March 28, 2025, 00:05 ET | Source: Keystone Dental Group

Irvine, CA – March 27, 2025 – Keystone Dental Holdings, Inc. announced the appointment of Tony Susino as Chief Executive Officer and member of its Board of Directors, effective immediately.

“Tony brings a proven track record of clear strategic vision, commercial success, and principled leadership,” said Uri Geiger, Chairman of the Board. “He is the ideal leader to guide Keystone through its next chapter of innovation and global expansion. We are also deeply grateful to Melker Nilsson for his leadership as CEO since 2019—and his many contributions during a pivotal period for the company.”

Mr. Susino has held executive roles at leading healthcare companies, including Dentsply Sirona, Henry Schein, LifeScan, and The Straumann Group. Most recently, he led the global implant and prosthetics business unit at Dentsply Sirona, overseeing a broad portfolio of implant, regenerative, and laboratory solutions. Throughout his career, he has driven commercial expansion and helped shape global strategy in implant dentistry.

“We are entering a new era at Keystone—one grounded in integrity, optimism, and a relentless commitment to our customers and the patients they serve,” said Tony Susino. “I’m energized to work alongside this outstanding team to redefine what’s possible in dental surgical technology, drive extraordinary growth, and deliver innovations that elevate care worldwide.”

About Tony Susino

Tony Susino is a seasoned global dental industry executive. He serves as Chief Executive Officer and member of the Board of Directors at Keystone Dental Holdings. Previously, he led Dentsply Sirona’s global implant and prosthetics business unit and held leadership roles at LifeScan, Henry Schein, and the Straumann Group, where he served as CEO of Neodent, USA. He serves on the Boards of Advisors at the Harvard University School of Dental Medicine, and High Point University Workman School of Dental Medicine. He is an alumnus of St. Francis College and Columbia Business School’s Advanced Management Program.

About Keystone Dental Holdings, Inc.

Keystone Dental is a global medical technology company delivering end-to-end solutions for tooth replacement procedures. With facilities in Burlington, MA; Irvine, CA; Caesarea, Israel; and Melbourne, Australia, Keystone provides a comprehensive portfolio of dental implants, prosthetics, biomaterials, and digital workflow solutions distributed globally in more than 35 countries.

The company’s portfolio includes a proprietary and comprehensive suite of dental implant systems including Genesis Active™, Paltop Dynamic, and Prima Plus Conical™. The biomaterials portfolio includes DynaMatrix® extracellular membrane, Dyna Blast® and Accell Connex® bone graft substitutes. Through its company Osteon Medical, Keystone offers a full range of prosthetic and digital workflow capabilities including the patented Nexus iOS® full-arch restorative solution.

Keystone continues to expand globally and invest in digital innovation to support the evolving needs of clinicians and patients.

For more information, visit www.keystonedental.com.

For media inquiries, please contact: Gisela Landreville Vice President, Global Marketing glandreville@keystonedental.com Tel: (949)290-2100

November 28, 2023 11:42 ET | Source: Keystone Dental Group

Q3 revenue increased 18.9% year-over-year to $16.8M, including $11.9M from the U.S.

Check-Cap shareholders to vote on proposed Business Combination Agreement with Keystone Dental at Annual General Meeting on Monday, December 18th, 2023

IRVINE, Calif., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Keystone Dental Holdings (“Keystone Dental” or the “Company”), a pioneer in dental implant technology, announced today financial results and provided a corporate update for the third quarter and nine months ended September 30, 2023.

“We are pleased by the increased revenue growth over the first few quarters of 2023. This growth coincides with the exciting expansion of our portfolio of products and services over the past year. This momentum is expected to continue to build with the recent launch of several groundbreaking new products, including the GENESIS ACTIVE™ Implant System and Nexus Connect,” commented Melker Nilsson, CEO of Keystone Dental.

Recent Financial Results and Business Highlights

Sustained Revenue Growth – Total third quarter 2023 revenue increased 18.9% to $16.8 million compared to the same period in 2022, which was driven by increased sales of dental implants and Osteon product groups. Total revenue for the nine months ended September 30, 2023 increased 12.7% to $50.2 million compared to the same period in 2022. Revenue generated in the U.S. totaled $11.9 million in the third quarter of 2023 and $35.9 million for the nine months ended September 30, 2023.

GENESIS ACTIVE™ Implant System Commercial Launch – Keystone Dental announced the commercial launch of GENESIS ACTIVE™ Implant System, a state-of-the-art surgical and prosthetic solution that is expected to transform how dental professionals approach implant placement and restoration. The system contains an innovative restorative portfolio of dental implant technologies in one system that enables dental professionals to deliver implant treatments with greater efficiency.
Nexus Connect Market Launch – Keystone Dental announced market launch of Nexus Connect, a unique software solution that utilizes proprietary technology and a machine-learning model to analyze implant scans performed with an intraoral scanner. The Nexus Connect employs proprietary 3D computer vision algorithms and geometric processing to detect Nexus Scan Gauges, segment them from tissue, and calculate their positions to ensure the captured data can proceed to prosthetic design. The analysis mechanism is a mathematical regression model based on thousands of completed real-world cases enabling immediate scan data results at the source of capture.

