UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02. | Results of Operations and Financial Condition. |
On August 11, 2022, AVITA Medical, Inc. (the “Company”) issued a press release announcing financial results for its second quarter ended June 30, 2022, as well as certain additional business information. A copy of the press release is attached hereto as Exhibit 99.1.
Item 8.01. | Other Events. |
Also on August 11, 2022, the Company issued a press release announcing topline results from its pivotal randomized, controlled trial evaluating the safety and effectiveness of the RECELL System combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction. A copy of the press release is attached hereto as Exhibit 99.2.
The information under Item 2.02, Item 8.01 and in Item 9.01 below is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 and shall not be deemed incorporated by reference into any filing made under the Securities Act of 1933 except as expressly set forth by a specific reference in such filing.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit |
Description | |
99.1 | AVITA Medical Reports Second Quarter 2022 Financial Results | |
99.2 | AVITA Medical Announces Topline Results from Pivotal Trial in Patients with Soft-Tissue Injuries using the RECELL® System | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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 hereunto duly authorized.
Date: August 12, 2022 | ||||||
AVITA MEDICAL, INC. | ||||||
By: | /s/ Donna Shiroma | |||||
Name: | Donna Shiroma | |||||
Title: | General Counsel |
Exhibit 99.1
AVITA Medical Reports Second Quarter 2022 Financial Results
VALENCIA, California, August 11, 2022 and MELBOURNE, Australia, August 12, 2022 AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the Company), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today reported financial results for its second quarter ended June 30, 2022.
Second Quarter Highlights and Recent Updates:
| Reported commercial revenue, which excludes BARDA revenue, of $8.2 million a 23% increase compared to $6.7 million in the corresponding period in the prior year |
| Reported total revenue, which includes BARDA revenue, of $8.3 million compared to $10.3 million in the corresponding period in the prior year, which included $3.6 million in BARDA revenue |
| Gross profit margin improved by 3% to 83% compared corresponding period in the prior year |
| Topline results from its pivotal randomized controlled trial evaluating the safety and effectiveness of the RECELL® System for healing of soft tissue reconstruction with reduced donor skin |
| As of June 30, 2022, the Company had $91.1 million in cash, cash equivalents, and marketable securities, with no debt |
Year to date Highlights:
| Reported commercial revenue, which excludes BARDA revenue, of $15.7 million, a 39% increase compared to $11.3 million in the corresponding period in the prior year |
| Reported total revenue, which includes BARDA revenue, of $15.9 million compared to $19.1 million in the corresponding period in the prior year, which included $7.8 million in BARDA revenue |
| Gross profit margin improved by 2% to 80% compared to the corresponding period in the prior year |
Our commercial team continued to drive further RECELL utilization and penetration within burn centers, and our clinical team advanced our soft tissue reconstruction and vitiligo trials, said Dr. Mike Perry, AVITA Medical Chief Executive Officer. We look forward to topline data from our vitiligo clinical trial in the second half of this year.
Three Months Ended June 30, 2022 Financial Results
Our commercial revenue, which excludes BARDA revenue, was $8.2 million in the three months ended June 30, 2022, an increase of $1.5 million or 23%, compared to $6.7 million the corresponding period in the prior year. Total revenue, which includes BARDA revenue, was $8.3 million in the second quarter compared to $10.3 million in the corresponding period in the prior year which included $3.6 million in BARDA related revenue that resulted from our delivery of units to managed inventory for BARDA for emergency response preparedness. The growth in commercial revenues was largely driven by an increase in the number of customers ordering as well as the average order size for those customers.
Gross profit margin improved by 3% to 83% compared to the corresponding period in the prior year.
Total operating expenses increased by 3% to $13.9 million compared to $13.4 million in the corresponding period in the prior year. The increase in operating expenses is primarily attributable to higher compensation costs, sales commissions, and professional fees, partially offset by lower clinical trial related expenses. Higher compensation costs resulted from an expansion of our commercial team, while higher commissions were driven by an increase in revenues. Higher professional fees are driven by an increase in pre-commercialization activities for RECELL launches in soft tissue reconstruction and vitiligo. Clinical trial expenses incurred in our soft tissue and vitiligo trials were lower during the period, as the trial participants were in the follow-up phase which is less costly than the earlier recruitment and treatment phase.
AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 | Page 1 |
Net loss increased by 33% or $1.5 million to $6.3 million, or $0.25 per share, compared to a net loss of $4.7 million, or $0.19 per share, in the corresponding period of the prior year.
