KENSEY NASH CORP

KENSEY NASH CORP

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Company Overview
Kensey Nash Corporation is a medical device company and a pioneer in the development of a wide variety of products for the cardiovascular, endovascular, sports medicine, spine and trauma marketplaces. The company traces its beginnings to 1984 with its first two employees being co-founders John Nash and Kenneth Kensey, M.D. It has its registered office address in Exton, Pennsylvania.
Kensey Nash is a leading developer and manufacturer of resorbable medical implants. Its capabilities and expertise have enabled them to develop relationships with several major medical device companies to whom the company provide many hard and soft tissue repair products. The company’s product brands are Angio-Seal, ThromCat, HeliFlex, QuickCat, and Safe-Cross.
Kensey Nash provides a range of products into multiple medical markets, primarily in the cardiovascular, sports medicine and spine markets. It has invented the angio-seal vascular closure device (angio-seal), a device designed to seal and close femoral artery punctures made during diagnostic and therapeutic cardiovascular catheterizations.
The company is committed to bringing to the marketplace new and exciting medical products to improve quality of life and reduce healthcare costs.
Business Summary
Kensey Nash Corporation is a medical device company primarily focused in the field of regenerative medicine, which is the application of devices, materials and other therapies to help repair damaged or diseased tissues. The Company has a range of products, which are sold through strategic partners in multiple large medical markets, including cardiology, orthopaedic, sports medicine, spinal and general surgery. It also has an ongoing development and manufacturing program for products in the endovascular market. During the fiscal year ended June 30, 2010 (fiscal 2010), the Company manufactured and sold over 4.5 million resorbable product units representing approximately 230 commercialized products, to strategic partners and customers. The Company’s Optrix process allows it to manufacture extracellular matrix (ECM) products.
Description and history
Kensey Nash Corporation, incorporated on August 6, 1984, is a medical device company primarily focused in the field of regenerative medicine, which is the application of devices, materials and other therapies to help repair damaged or diseased tissues. The Company has a range of products, which are sold through strategic partners in multiple large medical markets, including cardiology, orthopaedic, sports medicine, spinal and general surgery. It also has an ongoing development and manufacturing program for products in the endovascular market. During the fiscal year ended June 30, 2010 (fiscal 2010), the Company manufactured and sold over 4.5 million resorbable product units representing approximately 230 commercialized products, to strategic partners and customers.

The Company’s Optrix process allows it to manufacture extracellular matrix (ECM) products. Its ECM product, Medeor Matrix, made from porcine dermis (pigs skin), received 510(k) clearance from the United States Food and Drug Administration (FDA) in October 2009, and CE Mark approval in April 2010. In May 2010, its second ECM product, the Meso BioMatrix product, which is made from porcine-mesothelium (Meso) tissue (derived from the abdominal wall of a pig), received 510(k) clearance from the FDA. During fiscal 2010, Kensey Nash Corporation announced two strategic porcine dermis ECM agreements, one with Synthes, and the other with Arthrex. Synthes launched the XCM Biologic Tissue Matrix, the first commercial Medeor Matrix product, initially focused on ventral hernia repair and breast reconstruction, in the United States in May 2010.

The Company focuses on commercializing a range of products used in the orthopaedic markets, including the sports medicine and spinal markets, and supporting the Angio-Seal product line in the vascular closure market. The Company has commercialized a variety of products for the orthopaedic applications of biomaterials. Applications in the orthopaedic market for its biomaterials products include soft tissue and bone fixation, bone void fillers and scaffolds. Many of its biomaterials products are designed to replace metallic devices used in the fixation and repair of musculoskeletal tissues.

The primary application for its biomaterials in the sports medicine arena is soft tissue fixation. Soft tissue fixation includes the repair of tendons and ligaments in the knee, such as the anterior cruciate ligament; in the shoulder, such as the rotator cuff; and in the extremities. Kensey Nash Corporation manufactures products, such as suture anchors, interference screws and reinforcement materials for all of these applications from resorbable synthetic polymers and synthetic polymer/ceramic composites. It also manufactures pins, plates and screws of various designs for repair of the small bones of the extremities, for certain applications in the spine, and for other orthopaedic trauma applications. Key customers of these products include Arthrex and Stryker.

The Company has developed or co-developed several different bone void fillers, essentially synthetic bone graft substitutes, for use in various clinical applications. It has fabricated these products from collagen, collagen/ceramic composites, synthetic polymers and synthetic/ceramic composite biomaterials. Key customers of these products include Orthovita, Medtronic, Zimmer and Johnson & Johnson. It has developed the original Angio-Seal device, a vascular closure device, and manufactured two of the key resorbable components of the Angio-Seal device for St. Jude Medical.

The Company commercialized with its partner, Synthes, its ECM product, a porcine dermis surgical mesh used for abdominal wall reconstruction, breast reconstruction and select head and neck plastic surgery repair. The Company develops, manufactures and sells a variety of biomaterials-based products designed for other market applications. These products include dental barrier membranes and resorbable materials used in ophthalmology and oncology applications.

Kensey Nash Corporation sells its biomaterials products to over 30 companies that ultimately sell them into the end-user marketplace. Its biomaterials customers include St. Jude Medical, to which it supplies Angio-Seal components; Arthrex, to which it supplies a broad range of sports medicine and trauma products; and Orthovita, to which it supplies products for use in repair of spinal and orthopaedic trauma injuries. It also supplies biomaterials products and development expertise to other orthopaedic companies including, BioMimetic Therapeutics, Johnson & Johnson, Medtronic, Stryker, Synthes and Zimmer. In August 2009, the Company entered into a strategic agreement with Synthes to market and distribute its porcine dermis-based ECM products for select reconstructive surgical applications. In June 2010, it announced a second strategic distribution agreement for its ECM products with Arthrex for rotator cuff and other tendon repair procedures.

The Angio-Seal device is a biomaterials-based product which acts to close and seal femoral artery punctures made during diagnostic and therapeutic cardiovascular catheterizations. The Angio-Seal device consists of products developed for the purpose of closing and sealing of femoral artery punctures made during cardiovascular catheterizations. Other treatment options include manual pressure and device based therapy. The Angio-Seal technology is licensed to St. Jude Medical, which manufactures, markets and sells the Angio-Seal device worldwide. Under its license agreement, St. Jude Medical has exclusive worldwide rights to manufacture, market and distribute the patented Angio-Seal device for hemostatic puncture closure. It retains the rights to use this technology for applications outside the cardiovascular system.

The Company competes with Abbott Laboratories, Inc., Access Closure, Inc., Arstasis, Inc., Johnson & Johnson, Kinetic Concepts, Inc., Covidien, C.R. Bard Medical, Cook Medical and Wright Medical.

Traces its beginnings with its first two employees being co-founders John Nash and Kenneth Kensey, M.D.

Business Line
A medical device company and a pioneer in the development of a wide variety of products for the cardiovascular, endovascular, sports medicine, spine and trauma marketplaces
Subsidiary
ILT ACQUISITION SUB INC.
Advisor
DELOITTE & TOUCHE LLP
IPO date
10/1995
US SIC Code
3841
Company Address
735, Pennsylvania Drive

City province or state postal code
19341, EXTON, PA
Phone: +1 484 713 2100
Fax: +1 484 713 2900
Country address: UNITED STATES OF AMERICA
Website url: www.kenseynash.com