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): March 17, 2025 |
AVITA Medical, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-39059 |
85-1021707 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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28159 Avenue Stanford Suite 220 |
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Valencia, California |
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91355 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 661 367-9170 |
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(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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Common Stock, par value $0.0001 per share |
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RCEL |
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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 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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 1.01 Entry into a Material Definitive Agreement.
Contract Manufacturing Agreement
On March 17, 2025, AVITA Medical Americas, LLC (“AVITA Medical”), a wholly-owned subsidiary of AVITA Medical, Inc. (the “Company”), entered into a contract manufacturing agreement (the “Manufacturing Agreement”) with Stedical Scientific, Inc. (“Stedical Scientific”) to manufacture PermeaDerm® Biosynthetic Wound Matrix (“PermeaDerm”) in the United States. PermeaDerm is cleared by the Food and Drug Administration as a transparent biosynthetic wound matrix for use in the treatment of a variety of wound types until healing is achieved.
Under the terms of the Manufacturing Agreement, AVITA Medical will manufacture PermeaDerm in the United States for the purposes of (i) sale in the United States under the terms of the existing Distribution Agreement (defined below) and (ii) sale to Stedical Scientific for sale or distribution outside the United States. The term of the Manufacturing Agreement is ten years.
Amendment Two to the Exclusive Distribution Agreement
On March 17, 2025, AVITA Medical and Stedical Scientific entered into an Amendment Two (the “Amendment”) of their existing exclusive distribution agreement under which AVITA Medical distributes PermeaDerm in the United States (the “Distribution Agreement”).
Under the terms of the Amendment, AVITA Medical's share of revenue from PermeaDerm sales increases from 50% to 60% and Stedical Scientific becomes eligible for certain milestone payments conditioned upon AVITA Medical's achievement of specified sales targets. The Amendment revises the initial term of the Distribution Agreement to ten years from the date of the Amendment.
Item 7.01. Regulation FD.
On March 17, 2025, the Company issued a press release announcing the entry into the Manufacturing Agreement and the Amendment. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
The information under Item 7.01 and Exhibit 99.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed incorporated by reference into any filing made under the Securities Act of 1933 (except as expressly set forth by specific reference in such filing).
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description of Exhibit |
10.1 |
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10.2 |
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99.1 |
AVITA Medical Announces Exclusive Manufacturing and Distribution Agreements with Stedical Scientific |
104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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.
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AVITA Medical, Inc |
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Date: |
March 17, 2025 |
By: |
/s/ David O'Toole |
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David O'Toole |
Exhibit 10.1
Contract Manufacturing Agreement
This Contract Manufacturing Agreement, (the "Agreement"), is effective as of March 17, 2025 (the “Effective Date”) and is entered into by and between AVITA Medical Americas, LLC having its principle place of business at 28159 Avenue Stanford, Suite 220 Valencia, CA ("Seller"), and Stedical Scientific, Inc. having its principle place of business at 2888 Loker Avenue East, Suite 319 Carlsbad, CA 92010 ("Buyer", and together with Seller, the "Parties", and each, a "Party").
WHEREAS, Seller is in the business of manufacturing and commercializing medical devices and supplies;
WHEREAS, Seller currently distributes certain Goods (as defined below) in the Territory (as defined below) on behalf of Seller under an existing Distribution Agreement (as defined below);
WHEREAS, Buyer wishes for Seller to now also manufacture such Goods;
WHEREAS, Buyer wishes to purchase Goods (as defined below) from Seller for the purpose of selling such Goods outside the Territory; and
WHEREAS, Seller desires to manufacture the Goods for sale to Buyer for the purposes outlined above and for sale to Seller’s customers under the Distribution Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
"Action" means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena or investigation of any nature, civil, criminal, administrative, regulatory, or other, whether at law, in equity or otherwise.
"Affiliate" of a Person means any other Person that directly or indirectly, through one or more intermediaries, Controls, is Controlled by, or is under common Control with, such Person.
