Exhibit 99.1

 

 

 

Ticker: MRIC Investor Presentation August 18, Transforming minimally invasive neurosurgery by enabling real-time visualization with MRI © 2016 MRI INTERVENTIONS, INC. | 1

 

 

 

 

Forward Looking Statements Certain statements in this presentation may constitute forward-looking statements 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, we undertake no obligation to publicly update or revise any forward-looking statements made in this presentation to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statements are based. © 2016 MRI INTERVENTIONS, INC. | 2

 

 

 

 

MRI Interventions Investment Opportunity Commercial Business Focused commercial effort in neurosurgery; FDA/CE cleared products Enabling real-time MRI guided surgery; FDA-cleared, CE- marked and 45+ ClearPoint sites; growing procedure business Drug Delivery Upside Growing Presence in Drug Delivery ClearPoint System now in 7 clinical trials; biotech like upside Investment TimingRestructuring complete; operating cash burn dramatically lower. Several near-term milestones: 1 for 40 reverse split completed in July 2016 St. Jude’s entry into the DBS market in the US – Q3/Q4 2016 Voyager reports results of first 10 patients – Q4, 2016* UniQure initiates second cohort of Phase 1 trial – Q1, 2017 Additional drug delivery partnerships under evaluation * Estimated date © 2016 MRI INTERVENTIONS, INC. | 3

 

 

 

  

Experienced, Medical Device Leadership Team Key Management Executive Frank Grillo Peter Piferi Wendelin Maners Robert Korn Hal Hurwitz Title President, CEO COO VP Marketing VP Sales CFO Prior Experience Board of Directors Kimble Jenkins, Maria Sainz Dr. Phillip Pizzo Pascal Girin Timothy Frank Grillo, Chairman Richards CEO Jack Spencer Charles Koob Andrew Rooke Major Investor © 2016 MRI INTERVENTIONS, INC. | 4

 

  

 

 

ClearPoint® Neuro Navigation System Utilizes an existing diagnostic or intraoperative MRI to enable real time, intra-operative MRI Imaging during Neurosurgery ClearPoint Software Proprietary software for targeting and trajectory calculation / determination Dicom image based MRI Safe Hardware MRI safe head fixation frame, monitor, other components for the procedure SmartFrame®; SmartGrid® Single use devices, with MRI fiducials “seen” in MRI images, enable targeting and trajectory calculations Proprietary drape for creating sterile environment Per procedure revenue Compatible with All Major MRI Platforms © 2016 MRI INTERVENTIONS, INC. | 5

 

 

 

 

Key Procedures for Our Technology …and the challenges we address Therapies Deep Brain Stimulation Medtronic St. Jude* Boston Scientific* Laser Ablation Visualase/Medtronic Monteris Drugs/Biologics Voyager UniQure Merrimack Int’l Stem Cell Medicenna Plus others Patient Populations Parkinson’s Disease Dystonia Epilepsy Brain Tumor Parkinson’s Disease Brain Tumor Key Challenges We Address 65% plus opt-out rate for DBS due to fear of surgery itself Two room procedure Patient transport mid-procedure Accuracy of ablation is critical Precise, Controlled Delivery is Essential Drug diffusion visualization is a must have Need for ClearPoint underscored in Voyager S-1 © 2016 MRI INTERVENTIONS, INC. | 6

 

 

  

 

  

Without ClearPoint, Minimally Invasive Neuro Procedures Are Performed “Blind” Conventional Stereotactic Procedure No real time images – images from earlier in the day or week ClearPoint Neuro Procedure 80% of interviewed neurosurgeons/neurologists believe real time MRI-guidance will or can become the future of functional neurosurgery. (*) *Interviews conducted by a third party on behalf of MRI Interventions (n=36) © 2016 MRI INTERVENTIONS, INC. | 7

 

  

 

 

ClearPoint Procedure Overview Target Selection & Entry Planning © 2016 MRI INTERVENTIONS, INC. | 8

 

  

 

 

ClearPoint Procedure Overview SmartFrame® Trajectory Guide SmartFrame® Hand Controller Trajectory Alignment & Device Insertion © 2016 MRI INTERVENTIONS, INC. | 9

 

 

 

 

Clinical Support, Validation Notable Neurosurgeon Supporters Dr. Philip Starr ASSFN Past President Dr. Paul Larson UCSF & VA Dr. Robert Gross Emory University Dr. Robert Wharen, Jr. Mayo Clinic - Jacksonville Dr. Krys Bankiewicz Bankiewicz Lab, UCSF Dr. Russ Lonser OSU - NIH Published Peer-Reviewed Journal Support © 2016 MRI INTERVENTIONS, INC. | 10

 

  

 

 

Patented Intellectual Property Over 100 issued patents around the world 20+ U.S. 30+ OUS 70+ 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 SmartFrame® trajectory guide; other ClearPoint® disposable components; active intracranial probes; MRI-compatible catheters and Hand Drill; MRI-safety technology; Scalp Mount Base Key ClearPoint-related patents do not begin to expire until 2027 © 2016 MRI INTERVENTIONS, INC. | 11

