Codman Neuro Announces Acquisition Of Neuravi Limited To Accelerate Innovation In Acute Ischemic Stroke Therapy

Second Acquisition in Months Demonstrates Commitment to Addressing Unmet Needs in Stroke

IRVINE, Calif. -- Codman Neuro today announced the acquisition of Neuravi Limited, a privately held Irish company dedicated to advancing neurovascular therapies and improving clinical outcomes for acute ischemic stroke patients. This acquisition, and the recent acquisition of Pulsar Vascular Inc., demonstrates the company's strong commitment to delivering innovative products for stroke therapy and complements its comprehensive portfolio of products for hemorrhagic and ischemic stroke. DePuy Ireland Unlimited Company, an affiliate of Codman Neuro, is the acquiring entity. Financial terms of the transaction were not disclosed.

Founded in 2009, Neuravi has invested extensively in scientific research on the varieties of clots that cause acute ischemic stroke, and has translated learnings into its EmboTrap® Revascularization Platform. The EmboTrap® device is engineered to restore blood flow to the brain by retrieving a clot with its proprietary dual-layer stent-like structure, and it has already been used to treat over 3,000 patients in Europe.

Globally, stroke is the second leading cause of death after the age of 601, and ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes.2 According to the European Journal of Neurology, the number of stroke events in Europe is projected to rise from 1.1 million in 2000 to 1.5 million per year by 20253, while the American Heart Foundation estimates someone dies of a stroke every 4 minutes.4 In the U.S. alone, the economic burden of stroke is estimated at $33 billion annually, including the cost of health care services, medications, and lost productivity.5

"Rapid restoration of flow is of utmost importance when treating stroke patients," said Shlomi Nachman, Company Group Chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. "The EmboTrap® platform was designed to address this critical need and we are excited to combine Neuravi's expertise in clot research with Codman Neuro's global resources to accelerate innovation in acute ischemic stroke treatment."

The EmboTrap and EmboTrap II Revascularization Devices are commercially available in Europe and has been available in the U.S. for investigational use only under the ARISE II clinical trial, which will support a U.S. Food and Drug Administration (FDA) submission planned for later this year.

About Codman Neuro
 

Codman Neuro is a global neurosurgery and neurovascular business 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. Visit www.codman.com for more information.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of Neuravi Limited and anticipated market expansion of Neuravi Limited's technology and products. 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 Ireland Unlimited Company and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges related to integrating the products and employees of Neuravi Limited, as well as the ability to ensure continued performance or market growth of its products; the potential that the expected benefits and opportunities related to the transaction may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of obtaining regulatory approvals; challenges to patents; competition, including technological advances, new products and patents attained by competitors; 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; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and descriptions 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 1, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," 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 Ireland Unlimited Company nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1 World Heart Federation http://www.world-heart-federation.org/cardiovascular-health/stroke/
2 Stroke Facts, Centers For Disease Control and Infection https://www.cdc.gov/stroke/facts.htm
3 Truelsen T, Piechowski-Jozwiak B, Bonita R et al. Stroke incidence and prevalence in Europe: a review of available data. European Journal of Neurology, 2006, 13: 581–598
4 Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association http://circ.ahajournals.org/content/135/10/e146#sec-2
5 Centers for Disease Control https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/docs/fs_stroke.pdf

Neuravi Announces Completion of Patient Enrollment in Clinical Trial of a Novel Stent Retriever for Acute Ischemic Stroke

ARISE II Data Will Be Submitted to the FDA in Support of Market Clearance for EmboTrap in the U.S.

Galway, Ireland - Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced completion of enrollment in the company’s international clinical trial assessing the safety and effectiveness of the EmboTrap®II Revascularization Device, an advanced stent retriever platform for the treatment of acute ischemic stroke.   

Data from the pivotal study, called ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap), will be submitted as part of an application to U.S. Food and Drug Administration (FDA) for market clearance of the device in the United States.

The ARISE II study enrolled 228 patients in 19 enrolling sites across the United States and Europe.  Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital in Toledo, Ohio, is the study’s principal investigator.  Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden, is the European principal investigator of the study.

“The value of stent retrievers has been demonstrated by multiple positive trials. Now our focus has moved on to further refinements of mechanical thrombectomy that will yield better patient outcomes,” said Dr. Zaidat. “International cooperation has been excellent. I’m excited to be a part of the process to provide physicians and patients in the United States with access to the latest technology.” 