"Basic Purchase Order Terms" means, collectively, any one or more of the following terms specified by Buyer in a Purchase Order pursuant to Section 7.2: (a) a list of the Goods to be purchased, including SKU; (b) the quantity of each of the Goods ordered; (c) the Requested Delivery Date; (d) the unit Price for each of the Goods to be purchased; (e) the billing address; and (f) the Delivery Location. For the avoidance of doubt, the term "Basic Purchase Order Terms" does not include any general terms or conditions of any Purchase Order.
"Business Day" means any day except Saturday, Sunday, or any other day on which commercial banks located in California are authorized or required by Law to be closed for business.
"Buyer" has the meaning set forth in the preamble to this Agreement.
"Buyer Contracts" means all contracts or agreements to which Buyer is a party or to which any of its material assets are bound.
"Buyer’s Intellectual Property Rights" means all Intellectual Property Rights owned by or licensed to Buyer.
"Control" (and with correlative meanings, the terms "Controlled by" and "under common Control with") means, with respect to any Person, the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of another Person, whether through the ownership of voting securities, by contract, or otherwise.
"Defective" means not conforming to the Product Warranty.
"Defective Goods" means goods shipped by Seller to Buyer pursuant to this Agreement that are Defective.
"Delivery Location" means the street address within the Territory for delivery of the Goods specified in the applicable Purchase Order.
"Distribution Agreement" means that certain Distribution Agreement entered into between Buyer and Seller on January 10, 2024 as amended from time to time wherein Buyer is designated as “Seller” or “Stedical” and Seller is designated as the “Distributor”.
"Forecast" means, with respect to any calendar quarter, a good faith projection or estimate of Buyer's requirements for Goods during each month during the quarter, which approximates, as nearly as possible, based on information available at the time to Buyer, the quantity of Goods that Buyer may order for each such month.
"Goods" means the goods identified on Schedule A and described in the Specifications.
"Governmental Authority" means any federal, state, local or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court or tribunal of competent jurisdiction.
"Governmental Order" means any order, writ, judgment, injunction, decree, stipulation, award, or determination entered by or with any Governmental Authority.
"Intellectual Property Rights" means all industrial and other intellectual property rights comprising or relating to: (a) Patents; (b) Trademarks; (c) internet domain names, whether or not Trademarks, registered by any authorized private registrar or Governmental Authority, web addresses, web pages, website, and URLs; (d) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, data, data files, and databases and other specifications and documentation; (e) Trade Secrets; (f) know-how; and (g) all industrial and other intellectual property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world. For clarity and notwithstanding the foregoing, Buyer and Seller's ownership in and of their separate and pre-existing Intellectual Property Rights shall continue in full force and effect.
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"Law" means any statute, law, ordinance, regulation, rule, code, constitution, treaty, common law, Governmental Order, or other requirement or rule of law of any Governmental Authority.
"Legacy Goods" means Goods manufactured in the Territory under any existing agreement entered into by Buyer as of the Effective Date.
"Nonconforming Goods" means any goods received by Buyer from Seller pursuant to a Purchase Order that: (a) do not conform to the SKUs listed in the applicable Purchase Order; (b) do not fully conform to the Specifications; or (c) materially exceed the quantity of Goods ordered by Buyer pursuant to this Agreement or any Purchase Order. Where the context requires, Nonconforming Goods are deemed to be Goods for purposes of this Agreement.
"Patents" means all patents (including all reissues, divisionals, provisionals, continuations and continuations-in-part, re-examinations, renewals, substitutions and extensions thereof), patent applications, and other patent rights and any other Governmental Authority-issued indicia of invention ownership (including inventor's certificates, petty patents, and patent utility models).
"Person" means any individual, partnership, corporation, trust, limited liability entity, unincorporated organization, association, Governmental Authority, or any other entity.
"Personnel" of a Party means any agents, employees, contractors, or subcontractors engaged or appointed by such Party.
"Purchase Order" means Buyer's purchase order issued to Seller hereunder.
“Quality Agreement” means a written document agreed to and signed by both Parties defining each Party’s respective obligations under relevant regulations and quality management standards pertaining to the manufacture of medical devices.