Adjusted EBITDA* loss increased by 51%, or $1.6 million to $4.7 million, over the $3.1 million recognized in the corresponding period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
Six Months Ended June 30, 2022, Financial Results
Our commercial revenue, which excludes BARDA revenue, was $15.7 million in the six months ended June 30, 2022, an increase of $4.4 million or 39%, compared to $11.3 million in the corresponding period in the prior year. Total revenue, which includes BARDA revenue, was $15.9 million in the current year compared to $19.1 million in the corresponding period in the prior year which included $7.7 million in BARDA related revenue that resulted from our delivery of units to managed inventory for BARDA for emergency response preparedness. The growth in commercial revenues was largely driven by an increase in the number of customers ordering as well as the average order size for those customers.
Gross profit margin improved by 2% to 80% compared to the corresponding period in the prior year.
Total operating expenses increased by 12% to $29.9 million compared to $26.6 million in the corresponding period in the prior year. The increase in operating expenses is primarily attributable to higher compensation costs and professional fees, partially offset by lower clinical trial related expenses. Higher compensation costs were primarily a result of increased share-based compensation expenses due to certain performance milestones being met, higher commissions driven by an increase in revenues, and an expansion of our commercial team. Increased professional fees were driven by an increase in pre-commercialization costs for RECELL launches in soft tissue reconstruction and vitiligo. Research and development expenses were lower relative to the prior year during which higher costs were incurred relating to recruitment and treatment for the soft tissue and vitiligo clinical trials.
Net loss increased by 47% or $5.0 million to $15.7 million, or $0.63 per share, compared to a net loss of $10.7 million, or $0.45 per share, in the corresponding period of the prior year.
Adjusted EBITDA* loss increased by 46%, or $3.5 million to $11.1 million, over the $7.6 million recognized in the corresponding period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
Calendar Year 2022 Revenue Guidance
Commercial revenues in calendar year 2022 are projected to be approximately $30 million, excluding BARDA revenues, which represents a 20% increase year-over year. We project BARDA revenues of approximately $0.3 million in calendar year 2022, as compared to $7.9 million in calendar year 2021, since we completed delivery of RECELL units into the national stockpile in 2021.
*Adjusted EBITDA is a non-GAAP financial measure. See the appendix to this release for a discussion of non-GAAP financial measures, including a reconciliation to the most closely correlated GAAP measure.
Webcast and Conference Call Information
The Company will host a conference call to discuss the second quarter financial results after market close on Thursday August 11, 2022, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time (being 7.00 a.m. Australian Eastern Standard Time on Friday August 12, 2022). To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. The live webinar can be accessed at https://ir.avitamedical.com.
AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 | Page 2 |
Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
# # #
ABOUT AVITA MEDICAL, INC.
AVITA Medical, Inc. is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical Inc.s patented, and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The Companys lead product is the RECELL® System, a device that enables healthcare professionals to Spray-On Skin Cells using a small sample of the patients own skin to create an autologous suspension. The RES® Regenerative Epidermal Suspension is then sprayed onto the areas of the patient requiring treatment to regenerate natural healthy epidermis.
AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.
The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 15,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USERECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.
In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe, and received Japans Pharmaceuticals and Medical Devices Act (PMDA) approval for burns in Japan.
To learn more, visit www.avitamedical.com.
* Use of non-GAAP Measure
AVITA Medicals reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. AVITA Medical has provided in this release certain financial information that has not been prepared in accordance with GAAP. AVITA Medicals management believes that the non-GAAP adjusted EBITDA described in the release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding AVITA Medicals underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in AVITA Medicals industry. However, the non-GAAP financial measures that AVITA Medical uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.
AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 | Page 3 |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational, and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing and realization of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
FOR FURTHER INFORMATION:
U.S. Media Sam Brown, Inc. Christy Curran Phone +1 615 414 8668 christycurran@sambrown.com
O.U.S Media Monsoon Communications Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.au |
Investors ICR Westwicke Caroline Corner Phone +1 415 202 5678 caroline.corner@westwicke.com |
AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 | Page 4 |
AVITA MEDICAL, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
As of | ||||||||
June 30, 2022 | December 31, 2021 | |||||||
ASSETS |
||||||||
Cash and cash equivalents |
$ | 34,737 | $ | 55,511 | ||||
Marketable securities |
49,618 | 29,649 | ||||||
Accounts receivable, net |
3,884 | 3,118 | ||||||
BARDA receivables |
338 | 308 | ||||||
Prepaids and other current assets |
1,005 | 1,213 | ||||||
Restricted cash |
202 | 201 | ||||||
Inventory |
2,022 | 2,132 | ||||||
|
|
|
|
|||||
Total current assets |
91,806 | 92,132 | ||||||
Marketable securities, long-term |
6,743 | 19,692 | ||||||
Plant and equipment, net |
1,249 | 1,262 | ||||||
Operating lease right-of-use assets |
1,203 | 1,544 | ||||||
Intangible assets, net |
428 | 443 | ||||||
Other long-term assets |
1,240 | 942 | ||||||
|
|
|
|
|||||
Total assets |
$ | 102,669 | $ | 116,015 | ||||
|
|
|
|
|||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Accounts payable and accrued liabilities |
2,495 | 2,708 | ||||||
Accrued wages and fringe benefits |
4,174 | 5,363 | ||||||
Other current liabilities |
1,217 | 1,075 | ||||||
|
|
|
|
|||||
Total current liabilities |
7,886 | 9,146 | ||||||
Contract liabilities |
813 | 952 | ||||||
Operating lease liabilities, long-term |
532 | 918 | ||||||
Other long-term liabilities |
715 | 375 | ||||||
|
|
|
|
|||||
Total liabilities |
9,946 | 11,391 | ||||||
|
|
|
|
|||||
Non-qualified deferred compensation share awards |
163 | | ||||||
Contingencies (Note 12) |
||||||||
Shareholders Equity: |
||||||||
Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,003,088 and 24,925,743 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively |
3 | 3 | ||||||
Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at June 30, 2022 and December 31, 2021 |
| | ||||||
Additional paid-in capital |
336,668 | 332,484 | ||||||
Accumulated other comprehensive income |
7,536 | 8,060 | ||||||
Accumulated deficit |
(251,647 | ) | (235,923 | ) | ||||
|
|
|
|
|||||
Total shareholders equity |
92,560 | 104,624 | ||||||
|
|
|
|
|||||
Total liabilities and shareholders equity |
$ | 102,669 | $ | 116,015 | ||||
|
|
|
|
AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 | Page 5 |
AVITA MEDICAL, INC.
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues |
$ | 8,335 | $ | 10,304 | $ | 15,874 | $ | 19,069 | ||||||||
Cost of sales |
(1,386 | ) | (2,053 | ) | (3,164 | ) | (4,199 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
6,949 | 8,251 | 12,710 | 14,870 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
BARDA income |
551 | 440 | 1,285 | 1,010 | ||||||||||||
Operating expenses: |
||||||||||||||||
Sales and marketing expenses* |
(5,332 | ) | (4,146 | ) | (10,160 | ) | (7,795 | ) | ||||||||
General and administrative expenses* |
(5,471 | ) | (5,275 | ) | (13,005 | ) | (10,697 | ) | ||||||||
Research and development expenses* |
(3,059 | ) | (3,974 | ) | (6,679 | ) | (8,083 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
(13,862 | ) | (13,395 | ) | (29,844 | ) | (26,575 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating loss |
(6,362 | ) | (4,704 | ) | (15,849 | ) | (10,695 | ) | ||||||||
Interest expense |
(4 | ) | (9 | ) | (4 | ) | (12 | ) | ||||||||
Other income |
109 | 2 | 137 | 9 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss before income taxes |
(6,257 | ) | (4,711 | ) | (15,716 | ) | (10,698 | ) | ||||||||
Income tax expense |
(4 | ) | (7 | ) | (8 | ) | (17 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ | (6,261 | ) | $ | (4,718 | ) | $ | (15,724 | ) | $ | (10,715 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per common share: |
||||||||||||||||
Basic |
$ | (0.25 | ) | $ | (0.19 | ) | $ | (0.63 | ) | $ | (0.45 | ) | ||||
Diluted |
$ | (0.25 | ) | $ | (0.19 | ) | $ | (0.63 | ) | $ | (0.45 | ) | ||||
Weighted-average common shares: |
||||||||||||||||
Basic |
24,971,243 | 24,860,738 | 24,954,712 | 23,803,460 | ||||||||||||
Diluted |
24,971,243 | 24,860,738 | 24,954,712 | 23,803,460 |
* Total operating expenses include impact of share-based compensation as follows:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Sales and marketing expenses |
$ | 285 | $ | 63 | $ | 614 | $ | 301 | ||||||||
General and administrative expenses |
983 | 1,172 | 3,310 | 2,102 | ||||||||||||
Research and development expenses |
146 | 175 | 422 | 340 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
1,414 | 1,410 | 4,346 | 2,743 | ||||||||||||
|
|
|
|
|
|
|
|
AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 | Page 6 |
Reconciliation of reported Net Loss (GAAP) to Adjusted EBIDTA (NON-GAAP) Measure Unaudited
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Net Loss |
$ | (6,261 | ) | $ | (4,718 | ) | $ | (15,724 | ) | $ | (10,715 | ) | ||||
Depreciation expense |
129 | 145 | 258 | 282 | ||||||||||||
Patent Amortization |
8 | 31 | 42 | 61 | ||||||||||||
Share-based expense |
1,414 | 1,410 | 4,346 | 2,743 | ||||||||||||
Interest Expense |
4 | 9 | 4 | 12 | ||||||||||||
Income Tax Expense |
4 | 7 | 8 | 17 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Adjusted EBITDA (Non-GAAP) |
$ | (4,702 | ) | $ | (3,116 | ) | $ | (11,066 | ) | $ | (7,600 | ) | ||||
|
|
|
|
|
|
|
|
PR 08112022
AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 | Page 7 |
Exhibit 99.2
AVITA Medical Announces Topline Results from Pivotal Trial in Patients with Soft-Tissue Injuries using the RECELL® System
| AVITA Medical plans to submit PMA supplement for this new indication to FDA by the end of 2022 |
VALENCIA, Calif. and MELBOURNE, Australia, 11 AUGUST 2022 AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced topline results from its pivotal randomized, controlled trial evaluating the safety and effectiveness of the RECELL System combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction. Injuries considered for the clinical trial included any full-thickness acute skin defect, such as degloving or peeled back skin injuries, road rash, surgical wounds, and flesh-eating disease.