The study enrolled ahead of schedule, with enrollment led by Dr. Hormozd Bozorgchami’s team at Oregon Health Sciences University in Portland and Dr. Marc Ribo’s team at Vall d’Hebron in Barcelona. 

 “Evaluating new technology is an important part of advancing stroke treatment and we are enthusiastic about our experience in the ARISE II trial,” said Raul Nogueira, M.D., director of Neuroendovascular Service at Grady Memorial Hospital at Emory University in Atlanta, where the final U.S. patient was enrolled. “As we continue to learn more about the clots that cause stroke, it is important that we have the best tools available to treat those occlusions.”     

The EmboTrap platform is designed to restore blood flow to the brain by retrieving and retaining clot with a proprietary dual-layer stent-like structure. 

“We’d like to thank the stroke center teams in the United States and Europe for their dedication and commitment to the ARISE II trial. In fully enrolling the ARISE II clinical trial, we are building a strong data set in support of our EmboTrap device as well as adding to the broader pool of stent retriever thrombectomy data for stroke treatment,” said Eamon Brady, Neuravi CEO. “Our vision is to be the therapy leader in acute ischemic stroke intervention and we will continue to develop innovative therapy solutions to advance patient care.”

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability. Approximately one million Europeans and 700,000 Americans suffer ischemic strokes each year. 

About Neuravi
Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s stroke therapy platform, the EmboTrap®II Revascularization Device, is CE marked and commercially available in Europe.   The device has been available for investigational use only in the United States.   Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

 

 
Media Contact:
Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com
 
 

Neuravi Secures €15 Million to Fund Expansion

Financing Will Support U.S. Commercialization and Broaden the Company’s Product Offering for Stroke Treatment

 

Galway, Ireland – Neuravi, a company dedicated to better clinical outcomes for stroke patients, today announced €15 million in venture debt financing from IPF Partners, a leading alternative financing provider focused on the healthcare sector.
 
This financing allows Neuravi to invest in U.S. commercialization and stroke treatment portfolio expansion, building upon successful commercialization of the company’s EmboTrap® Revascularization Device in Europe and rapid progress enrolling the ARISE II U.S. pivotal study.
 
Landmark acute stroke clinical trials published in 2014 and 2015 demonstrating the superiority of stent retriever technology in treating large vessel strokes have driven a surge in the number of stent retriever procedures. Based on extensive physician engagement and Neuravi’s groundbreaking work on the science of clot, Neuravi has built a strong pipeline of products focused exclusively on acute ischemic stroke and intends to commercialize this pipeline globally in the years ahead.
 
“With the recent European launch of the EmboTrap II device and the excellent progress in enrolling our pivotal clinical trial, we are making significant headway in delivering next-generation technology for stroke treatment to physicians. This financing allows us to build our commercial presence in the U.S. and further invest in R&D for our exciting product pipeline,” said Eamon Brady, Neuravi CEO. “We see significant innovation opportunity due to the under-developed stroke treatment ‘toolbox’ available to stroke clinicians today. Our vision is to design and build devices that truly address the needs of acute stroke patients and put them in the hands of stroke physicians all over the world. This funding is an important step on our roadmap.”
 

About EmboTrap
The EmboTrap Revascularization Device is engineered to restore blood flow to the brain by retrieving clot with a proprietary dual-layer stent-like structure. The device’s integrated distal protection zone is designed to reduce the risk of clot fragmentation during retrieval, which could cause additional harm to the patient.  The EmboTrap II Revascularization Device is available in Europe to treat patients with acute ischemic stroke. The EmboTrap is currently available for investigational use only in the U.S. under the ARISE II clinical trial, which will support a U.S. Food and Drug Administration (FDA) submission for approval to market the device in the United States. 
 

About Neuravi
Neuravi designs, develops and manufactures innovative medical devices for the treatment of acute ischemic stroke. Through the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to improve patient outcomes in stroke by deepening the understanding of the science of clot and occlusions.  Neuravi is exclusively focused on acute ischemic stroke.  More information can be found at www.neuravi.com.
 

IPF Partners
IPF Partners, based in Luxembourg, is a leading alternative financing provider focused on the healthcare sector. IPF invests directly in emerging pharma/biotech, medtech and diagnostics companies. Founded in 2011 by a seasoned multi-disciplinary team combining over fifty years of finance and investment and over thirty years of healthcare experience, IPF has developed a unique business model using the team’s specialist sector knowledge to provide bespoke, long-term financing. For more information visit www.ipfpartners.com.
 