"Representatives" means a Party's Affiliates and each of their respective Personnel, officers, directors, partners, shareholders, attorneys, third-party advisors, successors, and permitted assigns.
"Requested Delivery Date" means the requested delivery date for Goods ordered hereunder that is set forth in a Purchase Order, which must be a Business Day no less than thirty days following delivery of the applicable Purchase Order to Seller.
"Seller" has the meaning set forth in the preamble to this Agreement.
"Seller Distributed Goods" means Goods manufactured by Seller for distribution in the Territory by the Seller.
"Seller's Intellectual Property Rights" means all Intellectual Property Rights owned by or licensed to Seller.
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"Seller's Trademarks" means all Trademarks owned by or licensed to Seller.
"Specifications" means the specifications for the manufacturing of Goods established by the Buyer and transmitted to Seller as modified from time to time by mutual agreement of the Parties, and subject to the applicable Quality Agreement(s).
"Taxes" means any and all present and future sales, income, stamp, and other taxes, levies, imposts, duties, deductions, charges, fees or withholdings imposed, levied, withheld, or assessed by any Governmental Authority, together with any interest or penalties imposed thereon.
"Territory" means the US and its territories and possessions.
"Trademarks" means all rights in and to US and foreign trademarks, service marks, trade dress, trade names, brand names, logos, corporate names and domain names, and other similar designations of source, sponsorship, association, or origin, together with the goodwill symbolized by any of the foregoing, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights and all similar or equivalent rights or forms of protection in any part of the world.
"Trade Secrets" means all inventions, discoveries, trade secrets, business and technical information and know-how, databases, data collections, patent disclosures, and other confidential and proprietary information and all rights therein.
"US" means the United States of America.
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Buyer shall ship, at Buyer's expense and risk of loss, all Nonconforming Goods to Seller's facility or to such other location as Seller may instruct Buyer in writing. If Seller exercises its option to replace Nonconforming Goods, Seller shall ship to the Delivery Location, at Seller's expense and risk of loss, the replacement Goods.
THE REMEDIES SET FORTH IN THIS SECTION ARE BUYER'S EXCLUSIVE REMEDY FOR THE DELIVERY OF NONCONFORMING GOODS, SUBJECT TO BUYER'S RIGHTS UNDER SECTION 13.5 WITH RESPECT TO ANY SUCH GOODS FOR WHICH BUYER HAS ACCEPTED DELIVERY UNDER THIS SECTION.
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Any termination under this Section will be effective on Buyer's receipt of Seller's written Notice of termination or such later date (if any) set forth in such Notice.
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Buyer has no right to return for repair, replacement, credit, or refund any Good except as set forth in this Section (or if otherwise applicable, Section 8.6 or Section 13.7). In no event shall Buyer reconstruct, repair, alter or replace any Good, in whole or in part, either itself or by or through any third party.
THIS SECTION SETS FORTH SELLER'S ENTIRE LIABILITY FOR ANY BREACH OF, AND BUYER'S SOLE REMEDY RELATING TO, THE LIMITED PRODUCT WARRANTY.
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Notwithstanding anything to the contrary in this Agreement, this Section does not apply to any Claim (whether direct or indirect) for which a sole or exclusive remedy is provided for under another section of this Agreement.
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Notice to Seller: |
2888 Loker Avenue East, Suite 319 Carlsbad, California, 92010 |
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Attention: Scott Moote, Director, Operation, |
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[***] |
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CC: Shuang Miao, Manager, Internal Control, [***] |
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Notice to Buyer: |
28159 Avenue Stanford, Suite 220 Valencia, CA, 91355 |
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Attention: David Melbye, SVP Operations |
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[***] |
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CC: Legal Department legal@avitamedical.com |
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[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the Parties hereto have executed this Contract Manufacturing Agreement as of the date first set forth above.
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AVITA Medical Americas, LLC
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By_____________________ Name: Jim Corbett Title: CEO
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Stedical Scientific, Inc.
