8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

September 27, 2018

MRI INTERVENTIONS, INC.

(Exact name of registrant as specified in its charter)

DELAWARE	001-34822	58-2394628
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

5 Musick

Irvine, Ca. 92618

(Address of principal executive offices, zip code)

(949) 900-6833

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On September 27, 2018, MRI Interventions, Inc. posted an updated investor presentation to its website at http://ir.stockpr.com/mriinterventions/investor-presentation. A copy of the investor presentation is being furnished herewith as Exhibit 99.1. The Company may use the investor presentation from time to time in conversations with analysts, investors and others.

The information in Item 7.01 of this Form 8-K, as well as Exhibit 99.1 attached hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item  9.01 Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit is furnished herewith:

Exhibit 99.1 Investor Presentation dated September 2018.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: September 27, 2018	MRI INTERVENTIONS, INC.
	By:	/s/ Harold A. Hurwitz
		Harold A. Hurwitz
		Chief Financial Officer

EX-99.1

Exhibit 99.1

 

Investor Presentation

Joe Burnett, President & CEO June 2018

 

Forward Looking Statements

Statements herein concerning MRI Interventions, Inc. (the “Company”) plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s ability to obtain additional financing; estimates regarding the sufficiency of the Company’s cash resources; future revenues from sales of the Company’s ClearPoint® System products; and the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint System products. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which the Company intends to file with the Securities and Exchange Commission on or before May 15, 2018.

 

Only a Fraction of Patients with Debilitating Neurological 

Disorders are being Treated Surgically Today… 

Prevalence of Neurological Disorders 

Parkinson's Epilepsy Tumor ICH Surgical Procedures 

Note: Prevalence numbers are 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.

 

The Movement to Minimally Invasive Procedures has 

Happened Everywhere Else in the Body… 

This transition has always had two things in common; 

1. More patients being treated 

2. Procedures are ENABLED BY LIVE IMAGE GUIDANCE

 

Traditional Stereotactic Neurosurgery is Limited 

Primary Challenge: The 

Skull in not ‘See Through’ 

1. X-Ray and CT do not show structures of the brain 

2. Large, Metallic Navigation Frames are not compatible inside an MRI Magnet

 

Our Solution: ClearPoint® Neuro Navigation System Platform 

The only Neuro-Navigation System with ‘Sub-millimeter’ Accuracy 

ClearPoint Procedure Overview: 

ClearPoint Video 

Entry and Trajectory 

ClearPoint Video 

Alignment and Insertion

 

Our Value: We DECIDE, GUIDE & CONFIRM the most

challenging neurosurgery therapies Decide 1 Advanced Planning Software and Fusion Algorithms enable ‘Fly Through’ entry point and trajectory planning the day of the procedure using live MRI Images Guide 2 Uniquely enable changes to trajectory live, in the MRI, to accommodate anatomical shift or procedural challenges to deliver pinpoint or CLEARPOINT accuracy Confirm 3 Take final images and measurements of the targeting cannula in place to confirm the patient had the best possible chance at success before ending the therapy procedure 

Our PLATFORM enables CHOICE of Precision-Guided 

Therapies for DBS, LITT, Biopsy and Drug Delivery

 

MRIC: The Premier Company for Precision MRI-Guided Therapy 

• MRI Interventions: Leader in Precision MRI-Guided Therapy 

• Unique Platform that allows delivery of therapies to the brain with pinpoint accuracy under live MRI Guidance 

• Entire procedure can take place in the MRI suite, reducing the risk of hospital acquired infections and complications 

• Extensive Intellectual Property position: 70+ issued US patents, 45 international 

• Procedure Growth Fueled By Expanding Installed Base and Increased Utilization 

• 53 Installed systems in the U.S. at leading Neurosurgery Hospitals and Teaching Programs 

• Each new system placement enables razor – razorblade disposable product sales 

• Procedure count continues to grow; 43% CAGR (est.) the past four years 

• Established direct sales channel totaling 16 people supporting cases in the U.S. 

