SILVER SPRING, Md. and IRVINE, Calif., March 22, 2023 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, and Sientra, Inc. (Nasdaq: SIEN) (“Sientra”), a medical aesthetics company uniquely focused on plastic surgery, today announced they have entered into an agreement to expand the distribution of Aziyo’s SimpliDerm product line. Under the agreement terms, Aziyo will grant Sientra certain non-exclusive rights in the United States to market, sell and distribute SimpliDerm for select use in reconstruction surgery.
“At Aziyo, our mission is to improve compatibility between medical devices and the patients they serve. With this partnership, we significantly expand women’s access to biologic solutions necessary for successful reconstruction procedures,” said Randy Mills, Ph.D., President and Chief Executive Officer of Aziyo Biologics. “We are excited to partner with Sientra, a proven commercial company that brings a highly-specialized commercial team with reach and relationships to help drive growth of the SimpliDerm portfolio in reconstructive surgery. This agreement is intended to help drive meaningful revenue growth and support our strategy of quickly and profitably expanding the reach of our proprietary biologics platforms.”
SimpliDerm is a pre-hydrated human acellular dermal matrix (hADM) that uses a proprietary process to preserve key growth factors of native dermis that support faster integration and more rapid revascularization while demonstrating a lower risk of inflammatory response. Due to this unique process, SimpliDerm has been able to provide a pliable, conforming matrix in a ready-to-use format and achieve a sterility assurance level (SAL) of 10-6.
“At Sientra, we believe that putting the best products in the hands of the most qualified surgeons leads to the most optimal results. The partnership with Aziyo allows our customer to access the innovative SimpliDerm portfolio to provide the industry’s most compelling reconstruction portfolio,” said Ron Menezes, President and Chief Executive Officer of Sientra. “The addition of SimpliDerm to our portfolio fits perfectly with our strategy of being the leader in reconstruction, while enhancing our path to profitability.”
SimpliDerm is to be used for the repair or replacement of damaged or insufficient integumental tissue or for other homologous uses of human integument.
About Aziyo Biologics
Aziyo develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes. For more information, visit www.Aziyo.com.
Headquartered in Irvine, California, Sientra is a medical aesthetics company exclusively focused on plastic surgery. The Company’s mission is to offer proprietary innovations and unparalleled partnerships that radically advance how plastic surgeons think, work and care for their patients. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company’s product portfolio includes its Sientra round and shaped breast implants, the first fifth generation breast implants approved by the FDA for sale in the United States, its ground-breaking Allox2® breast tissue expander with patented dual-port and integral drain technology, the Viality™ with AuraClens™ fat transfer system, and BIOCORNEUM®, the #1 performing, preferred and recommended scar gel of plastic surgeons(*). For more information, visit www.sientra.com.
(*) Data on file.
Aziyo Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements and information concerning the anticipated benefits and financial results from the partnership with Sientra and the benefits from and efficacy of SimpliDerm. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, and other important factors that may cause actual results, performance or achievements to differ materially from those contemplated or implied in this press release, including, but not limited to, risks regarding the Company’s operating losses and ability to become profitable; adverse changes in economic conditions and disruptions in credit markets; the Company’s ability to continue as a going concern; the Company’s products and its ability to enhance, expand, develop and commercialize its product offerings; the impact on the Company’s business of the recall of a single lot of its FiberCel product and the discontinuation of its sales by its distribution partner; the Company’s dependence on its commercial partners; the Company’s future capital needs and available sources of funding; the adverse impacts of COVID-19 or adverse changes in economic conditions and credit markets; physician awareness of the distinctive characteristics, and acceptance by the medical community, of the Company’s products; the ability to obtain regulatory approval or other marketing authorizations; and the Company’s intellectual property rights, and other important factors which can be found in the “Risk Factors” section of Aziyo’s public filings with the Securities and Exchange Commission (“SEC”), including Aziyo’s Annual Report on Form 10-K for the year ended December 31, 2021, as such factors may be updated from time to time in Aziyo’s other filings with the SEC, including, without limitation, Aziyo’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Aziyo’s website at https://investors.aziyo.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Aziyo in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Aziyo expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Sientra Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are made only as of the date of this release. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” “position,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections and other forward-looking statements. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Forward-looking statements may include information concerning Sientra’s launch of the SimpliDerm product, the Sientra’s ability to promote the SimpliDerm product to its customers, Sientra’s profitability projections, and Sientra’s long-term strategic plans. Such statements are subject to risks and uncertainties, including the positive reaction from plastic surgeons and their patients to the SimpliDerm product, the Company’s ability to execute on its commercial, sales and marketing plans, the regulatory environment related to Sientra’s products, as well as other risks and uncertainties described under the “Risk Factors” contained in the Company’s periodic and interim SEC reports, including but not limited to, the preliminary prospectus supplement relating to this offering, its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, its Quarterly Reports on From 10-Q, and its Current Reports on Form 8-K filed from time to time with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Aziyo Biologics, Inc.
INDICATIONS FOR USE
SimpliDerm® is to be used for the repair or replacement of damaged or insufficient integumental tissue. It may also be used for the repair, reinforcement, or supplemental support of soft tissue defects or any other homologous use of human integument. Each package of SimpliDerm® is intended for use in one patient on a single occasion by a licensed physician.