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Media Contact:
Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com

Neuravi Announces European Launch of EmboTrap II Stent Retriever for the Treatment of Acute Stroke

Advancements to Stent Retriever Platform Designed to Enhance Procedure

GALWAY, Ireland--(BUSINESS WIRE)--Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced Conformité Européenne (CE) Mark approval and launch of the company’s newly available enhancements to the EmboTrap stent retriever platform, the EmboTrap® II Revascularization Device.

Adoption of endovascular stroke therapy procedures for the treatment of acute ischemic stroke continues to grow significantly following compelling data from multiple large-scale randomized trials last year. These trials confirmed the value of using stent retriever thrombectomy to rapidly clear occlusive clots from large cerebral vessels.

The novel EmboTrap was fully commercialized in Europe last year, and with the introduction of the EmboTrap II, Neuravi is bringing further innovation to the market. The new device leverages the EmboTrap platform design, engineered to trap and remove a variety of clot types and rapidly re-establish flow, with an integrated fragment protection zone. The EmboTrap II device is designed to address a broader range of clot lengths, with sizes that are deliverable through an 0.021” microcatheter.

“The EmboTrap platform has been a great addition to my clinical practice. In my first nine cases using the device, I was able to get TICI 2b-3 reperfusion in one pass. Now with the EmboTrap II, I’ve had comparably good results when treating longer occlusions,” said Christian Taschner, M.D., professor of Radiology, University of Freiburg, Germany. “In fact, in early evaluations of the EmboTrap II 5x33 at six centers, 16 of 17 cases resulted in TICI 2b-3 flow. The open design of the device helps trap clot inside and also makes it quite flexible, which is important when removing clot from the arteries of the brain.”

“Neuravi is committed to ongoing research to deepen our understanding of the science of clot and to find new ways to advance stroke therapy. As the company continues to gain new insights into clot-device interaction, that learning informs ongoing innovation. We believe this scientific approach not only improves our technology to make it better and easier to use for physicians, but will also maximize clinical benefits for patients,” said Eamon Brady, CEO of Neuravi. “We are extremely happy with the clinical reception to date of the EmboTrap II and look forward to offering the technology more broadly to physicians over the next few months.”

Neuravi will be introducing the system at the 8th annual Congress of the European Society of Minimally Invasive Neurological Therapy in Nice, France, from September 8 to 10, 2016.

The EmboTrap and EmboTrap II revascularization devices are available in Europe to treat patients with acute ischemic stroke. The EmboTrap is currently available for investigational use only in the U.S. under the ARISE II clinical trial, an international clinical trial assessing safety and effectiveness in the United States and Europe. Data from the trial will support a U.S. Food and Drug Administration (FDA) submission for approval to market the device in the United States.

About Neuravi

Neuravi designs, develops and manufactures innovative medical devices for the treatment of acute stroke. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics to improve patient outcomes in stroke. More information can be found at www.neuravi.com.

Contact
Neuravi
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com

Neuravi Selects Robert Colloton to Lead U.S Commercialization of Innovative Stent Retriever

Veteran Medtech Executive Brings Deep Neurovascular, Sales and Marketing Experience
 
Galway, Ireland — 25 July, 2016 — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced that Robert Colloton has joined the company’s senior management team as vice president of U.S. Sales and Marketing.
 
Colloton brings 25 years of experience in medical device sales and market development and branding expertise, with a deep understanding of the neurovascular market in particular. Most recently, he was vice president of Marketing and Sales at Revision Optics. Previously, he served as vice president of Global Sales and Marketing at Micrus Endovascular, where he built the sales team and grew the business to become a leading player in aneurysm therapy. He also held senior leadership positions in sales and marketing at VNUS Medical, TransVascular, Inc., and Cardiometrics. 
 
“We are excited to bring our unique stroke therapy to physicians in the United States. Enrollment in our ARISE II clinical study of the EmboTrap Revascularization Device is progressing ahead of our plan, so this is the right time for Neuravi to invest in building the leadership team for our U.S. program,” said Eamon Brady, CEO. “Bob truly understands this market and the needs of the neurointerventionalists, and he shares our passion for delivering value and striving for excellence. We are thrilled to welcome him to the Neuravi family.”    
 
