Titan Medical Inc.

greetings and welcome to the titan medical inc fourth quarter and year end 2021 financial results conference call and webcast at this time all participants are on a listen-only mode a question and answer session will follow the formal presentation if anyone should require operator assistance during the conference please press star 0 on your telephone keypad as a reminder this conference is being recorded it is now my pleasure to introduce your host Kristen Galfetti, Vice President of Investor Relations. Thank you. Please go ahead.

Thank you, Operator. Good morning, and thank you for joining us for Titan Medical's year-end earnings conference call. Earlier this morning, we issued a press release summarizing Titan's fourth quarter and year-end financial results for 2021 and business highlights. A copy of the release can be found in the Investor Relations section of our website at www.titanmedicalinc.com. As a reminder, certain statements made during this conference call constitute forward-looking statements that reflect management's current expectations of the company's future growth, results of operations, performance, and business prospects and opportunities. 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 on the Caution Regarding Forward-Looking Statements and Risk Factors section of the company's annual report for the fiscal year ended December 31, 2021, as well as the assumptions discussed under the section titled Development Plan from the company's recent MD&A, each of which may be viewed at CDER.com and at the SEC.gov. Please read all forward-looking statements and risk cautions in these sections and in today's news release announcing our financial and operating results and be guided by their contents in making investment decisions or recommendations. The release is available at www.titanemedicalinc.com. With that, I will turn the call over to Paul Catafort, TITAN's Interim President and Chief Executive Officer. Paul?

