Exhibit 99.1

 

Nexeon MedSystems Inc. Corporate Overview www.nexeonmed.com Nexeon MedSystems Inc Corporate Overview www.nexeonmed.com

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Safe Harbor Statement 2 This presentation contains forward - looking statements and projections. The company makes no express or implied representation or warranty as to the completeness of this information or, in the case of projections, as to their attainability or the accuracy an d completeness of the assumptions from which they are derived. It must be recognized that estimates of the company’s performanc e are necessarily subject to a high degree of uncertainty and may vary materially from actual results. In particular, this pres ent ation contains statements, including, without limitation the projections, that constitute “forward - looking statements” within the mean ing of the Private Securities Litigation Reform Act of 1995. These statements appear in a number of places in this presentation and inc lude, but are not limited to, statements regarding the company’s plans, intentions, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. The company commonly uses words in this presentation such as “will,” “m ay, ” “plans,” “potential,” “preliminary,” “anticipates”, “believes”, “plans”, “expects”, “future”, “intends” and similar expressio ns to identify forward - looking statements and projections. You are cautioned that these forward - looking statements and projections are not guarantees of future performance and involve risks and uncertainties. The company’s actual results may differ materially from th ose in the forward - looking statements and projections due to various factors, including those set forth in the sections titled “Risk Fa ctors” in filings with the Securities and Exchange Commission. The information contained in this presentation describes several, but no t necessarily all, important factors that could cause these differences. Any forward - looking statements in this presentation reflects our current view with respect to future events and is subject to th ese and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Giv en these uncertainties, you should not place undue reliance on these forward - looking statements. Except as required by law, we assume no obligation to update or revise these forward - looking statements for any reason, whether as a result of new information results o f future events or otherwise, after the date on which statements are made or to reflect the occurrence of unanticipated events. The company has provided certain non - GAAP financial information as supplemental information regarding its operating results. The se measures are not in accordance with, or an alternative for, U.S. GAAP and may be different from non - GAAP measures reported by other companies. The company believes that its presentation of non - GAAP measures, adjusted EBITDA and adjusted EBITDA /GP margin provides useful information to management and investors regarding certain financial and business trends relating to it s f inancial condition and results of operations. In addition, the company’s management uses these measures for reviewing the financial re sul ts of the company and for budgeting and planning purposes.

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Nexeon Overview 3 Best - in - Class Device Large Addressable Market Multiple Near - Term Catalysts Protected Platform Current Business Highlights Neurostimulation device combining current steering, directional leads, closed loop sensing all on a rechargeable platform Existing $750M market 1 with EU/US reimbursement CE Mark and FDA approvals in process 2 nd product launch in non - invasive vagus nerve stimulation ~150 patent matters from Medtronic / Siemens Existing profitable OEM business with long term contracts $10M in non - dilutive financing from NIH/strategic validating the platform https://www.grandviewresearch.com/industry - analysis/deep - brain - stimulators - dbs - market 1

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com 4 Catalysts Q1 Q2 Q3 Q4 2019 Data Targeted Withdrawal feasibility Data Targeted Atrial fibrillation pilot DBS CE Mark Target filing for CE Mark for sales in EU Q1 Q2 Q3 Q4 2020 Withdrawal target approval Targeted Sales begin DBS CE Mark targeted approval Targeted EU sales begin . DBS PMA targeted approval Targeted US Sales begin Data Target Withdrawal pivotal N=60 DBS PMA Target Filing Afib de Novo Targeted PMA Submission Data Targeted Atrial fibrillation pivotal Withdrawal de Novo Targeted PMA Submission

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com DBS Market: Our Primary Opportunity 5 11.5% CAGR 2014 - 2025 1 Large, robust provider network with established $750M+ annual revenue 1 Strong reimbursement Believed to be an underpenetrated market with potentially growing patient base Anemic innovation for over 20 years – industry ripe for disruption Closed - loop stimulation at the forefront for the market $796 $887 $989 $1,103 $1,230 $1,371 2016 2017 2018 2019 2020 2021 https://www.grandviewresearch.com/industry - analysis/deep - brain - stimulators - dbs - market 1

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Unmet Need 6 • Significant unmet need for alternative to trial - and - error based manual DBS reprogramming • Reduce physician burden • Facilitate use of more complex lead designs, potentially contributing to greater patient benefit Manual Adaptive Basis for Adjustment Observable symptoms and side effects Brain signal detection and measurement Time to Optimization 18 - 32 hours over multiple doctor visits during first year post - procedure Near - real - time, based on defined parameters Lead Design Simple: Cylindrical Contacts Complex: Directional Leads Source: Daria Nesterovich Anderson et al 2017 J. Neural Eng. Algorithmic Reprogramming has the potential to maximize therapeutic benefit while mitigating side effects

