Shaping the Future of Endovascular Medicine

Amnis Theraputics Corporate Presentation

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Page 1: Amnis Theraputics Corporate Presentation

Shaping the Future ofEndovascular Medicine

Page 2: Amnis Theraputics Corporate Presentation

Forward Looking StatementsThe information contained in this presentation does not constitute an offer to purchase securities or an invitation for offers to purchase securities and it is published for information purposes only.

This presentation was edited only for summary and convenience purposes and does not intend to replace the need to read the Immediate Reports the Company has published, before any decision regarding investments in the Company's securities is made.

This presentation contains forward-looking statements as defined in the Israeli Securities Law, 1968. These statements include, inter alia, forecast, goals, uncertainties and assumptions.

The forward-looking statements are based on management's current subjective expectations and beliefs based, amongst others, on analysis of general information which is known to the Company's management at the time of preparing this presentation. All forward-looking statements are subject to certain risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. If one or more of these risks and / or uncertainties materialize, or if the underlying assumptions prove to be incorrect, the Company's actual results, performance or achievements could differ materially from those expressed in, or implied by, any such forward-looking statements or results which are based upon such assumptions.

Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them will transpire or occur, what impact it will have on the results of the operations or financial condition of the Company.

In addition, the Company is providing this information as of the date of this presentation and doesn't undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise.

Page 3: Amnis Theraputics Corporate Presentation

Amnis specializes in developing innovative devices addressing unmet needs in interventional cardiology and neuro-radiology.

Amnis has two CE marked products, Coronary & Neuro Covered Stents, commercialized in over 20 countries through a strong network of distributors established over the past seven years. Since it’s inception, Amnis’ revenues have surpassed 10 million dollars. Amnis is developing a unique technology that revolutionizes blood clot retrieval, indicated by the Cleveland Clinic as one of the top 2016 innovations markets, estimated to exceed $1 billion value by 2018. (1)

Amnis protects its Intellectual property through a collection of patent families in the field of endovascular intervention and biological tissue engineering.

Amnis continues to have close ties with every day clinical practices in the cath lab with the assistance of our prominent clinical advisory board consisting of key opinion leaders.

Company Profile

Page 4: Amnis Theraputics Corporate Presentation

StrokeCurrent Overview

Stroke is a leading cause of death and disability worldwide

Every year, Over 15 million people worldwide suffer a stroke

87% 35-40%

87% of all strokes are ischemic (associated with a blood clot)

Potentially 35-40% of all acute strokes require mechanical intervention (2)

Page 5: Amnis Theraputics Corporate Presentation

StrokeGolden revolutionizes blood clot retrievalThe Golden retriever is the future of fast and efficient blood clot retrieval. The Unique design is the thinnest on the market today, navigating like a wire to the clot, it retrieves the clot exerting minimal radial force on the vessel wall, making it the ultimate non-traumatic device.

Since the publication of MR CLEAN, ESCAPE, Swift Prime, REVASCAT and EXTEND-IA, the number of mechanical thrombectomy procedures performed annually has increased by 80% and is expected to reach 60,000 in the U.S. by 2020, up from 18,000 patients in 2015. (3)

The American Heart and Brain Association’s new guidelines establish the addition of Mechanichal retriever technology as the frontline treatment for patients suffering a stroke.

In its yearly innovation summit, the Cleveland Clinic chose the neuro blood clot retrieval market as one of the most innovative markets in 2016, expected to peak in the next two years. (4)

Page 6: Amnis Theraputics Corporate Presentation

The Golden retriever is a 0.014’’ wire tube equipped with a soft tip that is advanced and positioned inside the clot independent of a micro-catheter.

The Golden’s deployment mechanism unfolds five “crown” elements, each composed of 12 micro-strands which embeds into the clot by rotational movement.

Full extension of the micro-strands forms four engagement zones for efficient clot retrieval.

Golden Our Solution Golden

Deployed

Undeployed

Deployment

Page 7: Amnis Theraputics Corporate Presentation

Superior technology

Engagement mechanism relies on cage formation enhancing the grip on the clot regardless of clot morphology and length. Enables enhanced clot engagement. Device deployment is independent of a micro catheter. One size device suits all clots. Reduced friction within the micro-catheter.

Reduced puncture to revascularization time

The smallest device diameter on the market (0.014”). Improved delivery in tortuous anatomy. No need to wait between deployment and retrieval.

Enhanced Safety Mechanism

Engagement and retrieval does not rely on radial force, thus minimizing vessel injury risk. Capturing zones trap the clot from all sides simultaneously reinforcing it and preventing fragmentation and emboli risk.