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By_____________________ Name: Lin Sun Title: Chairman |
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SCHEDULEA
GOODS
SKU |
Product |
UOM |
QTY |
C2050500 |
PermeaDerm® C - 5" x 5" |
CT |
10 |
B1051000 |
PermeaDerm® B - 5" x 10" |
CT |
8 |
B2101500 |
PermeaDerm® B - 10" x 15" |
CT |
3 |
B4153000 |
PermeaDerm® B -15" x 30" |
CT |
1 |
G2S00000 |
PermeaDerm® Glove S |
CT |
2 |
G3M00000 |
PermeaDerm® Glove M |
CT |
2 |
G4L10000 |
PermeaDerm® Glove L |
CT |
2 |
G5XL0000 |
PermeaDerm® Glove XL |
CT |
2 |
G6XXL000 |
PermeaDerm® Glove XXL |
CT |
2 |
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Exhibit 10.1
SCHEDULE B
Seller’s Cost
Exhibit 10.1
SCHEDULE C
Buyer-owned Tooling
Equipment |
Qty |
Large BioDot |
1 |
Size B slitter |
1 |
Size C slitter |
1 |
Tools |
Qty |
Layering Tool |
2 |
Layering Frame |
24 |
Die Cut Tool SM |
1 |
Die Cut Tool M |
1 |
Die Cut Tool L |
1 |
Die Cut Tool XL |
1 |
Die Cut Tool XXL |
1 |
Exhibit 10.2
Amendment Two to the Exclusive Distribution Agreement
This Amendment Two (this “Amendment Two”), is effective as of March 17, 2025 (the “Effective Date”), and amends the Exclusive Distribution Agreement with an Effective Date of January 10, 2024, previously amended on April 30, 2024 (the “Agreement”), by and between AVITA Medical Americas, LLC (“Distributor”) and Stedical Scientific, Inc. (“Seller” or “Stedical”). Distributor and Stedical are referred to herein individually as “Party”, or collectively as “Parties.”
WHEREAS, the Parties now desire to amend the terms of the Agreement to better align with their ongoing needs.
NOW, THEREFORE, in consideration of the mutual covenants contained below, the Parties agree to amend the Agreement as follows:
“WHEREAS, Stedical desires to have the Products (as defined in Schedule A) manufactured, distributed, and sold;
WHEREAS, Distributor intends to manufacture the Products under the terms of a separate Manufacturing Agreement with Stedical (the “Manufacturing Agreement”);”
“4. Revenue Sharing Arrangement; Milestone Payment Opportunities; Growth Targets.
4.1 Revenue Sharing. For all Products sold by Distributor under this Agreement, Distributor shall retain 60% of the revenue from each sale and, in exchange for the Buyer IP License granted in the Manufacturing Agreement (as that term is defined in the Manufacturing Agreement), remit the remaining 40% of revenue to Stedical, less the manufacturing cost and overhead allocation for Seller Distributed Goods (as that term is defined in the Manufacturing Agreement).
4.2 Payment Terms. Distributor shall pay all amounts due to Stedical on a monthly basis. Distributor shall make all payments in USD by wire transfer or automated clearing house. Stedical’s bank wire information is provided in Schedule A.
4.3 Milestone Payment Opportunities. During the Term and any Renewal Term, Stedical will have the opportunity to earn certain performance-based payments (each a “Milestone Payment”) on following terms and conditions:
(a) If Distributor achieves total sales of the Products in the Territory greater than $45,000,000, then Distributor shall pay to Stedical a milestone payment of $1,000,000 (equal to 2% of the first $45,000,000 in gross sales of the Products) within ninety days of the end of the month in which the achievement is accomplished (the “First Milestone Payment”).
