Source: Device Home

Recently,Edwards LifesciencesAnnounce, withFrench medical device company Affluent Medical has completed three acquisition deals totaling €15 million (approximately RMB 120 million) to acquire its mitral valve technology.

Edwards Lifesciences Acquires for €5 Million Euros RespectivelyAffluent Subsidiary Kephalios Exclusive Option, including the Kalios adjustable mitral annuloplasty ring produced by the company. This option is based on the clinical results of the research on this technology, and Affluent will continue to develop it during the validity period of the option;

For €5 million,Obtain a global non-exclusive license for the Affluent intellectual property (IP) related to bioprosthetic heart mitral valve replacement technology;

And further invest 5 million eurosAcquired 9.21% of Affluent's shares。

Following the announcement, Affluent Medical's share price on the Paris Stock Exchange surged by 23.13% this Friday.

The natural asymmetry of native valves creates rotational flow or vortices in the ventricle, minimizing energy loss and aiding in directing blood directly into the aortic outflow tract, which is the structure mimicked by Epygon's design.

Epygon is the first "physiological" mitral bioprosthetic valve that can restore the natural blood vortex in the left ventricle, thereby flushing the endocardium to prevent endocardial thrombosis. It can also promote early coaptation of the mitral valve leaflets during diastole, thus increasing cardiac output and facilitating the recovery of ventricular function.Epygon's unique design includes a pericardial tissue monoleaflet with a D-shaped ring, which has a lower risk of left ventricular outflow tract obstruction.

The asymmetric nitinol frame and its anatomical anchoring system ensure stable coupling below the mitral annulus, capture the native leaflets, and achieve optimal fit with a low risk of LVOT obstruction.

According to the introduction, Epygon can generate blood flow that is closest to the normal blood flow in the left ventricle, especially avoiding blood stagnation within the ventricle. In addition, this asymmetric valve has a lower height on the ejection side of the left ventricle, just below the aortic valve, optimizing the ejection function. It does not obstruct the aortic valve like some other devices.

Epygon is currently in the clinical trial stage.Through this acquisition, Edwards Lifesciences has obtained a global non-exclusive license for the Epygon biomimetic heart mitral valve replacement technology IP, which is limited to open-heart surgeries. It may include future royalties from all potential commercial products utilizing the licensed patents.

According to Affluent Medical, Kalios is the first device that can be repeatedly adjusted percutaneously at any time after implantation, without stopping the heart, to adapt to the patient's actual needs, thereby avoiding the need for a second surgery.

Kalios™ can be implanted as a traditional "Carpentier" ring to perform standard annuloplasty. In the case of recurrent mitral regurgitation, months or years after the initial surgery, when the implant is fully stabilized under a layer of cell ingrowth,The device can still be adjusted as needed and the co-anastomosis can be improved.

On September 13, 2023, Affluent Medical announced the Pivotal Optimise II study for the KaliosTM adjustable ring used in mitral valve repair, which targets 20 patients.Showed efficacy and excellent safety within 1 year。

The results of the report include interim data packages for the first 20 patients treated at five centers in Europe one year after implantation. Among them, 13 patients had primary (degenerative) mitral regurgitation, and 7 patients had functional secondary mitral regurgitation. Five post-implantation adjustments have been performed, with one patient undergoing adjustment 11 months after the surgery. Excellent outcomes (residual mitral regurgitation (MR) grade <2) were observed in four perioperative patients following adjustments, and these results have been maintained for up to one year.

At 1 year, no patient had MR >2+, thereby reaching the pre-defined efficacy endpoint of the study.

The NYHA functional class improved in 12 patients,79% of patients had NYHA functional class I or II.The safety of the study was excellent: no deaths, no myocardial infarction, no valve thrombosis, and no endocarditis were reported for up to 1 year.

Professor Alberto Albertini, Director of the Department of Cardiothoracic Surgery at Hesperia Hospital Modena in Italy, explained: "The results of this interim 1-year analysis are very exciting. Five patients were adjustable post-surgery with a good prognosis. Mitral regurgitation was optimized or corrected through catheter adjustments without the need for open-heart surgery."

Following this acquisition, Edwards Lifesciences supports the innovative adjustable Kalios™ mitral annuloplasty ring by acquiring the exclusive option to purchase Kephalios, a wholly-owned subsidiary of Affluent Medical SA. During the option period, the development and operational activities of Kalios™ will continue to be exclusively managed by Affluent Medical.

