PALO ALTO, Calif., Feb. 15, 2011 — Nfocus Neuromedical, Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, announced today that its Luna™ Aneurysm Embolization System (AES) received CE Mark for the treatment of patients with brain aneurysms. The Luna AES is designed to be a single-deployment, easy-touse system for the treatment of brain aneurysms both pre- and post-rupture.

“Brain aneurysm treatment historically has been the domain of either surgery or, more recently, catheter-placed wire coils,” said Eric Milledge, CEO, Nfocus Neuromedical. “Surgery can be traumatic and expensive, and coils may fail to fully treat an aneurysm. The Luna AES represents a dramatic step forward in the treatment of these patients.” It is estimated that up to one in 15 people will develop a brain aneurysm during their lifetime.

Rupture of an aneurysm can cause stroke, brain damage and even death. The Luna AES treats brain aneurysms by blocking (embolizing) blood flow while providing a scaffold to encourage tissue growth across an aneurysm opening and create a plug. The Luna uses a self-expandable, multi-layer oval implant made from Nitinol, a nickel-titanium alloy. The properties of the device allow it to easily compress within a conventional catheter, and then rapidly and easily open to full size once deployed within an aneurysm.

“CE Mark approval is an important milestone for Nfocus,” said Robert O’Holla, vice president of regulatory affairs, Nfocus Neuromedical. “The Luna AES is our flagship product and we look forward to working with physicians and hospitals in Europe to advance this important new technology.”

About Nfocus Neuromedical, Inc.

Nfocus is developing the next generation treatment for brain aneurysms. The company’s innovative LUNA™ product is a single-deployment, easy-to-use embolization device designed to be a direct replacement to detachable coils. Nfocus is backed by three major U.S.- and OUSbased venture funds: DFJ ePlanet Capital, Technology Partners, and InCube Ventures. Other investors include Raffles Capital and Endeavor Vision. More information can be found at: www.nfocusneuro.com.

VAL d’ISERE, France, January 20, 2011 — Nfocus Neuromedical, Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, announced the presentation of preliminary clinical experience for the company’s Luna™ Aneurysm Embolization System (AES). Drs. Gyula Gál and Karlis Kupc of the Departments of Radiology University Hospitals in Odense, Denmark and Riga, Latvia presented results from their first use
of the Luna AES at the annual ABC-WIN meeting here.

Drs. Gál and Kupc presented cases involving a 65-year-old woman with a bifurcation brain aneurysm and a 44-year-old woman with a wide-neck lateral wall brain aneurysm. Both complex aneurysms were treated successfully using the minimally-invasive Luna AES. “The Luna performed well, particularly in these challenging and relatively complicated cases,” said Dr. Gál. “Deployment of the Luna device went smoothly in both instances and prevented
blood flow from reaching the weakened portions of the aneurysms. Without the Luna, the procedures would have been considerably more complex, involving multiple devices and longer procedure times. I look forward to further clinical evaluation of this promising new device.”

A brain aneurysm is an abnormal bulging outward of one of the arteries in the brain. Up to one in 15 people will develop a brain aneurysm in their lifetime. Rupture of an aneurysm can cause stroke, brain damage and even death.

The Luna AES is designed to be a single-deployment, easy-to-use device that treats brain aneurysms by blocking (occluding) blood flow and providing a scaffold for tissue to form a durable plug. The Luna uses a self-expandable, multi-layer oval implant made from Nitinol, a nickel-titanium alloy. Nitinol’s properties allow the device to easily compress within a conventional catheter, and then rapidly and easily open to full size once deployed within an
aneurysm.

Treatment of intracranial aneurysms has historically involved surgery, which is traumatic (and expensive), or, more recently, the placement of small wire coils to occlude the targeted blood vessel. Over the past decade coils have become the preferred catheter-based treatment, but this procedure has limitations. Coil placement involves long, unpredictable procedure times and multiple coils are typically required to occlude an aneurysm. In addition, coils will often compact within the aneurysm and allow blood flow to return. This may require re-treatment, including an additional coil insertion procedure.