Soft-tissue injuries can be challenging to treat and I am very pleased with the outcomes using RECELL especially the use of less donor skin when treating a variety of injuries, said Dr. Steven E. Mapula, Assistant Professor of Surgery TCU and Division Chief of Plastic Surgery at John Peter Smith Hospital. Following FDA approval, I look forward to utilizing RECELL broadly to help patients with a wide variety of soft-tissue injuries.
The study design included co-primary endpoints, based on pairwise comparisons where each subject received both RECELL used in combination with widely-meshed skin grafting and the Control treatment of conventional skin grafting; one endpoint had a hypothesis of superiority for donor skin sparing and the other co-primary endpoint had a hypothesis of non-inferiority for healing. Preliminary review of adverse events shows consistency with our years of prior RECELL experience, reinforcing the products compelling safety profile. The primary study outcomes are as follows:
| The donor sparing endpoint was met, showing a superior ratio of treated injury area to donor site area (p<0.001) with RECELL versus Control |
| The healing endpoint did not reach pre-specified statistical non-inferiority, however, observed values for healing with RECELL were the same or slightly better than Control |
AVITA Medical Inc, 28159 Avenue Stanford, Valencia, CA 91355
Page 1
Our study has shown statistically superior donor sparing and comparable healing rates for RECELL treatment of soft tissue injuries and we are confident in moving forward with our plan for a PMA submission later this year, said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. The RECELL System has been used to effectively treat serious burn injuries and we anticipate that the RECELL System will be well-positioned to treat patients with soft-tissue injuries, pending FDA review and approval.
The Company also plans to submit detailed results from the trial for peer-reviewed publication.
Skin grafting is the standard of care for soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction. Skin grafting requires the harvesting of donor skin, resulting in an additional wound to the patient. Significant pain, delayed healing, risk of infection, the need for multiple procedures, discoloration and scarring are associated with donor site wounds.i The total addressable market (TAM) for soft tissue repair is approximately $1 billion and more than twice as large as the TAM for burns. Further, if FDA approved, the existing reimbursement codes utilized for burn treatment with the RECELL System will apply to this indication.
# # #
ABOUT AVITA MEDICAL, INC.
AVITA Medical, Inc. is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical Inc.s patented, and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The Companys lead product is the RECELL® System, a device that enables healthcare professionals to Spray-On Skin Cells using a small sample of the patients own skin to create an autologous suspension. The RES® Regenerative Epidermal Suspension is then sprayed onto the areas of the patient requiring treatment to regenerate natural healthy epidermis.
AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.
The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 15,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USERECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.
AVITA Medical Inc, 28159 Avenue Stanford, Valencia, CA 91355
Page 2
In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe, and received Japans Pharmaceuticals and Medical Devices Act (PMDA) approval for burns in Japan.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational, and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing and realization of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
This press release was authorized by the review committee of AVITA Medical, Inc.
AVITA Medical Inc, 28159 Avenue Stanford, Valencia, CA 91355
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FOR FURTHER INFORMATION:
U.S. Media Sam Brown, Inc. Christy Curran Phone +1-615-414-8668 christycurran@sambrown.com
O.U.S. Media Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.au |
Investors Westwicke Partners Caroline Corner Phone +1-415-202-5678 caroline.corner@westwicke.com |
PR 08082022
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i | Ter Horst B, Chouhan G, Moiemen NS, Grover LM. Advances in keratinocyte delivery in burn wound care. Advanced drug delivery reviews. 2018 Jan 1; 123:18-32. |
AVITA Medical Inc, 28159 Avenue Stanford, Valencia, CA 91355
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