(b) If Distributor achieves total sales of the Products in the Territory greater than $90,000,000, then Distributor shall pay to Stedical a milestone payment of $1,500,000 (equal to 3% of the second $45,000,000 in gross sales of the Products) within ninety days of the end of the month in which the achievement is accomplished (the “Second Milestone Payment”)
(c) If Distributor achieves the First and Second Milestone Payments, then Distributor shall pay to Stedical, on a quarterly basis, an additional Milestone Payment equal to 2.5% of all amounts that are paid to Stedical under Section 4.1 of this Agreement after the payment of the First and Second Milestone Payments.”
4.4 Growth Minimums and Goals. Distributor shall commit to certain annual revenue minimums for sale of Products under this Agreement. For 2025, Distributor shall achieve $6,000,000 in gross sales of Products (the “Initial Growth Minimum”). For every year thereafter, Distributor shall achieve a minimum 20% increase in revenue from sale of the Products (“Annual Growth Minimum(s)”). Additionally, and also for every year thereafter, Distributor and Stedical shall negotiate in good faith to agree upon an annual revenue goal for sale of Products under this Agreement that is reasonably tied to Distributor’s annual revenue growth rate, excluding revenue from Products (each, a “Growth Goal”). Distributor may fail to meet a single Initial Growth Minimum or Annual Growth Minimum (each a “Growth Minimum”) without any effect. In the event that Distributor fails to achieve a Growth Minimum for two subsequent years, Distributor shall be able to cure such failure by making a cash payment equal to the difference between the revenue that would have been remitted to Stedical under Section 4.1 if Distributor had achieved such Growth Minimums and the revenue actually remitted to Stedical over that same time period.
“9.1 Term. The term of this Agreement, as amended, commences on the Effective Date of Amendment Two and terminates on the tenth anniversary of that date, unless terminated earlier under the terms of this Agreement (the "Term"). At least thirty days before the expiration of the Term, the Parties may extend the Term by a mutual written agreement. If Distributor has successfully achieved $90,000,000 in sales in the Territory during the Term, the Agreement shall automatically renew for an additional ten-year period (a “Renewal Term”), unless terminated earlier under the terms of this Agreement.”
“9.3 Distributor Termination Rights. Distributor may terminate this Agreement by providing written notice to Stedical:
(a) if, after thirty (30) days’ written notice from Distributor and Stedical’s failure to take corrective action, Stedical sells or attempts to sell Products in the Territory;
(b) if Distributor terminates the Manufacturing Agreement due to Stedical’s or Stedical’s Affiliates’ breach or non-performance thereof;”
“19. Contingency & Read Together. This Amendment Two is contingent upon the execution and delivery of the Manufacturing Agreement. In the event that the Manufacturing Agreement (attached as Exhibit A) is not signed within two days of the execution of this Amendment Two, this Amendment Two shall be null and void. This Amendment Two shall be read and construed in conjunction with the Agreement, any previous amendments thereto, and the Manufacturing Agreement.
IN WITNESS WHEREOF, the Parties have caused this Amendment Two to be executed by their duly authorized officers as of the Effective Date.
AVITA Medical Americas, LLC |
Stedical Scientific, Inc. |
By: |
By: |
Name: Jim Corbett |
Name: Lin Sun |
Title: CEO |
Title: Chairman |
Date: |
Date:
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Schedule A
Products
Beneficiary Name |
Stedical Scientific, Inc. |
Account Number |
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Beneficiary Address |
2888 Loker Ave E STE 319, Carlsbad, CA 92010, USA |
SWIFT CODE |
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ACH Routing Number |
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ABA Routing Number |
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Receiving Bank Name |
Bank of America, N.A. |
Receiving Bank Address |
Bank of America, N.A., 222 Broadway, New York, NY 10038 (U.S. dollars) Bank of America, N.A., 555 California St, San Francisco, CA 94104 (Foreign currency) |
Schedule B
Monthly Reporting Parameters
Distributor shall provide to Stedical, beginning on the tenth business day after the one-month anniversary of the Effective Date, monthly reports that provide the following information from the previous calendar month:
a realistic estimate)
EXHIBIT A
[MANUFACTURING AGREEMENT]
Exhibit 99.1
AVITA Medical Announces Exclusive Manufacturing and Distribution Agreements with Stedical Scientific
VALENCIA, Calif., March 17, 2025 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions, today announced it has entered into a new Contract Manufacturing Agreement for PermeaDerm® Biosynthetic Wound Matrix, along with an Amendment to its existing Exclusive Distribution Agreement with Stedical Scientific, Inc. These agreements further strengthen the strategic relationship between the two companies to expand the reach and availability of PermeaDerm.
