Johnson & Johnson Acquires V-Wave for $1.7 Billion to Advance First-in-Class Interatrial Shunt for Heart Failure

The transaction is expected to be completed by the end of 2024. Tim Schmid, Executive Vice President of Johnson & Johnson, stated: "We have a deep understanding of technology and science, as well as V-Wave's commitment to patients. We look forward to collaborating with the V-Wave team during this critical phase of their development to assist patients with V-Wave's atrial shunt technology."

V-Wave CEO Neal Eigler stated, "We believe that Johnson & Johnson has the ability to ensure V-Wave's breakthrough ideas and technologies reach patients in need as quickly and effectively as possible. We look forward to continuing to build a world that prevents, treats, and cures cardiovascular diseases."

On July 17, Johnson & Johnson released its 2024 half-year report, disclosing medical technology segment revenue of $15.778 billion, a year-on-year increase of 3.3%.

This revenue growth rate may not be considered outstanding, but looking further, in the first half of 2024, its cardiovascular business achieved a revenue of $3.679 billion, increasing by 17.8% year-on-year, ranking first in revenue growth within the medical technology business segment.

Later, Johnson & Johnson's management clearly stated in the conference call: "Johnson & Johnson is aggressively entering the cardiovascular device business. In a field with significant unmet needs, we have tremendous opportunities to gain premium pricing for differentiated innovation."

It is worth noting that the high growth of Johnson & Johnson's cardiovascular business is closely related to two major acquisitions in the past two years.

In November 2022, Johnson & Johnson acquired Abiomed, the leader in the artificial heart field, for $16.6 billion, directly making this acquisition the "largest M&A deal in the global medical device industry in 2022." It is reported that through a series of M&A transactions and independent research and development, Abiomed has formed a product pipeline including the Abiomed Breethe OXY-1 System cardiopulmonary support system (ECMO) & ECPella, preCARDIA, and the Impella product portfolio, covering clinical indications such as high-risk PCI, cardiogenic shock, right heart failure, and severe pulmonary failure.

Among them, the Impella product portfolio is Abiomed's core product line, primarily designed to improve blood flow and assist the heart’s pumping function, thereby allowing the heart to rest and recover. Following Johnson & Johnson's acquisition of Abiomed, efforts were focused on expanding the global market sales of the Impella product series while continuing to invest in supporting Abiomed to accelerate the development of innovative products. That year, with Johnson & Johnson's support, Abiomed's Impella product series achieved revenue of $1.306 billion, reflecting a 32.6% year-over-year increase. This figure directly contributed to a 47.7% high growth rate in Johnson & Johnson's cardiovascular device business.

And in April this year, Johnson & Johnson once again made a premium acquisition of Shockwave, a company in the cardiovascular intervention field, for $13.1 billion, securing a spot for the world's top 3 or even the largest medical device M&A deal of 2024.

Like Abiomed, Shockwave is also a star enterprise in the global cardiovascular field. Its product, Intravascular Lithotripsy, is the world's first coronary intravascular shock wave system, which can solve the problem of coronary artery calcification.

The total amount of the two M&A deals reached nearly 30 billion US dollars, which fully demonstrated Johnson & Johnson's determination to strengthen its cardiovascular device business. The acquisition on August 20th was enough to show that 30 billion US dollars did not stop Johnson & Johnson from continuing its acquisition spree.

The other party to this transaction—V-Wave—was founded in 2009 and primarily focuses on developing percutaneous implantation technology for patients with chronic heart failure. It is committed to alleviating symptoms and improving the quality of life for heart failure patients through its core product, the Ventura Interatrial Shunt. Atrial shunt technology is an emerging therapy for heart failure in recent years, attracting participation from numerous innovative companies and investors.

Specifically, increased left atrial pressure and pulmonary venous congestion are among the characteristics of heart failure. Left atrial pressure increases with exercise load and volume load, making this condition extremely difficult to treat with medication. However, an atrial shunt device can reduce left atrial pressure through an autonomous regulatory mechanism, thereby alleviating heart failure symptoms and improving prognosis.

Currently, no interatrial shunt device has received FDA approval. However, Johnson & Johnson believes that V-Wave's Ventura Interatrial Shunt is highly likely to become the first FDA-approved interatrial shunt device. Previously, this product was granted the FDA Breakthrough Device Designation in 2019 and received CE certification in 2020.

Specifically, V-Wave's atrial shunt device has two versions. The first-generation version was phased out due to a design flaw in its one-way valve, which led to suboptimal patency rates. The second-generation version consists of an hourglass-shaped nitinol frame covered with ePTFE material, ensuring consistent internal lumen patency and preventing late lumen loss. Its overall structure features a funnel-shaped design, enabling secure and non-traumatic in-situ fixation.