 

  

 

 

MRIC‘s Unique Opportunity in Drug Delivery Major Challenges in Delivering Drugs to the Brain - Blood brain barrier blocks systemic delivery (pills, shots, IV) of almost all drugs – 98% of small molecules - Direct injection without ClearPoint is blind, so target is frequently missed - Neopharm Trial - 51% of 572 catheters failed to meet all positioning criteria Major Benefits of Drug Delivery with ClearPoint - Neurosurgeon sees 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 volume) 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 Provides MRIC with “biotech-like upside” without “all or nothing downside” © 2016 MRI INTERVENTIONS, INC. | 12

 

  

 

 

ClearPoint Drug Delivery w/ SmartFlow Cannula MR visualization of neuro target MR-guided placement of catheter Therapeutic agent delivered under MR-guidance* Specialized, FDA-cleared drug delivery cannula’s / catheters Drug infusion is visible under real- time MRI Growing Set of Peer-reviewed Publications… Conclusion: The ClearPoint system allows Real-time Convection- enhanced Delivery to be performed with a high level of precision, predictability, and safety. * CAUTION: SmartFlow™ Cannula is approved for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. Uses other than the approved indication are limited by Federal law to investigational use. © 2016 MRI INTERVENTIONS, INC. | 13

 

  

 

 

ClearPoint‘s Use in Drug Delivery Seven Programs Underway Now... Current Drug Delivery Trials Utilizing the ClearPoint System: AAV2-hAADC for Parkinson’s disease Phase 1 Study at UCSF Initial sponsorship by Michael J. Fox Foundation AAV2-GDNF for Parkinson’s disease Phase 1 Study at the NIH MDNA55 for Recurrence or Progression of Glioblastoma Preparing Phase 2 Human Parthenogenetic Stem Cell-Derived Neural Stem Cells for Parkinson’s disease Pre-clinical leading to Ph. 1 IL13 for Brain Tumor Phase 1 study at the NIH Radio Immunotherapy for Brain Tumor Phase 1 Study at MSK Nanoliposomal Irinotecan for Brain Tumor Phase 1 Study at UCSF The ClearPoint System is being used in the ongoing Phase 1b clinical trial of VY-AADC01 as a treatment for advanced Parkinson’s disease, and we expect to continue to use the ClearPoint System in future clinical trials of VY-AADC01 and any other of our product candidates that are injected directly into the brain. IPO S-1, Voyager Therapeutics © 2016 MRI INTERVENTIONS, INC. | 14

 

  

 

 

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 © 2016 MRI INTERVENTIONS, INC. | 15

 

  

 

 

Growing the ClearPoint Footprint Installed Base of 44 sites in the US Europe: Warsaw, Poland © 2016 MRI INTERVENTIONS, INC. | 16

 

  

 

 

ClearPoint US Market Opportunity Total Prevalence (US) Prevalence – Drug Treatment Resistant (DTR) Incidence – DTR ClearPoint Enabled Therapy Potential ClearPoint Procedures, Annually2 Parkinson’s 1,500,000 125,000 7,500 Electrode Placement (DBS) 12,500 Epilepsy 2,200,000 264,000 18,000 Laser Ablation RNS1 28,000 Brain Tumors 80,000 (annual diagnosis) Resections: 80,000 Stereotactic Biopsy: 10,000 Biopsy / Laser Ablation / Drug Delivery 14,500 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 research conducted 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. © 2016 MRI INTERVENTIONS, INC. | 17

 

  

 

 

ClearPoint Consumable Revenues Consumables $1,200,000 $1,000,000 $800,000 $600,000 $400,000 $200,000 $- Q3 Q4 2013 Q1 Q2 Q3 Q4 2014 Q1 Q2 Q3 Q4 2015 Q1 Q2 2016 © 2016 MRI INTERVENTIONS, INC. | 18

 

  

 

 

Total Revenue, 2013 - 2016 Total Revenue $1,600,000 $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 Q1 Q2 2013 2014 2015 2016 Consumables Capital / Service Other © 2016 MRI INTERVENTIONS, INC. | 19

 

  

 

 

Cash Flow From Operations $0 -$500,000 -$1,000,000 -$1,500,000 -$2,000,000 -$2,500,000 -$3,000,000 Payment of $739,000 in accrued interest to Brainlab, as part of note restructuring Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2014 2015 2016 © 2016 MRI INTERVENTIONS, INC. | 20

 

  

 

 

Leading a New, Emerging Industry Trend © 2016 MRI INTERVENTIONS, INC. | 21

 

  

 

 

Ticker: MRIC MRI Interventions, Inc. Irvine, CA 949.900.6833 www.mriinterventions.co m Transforming minimally invasive neurosurgery by enabling real-time visualization with MRI © 2016 MRI INTERVENTIONS, INC. | 22