8-K
false 0001762303 0001762303 2022-08-11 2022-08-11

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2022

 

 

Avita Medical, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39059   85-1021707
(State or other jurisdiction
of incorporation)
 

(Commission

File Number)

  (IRS Employer
Identification No.)

 

28159 Avenue Stanford, Suite 220, Valencia, CA 91355   661.367.9170
(Address of principal executive offices, including Zip Code)   (Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   RCEL   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934. Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


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
No.

  

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
EX-99.1

Exhibit 99.1

 

LOGO

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 patient’s own skin. The Company’s lead product is the RECELL® System, a device that enables healthcare professionals to Spray-On Skin Cells using a small sample of the patient’s 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 patient’s 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 USE—RECELL 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 Japan’s Pharmaceuticals and Medical Devices Act (PMDA) approval for burns in Japan.

To learn more, visit www.avitamedical.com.

* Use of non-GAAP Measure

AVITA Medical’s 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 Medical’s 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 Medical’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in AVITA Medical’s 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 company’s 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
EX-99.2

Exhibit 99.2

 

LOGO

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 product’s 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 patient’s own skin. The Company’s lead product is the RECELL® System, a device that enables healthcare professionals to Spray-On Skin Cells using a small sample of the patient’s 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 patient’s 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 USE—RECELL 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

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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 Japan’s 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 company’s 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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