Affluent Medical SA CEO Sébastien Ladet said:"We are proud to sign these agreements with the global leader in structural heart innovation. We look forward to welcoming Edwards as a shareholder of our company. Edwards' strong global market presence and commercial infrastructure offer significant potential to support our product Kalios in helping doctors and patients worldwide, while leveraging our technology to build a robust partnership for Kalios and surgical mitral valves. Affluent will continue to develop its transcatheter mitral valve Epygon and artificial sphincter."

Affluent Medical is a French medical technology company founded by Truffle Capital, with the goal of becoming a global leader in the treatment of structural heart disease and urinary incontinence. Structural heart disease is the leading cause of death worldwide, and urinary incontinence currently affects one in four adults.

Currently, the four products under Affluent Medical:Kalios, Epygon, KARDIOZIS (Endovascular prosthesis for the treatment of abdominal aortic aneurysms), Artus Artificial Urethral SphincterAll are in the preclinical and clinical research stages.

Affluent Medical was formed through the restructuring of four companies. In 2011, Kephalios and Kardiozis were established successively, focusing on minimally invasive correction of mitral regurgitation and long-term treatment of abdominal aortic aneurysms, respectively. In 2012, Epygon, a company developing mitral valve replacement devices, was founded; in 2014, Myopowers, a company researching urinary incontinence devices, was successfully established.

In 2018, considering the business coverage and development prospects, Kephalios, Kardiozis, Epygon, and Myopowers decided to integrate and reorganize, and Affluent Medical was born.

In order to advance the development and commercialization of the company's products in China in the future, Shanghai Aibai Medical Technology Co., Ltd. was jointly established in April 2018 by Shanghai Zuquan Investment Management Co., Ltd. and French EPYGON Co., Ltd., focusing on the research and development and production of innovative cardiac medical devices.

On June 3, 2024, Edwards Lifesciences announced that it plans to sell its Critical Care business to Becton Dickinson (BD) in an all-cash transaction valued at $4.2 billion.Thereby further strengthening the focus on the structural heart device business. The transaction is expected to be completed by the end of 2024.

In April this year, Edwards announced the spin-off of its critical care division, which develops and sells blood and heart monitoring system devices for surgical and intensive care environments. After spinning off the critical care division, Edwards stated that it would expand its market opportunities for cardiac devices and invest in new technologies.

Data shows that in 2023,Edwards' structural heart disease department revenue exceeds $900 million, the department also sells other patient monitoring products, sensors and catheters, as well as predictive software and applications. After completing the divestiture of the critical care department,Edwards Lifesciences will become a pure structural heart company.

Edwards stated that it would use the post-tax cash proceeds to support subsequent strategic growth needs. This sale enhances the flexibility of Edwards' balance sheet, allowing for disciplined investment in new therapeutic areas such as treatment technologies for patients with aortic, mitral, tricuspid, and pulmonary valve diseases, as well as interventional therapies for heart failure. Edwards is focused on helping more patients worldwide by pursuing breakthrough technologies, expanding indications, and conducting world-class evidence-based research on its innovative products in the fields of surgical procedures, transcatheter aortic valve replacement, and transcatheter mitral and tricuspid therapies, aiming to build the most comprehensive portfolio of structural heart disease products.

*Medtronic and Terumo's fiscal year 2023 both span from April 2022 to April 2023. The data here is calculated based on the fourth quarter of fiscal year 2023 and the first three quarters of fiscal year 2024, representing the actual sales revenue for the entire year of 2023.

*Terumo's revenue is denominated in USD and converted using the official JPY to USD exchange rates published by Japan for 2022 and 2023.

*Edwards Lifesciences' cardiovascular business revenue comes solely from the valve business.

*Stryker's cardiovascular business sales revenue is only related to the neurointerventional business.

*In 2021, Cordis was sold by its parent company Cardinal (Cardinal Health) to private equity firm Hellman & Friedman (H&F) for $1 billion, and its performance has not been disclosed since.

According to data compiled by Yi Medical Device, in terms of revenue ranking in 2023 within the cardiovascular intervention field, Edwards Lifesciences ranked fifth globally, following Medtronic, Abbott, Boston Scientific, and Johnson & Johnson Medical Technologies. Known as the pioneer of heart valves, Edwards Lifesciences is facing intensifying competition with increased investments from major industry giants.

From the revenue composition in 2023, Edwards Lifesciences' revenue sources were relatively concentrated, with the transcatheter aortic valve replacement business contributing approximately 76% of the company's overall valve business revenue. This indicates that Edwards needs to expand its product portfolio and strategically invest in innovative products.

So, in which fields will Edwards focus on in the future? We will continue to pay attention.

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