“The cases presented today demonstrate what we repeatedly observed during rigorous preclinical testing of the Luna AES,” said Martin Dieck, president and COO, Nfocus Neuromedical. “The system is simple to use and the results to date have been excellent. The Luna has the potential to be a valuable advance in the treatment of both ruptured and unruptured aneurysms. Nfocus is currently conducting a prospective clinical study in select European centers.”

About Nfocus Neuromedical, Inc.

Nfocus is developing the next generation treatment for brain aneurysms. The company’s innovative LUNA™ product is a single-deployment, easy-to-use embolization device designed to be a direct replacement to detachable coils. Nfocus is backed by three major U.S. and OUSbased venture funds: DFJ ePlanet Capital, Technology Partners, and InCube Ventures. Other investors include Raffles Capital and Endeavor Vision. More information can be found at: www.nfocusneuro.com.

PALO ALTO, Calif., January 11, 2011 – Nfocus Neuromedical Inc, an innovative medical device company with a focus on the next generation treatment for brain aneurysms, today announced that the company received U.S. Food and Drug Administration 510(k) clearance for its ActaTM Vessel Occlusion System (VOS). The Acta VOS provides physicians with a minimally-invasive alternative to current treatment options for an array of common and potentially serious vascular lesions.

The Acta VOS is designed to occlude (close) targeted veins and arteries with great precision. Vascular occlusion is often used to block blood flow to malformed, weakened or leaking vessels, or to benign or malignant tumors.
“The Acta VOS and the Nfocus technology platform on which it’s based address an important and, to this date, insufficiently resolved medical need,” said Eric Milledge, chairman and CEO, Nfocus Neuromedical. “The Acta 510(k) clearance is a tangible demonstration of our company’s progress and is the first step toward clearance of the Nfocus platform of braided occluders, which includes the Luna™, our flagship product for treating brain aneurysms.”

Vascular occlusions were historically accomplished by surgically closing the targeted blood vessel – a traumatic and expensive procedure. More recently, surgeons began placing small wire coils and other vascular plugs through catheters to stop blood from flowing to the area of concern. However, several coils may be required to occlude a single vessel, and occlusions frequently re-open. Pre-clinical studies demonstrate that the Acta VOS stops blood flow in a vessel more quickly and durably than both coils and a predicate plug device.

The Acta VOS uses a self-expandable, multi-layer oval implant made from Nitinol, a nickeltitanium alloy. Nitinol’s properties allow the device to easily compress within a conventional catheter, and then rapidly open to full size once deployed within a vessel. The Acta VOS is mounted on an elegant delivery system that allows physicians to easily retract and reposition the device. Once the device is deployed and the desired location is achieved, a single lever detaches the Acta VOS, leaving it behind to occlude blood flow.

“The FDA has rigorous requirements for embolization devices such as the Acta VOS,” said Robert O’Holla, vice president of regulatory affairs, Nfocus Neuromedical. “This 510(k) clearance provides strong validation for both our technology platform and development approach.”

About Nfocus Neuromedical, Inc.

Nfocus is developing the next generation treatment for brain aneurysms. The company’s innovative LUNA™ product is a single-deployment, easy-to-use embolization device designed to be a direct replacement to detachable coils. Nfocus is backed by three major U.S. and OUSbased venture funds: DFJ ePlanet Capital, Technology Partners, and InCube Ventures. Other investors include Raffles Capital and Endeavor Vision. More information can be found at: www.nfocusneuro.com.

PALO ALTO, Calif., October 25, 2010 – Nfocus Neuromedical Inc., an innovative medical device company focused on the next generation treatment for brain aneurysms, today announced the appointment of Eric Milledge to Chairman and CEO effective immediately. Milledge has served as the company’s Chairman of the Board since April 2009. Former CEO, Martin Dieck, will assume the role of President and COO.

Prior to joining Nfocus’ Board, Milledge most recently served as Company Group Chairman for the LifeScan division of Johnson & Johnson and as a member of the J&J Medical Devices & Diagnostics Group Operating Committee. Milledge also previously held the position of President of Ortho-McNeil Pharmaceuticals, a world leader in women’s healthcare, infectious disease and epilepsy.

“I am very excited about Eric joining the management team. Eric’s 34 year history with J&J along with Martin’s 18 year neurovascular experience is a powerful combination,” said Mir Imran, Nfocus Director and CEO of InCube Labs. “The company’s novel approach to treating aneurysms has the potential to become the new standard of care and is expected to offer significant benefits over coils. With Eric and Martin at the helm, I’m confident that Nfocus is poised for clinical and commercial success in this greatly important area of aneurysm therapy.”

