8-K

Sonendo, Inc. (SONX)

8-K 2023-08-01 For: 2023-08-01
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Added on April 06, 2026

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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): August 01, 2023

Sonendo, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware 001-40988 20-5041718
(State or Other Jurisdiction<br>of Incorporation) (Commission File Number) (IRS Employer<br>Identification No.)
26061 Merit Circle, Suite 102
Laguna Hills, California 92653
(Address of Principal Executive Offices) (Zip Code)
Registrant’s Telephone Number, Including Area Code: (949) 766-3636
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(Former Name or Former Address, if Changed Since Last Report)

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<br>Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.001 per share SONX New York Stock Exchange

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 August 1, 2023, Sonendo, Inc. (the "Company") issued a press release announcing enhancements to its CleanFlow™ Procedure Instrument. A copy of the press release is attached hereto as Exhibit 99.1.

The information contained in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On August 1, 2023, the Company announced enhancements to its CleanFlow™ Procedure Instrument, which are designed to improve its applicability and effectiveness. The CleanFlow™ Procedure Instrument can now be used on anterior teeth (the teeth located at the front of the mouth), replacing the Company’s legacy APM (Anterior Pre-Molar) Procedure Instrument.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description
99.1 Press Release Dated August 1, 2023
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 thereunto duly authorized.

Sonendo, Inc.
Date: August 1, 2023 By: /s/Bjarne Bergheim
Bjarne Bergheim<br>President and Chief Executive Officer

EX-99.1

FOR IMMEDIATE RELEASE

MEDIA CONTACT:

Macy Hyland

Crowe PR

sonendo@crowepr.com

Sonendo's Enhanced CleanFlow™ Procedure Instrument Now Indicated for Use on Anterior Teeth

The GentleWave® Procedure with CleanFlow Technology is now further optimized for advanced performance in complex root canal systems

LAGUNA HILLS, Calif. August 1, 2023 – Sonendo, Inc. (NYSE: SONX), a leading dental technology company and developer of the GentleWave® System, today announced enhancements to its CleanFlow™ Procedure Instrument, which are designed to improve its applicability and effectiveness. The CleanFlow Procedure Instrument can now be used on anterior teeth (the teeth located at the front of the mouth), replacing the Company’s legacy APM (Anterior Pre-Molar) Procedure Instrument.

"We launched CleanFlow Technology last year to simplify workflows for clinicians and enhance the overall patient experience,” said Michael Smith, chief commercial officer of Sonendo. “We remain committed to product innovation and are proud to announce that the CleanFlow Procedure Instrument is now indicated for use on anterior teeth, improving the GentleWave Procedure process for clinicians.”

Through continuous optimization of the manufacturing process, the CleanFlow Procedure Instrument was also refined to direct more of the fluid energy into the tooth.

“I’ve been using the enhanced CleanFlow Procedure Instrument exclusively for all case types, including anterior teeth, for several months. I can confidently say it’s a win for GentleWave System practitioners and their patients,” said Dr. Jim Smith of Advanced Endodontics. “I appreciate the streamlined workflow and only having to use one procedure instrument for all treatment scenarios. We’re seeing that the inside of the tooth, once we’ve completed the GentleWave Procedure, is pristine.”

According to an ongoing clinical study from Sonendo, the GentleWave Procedure with CleanFlow Technology demonstrated three- and six-month healing rates up to three times faster than conventional root canal methods. Additionally, according to a recent study published in The Cureus Journal of Medical Science, the GentleWave System with CleanFlow Technology was found to be significantly more effective than conventional methods at dissolving tissue in an in-vitro model system. The rate of tissue dissolution using the GentleWave System was 7 to 11 times higher than that of laser irrigation and even higher for conventional methods, including syringe needle irrigation and passive ultrasonic irrigation.

The CleanFlow Procedure Instrument is designed for one-handed use, reinforcing why more than one million patients have benefited from the GentleWave Procedure across more than 1,000 GentleWave Systems.

For more information on the GentleWave System, visit https://gentlewave.com/doctor/.

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About Sonendo Sonendo is a commercial-stage medical technology company focused on saving teeth from tooth decay, the most prevalent chronic disease globally. Sonendo develops and manufactures the GentleWave® System, an innovative technology platform designed to treat tooth decay by cleaning and disinfecting the microscopic spaces within teeth without the need to remove tooth structure. The system utilizes a proprietary mechanism of action, which combines procedure fluid optimization, broad-spectrum acoustic energy and advanced fluid dynamics, to debride and disinfect deep regions of the complex root canal system in a less invasive procedure that preserves tooth structure. The clinical benefits of the GentleWave System when compared to conventional methods of root canal therapy include improved clinical outcomes, such as superior cleaning that is independent of root canal complexity and tooth anatomy, high and rapid rates of healing and minimal to no post-operative pain. In addition, the GentleWave System can improve the workflow and economics of dental practices. Sonendo is also the parent company of TDO Software, the developer of widely used endodontic practice management software solutions, designed to simplify practice workflow. TDO Software integrates practice management, imaging, referral reporting and CBCT imaging, and offers built-in communication with the GentleWave System.

For more information on Sonendo, visit www.sonendo.com. For more information on the GentleWave System, visit www.gentlewave.com/doctor.