“I’m eager to be re-entering the neurovascular market, especially at this exciting time of tremendous growth in acute ischemic stroke treatment,” said Colloton. “Neuravi is a dynamic, innovative company that made the gutsy decision early on to take the time to invest in understanding the science of the clots that cause strokes before developing a solution. I’m inspired by the dedication of the team, and I look forward to working with neurointerventionalists to help advance stroke treatment for patients in the U.S.”
 
The design of Neuravi’s EmboTrap® Revascularization Device is informed by extensive research on the wide range of different clot types that cause ischemic stroke. With this foundation of research, the EmboTrap platform is engineered to restore blood flow to the brain by retrieving and retaining clot with a proprietary dual-layer stent-like structure. The device’s integrated distal protection zone is designed to reduce the risk of clot fragmentation during retrieval, which could cause additional harm to the patient.

The ARISE II study is an international clinical trial assessing the safety and effectiveness of EmboTrap, and it will enroll 210 patients in up to 30 sites across the United States and Europe. Data from the trial will support a U.S. Food and Drug Administration (FDA) submission for approval to market the device in the United States. 
 
Adoption of endovascular stroke therapy procedures is growing significantly since compelling data from multiple large-scale randomized trials last year confirmed the value of using stent-retriever thrombectomy to rapidly clear occlusive clot from large cerebral vessels.     
 
The EmboTrap Revascularization Device is available in Europe to treat patients with acute ischemic stroke. The EmboTrap is currently available for Investigational Use Only in the U.S. under the ARISE II clinical trial.
 
 

About Neuravi
Neuravi designs, develops and manufactures innovative medical devices for the treatment of acute stroke.  Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics to improve patient outcomes in stroke. More information can be found at www.neuravi.com.
 
 

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Media Contact:
Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com

Neuravi Strengthens Patent Portfolio for Novel Stent Retrievers with Newly Issued U.S. and European Patents

Galway, Ireland — 3 May, 2016 — Neuravi, a developer of innovative, minimally invasive stroke therapy solutions, announced today that the U.S. Patent and Trademark Office (USPTO) has approved a patent providing additional coverage of the company’s therapeutic stent-retriever platform for the endovascular treatment of acute ischemic stroke. Earlier this year, Neuravi also received a European patent grant for this platform.

The Neuravi intellectual property estate now extends to 63 U.S. filings, 34 granted patents, one notice of allowance, and 28 pending applications. Outside the United States, Neuravi has multiple pending applications with the European Patent Office, in China and Japan, and internationally under the Patent Cooperation Treaty.

“Neuravi is committed to innovation that improves clinical outcomes,” said David Vale, chief technology officer, Neuravi. “Our extensive patent portfolio has early priority dates and we continue to strengthen it with key features important to stent-retriever performance.  We will continue to invest in technology and in clot research to help address the challenges of treating acute ischemic stroke. ”

The design of Neuravi’s EmboTrap® Revascularization device was informed by extensive research on the wide range of different clot types that cause ischemic stroke. Insights from this clot research have added significant value to the innovation process, enhancing the proprietary design of both the EmboTrap and future Neuravi devices in development.

The EmboTrap Revascularization Device is available in Europe to treat patients with acute ischemic stroke.  The EmboTrap is not currently approved in the U.S., where it is available for investigational use only in the ARISE II clinical trial.

About Neuravi

Neuravi designs, develops and manufactures innovative medical devices for the treatment of acute stroke.  Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics to improve patient outcomes in stroke. More information can be found at www.neuravi.com.

Media Contact:

Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com

Neuravi Announces Meeting of World Stroke Leaders at Inaugural Clot Summit 2015

Galway, Ireland - The world’s first Clot Summit was held in Heidelberg, Germany, last week, chaired by Werner Hacke, MD, PhD, senior professor of Neurology at the University of Heidelberg Medical School, an eminent leader in the field of stroke.

The meeting was attended by internationally renowned clinicians from 12 countries, including many who played leadership roles in the recent positive clinical trials for endovascular stroke therapy, together with engineers and scientists focused on various areas of research in clot and acute stroke. The purpose of the multidisciplinary gathering was to identify ways to further advance the field of stroke therapy and improve patient care, with a focus on the main culprit in ischemic stroke – the clot that causes the occlusion. The summit’s design emphasized collaboration and cross-fertilization of ideas from clinicians, academics and engineers.

“This gathering of experts provided a valuable exchange of ideas and knowledge, and I am grateful for the opportunity to learn from respected colleagues in the field,” Prof. Hacke said. “The summit was well received, with attendees expressing interest in further interdisciplinary research on clot to improve stroke intervention and patient outcomes.”