Competitive Advantages

Golden Retrieval System

Page 8: Amnis Theraputics Corporate Presentation

Market

The global neurointerventional devices market for the treatment of cerebrovascular disease is set to expand in the coming years, with its value increasing from $1.37 billion in 2013 to $1.66 billion by 2020. (5)

Increasing evidence of the benefits of stent retrievers, including the new guidelines of the American Heart Association, means the devices are expected to treat 60,000 patients in the U.S. by 2020, up from 18,000 patients in 2015.

Meanwhile Medtronic says that the addressable market in the U.S. for mechanical thrombectomy is 240,000 stroke victims per year. (6)

With 2.5 million new stroke cases each year, China reports more stroke patients than anywhere else in the world with nearly three times the frequency in North American stroke registries. (7)

Page 9: Amnis Theraputics Corporate Presentation

MR CLEAN Appears to Redeem Endovascular Therapy for Acute Stroke:

“The positive results from MR CLEAN will likely have dramatic impact on the treatment of acute ischemic stroke.”

Cleveland Clinic announces top 10 list of breakthrough technologies for 2016:

“This new solution to ischemic stroke treatment will be a game-changer within the next year as it allows a blood clot to actually be removed in addition to traditional drug therapy.”

Endovascular Treatment Shows Dramatic Benefits for Large Strokes in 3 Trials:

“The new findings “provide definitive, overwhelming evidence that in select patients who have large strokes… the use of these new catheters in a very well-coordinated, time-efficient way can improve outcomes dramatically.”

From The Press

"Medtronic announced it has acquired Lazarus Effect, a medical device company focused on acute ischemic stroke products that facilitate the capture and removal of clots, in an all-cash transaction of $100 million."

"Covidien’s Medical Devices segment acquired MindFrame Inc. a designer and manufacturer of devices designed to optimize rapid perfusion and clot removal in the treatment of patients suffering from ischemic stroke, for approximately $75 million in cash."

Page 10: Amnis Theraputics Corporate Presentation

Medtronic Stryker Corporation Johnson & Johnson

Covidien Ltd.

ev3

Comparables

Acquisition of the Lazarus Effect $100 million all-cash transaction

Sep 2015 (Resource)

Acquisition of Concentric medical $135 million

Oct 2011 (Resource)

Acquisition of Micrus Endovascular $480 million

Sep 2010 (Resource)

Acquirement of ev3

$2.6 billionJul 2010 (Resource)

Acquirement of MindFrame

$75 millionJul 2009 (Resource)

Acquirement of Surpass Medical $135 million

Oct 2011 (Resource)

acquisition of Boston Scientific neurovascular

$1.5 billion

Jan 2011 (Resource)

Acquisition of Covidien $42.9 billion

Jan 2015 (Resource)

Page 11: Amnis Theraputics Corporate Presentation

FDATechnology acquisition

Successful animal trials

stage

Submission of an additional

patent

Design freeze Conclusion of pre-clinical

studies

First in Man case

CE mark

Nov 2014 Q4 2015 Q1 2017Q2 2016 Q3 2016Q4 2015Q3 2015 2018

Regulatory Path

Product Milestones

• Europe (CE Mark) - the device is defined as a class III device and will require pre-clinical trials, including V&V. May require clinical data.

• US (FDA Clearance) - the device is defined as a class II device. Will require pre-clinical and clinical trials.

Page 12: Amnis Theraputics Corporate Presentation

AneugraftDx is the only biological membrane-covered coronary stent available today. Among its indications are emergency vessel reconstructions in cases of acute rupture or dissection of a coronary artery, treatment of coronary aneurysms, or saphenous vein graft reperfusion.

Superior Biocompatibility. Strong clinical record (2007-2014). 6F GC compatible for all diameters and improved deliverability. Many esteemed and loyal users in over 20 countries. Long shelf life (3 years). Since the launch of AneugraftDx sales revenues exceeded $9M.

“Immediate success is excellent and no stent thrombosis was observed in our consecutive series of 20 patients with a prolonged follow-up of 2½ years.” Prof. Carlo Di Mario ICI 2015

“The use of the pericardial covered stent is a valid option to treat coronary perforation even in cases with complex coronary anatomy due to vessel tortuosity and presence of calcifications.”Lotan et al. CCI, 2015

The Ultimate Lifeguard

Biocompatible Pericardium Covered Stent

Aneugraft | Dx ANEURYSM

Pre procedure

Pre procedure

Pre procedure

Perforation

SVG

Post procedure

Post procedure

Post procedure

Biological tissue-covered stents

034413485

AMAR approved

Page 13: Amnis Theraputics Corporate Presentation

We’ve got you covered

Biocompatible Pericardium Covered Stent

Aneugraft | Nx

Pre-Intervention

Pre-Intervention

Post-Intervention

Post-Intervention

AneugraftNx is the only covered stent designed specifically for intracranial indications. Among its benefits are immediate reconstruction of cerebral arteries in high-risk indications such as wide neck cerebral aneurysms, Cavernous Carotid Fistulas (CCFs) and ruptures.

