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TransMedics Group, Inc. (NASDAQ: TMDX) is a leading commercial-stage medical technology company revolutionizing organ transplant therapy for end-stage organ failure patients. Based in Andover, Massachusetts, the company was established to address the critical need for more and better organs for transplantation. TransMedics has developed the Organ Care System (OCS), a proprietary technology that preserves and optimizes donor organs outside the human body under near-physiological conditions.
TransMedics' breakthrough solutions aim to increase organ utilization, improve patient outcomes, and reduce transplant costs across the healthcare system. The company's flagship products, the OCS™ Lung and OCS™ Heart systems, are CE-marked and actively used commercially outside the U.S., while being under review by the FDA for U.S. market access. Additionally, the OCS™ Liver is undergoing an FDA pivotal trial (the OCS™ Liver PROTECT Trial) in the United States and a CE-mark trial (the Revive Trial) in Europe.
In a strategic move, TransMedics recently signed an agreement to acquire Summit Aviation, a premier U.S. charter flight operator, with the intent to establish TransMedics Aviation as the first national provider of air logistics dedicated to organ transplantation in the U.S. This acquisition aligns with the company's commitment to expanding its National OCS Program (NOP) and enhancing its logistics capabilities.
Financially, TransMedics has demonstrated significant growth. For the second quarter of 2023, the company reported total revenue of $52.5 million, a 156% increase from the same quarter the previous year. By year-end 2023, total revenue reached $241.6 million, a 159% increase compared to the prior year, driven by the increased utilization of the OCS through the NOP and additional revenue from logistics services.
TransMedics remains focused on advancing its product offerings and clinical indications while continuing to scale its operational infrastructure. As of the first quarter of 2024, the company achieved a revenue of $96.9 million, marking a 133% year-over-year increase, and recorded net income of $12.2 million. The full-year 2024 revenue forecast is projected to be in the range of $390 million to $400 million, reflecting continued strong growth.
With its innovative technologies and strategic expansions, TransMedics is poised to significantly contribute to the field of organ transplantation, enhancing the quality of life for patients worldwide.
TransMedics Group, Inc. (Nasdaq: TMDX) will announce its fourth quarter and full year 2021 financial results on February 23, 2022, after market close. A conference call to discuss the results will take place at 4:30 p.m. ET. The company specializes in portable extracorporeal warm perfusion for organ transplants, aiming to enhance organ availability for patients with end-stage conditions. Interested investors can access the call via phone or through a live webcast available on their website.
TransMedics Group, Inc. (Nasdaq: TMDX) announced on January 5, 2022, the publication of results from the OCS™ Liver PROTECT Trial in JAMA Surgery. The trial, which involved 300 participants, demonstrated significant improvements in short-term and mid-term clinical outcomes for liver transplants using the OCS™ Liver System. Key findings include a 41% reduction in early allograft dysfunction (EAD) and a higher utilization of livers from cardiac death donors. CEO Waleed Hassanein emphasized that these results could expand the donor pool and improve patient outcomes.
TransMedics Group, a leader in organ transplant technology, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 7:30 a.m. EST. The virtual event aims to showcase the company's advancements in portable warm perfusion and assessment of donor organs for transplantation. Founded to enhance organ availability and quality, TransMedics is dedicated to addressing the needs of patients with end-stage heart, lung, and liver failure. Interested parties can access the presentation live and archived on the TransMedics website.
TransMedics Group, Inc. (TMDX) announced the grant of non-qualified stock options for 240,500 shares of its common stock to eleven employees on November 5, 2021. The options, aimed at incentivizing new hires, were approved by the Compensation Committee and adhere to Nasdaq Listing Rule 5635(c)(4). Each option has a ten-year term with an exercise price of $31.49, the stock's closing price on the grant date. Vesting occurs at 25% after one year and monthly thereafter over three years, contingent on continued employment.
TransMedics Group, Inc. (TMDX) reported Q3 2021 net revenue of $5.4 million, a 24% decrease from Q3 2020. This decline is attributed to the end of revenue from clinical trials for OCS Heart and OCS Liver before FDA approvals. Notable achievements include FDA 510(k) clearance for OCS Lung and PMA for OCS Heart and Liver systems in July and September 2021, respectively. Operating expenses rose to $15.5 million, leading to a net loss of $13.0 million. The company anticipates full-year revenue between $27.6 million and $28.6 million, indicating 8% to 12% growth compared to 2020.
TransMedics Group, Inc. (Nasdaq: TMDX), a leader in organ transplantation technology, will host one-on-one meetings at the Canaccord Genuity MedTech, Diagnostics, and Digital Health & Service Forum on November 18, 2021. The company is dedicated to improving organ transplant therapy for patients with end-stage lung, heart, and liver failure. TransMedics specializes in portable extracorporeal warm perfusion and assessment of donor organs, aiming to enhance organ quality and increase the utilization of donor organs.
On November 4, 2021, TransMedics Group announced positive topline results from its OCS DCD Heart Trial, the first randomized trial comparing outcomes of hearts from DCD donors using the OCS Heart System to those from DBD donors. The trial achieved a 95% patient survival rate at 6 months for the OCS DCD arm, outperforming the 89% for DBD controls. A total of 90 out of 101 DCD donor hearts were successfully transplanted, yielding an impressive 89% utilization rate. These results will be submitted to the FDA for further OCS DCD heart indication approval.
TransMedics Group (TMDX) will announce its third-quarter financial results on November 9, 2021, after market close. A conference call with management is scheduled for 4:30 p.m. ET. The company specializes in organ transplant technology, focusing on enhancing organ quality and viability for patients with end-stage organ failure. Investors can listen to the call by dialing specific numbers provided or accessing the webcast on TransMedics’ website.
TransMedics Group, Inc. (Nasdaq: TMDX) announced FDA premarket approval for its OCS Liver System on September 29, 2021, marking it as the first liver perfusion technology approved in the U.S. This system enhances the preservation and monitoring of liver allografts, facilitating the assessment of donor livers from both DBD and DCD sources. The approval is based on results from the OCS Liver PROTECT Trial and positions TransMedics to expand its commercial efforts for lung, heart, and liver transplantation, aiming to increase the availability of donor organs.
TransMedics Group, Inc. (TMDX) announced FDA premarket approval (PMA) for its OCS Heart System for donor hearts from patients with brain death. This approval enhances the preservation of hearts previously deemed unsuitable for transplantation, following the OCS Heart EXPAND Trial. The system allows real-time assessment of donor heart viability, potentially increasing the donor pool and meeting the growing demand for heart transplants in the U.S. TransMedics aims to commercialize the OCS Heart System and expand its clinical indications while continuing to seek regulatory approval for its OCS Liver System.
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