Exhibit 99.2

 

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Ticker: MRIC

 

Investor Presentation

 

January 7th, 2016

 

Transforming minimally invasive neurosurgery by enabling real-time visualization with MRI

 

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Forward Looking Statements

 

Certain statements in this presentation may constitute forward-lookingstatements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements often can be identified by words such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” or the negative of these words or other words of similar meaning. Forward-looking statements by their nature address matters that, to different degrees, are uncertain and involve risk. Uncertainties and risks may cause MRI Interventions’ actual results and the timing of events to differ materially from those expressed in or implied by MRI Interventions’ forward-looking statements. Particular uncertainties and risks include, among others: demand and market acceptance of our products; our ability to successfully expand, and achieve full productivity from, our sales, clinical support and marketing capabilities; availability and adequacy of reimbursement from third party payors for procedures utilizing our products; the sufficiency of our cash resources to maintain planned commercialization efforts and research and development programs; future actions of the FDA or any other regulatory body that could impact product development, manufacturing or sale; our ability to protect and enforce our intellectual property rights; our dependence on collaboration partners; the impact of competitive products and pricing; the impact of the commercial and credit environment on us and our customers and suppliers; and our ability to successfully complete the development of, and to obtain regulatory clearance or approval for, our ClearTrace system. More detailed information on these and additional factors that could affect MRI Interventions’ actual results and the timing of events are described in its filings with the Securities and Exchange Commission. Except as required by law, MRI Interventionsundertakesnoobligationtopubliclyupdateorreviseanyforward-looking statementsmadeinthispresentationtoreflectanychangeinMRIInterventions’expectationsoranychange inevents,conditionsorcircumstancesonwhichanysuchstatementsarebased.

 

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MRI Interventions Opportunity

 

Market potential

 

Market Potential 55,000 potential ClearPoint procedures across multiple therapies

 

Electrode placement for deep brain stimulation

 

NavigationSystem

 

Laser Ablation for ablation of epileptic foci or Brain Tumors

 

forMultiple

 

Brain Tumor Biopsy for deep seated tumors

 

Therapies

 

Precise Drug Delivery to target lesions

 

Opportunityto Area of interest to large medical device companies

 

AttractMultiple Medtronic, St. Jude and Boston Scientific investing in neuro market Players MRI Scanner Companies embracing MRI-guided therapies

 

Drug Companies pursuing direct delivery

 

Focused commercial effort in neurosurgery; FDA/CE approved products

 

Uniquely Delivery platform for multiple therapies Positioned Established, proprietary IP position

 

Recent restructuring complete

 

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MRI Interventions:

 

Real Time MRI Guided Surgery

 

Firstto-markettechnologyplatformenabling altime MRI guideded surgery; Acleared, CE-marked and nd40+ ClearPoint sites

 

Focused commercialization of neuro platform underway; recent restructuring complete

 

Attractive razor/razorblade business model with strongng potential margins

 

Compatiblewithall major MRI manufacturers; Interoperability w/ Medtronic, Monteris, neuro roducts

 

Established intellectual property portfolio

 

Professionalmanagementteamwithrelevantmedicaldevicecommercialization experience: Intuitive, Medtronic, Kyphon, Boston Scientific, ev3, Edwards Lifescience, Cordis

 

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Leadership A History of Med Device Experience

 

Key Management

 

Executive Title Prior Experience

 

Frank Grillo President, CEO

 

Peter Piferi COO

 

Wendelin Maners VP Marketing

 

Robert Korn VP Sales

 

Hal Hurwitz CFO

 

Board of Directors

 

Kimble Jenkins, Maria Sainz Dr. Phillip Pizzo Pascal Girin Timothy Frank Grillo, Exec Chair Richards CEO

 

Jack Spencer Charles Koob Andrew Rooke

 

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Investor

 

Technology: ClearPointR Neuro Navigation System

 

Navigation System consisting of Integrated Devices and Software for Real-Time, MRI Guided, Minimally Invasive Neurosurgical Procedures

 

Visualize Verify Confirm

 

Identify target Observe progress to target Confirm precise placement at target

 

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Without ClearPoint, minimally invasive neuro procedures are performed “blind”

 

Conventional Stereotactic Procedure ClearPointnt Neuro Procedure

 

No real-time visualization

 

