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Elutia Inc. (symbol: AZYO) is a pioneering company in the field of biologic products, dedicated to improving the compatibility between medical devices and patients. The company’s mission is to humanize medical devices to enhance patient outcomes, addressing the growing need for implantable technologies in an aging population.
Elutia's core business revolves around the development and commercialization of innovative biologic solutions. One of its prominent products is the viable bone matrix, designed for orthopedic applications. These products are engineered to integrate seamlessly with the human body, thereby reducing complications and improving healing processes.
Recently, Elutia has been proactive in addressing a significant challenge. The company issued a voluntary recall for certain lots of its viable bone matrix product after post-surgical Mycobacterium tuberculosis (MTB) infections were detected in two patients. Despite initial testing showing negative results for MTB, Elutia has suspended shipments from all donor lots and is cooperating with the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC). Elutia is also notifying physicians involved to initiate post-exposure prophylaxis for affected patients.
Dr. Randy Mills, President and CEO of Elutia, emphasized the company's commitment to patient safety and its collaboration with the medical community and regulatory authorities during this investigation. This recall exemplifies the company's dedication to maintaining high standards of quality and patient care.
Elutia also made headlines with its CanGaroo product. A recent biopsy showed that the CanGaroo implant was fully resorbed, with the surrounding tissue indicating successful remodeling and vascularization. This development highlights Elutia's ongoing innovation and impact in the medical field.
Financially, Elutia continues to focus on growth and sustainability. The company’s quarterly reports and investor communications, managed by FINN Partners, provide transparency and keep stakeholders informed about its financial health and strategic direction. For further details and the latest updates, visit the company’s official website or the investor relations page.
Aziyo Biologics (Nasdaq: AZYO) has initiated a multi-center observational study to analyze clinical outcomes in patients undergoing cardiac implantable electronic device (CIED) placement with or without its CanGaroo® Envelope. This study will enroll up to 500 participants, aiming to collect data over 21 months, with long-term follow-ups for some patients extending to five years. The CanGaroo Envelope is designed to reduce complications and enhance patient comfort during CIED procedures, marking a significant advancement for Aziyo in regenerative medicine.
Aziyo Biologics, a regenerative medicine company listed on Nasdaq under the ticker AZYO, announced its participation in the Truist Securities Life Sciences Summit. The event is scheduled for Wednesday, May 5, 2021, featuring a fireside chat at 11:20 a.m. ET. Aziyo Biologics focuses on innovative products to enhance surgical outcomes, particularly for patients using implantable medical devices. Since its inception in 2015, the company has developed a portfolio of products aimed at cardiovascular, orthopedic, and reconstructive specialties. For details, visit www.Aziyo.com.
Aziyo Biologics (Nasdaq: AZYO) announced plans to release its first quarter earnings results on May 4, 2021, after market close. The management will host a conference call at 4:30 PM ET to discuss financial performance, which will also be available via webcast. Aziyo focuses on developing products aimed at improving surgical outcomes, particularly for patients with implantable medical devices. The company has a portfolio in cardiovascular, orthopedic, and reconstructive specialties, highlighting its growth in the regenerative medicine sector.
Aziyo Biologics reported Q4 and full-year 2020 financial results amid COVID-19 impacts. Q4 net sales reached $12.5 million, a 3% increase from 2019; core product sales were $10.3 million, up 10%. For the full year, net sales were $42.7 million, down 0.5% year-over-year. Gross margin improved to 48% in Q4, adding to a full-year margin of 48%. However, operating expenses surged 21% to $34.2 million, resulting in a net loss of $21.8 million, compared to $11.9 million in 2019. For 2021, total net sales are projected between $50 million and $52 million.
Aziyo Biologics, Inc. (Nasdaq: AZYO) announced its participation in the Cowen 41st Annual Health Care Conference, scheduled for March 4, 2021. The event will feature a fireside chat starting at 12:50 p.m. ET. Aziyo focuses on developing advanced regenerative medicine products to enhance surgical outcomes, particularly for patients receiving implantable medical devices. Since its inception in 2015, the company has established a portfolio of commercial-stage products across various medical specialties.
Aziyo Biologics (Nasdaq: AZYO) has enrolled its first patient in the HEAL Study, aimed at assessing the effects of device envelopes around cardiovascular implantable electronic devices (CIEDs). The national multi-center study will evaluate approximately 100 patients with either an Aziyo CanGaroo® Envelope or Medtronic’s Tyrx™, focusing on soft tissue healing characteristics. Dr. Ziad Issa is leading the study, which aims to reduce complications during device revision procedures. Ron Lloyd, President and CEO, expressed optimism about the study validating the CanGaroo Envelope's benefits for patient outcomes.
Aziyo Biologics, Inc. (Nasdaq: AZYO) will report its fourth quarter and full year earnings results on March 1, 2021, after market close. The management team will host a conference call to discuss the financial performance at 4:30 p.m. ET. Investors can access the details through the company's website and listen by dialing the provided numbers with the conference ID 4158569. Aziyo focuses on regenerative medicine, offering products for cardiovascular, orthopedic, and reconstructive specialties since its establishment in 2015.
Aziyo Biologics (Nasdaq: AZYO) has completed the product design for CanGaroo® with antibiotics, enhancing its existing CanGaroo Envelope. This innovative product aims to mitigate post-operative infection risks by incorporating rifampin and minocycline into the biologically-derived envelope. The CanGaroo Envelope is designed to create a natural tissue pocket for implantable devices, promoting healthier tissue integration. Aziyo has partnered with Cook Biotech for further development, with plans for FDA submission anticipated in early 2022.
Aziyo Biologics (Nasdaq: AZYO) announced CE Mark approval for updated labeling of its CanGaroo® Envelope, allowing hydration with gentamicin prior to device implantation. This enhancement aims to reduce post-operative infections, bolstering product efficacy. The CanGaroo Envelope, a biological solution for implantable cardiac devices, is recognized for its ability to lower complication risks. Aziyo markets the CanGaroo primarily in Europe through BIOTRONIK and other distributors, expanding its portfolio in regenerative medicine.
Aziyo Biologics reported net sales of $11.8 million for Q3 2020, a 6% increase from Q3 2019, with Core Products sales up 31%. The company completed its IPO, raising about $43 million in net proceeds. Gross profit was $5.5 million, with a gross margin of 47%, slightly down from the previous year. Operating expenses increased 11% to $8.2 million, driven by R&D investments and G&A expenses. The net loss was $6.7 million, compared to $3.1 million a year ago. Cash and equivalents stood at $1.6 million before the IPO.
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