Thank you, Kristen. Good morning and welcome to Titan Medical's fourth quarter and year-end 2021 financial update call. Also joining me on the call today is Stephen Lemieux, our Chief Financial Officer. Building upon accomplishments we discussed on prior quarterly calls, we are pleased to share with you today details of our progress and updates on what we see on the horizon for Titan. The past several months, we have had our heads down focused on getting the Eno Single Access Robotic Assisted Surgical Platform ready for an investigational device exemption application with the FDA. As discussed in recent presentations, the FDA marketing authorization of the ENO system using a de novo pathway is a multi-step process. We are confident in our understanding of the process and have resourced and partnered with Benchmark with productive effect. We remain on track with our previously disclosed timeline and are looking to file the IDE application in Q1 2023 and commence human clinical trials after approval. In anticipation of clinical trials beginning mid 2023, we have started reaching out to clinical trial sites. Our employees and partners have worked hard to deliver on our mission to bring this innovative, proprietary, and differentiated platform to market. Our company goal of improving patient outcomes and meeting the demands of surgeons and hospitals to the interaction of the ENOS single access robotic assisted surgical platform drives all of us. During the fourth quarter of 2021 and over the past few months, Titan has achieved several accomplishments that put us steps ahead, steps closer to our goal, including the receipt of a final payment for Medtronic after completion of the last milestone in Q4. A portion of the proceeds were used to retire a senior secured loan with Medtronic. We announced Benchmark as our capital equipment manufacturing partner and are now in the process of having first production surgeon workstations and patient carts delivered over the summer. These units will be leveraged with our proprietary cameras and multi-articulating instruments and loaded up with software prior to system validation and verification testing at our Chapel Hill, North Carolina operations facility. We are currently building out our camera and instrument manufacturing capability and look to announce a new head of manufacturing operations before the beginning of the summer. We have expanded our patent portfolio to more than 200 patents and applications. This IP portfolio continues to grow. We're continuing to evaluate options for geographical expansion and revenue generating opportunities with third parties. The company's comprehensive robotic surgery Surgery intellectual property portfolio includes coverage in the United States, Europe, Canada, China, Japan, Korea, and Australia. To be clear, while we have licensed some of our IP to third parties, we retain the rights to the entire IP portfolio for our own use and our own products and services. With respect to the NASDAQ notification regarding minimum bid price deficiency, we continue to evaluate all available options to resolve this deficiency. We also announced the CEO transition, where I have taken the role of interim president and CEO. We have already started a formal CEO search process using a top-tier recruiting firm and are hopeful for a transition later on this year. In addition, Deepak Basra, our VP Strategy and Business Development, and Chris Siebert, our VP Upstream Marketing, attended the Society of American Gastrointestinal and Endoscopic Surgeons, SAGES, annual meeting last week. In addition to updating surgeons on our latest advancements, they looked at innovations in advanced software. Finally, I presented and participated in the H.C. Wainwright & Company BioConnect 2022 Investor Conference in January and in Oppenheimer's 32nd Annual Investor Conference earlier this month. Both presentations are available on our website. Our timeline to marketing authorization of the ENO system remains unchanged since we updated investors last fall. As we progress on our timeline, we continue to mitigate against risks. We are proceeding with plans for marketing authorization utilizing the de novo classification request pathway as a result of discussions with the FDA using the productive and informative Q submission facility. As mentioned, The company plans to file the IDE application with the FDA in the first quarter of 2023 and anticipates receiving a response on the IDE from the FDA in the first half of 2023. Following IDE approval, we expect to start the IDE human clinical study in the second half of 2023. We anticipate, given information currently available to us, that our IDE study will include total laparoscopic hysterectomies performed on 30 to 40 patients at three to four clinical sites. Upon completion of the clinical trials, we plan to submit a de novo classification request with the FDA in 2024. Commencing launch of the e-mail system, oh, I'm sorry, commercial launch of the e-mail system will begin upon receipt of marketing authorization from the FDA anticipated in early 2025. Our timelines remain unchanged. from what we have previously disclosed during our Q3 2021 update, and I am happy to report the team is executing extremely well. They are focused, properly resourced, and driven. Our partnership with Benchmark, our capital equipment contract manufacturer, is going well and on track to have the first production workstations and patient carts built this summer. We will run these systems through extensive verification and validation testing, with results all being incorporated into our IDE application. We continue to build out our in-house manufacturing facility in Chapel Hill, where we will assemble our proprietary cameras and instruments. Although we are not currently impacted by world events, including the Ukraine-Russia conflict, COVID variants, and supply chain issues, we continue to monitor this rapidly changing environment and put contingency plans and mitigations in place. The long-term outlook for our company and our shareholders remains positive and optimistic. We believe that the proprietary and highly differentiated single access robotic assisted email surgical platform will be a game changer. Our intellectual property portfolio continues to grow and partnerships like the recently concluded Medtronic development and licensing program independently validate our role as a leading innovator in single access robotic assisted surgery. Looking at the EnoSystem US market opportunity, Titan's initial clinical focus will include benign gynecology surgery for the US market. We believe this patient population is particularly motivated to embrace our single access surgical solution as it aligns with the patient's needs and demands. Reduce trauma to the body, faster healing, minimize scarring, and fewer pain medications. We anticipate the next area of clinical focus will be urology and natural extension. As you see on this slide, based on independent market research conducted in 2021 and company estimates, there are approximately 900,000 RAS and non-RAS gynecology and urology procedures performed in the U.S. annually. We are targeting to capture 5% market share, expecting 225 annual procedures per ENOS system per year, and we calculate a long-term value, or LTV, of approximately $4 million per system. Based on recently completed market research and our own financial calculations, we believe we'll offer investors a risk-weighted return on their capital investment. Moreover, based on our wide range of preclinical studies, we anticipate that the versatility of the ENO system could be very attractive for broad use in multiple subspecialties. We plan to work closely with our Surgeon Advisory Board and other leading surgeons to obtain feedback and insights regarding opportunities for us to satisfy other unmet needs. Stephen and I will continue to participate in investor conferences and meet with institutional investors as part of our increased investor outreach activities. We have strengthened our relationships with health technology journalists developing Titan's narrative for the e-mail system and how we see it positively impacting patient outcomes, providing a heightened ergonomic alternative to surgeons and improving hospital economics. I will now turn the call over to Stephen Lemieux, our Chief Financial Officer, to review our financial results. Stephen.