Under the terms of the new Contract Manufacturing Agreement, effective as of March 17, 2025, AVITA Medical is to manufacture PermeaDerm at its state-of-the-art manufacturing facility in Ventura, California. This agreement ensures the continued availability of this innovative transparent biosynthetic wound matrix while optimizing AVITA Medical’s production capabilities to meet growing market demand. AVITA Medical will utilize its existing infrastructure to support the further commercialization of PermeaDerm in the U.S. while streamlining production, increasing scale, and optimizing manufacturing cost efficiencies to drive greater value.
The Exclusive Distribution Agreement originally executed in January 2024 has been amended to align with the new manufacturing arrangement. This revised agreement modifies revenue-sharing terms, establishes performance-based milestones, and extends the contract term. Under these new terms, AVITA Medical will retain 60% of the average sales price from PermeaDerm sales while remitting 40% to Stedical after deducting manufacturing costs. Prior to the amendment, each party retained 50% of the average sales price from the sale of PermeaDerm.
“These strategic agreements reflect our shared commitment to driving innovation and expanding market access, while ensuring that patients continue to receive first-in-class care,” said Jim Corbett, CEO of AVITA Medical. "We look forward to leveraging our expertise to continue to drive innovation and growth in therapeutic acute wound care."
Lin Sun, Chairman of Stedical Scientific, added, "PermeaDerm has demonstrated great healing results when used for various wounds. We are excited to expand our collaboration with AVITA Medical through this manufacturing agreement. This partnership ensures a robust supply chain for PermeaDerm and strengthens our commitment to delivering cutting-edge solutions to the global market."
PermeaDerm is a biosynthetic matrix that facilitates wound healing while also providing a high level of permeability and biocompatibility. PermeaDerm is cleared by the FDA for use in the treatment of a variety of wound types until healing is achieved. For partial and full-thickness injuries treated with Spray-On Skin™Cells prepared with AVITA Medical’s RECELL® devices, PermeaDerm can be applied to further support healing. Additionally, PermeaDerm is eligible for reimbursement in the U.S. across inpatient and outpatient settings, making it more accessible to healthcare providers and patients.
About AVITA Medical, Inc.
AVITA Medical® is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies are designed to optimize wound healing, effectively accelerating the time to patient recovery. At the forefront of our platform is the RECELL® System, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects. RECELL harnesses the healing properties of a patient’s own skin to create Spray-On Skin™ Cells, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the exclusive rights to market, sell, and distribute both Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix, and PermeaDerm®, a biosynthetic wound matrix.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns and full-thickness skin defects. The RECELL System, excluding RECELL GO®, is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
About Stedical Scientific, Inc.
Stedical Scientific, Inc. is an innovative tissue engineering and regenerative medicine company that develops, manufactures and sells cutting-edge products delivered from a proprietary biosynthetic technology platform for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery. Stedical Scientific’s mission is to expand its portfolios of disruptive innovations and to serve millions of people around the globe. Stedical Scientific has brought extraordinary clinical experience to patients through its signature product, PermeaDerm, revolutionizing wound care.
Stedical Scientific’s growth strategy, in addition to marketing products in the U.S., is to expand extensively in the international market, while committed to substantially improving patient and clinician experiences through breakthrough technologies and changing the course of human health.
To learn more, visit www.stedical.com.
Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “would,” “may,” “will,” “believe,” “continue,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “outlook,” “guidance,” “future,” and similar words or expressions, and the use of future dates. Forward-looking statements include, but are not limited to, statements relating to 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 or adoption of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and risks of other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. These statements are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
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may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.
Investor & Media Contact:
Jessica Ekeberg
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com
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