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Viant ™ Designed to alleviate shortcomings in today’s therapy, resulting in potentially fewer compromises for MD’s and patients 7 TWO - WAY DATA FLOW Existing DBS devices are unable to record brain function necessitating a trial and error adjustment process which relies on a patient’s observable symptoms. This requires multiple doctor visits to achieve optimal stimulation patterns to treat each individual patient. Benefits Designed to detect, measure and collect brain signals while simultaneously providing targeted DBS therapy to reduce the need for poorly reimbursed and lengthy, painful reprogramming visits. Rechargeable technology designed to reduce the number of surgeries for patients and allow unconstrained use of the sensing ability. Data Integration – Designed to record and store large amounts of neural data for the first time, integrated into our cloud based Neural Hub. Asleep Procedure - Using brain signals, patients will have the potential to one day be able to have an implant done under general anesthesia, removing one of the greatest hesitations for patients to undergo the surgery.

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Our Goal: To Address Unmet Needs 8 Uniquely positioned platform, combining all necessary capabilities to potentially advance DBS Rechargeable, one surgery versus multiple Recording designed to enable disease discovery to lower reprogramming time Deliver any conceivable waveform; designed to enable new discoveries and potentially create IP opportunities 16 controllable current source enables customized therapy Pathway to closed loop stimulation, 24/7 patient symptom optimization Directional leads designed to increase efficacy a nd potentially lower side effects Neural Hub Analytics Platform, Dropbox for neurologists designed to make new discoveries and optimize patient care

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Clinical Results 9 Encouraging outcome for both patient & surgeon* “The described excellent surgical response adds to the notion that combined thalamic and pallidal DBS is a safe and effective tr eatment option in selected MDS patients”* “The used deep brain stimulation device has proven safe and efficient for the multi - electrode treatment”* Data presented at EFSSN conference Sept 2016* Clinical Grade Platform utilized by GSK as part of their $750M JV with Google 2017 Acute clinical study, N=6 to optimize signal to noise in LFP recording *C.K.E. Moll, et al: Long - term follow - up of concomitant thalamic and palladial stimulation in a dystonic head tremor patient using the Synapse™ System, ESSFN 2016

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com European Commercialization Summary 10 UK Netherlands Germany Austria France Spain 50 top providers in close proximity (roughly the size of New England area) Small direct sales force with distributors in most countries Strong reimbursement and technology driven KOL’s limit need for large sales force

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Attractive margins at scale Provider Network US Reimbursement Procedure Established Market Strong Health Economics Potential Opportunity Known Reimbursements Health Economics Strong health economic with rechargeable battery Hospital Competitiveness Attract patients who want asleep procedure Technology Cutting edge technology Competitive Differentiators Representative sales pricing from Medtronic * Implantable Pulse Generator - Neurostimulator $26,900 Extensions - 8 Channel X2 2,000 Lead - 8 Channel Directional X2 8,000 Patient Programmer 1,190 Charger 2,390 Total System Sales Price $40,480 US Commercialization Summary Patient / Caregiver Value Designed to provide value to patient / caregiver by lowering reprogramming time and visits Profitable for physicians and hospitals 11 https://www.medtronic.com/content/dam/medtronic - com/professional/documents/deep - brain - stimulation - reimbursement - guide - 2018.pdf *

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Manufacturing Business: Historical Revenues & Synergies 12 • Attractive cash flows and EBITDA margins • Long - term contracts with key accounts • Production capacity to support growing pipeline Synergies include supply chain and lead manufacturing, potentially leading to 2nd product launch 2013 2014 2015 2016 2017 Total Revenue $5.6M $6.4M $6.1M $6.1M $7.4M Revenue Growth - 7% 15% - 4% - 1% 20% Gross Profit $1.4M $2.2M $1.8M $1.8M $2.0M Adjusted EBITDA $586,529 $686,181 $424,265 $717,020 $556,805 Adjusted EBITDA/GP Margin % 45% 31% 23% 39% 27% Unaudited: Reflects Medi - Line Fiscal Year Apr - Mar and adjusted to U.S. GAAP. Euros converted to U.S. dollars at historic conversion rates.

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com 13 Auricular vagus nerve stimulation (“ aVNS ”) • Non - invasive activation of the vagus nerve for a variety of indications • Primary product launch in the treatment of opioid withdrawal symptoms • Funded clinical programs in atrial fibrillation and foreign language acquisition The risk of developing Atrial Fibrillation at age 40 is 1 in 4 3 Intermittent neurostimulation program Annual Economic COSTS of atrial fibrillation 4 estimated ~$4,700 per patient $6.65B with 276,000 ER visits and 350,000 hospitalizations 3 http://www.preventaf - strokecrisis.org/ ; 4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3324990/ Opioid Use Disorder (OUD), characterized by problematic symptoms of addiction to and withdrawal from opioids, is part of a public health crisis affecting more than 1.9 million Americans. 1 Annual Economic COSTS of opioid abuse is estimated ~$12,000 per patient 2 1 Ann Intern Med. 2017 Sep 5;167(5):293 - 301. doi : 10.7326/M17 - 0865. Epub 2017 Aug 1. 2 Kirson , Noam Y., et al. "The economic burden of opioid abuse: updated findings." Journal of managed care & specialty pharmacy 23.4 (2017): 427 - 445.

