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Affluent Medical
Affluent Medical : 2023 financial results and update on clinical activities under development.
25-Apr-2024 / 17:45 CET/CEST
Dissemination of a French Regulatory News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.

PRESS RELEASE



2023 financial results and update on clinical activities
under development

-- Excellent one-year interim follow-up results with the KaliosTM mitral ring and strategic shift towards
the US market
-- Excellent performance of the Epygon valve after one year of follow-up and growing recognition of the
biomimetic mitral valve concept
-- First in human successful implantation for the Artus artificial sphincter, for the treatment of urinary
incontinence
-- Reiterated confidence of key shareholders through the granting of current account advances, extending its
financial horizon until end of July 2024


Aix-en-Provence, 25 April 2024 - Affluent Medical (ISIN: FR0013333077 - Ticker: AFME), a French clinical-phase MedTech
company specialising in the international development and industrialisation of innovative medical prostheses, is today
publishing its 2023 annual results and providing an update on its clinical studies.

Several key milestones achieved in 2023
Several key milestones were achieved in 2023, especially regarding the progress of clinical studies, with the start of
the Epygon pilot study and the excellent clinical results for KaliosTM in terms of efficacy and safety profile at one
year. The period was also marked by the strengthening of the management team by adding valuable expertise to the
important areas of product development through to marketing.
At the same time, the Company successfully completed a financing in the form of a capital increase with pre-emptive
subscription rights maintained, carried out by issuing shares with redeemable share subscription warrants in the gross
amount of EUR13.7 million and with the acquisition of 10% of the share capital by LCEA.

KaliosTM: Strategic shift towards the US market following the positive one-year results of the Optimise II pivotal
study
KaliosTM is the only mitral valve annuloplasty device that can be percutaneously adjusted to treat residual and
recurrent mitral insufficiency at any time after implantation, repeatedly and with a beating heart, thereby avoiding
another open-heart operation. Affluent Medical estimates that KaliosTM would avoid repeat surgery for 30-40% of
patients within five years of their operation.
The market for mitral valve repair surgery was worth an estimated at USD1.5 billion in 2023 in the US and Europe, up 3.5%
per year.
The Optimise II pivotal study on KaliosTM was designed to assess the medical device's safety and efficacy in the
surgical treatment of mitral regurgitation with catheter-based adjustment.
In September 2023, the Company presented interim data on 20 patients treated in five clinical centers in Europe after
one year of implantation. After one year, none of the patients had mitral regurgitation > 2+, which met the study's
primary objective.
The study's safety profile is excellent: no deaths, myocardial infarction, valvular thrombosis or endocarditis were
reported. The study involved 13 patients with degenerative mitral regurgitation and 7 with functional mitral
regurgitation. Five intraoperative adjustments were performed, and one patient was adjusted 11 months after surgery.
From the four patients adjusted perioperatively, with one year follow up, excellent results were observed and were
maintained (grade 1+).
Following the analysis of these positive one-year data, Affluent Medical decided to refocus its resources on the US
market and enter into discussions with the US Food and Drug Administration (FDA). In December 2023, the Company made a
pre-submission to the FDA to assess the marketing authorisation process for its KaliosTM medical device as a Class 2
device that can rely on an equivalent (510(k)) or a risk analysis (De Novo). Class 2 pathway would allow simplified
access to the market compared to the initial European strategy.
The US market offers several marketing advantages; the average selling price of a mitral ring is 25-30% higher than in
Europe and obtaining approval in the US is perfectly aligned with the strategy to secure commercial partners primarily
located in the US (Medtronic, Boston Scientific, Abbott, Edwards Life Science, etc.). As such, the European study was
suspended during this strategic refocusing.
Epygon: First successful implantation of the valve and opening of new investigation centres
Epygon is the only biomimetic cardiac mitral valve, mimicking the anatomy of the native mitral valve and physiological
blood flows, implantable via transcatheter delivery. This transcatheter approach avoids an invasive open-heart
procedure and associated complications in treating mitral failure. This serious and potentially fatal disease affects
2% of the world's population, around 160 million people. However, less than 4% of patients with a severe form can have
open-heart surgery, which poses a high risk of death and hospitalisation. The TMVI (transcatheter mitral valve
implantation) market for endovascular valves has greater market potential than TAVI (transcatheter aortic valve
implantation - over USD8 billion at maturity), according to Allied Market Research and Azoth Market Research.
In March 2023, Affluent Medical announced the successful first implantation of the Epygon biomimetic mitral heart valve
in a patient presenting a profile of severe mitral insufficiency associated with several comorbidity factors.
This implantation was performed by the minimally invasive transcatheter route, by Prof. Stefano Salizzoni, MD, PhD -
co-investigator in the Minerva pilot clinical study - and his team, at the Molinette Hospital of Health and Science in
Turin, Italy. After one month of follow-up, the patient improved her functional condition, increasing her New York
Heart Association (NYHA) functional status from III to II; this results in a resumption of the person's daily
activities without becoming completely breathless. The echocardiogram showed excellent function of the Epygon valve.
Approval by the data monitoring and safety committee enabled the Company to treat other patients with the Epygon valve.
Two additional investigation centres were approved to participate in the clinical trial (Seville and Budapest).
Applications were submitted at five new centres (Linz in Austria, Modena and Milan in Italy, Bad Nauheim in Germany,
and Madrid) with the target to open these new centres by the second half of the year.
Affluent Medical accelerated patient assessments to 92 patients in 2023, with the goal of implanting up to 10 patients
to complete the pilot phase. A Simulands simulator was developed and validated in 2023 to strengthen the surgical
training of clinical investigators and provide the Company with greater organisational flexibility. The Company has
also expanded the valve-size portfolio with two new sizes (40 and 42) and has initiated activities to enable the
treatment of patients with size 44. These additional developments will speed up patient screening as they are
progressively approved at the investigation centres.