Nfocus is developing the next generation treatment for brain aneurysms called the LUNA™, designed to be a direct replacement to detachable coils. It will provide physicians with a single-deployment, easy-to-use embolization device. Building off a strong patent position, Nfocus has conducted extensive testing of the LUNA with outstanding results.

Eric Milledge, Nfocus’ newly appointed CEO commented, “Nfocus’ LUNA™ technology has the potential to be a breakthrough in treating aneurysms. This is an exciting and critical time as we continue to expand our clinical trials in Europe, and I look forward to working closely with Martin and the Nfocus team as we strive to improve the standard of care for the treatment of aneurysms.”

“We have made great progress since our founding including building a world-class team and developing the LUNA™ product. We now have major milestones ahead of us including LUNA™ clinical efforts, CE Mark and US regulatory approval,” said Martin Dieck, Presidentand COO. “Eric brings significant and highly relevant experience that will be instrumental as we enter this next phase of clinical studies, regulatory approvals and ultimately commercialization.”

“I believe that there are great prospects for Nfocus with Eric and Martin leading the company,” said Roger Quy, a Director of Nfocus and General Partner of Technology Partners, who specializes in neurotechnology investments. “With this leadership team in place, coupled with Nfocus’ disruptive technology for the treatment of aneurysms, the company is in a great position to displace coils as the standard of care and capture a major market opportunity.”

About Nfocus Neuromedical, Inc.

Nfocus is developing the next generation treatment for brain aneurysms. The company’s innovative LUNA™ product is a single-deployment, easy-to-use embolization device designed to be a direct replacement to detachable coils. Nfocus is backed by a premier venture fund, Technology Partners (www.technologypartners.com). Other investors include InCube Ventures, Raffles Capital and Endeavor Vision. Nfocus was incubated at InCube Labs (www.incubelabs.com), a medical device research lab led by Mir Imran. To learn more about the Nfocus Neuromedical, please visit our website: www.nfocusneuro.com.

PALO ALTO, CA, August 18, 2009 – Nfocus Neuromedical Inc. announced today that the Food & Drug Administration has cleared its novel guiding catheter, the Echo™ Distal Access Guiding Catheter, for marketing in the US.

“Nfocus works closely with key clinical opinion leaders to direct all of our design and development projects, and the Echo is our latest success story” said President and CEO Martin Dieck. “Our advisors identified the need for a guiding catheter with improved performance and our team has responded with Echo.”

The Echo™ Distal Access Guiding Catheter has been cleared by the FDA for introduction of interventional and/or diagnostic devices in peripheral, coronary and neurovascular vessels. A high-quality guiding catheter is required in today’s advanced and complex endovascular procedures to assist in reaching the target vessel with stents and other operative devices. The guiding catheter must be atraumatic and flexible within the distant and smaller target vessel – yet provide stable and firm support in the larger vessels where the device enters the body.

“The Echo is a stable platform for placing today’s most advanced interventional devices and its unique construction gives it the ability to maintain a round lumen to enable endovascular procedures in very far-reaching vessel locations” continued Mr. Dieck.

“Combined with Echo’s earlier CE Mark approval, the US FDA clearance gives Nfocus the ability to enter the top end of interventional guiding catheter markets worldwide. Endovascular surgeons and interventional neuroradiologists will appreciate the supple distal end which resists ovalizing of the lumen and the exceptional support of the proximal section – both produced by the unique catheter skeleton.”

About Nfocus Neuromedical, Inc.

Nfocus is positioning itself to be the world-wide leader in the development of next-generation endovascular neurosurgery solutions (surgery through less-invasive catheter devices) . Backed by premier venture investors, the Company is developing revolutionary systems to treat neurovascular disease, including brain aneurysms, that are simple, safe, cost-effective and curative.

To learn more about the Nfocus Neuromedical development programs focused on providing faster, simpler and more permanent treatment of vascular diseases of the brain and spine, please visit the new Nfocus website at: www.nfocusneuro.com.