Patent for Nexus IOS Solution – Keystone Dental announced that the United States Patent and Trademark Office (USPTO) has granted Osteon Medical, a subsidiary of Keystone Dental, a patent for the innovative Nexus IOS solution. The Nexus iOS Scan Gauge technology allows implant dentists to perform direct full-arch implant scans using an Intraoral Scanner with predictable and passive fitting prosthetic outcomes. This technology replaces the traditionally manual impression-taking process through a faster, cost-effective, and accessible workflow. Appointed Industry Veteran to Lead Osteon Medical Subsidiary – Appointed Greg Minzenmayer as Vice President & Global General Manager for Osteon Medical, a leading digital dentistry technology company acquired by Keystone Dental in 2021.

Propose Business Combination Agreement with Check-Cap

In August 2023, Keystone Dental and Check-Cap announced entering into a definitive Business Combination Agreement (the "Business Combination Agreement") under which the stockholders of Keystone Dental will become the majority holders of the combined company. If completed, the business combination will create a public company headquartered in Irvine, CA and focused on advancing commercial execution and market development of Keystone Dental’s comprehensive portfolio of implants, full arch restorations, and other tooth replacement solutions, in addition to biomaterial and digital dentistry capabilities. Upon closing of the transaction, the combined company will trade on the NASDAQ under the symbol “KSD.” The executive team of Keystone Dental will serve as the executive team of the combined company, led by Melker Nilsson, Keystone’s Chief Executive Officer.

Check-Cap has scheduled an Annual General Meeting of Shareholders (the “Meeting”) to be held on Monday, December 18, 2023 at 2:00 p.m. (Israel time) at the offices of Check-Cap’s Israeli legal counsel, FISCHER (FBC & Co.), located at 146 Menachem Begin Rd., Tel Aviv 6492103, Israel. At the Meeting, investors will be asked to consider and vote on several proposals, including a proposal to approve the Business Combination Agreement. Only shareholders of record at the close of business on November 10, 2023, are entitled to notice of and to vote at the Meeting or at any adjournment thereof.

About Keystone Dental Group:
Keystone Dental is a global commercial-stage medical technology company focused on providing end-to-end tooth replacement solutions for dental practitioners. Headquartered in Irvine, California, and with research and development and manufacturing sites in Caesarea, Israel and Melbourne, Australia, Keystone Dental markets its products worldwide. The Company's product portfolio includes proprietary offerings such as its innovative implant systems Genesis Active, Molaris™ and Prima Plus™ that offer unique solutions to dental practitioners. In addition, the Company also offers an attractive dental implant value brand in Paltop, and a well-regarded portfolio of biomaterials mainly sold under the DYNA brand. Keystone Dental acquired Implant Solutions Pty Ltd ("Osteon") in 2021, adding a comprehensive portfolio of prosthetic solutions on implants and digital workflow capabilities, not least of which is the groundbreaking Nexus iOS digital workflow solution for restoring the fully edentulous patient. For more information, refer to www.keystonedental.com.

About Check-Cap
Check-Cap (NASDAQ: CHEK) is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, a screening test designed to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. C-Scan is an investigational device and is not available for sale in the United States.

Important Additional Information and Where to Find It
In connection with the business combination, a newly formed wholly owned subsidiary of Keystone Dental (“Keystone Parent”) has filed with the SEC a registration statement on Form S-4 and that will constitute a prospectus with respect to shares of common stock of Keystone Parent to be issued in the business combination and Check-Cap has delivered a proxy statement to its shareholders in connection with the annual general meeting of its shareholders. Check-Cap and Keystone Parent may also file other documents with the SEC regarding the business combination. This press release is not a substitute for the prospectus or any other document which Keystone Parent or Check-Cap may file with the SEC. INVESTORS, KEYSTONE SECURITY HOLDERS AND CHECK-CAP SECURITY HOLDERS ARE URGED TO READ THE PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED BY KEYSTONE PARENT OR CHECK-CAP WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE BUSINESS COMBINATION AND RELATED MATTERS. Investors, Keystone security holders and Check-Cap security holders will also be able to obtain free copies of the prospectus and other documents containing important information about Check-Cap, Keystone and the business combination that are or will be filed with the SEC by Check-Cap or Keystone through the website maintained by the SEC at www.sec.gov.

Participants in the Solicitation
Check-Cap, Keystone Parent and their respective directors and executive officers may be deemed under SEC rules to be participants in the solicitation of proxies from the shareholders of Check-Cap in connection with the business combination. Information about Check-Cap's directors and executive officers is set forth in Check-Cap's Annual Report on Form 20-F for the year ended December 31, 2022 which was filed with the SEC on March 31, 2023. Information about Keystone Dental's directors and executive officers is set forth in the prospectus. Other information regarding the interests of such individuals, as well as information regarding other persons who may be deemed participants in the business combination, is set forth in the prospectus, the proxy statement and other relevant materials filed or submitted with the SEC. Investors, Keystone security holders and Check-Cap security holders and other readers should read the prospectus and the proxy statement carefully before making any voting or investment decisions.

