Hello, and welcome to the annual meeting of stockholders of AVITA Medical, Inc. Please note that today's meeting is being recorded. It is now my pleasure to turn the meeting over to Lou Panaccio, Chair of the Board. Mr. Panaccio, the floor is yours.
Thank you. Will the meeting please come to order? Good day. It is 2:00 P.M. Pacific Standard Time and 9:00 A.M. Australian Eastern Daylight Time. I am Lou Panaccio, Chair of the Board of AVITA Medical. It is my pleasure to be presiding at this meeting. On behalf of the company's Board of Directors, I thank you for joining us. Along with my fellow directors and executive officers of the company, I welcome you to our virtual annual meeting of stockholders. We appreciate your attendance, your interest, and most importantly, the support of AVITA Medical. This annual meeting of stockholders is held pursuant to the bylaws of the company and written notice to all stockholders. You are participating in the meeting virtually. This annual stockholders meeting is being held exclusively by way of this live webcast, and there is no physical meeting.
Stockholders may submit questions at any time during this meeting in the space provided on the virtual meeting screen, and we will have a general question and answer period following the presentation of voting items to address appropriate questions that may have been submitted. As the first order of business, I will present a brief overview of AVITA Medical's performance during the second half of 2021 and the first nine months of 2022. First, I will start with sales. I am proud to report that for the 6-month period from July 1, 2021 to December 31, 2021, AVITA Medical's total revenue was $13,956,000, and its gross profit was $12,051,000.
Additionally, for the nine-month period from January 1, 2022 to September 30, 2022, AVITA Medical's total revenue was $24,966,000, and its gross profit was $20,272,000. AVITA Medical also ended that period with a strong balance sheet of over $88,184,000 US dollars in cash reserves and marketable securities and zero debt. Moving to clinical trials and the RECELL System platform, I'm happy to report that the enrollment of the company's soft tissue pivotal trial was completed in January 2022, and top line results were announced in August of 2022. In November 2022, with updated analysis that both co-primary endpoints were met. RECELL achieved statistically significant donor sparing over control, and RECELL achieved statistical non-inferiority for healing versus control. AVITA Medical has made its PMA submission to the FDA last Friday.
Additionally, enrollment in AVITA Medical's vitiligo pivotal trial was completed in December 2021, and positive top-line results were announced in September of 2022. The study achieved its primary effectiveness endpoint, showing super superiority for repigmentation with RECELL versus control. AVITA Medical plans for submission to the FDA in December 2022. Additionally, other highlights in 2022 for the company include: In February of 2022, AVITA Medical received approval from Japan's Pharmaceuticals and Medical Devices Agency for its collaboration with COSMOTEC to market and distribute the RECELL System in Japan. In November 2022, the FDA granted the RECELL System designations as a breakthrough device for its proposed soft tissue repair indication, as well as its vitiligo indication.
The goal of the FDA Breakthrough Devices Program is to provide patients and healthcare providers with timely access to new medical devices and technologies by expediting the development, assessment, and review of devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the pre-market review phase. AVITA Medical's strongest resource, its people, continued to grow this year as well. The company welcomed many talented additions to its management and staff, AVITA Medical continues to be an excellent place to work. Accordingly, whether the topic is the company's sales, financial position, growth into new markets, or corporate health, AVITA Medical continues to be in a strong position.
Our board of directors is committed to working alongside management to achieve our corporate goals and continue to deliver value for our shareholders. We are appreciative of our shareholders' support, as well as our employees, medical professionals, and patients. On September 28, 2022, AVITA Medical announced the appointment of James Corbett as Chief Executive Officer. Mr. Corbett has 40 years of leadership experience in the life sciences field, with extensive global commercial and operating experience. Along with vast experience in capital markets and governance from both public and private environments. During his career, Jim has served as CEO of three publicly listed companies, MicroTherapeutics, eV3, and Alphatec Spine. Jim has also led two privately funded companies as CEO, Home Diagnostics and Vertos Medical. Jim succeeds Dr. Michael Perry, who had served as Executive Director and Chief Executive Officer of our company since June 2017.
AVITA Medical is grateful to Dr. Perry for his many contributions. We thank him for his commitment to the company, its customers, employees, shareholders, and patients. Following conclusion of this meeting's formal business, Jim will provide a more detailed update, including the company's progress since the last shareholder meeting. Should you be experiencing any technical difficulties during today's telecast, please call the phone numbers on the screen. After introducing the directors and officers in attendance and dealing with a few procedural matters, we will take up the items to be acted upon. I would like to introduce the directors of AVITA Medical who are in attendance today. I welcome our new CEO and Executive Director, Jim Corbett. Also non-executive directors, Mr. Jeremy Curnock Cook, Professor Suzanne Crowe, and Ms. Jan Stern Reed.