For more information about aneurysms and hemorrhagic stroke see: www.strokeassociation.org and www.snisonline.org.

PALO ALTO, CA, August 12, 2009 – Nfocus Neuromedical Inc. announced today that its CardioVasc Advantage™ Vascular Reconstruction Device has been granted CE Mark approval by the European Notified Body, G-Med.

“The technology of the Advantage VRD is an important demonstration of Nfocus design talent and teamwork,” noted company Chairman, Eric P. Milledge. “The technical platform behind this device will pave the way for future Nfocus neurovascular products currently in development.”

The CardioVasc Advantage™ Vascular Reconstruction Device has been cleared in Europe for the treatment of coronary artery perforations, aneurysms and saphenous vein graft lesions. Today, these critical pathologies are most frequently treated through less-invasive endovascular procedures. The Advantage VRD was designed to provide clinical benefits in these exacting procedures performed in small vessels.

“The Advantage VRD is a significant advance over previous small-vessel stent-grafts” said Martin S. Dieck, President & CEO.

“The Advantage VRD has greatly improved flexibility and a smaller crossing profile when compared to competitive devices. The European CE Mark approval gives Nfocus the ability to market this advanced system for the treatment of serious coronary vascular indications. The device is capable of attaining more distal placement with less vessel trauma due to its innovative design.”

About Nfocus Neuromedical, Inc.

Nfocus is positioning itself to be the world-wide leader in the development of next-generation endovascular neurosurgery solutions (surgery through less-invasive catheter devices) . Backed by premier venture investors, the Company is developing revolutionary systems to treat neurovascular disease, including brain aneurysms, that are simple, safe, cost-effective and curative.

To learn more about the Nfocus Neuromedical development programs focused on providing faster, simpler and more permanent treatment of vascular diseases of the brain and spine, please visit the new Nfocus website at: www.nfocusneuro.com.

For more information about aneurysms and hemorrhagic stroke see:www.strokeassociation.org and www.snisonline.org.

PALO ALTO, CA, July 29, 2009 – Nfocus Neuromedical Inc. announced today at the 6th Annual Meeting of the Society of NeuroInterventional Surgery (www.snisonline.org) that Nfocus has earned a European CE Mark approval for its novel guiding catheter, the Echo™ Distal Access Catheter.

“The Echo’s unique construction gives it the ability to enable endovascular procedures in very far-reaching vessel locations – yet provide a stable platform for placing today’s most advanced interventional devices,” noted President and CEO Martin S. Dieck. “The European CE Mark approval gives Nfocus the ability to enter the top end of the interventional guiding catheter market with our new Echo catheter. Endovascular surgeons and interventional neuroradiologists will appreciate the extreme suppleness of the distal end and the exceptional support of the proximal section – both produced by the key uni-body construction.”

The Echo™ Distal Access Catheter has been cleared in Europe to provide support and vessel access in peripheral, coronary and neurovascular interventional and diagnostic procedures. In today’s advanced and complex endovascular
required to allow operative devices or implants to reach the target vessel. It is critical for the guiding catheter to be atraumatic and flexible within the distant and smaller target vessel – yet provide stable and firm support in the larger vessels where the device enters the body. “Nfocus recognized a key market opportunity and has applied its unique design and development talents to produce the Echo,” continued Mr. Dieck. “Echo will help enable many advanced endovascular procedures.”

About Nfocus Neuromedical, Inc.

Nfocus is positioning itself to be the world-wide leader in the development of next-generation endovascular neurosurgery solutions (surgery through less-invasive catheter devices) . Backed by premier venture investors, the Company is developing revolutionary systems to treat neurovascular disease, including brain aneurysms, that are simple, safe, cost-effective and curative.

Nfocus was incubated at In-Cube Labs and is backed by Oxford Bioscience Partners, Technology Partners and DFJ-ePlanet Ventures. To learn more about the Nfocus Neuromedical development programs focused on providing faster, simpler and more permanent treatment of vascular diseases of the brain and spine, please visit the new Nfocus website at: www.nfocusneuro.com.

For more information about aneurysms and hemorrhagic stroke see: www.strokeassociation.org and www.snisonline.org.

