On July 24, Edwards Lifesciences Corporation (NYSE: EW) announced that it is continuing its merger and acquisition activities and has reached two significant deals. The cardiac device company stated it will spend $1.2 billion (equivalent to RMB 8.7 billion) to acquire two companies, JenaValve Technology and Endotronix.
Just last week, Edwards Lifesciences acquired mitral valve company Innoval for $300 million and reached a series of agreements with Affluent Medical for $120 million, obtaining the license and development rights for the Kalios adjustable mitral annuloplasty ring and mitral valve technology.
$870 Million, Further Strengthening the Aortic Regurgitation and Heart Failure Sector
Officials from Edwards Lifesciences stated that the JenaValve Trilogy Heart Valve System for treating aortic regurgitation (AR) could receive FDA approval by the end of 2025, becoming the first approved treatment for AR patients. Meanwhile, the Endotronix Cordella Implantable Pulmonary Artery Pressure Sensor received FDA approval last month, with CMS national coverage in China expected to be finalized early next year.Edwards Lifesciences CEO Bernard Zovighian said in the press release, "These acquisitions expand our opportunity to address the unmet needs of patients globally with aortic regurgitation (AR) and heart failure. We are excited to enter these structural heart therapy areas with innovative, world-class science and clinical evidence to deliver life-saving technologies to patients worldwide."JenaValve Technology, Inc. is a global leader in the field of Transcatheter Aortic Valve Replacement (TAVR) therapy. In March 2024, data from its pivotal ALIGN-AR trial were published in *The Lancet*, providing preliminary evidence that the Trilogy Transcatheter Heart Valve (THV) System can improve severe symptomatic aortic regurgitation (AR).Trilogy is the world's first and currently the only trans-femoral TAVR approved (CE) for treating severe symptomatic aortic regurgitation or aortic stenosis. In this field, Edwards Lifesciences' biggest competitor in the aortic regurgitation space is Medtronic.Endotronix is a medical technology company focused on heart failure management and monitoring. The company is committed to improving the quality of life and clinical outcomes for heart failure patients through advanced digital health platforms and implantable sensor technologies.Its product Cordella received FDA approval last month for market release (for treating NYHA Class III heart failure patients). This is the first PA pressure-guided platform, providing comprehensive patient management by utilizing daily PA pressure and vital signs at home to guide treatment management and improve patient outcomes. In the field of remote heart failure monitoring, Edwards Lifesciences' biggest competitor is Abbott.JenaValve Technology, Inc. Acquired,Impact on domestic enterprises?It is worth noting that,At the end of 2021, China-based innovative medical device company Peijia Medical signed an exclusive license agreement with JenaValve for the Trilogy™ heart valve system in the Greater China region and became a minority shareholder of JenaValve.Subsequently, Peijia Medical renamed the technology trademark to TaurusTrio™ Transcatheter Aortic Valve System, launched a registration clinical trial in China, and successfully completed the enrollment of all patients in January 2024, entering the one-year follow-up phase.Today,Peijia Medical stated that the merger by Edwards Lifesciences will not affect the exclusive license between the Group and JenaValve or the Group’s rights to develop and commercialize TaurusTrio™.Upon completion of the merger, the group will maintain the aforementioned exclusive license to develop the AR and AS THV systems within the region. The company believes that the merger demonstrates strong confidence in the future prospects of utilizing JenaValve technology for treating AR."As a partner of JenaValve, Peijia Medical congratulates JenaValve and Edwards Lifesciences teams on announcing a transformative collaboration in the structural heart field," said Dr. Zhang Yi, Chairman and CEO of Peijia Medical.Edwards Q2 Earnings Report Falls Short of Analysts' Expectations
At the same time as announcing the acquisition plan, Edwards also released its second-quarter results, with revenue falling short of Wall Street analysts' expectations.Edwards Lifesciences Corporation, headquartered in Irvine, California, reported revenue of $1.39 billion and a profit of $365 million, or 61 cents per share, for the quarter ended June 30, 2024. The company's profit increased by 44% and revenue grew by 7% compared to the same period last year.Edwards Lifesciences Corporation has seen strong sales momentum this year for its Transcatheter Mitral and Tricuspid Therapies (TMTM), and the company now forecasts full-year TMTM sales to reach the higher end of its previous guidance range of $320 million to $340 million.However, the majority of the company's sales come from transcatheter aortic valve replacement (TAVR). Based on the sales trend of TAVR, the company is lowering its full-year sales forecast in this area. Edwards now expects TAVR sales to grow by 5% to 7% this year, down from the previous forecast of 8% to 10%. In the second quarter, the company reported TAVR sales of $1 billion, representing a 5% increase, or a 6% increase on a constant currency basis.Edwards CEO Zovighian stated, "Edwards is well-positioned to achieve sustainable TAVR growth in 2025 and beyond, driven by advancements in our leading Sapian platform, expanded indications for a broader patient population, and improved patient access to this critical therapy." "Our vision for TMTT is becoming a reality, and our strategic commitment has evolved into a growth portfolio of differentiated technologies. We are confident in Edwards' strategy in the structural heart space, supported