Elutia Inc. - AZYO STOCK NEWS

Aziyo Biologics, Inc. (Nasdaq: AZYO) and Sientra, Inc. (Nasdaq: SIEN) have partnered to expand the distribution of Aziyo’s SimpliDerm product line for reconstruction surgery in the U.S. This agreement grants Sientra non-exclusive rights to market and sell SimpliDerm, which is a pre-hydrated human acellular dermal matrix designed to improve surgical outcomes. Aziyo aims to enhance women's access to biologic solutions in reconstruction procedures. Both companies anticipate that this collaboration will drive significant revenue growth and profitability. SimpliDerm utilizes a proprietary process to ensure lower inflammatory response risk and achieve a high sterility assurance level.

Aziyo Biologics, Inc. (Nasdaq: AZYO) provided an update regarding its FDA submission for the CanGaroo^® RM Antibacterial Envelope, a biomaterial designed for cardiac and neurostimulator implants. The FDA issued a Not Substantially Equivalent determination on March 16, 2023, highlighting issues primarily related to drug testing and a request for a modified in vitro drug release assay. The company plans to collaborate with the FDA to address these issues but does not plan to appeal the decision. Dr. Randy Mills expressed disappointment yet confidence in resolving the FDA's questions. A financial results conference is scheduled for March 22, 2023.

Aziyo Biologics, Inc. (Nasdaq: AZYO) announced the release of its fourth quarter and full year 2022 financial results scheduled for March 22, 2023, after market close. A management conference call and webcast will follow at 4:30 p.m. ET, featuring discussions on the financial performance and outlook. Investors can access the call via a dedicated phone line or through an online webcast. Aziyo focuses on developing biologic products aimed at enhancing compatibility between medical devices and patients, addressing a growing demand for implantable technologies. More information can be found on their official website.

Aziyo Biologics, Inc. (Nasdaq: AZYO) announced that CEO Dr. Randy Mills and CFO Matt Ferguson will present at the Cowen 43rd Annual Health Care Conference. The event is scheduled for March 6, 2023, at 9:50 am ET, located at the Boston Marriott Copley Place. Investors and interested parties can access a live webcast of the presentation through the company’s investor page. A replay will also be available post-event. Aziyo focuses on developing biologic products that enhance compatibility between medical devices and patients, aiming to improve patient outcomes through innovative solutions in the growing market of implantable technologies.

Aziyo Biologics, Inc. (Nasdaq: AZYO) reported preliminary net sales for Q4 and the full year of 2022. Q4 sales are expected to reach $12.5-$12.7 million, marking a 15%-17% increase year-over-year. For the full year, net sales are projected at $49.0-$49.2 million, a 3%-4% rise compared to 2021, with a significant 15%-16% growth after excluding sales from a discontinued product. Strong performance from product lines SimpliDerm and CanGaroo is noted, with anticipated combined sales growth of about 30% in Q4 2022. Full financial results will be reported in early March 2023.

Aziyo Biologics has secured a $4 million term loan from SWK Holdings, enhancing its funding to advance the development of CanGaroo® RM, a biomaterial envelope aiming for FDA clearance in Q1 2023. This loan is part of a $25 million credit facility, complementing a recent $11.2 million public stock offering, totaling $15.2 million in gross proceeds. The funds will support product development, clinical research, and expanded sales efforts. Aziyo is focused on growing its medical device compatibility business, targeting significant market opportunities.

Aziyo Biologics, Inc. (Nasdaq: AZYO) announced a public offering of 2,350,000 shares of common stock priced at $4.75 per share, aiming for gross proceeds of $11.2 million. The underwriter, Cantor Fitzgerald & Co., has a 30-day option to purchase an additional 352,500 shares. The company plans to use proceeds to enhance product development, clinical research, hire sales personnel, and cover general corporate expenses. The offering is projected to close on or around December 5, 2022, subject to customary conditions.

Aziyo Biologics, Inc. (Nasdaq: AZYO) has initiated an underwritten public offering of its common stock, subject to market conditions. The company plans to provide the underwriter with a 30-day option for additional shares equivalent to 15% of the offering. Proceeds will support product development, clinical research, and sales personnel expansions. The offering is registered under an effective shelf registration statement with the SEC, filed on August 31, 2022. There is no assurance on the timing or completion of the offering.

Aziyo Biologics reported strong third-quarter results, with net sales of $12.4 million, an 8% increase year-over-year. Key growth was noted in the device compatibility segment, with an 18% rise in sales. The company anticipates CanGaroo® RM clearance in Q1 2023 following a positive FDA meeting. Gross profit improved to $5.0 million (41% margin), up from $3.7 million (32%) a year earlier. However, total operating expenses rose by 20% to $12.8 million, contributing to a net loss of $9.9 million. The company raised its revenue guidance for 2022 to $48 million to $50 million.