No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Legal Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements”. Forward-looking statements include, but are not limited to, statements regarding expectations, hopes, beliefs, intentions or strategies of Check-Cap and/or Keystone Dental regarding the future including, without limitation, statements regarding Keystone’s technology and the benefits of tooth replacement solutions, expectations regarding the ownership structure of the combined company, and the structure, timing and completion of the proposed business combination. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions; the outcome of any legal proceedings that may be instituted against Keystone Dental or Check-Cap following the announcement of the business combination; the inability to complete the business combination, including due to the inability to concurrently close the business combination or due to failure to obtain approval of the shareholders of Check-Cap; delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals, or delays in completing regulatory reviews, required to complete the business combination; the risk that the business combination disrupts current plans and operations as a result of the announcement and consummation of the business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth, maintain relationships with customers and suppliers and retain key employees; costs related to the business combination; the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors; other risks and uncertainties indicated from time to time in the registration statement on Form S-4 filed by Keystone Parent with the SEC and other risks, uncertainties and factors set forth under “Risk Factors” therein as well as in the section entitled “Risk Factors,” in Check-Cap’s Report on Form 6-K furnished to the SEC on August 4, 2023, and its other filings with the SEC, as well as factors associated with companies, such as Keystone and Check-Cap, that operate in the life science industry. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Neither Check-Cap nor Keystone undertakes or accepts any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or in the events, conditions or circumstances on which any such statement is based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Keystone, Check-Cap or the combined company.

Jeremy Feffer
LifeSci Advisors
212-915-2568
jfeffer@lifesciadvisors.com

November 13, 2023, 16:05 ET

IRVINE, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Keystone Dental Holdings (“Keystone Dental” or the “Company”), a pioneer in dental implant technology, announced today the commercial launch of GENESIS ACTIVE™ Implant System, a state-of-the-art surgical solution that is expected to transform how dental professionals approach implant placement and restoration.

“The GENESIS ACTIVE Implant System is a game-changing innovation that marks a new area in dental implantology. With a solid commitment to meaningful innovation, patient care, and scientifically proven concepts, we aim to redefine the standard of implant procedures,” said Melker Nilsson, CEO of Keystone Dental. “The GENESIS ACTIVE Dental Implant System brings together a robust portfolio of dental implant technologies into a single solution that is intended to empower dental professionals to deliver clinically proven implant treatment with greater efficiency.”

The GENESIS ACTIVE Implant System is a comprehensive, innovative restorative portfolio of solutions that is backed by over a decade of research and development. The system offers one connection, three emergence profiles, and multiple restorative platforms facilitating aesthetic restorations that follow the natural tooth contour while simplifying the restorative protocol. The GENESIS ACTIVE Implant System brings together:

AnaTite™ - a cutting-edge, gradual pink anodization process on the coronal aspect designed to emulate the hue of natural soft tissue. BioSpark™ - a proven surface treatment covering the remainder of the implant body, mimicking natural bone, promoting bone growth and fast osseointegration, making the GENESIS ACTIVE Implant System beneficial for immediate load protocols.

Digital Guidance Sleeve (DGS) – allows a GENESIS ACTIVE implant to be placed guided by engaging the handpiece, eliminates the need for drill guide keys, and allows for an increased entry angle in limited posterior interarch spaces.

GENESIS ACTIVE conical implant connection - creates a secure implant-to-abutment interface, offering a bacterial barrier and high mechanical stability.

Multi-Unit Abutments solutions – a line of pink premium abutments with concave profiles designed to reduce the need for bone profiling. The complete line of digital Multi-Unit abutment prosthetics, offer an ANGLEBase® Abutment which features a 0° to 25° of angle correction in a 360° radius. ELLIPTIBase® Abutment – a solution for areas of limited interdental space. Allowing up to 20° angle correction for screw-retained solutions. The SelectGrip® - a new and innovative abutment surface, improves restorative adhesion to the final prosthetic, thus completing the diverse range of restorative innovations.

About Keystone Dental Group:
Keystone Dental is a global commercial-stage medical technology company focused on providing end-to-end tooth replacement solutions for dental practitioners. Headquartered in Irvine, California, and with research and development and manufacturing sites in Caesarea, Israel and Melbourne, Australia, Keystone Dental markets its products worldwide. The Company's product portfolio includes proprietary offerings such as its innovative implant systems Genesis Active, Molaris™ and Prima Plus™ that offer unique solutions to dental practitioners. In addition, the Company also offers an attractive dental implant value brand in Paltop, and a well-regarded portfolio of biomaterials mainly sold under the DYNA brand. Keystone Dental acquired Implant Solutions Pty Ltd ("Osteon") in 2021, adding a comprehensive portfolio of prosthetic solutions on implants and digital workflow capabilities, not least of which is the groundbreaking Nexus iOS digital workflow solution for restoring the fully edentulous patient. For more information, refer to www.keystonedental.com.

