CODMAN NEURO TO BE EXCLUSIVE DISTRIBUTOR OF MINIMALLY INVASIVE,
WIDE-NECK ANEURYSM RECONSTRUCTION DEVICE
Company Gains Exclusive Rights from Pulsar Vascular to
Market and Promote PulseRider® in Europe, the Middle East and Africa
NICE, FRANCE – September 5, 2014 – Codman Neuro*, part of DePuy Synthes Companies of Johnson & Johnson, today announced it has reached an exclusive distribution agreement with Pulsar Vascular to market and promote that company’s PulseRider® in Europe, the Middle East and Africa. PulseRider® is a minimally invasive device intended for use with embolic coils in the treatment of unruptured wide-neck intracranial aneurysms originating on or near a bifurcation. The device received initial CE Mark approval in Europe in late 2013. The agreement was entered into by one of Codman Neuro’s EU affiliated companies.
The announcement was made at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress. This distribution agreement marks the latest expansion of Codman Neuro’s neurovascular portfolio, which includes a wide range of products for hemorrhagic and ischemic stroke, cerebral aneurysms and other neurovascular and neurological diseases and conditions. PulseRider® is a self-expanding nitinol implant that is used in conjunction with embolic coils to bridge the neck of cerebral aneurysms.
“We are excited about this new agreement with Pulsar Vascular and the greater access physicians and their patients in Europe will now have to a potentially lifesaving endovascular procedure,” said P. Laxmin Laxminarain, Worldwide President of Codman Neuro. “There is a significant unmet clinical need in the treatment of unruptured, wide-neck bifurcation aneurysms, and we hope to help fill it with this innovative device.”
According to the Brain Aneurysm Foundation, cerebral aneurysms claim nearly 500,000 lives worldwide each year and half the victims are younger than 50. Many of these aneurysms develop in vascular bifurcations, which may be difficult to treat with conventional devices.
“Repairing wide-neck intracranial aneurysms is a challenging endovascular procedure and treatment options are extremely limited,” said Professor Monika Killer-Oberpfalzer**, Paracelsus Medical University Salzburg, Austria. “We welcome technology specifically designed to enhance our ability to treat these complex aneurysms more easily with less risk in the hope that more lives can be saved.”
PulseRider® is limited to investigational use only in the United States and has not been approved by the U.S. Food and Drug Administration (FDA) for distribution. Pulsar Vascular, the developer of PulseRider®, is a privately-held San Francisco Bay-area neurovascular company founded by Sanderling Ventures.
About Codman Neuro
Codman Neuro is a global neurosurgery and neurovascular company that offers a broad portfolio of devices for hydrocephalus management, neuro intensive care and cranial surgery, as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Codman Neuro is part of DePuy Synthes Companies of Johnson & Johnson. Visit www.codman.com and www.depuysynthes.com for more information.
*Codman Neuro is a division of DePuy Orthopaedics, Inc.
**Dr. Killer-Oberpfalzer is a paid consultant for Codman Neuro
The third party trademarks used herein are trademarks of their respective owners.
NOTE TO INVESTORS
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 DePuy Orthopaedics, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the ability to successfully market and promote the PulseRider®; competitive developments, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to regulations and domestic and foreign health care reforms; and general industry conditions, including 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 December 29, 2013, 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. Neither DePuy Orthopaedics, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)