The device is 12mm in length, with a left atrial inner diameter of 14mm, a right atrial inner diameter of 11mm, and a funnel neck inner diameter of 5.1mm. After being implanted via the delivery system, the device establishes a channel between the left atrium and the right atrium, allowing blood to flow from the higher-pressure left atrium to the lower-pressure right atrium, thereby "releasing" pressure in the left atrium and pulmonary veins. Following implantation, patients are required to undergo six months of standard dual antiplatelet therapy.

However, despite Johnson & Johnson's high hopes for V-Wave's product, the key preliminary results of the RELIEF-HF trial announced at ACC.24 this year were not as encouraging as expected. Although the data demonstrated that V-Wave’s atrial shunt device showed potential clinical value and had an excellent safety profile, the primary effectiveness endpoint was neutral, indicating neither significant benefit nor harm.

Specifically, in the subgroup of patients with LVEF ≤ 40%, the experimental group showed a 45% reduction in cardiovascular events compared to the placebo group. However, in the patient group with LVEF > 40%, the experimental group exhibited a higher rate of cardiovascular events, approximately 24% higher. In other words, not all patients with symptomatic heart failure can benefit from the implantation of the V-Wave atrial shunt.

Coincidentally, as early as 2022, atrial shunt devices worldwide faced significant skepticism. The reason behind this was related to Corvia Medical's Corvia atrial shunt device.

In the global market, V-Wave's atrial shunt, Corvia Medical's Corvia atrial shunt, and Occlutech's AFR atrial shunt from Germany have the most first-mover advantages. All three have received the FDA Breakthrough Device Designation.

Among them, the AFR atrial shunt consists of a nitinol mesh device, two flat discs, and a connecting neck with a central window. Blood can flow from the left atrium to the right atrium through the central shunt hole.

Corvia Medical's Corvia Atrial Shunt is the world's first atrial septal shunt for the treatment of HFpEF (Heart Failure with Preserved Ejection Fraction) patients and the first atrial shunt to receive CE certification. The product consists of a nitinol memory alloy stent, with left and right atrial discs forming an interlocking structure.

In 2022, the phase III clinical trial of the Corvia atrial shunt device failed. Relevant results showed that the subjects did not experience a reduction in heart failure incidence or improvement in health status after implantation of this product. The trial results did not significantly differ from those of the placebo group.

However, this does not actually declare the failure of the entire atrial shunt device industry. One reason is that heart failure is a heterogeneous disease, and the results of this clinical trial failure should not be viewed in a "one-size-fits-all" manner.

The second reason is related to the selection of subjects. A relevant person stated, "The main reason for the negative results of this multi-center clinical trial is whether the patients were reasonably selected. Factors such as pulmonary vascular resistance, left ventricular ejection fraction, and gender may all influence the efficacy of the atrial shunt device."

A similar situation also appeared in the previously mentioned V-Wave RELIEVE-HF study. Professor Sun Zhijun, Director of the Second Cardiology Department of Shengjing Hospital affiliated with China Medical University, stated: "The reasons for not obtaining conclusive results in this study may be multifaceted, such as a wide range of enrolled populations with significant heterogeneity, or factors like the size of the shunt device, the diameter of the shunt hole, and the pressure differences between the two atria."

Perhaps, it is precisely because of these reasons that Johnson & Johnson overlooked the negative results of this study and firmly bet on V-Wave.

Naturally, Johnson & Johnson is not the only company betting on atrial shunt devices. The Corvia atrial shunt mentioned earlier has been acquired by Edwards Lifesciences. In addition, Edwards Lifesciences has also developed the Root Device in-house. This device can implant an H-shaped stent into the center of the coronary sinus of the left atrium via the internal jugular vein pathway. As of 2022, the device has completed a small number of FIM studies.

Besides these international giants, domestic companies in China are also catching up, focusing on the development of atrial shunt technology.

For example, companies such as MicroPort CardiFlow, Nuova Medical, V-Medical, and Qisheng Medical are all involved in this field. Among them, Nuova Medical's NoYA atrial shunt system is the world's first self-developed, non-implantable, adjustable atrial shunt product. The product features an adjustable shunt orifice diameter design, with a stent diameter range of 4-10mm, meeting various shunting needs.

WeK Medical's D-Shant atrial shunt is the first domestically developed implantable atrial shunt product in China. It features an inward-facing metal stent structure, with a size comparable to a coin and excellent radial support.

This shows that, despite certain controversies surrounding atrial shunt technology, atrial shunt devices have still become a fiercely contested area among major companies as a potentially effective treatment for heart failure-related conditions. With Johnson & Johnson's strong entry into the market this time, the atrial shunt device industry may see another wave of momentum.