Biological tissue covering. Partially covered scaffold reduces the

risk of side branch occlusion. No risk of aneurysm rupture. Soft 20 mm trackable tip provides optimized navigation. Long shelf life (3 years). Since the launch of AneugraftNx sales revenues exceeded $1M.

“Covered neurological stents may provide an effective tool for the safe and immediate exclusion of aneurysms in the cerebral vasculature, and particularly in the treatment of wide-necked aneurysm.”Prof. Erol Akgul ABCWIN 2014

“Neurological Covered stents may be an efficient and effective treatment in emergency procedures and demonstrates high deliverability with successful deployment to target lesion.”Prof. Francis Turjman WFITN 2015

034413485

AMAR approved

Biological tissue-covered stents

Page 14: Amnis Theraputics Corporate Presentation

Amniotic Membrane solution

Amnis is developing a new platform to leverage the regenerative effects of the human placental amniotic membrane and bring it’s pro-healing properties to everyday medicine.

Excellent mechanical properties Ultra-thin, flexible cover. Only a tenth the width of the grafts currently used. Unprecedented flexibility & deliverability that will enable the

treatment of a significantly greater number of indications.

Exceptional biocompatibility Optimal interaction with the surrounding vascular tissue. Enhanced endothelialization, anti-inflammatory properties,

anti-scarring, pro-healing properties.

EVE

Development Pipeline

Page 15: Amnis Theraputics Corporate Presentation

Restoration of vascular flow

A breakthrough in covered stent technologySignificant reduction of metal scaffold per stent length.Device is fully covered - no contact between metal and blood fluid.

Potential applications: Repair of intracranial vascular pathologies. Coronary angioplasty - negating the need for antiplatet therapy, preventing restenosis without drug elusion. Peripheral vascular disease. Large vessel disease. Reconstruction of non-vascular organs, such as: Airways. Gastrointestinal tract. Biliary tract. Urinary tract.

EVE

Development Pipeline

Amniotic Membrane solution

Page 16: Amnis Theraputics Corporate Presentation

Scientific Advisory Board

Prof. Chaim LotanProf. Chaim Lotan is the Director of Heart Institute of the Hadassah Medical Center in Jerusalem, Israel and served as the president of the Israel Heart Society in 2011-3. Prof. Lotan established the Israeli Working Group for Interventional Cardiology and initiatedand helped build the Bio-Design Innovation Program at the Hebrew University in Jerusalem. For the past 10 years he is acting as a joint chairman of the ICI Meeting, which is considered one of the world's leading conferences in the cardiovascular innovation arena. Prof. Adnan H. SiddiquiProf. Adnan Siddiqui is a Professor of Neurosurgery and Radiology at the State University of New York, Buffalo. Prof. Siddiqui acts as the Head of The Neuroendovascular Research and Stroke Service at the Toshiba Stroke & Vascular Research Center and is currently a member of the Executive Council of the Joint Section of Cerebrovascular Surgery of the American Association of Neurological Surgery.

Prof. Haim DanenbergProf. Danenberg is a specialist in Internal Medicine and Cardiology and acts as the Director of Interventional Cardiology at the Hadassah-Hebrew University Medical Center and a Professor of Medicine at the Hebrew University of Jerusalem. Prof. Danenberg completed a post-doctoral fellowship at Harvard-MIT Division of Health Sciences and Technology where he acts as a visiting scientist. Prof. Danenberg currently acts as Secretary for the Israeli Workgroup for Interventional Cardiology.

Prof. Ronit AgidProf. Ronit Agid is a diagnostic and Interventional Neuroradiologist at the Toronto Western Hospital and is an associate professor of Radiology at the University of Toronto, Canada. Prof. Agid is a part of the Toronto Brain Vascular Malformation Group and a member of the Gamma Knife Data Oversight Committee.

Page 17: Amnis Theraputics Corporate Presentation

Take Home Message

Amnis’ innovative Golden retrieval system is specifically engineered for blood clot removal and will enable a more simple & effective procedure.

The blood clot retrieval market is extremely active and is expected to triple in size in the next two years, exceeding a $1 Billion market. (8)

Amnis covered stents, the only biological tissue covered stents on the market, are commercialized over eight years and have helped save thousands of patients worldwide.

Amnis is developing the EVE amniotic membrane technology to bring a never seen before biological solution to vascular unmet needs.

Amnis is “Flow” in Latin - and in Amnis, we are all about restoring the blood flow for fast and efficient revascularization.

The Golden

The Market

Products

InnovativeTechnology

Our Vision

Page 18: Amnis Theraputics Corporate Presentation

22 Ha'ilan StreetP.O. Box 146,Or Akiva.3060000 Israel .

T +972 72 22 00 330F +972 72 22 00 [email protected]