# EDGAR Filing Document

**Accession Number:** 0001285550
**File Stem:** 0001285550-23-000010
**Filing Date:** 2023-1
**Character Count:** 30063
**Document Hash:** 087a0da68f5bc28d92f9f815b21f9726
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001285550-23-000010.hdr.sgml**: 20230111

**ACCESSION NUMBER**: 0001285550-23-000010

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 34

**CONFORMED PERIOD OF REPORT**: 20230111

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230111

**DATE AS OF CHANGE**: 20230111

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ClearPoint Neuro, Inc.
- **CENTRAL INDEX KEY:** 0001285550
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 582394628
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-34822
- **FILM NUMBER:** 23522572

**BUSINESS ADDRESS:**
- **STREET 1:** 120 S. SIERRA AVENUE
- **STREET 2:** SUITE 100
- **CITY:** SOLANA BEACH
- **STATE:** CA
- **ZIP:** 92075
- **BUSINESS PHONE:** 9499006833

**MAIL ADDRESS:**
- **STREET 1:** 120 S. SIERRA AVENUE
- **STREET 2:** SUITE 100
- **CITY:** SOLANA BEACH
- **STATE:** CA
- **ZIP:** 92075

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** MRI INTERVENTIONS, INC.
- **DATE OF NAME CHANGE:** 20110714

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SURGIVISION INC
- **DATE OF NAME CHANGE:** 20091106

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SURGI VISION INC
- **DATE OF NAME CHANGE:** 20040331

?xml version="1.0" ? clpt-20230111

**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):** 

**January 11, 2023**

_________________________________________

**CLEARPOINT NEURO, INC.**

**(Exact name of registrant as specified in its charter)**

_________________________________________

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-34822** | **58-2394628** |
| **(State or other jurisdiction**<br>**of incorporation)** | **(Commission<br>File Number)** | **(I.R.S. Employer**<br>**Identification Number)** |

---

**120 S. Sierra Ave., Suite 100** 

**Solana Beach, CA 92075**

**(Address of principal executive offices, zip code)**

**(888) 287-9109**

**(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))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.01 par value per share | CLPT | Nasdaq Capital Market |

---

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 2.02. Results of Operations and Financial Condition.**

On January 11, 2023, ClearPoint Neuro, Inc. (the "Company") issued a press release announcing its preliminary, unaudited financial results for the fourth fiscal quarter ended December 31, 2022. A copy of the press release is furnished herewith as Exhibit 99.1.

The information in Item 2.02 of this Form 8-K, as well as Exhibit 99.1 attached hereto, shall not be deemed "filed" for 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 (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

**Item 7.01. Regulation FD Disclosure.**

On January 11, 2023, the Company posted an updated investor presentation to its website at http://ir.stockpr.com/clearpointneuro/investor-presentations. A copy of the investor presentation is being furnished herewith as Exhibit 99.2. 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 99.2 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act 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 | <u>[Press Release](clpt-2023111xexx991.htm)[dated January 11, 2023](clpt-2023111xexx991.htm)</u> |
| Exhibit 99.2 | <u>[Investor Presentation dated](clptirdeckjan23.htm) January 11, 2023</u> |
| Exhibit 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

------

**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: January 11, 2023 | **CLEARPOINT NEURO, INC.** | **CLEARPOINT NEURO, INC.** |
|  | By: | /s/ Danilo D'Alessandro |
|  |  | Danilo D'Alessandro |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

Exhibit 99.1

![image_0.jpg](image_0.jpg)

**ClearPoint Neuro Reports Fourth Quarter and Full Year 2022 Preliminary Revenue Results and Guidance for Full Year 2023 Revenue**

SOLANA BEACH, CA, January 11, 2023 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced preliminary, unaudited financial results for its fourth quarter and full year ended December 31, 2022.