Proposed Business Combination Agreement
In August 2023, Keystone Dental and Check-Cap Ltd. ("Check-Cap") (NASDAQ: CHEK) announced entering into a definitive Business Combination Agreement (the "Business Combination Agreement") under which the stockholders of Keystone Dental will become the majority holders of the combined company. If completed, the business combination will create a public company headquartered in Irvine, CA and focused on advancing commercial execution and market development of Keystone Dental’s comprehensive portfolio of implants, arches and other tooth replacement solutions comprised of restoration products, prosthetic solutions, biomaterial, and digital dentistry capabilities. Upon closing of the transaction, the combined company will trade on the NASDAQ under the symbol “KSD.” The executive team of Keystone Dental will serve as the executive team of the combined company, led by Melker Nilsson, Keystone’s Chief Executive Officer.

About Check-Cap
Check-Cap (NASDAQ: CHEK) is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, a screening test designed to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. C-Scan is an investigational device and is not available for sale in the United States.

Important Additional Information and Where to Find It
In connection with the business combination, a newly formed wholly owned subsidiary of Keystone Dental (“Keystone Parent”) has filed with the SEC a registration statement on Form S-4 and that will constitute a prospectus with respect to shares of common stock of Keystone Parent to be issued in the business combination and Check-Cap intends to deliver a proxy statement to its shareholders in connection with the special meeting of its shareholders. Check-Cap and Keystone Parent may also file other documents with the SEC regarding the business combination. This press release is not a substitute for the prospectus or any other document which Keystone Parent or Check-Cap may file with the SEC. INVESTORS, KEYSTONE SECURITY HOLDERS AND CHECK-CAP SECURITY HOLDERS ARE URGED TO READ THE PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED BY KEYSTONE PARENT OR CHECK-CAP WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE BUSINESS COMBINATION AND RELATED MATTERS. Investors, Keystone security holders and Check-Cap security holders will also be able to obtain free copies of the prospectus (when available) and other documents containing important information about Check-Cap, Keystone and the business combination that are or will be filed with the SEC by Check-Cap or Keystone through the website maintained by the SEC at www.sec.gov.

Participants in the Solicitation
Check-Cap, Keystone Parent and their respective directors and executive officers may be deemed under SEC rules to be participants in the solicitation of proxies from the shareholders of Check-Cap in connection with the business combination. Information about Check-Cap's directors and executive officers is set forth in Check-Cap's Annual Report on Form 20-F for the year ended December 31, 2022 which was filed with the SEC on March 31, 2023. Information about Keystone Dental's directors and executive officers will be set forth in the prospectus (when available). Other information regarding the interests of such individuals, as well as information regarding other persons who may be deemed participants in the business combination, will be set forth in the prospectus, the proxy statement and other relevant materials to be filed or submitted with the SEC when they become available. Investors, Keystone security holders and Check-Cap security holders and other readers should read the prospectus and the proxy statement carefully when they become available before making any voting or investment decisions.

No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Legal Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements”. Forward-looking statements include, but are not limited to, statements regarding expectations, hopes, beliefs, intentions or strategies of Check-Cap and/or Keystone Dental regarding the future including, without limitation, statements regarding Keystone’s technology and the benefits of tooth replacement solutions, expectations regarding the ownership structure of the combined company, and the structure, timing and completion of the proposed business combination. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions; the outcome of any legal proceedings that may be instituted against Keystone Dental or Check-Cap following the announcement of the business combination; the inability to complete the business combination, including due to the inability to concurrently close the business combination or due to failure to obtain approval of the shareholders of Check-Cap; delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals, or delays in completing regulatory reviews, required to complete the business combination; the risk that the business combination disrupts current plans and operations as a result of the announcement and consummation of the business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth, maintain relationships with customers and suppliers and retain key employees; costs related to the business combination; the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors; other risks and uncertainties indicated from time to time in the registration statement on Form S-4 filed by Keystone Parent with the SEC and other risks, uncertainties and factors set forth under “Risk Factors” therein as well as in the section entitled “Risk Factors,” in Check-Cap’s Report on Form 6-K furnished to the SEC on August 4, 2023, and its other filings with the SEC, as well as factors associated with companies, such as Keystone and Check-Cap, that operate in the life science industry. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Neither Check-Cap nor Keystone undertakes or accepts any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or in the events, conditions or circumstances on which any such statement is based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Keystone, Check-Cap or the combined company.

Contact:
Jeremy Feffer
LifeSci Advisors
212-915-2568
jfeffer@lifesciadvisors.com

Nexus Connect is a free software that provides real-time chairside results - designed to compare intraoral scan gauge scans and give users direct feedback regarding the accuracy of their implant scans

November 06, 2023, 17:08 ET

IRVINE, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Keystone Dental Holdings (“Keystone Dental” or the “Company”), announced today the market launch of Nexus Connect (the “system”), a unique software system that utilizes proprietary technology and a machine-learning model to analyze implant scans performed with an intraoral scanner.