During the summit, Neuravi presented insights gained from five years of the company’s pioneering research on the mechanical characteristics of clot and acute stroke occlusion dynamics.

“Understanding the science of occlusions is fundamental to Neuravi’s interest in advancing stroke therapy, and having the opportunity to collaborate with a diverse group of experts greatly enriches the process of discovery and learning. We are delighted with the success of the inaugural Clot Summit,” said Eamon Brady, CEO of Neuravi. “Through the Neuravi Thromboembolic Initiative (NTI), we will continue to pursue research, facilitate discussions, and build collaborations to deepen the understanding of the role of clot in acute stroke.”

“Thrombectomy has been proven as the best treatment for large vessel occlusive stroke, and now it is time to better understand clot in order to further advance care. This summit has contributed greatly to that discussion,” said Diederik Dippel, MD, PhD, senior consultant in the Department of Neurology at the Erasmus Medical Center in Rotterdam, the Netherlands and lead investigator of the MR CLEAN trial.

Raul Nogueira, MD, director of Neuroendovascular Service and Neurocritical Care at Grady Memorial Hospital in Atlanta, Georgia, also recognized the need for better clot science. “It is up to us to continue to push the envelope to further improve stroke care so that even more patients will benefit. I strongly believe that one of the best ways to do this is to build a better understanding of clot and occlusions.”

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

Neuravi Announces First Patient Treated in International Pivotal Clinical Trial of Novel Stent Retriever for Acute Ischemic Stroke

Data from ARISE II Will Be Submitted to FDA in support of Market Clearance for EmboTrap in the U.S.

Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, announced today that the Tennessee Interventional and Imaging Associates at Erlanger Medical Center in Chattanooga, Tenn., have treated the first patient in an international clinical trial assessing safety and effectiveness of the EmboTrap® Revascularization Device, a novel stent retriever for the treatment of acute ischemic stroke. Data from the pivotal study, called ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap), will be submitted as part of an application to U.S. Food and Drug Administration (FDA) for approval for the device.

The ARISE II study will enroll 210 patients in up to 25 sites across Europe and the United States. Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital, Toledo, Ohio and Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden are the U.S. and European principal investigators of the study. Neurologists Jeff Saver, M.D., of UCLA Medical Center in Los Angeles, Calif. and Heinrich Mattle, M.D., of Inselspital in Bern, Switzerland, serve on the study’s initiating Executive Steering Committee.

“Stroke care has entered a new age. Now that multiple trials have demonstrated the value of endovascular therapy for treating acute ischemic stroke, we are looking for ways to further improve patient care through new technology, better techniques, and streamlined systems,” stated Dr. Zaidat. “The ARISE II trial is the first IDE clinical trial to evaluate innovative stent retriever technology in this new era for stroke.”

The Southeast Regional Stroke Center at Erlanger Medical Center was the first of the ARISE II sites to treat a patient as part of the trial. The center is a Joint Commission-certified Comprehensive Stroke Center that has played a leadership role in international clinical trials for stroke treatment.

“We are pleased to treat the first patient in this international trial of a cutting edge technology that may offer advantages over currently available devices,” said Blaise Baxter, M.D., chief of radiology at Erlanger. “Evaluating new technology with the goal of improving patient outcomes is all part of our effort to deliver the best patient care possible. ”

Following a stroke, rapid intervention is critical. Recent highly positive multinational clinical trials have demonstrated the benefit of acute endovascular intervention to remove the clot and rapidly restore blood flow to the brain. Physicians use minimally invasive thrombectomy devices, also known as ‘stent retrievers’, to perform these life-saving procedures.1 The Cleveland Clinic recently recognized stent retrievers as one of the top 10 medical innovations for 2016.

The design of the EmboTrap thrombectomy device is informed by extensive research on a full range of clots that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot escaping during retrieval, which could cause additional harm to the patient.

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability.2 Approximately one million Europeans3 and 700,000 Americans suffer ischemic strokes each year.4

“Working to improve clinical outcomes in stroke is central to Neuravi’s mission, and we are committed to investing in clinical research in order to deliver advanced technologies and new clinical tools to physicians,” said Mairsil Claffey, vice president of Clinical, Regulatory & Quality for Neuravi. “We are honored to be working with an esteemed group of global leaders in stroke treatment as part of the ARISE II trial.”