Artus: Start of the European pilot study
Affluent Medical points out that the Artus medical device is the first mechanical artificial sphincter that patients
can activate via remote control, for the treatment of moderate to severe urinary incontinence in both men and women.
The urinary sphincters currently on the market were not initially developed for women, even though women account for
80% of patients. According to Optima Insights, the global market for medical devices for treating urinary incontinence
(including strips, neurostimulators and artificial sphincters) is expected to reach USD4.3 billion by 2027, growing an
annual 11% on average between 2019 and 2027.
In December 2023, the first clinical investigation centre in Prague, Czech Republic, began screening patients to
initiate the Dry pilot study. Several other centres have opened in Europe, including in Poland, where the first phase
of the assessment and approval of the protocol with the ethics committee has been completed. Affluent Medical is
awaiting approval from the Polish authorities to begin patient recruitment. A total of 70 patients are to be recruited
for the pilot and pivotal phases of this study.
The pilot phase, which is expected to be completed by the second half of 2024, will first focus on men, then another
pilot study will initiate trials in women.
Urinary incontinence is a major public health problem for over 400 million people worldwide without any innovation for
40 years, with patients suffering from poor quality of life associated with the psychological disorders linked to this
condition.

Success of the 2023 capital increase
On 6 March 2023, Affluent Medical announced the success of its capital increase with pre-emptive subscription rights
maintained, carried out by issuing shares with redeemable share subscription warrants in the gross amount of EUR13.7
million (excluding any exercise of the redeemable share subscription warrants).

Changes in shareholder structure and governance
Following LCEA's subscription to the capital increase carried out by Affluent Medical on 6 March 2023, the fund
management Company became the second largest shareholder in Affluent Medical, with 10.25% of the share capital and
7.10% of the voting rights alongside the long-standing shareholder Truffle Capital. Vincent Bourgeois was co-opted as
director to represent LCEA, this new shareholder.

Strengthening of the executive committee with several appointments
In January 2023, Affluent Medical announced the recruitment of three members of the management team with the
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April 25, 2024 11:45 ET (15:45 GMT)