The system employs proprietary 3D computer vision algorithms and geometric processing to detect Nexus Scan Gauges, segment them from tissue, and calculate their positions to ensure the captured data can proceed to prosthetic design. The analysis mechanism is a mathematical regression model based on thousands of completed real-world cases enabling immediate scan data results at the source of capture.

For the first time, implant clinicians can get chairside results that indicate the quality and accuracy of their digital implant-scans. A successful result using Nexus Connect denotes that a prosthetic device manufactured by Osteon Medical, which Keystone Dental acquired in September 2021, using this data will achieve a passive fit prior to production. They AI enabled technology also provide feedback how to improve the scan is it is unsuccessful.

“We are proud to be able to offer Nexus Connect to all Nexus Users globally. The introduction of this A.I. enabled intraoral implant-scan analyzer software represents another example of Osteon Medical bringing forward a paradigm shift in the world of digital implant dentistry," said Melker Nilsson, CEO of Keystone Dental. “Nexus Connect was developed over a two-year period, beginning as an engineering assessment tool and expanding to become a sophisticated doctor facing analyzer. We are excited to see this innovative system come to the market to help dentists ensure that a prosthetic fits a patient the first time."

“We are excited to bring this software into the hands of our users and help them streamline their treatment cycles whilst improving on predictability,” said Michael Tuckman, Chief R&D Officer of Keystone Dental, founder of Osteon Medical, and inventor of Nexus iOS Scan Gauge technology.

The Nexus Connect PC startup page

Nexus Connect launches on a PC. Visit www.nexusios.com/nexus-connect to download Nexus Connect.

The Nexus Connect Offers Clear Outcomes

Upon uploading a patient’s scans of 2.0 Scan gauges in both Left to Right and Right to Left sequences and following a few steps, a dentist will receive one of three outcomes: SUCCESS, CONSIDER RESCAN, SCAN FAILURE. Above is an example of a successful scan that passed alignment analysis, allowing a dentist to confidently continue to order a Nexus prosthesis.

About Keystone Dental Group:
Keystone Dental is a global commercial-stage medical technology company focused on providing end-to-end tooth replacement solutions for dental practitioners. Headquartered in Irvine, California, and with research and development and manufacturing sites in Caesarea, Israel and Melbourne, Australia, Keystone Dental markets its products worldwide. The Company's product portfolio includes proprietary offerings such as its highly innovative implant systems Genesis Active, Molaris™ and Prima Plus™ that offers unique solutions to the dental practitioners. In addition, the Company also offers an attractive dental implant value brand in Paltop, and a well-regarded portfolio of biomaterials mainly sold under the DYNA brand. Keystone Dental acquired Implant Solutions Pty Ltd ("Osteon") in 2021, adding a comprehensive portfolio of prosthetic solutions on implants and digital workflow capabilities, not least the groundbreaking Nexus iOS digital workflow solution for restoring the fully edentulous patient. For more information, refer to www.keystonedental.com.

Proposed Business Combination Agreement
In August 2023, Keystone Dental and Check-Cap Ltd. ("Check-Cap" or the “Company”) (NASDAQ: CHEK) announced entering into a definitive Business Combination Agreement (the "Business Combination Agreement") under which the stockholders of Keystone Dental will become the majority holders of the combined company. If completed, the business combination will create a public company headquartered in Irvine, CA and focused on advancing commercial execution and market development of Keystone Dental’s comprehensive portfolio of implants, arches and other tooth replacement solutions comprised of restoration products, prosthetic solutions, biomaterial, and digital dentistry capabilities. Upon closing of the transaction, the combined company will trade on the NASDAQ under the symbol “KSD.” The executive team of Keystone Dental will serve as the executive team of the combined company, led by Melker Nilsson, Keystone’s Chief Executive Officer.

About Check-Cap
Check-Cap (NASDAQ: CHEK) is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, a screening test designed to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. C-Scan is an investigational device and is not available for sale in the United States.

Important Additional Information and Where to Find It
In connection with the business combination, a newly formed wholly owned subsidiary of Keystone Dental (“Keystone Parent”) has filed with the SEC a registration statement on Form S-4 and that will constitute a prospectus with respect to shares of common stock of Keystone Parent to be issued in the business combination and Check-Cap intends to deliver a proxy statement to its shareholders in connection with the special meeting of its shareholders. Check-Cap and Keystone Parent may also file other documents with the SEC regarding the business combination. This press release is not a substitute for the prospectus or any other document which Keystone Parent or Check-Cap may file with the SEC. INVESTORS, KEYSTONE SECURITY HOLDERS AND CHECK-CAP SECURITY HOLDERS ARE URGED TO READ THE PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED BY KEYSTONE PARENT OR CHECK-CAP WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE BUSINESS COMBINATION AND RELATED MATTERS. Investors, Keystone security holders and Check-Cap security holders will also be able to obtain free copies of the prospectus (when available) and other documents containing important information about Check-Cap, Keystone and the business combination that are or will be filed with the SEC by Check-Cap or Keystone through the website maintained by the SEC at www.sec.gov.

