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On July 12, 2024, Edwards Lifesciences announced,Reached three acquisition deals totaling 15 million euros (approximately 120 million RMB) with the French medical device company Affluent Medical to acquire its mitral valve technology.

Edwards Lifesciences acquired the exclusive option to purchase Kephalios, a subsidiary of Affluent Medical SA, for €5 million, including the company’s Kalios adjustable mitral annuloplasty ring. This option is based on the clinical results of the research on this technology, and Affluent will continue to develop it during the option period.

Epygon's First "Physiological" Mitral Bioprosthetic Valve

For €5 million, obtain a global non-exclusive license for Affluent Medical's IP related to the bionic heart mitral valve replacement technology.

And further invested 5 million euros to acquire 9.21% of Affluent's shares.

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

First "Physiological" TMVR

The natural asymmetry of native valves creates a rotational flow or vortex in the ventricle, which minimizes energy loss and helps direct blood straight into the aortic outflow tract, a structure mimicked in the design of Epygon.

Epygon is the first "physiological" mitral bioprosthetic valve that can restore the natural vortex blood flow of the left ventricle, thereby flushing the endocardium to prevent endocardial thrombosis. It can promote early coaptation of the mitral leaflets during diastole, thus increasing cardiac output and promoting recovery of ventricular function. Epygon's unique design includes a pericardial tissue single leaflet combined with a D-shaped ring, presenting 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. Additionally, this asymmetric valve has a lower profile on the left ventricular outflow side, 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 intellectual property (IP) of Epygon's bionic heart mitral valve replacement technology, which is limited to open-heart surgery. It may include future royalties on all potential commercial products utilizing the licensed patents.

The First Post-Implantation Adjustable Artificial Mitral Valve Annuloplasty Ring

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 with a layer of cell ingrowth, the device can still be adjusted as needed to improve coaptation.

On September 13, 2023, Affluent Medical announced that the KaliosTM adjustable ring for mitral valve repair demonstrated efficacy and excellent safety within 1 year in the Pivotal Optimise II study involving 20 patients.

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+, thus reaching the pre-defined efficacy endpoint of the study.

The NYHA functional class improved in 12 patients, with 79% of patients achieving NYHA functional class I or II. The safety profile of the study was excellent: no deaths, no myocardial infarctions, no valve thrombosis, and no reports of endocarditis up to 1 year.

Professor Alberto Albertini, Chief 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 due to 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 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 in 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 forging a robust partnership for Kalios and surgical mitral valve technologies. Affluent will continue to develop its transcatheter mitral valve Epygon and artificial sphincter."

Establish a Joint Venture in China

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 prostheses for the treatment of abdominal aortic aneurysms), and Artus artificial urinary sphincter are all in the preclinical and clinical research stages.

Affluent Medical was formed through the reorganization 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 specializing in urinary incontinence device research and development, was successfully established.

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

In order to advance the development and commercialization of the company's products in China,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, development, and production of innovative cardiac medical devices.

Focus on Core Business

On June 3, 2024, Edwards Lifesciences announced,Plans to sell its critical care product division to Becton Dickinson for $4.2 billion in an all-cash transaction, further strengthening its focus on structural heart device business. The deal 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, the revenue of Edwards Lifesciences' Structural Heart division exceeded $900 million. The division also sells other patient monitoring products, sensors and catheters, as well as predictive software and applications.After completing the divestiture of its critical care business, Edwards will become a pure-play 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.In order to make orderly investments in new treatment areas such as treatment technologies for patients with aortic, mitral, tricuspid, and pulmonary valve diseases, as well as interventional therapies for heart failure.Edwards focuses on helping more patients worldwide, aiming to build the most comprehensive structural heart disease product portfolio through breakthrough technologies, indication expansions, and world-class evidence-based research on innovative products in the fields of surgical procedures, transcatheter aortic valve replacement, and transcatheter mitral and tricuspid therapies.

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 lay out innovative products in advance.

So, what areas will Edwards focus on in the future? Medical Device News will continue to follow.

END

 

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