# EDGAR Filing Document

**Accession Number:** 0001285550
**File Stem:** 0001193125-25-290003
**Filing Date:** 2025-11
**Character Count:** 20186
**Document Hash:** 1da1275d17bb078d1612faa71fc7cc2d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-290003.hdr.sgml**: 20251120

**ACCESSION NUMBER**: 0001193125-25-290003

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20251120

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Completion of Acquisition or Disposition of Assets

**ITEM INFORMATION**: Unregistered Sales of Equity Securities

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251120

**DATE AS OF CHANGE**: 20251120

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ClearPoint Neuro, Inc.
- **CENTRAL INDEX KEY:** 0001285550
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 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:** 251503875

**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' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** November 20, 2025<br>

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CLEARPOINT NEURO, INC.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-34822 | 58-2394628 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 120 S. Sierra Ave., Suite 100 |  |  |
| Solana Beach**,** California |  | 92075 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 888 287-9109<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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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:**

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

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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. ☐

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## Item 1.01 Entry into a Material Definitive Agreement.
The information reported in Item 2.01 is incorporated by reference into this Item 1.01.

## Item 2.01 Completion of Acquisition or Disposition of Assets.
The information reported in Item 3.02 is incorporated by reference into this Item 2.01.

*Merger Agreement with IRRAS Holdings, Inc.*

On November 20, 2025 (the "Closing Date"), ClearPoint Neuro, Inc., a Delaware corporation (the "Company"), completed its acquisition of IRRAS Holdings, Inc., a Delaware corporation ("IRRAS"), pursuant to the previously announced Agreement and Plan of Merger and Reorganization (the "Merger Agreement") with Ignite Merger Sub, Inc., a Delaware corporation and a direct wholly-owned subsidiary of the Company ("First Merger Sub"), ClearPoint Holdings, LLC, a Delaware limited liability company and a direct wholly-owned subsidiary of the Company ("Second Merger Sub"), IRRAS, the seller representative and the equityholders of IRRAS that are parties to the Merger Agreement. Pursuant to the Merger Agreement, the First Merger Sub merged with and into IRRAS (the "First Merger"), with IRRAS surviving the First Merger, and, immediately following the First Merger, IRRAS merged with and into the Second Merger Sub (the "Second Merger" and together with the First Merger, the "Merger"), with the Second Merger Sub surviving the Second Merger.

*Merger Consideration*

Pursuant to the Merger Agreement, the Company delivered closing consideration of $5,000,000 in cash and 1,325,000 shares of Company common stock to IRRAS shareholders (the "Closing Shares").

*Earnout Consideration*

As additional consideration for IRRAS' stockholders, the Merger Agreement provides for the Company to pay earnout consideration during three one-year earnout periods equal to 25% of net sales of certain IRRAS products above certain thresholds.

## Item 3.02 Unregistered Sales of Equity Securities.
The information reported in Item 2.01 is incorporated by reference into this Item 3.02.

The Company delivered the Closing Shares as closing consideration for the Merger on the Closing Date. The issuance of the Closing Shares was not registered under the Securities Act of 1933, as amended (the "Securities Act") or any state securities laws, and the Closing Shares may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. The Closing Shares were issued in a private transaction in reliance upon exemptions from registration under Section 4(a)(2) under the Securities Act and Regulation D promulgated thereunder to persons reasonably believed to be "accredited investors" as defined in Rule 501 under the Securities Act, or pursuant to Regulation S under the Securities Act to non-U.S. persons outside the United States.

Pursuant to the Merger Agreement, the Company may issue up to 1,325,000 shares of its common stock. Of the 1,325,000 shares of common stock, the Company retained 15,000 shares to cover any deficit in the post-closing working capital adjustment and 190,000 shares to securing IRRAS's indemnification obligations under the Merger Agreement. The Company has the right, but not the obligation, to deliver additional shares of its common stock as a post-closing working capital adjustment. The Company may also deliver up to 205,000 shares of its common stock to the extent they are not cancelled in connection with post-closing working capital adjustment or post-closing indemnification claims. Any such additional issuances of the Company's common stock pursuant to the Merger Agreement are also expected to be issued in reliance upon exemptions from registration under the Securities Act.

*Registration Rights*

Pursuant to the Merger Agreement, the Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock of the Company to be issued in connection with the Merger within 30 days of the closing date of the Merger.

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

Statements in this Current Report and 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, including, but not limited to the expectations for expansion of the Company's market reach, portfolio of neurosurgical technologies and biologics and drug delivery platforms and commercial scale; the Company's positioning to serve patients, hospital systems and biopharma partners with its combined technology and product portfolio; and the Company's ability to drive meaningful value for its stakeholders, are forward-looking

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statements within the meaning of these laws. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which 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 possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the successful integration of IRRAS Holdings, Inc. into the Company; the size of total addressable markets or the market opportunity for the IRRAS products; the Company's expectation for revenues for the IRRAS products; the Company's expectations for operating expenses and the adequacy of cash and cash equivalent balances to support operations and meet the future obligations of the combined entity; the Company's ability to market, commercialize and achieve broader market acceptance for the IRRAS products; risks in the development, marketing, or regulatory approval of the IRRAS products for use in specific drug delivery applications; diversion of management's attention on integration of IRRAS Holdings, Inc.; the Company's ability to retain key employees after the consummation of the transaction; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; and the ability of the Company to manage the growth of its business. For a detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

## Item 7.01 Regulation FD Disclosure.
On November 20, 2025, the Company issued a press release announcing the closing of the Merger, a copy of which is attached and furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.

