Titan Medical Inc.

Good morning, ladies and gentlemen, and welcome to Titan Medical's first quarter 2022 earnings conference call. At this time, all participants are in listen-only mode. After the presentation, there will be an opportunity for call participants to ask questions. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, today's conference is being recorded. I will now turn the conference over to Kristen Galfesi, Titan Medical Vice President of Investor Relations and Corporate Communications. Please proceed.

Thank you, Denae. Good morning, everyone, and thank you for joining us for Titan Medical's first quarter 2022 earnings conference call. Earlier this morning, we issued a press release summarizing Titan's first quarter 2022 financial results 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 risk, 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 Caution Regarding Forward-Looking Statements and Risk Factors section of the Companies and the Report on Form 20F for the fiscal year ended December 31, 2021, which may be viewed at cedar.com and at 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 content in making investment decisions or recommendations. The news release is available at www.titanmedicalinc.com. With that, I'll turn the call over to Paul Catterford, Titan's Interim President and Chief Executive Officer.

Paul? Thank you, Kristen. Good morning, everyone, and welcome to Titan Medical's first quarter 2022 financial update call. Also joining me today on the call is Stephen Lemieux, our Chief Financial Officer. Today, we'd like to share with you our recent accomplishments and discuss what we see on the horizon for Titan Medical. As many of you are familiar, we are a leading innovator in single-access robotic-assisted surgery, having designed our ENO surgical system from the ground up, utilizing proprietary technology that is protected by a broad patent portfolio, trade secrets, and know-how. Our ENO system has been designed and developed to make surgical procedures easier and more More comfortable and more effective for surgeons to improve outcomes for patients by reducing the number of incisions or access points resulting in smaller and fewer scars. Faster recovery and less pain and trauma and to drive adoption at hospitals by lowering costs, decreasing the size of the equipment and increasing efficiency. We have developed our surgeon workstation with ergonomics in mind. We have created a workstation which allows the surgeon to openly interact with operating room team members. The surgeon interface, like pedals, hand controllers, and 3D HD screen for displaying images of the surgical site and graphical overlays are easy to learn and master. A dexterous and extendable 3D HD camera and precision instruments convert easy to learn and natural hand gestures to accurate surgical movements. The instruments have been designed to allow surgeons to operate close to the abdominal wall or entry point in a tight surgical volume. but also extend to increase versatility when required without having to reposition the patient cart. The InnoSystem patient cart is designed to deliver an integrated 2D HD camera with illumination in addition to a steerable 3D HD endoscope camera with illumination and two multi-articulating instruments through a single 25mm incision. Additionally, the patient cart is designed to offer a swift docking, multi-quadrant positioning, easy to load instruments, and easy draping. We believe these features will allow hospitals to turn over the surgical suites faster and more efficiently. The market for robotic-assisted surgical systems is robust and continues to grow. And while the install base for single access, like the ENO system, is somewhat small in comparison to multiport systems, we believe the opportunity for single access will eventually overtake the multiport install base. We're initially targeting gynecology indications where the benefits for single access are likely most impactful. We intend to follow up with urology and other indications upon regulatory clearance and launch of the ENOS. Based on a wide range of preclinical studies and discussions with leading surgeons, we are confident that the ENOS system will eventually be used in a number of procedures. Our Surgeon Advisory Board comprised of leading laparoscopic and robotic-assisted surgery surgeons continues to provide feedback, insight, and direction on where the ENOS system and underlying technology might be applied to address unmet needs and applications. We are proud of our team here at Titan, who, through tireless work, creativity, and commitment, remain on track with our project plan and regulatory approval path. We are also grateful to our many partners and collaborators who are all assisting in our mission to bringing Eno's system to market. During the first quarter of 2022 and the weeks leading up to today, Titan has accomplished quite a bit. We announced a purchase order with Medtronic that covers the purchase of instruments and cameras that will be used in pre-clinical activities and the evaluation of Titan Medical as a potential manufacturing and supplying partner for Medtronic. We believe that this purchase has strategic benefits for our company, highlighting the confidence of third parties in our technology and know-how in single-access surgery and providing further reason to build and expand on our in-house manufacturing capabilities. We completed another preclinical lab study, adding to the over 80 procedures already completed. These labs not only provide additional surgeon validation, but real-time feedback on some of the recent improvements we've made to the vision system and electrical energy instrumentation. In this most recent lab, new insights on how a traditional laparoscopic surgeon adapts to robotic surgery will be helpful as we develop training programs for our human clinical trials after our ID submission. Our interactions with the FDA continue to be productive and informative as we use the Q submission process. In the quarter, we completed another conference call with the FDA after submitting a Q submission at the end of last year. The company anticipates submitting another Q submission later this year. Transfer to manufacturing continues as we continue with our product development. The company completed the final design transfer to benchmark of capital equipment, a surgeon workstation and patient cart, and is working to finalize selection for contract manufacturers for draping and consumables. The permanent CEO search is progressing well. The board's ad hoc CEO selection committee has now met with a number of qualified candidates, with a few moving to a leadership assessment analysis. We continue to evaluate options to address the NASDAQ notification regarding minimum bid price deficiency. Finally, Stephen and I participated in the Bloom Burton & Company Healthcare Investor Conference in Toronto, on May 2, 2022, where I had the opportunity to present, and we encourage you all to listen to the webcast, which is available on our website. Our timeline to commercialization remains unchanged, and we continue to evaluate this timeline on a regular basis and mitigate against uncontrollable items. As previously outlined, we are proceeding with plans for marketing authorization utilizing the de novo classification request pathway. communications with the FDA have been informative and productive. We currently plan to file the IDE application with the FDA in the first quarter of 2023 and anticipate 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 trial or human clinical study in the second half of 2023. We anticipate, given what we know today, that our IDE clinical study will include total laparoscopic hysterectomies performed on 30 to 40 patients at three to four clinical sites. Upon completion of the clinical study, we plan to submit a de novo classification request with the FDA in 2024. Commercial launch of the ENO system is scheduled to begin upon receipt of marketing authorization from the FDA anticipated in early 2025. I've got to tell you, it's a privilege to work with such a committed and talented team. Our capital equipment manufacturing partner, Benchmark, continues to perform. Our engineering, procurement, regulatory, and quality management team are fully integrated with their team and working well with their benchmark counterparts. While we all remain concerned about the ongoing Ukraine-Russia conflict, market instability, COVID variants, supply chain issues, and a tightening labor market, we continue to diligently monitor these factors, trying to mitigate risk and impact where we are able. We remain optimistic as we look at the long-term opportunity for our company and our shareholders. We believe that our innovative and differentiated single-access robotic-assisted neurosurgical platform, once cleared by the FDA, will be well-received by surgeons and hospitals. Our intellectual property portfolio, our knowledge and experience, and our talented team all continue to grow. Partnerships with companies like Medtronic tell us we're on the right path, and our role and contribution to single-access robotic-assisted surgery technology industry is meaningful and needed. Steve and I look forward to participating in additional investor conferences and meeting with current and new institutional investors as market conditions improve and in-person meetings come back into favor. Our increased investor outreach activities and focus on developing Titan's narrative for the Eno system have resulted in increased coverage by health technology journalists. Our story on how the Eno system is positioned to positively impact patient outcomes, provide performance benefits to surgeons, and improve hospital economics is resonating. I'll now turn the call over to Stephen Lemieux, our Chief Financial Officer, to review our financial results. Stephen?