**<u>Fourth Quarter 2022 Preliminary Unaudited Financial Highlights</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Preliminary unaudited revenue of $5.2 million, a 21% year-over-year increase;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Increased biologics and drug delivery revenue to $2.3 million, a 37% year-over-year increase;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Increased functional neurosurgery products and services to $2.3 million, a 7% year-over-year increase;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Cash burn of approximately $3.0 million in the fourth quarter. The Company had approximately $37.5 million in cash, cash equivalents, and short-term investments at December 31, 2022.

**<u>Full Year 2022 Preliminary Unaudited Financial Highlights</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Achieved preliminary unaudited record revenue of $20.6 million, a 26% year-over-year increase, versus most recent guidance of $21.0 - $22.0 million;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Increased biologics and drug delivery revenue to $9.1 million, a 34% year-over-year increase;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Increased functional neurosurgery products and services revenue to $9.1 million, a 13% year-over-year increase;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Added multiple new biologics and drug delivery partners in the year to bring the total to more than 50 partners.

**<u>Business Outlook and Planned Value Creating Milestones</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Company estimates revenue in 2023 to be between $25.0 million and $27.0 million, representing growth between 22% and 31%;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Submission to the FDA of a Biologics License Application (BLA) by PTC Therapeutics for Upstaza<sup>™</sup>, using the ClearPoint SmartFlow<sup>®</sup> Cannula for minimally invasive infusion of the gene therapy;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Initiation of multiple pharmaceutical partner clinical trials globally;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Expansion of the installed base to approximately 10 additional centers worldwide;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Revenue growth from international customers driven by 8 active centers installed in the E.U. and U.K.;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Commercialization of the ClearPoint PRISM<sup>™</sup> Neuro Laser Therapy System and expansion into limited market release centers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Completion of Phase 1 safety study in Lund, Sweden, for the use of PRISM<sup>™</sup> for brain lesions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Up to 8 FDA submissions for new hardware and software products in our portfolio;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Production of first devices at our new expanded manufacturing facility in California.

------

"Our team made tremendous progress toward our four-pillar growth strategy in 2022 and finished the year with approximately 26% growth in revenue, driven by the 34% revenue growth in our biologics and drug delivery business, and 11 new centers installed worldwide," commented Joe Burnett, President and CEO of ClearPoint Neuro. "While recognized revenue in the fourth quarter was below our expectations based on timing and delivery for certain products and services, our backlog of received purchase orders grew to the highest level in our history setting us up for a strong 2023. We are forecasting revenue for 2023 in the range of $25.0 million to $27.0 million, representing growth of between 22% and 31% percent. Our team has done a great job managing our cash position in the past year by pausing less crucial programs while continuing to invest in our supply chain to ensure product availability to hospitals and our pharmaceutical partners. As a result, our cash burn in the fourth quarter was approximately $3.0 million, which was the lowest in several quarters, bringing our current cash, cash equivalents, and short-term investments balance at year end to approximately $37.5 million."

The preliminary unaudited financial results described in the press release are estimates only and subject to revision until we report our full financial results for the fourth quarter and full year 2022 during our upcoming earnings announcement.

**<u>About ClearPoint Neuro</u>**

ClearPoint Neuro's mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Company's current product portfolio include deep brain stimulation, laser ablation, biopsy, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint<sup>®</sup> Neuro Navigation System has FDA clearance, is CE-marked, and is installed in more than 65 sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with more than 50 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 5,000 cases have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners. For more information, please visit www.clearpointneuro.com.

**<u>Forward-Looking Statements</u>**

Statements in this press release covering preliminary financial results for completed periods and expected results in future periods, and statements concerning the Company's 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, the size of total addressable markets or the market opportunity for the Company's products and services, 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 impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company's ClearPoint Neuro Navigation System and other new products offered by the Company; the Company's ability to market, commercialize and achieve broader market acceptance for the Company's ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; and risks inherent in the research, development, and regulatory approval of new 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, 2021, and the Company's Quarterly Report on Form 10-Q for the three months ended September 30, 2022, both of which have been filed with the Securities and Exchange Commission, and the Company's Annual Report on Form 10-

------

K for the year ended December 31, 2022, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2023.