We're also joined by the company's Chief Financial Officer, Michael Holder, and the company's General Counsel, Donna Shiroma. Representatives are also present from our U.S. legal advisors, K&L Gates, represented by Chris Cunningham, our Australian legal advisors, Lander & Rogers, represented by David Morris and Bree Taylor. Our Australian share registry, Computershare, represented by Rob Soames, with a portion of our share registry held in Australia in the form of CDIs. Mark Ricciardo from Acclime Australia, formerly Mertons Corporate Services, who serves as the company's Australian local agent. Our independent registered public accounting firm, Grant Thornton, represented by Mark Bottom. In accordance with our bylaws, I will act as chairman of the meeting, and Ms. Donna Shiroma, our General Counsel, will act as secretary of the meeting.
In addition, the board of directors has appointed Ashley Schultz of Computershare US to serve as the independent inspector of the election for this meeting. I request that she file her oath of office with the secretary of the meeting for inclusion in the minutes of this meeting. Will the secretary please report on the proof of notice of meeting? Donna?
I have an affidavit of mailing from Broadridge Financial Solutions certifying as to the giving of notice of this meeting and the sending to holders of common stock of record as of October 19, 2022, Pacific Time, the notice of internet availability of proxy material, all of which Broadridge commenced distributing to stockholders on October 25, 2022. I also received confirmation of mailing from Computershare Australia, confirming as to the giving of notice of this meeting and the sending to holders of CDIs the proxy material and voting instruction form, all of which Computershare Australia completed distributing to holders of CDIs on October 27, 2022. I also have a copy of the annual report on Form 10-K for the transition period from July 1, 2021 to December 31, 2021, which includes financial statements certified by Grant Thornton.
A copy of this annual report was sent or made available to each stockholder entitled to vote at this meeting, and an electronic copy of the annual report can be accessed by clicking on the link located at the virtual meeting center titled Annual Meeting Materials. The notice of meeting and the affidavit of mailing, together with the attachments thereto and the annual report for the transition period from July 1, 2021 to December 31, 2021, will be filed with the minutes of this meeting.
Thanks, Donna. The secretary has the list of the holders of record of common stock of the company at the close of business on the record date. This list of stockholders can be made available upon request to stockholders. The secretary will file a copy of the list of stockholders with the records of the company. Donna, would you please present your report of attendance at this meeting so that we can determine whether a quorum is present?
Mr. Chairman, on October 19, 2022 , the record date for this annual meeting, there were outstanding and entitled to vote a total of 25,030,902 shares of common stock, including the underlying shares of common stock represented by CDIs. I have been informed by the Inspector of Election that there are 12,913,899 shares of stock represented by proxy, or approximately 52% of all the shares entitled to vote at this annual meeting. The shares so represented exceed 50% of the total shares entitled to vote at this meeting and thus constitute a quorum.
Thank you, Ms. Shiroma. On the basis of the report of the Secretary and the Inspector of Election, I find that proper notice has been given and that a quorum is present. Accordingly, this meeting has been properly convened. It is 9:14 A.M. Pacific Time on December 12, 2022, and the polls for voting on all matters are open. All U.S. holders of common stock entitled to vote at this meeting have the ability to do so online, as referenced in your proxy materials. If you are a stockholder entitled to vote and have not yet voted, or if you want to change your previously cast vote, please do so via the website you used to access this meeting or via the instructions in your proxy materials for submitting your proxy vote.
If you are a holder of CDIs, in accordance with your voting instructions, you should have previously submitted your voting instructions to Computershare Australia no later than 9:00 A.M. Australian Eastern Daylight Time on December 9, 2022. Please remember that if you have already voted by proxy, it is not necessary to vote again. After voting has been completed on all matters on the agenda, we will close the polls. The board of directors recommend a vote for all of the nominees listed in proposal one and a vote for proposals two through to nine. We will now move to a review of the proposals. The first proposal that come before the meeting is the election of directors. At this meeting, we will be electing each of the five directors for a one-year term or until their respective successors have been duly elected and qualified.
The nominees are Mr. Lou Panaccio, Non-Executive Chair, Mr. James Corbett, Executive Director and CEO, Mr. Jeremy Curnock Cook, Non-Executive Director, Professor Suzanne Crowe, Non-Executive Director, and Ms. Jan Stern Reed, Non-Executive Director. Information concerning their principal occupations, services of AVITA Medical board members, skills and qualifications, and other matters which may be of interest are contained in the proxy statement and the annual report. No other nominations were received prior to the deadline established by the company's bylaws. Therefore, no additional nominations may be made at this meeting. I declare the nominations to be closed. Proposal two asks stockholders to ratify the appointment of Grant Thornton as the company's independent registered public accounting firm for the fiscal year ending December 31, 2022, as described in your proxy statement.
