Transmedics Group Stock Price, News & Analysis

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.

TransMedics Group, Inc. (Nasdaq: TMDX) announced on August 4, 2021, the grant of non-qualified stock options totaling 160,800 shares to five employees. This move, aimed at incentivizing new hires, was approved by the Board of Directors and follows Nasdaq Listing Rule 5635(c)(4). Notably, Chief Digital Officer Rakesh Godhani received options for 140,000 shares at an exercise price of $27.87, the stock's closing price on that date. The options vest over a four-year period and have a 10-year term.

TransMedics specializes in organ transplant technology.

TransMedics Group, Inc. (Nasdaq: TMDX) reported a strong second quarter for 2021, with a net revenue of $8.2 million, a remarkable 141% increase over the same period last year. This growth was driven by increased sales of its OCS Lung and Heart sets. Gross margin improved to 68%, up from 56% a year ago. However, net loss widened to $10.7 million compared to $8.5 million in Q2 2020, reflecting increased operating expenses of $15.5 million. The company's cash position remains strong at $112.2 million as of June 30, 2021.

TransMedics Group, Inc. (Nasdaq: TMDX) announced FDA 510(k) clearance for its OCS™ Lung Solution, enabling the cold storage of donor lungs for transplantation. This achievement highlights the company's focus on advancing organ transplant therapy. The OCS Lung Solution is a sterile, low potassium solution with a shelf life of 24 months. Additionally, the OCS Lung System is already approved in the U.S., while the OCS Heart and Liver Systems await FDA review. CEO Waleed Hassanein emphasized TransMedics' commitment to providing innovative organ preservation products.

TransMedics Group, Inc. (Nasdaq: TMDX) announced that its management team will engage in a virtual fireside chat during the Canaccord Genuity 41st Annual Growth Conference on August 11, 2021, at 4:30 p.m. ET. This discussion will be accessible via a live and archived webcast in the Investors section of the TransMedics website. Based in Andover, Massachusetts, TransMedics is pioneering portable organ perfusion technology to enhance organ transplantation outcomes, addressing critical needs in heart, lung, and liver failure treatment.

TransMedics Group, Inc. (TMDX), a leader in organ transplant technology, will release its second quarter financial results on August 5, 2021, after market close. The management team will host a conference call at 4:30 p.m. ET. Interested investors can join by dialing (833) 378-1026 or (236) 712-2500 for international calls. TransMedics focuses on improving organ quality and viability assessments, addressing the critical need for better organ transplants for patients with end-stage heart, lung, and liver failure.

TransMedics Group, Inc. (Nasdaq: TMDX) announced a positive FDA advisory committee vote for the OCS Liver System on July 14, 2021. The panel voted 14-0 for effectiveness and safety, with a 12-1 vote indicating the benefits outweigh risks. This milestone moves TransMedics closer to potential FDA approval, which could enhance liver transplant outcomes for patients with end-stage liver failure. The OCS Liver PROTECT trial showed significant improvements in early allograft dysfunction, utilization of donor livers, and patient survival rates.

TransMedics Group, Inc. (Nasdaq: TMDX) announced on July 14, 2021, that trading of its common stock has been halted by Nasdaq. The halt coincides with a meeting of the FDA's Gastroenterology and Urology Devices Panel, which is set to review TransMedics' Organ Care System™ (OCS) Liver System. This medical device aims to preserve donor liver organs in a near-physiologic state, enhancing their viability for transplantation. Investors are advised to monitor the outcome of the FDA meeting as it may impact future stock performance.

TransMedics Group, Inc. (TMDX), based in Andover, Massachusetts, announced a public advisory committee meeting by the FDA scheduled for July 14, 2021. This meeting will discuss the premarket approval application for the OCS Liver System. The FDA's Gastroenterology and Urology Devices Panel will review the system, which aims to improve organ transplant therapy for patients with end-stage organ failure. CEO Waleed Hassanein highlighted this as a key milestone in obtaining FDA approvals for their organ platforms in 2021.