TransMedics completes Summit Aviation acquisition

TransMedics (Nasdaq:TMDX) announced that it completed its previously announced acquisition of Summit Aviation.

Andover, Massachusetts-based TransMedics initially announced its plans to acquire the U.S. charter flight operator on Aug. 1. It did not disclose financial terms at the time. With the closing of the deal, Summit founder Ben Walton joins the company as VP of Aviation Services.

At the time of the initial announcement, TransMedics President and CEO Dr. Waleed Hassanein called Summit “one of the leading teams in the air charter industry.” Hassanein cited a “stellar reputation for exceptional service,” among other things that align with TransMedics’ aims.

In announcing the closing of the deal, the company says this enables the establishment of TransMedics Aviation. The company said it’s the first integrated national provider of air logistics dedicated exclusively to organ transplantation in the U.S.

“W…

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TransMedics proposes $300M offering

TransMedics (Nasdaq:TMDX) announced today that it intends to offer $300 million in convertible senior unsecured notes.

Andover, Massachusetts-based TransMedics’ offering remains subject to market and other conditions. The notes mature on June 1, 2028, unless earlier redeemed, repurchased or converted, according to a news release.

TransMedics expects to grant the initial purchasers an option to purchase up to an additional $45 million in notes. That option falls within a 13-day period beginning on and including the issuance date of the notes. The company intends to use a portion of its proceeds to pay the cost of certain capped call transactions.

With the remaining proceeds, TransMedics plans to expand its logistics network. This could come through potential partnerships or acquisitions. The company also intends to use proceeds for general corporate purposes.

Details of the Transmedics offering

The notes — senior, unsecured obligations of Tra…

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TransMedics more than doubles revenue in Q1, raises guidance

TransMedics (Nasdaq:TMDX) shares rose this morning on first-quarter results that beat the consensus forecast.

Shares of TMDX ticked up 1.2% at $78.78 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.3%.

The Andover, Massachusetts-based organ transplant technology developer posted losses of $2.6 million. That amounts to losses of 8¢ per share on sales of $41.6 million for the three months ended March 31, 2023.

TransMedics posted a 75% bottom-line gain as it crept closer to breakeven. It more than doubled its sales from revenues of $15.9 million in the same period a year ago. The company attributed its growth primarily to National OCS (organ care system) Program (NOP) adoption in the U.S. That led to an increase in OCS Liver and OCS Heart sales.

Earnings per share came in 17¢ ahead of expectations on Wall Street, where analysts projected s…

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TransMedics grows sales more than 200% in Q4 results

TransMedics (Nasdaq:TMDX) this week announced fourth-quarter results that beat the overall consensus on Wall Street.

The Andover, Massachusetts-based company reported profit losses of $6.7 million, or -21¢ per share, on sales of $31.4 million, for the three months ended Dec. 31, 2022, for a sales growth of 224.52% compared to Q4 2021. NuVasive also reported profit gains year-over-year when it reported $12.7 million in losses.

Earnings per share were 11¢ ahead of The Street, where analysts were looking for sales of $23.6 million.

“2022 was a transformative year for TransMedics as we delivered exceptional 209% revenue growth. We strongly believe that we are in the early stage of a long sustained growth period for our business and organ transplantation in the U.S.,” President and CEO Waleed Hassanein said in a news release. “We are now laser-focused on scaling our production capacity and NOP clinical and logistics infrastructure to achieve this goal.”

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TransMedics grows sales 151% in Q2

TransMedics (NSDQ:TMDX) this week posted second-quarter financial results that beat the revenue consensus on Wall Street and missed earnings estimates.

The Andover, Massachusetts-based organ preservation tech company reported losses of $11.5 million, or -41¢ per share, on sales of $20.5 million for the three months ended June 30, for a bottom-line loss of 8% on sales growth of 151.14%.

Earnings per share were 6¢ behind The Street, where analysts were looking for sales of $16.27 million.

“For the third sequential quarter, we posted significant growth over the same period from the previous year. The second quarter results further validated that NOP is a critical catalyst that will fuel our expected growth for the foreseeable future,” President and CEO Waleed Hassanein said in a news release.

“We are still very early on our growth trajectory, and we fully expect to continue to build on our momentum. We look forward to further broade…

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TransMedics skyrockets on Q1 results, increased 2022 guidance

TransMedics (Nasdaq:TMDX) shares got a massive boost today on first-quarter results that were mixed compared to the consensus forecast.