• Expanding Platform into Adjacent Areas to Address Additional Unmet Medical Needs 

• Five current Biologics and Drug Partners using MRIC for delivery in therapy trials 

• Internally developed Neuro-Aspiration device will add therapy to our sales team portfolio 

• Existing and New addressable markets > $1B in potential

 

MRIC: A Proven Platform  MRI Interventions, Inc.: Headquarters: Irvine, CA Employees: 39 (16 Sales, 14 Product Dev.) 2017 Revenue: $7.4 Million Market Cap: $23 Million Cash: $7.5 million Gross margin: 63.7% Financial data as of March 31, 2018 quarter end Share data as of June 1, 2018  Key Products:  ClearPoint SmartFrame SmartFlow Platform & Accessories Canulae Mix FDA / CE Marked Platforms 79 U.S. Patents, 27 Pending Applications Increasing Market Adoption:  43% Case CAGR  700 600 500 400 300 200 100 0  2013 2014 2015 2016 2017  Proven Revenue Growth:  32% CAGR  $8,000 $7,000 $6,000 $5,000 $4,000 $3,000 $2,000 $1,000 $ millions $-  2013 2014 2015 2016 2017 

Consumables Capital / Service Other  © 2018 MRI INTERVENTIONS, INC. | 9 

 

Broad and Growing User Base of Leading Neurosurgeons ClearPoint Is Installed in 53 Top US Hospitals and Growing UC San Francisco San Francisco VA Stanford Univ UCSF Benioff Childrens USC 

UC San Diego Univ of Colo Univ of Utah Univ of Arizona Cook Children’s MD Anderson Methodist Hosp  Texas Children’s Hosp  Riverside  Nationwide Children’s Children’s Mercy Kansas Univ Med Center Univ of Wisconsin Spectrum Health Ohio State Univ Univ of Cincinnati Univ of Michigan  Univ of Minnesota Med Ctr Brigham & Women’s Boston Children’s  Yale Univ Univ of Pitt Med Center Memorial Sloan Kettering Hackensack Univ Med Center Cornell Central Du Page Nat. Institutes of Health Nat Children’s Hospital Children’s Hosp of Philadelphia Univ of Virginia Emory University Carillion Duke University Children’s of Alabama CHOA Scottish Rite Willis Knighton Mayo Clinic Jacksonville Miami Children’s Strong Commercial Sales and Clinical Support Teams in Place

 

Our MRI-Guided Therapy Platform is Currently Being Used to: Implant Neuro Stimulation Leads from: Medtronic • St. Jude Medical • Boston Scientific • NeuroPace Place Laser Ablation Probes from: • Medtronic-Visualase • Monteris Medical MRIC Platform Runs on All Major Scanners: • Siemens • GE • Philips • IMRIS 

 

 Market Potential for Procedures MRIC Growth Cntribution New Therapy Product Sales Direct & Though Partnerships ClearPoint & Caths in Drug Therapy Trials & Commercial Strategic & Focused Expansion to new geographies either direct or through partners 2+ Therapy Products & Opportunities to Distribute (e.g. ICH Clot Extraction) 5+ Current Phase I Trials Tumor Biopsy & Ablation Included 4 Below 50,000+ 3 50,000+ 2 12,500+ Growth from New Markets Growth from Existing Markets ClearPoint® Platform Sales Into Existing Device Markets LITT and NeuroPace for Epilepsy Deep Brain Stimulation (DBS) for Parkinson’s 28,000+ 1 15,000+ 2017 Base Revenue 2017 2022 Target Indications of > 150,000 procedures per year represents Potential Addressable Market for MRIC of $1B+ Note: Market sizes for brain tumor, ICH are Pancreatic cancer are incidence numbers because of the nature of those diseases. Prevalence numbers are 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.