**Contact:**

Danilo D'Alessandro, Chief Financial Officer

(949) 900-6833

info@clearpointneuro.com

Caroline Corner, Investor Relations

ir@clearpointneuro.com

## Exhibit 99.2

![](clptirdeckjan23001.jpg)

TM

------

![](clptirdeckjan23002.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 2 Statements herein concerning the Company's 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, preliminary financial results for completed periods and expected results in future periods, the size of total addressable markets or the market opportunity for the Company's products and services, 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 impact of the COVID-19 pandemic, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company's ClearPoint Neuro Navigation System and other new products offered by the Company; the Company's ability to market, commercialize and achieve broader market acceptance for the Company's ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; and risks inherent in the research, development, and regulatory approval of new 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, 2021, and the Company's Quarterly Report on Form 10-Q for the three months ended September 30, 2022, both of which have been filed with the Securities and Exchange Commission, and the Company's Annual Report on Form 10-K for the year ended December 31, 2022, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2023.

------

![](clptirdeckjan23003.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 3 A Neuro Navigation and Device Company with; • A growing portfolio of Navigation, Therapy and Access Devices supporting DBS, Laser Ablation, Biopsy and Brain Computer Interface implantation • An expanding global installed base of more than 65 centers A Biologics & Drug Delivery Enabling Company with; • A unique portfolio of Navigation Tools, Infusion Cannulas, Pre-Clinical and Clinical Services • More than 50 active pharma/biotech, academic and contract research organization partners • A Common Installed Base Platform and Clinical Specialist Support team • 35 Active Indications totaling more than 1 million patients diagnosed annually • A $12B+ Potential Total Addressable Market 1 2

------

![](clptirdeckjan23004.jpg)

4 100+ $20.6m (A) $37.5m (A) Solana Beach, CA Key Products: Marked Platforms Capital Equipment Razor / Razorblade model with ~95% of revenue from single- use disposables and services 69% (A,C) ~5% ~95% Disposables and Services© 2 0 2 3 C L E A R P O I N T N E U R O Irvine, CA London, UK 75+ (B)

------

![](clptirdeckjan23005.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 5 PRIMARY CHALLENGE For minimally invasive procedures to be successful, the surgeon needs imaging to see into the head MRI is the best imaging tool for the brain Large, metallic frames are not MRI compatible Video source: https://www.youtube.com/watch?v=PsL9B7ftbG4 Big Iron companies like Siemens and Philips are innovating to make interoperative MRI scanners more accessible

------

![](clptirdeckjan23006.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 6 Leverage live MR Imaging to Decide, Guide, Treat and Confirm with sub-millimetric accuracy.

------

![](clptirdeckjan23007.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 7 SmartFrame XG Trajectory Tower with ClearPoint 2.1 Software SmartFrame Array Tower with "virtual array" Software and next generation robotic system with increased automation and enabling software\* ClearPoint plans to translate more than 10 years of experience and over 5,000 cases performed in the complex MRI suite into unique and competitive products for the Operating Room \*Software and Robotic System are currently under development.

------

![](clptirdeckjan23008.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 8 1. Shape Constrained, triangular mesh model enables point- based correspondence across multiple subjects. 2. Fast and capable of peri-procedural imaging without CPU acceleration. 3. This model is the basis for future navigation tools, for both the MRI suite and OR, across Biologics & Drug Delivery, DBS Navigation, Brain Computer Interface, Laser Ablation and more. \*The ClearPoint Maestro™ Brain Model is only available in the United States.

