Form 6-K TITAN MEDICAL INC For: Jul 28

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of July 2022

 

Commission File Number: 001-38524

 

Titan Medical Inc.
(Exact Name of Registrant as Specified in Charter)

 

76 Berkely Street
Toronto, Ontario  M5A 2W7
Canada
(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [  X ]      Form 40-F [  ]

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):        

 

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):        

 

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

 

 

SIGNATURE

 

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.

 

		Titan Medical Inc.
		(Registrant)
Date: July 28, 2022		/s/ Stephen Lemieux
		Stephen Lemieux
		Chief Financial Officer

 

 

 

 

 

 

 

 

EXHIBIT INDEX

 

Exhibit No.	Description
99.1	Material Change Report

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

MATERIAL CHANGE REPORT

Form 51-102F3

 

Item 1 Name and Address of Company

 

Titan Medical Inc. (the “Company” or “Titan”)

76 Berkeley Street

Toronto, Ontario

M5A 2W7

 

Item 2 Date of Material Change

 

June 28, 2022

 

Item 3 News Release

 

Attached as Schedule “A” is a copy of a news release relating to a material change, which was disseminated on June 28, 2022, through GlobeNewswire. The news release was subsequently filed on the System for Electronic Document Analysis and Retrieval at www.sedar.com.

 

Item 4 Summary of Material Change

 

On June 28, 2022, the Company announced that multiple distruptions have resulted in an updated Investigational Device Exemption (IDE) submission timeline for the Enos^TM robotic single access surgery system. The company now expects the IDE submission to occur mid-year 2023 instead of the first quarter of 2023. Pending successful regulatory review and upon receipt of marketing authorization, the expected U.S. product launch for the Enos system remains on schedule for early 2025.

 

Item 5 Full Description of Material Change

 

Please see the press release attached as Schedule “A” hereto.

 

Item 6 Reliance on subsection 7.1(2) of National Instrument 51-102

 

Not applicable.

 

Item 7 Omitted Information

 

Not applicable.

 

Item 8 Executive Officer

 

The following executive officer is knowledgeable about the material change and may be contacted about this report:

 

Stephen Lemieux

Chief Financial Officer

(416) 613-6203

 

Email:		[email protected]
Website:		www.titanmedicalinc.com

 

Item 9 Date of Report

 

July 5, 2022

 

 

 

 

 

SCHEDULE “A”

 

See attached news release.

 

 

 

 

 

EXHIBIT 99.1

Titan Medical Provides Update to Enos Project Timeline

De Novo marketing authorization planned for early 2025 remains unchanged

TORONTO, June 28, 2022 (GLOBE NEWSWIRE) -- Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery (RAS), today announced that multiple disruptions have resulted in an updated Investigational Device Exemption (IDE) submission timeline for the Enos™ robotic single access surgery system. The company now expects the IDE submission to occur mid-year 2023 instead of the first quarter of 2023. Pending successful regulatory review and upon receipt of marketing authorization, the expected U.S. product launch for the Enos system remains on schedule for early 2025.

“We have been fortunate to have avoided and mitigated against many of the issues facing almost all other technology companies over the last few months. However, we now expect our targeted IDE application date to be pushed out to the summer of 2023. Human clinical trials are still planned to start in 2023 and we expect to receive marketing authorization in the U.S. in early 2025,” said Paul Cataford, Interim President and CEO.

The Enos project timeline has been impacted by several factors including:

• Supply of certain key components and materials has affected the production of instruments and camera systems and the delivery of capital equipment resulting in delays for verification and validation testing.
• Recruitment and resourcing of software engineers and developers has resulted in delays in unit testing procedures and certain documentation activities.
• Delayed procurement of disposable and consumable components resulted in delays in cleaning and disinfection testing and the GLP study required for the IDE submission.
  
  

“We continue to carefully monitor our project plan. With recent changes, we believe we have the right people, resources and partners in place to execute against our project delivery timeline. This team is committed, engaged and accountable, and we’re excited to bring our vision of single access robotic assisted surgery to the market,” concluded Paul Cataford.

About Titan Medical

Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company headquartered in Toronto, Ontario and with operations in Chapel Hill, North Carolina, is focused on enhancing robotic assisted surgery using innovative technology through a single access point. The Enos™ robotic single access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand and includes multi-articulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.

Enos™ is a trademark of Titan Medical Inc.

For more information, visit www.titanmedicalinc.com and follow @TitanMedical on Twitter and LinkedIn.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of the company’s future growth, results of operations, performance, and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements, including, without limitation, references to: the company’s focus on the design and development of surgical technologies for robotic single access surgery; the timelines related to the development of the Enos system, including the expectation of the Company for IDE submission to occur mid-year 2023, clinical trials in 2023, and upon receipt of marketing authorization, the expected U.S. product launch for the Enos system in early 2025; the Enos system providing a surgical experience that imitates real-life movements; and the company’s intention to initially pursue gynecologic surgical indications with the Enos system. These statements reflect management’s current beliefs and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the company’s Annual Report for the fiscal year ended December 31, 2021, which may be viewed at www.sedar.com and at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, the company expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Contact
Kristen Galfetti
Vice President, Investor Relations & Corporate Communications
+1-781-869-2553
[email protected]

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