Participants in the Solicitation
Check-Cap, Keystone Parent and their respective directors and executive officers may be deemed under SEC rules to be participants in the solicitation of proxies from the shareholders of Check-Cap in connection with the business combination. Information about Check-Cap's directors and executive officers is set forth in Check-Cap's Annual Report on Form 20-F for the year ended December 31, 2022 which was filed with the SEC on March 31, 2023. Information about Keystone Dental's directors and executive officers will be set forth in the prospectus (when available). Other information regarding the interests of such individuals, as well as information regarding other persons who may be deemed participants in the business combination, will be set forth in the prospectus, the proxy statement and other relevant materials to be filed or submitted with the SEC when they become available. Investors, Keystone security holders and Check-Cap security holders and other readers should read the prospectus and the proxy statement carefully when they become available before making any voting or investment decisions.

No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Legal Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements”. Forward-looking statements include, but are not limited to, statements regarding expectations, hopes, beliefs, intentions or strategies of Check-Cap and/or Keystone Dental regarding the future including, without limitation, statements regarding Keystone’s technology and the benefits of tooth replacement solutions, expectations regarding the ownership structure of the combined company, and the structure, timing and completion of the proposed business combination. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions; the outcome of any legal proceedings that may be instituted against Keystone Dental or Check-Cap following the announcement of the business combination; the inability to complete the business combination, including due to the inability to concurrently close the business combination or due to failure to obtain approval of the shareholders of Check-Cap; delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals, or delays in completing regulatory reviews, required to complete the business combination; the risk that the business combination disrupts current plans and operations as a result of the announcement and consummation of the business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth, maintain relationships with customers and suppliers and retain key employees; costs related to the business combination; the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors; other risks and uncertainties indicated from time to time in the registration statement on Form S-4 filed by Keystone Parent with the SEC and other risks, uncertainties and factors set forth under “Risk Factors” therein as well as in the section entitled “Risk Factors,” in Check-Cap’s Report on Form 6-K furnished to the SEC on August 4, 2023, and its other filings with the SEC, as well as factors associated with companies, such as Keystone and Check-Cap, that operate in the life science industry. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Neither Check-Cap nor Keystone undertakes or accepts any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or in the events, conditions or circumstances on which any such statement is based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Keystone, Check-Cap or the combined company.

Contact:

Jeremy Feffer
LifeSci Advisors
212-915-2568
jfeffer@lifesciadvisors.com

Keystone Dental Holdings and Check-Cap Ltd Enter into Definitive Business Combination Agreement

Keystone Dental Appoints Vice President & General Global Manager for Osteon

August 16, 2023, 17:08 ET

Proposed business combination to create a Nasdaq-listed medical device company focused on advancing the commercial execution and market development of Keystone’s comprehensive portfolio of implants, arches and other tooth replacement solutions

Keystone 2022 revenues exceeded $60 million

The combined company will trade on the NASDAQ with the ticker “KSD”

Investor conference call and webcast scheduled for 8:30 a.m. ET on Thursday, August 17th

IRVINE, Calif. and BURLINGTON, Mass., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Keystone Dental Holdings, Inc. ("Keystone Dental") and Check-Cap Ltd. ("Check-Cap" or the “Company”) (NASDAQ: CHEK) today announced that they have entered into a definitive Business Combination Agreement (the "Business Combination Agreement") under which the stockholders of Keystone Dental will become the majority holders of the combined company. If completed, the business combination will create a public company headquartered in Irvine, CA and focused on advancing commercial execution and market development of Keystone Dental’s comprehensive portfolio of implants, arches and other tooth replacement solutions comprised of restoration products, prosthetic solutions, biomaterial, and digital dentistry capabilities.

Upon closing of the transaction, the combined company will trade on the NASDAQ under the symbol “KSD.” The executive team of Keystone Dental will serve as the executive team of the combined company, led by Melker Nilsson, Keystone’s Chief Executive Officer.

"We are excited to enter into a definitive business combination agreement with Keystone Dental, a commercial-stage medical technology company focused on providing end-to-end solutions for dental practitioners and tooth replacement procedures,” said Steven Hanley, Chairman of the Board of Directors of Check-Cap. “Following a comprehensive and thorough review of strategic alternatives that Check-Cap’s board and its advisors undertook involving the review of over 40 formal offers, Check-Cap’s Board of Directors concluded that the proposed transaction with Keystone Dental is in the best interest of our shareholders. We intend to hold a special meeting of Check-Cap shareholders in the fourth quarter of 2023 to vote on this business combination."

“The proposed business combination with Check-Cap is expected to be a transformative step forward in the execution of our mission to establish Keystone Dental as a leading, pure-play global provider of tooth replacement solutions. Over the past few years, we have developed a comprehensive portfolio of end-to-end solutions for dental practitioners and tooth replacement procedures with the goal of giving patients a better and more comfortable experience while providing our customers with unique tools to enhance their daily workflow. During that time, we have also established a growing salesforce across the U.S. and distribution system, which has contributed to our robust revenue growth and improved market share position among the premium players,” stated Mr. Nilsson.