------

![](clptirdeckjan23009.jpg)

------

![](clptirdeckjan23010.jpg)

10 LASER THERAPY VISUALASE CLPT PLATFORM RUNS ON ALL MAJOR SCANNERS© 2 0 2 3 C L E A R P O I N T N E U R O IMPLANT NEURO STIMULATION LEADS … More than 50 total commercial and academic partners DELIVER BIOLOGICS AND DRUGS

------

![](clptirdeckjan23011.jpg)

11© 2 0 2 3 C L E A R P O I N T N E U R O $ M ill io n s $7.4 $11.2 $12.8 $7.4 $5.7$4.6 $3.6 $16.3 $25 $27 $20.6 $2.6 $3.4 $4.0 $5.2 $5.4 $7.1 $6.3 $8.1 $9.1 $0.9 $1.1 $1.0 $1.4 $0.8 $1.7 $1.5 $1.4 $2.3 $0.6 $1.2 $0.8 $0.6 $1.1 $2.4 $5.0 $6.8 $9.1 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Biologics and Drug Delivery Capital and Software Functional Neurosurgery

------

![](clptirdeckjan23012.jpg)

Parkinson's Disease 1,000, 0001 60, 0001 • $270 M - $1.35 B Drug Resistant Epilepsy 1,000, 0002 11, 0003 • $49.5 M - $198 M Refractory Essential Tremor 3,500, 0004 60, 0005 $180 M - $1.08 B Brain Tumors (n=3)6 35, 0007,8 13, 3007,8 $33.3 M - $300 M Severe Obsessive-Compulsive Disorder 500, 0009,10 10, 0009,10 $45 M - $75 M Dystonia 250,00011 8,00012 $36 M - $60 M Rare Genetic/Lysosomal (n=7)13 36,50014-18 3,00014,19,20 $13.5 M - $67.5 M Paralysis / Spinal Cord (n=15)21,22 331,00022-24 17,90023 $80.6 M - $403 M Huntington's Disease 30,00025 4,00025 $18 M - $90 M Auditory Nerve Implant 1,867,00026,27 7,00026,27 $31.5 M - $63 M Alzheimer's Disease 6,000,00028 500,00028 $1.5 B - $11.3 B Severe Major Depressive Disorder 1,000,00010 20,00010,29 $90 M - $150 M Stroke Rehabilitation 2,000,00030 610,00030 $1.83 B - $5.49 B Frontotemporal Dementia 60,00031 12,00031 $54 M – $270 M $4.2 B - $20.8 B© 2 0 2 1 C L E A R P O I N T N E U R O 12 \*Citations & footnotes on next slide Indication Patient Population Annual Incidence Pillar 2: DBS & BCI Pillar 3: Laser Therapy Pillar 1: Drug/Cell Delivery Incremental Revenue from Annual Incidence Pillar 4: Global Expansion Commercial U.S & EU ClearPoint procedures today ~2 X U.S. Revenue Active clinical trial Pre-clinical study/testing