Nextt generationn platform enabling realtime, MRIIguided, minimally invasive brain surgery

 

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ClearPointR Neuro Navigation System

 

1.5T or 3T MR Scanners, also works in intraop MRI Suites

 

MRI Safe Disposable Components:

 

SmartGridR and SmartFrameR Integrated ClearPoint Targeting and Trajectory Precision

 

ClearPointR Drape provides sterile procedural field in any diagnostic or intraoperative MRI scanner

 

Emory University Hospital UCSF Medical Center University of Pittsburgh Brigham and Women’s Medical Center Hospital*

 

* Image courtesy of IMRIS

 

Integrates with All Major Scanner Platforms

 

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ClearPoint Procedure Overview

 

Target Selection & Entry Planning

 

VIDEO

 

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ClearPoint Procedure Overview

 

SmartFrameR Trajectory Guide Trajectory Alignment & Device Insertion

 

VIDEO

 

SmartFrameR Hand Controller

 

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ClearPoint Procedure Overview

 

Delivery of Neurological Therapy

 

Drug Deliveryry(1) Electrode Placement Laser Ablationn(2)

 

VIDEO VIDEO VIDEO

 

Drug Delivery1 Electrode Placement Laser Ablation2

 

(1)Drug Delivery -The SmartFlowR cannula received 510(k) clearance for injection of cytarabine, a chemotherapy drug, to the ventricles or removal of CSF from the ventricles during intracranial procedures. Delivery of other therapeutic agents, and delivery of agents to other areas of the brain, using the SmartFlow cannula is investigational.

 

(2)Laser Ablation -MR Thermometry is an MRI-based functionality available on most MR scanner platforms and it is a feature built into products from several third party vendors. The ClearPoint system enables MRI-guided procedures and allows physicians to use this inherent MR capability during a procedure.

 

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ClearPoint Hospital Economics

 

Increase Patients

 

Better potential patient experience provides hospitals the opportunity to reach additional patient populations that may otherwise forego surgery

 

65% of eligible DBS patients refuse treatment, due to fear of surgery(1)

 

Established, Attractive Reimbursement

 

Move procedures from the more expensive OR to the less expensive MR suite, with equivalent reimbursement

 

Improved Utilization of Existing MRI’s

 

1 hour of MR Scanner time used for diagnostic imaging could generate $1,200(2)

 

1 hour of MR scanner time used for a ClearPoint procedure could generate $5,275(3)

 

Utilizes existing MRI’s already in hospital

 

(1) Medtronic Investor Presentation, June, 2014

 

(2) Estimated average US hospital-based MRI suite revenue per hour for outpatient diagnostic scans, based on data gathered by MRI Interventions. Excludes professional fees. Actual revenues will vary by hospital, procedure and payor.

 

(3) Based on a weighted average payment to MRI Interventions’ customers (as of September 2014) for an electrode placement procedure for Medicare and private insurance patients, calculated by MRI Interventions using a payor mix weighted 67% to average Medicare reimbursement and 33% to average private insurance reimbursement. Average Medicare reimbursement calculated as the weighted average Medicare payment for MRI Interventions’ customers (as of September 2014) for an electrode placement procedure under MS-DRGs 025, 026 and 027. Average private insurance reimbursement calculated as 1.5x Medicare reimbursement, based on published data. Hourly amount assumes 4.5 hour procedure duration. Excludes professional fees. Actual revenues will vary by hospital, procedure and payor.

 

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Multi-Therapy MRI-Guided Navigational System

 

Notable Neurosurgeon Supporters

 

Dr. Philip Starr Dr. Paul Larson Dr. Robert Gross Dr. Robert Wharen, Jr. Dr KrysBankiewicz DrRussLonser ASSFN Past President UCSF & VA Emory University Mayo Clinic - Bankiewicz Lab, UCSF OSU NIH

 

Jacksonville

 

Published Peer-Reviewed Journal Support

 

Compatible With Multiple Therapies

 

VisualaseR

 

SmartFlow™ cannula for local drug delivery

 

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Patented Intellectual Property

 

Close to 100 issued patents around the world

 

40+ U.S. 50+ OUS 50+ U.S. Patents 45+ OUS Patents Patent Applications Patent Applications

 

Issued patents cover areas such as: MRI-guided surgical systems that include software and devices; the SmartFrameR trajectory guide; other ClearPointR disposable components; active intracranial probes; MRI-compatible catheters; MRI-safety technology