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

Neuravi Announces European Launch of Innovative Minimally Invasive Stroke Therapy

Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced commercial availability of the company’s EmboTrap® Revascularization Device for the treatment of acute ischemic stroke in Europe. The device will be marketed through the sales and distribution network the company has established in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden and Switzerland.

Following a stroke, rapid intervention is critical. Recent highly positive multinational clinical trials have demonstrated the benefit of acute endovascular intervention to remove the clot and rapidly restore blood flow to the brain. Physicians use minimally invasive thrombectomy devices, also known as ‘stent-retrievers’, to perform these life-saving procedures.1

The design of the EmboTrap thrombectomy device is informed by extensive research on the wide range of different clot types that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot dislodging during retrieval, which could cause additional harm to the patient.

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability.2 Approximately one million Europeans3 and 700,000 Americans suffer ischemic strokes each year.4

The EmboTrap has been used extensively to treat patients with large vessel ischemic stroke during clinical evaluation and in an initial phased launch in Europe. Professor Michael Söderman, Chief of Neuroangiography at Karolinska University Hospital in Sweden, shared his experience with the device during the European Society of Minimally Invasive Neurological Therapy (ESMINT) congress in Nice, France, last month.

“At Karolinska, we are using the EmboTrap to treat the majority of our stroke patients. It is our first choice for middle cerebral artery occlusions because it is highly deliverable, and we have found the device to be very effective in removing clots in just one to two passes. It is also quite flexible, which is important both for getting to the clot quickly and helps in being gentle on the cerebrovasculature during removal,” stated Prof. Söderman.

At the congress, Prof. Söderman presented data from a case series evaluating use of the EmboTrap device in 42 stroke patients at two European centers. In the series, treatment with the device restored significant blood flow in 86 percent of patients, with the majority of patients recovering to be able to function independently.5

“The EmboTrap device represents a new wave in innovation for stent retrievers based on clot research and a fuller understanding of the underlying challenge,” said Eamon Brady, Neuravi’s CEO. “We are excited to announce our launch and pleased that, following the compelling clinical data published earlier this year, use of thrombectomy devices for endovascular stroke therapy is on the rise, which should save and improve the lives of many patients.”

The company’s ARISE II clinical trial will begin enrolling patients this year at select centers in the United States and Europe. The trial will gather data to support the use of the EmboTrap and to seek FDA approval.

The EmboTrap Revascularization Device is not currently approved in the U.S., where it is available for investigational use only.

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

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[1] Furlan AJ. Endovascular therapy for stroke—it’s about time [editorial]. N Engl J Med. 2015.

[2] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015 ;e29-322.

[3] Truelsen T, Piechowski-Jozwiak B, Bonita R et al. Stroke incidence and prevalence in Europe: a review of available data. European Journal of Neurology, 2006, 13: 581–598.

[4] CDC, NCHS. Underlying Cause of Death 1999-2013 on CDC WONDER Online Database, released 2015.

[5] Söderman et al, ‘Initial Experience in 42 patients from 2 European Centers’, presented at ESOC 2015 and ESMINT 2015.

Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com

Neuravi Ltd. Appoints Experienced Neurovascular Executive Robert Stern to Board of Directors

25-Year Health Care and Startup Veteran Brings Wealth of Experience to Board

Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced that Robert A. Stern has joined the company’s board of directors.

Mr. Stern has more than 25 years of experience as a senior executive for medtech and biotech health care companies, including deep neurovascular experience. He is currently chief executive officer and president of Vascular Dynamics, Inc., a venture-backed company developing a novel implantable technology designed to manage resistant hypertension. Prior to Vascular Dynamics he held several senior executive roles in publicly traded companies, including president and chief operating officer at Micrus Endovascular Inc., a manufacturer of medical devices to treat cerebrovascular disease, which was acquired by Johnson & Johnson in 2010. He has also served as a director on the boards of Reverse Medical and Flexible Stenting Solutions.

“We’re thrilled that Bob has joined the Neuravi board at this important time in the company’s growth. His track record of value creation and direct neurovascular experience are key as we embark upon European commercialization of the EmboTrap® Revascularization Device and the initiation of ARISE II, our international clinical trial,” said Eamon Brady, CEO.

Mr. Stern’s organizational experience includes spearheading global licensing and distribution agreements, forging corporate alliances, improving profitability, and developing corporate infrastructure for companies in a variety of industries. In addition, he has played an instrumental role in initial public offerings and acquisitions.