Based upon the number of shares to be issued in the business combination, current Check-Cap security holders are expected to own approximately 15% of the combined company representing an equity valuation of $39.7 million and Keystone Dental security holders are expected to own approximately 85% of the combined company representing an equity valuation of $225 million. The actual allocation will be subject to adjustment based on Check-Cap’s net cash balance at the time of closing. The Business Combination Agreement provides for a Check-Cap net cash target of $22.3 million at closing of the transaction which implies a $17.4 million premium to the Check-Cap net cash target.

The proposed transaction has been approved by the board of directors of both companies. The business combination is subject to the approval of Check-Cap shareholders at a special meeting of shareholders, which is expected to occur in the fourth quarter of 2023, along with the satisfaction or waiver of other customary conditions.

Ladenburg Thalmann & Co. Inc. is acting as financial advisor to Check-Cap for the transaction. BofA Securities is acting as capital markets advisor to Keystone Dental.

Conference Call Information
Keystone Dental and Check-Cap will host a conference call and webcast tomorrow, August 17, at 8:30 AM Eastern Time. The call can be accessed by dialing (877) 269-7751 (U.S. and Canada) or (201) 389-0908 (international) and entering passcode 13740624. A link to the live webcast, including the presentation of corporate slides, by clicking here. To access a subsequent archived recording, visit the “Events & Presentations” section of the Check-Cap website at https://ir.check-cap.com/events-and-presentations, or the “Events” section of the Keystone Dental website at https://keystonedental.com/pages/events.

About Keystone Dental Holdings, Inc.
Keystone Dental is a global commercial-stage medical technology company focused on providing end-to-end tooth replacement solutions for dental practitioners. Headquartered in Irvine, California, and with research and development and manufacturing sites in Caesarea, Israel and Melbourne, Australia, Keystone Dental markets its products worldwide. The company's product portfolio includes proprietary offerings such as its highly innovative implant systems Genesis Active, Molaris™ and Prima Plus™ that offers unique solutions to the dental practitioners. In addition, the company also offers an attractive dental implant value brand in Paltop, and a well-regarded portfolio of biomaterials mainly sold under the DYNA brand. Keystone acquired Implant Solutions Pty Ltd ("Osteon") in 2021, adding a comprehensive portfolio of prosthetic solutions on implants and digital workflow capabilities, not least the groundbreaking Nexus iOS digital workflow solution for restoring the fully edentulous patient. For more information, refer to www.keystonedental.com.

About Check-Cap
Check-Cap (NASDAQ: CHEK) is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC) screening through the introduction of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they may transform into colorectal cancer and enable early intervention and cancer prevention. C-Scan is an investigational device and is not available for sale in the United States.

Important Additional Information and Where to Find It
In connection with the business combination, a newly formed wholly owned subsidiary of Keystone Dental (“Keystone Parent”) intends to file with the SEC a registration statement on Form S-4 and that will constitute a prospectus with respect to shares of common stock of Keystone Parent to be issued in the business combination and Check-Cap intends to deliver a proxy statement to its shareholders in connection with the special meeting of its shareholders. Check-Cap and Keystone Parent may also file other documents with the SEC regarding the business combination. This press release is not a substitute for the prospectus or any other document which Keystone Parent or Check-Cap may file with the SEC. INVESTORS, KEYSTONE SECURITY HOLDERS AND CHECK-CAP SECURITY HOLDERS ARE URGED TO READ THE PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED BY KEYSTONE PARENT OR CHECK-CAP WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE BUSINESS COMBINATION AND RELATED MATTERS. Investors, Keystone security holders and Check-Cap security holders will also be able to obtain free copies of the prospectus (when available) and other documents containing important information about Check-Cap, Keystone and the business combination that are or will be filed with the SEC by Check-Cap or Keystone through the website maintained by the SEC at www.sec.gov.

Participants in the Solicitation
Check-Cap, Keystone Parent and their respective directors and executive officers may be deemed under SEC rules to be participants in the solicitation of proxies from the shareholders of Check-Cap in connection with the business combination. Information about Check-Cap's directors and executive officers is set forth in Check-Cap's Annual Report on Form 20-F for the year ended December 31, 2022 which was filed with the SEC on March 31, 2023. Information about Keystone Dental's directors and executive officers will be set forth in the prospectus (when available). Other information regarding the interests of such individuals, as well as information regarding other persons who may be deemed participants in the business combination, will be set forth in the prospectus, the proxy statement and other relevant materials to be filed or submitted with the SEC when they become available. Investors, Keystone security holders and Check-Cap security holders and other readers should read the prospectus and the proxy statement carefully when they become available before making any voting or investment decisions.