 

Key ClearPoint-related patents do not begin to expire until 2027

 

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Patient Impact

 

Martin’s Story

 

ClearPoint-Enabled Electrode Placement

 

VIDEO

 

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Patient Benefit Minimally Invasive Procedure

 

7days after ClearPoint procedure Arrow Indicates Surgery Site

 

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ClearPoint Drug Delivery

 

MR visualization of neuro target

 

MR-guided placement of catheter

 

Therapeutic agent delivered under MR-guidance*

 

Specialized drug delivery cannula’s / catheters

 

Conclusion: The ClearPoint system allows Real-time Convection-enhanced Delivery to be performed with a high level of precision, predictability, and safety.

 

Drug infusion is visible real time under MRI

 

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Uses other than the approved indication are limited by Federal law to investigational use.

 

MRIC’s Unique Opportunity for Drug Delivery

 

Major Challenges in Delivering Drugs to the Brain

 

- Blood brain barrier blocks systemic delivery of almost all drugs up to 98% of small molecules

 

- Direct injection without ClearPoint is blind, so target can frequently be missed

 

- Neopharm Trial-51% of 572 catheters failed to meet all positioning criteria

 

Major Benefits of Drug Delivery with ClearPoint

 

- Neurosurgeon can see that target is reached

 

- Eliminates the blood brain barrier issue; Reduces/eliminates unwanted systemic side effects; Reduces dosage levels(as little as 1/300th of systemic volumes)

 

Business Model MRIC Partners with Drug Companies and Researchers

 

- MRIC provides ClearPoint; Drug company provides drug candidate

 

- Drug company/sponsor pays for trial

 

- If drug is approved, MRIC gets device revs (~$7000/case); Drug co gets drug revs

 

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The ClearPoint Difference

 

Without ClearPoint (Stereotactic) With ClearPoint

 

Nodirectvisualization;Performedinanoperating Directhighresolutionvisualization;Performedin room an MRI Suite

 

Accuracy to target based on prior images Highly accurate, based on real time images Patient may be awake forown brain surgery(1) Patient may be undergeneralanesthesia(1) Long OR time for the patient Can be up to 8 hours Shorterprocedures Can be 3 hours or less

 

May require OR and MRI for same procedure (laser MRI only procedure -One procedure, one place ablation)

 

Poor economics for hospital and physician Attractive economics for hospital and physician

 

Better for Patients Better for Surgeons Better for Hospitals

 

(1) Microelectrode recording and macrostim are processes that involve listening to neuronal firings (i.e., physiological recordings) and observing physiological responses to stimuli during brain surgery. In connection with our 510(k) clearance in 2010, the FDA requested a warning within ClearPoint’s Instructions for Use based on the lack of data with respect to deep brain stimulation (DBS) procedures. The warning states that the ClearPoint system, alone, should not be usedtoguide a DBS lead to a specific brain target and that final placement of DBS leads requires physiological recordings to confirm that they are located in the correct brain targetand functioning as intended.

 

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ClearPoint Revenue Model

 

BUSINESS MODEL RAZOR / RAZORBLADE

 

ClearPoint Hardware/Software: $100,000 -$150,000 ASP

 

ClearPoint Disposables: $7,500 (average) ASP per procedure with potentially strong margins Recurring revenue from the sale of disposables Procedures covered by existing inpatient DRG reimbursement codes

 

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Growing the ClearPoint Footprint

 

Installed Base of 39 sites in the US

 

 

September, 2015

 

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ClearPoint US Market Opportunity

 

Parkinson’s Epilepsy Brain Tumors

 

Total Prevalence (US) 1,500,000 2,200,000 80,000 (annual diagnosis)

 

Prevalence Drug Treatment 125,000 264,000 Resistant (DTR)

 

7,500 18,000 Resections: 80,000

 

Incidence DTR

 

Stereotactic Biopsy: 10,000

 

Electrode Laser Ablation Biopsy / Laser Ablation /

 

ClearPoint Enabled Therapy

 

Placement (DBS) RNS1 Drug Delivery

 

Potential ClearPoint 12,500 28,000 14,500 Procedures, Annually2

 

55,000+ Potential Procedures Per Year

 

Note: Prevalence and Incidence based on either market research conducted by a third party on behalf of MRI Interventions or researchconducted by MRI Interventions of publicly available sources.