Proposal three seeks the approval of stockholders to amend the company's certificate of incorporation and amended and restated bylaws to reduce the quorum requirement for the company stockholder meetings. As I have a direct interest in the next proposal to be put to the meeting, I will hand the chair to Professor Suzanne Crowe. Thanks, Suzanne.
Thank you, Lou. Proposal four asks stockholders to approve the grant of restricted stock units to acquire shares of common stock of the company, which may be represented by CDIs equal in value to $87,500 at the time of the grant, the grant of options to acquire shares of common stock of the company which may be represented by CDIs equal in value to $37,500 at the time of the grant to Mr. Lou Panaccio on the terms and conditions set out in this proxy statement pursuant to and for the purposes of ASX Listing Rule 10.11. I now hand the chair back to Mr. Panaccio.
Thank you, Professor Crowe. I will now continue with the remaining proposals. Proposal 5 asks stockholders to approve the grant of restricted stock units to acquire shares of common stock of the company, which may be represented by CDIs, equal in value to $87,500 at the time of the grant, and the grant of options to acquire shares of common stock of the company, which may be represented by CDIs, equal in value to $37,500 at the time of the grant to Professor Suzanne Crowe on the terms and conditions set out in this proxy statement pursuant to and for the purposes of ASX Listing Rule 10.11.
Proposal six asks stockholders to approve the grant of restricted stock units to acquire shares of common stock of the company, which may be represented by CDIs, equal in value to $87,500 at the time of the grant, and the grant of options to acquire shares of common stock of the company, which may be represented by CDIs equal in value to $37,500 at the time of the grant to Mr. Jeremy Curnock Cook on the terms and conditions set out in this proxy statement pursuant to and for the purposes of ASX Listing Rule 10.11.
Proposal seven asks stockholders to approve the grant of restricted stock units to acquire shares of common stock of the company, which may be represented by CDIs, equal in value to $87,500 at the time of the grant. The grant of options to acquire shares of common stock of the company, which may be represented by CDIs, equal in value to $37,500 at the time of the grant to Ms. Jan Stern Reed on the terms and conditions set out in this proxy statement pursuant to and for the purposes of ASX Listing Rule 10.11.
Proposal eight asks stockholders to approve the grant of options to acquire shares of common stock of the company, which may be represented by CDIs, equal in value to $1 million at the time of grant to Mr. James Corbett on the terms and conditions set out in this proxy statement pursuant to and for the purposes of ASX Listing Rule 10.11.
The next proposal is advisory. Proposal nine asks stockholders to approve on a non-binding basis the compensation paid with the company's named executive officers as disclosed in the Executive Compensation Discussion section in the annual report on Form 10-KT, which was filed with the SEC and ASX on February 28, 2022 in the United States and on March 1, 2022 in Australia. No other businesses come before the meeting to be considered at this time. The polls are about to close. If you have not yet voted, please do so.
Since everyone has had the opportunity to vote, it is now, I think, 2:22 P.M. Pacific Time, 9:22 A.M. Australian Eastern Daylight Time. The polls are closed. We will announce the results of the voting as soon as possible following the close of this meeting via announcements to be filed with the U.S. Securities and Exchange Commission and the Australian Securities Exchange. That concludes the business of the meeting. The meeting is now adjourned. I now invite you to ask any questions you may have as it relates to the content of today's meeting. Please follow the instructions provided in the virtual meeting screen to submit questions. As I mentioned earlier, Jim Corbett will be making a presentation following the formal closure of the business of this meeting.
Thank you.
Donna, do we have any questions, please?
Mr. Chairman, we do not have any questions at this time.
Thank you, Ms. Shiroma. I think, this concludes the annual meeting of stockholders. Thank you all for your attendance. Thank you for attending today's meeting. I'd like to hand over to Jim Corbett now, who will present a company update. Thanks, Jim.
Thank you, Mr. Chairman. In Chairman Panaccio's earlier comments, he provided you with an update on our financial performance for the first nine months of calendar year 2022. I'm going to use this time to share with you our guidance for Q4 2022 and what the important events that are coming before us in 2023. With regard to Q4 2022, we are guiding to $33 million-$34 million in total commercial revenue, which represents a 33% growth over prior year. Noting that as we move through the year, our rate of growth has steadily increased, representing increased adoption of the RECELL System in U.S. burn centers. 2023 is going to represent a inflection point for AVITA Medical.
