by enabling lower extremity bypass surgery to be performed with several small incisions rather than one continuous ankle-to-groin incision, thereby reducing hospital stays and the likelihood of wound complications. Sales and Marketing As of December 31, 2022, the company’s sales force was consisted of 131 sales representatives in North America, Europe and the Asia Pacific, including two export managers. Approximately 94% of 2022 net sales occurred in territories in which it employs sales representatives. Outside its direct markets, the company sells its products through country-specific distributors. Strategy The key elements of the company's strategy include pursuing a focused call point, competing for the sale of low-rivalry, niche products, and expanding its worldwide direct sales force, while acquiring and, to a lesser extent, developing complementary devices. The company’s strategy is to transfer the manufacturing of most acquired lines into its Burlington operations. Manufacturing and Processing Most of the company’s components are readily available from several supply sources, but it does rely on single- and limited-source suppliers for several of its key product components and its third-party-manufactured products, most notably the purchase of CardioCel and VascuCel devices from Anteris Technologies Ltd (Anteris) in Malaga, Australia. Competition The company competes with a range of companies. Notable larger competitors include Abbott; Baxter International, Inc.; Artivion, Inc.; Becton; Dickinson and Company; Cardiovascular Systems, Inc.; Edwards Lifesciences Corporation; Getinge; LifeNet Health; Silk Road Medical, Inc; Terumo Medical Corporation; and W. L. Gore & Associates. Intellectual Property The company maintains a limited portfolio of patents in the United States, and its issued U.S. patents are set to expire from 2023 to 2031. Some of the company’s registered trademarks are LeMaitre, Artegraft, XenoSure, Pruitt, VascuTape, Glow ‘N Tell, and RestoreFlow, each of which is registered in the U.S., the European Union (EU), or both, and in certain cases in other foreign countries. Research and Development For the year ended December 31, 2021, the company’s research and development expenses were $13.3 million. Government Regulation Most of the company’s products are medical devices subject to extensive regulation by the FDA under 21 U.S. Code Chapter 9, the Federal Food, Drug, and Cosmetic Act (the FDCA). The company is subject to inspection and marketing surveillance by the FDA to determine its compliance with regulatory requirements. The company’s allografts are subject to extensive regulation by the FDA under Title 21 of the Code of Federal Regulations, Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products). These regulations were promulgated under Section 361 of the Public Health Service Act, which authorized the FDA to issue regulations to prevent the spread of communicable disease. The company voluntarily complies with the standards of the tissue bank industry’s accreditation organization, the American Association of Tissue Banks (the AATB). The EU has adopted numerous directives and standards relating to medical devices regulating their design, manufacture, clinical trials, labeling, and adverse event reporting, including the Medical Devices Directive (93/42/EEC) (MDD), and more recently, the Medical Device Regulation (MDR), which are applicable to the company’s products. The company’s products are regulated in the EU under the European MDD and the MDR. In order to market the company’s medical devices in the EU, it is required to obtain CE mark certifications, which denote conformity, and manufacturers of higher-risk devices generally must use a ‘Notified Body’—an appointed independent third party to assess conformity. As a holder of Canadian device licenses, the company is subject to inspection by Health Canada (HC) at its Vaughan, Canada office, and it must maintain a valid Medical Device Single Audit Program (MDSAP) certificate. As a holder of Japanese device licenses, the company is also subject to inspection by several Japanese authorities, including Japan’s Pharmaceutical and Medical Device Agency (PMDA), Tokyo Metropolitan Government (TMG), and third parties, such as Japan’s Electrical Safety & Environmental Technologies Laboratories (JET). As a holder of Australian device licenses, the company is also subject to inspection by Therapeutic Goods Administration (TGA) in both Australia and the United States. The company’s licenses are managed on its behalf by its sponsor, Emergo Group. As a holder of Chinese device licenses, the company is subject to inspection by the National Medical Products Administration (NMPA) in both China and the United States. Under the PPACA, the company is subject to the Physician Payments Sunshine Act, which was enacted as part of the Patient Protection and Affordable Care Act (the PPACA). History The company was founded in 1983. It was incorporated in Massachusetts in 1983 as Vascutech, Inc. In 1998, the company was reincorporated in Delaware. The company changed its name to LeMaitre Vascular, Inc. in 2001.