PALO ALTO, CA, April 30, 2009 – Endovascular device start-up Nfocus Neuromedical Inc. announced today the appointment of accomplished regulatory executive Robert O’Holla to its leadership team in the role of Vice President of Regulatory Affairs. “Bob O’Holla brings an unmatched wealth of regulatory and compliance experience to Nfocus, having served 18 of his last 30 years in the industry in the role of Worldwide Vice President of Regulatory Affairs, Medical Devices, for Johnson & Johnson,” said President and CEO Martin Dieck. “His disciplined and strategic approach to the product development and approval processes set him apart as a worldwide expert. We are thrilled to welcome him to Nfocus Neuromedical.”

O’Holla has an extensive background in the fields of R&D, quality, policy development and compliance, which uniquely position him for the dynamic needs of Nfocus and its nextgeneration endovascular devices. He chaired the Technology and Regulatory AdvisoryCommittee at AdvaMed, a premier medical technology industry group for 13 years, and was a key figure in the construction of the Medical Device User Fee and Modernization Act of 2002, which amended and refined food and drug
“I welcome the challenges and rewards of serving in my new role with Nfocus,” noted O’Holla, “as we strive to bring responsible and innovative products and emerging field of endovascular neurosurgery.”

About Nfocus Neuromedical, Inc.

Nfocus is positioning itself to be the world-wide leader in the development of next-generation endovascular neurosurgery solutions (surgery through less-invasive catheter devices) . Backed by premier venture investors, the Company is developing revolutionary systems to treat neurovascular disease, including brain aneurysms, that are simple, safe, cost-effective and curative.

Nfocus was incubated at In-Cube Labs and is backed by Oxford Bioscience Partners, Technology Partners and DFJ-ePlanet Ventures. To learn more about the Nfocus Neuromedical development programs focused on providing faster, simpler and more permanent treatment of vascular diseases of the brain and spine, please visit the new Nfocus website at: www.nfocusneuro.com.

For more information about aneurysms and hemorrhagic stroke see: www.strokeassociation.org and www.snisonline.org.

PALO ALTO, CA, April 30, 2009 – Nfocus Neuromedical Inc. announced today that its directors elected Eric P. Milledge as Chairman of the Board. “Mr. Milledge brings exceptional industry experience, business acumen and leadership to Nfocus, as we advance our pursuit of break- through technologies in the dynamic field of endovascular neurosurgery,” noted President and CEO Martin S. Dieck.

“The relevance of Milledge’s 34 years of experience with Johnson & Johnson is what attracted us to him. Most recently serving as Company Group Chairman for the LifeScan division of Johnson & Johnson and as a member of the J&J Medical Devices & Diagnostics Group Operating Committee, Milledge will prove invaluable in strategically guiding us through our development, regulatory approval and commercialization process.”

“Neurovascular disease is one of the leading causes of death and disability and is still widely underserved. I am impressed with the potential of the technological advances Nfocus brings to this medical field,” said Milledge. “It is an honor and a privilege to work with the Nfocus team in bringing surgeons simpler, less invasive devices that could change the lives of millions through improved endovascular surgery outcomes.”

Milledge began with J&J in 1973. He later held positions of Company Group Chairman of Johnson & Johnson Health Care Systems, Inc., President of Ortho-McNeil, and President of Ortho Pharmaceutical Corporation.

“Nfocus has its hand on the pulse of the dynamic developments in the emerging endovascular neurosurgery field,” added Milledge. “It’s an exciting time to add strategic guidance, which can further the advancement of our product technologies.”

About Nfocus Neuromedical, Inc.

Nfocus is positioning itself to be the world-wide leader in the development of next-generation endovascular neurosurgery solutions (surgery through less-invasive catheter devices) . Backed by premier venture investors, the Company is developing revolutionary systems to treat neurovascular disease, including brain aneurysms, that are simple, safe, cost-effective and curative.

Nfocus was incubated at In-Cube Labs and is backed by Oxford Bioscience Partners, Technology Partners and DFJ-ePlanet Ventures.

To learn more about the Nfocus Neuromedical development programs focused on providing faster, simpler and more permanent treatment of vascular diseases of the brain and spine, please visit the new Nfocus website at: www.nfocusneuro.com.

For more information about aneurysms and hemorrhagic stroke see: www.strokeassociation.org and www.snisonline.org.