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com 13 Patents Granted 7 Patents Pending 76 Patents Granted 6 Patents Pending Transvascular Stimulation (Bates, MD portfolio) Remote Monitoring (Medtronic portfolio) Internet of Medical Things (Siemens portfolio) Proprietary IPG (Synaptix acquisition) Intellectual Property Portfolio 14

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Leadership WILL ROSELLINI, JD, MBA Chairman, CEO CHRIS MILLER CFO • 6 advanced degrees related to neurotechnology • 15 - yr vet in neurotech • 4 successful exits (MTI in pivotal studies) • 15+ yrs serving as CFO, treasurer, and interim CFO for wide variety of early - stage & non - profit organizations, both public & private Doherty & Co., LLC Luc Van Immerseel, PHD Inventor and VP of Development • Inventor of sensing technology • 25 years of ASIC - neuro development and signal processing for neurostimulation devices 15

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Summary Consolidated Financial Data 16 2018 2017 % change 2017 2016 % change Revenues $ 7,666,827 $ 1,147,288 568% $ 3,302,775 $ 1,494,881 121% Gross Profit 2,133,654 409,624 421% 981,019 1,455,752 -33% Net Loss (3,067,224) (3,590,801) -15% (2,177,641) (802,463) 171% Basic and Diluted GAAP EPS $ (1.56) $ (2.08) -25% $ (1.23) $ (0.59) 108% Gross Margin 28% 36% 30% 97% (unaudited) (audited) For the Nine Months For the Years Ended Ended September 30, December 31,

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Summary Balance Sheet Data 17 September 30, 2018 (unaudited) Cash and cash equivalents $ 125,573 Total assets 18,577,891 Total liabilities 9,438,937 Total stockholder's equity $ 9,138,954 Long-Term Debt September 30, 2018 (unaudited) 12.00% Senior Convertible Secured Note, amortization begins 2018, 2019 maturity $ 1,120,000 1.27% Secured Bank Loan, monthly amortization, 2024 maturity 1,753,593 1.27% Secured Bank Loan, monthly amortization, 2024 maturity 272,623 0.72% Secured Bank Loan, monthly amortization, 2020 maturity 30,203 Floating Rate Secured Line of Credit 116,012 Loan Subsidy, amortization begins 2018, 2032 maturity 179,600 Revolving Credit 24,237 Capitalized Building Lease 607,687 Capitalized Equipment Lease 23,083 Less: Original purchase discount, net of amortization (125,705) Total Debt 4,001,333 Less: Current portion of debt, net of original discount current portion (1,673,667) Total Long-Term Debt $ 2,327,666

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com 18 Capitalization Table Issued and Outstanding 1,965,646 as of December 10, 2018 Warrants Outstanding 82,926 (WAEP - $19.39 per share) as of December 10, 2018 Options Outstanding 345,736 (WAEP - $13.81 per share; 75.5% vested) as of December 10, 2018 Long - term Debt $2,327,666 as of September 30, 2018 Leonite Capital, LLC holds an outstanding convertible promissory note in the principal amount of $1,080,000 as of December 10, 2018, wh ich is convertible into an aggregate of 123,429 shares of common stock at a conversion price of $8.75 per share, subject to adjustment.

 

 

PRIVATE AND CONFIDENTIAL NEXEON MEDSYSTEMS INC www.nexeonmed.com Non - GAAP Reconciliation Medi - Line S.A (manufacturing business) Adjusted EBITDA For the fiscal years 2013 - 2017 19 Unaudited: Reflects Medi - Line Fiscal Year Apr - Mar and adjusted to U.S. GAAP. Euros converted to U.S. dollars at historic conversion rates. 2017 2016 2015 2014 2013 Revenues $ 7,356,792 $ 6,123,371 $ 6,160,834 $ 6,439,433 $ 5,620,786 Adjusted EBITDA 556,805 717,020 424,265 686,181 586,529 Depreciation and amortization (348,091) (258,339) (288,205) (370,745) (362,857) Interest expense (9,652) (14,765) (20,234) (24,921) (53,368) Provision for taxes (41,413) (51,799) (32,046) (88,478) (35,355) Items of Other Income (Expense) Interest income 755 1,861 1,887 8,879 17,517 Bad debt (20,659) 17,009 (26,462) (3,859) 89,227 Extraordinary income (expense) - 1,975 (2,570) 10,144 - Provision for liabilities - - 80,214 (17,449) (64,384) Net Income $ 137,745 $ 412,962 $ 136,849 $ 199,752 $ 177,309