“I’m very pleased to be working with a company that will truly make a difference in improving the lives of patients suffering from acute ischemic stroke,” said Mr. Stern. “With recent clinical data reinforcing the value of device intervention for stroke patients, this is an exciting time for companies developing thrombectomy solutions, and Neuravi’s talented team has made significant progress with its innovative stent-retriever. I look forward to helping navigate this rapidly growing field.”

Mr. Stern received a B.S. degree from the University of New Hampshire, Whittemore School of Business, and an MBA from the University of New Mexico, Anderson School of Management.

About the EmboTrap Revascularization Device

The design of the EmboTrap Revascularization Device is informed by extensive research into a full range of clots that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot dislodging during retrieval, which could cause additional harm to the patient.

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked, and commercially available in Europe, while it is for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

Neuravi Announces €19M ($21M) in Financing to Advance Innovative Minimally Invasive Stroke Therapy

Galway, Ireland - Neuravi, a company dedicated to improving clinical outcomes for stroke patients, announced today that it has completed a Series B financing of €19M ($21M) to advance the company’s minimally invasive thrombectomy device for acute ischemic stroke, the EmboTrap® Revascularization Device. The round was led by European private equity firm LSP (Life Sciences Partners), with participation from returning Series A investors Fountain Healthcare Partners, Delta Partners and the Western Development Commission.

The funding will support European commercialization of the EmboTrap device, as well as Neuravi’s clinical trial, ARISE II, which will begin enrolling patients this year at select centers in the United States and Europe.

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87 percent of all strokes and are a leading cause of death and disability. Approximately one million Europeans and 700,000 Americans suffer ischemic strokes each year.

Following a stroke, rapid intervention is critical. Minimally invasive thrombectomy devices, also known as “stent retrievers,” are used by physicians in an acute intervention to remove a clot and reopen cerebral blockages to immediately restore blood flow to the brain. A series of recent highly positive multinational clinical trials have demonstrated that patients treated with thrombectomy have better outcomes than those treated with medical therapy alone.

Based on a foundation of clot mechanics research, Neuravi’s technology is designed to capture and remove clots while reducing the opportunity for embolization of clot particles that could potentially cause a new stroke in another territory, contributing to poor patient outcomes. In a case series presented at the European Stroke Organization Congress earlier this year evaluating use of the EmboTrap device in 42 stroke patients at two European centers, treatment with the device restored significant blood flow in 86 percent of patients, with the majority of patients recovering to be able to function independently.

“This is an exciting time to be backing a company dedicated to improving stroke therapy, given the recent series of positive trial results that have decisively demonstrated the value of endovascular treatment for large vessel occlusions. These are the most devastating types of stroke, creating a tremendous social and economic burden for patients, and improved treatment has the potential to both save lives and improve quality of life,” said Anne Portwich, partner, LSP. “The Neuravi team has impressed us tremendously with its thorough approach, from the clot research that informs the company’s technology development, to collaborations with leading experts in the treatment of stroke.”

As part of the financing, Anne Portwich and René Kuijten, partner, LSP, will join Neuravi’s board of directors.

“As the company moves into commercialization in Europe and into U.S. clinical trials, we are gratified to be supported by such a knowledgeable group of investors who share our vision of improving outcomes for stroke patients and see the value of our innovative technology,” said Eamon Brady, Neuravi’s CEO. “We look forward to working closely with the clinical community as we make the EmboTrap commercially available in Europe, and gather more data through ARISE II to support the device’s use clinically in the U.S.”

About the EmboTrap Revascularization Device

The design of the EmboTrap Revascularization Device is informed by extensive research into a full range of clots that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot dislodging during retrieval, which could cause additional harm to the patient.

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked, and commercially available in Europe, while it is for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

About LSP

LSP (Life Sciences Partners) is a leading independent European investment firm, providing financing for private and public life-science companies. Since the late 1980s, LSP’s management has invested in a large number of highly innovative enterprises, many of which have grown to become leaders of the global life-science industry. With over USD 1 billion of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is one of Europe’s largest and most experienced specialist life-science investors. LSP will participate with two funds in this financing, the LSP Health Economics Fund and the LSP 5 Fund. For more information, please visit www.lspvc.com.

About Fountain Healthcare Partners

Fountain Healthcare Partners fund is the largest dedicated life science venture capital fund in Ireland, with €176m under management. Exclusively focused on the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. For more information, please visit www.fh-partners.com.

