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TransMedics (TMDX) Receives FDA Nod for OCS Heart System

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  • TMDX

TransMedics Group, Inc. TMDX recently announced its receipt of the FDA’s premarket approval of its OCS Heart System for use with organs from donors after brain death (“DBD”). The system is indicated for the preservation of DBD donor hearts that are considered unsuitable for procurement and transplantation at the time of initial evaluation, based on limitations of extended cold static cardioplegic preservation.

For investors’ note, the indication is on the basis of the results of the OCS Heart EXPAND Trial, the associated OCS Heart EXPAND Continued Access Protocol and the OCS Heart PROCEED II Trial.

The latest FDA clearance is expected to significantly solidify TransMedics’ foothold in the U.S. heart transplantation space.

Significance of the Approval

Per management, the regulatory nod for its OCS Heart System is expected to provide access to its OCS technology for helping more heart transplant patients in the United States. Following the clearance, the OCS Heart System has become the only FDA-approved device indicated for ex-vivo perfusion and assessment of both donor hearts and lungs as an alternative to the antiquated cold storage preservation.

The company is currently working toward the next phase of its commercial activities, the initiation of the OCS Heart Perfusion Registry and potentially expanding its future clinical indications.

Per an expert associated with the OCS Heart EXPAND Trial, the system enables real-time assessment of the donor heart's viability and lowers the adverse effects of cold storage. This is likely to increase the utilization of donor hearts that are rarely used due to limitations of cold storage preservation. This will expand the donor pool of acceptable hearts and help the company meet the surging demand in the United States for heart transplantation.

Industry Prospects

Per a report by ReportLinker, the global heart transplant market was estimated to be $9,077.71 million in 2020 and is projected to reach $15,813.98 million by 2026 at a CAGR of approximately 9.7%. Factors like rising frequency of coronary artery diseases and heart failure cases, as well as increasing number of elderly population and patients with high blood cholesterol level, are expected to drive the market.

Given the market potential, the FDA’s approval is likely to provide a significant boost to TransMedics’ business globally.

Notable Developments

Of late, TransMedics has witnessed a few notable developments across its business.

In August, the company reported robust second-quarter 2021 results, driven by an increase in sales of OCS Lung and Heart disposable sets in the United States and internationally.

TransMedics, in July, announced the receipt of the FDA’s 510(k) clearance of its OCS Lung Solution for use in transplants using cold-storage techniques.

In June, the company announced favorable and complete results of the OCS Liver PROTECT Trial (PROTECT).

Price Performance

Shares of TransMedics have gained 87.4% in the past year compared with the industry’s 18.2% growth and the S&P 500's 34.9% rise.

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Zacks Rank & Stocks to Consider

Currently, TransMedics carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are Henry Schein, Inc. HSIC, IDEXX Laboratories, Inc. IDXX and Intuitive Surgical, Inc. ISRG.

Henry Schein’s long-term earnings growth rate is estimated at 13.9%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

IDEXX’s long-term earnings growth rate is estimated at 19.9%. It currently has a Zacks Rank #2.

Intuitive Surgical’s long-term earnings growth rate is estimated at 9.7%. It currently carries a Zacks Rank #2.


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TransMedics Group, Inc. (TMDX) : Free Stock Analysis Report

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