TMDX shares were up 22.5% at $26.80 per share as the markets opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was unchanged early on.

The Andover, Massachusetts-based company posted losses of $10.6 million, or 38¢ per share, on sales of $15.9 million for the three months ended March 31, 2022, for a bottom-line slide deeper into the red despite more than doubling its sales total from the first quarter of 2021.

TransMedics’ losses per share of 38¢ came in 1¢ behind expectations on Wall Street, where analysts were looking for sales of $9.7 million.

“We are proud of our strong first quarter revenue performance and are now laser focused on continuing to drive commercial growth across each of our three OCS technology platforms,” Tran…

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FDA approves Transmedics OCS Heart organ transplant system

TransMedics (Nasdaq:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system.

FDA PMA allows Andover, Massachusetts-based TransMedics to expand the pool of eligible heart donors in the U.S. to organs from donors after circulatory death (DCD). The company had previously received PMA for the OCS Heart system for use with organs from donors after brain death (DBD) in September 2021.

OCS Heart now has approval with the extended clinical indication for ex vivo reanimation, functional monitoring and beating-heart preservation of donation-after-circulatory-death hearts. The new indication was based on results of the OCS DCD Heart Trial and associated Continued Access Protocol, TransMedics said in a news release.

According to the release, final and long-term results from that trial will be unveiled on Friday, April 29, at the International Society of Heart and Lung Transplantation (ISHLT) 2022 Annual Meeting in Boston.

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FDA approves Transmedics’ OCS Liver preservation system

TransMedics (NSDQ:TMDX) today announced that it has received FDA premarket approval for its OCS Liver system for use with organs from donors after brain death and circulatory death.

Andover, Massachusetts-based Transmedics designed the device to preserve and monitor the hemodynamics and metabolic function to allow for ex-vivo assessment of liver allografts from brain dead and circulatory dead donor livers.

“We are extremely proud of this approval of our OCS Liver technology, as it represents the first and only liver perfusion technology to be approved by the FDA in the United States,” president and CEO Waleed Hassanein said in a news release. “TransMedics is now uniquely positioned to offer its OCS perfusion technology for lung, heart and liver transplantation. Our goal is to leverage these FDA approvals to make more donor organs available to help patients in need of the life-saving transplant procedure. We are looking forward to expanding our…

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FDA approves TransMedics’ OCS Heart system

TransMedics (NSDQ:TMDX) announced today that it received FDA premarket approval for its OCS Heart system.

Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death with indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation, according to a news release.

Get the full story at our sister site, MassDevice.

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FDA approves TransMedics’ OCS Heart system

Transmedics (NSDQ:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system.

Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death (DBD) with indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation, according to a news release.

The indication comes on the back of results from the OCS Heart Expand trial, the associated OCS Heart Expand continued access protocol (CAP) and the OCS Heart Proceed II trial, the company said.

Premarket approval follows FDA approval for and the subsequent commercialization of the OCS Lung system as the company continues to seek FDA approval for the OCS Liver system, for which an FDA advisory panel issued a favorable vote supporting approval in July.

“We are thrilled to achieve this importa…

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FDA clears TransMedics OCS Lung System

TransMedics (NSDQ:TMDX) has won FDA clearance of its OCS Lung System to provide hypothermic flushing, storage and transportation of donor lungs for transplantation.

“This FDA clearance marks another achievement for TransMedics as we assemble the most comprehensive, market-leading portfolio of organ preservation products to meet the clinical needs of the organ transplant market,” TransMedics CEO Dr. Waleed Hassanein said in a news release.

“With this new clinical indication, we are demonstrating our commitment to establishing TransMedics as the trusted partner to supply world-class organ preservation products to meet customer needs across all transplant indications as we execute on our mission to transform organ transplant therapy for the future,” Hassanein said.

The company’s OCS Heart System and OCS Liver System are presently under FDA after receiving positive FDA advisory panel votes in April and July respectively.

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FDA advisory panel gives positive ruling on TransMedics OCS Liver System

TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote in support of approval for its OCS Liver System.

Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a 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.

Shares of TMDX were up nearly 13% at $35.79 per share in pre-market trading as the news of the advisory committe’s ruling makes its way around.

Andover, Mass.-based TransMedics said in a news release that the panel voted 14-to-0 in favor of the fact that there is reasonable assurance that the OCS Liver System is effective, with a 14-to-0 vote favoring the fact that there is reasonable assurance of the OCS Liver System’s safety.

Th…

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