## Item 9.01 Financial Statements and Exhibits.
(a) Financial statements of business acquired.

The Company intends to amend this Current Report on Form 8-K to provide the financial statements of IRRAS to the extent and within the time required by Item 9.01(a) of Form 8-K.

(b) Pro forma financial information.

The Company intends to amend this Current Report on Form 8-K to provide pro forma financial information relative to the acquisition of IRRAS, to the extent and within the time required by Item 9.01(b) of Form 8-K.

(d) Exhibits.

The following exhibits are furnished herewith:

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| | |
|:---|:---|
| Exhibit 10.1 | [<u>Agreement and Plan of Merger and Reorganization, dated November 6, 2025, by and among the Company, Ignite Merger Sub, Inc., ClearPoint Holdings, LLC, IRRAS Holdings, Inc. and the Seller Representative (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K, filed with the SEC on November 6, 2025)</u>](https://www.sec.gov/Archives/edgar/data/1285550/000119312525269992/clpt-ex10_1.htm) |
| Exhibit 99.1 | [<u>Press Release dated November 20, 2025</u>](clpt-ex99_1.htm) |
| Exhibit 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | CLEARPOINT NEURO, INC. |
| Date: | November 20, 2025 | By:  | /s/ Danilo D'Alessandro |
|  |  |  | Danilo D'Alessandro<br>Chief Financial Officer |

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## Exhibit 99.1

Exhibit 99.1

![img164205336_0.jpg](img164205336_0.jpg)

**ClearPoint Neuro Completes Acquisition of IRRAS**

**Acquisition Will Enhance ClearPoint Neuro's Commercial Scale, Drive Operational Leverage, and Support Its Long-Term Strategy in CNS Drug Delivery Innovation**

SOLANA BEACH, CA, November 20, 2025 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that it has completed its previously announced acquisition of IRRAS Holdings, Inc. ("IRRAS"). The transaction closed on November 20, 2025 following receipt of IRRAS shareholder approval and satisfaction or waiver of all required closing conditions.

Under the terms of the merger agreement previously announced, the Company paid $5.0 million in cash and issued 1,325,000 shares of its common stock to IRRAS shareholders. The merger agreement also provides for the Company to pay a revenue share on net sales of certain IRRAS products for specific periods. IRRAS' results of operations commencing on the closing date will be reflected in the Company's consolidated results of operations for the fourth quarter of 2025 and for future periods.

The acquisition brings to the Company the novel IRRA*flow* active fluid-exchange system, a differentiated technology designed to modernize the management of intracranial bleeding. IRRAS also adds to the Company more than 50 active customers and an expansive commercial team of marketing, sales, and clinical specialists. The Company expects that the addition of these resources will further expand its presence to neurocritical care and complement its existing portfolio of neurosurgical technologies and biologics and drug delivery platforms.

"Closing the acquisition of IRRAS is a significant milestone in our strategy to build the leading platform for neuro drug delivery," said Joe Burnett, President and Chief Executive Officer of ClearPoint Neuro. "With IRRA*flow* now part of ClearPoint Neuro's portfolio, we believe that we are in a better position to serve patients, hospital systems and our biopharma partners by combining a differentiated neurocritical care technology with our existing navigation and therapy delivery ecosystem. We believe that the expanded footprint and enhanced commercial scale that IRRAS brings to ClearPoint Neuro will drive meaningful value for our stakeholders."

Will Martin, the former President and Chief Executive Officer of IRRAS, said, "Leading IRRAS through the development and expansion of the IRRA*flow* technology has been an extraordinary privilege. I believe ClearPoint Neuro is the right organization to take this technology forward, deepen its clinical impact, and extend its reach to benefit even more hospitals and patients. I look forward to seeing the progress the combined team will achieve in the years ahead."

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

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and

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research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.

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

Statements in this press release 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, including, but not limited to the expectations for expansion of the Company's market reach, portfolio of neurosurgical technologies and biologics and drug delivery platforms and commercial scale; the Company's positioning to serve patients, hospital systems and biopharma partners with its combined technology and product portfolio; and the Company's ability to drive meaningful value for its stakeholders, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which 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 possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the successful integration of IRRAS Holdings, Inc. into the Company; the size of total addressable markets or the market opportunity for the IRRAS products; the Company's expectation for revenues for the IRRAS products; the Company's expectations for operating expenses and the adequacy of cash and cash equivalent balances to support operations and meet the future obligations of the combined entity; the Company's ability to market, commercialize and achieve broader market acceptance for the IRRAS products; risks in the development, marketing, or regulatory approval of the IRRAS products for use in specific drug delivery applications; diversion of management's attention on integration of IRRAS Holdings, Inc.; the Company's ability to retain key employees after the consummation of the transaction; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; and the ability of the Company to manage the growth of its business. For a detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

**Contact:** 

Investor Relations:

Danilo D'Alessandro, Chief Financial Officer

(888) 287-9109 ext. 3

ir@clearpointneuro.com

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