 

Electrode Placement for Deep Brain Stimulation Laser Catheter Placement for Ablation Procedures Key Strategies & Tactics for 2018: • Add 8-10 new centers from existing funnel via capital sales and evaluation agreements • Publish ‘Best Practices’ workflows to get procedures predictably under four hours enabling two procedures a day in MRI scanners instead of one, present to entire installed base • Pursue clinical pathway for an ‘Asleep DBS’ Indication to allow more substantial marketing, training and education of the benefits of asleep procedures which patients desire

 

ClearPoint 2.0 Image Fusion Feature (Pending FDA Clearance) Designed to reduce procedure time by fusing pre-procedure planning to real-time MRI imaging

 

Precise, Quantifiable Drug Delivery ClearPoint 2.0 Software (Pending FDA Clearance)Key Strategies & Tactics for 2018: • Assign a ‘Sales Portfolio Manager’ to proactively build our brand as the premier partner in biologics and drug delivery to the brain • Launch ClearPoint® 2.0 software with live volumetric measurement capability • Begin VOYAGER phase II trial enrollment • Add 1-2 additional partnerships for Phase 1 Trials

 

Part 2 Become the Premier Partner for Biologics and Drug Delivery Focused Resources for Branding, Device Development and Distribution No MRI Guidance © 2018 MRI INTERVENTIONS, INC. | 16

 

Part 2 Become the Premier Partner for Biologics and Drug Delivery Focused Resources for Branding, Device Development and Distribution © 2018 MRI INTERVENTIONS, INC. | 17

 

Integrated Therapy Products benefit the patient and hospital by simplifying workflow and making procedures more efficient and cost effective Adding therapy helps MRIC generate additional revenue per procedure 

 

Initial Stroke Product (ClearPoint PURSUIT™) Targets Intracerebral Hemorrhage (ICH) • Collaboration with Mayo Clinic • Only major stroke subtype w/o clearly effective therapy – major unmet medical need • Affects 80,000 to 100,000 people in the US each year Current Approaches for Hemorrhage Removal and Decompression are Inadequate: • Open craniotomy provides visibility but is highly invasive, destroys brain tissue • Minimally invasive approach has very limited ability to quantify volume reduction of the hemorrhage or monitor subsequent bleeds Our Unique ClearPoint PURSUIT™ Approach to ICH • Detailed, continuous, high resolution, 4-D visibility • Minimally invasive approach 4-D Guidance of Neuro Clot Aspiration Key Strategies & Tactics for 2018: • Complete product development for FDA submission in Q3 • Perform first-in-human case by December 2018 • •

 

Relocating Clinical Specialists closer to case ‘clusters’ to reduce travel • Hiring new specialists to locations where new placements are planned • Prioritize shorter procedure times so two cases are performed in the same day •

 

 Manufacturing Facility in Irvine, CA • Current facility capable of producing 5x more product without expansion • Target gross margin expansion above 70% in next five years Global Strategy being prioritized based on adoption of partner therapies • SmartFlow® Cannulas is now CE Mark Approved and will be in more OUS drug trials •  

 

Cash Flow From Operations: 2015 - 2018 $- $(500,000) $(1,000,000) $(1,500,000) $(2,000,000) $(2,500,000) $(3,000,000) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Frcst Q3 Frcst Q4 Frcst 2015 2016 2017 2018

 

MRIC: Executive Summary • Unique, Platform technology enabling Precision MRI-Guided Therapies to restore quality of life for some of the most debilitating disorders • Large, Growing installed base in 53 of 250+ leading Neurology centers in U.S. • Procedure volume has grown 43%+ CAGR from 2013-2017 • 80%+ of current revenue from single-use, high-margin disposables • Pipeline of new revenue streams from product improvements, new drug therapy trials, and standalone therapy products • Total potential addressable market > $1B for our products and pipeline • Strong cash position to fund Commercial and R&D initiatives • A passionate team of embedded scientists and specialists