About Delta Partners

Delta Partners is a venture capital firm investing primarily in Ireland and the United Kingdom. Established in 1994 with €250 million under management, Delta is among the most active early-stage investors in Europe. The partners’ backgrounds in operations, strategy and finance complement the drive and ambition of entrepreneurial management teams. For more information, please visit www.deltapartners.com.

Neuravi Introduces Collaborative Clot Research Initiative at ESMINT Conference in September

Advancing Stroke Therapy through The Science of Clot

Galway, Ireland — Neuravi, a developer of innovative stroke therapy, announced today that it will introduce the Neuravi Thromboembolic Initiative (NTI) during a series of workshops on “The Science of Clot” at the upcoming European Society of Minimally Invasive Neurological Therapy (ESMINT) conference in Nice. The NTI brings together Neuravi engineers with clinicians and researchers from leading international institutions in an effort to deepen the understanding of the mechanical properties of clot and occlusion dynamics, with the goal of improving the physician’s ability to restore flow in acute ischemic stroke.

The ESMINT conference gathers leaders in minimally invasive neurological therapy from across Europe. “One of the goals of ESMINT is to advance the practice of neuro-intervention through the support of research, education and training,” observed Prof. Laurent Pierot, President ESMINT Congress. “Currently, there is a growing interest in identifying different clots and in understanding how different clot characteristics may impact treatment in acute ischemic stroke. The NTI workshops will help in these efforts.”

The NTI workshops will feature a presentation by Dr. Anastasios Mpotsaris, Uniklinik Köln, as well as interactive hands-on sessions with engineers exploring clot characterization, the dynamics of occlusion formation and clot-device interactions and any potential implications for revascularization. Physicians may sign up to attend the sessions being held September 4-6 by registering via email at clot@neuravi.com.

“The NTI represents Neuravi’s commitment to advance the treatment of stroke by investing and collaborating in research to unravel the science of stroke occlusion,” stated Eamon Brady, CEO of Neuravi. “We are excited to have this opportunity to both share and learn with the neurointerventional community during these interactive workshops.”

Irish Medical Device Company, Neuravi Completes €5.2m Series A Financing

Galway, Ireland, 11th July, 2012 – Neuravi Limited today announced that is has successfully completed a Series A financing round for €5.2m (US$6.5m) led by Fountain Healthcare Partners and Delta Partners. This funding will accelerate the on-going development of Neuravi’s ground breaking clot retrieval device for the treatment of acute ischemic stroke and will enable Neuravi to undertake clinical evaluation in patients. Established in 2009, Neuravi has assembled a large body of intellectual property in the field of mechanical retrieval devices for stroke and has positioned itself to be a major strategic player in this fast developing market.

Patients suffer an estimated 700,000 ischemic strokes in the US and a further 950,000 in Europe each year. Neuravi is developing a medical device to help stroke doctors treat patients very quickly after stroke onset by removing the lodged blood clot from the brain with its proprietary Stent Basket technology. A staggering 95% of patients currently receive no acute intervention for this often deadly or very debilitating condition, relying on rehabilitation only. The potential market could be as high as $2 billion per year following successful clinical trial completion and the products being approved for sale in major markets.

Commenting on the new funding, Dr Joe Mason at Delta Partners said, “Stroke is devastating to patients and their families. Its results impose huge burdens on society. Neuravi’s therapeutic device will potentially offer significant benefits to patients, clinicians and payors by improving treatment outcomes for large numbers of people who suffer from the condition.”

Commenting on their investment in Neuravi, Justin Lynch, Partner at Fountain Healthcare Partners said, “This talented Galway team has a successful track record in miniature endovascular product development from concept design to clinical approval and international commercialization. The neuro-vasculature is especially challenging because brain arteries are miniscule, delicate and tortuous and this team is on a path to developing the best in class thrombectomy device addressing what is set to become a multi-billion dollar market worldwide”.

Neuravi Chief Executive Eamon Brady commented, “We are delighted to welcome Fountain Healthcare Partners and Delta Partners as investors and appreciate the extensive industry expertise they bring onto the Board. We would also like to take the opportunity to thank Enterprise Ireland, PanEuro Technology Ventures and The Western Development Commission for the support they have provided Neuravi to date and their on-going commitment to the Company and its development of a novel therapeutic device for Ischemic Stroke”.

Neuravi expects to create 25 new jobs over the next three years as a result of this investment. This includes a series of both senior management and technical/functional hires over the coming months to fulfill the Research & Development, Quality Assurance, Regulatory Assurance, Manufacturing, Marketing and Finance functions of the company.