by expanding TAVR opportunities, accelerating contributions from our TMTT therapies, and our growing portfolio of structural heart innovations that address unmet needs for millions of patients worldwide."Affected by the profit report news, EW's stock price fell more than 13% in after-hours trading to $75 per share.Sell Critical Care Equipment Product Line for $4.2 BillionEdwards Lifesciences Corporation, known as the pioneer of heart valves, is a leader in the field of structural heart.On June 20 this year, BD announced that it had reached a definitive agreement with Edwards Lifesciences to acquire its Critical Care product line for $4.2 billion in cash. This is the second-largest acquisition in the medical device sector this year, only surpassed by Johnson & Johnson's acquisition of Shockwave.Edwards Lifesciences announced last month that it had reached an agreement to sell its critical care business to BD for $4.2 billion in cash. This is the second-largest M&A deal in the medical device sector this year, only surpassed by Johnson & Johnson's acquisition of Shockwave.Edwards had previously planned to spin off this business. The transaction is expected to be completed by the end of the third quarter of 2024. About a month after the announcement of the sale, Edwards began issuing transaction announcements in order to diversify its cardiology device products. With substantial funds, Edwards has made four moves in one month to strengthen its structural heart disease sector.Last week, Edwards announced a $300 million acquisition of mitral valve company Innovalve. The previous week, the company struck a series of deals with Affluent Medical, agreeing to pay $16.3 million for the licensing and development of Affluent's Kalios adjustable mitral annuloplasty ring and mitral valve technology.It is believed that in the future, Edwards will further strengthen the layout of its core business. This is because, in the field of structural heart disease, Edwards still faces fierce competition from giants such as Medtronic, Abbott, Johnson & Johnson, and Boston Scientific.Edwards Lifesciences and Medtronic are the leaders in the TAVR market, occupying the majority of the market share. Boston Scientific and Abbott are also actively expanding their market presence, further intensifying market competition.
North America and Europe are the main regions of the TAVR market, while the Asia-Pacific region has enormous market potential, especially with rapidly growing demand in countries like China and Japan. Companies are also accelerating their efforts to establish a presence in these emerging markets in order to gain larger market shares.
Aortic Regurgitation (AR) Market,Chinese Enterprises Start to Gain Momentum
Aortic Regurgitation (AR) is a type of heart valve disease characterized by the backflow of blood from the aorta into the left ventricle during diastole. This phenomenon is typically caused by the incomplete closure of the aortic valve, which may result from either valvular pathology or aortic root dilation.
Globally, the number of people suffering from aortic regurgitation continues to grow. According to data from the prospectus of JenShi Technology, the global patient population increased from 25.5 million in 2017 to 27.5 million in 2021 and is projected to reach 31.6 million by 2030. Other data shows that approximately 26 million people worldwide suffer from aortic regurgitation. The main treatment methods include aortic valve repair, aortic valve replacement, and transcatheter aortic valve implantation (TAVI/TAVR). TAVR surgery has become one of the key treatment options for aortic regurgitation due to its advantages such as minimal invasiveness and shorter operation time.
The TAVR valve products of Edwards and Medtronic, two multinational medical giants, currently account for a total of about 10% of the market share in China, with each company holding 5%. Domestic companies are also joining the ranks of research, development, and production. For the Chinese market, the TAVR valve market has become a fiercely competitive arena.
Jiecheng Medical (acquired by Gensmed) is a member company of Gensmed, and its "J-Valve" is currently the only product approved by the National Medical Products Administration (NMPA) that can simultaneously treat severe aortic regurgitation (reflux) and stenosis with dual indications.
Signed an exclusive license and technology transfer agreement with JenaValve Technology, Inc. for TAVR products applicable to aortic regurgitation. This indicates that Peijia Medical is also actively expanding into the treatment field of aortic regurgitation.
The Ken-Valve Transcatheter Aortic Valve System, independently developed by Jian Shi Technology, can simultaneously cover indications for aortic regurgitation or combined aortic stenosis.However, it is not difficult to see from Edward's actions that frequent mergers and acquisitions demonstrate its deep layout and strategic adjustment in the field of structural heart disease, aiming to enhance its competitiveness and market share in this high-growth, high-demand market by integrating and optimizing resources.▲Source: Medical Device Innovation Network▲Reproduction without permission is prohibited.And can be reprinted after 24 hours.！Disclaimer: This article is intended solely for the purpose of information transmission and is for reference only. It does not constitute any advice on investment or treatment. Please carefully evaluate the information. If the content involves issues related to the work, copyright, or other matters, to protect the rights and interests of both parties, please contact us and we will handle it immediately. If this article is reprinted by any platform, the platform must take responsibility for the content of the article. The Medical Device Innovation Network is not responsible for any secondary dissemination caused by reprints.
