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Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System

TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock.

Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday.

The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review the premarket approval application for its Organ Care System (OCS) Liver System, a portable organ perfusion and monitoring medical device.

Intended to preserve a donated liver in a near-physiologic, normothermic and functioning state, the OCS Liver System also optimizes liver function for eventual transplantation, according to a news release.

The FDA will meet at 9 a.m. ET today to review the PMA application. This story may be updated.

TransMedics says FDA advisory committee will review its OCS Liver System in July

TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month.

Andover, Mass.-based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021.

In the committee meeting, the FDA’s Gastroenterology & Urology Devices Panel of the Medical Devices Advisory Committee will discuss the platform, make recommendations and vote on a recommendation for approval of the OCS Liver System, according to a news release.

“We are looking forward to presenting the OCS Liver PROTECT data to the advisory committee panel in support of our PMA for the OCS Liver System,” TransMedics president & CEO Dr. Waleed Hassanein said in the release. “This is another important milestone to bring TransMedics closer to having all of our three organ platforms approved by F…

TransMedics slides on Q1 earnings miss

TransMedics (NSDQ:TMDX) shares took a massive hit today on first-quarter results that missed the consensus earnings forecast.

TMDX shares were down -12.4% at $24.58 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -1.2%.

The Andover, Mass.-based organ transplant technology developer posted losses of -$7.9 million, or -29¢ per share, on sales of $7.1 million for the three months ended March 31, 2021, for a 10.6% bottom-line gain on a sales decline of -6.3%.

TransMedics’ EPS of -29¢ came in 1¢ shy of projections on Wall Street, although the company’s revenues topped analysts’ estimates by 1.8%.

“We are pleased with our progress as we advance quickly toward several near term regulatory and commercial catalysts expected in 2021,” TransMedics president & CEO Dr. Waleed Hassanein said in a news release. “…

FDA advisory committee positive about TransMedics’ OCS Heart system

TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System.

The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable assurance that the OCS Heart System is effective. It also voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System’s safety.

“This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S. We are looking forward to working collaboratively with the FDA as it completes its review,” president and CEO Waleed Hassanein said in a news release. “We are grateful for the help and support of our investigators, the patients who enrolled in our trials, and the donor families who ga…

TransMedics jumps on Street-beating Q4 results

TransMedics (NSDQ:TMDX) posted fourth-quarter results this week that beat the consensus forecast on Wall Street.

The Andover, Mass.-based company reported losses of -$6.3 million, or -23¢ per share, on sales of $7.6 million for the three months ended Dec. 31, 2020, for a sales growth of 25% compared with Q4 2019.

Earnings per share were -23¢, 1¢ ahead of The Street, where analysts were looking for sales of $6 million.

“Fourth-quarter sales exceeded expectations and were driven primarily by the recovery of U.S. OCS Lung procedure volumes as well as progress with the OCS DCD Heart and the OCS Liver CAP clinical programs,” president and CEO Waleed Hassanein said in a news release. “We are now focused on leveraging the progress made with our National OCS Program in 2020 and advancing our FDA initiatives in the upcoming months to accelerate our growth through 2021 and beyond.”

TransMedics did not provide a financial outlook for the fiscal year 2021. Read more

TransMedics to get its virtual day with FDA panel on heart transplant tech

(Image from TransMedics)

After a six-month pandemic-related delay, TransMedics (NSDQ:TMDX) is set to have an FDA panel review the premarket approval application for its donor heart transport technology on October 7, 2020.

TransMedics’ organ care system (OCS) technology is designed to keep donated hearts, lungs and livers in near-living condition until transplantation. The FDA approved the Andover, Mass.-based company’s lung transport system in 2018.

If the panel votes in favor of approval following its virtual meeting, TransMedics expects the FDA to officially approve the device within 3 to 4 months, company CEO Waleed Hassanein said during the company’s second-quarter analyst call. TransMedics is also working toward PMA approval of its donor liver transport system, which Hassanein said he expects to be approved in 2021, according to the call transcribed by Seeking Alpha.

And …

TransMedics beats Street earnings projections in Q2

(Image from TransMedics)

TransMedics (NSDQ:TMDX) shares ticked slightly up today on second-quarter results that topped the consensus earnings forecast.

The Andover, Mass.-based organ transplant transportation technology developer posted losses of -$8.5 million, or -36¢ per share, on sales of $3.4 million for the three months ended June 30, 2020, for a 7.6% bottom-line gain on a sales decline of -40.2%.

Adjusted to exclude one-time items, earnings per share were also -36¢, coming in 6¢ ahead of Wall Street projections.

The company attributed much of its revenue decline to the decrease in organ transplant procedures performed over the three-month period as a result of the ongoing COVID-19 pandemic.

“Despite the continued impact of the COVID-19 pandemic on our revenue, we achieved several significant milestones in the second quarter,” TransMedics president & CEO Dr. Waleed Hassane…

TransMedics proposes public offering following positive OCS Liver Protect trial results

(Image from TransMedics)

TransMedics (NSDQ:TMDX) today announced a public offering following positive results from a clinical trial for its organ care system.

The Andover, Mass.-based organ transplant therapy developer revealed in a news release that it is offering $60 million in shares of common stock, plus a 30-day option to purchase additional shares that total up to 15% of the numbers of shares sold in the offering.

J.P. Morgan and Morgan Stanley are acting as joint lead book-running managers in the offering, while Canaccord Genuity is acting as lead manager.

TransMedics’ offering follows results from its OCS Liver Protect trial that achieved its primary clinical objectives by meeting primary and secondary effectiveness and safety endpoints.

The 300-patient trial randomized 153 patients for transplantation using the OCS liver and 147 patients in the control group with cold stor…