As our Chairman Panaccio mentioned earlier, we have submitted our soft tissue repair PMA supplement here just in the last couple days. What's important about that submission, and let me take a few minutes to describe in more detail. First of all, the soft tissue repair submission is designated by the U.S. FDA as a Breakthrough Device designation. What this means is, absent a significant deficiency, we can expect a real-time review of that submission and its 180-day time clock. As such, we project an expected approval in June of 2023. This market opportunity is in excess of 3 to 4 x the opportunity of treating patients with RECELL than that which is represented by the burns market in the United States.
A dramatic expansion of AVITA Medical's opportunity with RECELL in the U.S. market. I will come back to some forward thoughts on that approval in a moment. Secondarily, we expect during the month of December to submit the PMA supplement for the treatment of the autoimmune condition known as vitiligo. Vitiligo is essentially transplanting pigment with the melanocytes that come from the donor sample that is taken with the skin graft in the RECELL procedure. That market is significantly larger yet, and it also, on a separate basis, received Breakthrough Device designation from the FDA. Therefore, similarly, absent a significant deficiency, material deficiency, we should expect approval in June of 2023. These constitute two very different market opportunities for AVITA Medical and let me take a moment to describe.
For soft tissue repair, we will be using the same exact reimbursement codes that are used inpatient with burns. For outpatient applications for soft tissue repair, we will be using the transitional pass-through code that currently is in use for RECELL in the burns market segment. We will be coming to market with a three to four times greater opportunity for RECELL with reimbursement inpatient and with the reimbursement outpatient. Our intention is to expand our commercial organization during Q2 to accommodate the nearly 1,000 level one and two trauma centers where soft tissue repair exists. Let me take a moment and talk about soft tissue repair in a more tangible way for you. On a very macro basis, the surgeon who is doing the graft is either repairing something that the surgeon did or repairing a traumatic injury.
Examples of what a surgeon might have done is necrotizing bacteria, where they have to excise a large area of tissue along with skin, and they need a graft to close it. That happens to be a very significant portion of the trial that we concluded recently, which met the endpoints that we did for our FDA submission. The other category is the surgeon repairing traumatic injuries that might come from many, many things. It might come from a car accident, a gunshot wound, a wound, an abrasion of high significance. These patients present at treatment in level one and two trauma centers, and in the majority are treated outpatient. This opportunity really transforms the opportunity for AVITA Medical over the next three to four years, and we expect to grow commensurately.
In the February earnings call, we will be guiding to our expectations for 2023 in a different format as we have in the past. We of course will be providing annual guidance, but each quarter we will also be providing quarterly guidance, as we expect it to be a very dynamic year, and communication with shareholders will be benefited by our increased transparency on how our business is going. Moving to the vitiligo application. We will be expecting approval. That said, the work to be done is achieving reimbursement in the site of service of the physician outpatient, excuse me, the physician office as a site of service, and that will require some submissions by AVITA through the process of establishing codes and reimbursement with American Medical Association's CPT committee and subsequently working with CMS.
We expect that approval by January 25, that will begin the true commercial expansion for vitiligo. Between now and then, we are working on developing precision on best patients to treat. There'll be some physician-sponsored studies that we do, there will be some cash pay users for vitiligo during that time. That said, during the next three years, four, soft tissue and burns will constitute our U.S. growth opportunity. We expect that when we announce in February, we'll also be announcing the timeframe for the automation program that we are working on within AVITA to reduce the manual work performed by the surgeon into an automated disaggregation of skin, of the cells that are taken during the autologous sample. Now, when we make that announcement, we'll be projecting our submission date.
We'll be projecting also our, during that same call, our sales expansion and put some numbers around that for expectations as we expect that OpEx investment that we will be making will occur during Q2, and we start gaining the benefit in Q3, Q4 and onward. With that said, when we look ahead for the prospects of AVITA Medical, we see an incredible inflection point coming our way during this, during 2023, and that will be fully realized in 2024 and 25. The opportunity ahead for AVITA following soft tissue repair and burns will be followed in 25 by the introduction and the expected reimbursement that comes with the vitiligo application for in-office site of service. An exciting time for us. Lastly is our international strategy. We are presently primarily a domestic revenue company.
We do have a partner in Japan and did realize sales during Q3 at the initial launch from our partner COSMOTEC, located in Japan, of course. During the course of 2023, we will be putting in place and defining our international strategy. Later in 2023, we'll be making an announcement about that expansion. There are multiple pathways for growth for AVITA Medical. RECELL has great reach for many patients and many indications. Burns indication was the most difficult. The soft tissue repair is the most broad label. Vitiligo will truly be a unique application of skin grafting as it is actually a melanocyte repigmentation transplant. It really couldn't be more exciting for us going forward at AVITA. I thank you very much for attending our shareholder meeting today. This concludes the company update. Thank you for your attendance.
That concludes the conference call. Thank you for your participation. You may now disconnect your lines.