------

![](clptirdeckjan23013.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 13 1. "Parkinson's Disease Statistics," Parkinson's News Today, https://parkinsonsnewstoday.com/parkinsons-disease-statistics/#:~:text=An%20estimated%20seven%20to%2010,who%20are%2080%20and%20older 2. Neurona Therapeutics. (2021 November 4). Neurona Therapeutics Receives IND Clearance to Initiate Phase 1/2 Clinical Trial of Neural Cell Therapy NRTX-1001 in Chronic Focal Epilepsy Patients [Press release] https://www.neuronatherapeutics.com/wp-content/uploads/2021/11/2021_11_01_-INDClearance_FINALVersion.pdf 3. Asadi-Pooya AA, Stewart GR, Abrams DJ, Sharan A. Prevalence and Incidence of Drug-Resistant Mesial Temporal Lobe Epilepsy in the United States. World Neurosurg. 2017;99:662-666. 4. Zesiewicz TA, Chari A, Jahan I, Miller AM, Sullivan KL. Overview of essential tremor. Neuropsychiatr Dis Treat. 2010;6:401-408. Published 2010 Sep 7. 5. Diaz NL, Louis ED. Survey of medication usage patterns among essential tremor patients: movement disorder specialists vs. general neurologists. Parkinsonism Relat Disord. 2010;16(9):604-607. 6. Includes: Glioblastoma, Diffuse Intrinsic Pontine Glioma and deep small eloquent brain tumors. 7. "Glioblastoma Multiforme," American Association of Neurological Surgeons, https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Glioblastoma-Multiforme 8. "About DIPG/DMG," DIPG/DMG Registry, https://dipgregistry.org/patients-families/about-dipg-dmg/ 9. Medtronic Clinical Summary – Reclaim DBS for Chronic Extreme OCD M947128A001. 10. Mantovani A, Lisanby SH. Brain stimulation in the treatment of anxiety disorders. In: Simpson HB, Neria Y, Lewis-Fernández R, Schneier F, eds. Anxiety Disorders: Theory, Research and Clinical Perspectives. Cambridge: Cambridge University Press; 2010:323-335. 11. https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Dystonia 12. Medtronic DBS™ Therapy for Dystonia - Clinical Summary 2015. 13. Includes: AADC deficiency, Friedreich's ataxia, Angelman syndrome, multiple system atrophy, metachromatic leukodystrophy, and spinocerebellar ataxia type 3. 14. "Multiple System Atrophy," Medscape, https://emedicine.medscape.com/article/1154583-overview#a6 15. PTC Therapeutics November 30, 2021 Corporate Presentation, https://ir.ptcbio.com/static-files/0fd5d54f-55b8-416b-8006-4eb4c0d82f45 16. "Spinocerebellar ataxia type 3," Orphanet, https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=98757 17. Lysogene Corporate Presentation at 38th Annual J.P. Morgan Healthcare Conference on Jan 13, 2020, http://www.lysogene.com/wp-content/uploads/2020/01/jpm-2020-corporate-presentation_final.pdf 18. "Metachromatic Leukodystrophy," National Organization of Rare Disorders, https://rarediseases.org/rare-diseases/metachromatic-leukodystrophy/ 19. "Aromatic L'Amino Acid Decarboxylase Deficiency," National Organization for Rare Disorders, https://rarediseases.org/rare-diseases/aromatic-l-amino-acid-decarboxylase-deficiency/ 20. Puckett Y, Mallorga-Hernández A, Montaño AM. Epidemiology of mucopolysaccharidoses (MPS) in United States: challenges and opportunities. Orphanet J Rare Dis. 2021;16(1):241. Published 2021 May 29. 21. Includes: stroke, spinal cord injury, multiple sclerosis, cerebral palsy, other (traumatic brain injury, complications from surgery, amyotrophic lateral sclerosis, neurofibromatosis, Chiari malformation, syringomyelia, postpolio syndrome, spinal muscular atrophy, Friedreich's ataxia, transverse myelitis, and spina bifida). 22. Armour BS, Courtney-Long EA, Fox MH, Fredine H, Cahill A. Prevalence and Causes of Paralysis-United States, 2013. Am J Public Health. 2016;106(10):1855-1857. 23. Wyndaele M, Wyndaele JJ. Incidence, prevalence and epidemiology of spinal cord injury: what learns a worldwide literature survey?. Spinal Cord. 2006;44(9):523-529. 24. National Spinal Cord Injury Statistical Center (NSCISC): 2020 Annual Report and 2021 Facts and Figures. https://www.nscisc.uab.edu/ 25. "Huntington's Disease," Mov Disord. 2019 Jun; 34(6): 858–865. 26. "Cochlear Implants," National Institute on Deafness and Other Communication Disorders, https://www.nidcd.nih.gov/health/cochlear-implants 27. "Cochlear Implant Surgery," Medscape, https://emedicine.medscape.com/article/857242-overview 28. "Alzheimer's Disease: Facts & Figures," Brightfocus Foundation, https://www.brightfocus.org/alzheimers/article/alzheimers-disease-facts-figures 29. Goodman WK, Alterman RL. Deep brain stimulation for intractable psychiatric disorders. Annu Rev Med. 2012;63:511-524. 30. "Stroke Facts," Center for Disease Control and Prevention, https://www.cdc.gov/stroke/facts.htm 31. Onyike CU, Diehl-Schmid J. The epidemiology of frontotemporal dementia. Int Rev Psychiatry. 2013;25(2):130-137.

