New Agreement Strengthens Codman Neuro Position in
Fast Growing Intermediate Catheter Segment of Neurovascular Market
BOSTON – JULY 25, 2016 – Codman Neuro*, part of DePuy Synthes Companies of Johnson & Johnson, has entered into an agreement with InNeuroCo, Inc. for exclusive U.S. and European distribution rights for intermediate catheters that enable minimally invasive treatment of hemorrhagic stroke. The announcement was made here at the Society of NeuroInterventional Surgery (SNIS) 13th Annual Meeting.
The agreement includes the InNeuroCo Intermediate Catheter (IC) and the InNeuroCo Super Distal Access (SDA) device. The InNeuroCo IC, which has already received regulatory approval in the U.S. and Europe, has shown optimized tracking during insertion.1 The InNeuroCo SDA is pending U.S. FDA 510 (k) clearance. The catheters will be offered alongside the full line of Codman Neuro microcatheters and guiding catheters, which support the delivery of neurovascular products including the CODMAN ENTERPRISE® 2 Vascular Reconstruction Device.
“Intermediate catheters are increasingly used by neurovascular specialists to facilitate the delivery of other devices, including stents and thrombectomy devices for the treatment of stroke,” said P. Laxmin Laxminarain, Worldwide President of Codman Neuro. “This agreement with InNeuroCo demonstrates our commitment to neurovascular care and will help us strengthen our access portfolio and our ability to provide a total solution in this fast growing market.”
InNeuroCo, Inc. is a privately held, Florida-based company that develops and manufactures neurovascular products for hemorrhagic stroke (aneurysms).
According to the Centers for Disease Control and Prevention (CDC), stroke is the fifth leading cause of death in the United States and is a major cause of adult disability. About 800,000 people have a stroke each year and one American dies from a stroke every four minutes. The American Stroke Association estimates 3 to 5 million people in the United States have some form of brain aneurysm, though most do not produce any symptoms. However, between 0.5 and 3 percent of people with a brain aneurysm may suffer from bleeding and rupture and require treatment.3
The CODMAN ENTERPRISE Vascular Reconstruction Device and the CODMAN ENTERPRISE 2 Vascular Reconstruction Device are Humanitarian Use Devices approved by the FDA under a Humanitarian Device Exemption (HDE) in the United States Only, where it is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤4 mm. Wide-neck is defined as having a neck width ≥4 mm or a dome-to-neck ratio <2.
About DePuy Synthes Companies
DePuy Synthes Companies of Johnson & Johnson provides the most comprehensive orthopaedic and neurological solutions in the world. The company offers an unparalleled breadth of products, services, programs and research and development capabilities. DePuy Synthes Companies’ solutions in the specialties of joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information visit, www.depuysynthes.com.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding expected benefits of a distribution agreement. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Codman Neuro, DePuy Orthopaedics, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the DePuy Synthes Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
The third party trademarks used herein are the trademarks of their respective owners.
*A division of DePuy Orthopaedics, Inc.
©Codman Neuro, a division of DOI 2016. All rights reserved.
1. Codman Neuro, Data on File: Market Preference Case Evaluation.
2. http://www.cdc.gov/stroke/ accessed - May 2016
3. http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/HemorrhagicBleeds/What-You-Should-Know-About-Cerebral-Aneurysms_UCM_310103_Article.jsp#.Vz9MO2NllBy; - accessed May 2016.