No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Legal Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements”. Forward-looking statements include, but are not limited to, statements regarding expectations, hopes, beliefs, intentions or strategies of Check-Cap and/or Keystone Dental regarding the future including, without limitation, statements regarding Keystone’s technology and the benefits of tooth replacement solutions, expectations regarding the ownership structure of the combined company, and the structure, timing and completion of the proposed business combination. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions; the outcome of any legal proceedings that may be instituted against Keystone Dental or Check-Cap following the announcement of the business combination; the inability to complete the business combination, including due to the inability to concurrently close the business combination or due to failure to obtain approval of the shareholders of Check-Cap; delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals, or delays in completing regulatory reviews, required to complete the business combination; the risk that the business combination disrupts current plans and operations as a result of the announcement and consummation of the business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth, maintain relationships with customers and suppliers and retain key employees; costs related to the business combination; the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors; other risks and uncertainties indicated from time to time in the registration statement on Form S-4 which is expected to be filed by Keystone Parent with the SEC and other risks, uncertainties and factors set forth under “Risk Factors” therein as well as in the section entitled “Risk Factors,” in Check-Cap’s Report on Form 6-K furnished to the SEC on August 4, 2023, and its other filings with the SEC, as well as factors associated with companies, such as Keystone and Check-Cap, that operate in the life science industry. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Neither Check-Cap nor Keystone undertakes or accepts any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or in the events, conditions or circumstances on which any such statement is based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Keystone, Check-Cap or the combined company.

Contact:
Jeremy Feffer
LifeSci Advisors
212-915-2568
jfeffer@lifesciadvisors.com

14 Jun, 2023, 10:07 ET

BURLINGTON, Mass., June 14, 2023 /PRNewswire/ -- Keystone Dental Holdings, Inc. ("Keystone Dental"), a global commercial-stage medical technology company with a comprehensive portfolio of tooth replacement solutions comprised of implants, prosthetic solutions, biomaterial, and digital dentistry capabilities, announced that effective May 1, 2023, Greg Minzenmayer has been appointed Vice President & Global General Manager for Osteon Medical.

Mr. Minzenmayer assumes global responsibility for Osteon Medical ("Implant Solutions Pty Ltd"), a leading digital dentistry technology company founded in 2011 and acquired by Keystone Dental Holdings, Inc. in 2021.

Mr. Minzenmayer has over 27 years of industry experience finding and implementing ways to grow revenue and develop organizations. In his recent role, Mr. Minzenmayer served as Vice President and General Manager of the Prosthetic and Digital business unit for Nobel Biocare, part of Envista. Prior to that, he was the Chief Operating Officer of Glidewell Dental for over 15 years, leading Glidewell's digital transformation efforts.

Melker Nilsson, CEO of Keystone Dental, commented: "Keystone continues to attract great talent, and Greg will be a vital addition to our management team. Not only does he have significant operational know-how, but his general knowledge and experience of the dental market will be highly valuable as we continue to grow."

Michael Tuckman, the founder of Osteon Medical, and creator behind the highly acclaimed Nexus iOS technology, will transition into the Global Chief Research and Development Officer role for Osteon. This will allow Mr. Tuckman to focus on the development and commercialization of new digital technologies to further expand the competitive digital position of Keystone Dental globally within the $5 billion dental implant market. Mr. Tuckman will remain an active board member of the KDG Board of Directors.

"Innovation carries significant strategic value and is a core part of our business. With Michael Tuckman's proven track record in digital technologies, we will significantly expand our new developments," said Melker Nilsson.

About Keystone Dental Holdings, Inc.
Keystone Dental is a global commercial-stage medical technology company focused on providing end-to-end solutions for dental practitioners and tooth replacement procedures. Headquartered in Burlington, Massachusetts, with a distribution facility in Irvine, California, and a research and development and manufacturing site in Caesarea, Israel, Keystone Dental markets its products worldwide. The company's product portfolio includes proprietary offerings such as Osteon, Nexus iOS, Genesis – The Biomimetic Implant System™, the TILOBEMAXX™, PrimaConnex® and Prima Plus™ Implant Systems, the DynaMatrix® extracellular membrane, and the Dyna Blast® and DynaGraft D® bone graft substitutes. Keystone acquired Implant Solutions Pty Ltd ("Osteon") in 2021, adding a comprehensive portfolio of prosthetic solutions on implants and digital workflow capabilities. For more information, refer to www.keystonedental.com.

About Osteon Medical
Osteon Medical, a commercial-stage leader in digital dental implant solutions, develops innovative and advanced customized implant-retained prosthetics and advanced engineering solutions based on propriety CAD/CAM scanning and design technology. The result delivers a much more efficient, shorter, and more accurate complex implementation procedure. Nexus IOS solution includes a scanning component, AI-based design software, and industrialized additive and subtractive production processes. Osteon is headquartered in Melbourne, Australia, and supported by dedicated production facilities in Melbourne, Australia, Osaka, Japan, and Irvine, California. The company's products are available in Australia, Japan, Europe, and North America.

Contact:
Amnon TamirCFO Keystone Dental Groupatamir@keystonedental.com