------

![](clptirdeckjan23014.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 14 First Use in 2022 Expected First Clinical Use by 2025\* Fu n ct io n al N av ig at io n & T h e ra p y B io lo gi cs & D ru g D e liv e ry , A cc e ss T e ch n o lo gi e s ClearPoint Neuro Navigation Software v. 2.1 ClearPoint Maestro™ Brain Model ClearPoint Orchestra™ Head Fixation Frame Maestro Sub-Nuclei Brain Model Revolution™ Robotic-Assisted Navigation Closed Loop Robotic-Assisted Navigation MRI Suite Safe Drill Operating Room Drill ClearPoint Prism™ Neuro Laser Therapy System MR Safe and "Smart" Biopsy Needles Brain Computer Interface Navigation Spinal Infusion Catheter ClearPoint Orchestra™ Pre-Clinical Head Fixation Frame Expanded Pre-Clinical Development Services for Pharma ClearPoint Maestro™ Infusion Modeling App\* Micro-Electric Recording System (MER) ClearPoint Maestro™ Infusion Targeting App CT Based Navigation w/ Maestro Brain Model Flexible, Chronic Drug Delivery Infusion Catheters Patient Digital Health App \*Active Development Project in 2022 internally or through partnerships

------

![](clptirdeckjan23015.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 15 • Simulated training experience for surgeons and staff to perform mock procedures and provide development pipeline feedback • Showcase new technologies to Pharmaceutical and BCI partners • Home for Clinical Specialists to support cases remotely without travel

------

![](clptirdeckjan23016.jpg)

NEW THERAPY DEVICES NEURO NAVIGATION FOR DBS & BCI BIOLOGICS & DRUG DELIVERY 20252022 4 Pillar Growth Strategy by 2025 Target Indications of > 1,000,000 Patients Diagnosed Each Year Potential Total Addressable Market for CLPT of $12B+ Enter the Neuro Laser Therapy Market Launch Maestro Brain Model and Therapy Apps Penetrate 'Access' Markets to Improve Efficiency (Drill) Build the 'Smart' Biopsy Market ACHIEVE GLOBAL SCALE Expand Global Footprint to 100 Centers Open WW Training / Remote Support Facility Launch Robotic Platform into MRI and O.R. Release Digital Health Patient Portal Application© 2 0 2 3 C L E A R P O I N T N E U R O 16 Expand Translational & Clinical Services Accumulate Additional Global Partners Across Diverse Indications Execute on Development Pipeline for Intracranial and Spinal Routes of Administration Expand Partnership Models to Include Milestone Based Collaborative Agreements Expand into the Operating Room, Enter the MER Market Educate Patients on DBS Options including 'Asleep' and 'Awake' Procedures Participate in Trials for new DBS indications Launch surgical solution for Brain-Computer Interfaces (BCI)

------

![](clptirdeckjan23017.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O 17 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 65+ of 500+ leading Neurosurgery and research centers worldwide Expandable Platform with realizable synergies beyond the MRI and into the operating room and radiology suite Pipeline of new revenue streams from product improvements, biologic and drug delivery partnerships and services, standalone therapy products, and Brain Computer Interface Navigation Total potential addressable market > $12B for our products, pipeline and partnerships A growing and passionate team of embedded scientists and specialists

------

![](clptirdeckjan23018.jpg)© 2 0 2 3 C L E A R P O I N T N E U R O

------

![](clptirdeckjan23019.jpg)

------