 

(1) Responsive neurostimulation device (RNS)

 

(2) Potential Annual ClearPoint Procedures based upon 5% of prevalence and 85% of incidence; Potential Annual ClearPoint Procedures for brain tumors based on market research conducted by a third party on behalf of MRI Interventions.

 

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ClearPoint Future Opportunities

 

Multiple Therapies for Future Growth

 

Patient Treatment Resistant ClearPoint Enabled

 

Current Status Neuro Disorder Population Patient Population Therapy

 

Dystonia 250,000 25,000 DBS Active Use, HDE

 

OCD 3,300,300 100,000 DBS Active Use, HDE

 

SevereDepression 6,000,000 1,200,000 DBS IDE Trials (DBS)

 

Parkinson’s

 

1,500,000 125,000 Drug Delivery Clinical Trials Phase 1

 

Disease

 

Brain Tumors Clinical Trials Phase 1 11,000 11,000 Drug Delivery

 

(GBM)

 

Huntington’s 30,000 30,000 Drug Delivery Pre-Clinical

 

Pre-Clinical ALS 30,000 30,000 Drug Delivery

 

Alzheimer’s 5,400,000 500,000 DBS Research

 

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ClearPoint Consumable Revenues

 

Consumables

 

$1,200,000 $1,000,000 $800,000 $600,000 $400,000 $200,000

 

$-

 

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

 

2013 2014 2015

 

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Total Revenue, 2013 -2015

 

$1,600,000

 

Total Revenue

 

$1,400,000 $1,200,000 $1,000,000 $800,000 $600,000 $400,000 $200,000

 

$-

 

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

 

2013 2014 2015

 

Consumables Capital / Service Other

 

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Cash Flow From Operations 

$0 -$500,000 -$1,000,000 -$1,500,000 -$2,000,000

-$2,500,000 

-$3,000,000 

Q2 Q3 Q4 Q1 Q2 Q3 

2014 2015 

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Commercial Priorities

 

Focus on adding surgeons at existing accounts

 

ncrease

 

Target high volume sites, including epilepsy and tumor neurosurgeons within each Utilization account; gain greater share of their procedures

 

Add Clinical Specialists and sales reps to commercial team; compensate for utilization growth

 

Increase peer-to-peer events, presence at trade shows

 

Enhance Highlight existing data on ClearPoint applications to neurologists and neurosurgeons Communication Communicate value proposition across procedures:

 

Accuracy

 

Real time visualization

 

Improved workflow

 

Increase patient volume

 

Identify highest volume potential accounts across multiple procedures

 

ExpandAccountpand Acco

 

Support local hospital marketing efforts

 

Base Capitalize on interest in drug delivery to expand in oncology accounts

 

Add sales reps

 

Tightly control working capital, consumption of cash

 

Achieve Cash

 

Hire additional personnel only in key functions commercial team; engineering

 

Breakeven

 

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R&D Priorities

 

Seek significant upgrade to existing software; includes Software 2.0 real time fusion, enhanced graphic and User Interface

 

Technology licenses near complete with three additional software companies for this effort

 

Through partnership(s), expand our products OR SmartFrame and brand into the operating room for CT based neuro procedures

 

Establish additional drug delivery partnerships, Drug Delivery and participate in additional clinical trials

 

Become the neuro drug delivery device partner of choice

 

Continue to enhance product line with a focus Bolt Driver

 

Procedure on procedure simplification and consistency for

 

Enhancements

 

Laser Ablation

 

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At the Center of an Emerging Industry Trend

 

ClearPoint ClearPoint MRICisatthepointof

 

Electrode Laser Catheter

 

Placement Placement convergenceinan

 

industrytrendimpacting

 

Real Time

 

MRI- someofthemost

 

ClearPoint Guided ClearPoint

 

Direct Drug Procedures Performed influentialand

 

Delivery in MRI innovativemedical

 

Scanners

 

ClearTrace devicecompanies

 

Ablation and in the world Drug Delivery

 

In Development

 

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Ticker: MRIC

 

MRI Interventions, Inc.

 

Irvine, CA 949.900.6833 mriinterventions.com

 

Transforming minimally invasive neurosurgery by enabling real-time visualization with MRI

 

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