Announcement • Jun 16
Carvolix Announces Positive Three-Year Clinical Results for Kalios Adjustable Mitral Ring Carvolix announced positive long-term clinical results from a pivotal study with its mitral ring Kalios. The company previously reported the 1-year results from the Optimise II study on 20 patients treated with the Kalios™ adjustable mitral annuloplasty device in patients with both degenerative (58%) and functional (42%) mitral regurgitation (MR), including 6 patients who underwent peri-operative or later adjustment without cardiopulmonary bypass. As the cohort matures, follow-up is now available in 20 patients at 2 years and 15 patients who reached 3 years of follow-up. At 3 years, the results confirm both the safety and efficacy of the implant: No adverse events related to the device were reported up to 3 years; All evaluated patients have mitral regurgitation grade =2+ at 3 years which meet the primary endpoint of the study. Mitral regurgitation is evaluated by echocardiography with an independent core lab, confirming sustained long-term efficacy. The mitral valve leaflet coaptation length improved from 3.9 mm at baseline to 6.4 mm at 3 years, demonstrating significant and sustained improvement in structural valve function. These long-term results confirm and consolidate the previously reported 1-year interim data and continue to validate the value proposition of KaliosTM mitral ring. The analysis of the primary efficacy endpoint at 3 years of the adjustable mitral ring has been submitted to a peer-reviewed journal, and a related abstract is submitted for scientific communication. Kalios™ is the only mitral annuloplasty device that can be adjusted percutaneously to treat both residual and recurrent mitral insufficiency at any time after implantation, repeatedly and with a beating heart, thereby avoiding a repeat open-heart operation. Carvolix estimates that Kalios™ would prevent repeat surgery for potentially 30-40% of patients within 5 years. The market for mitral valve repair surgery is estimated to be worth $1.5 billion in the US-Europe region, growing at 3.5% per year. The European Optimise II pivotal study on KaliosTM has been 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. Up to 100 patients are to be enrolled to obtain 62 evaluable patients at 1 year. Treated patients will be followed for 5 years post-surgery. Primary endpoints are the success rate of annuloplasty surgery defined by absence of MR of grade >2 and the safety at 1 year. Major Estimate Revision • Jun 02
Consensus revenue estimates increase by 15% The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast increased from €1.22m to €1.40m. EPS estimate unchanged from -€0.46 at last update. Medical Equipment industry in France expected to see average net income growth of 25% next year. Consensus price target of €4.93 unchanged from last update. Share price rose 8.5% to €3.33 over the past week. Announcement • May 27
Carvolix SA, Annual General Meeting, Jun 30, 2026 Carvolix SA, Annual General Meeting, Jun 30, 2026. Location: 900 rue andre ampere batiments a et c, aix en provence France New Risk • May 22
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 20% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€12m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 20% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€38m net loss in 2 years). Revenue is less than US$5m (€900k revenue, or US$1.0m). Board Change • Apr 16
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Vice Chair Michel Therin was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. New Risk • Mar 20
New minor risk - Revenue size The company makes less than US$5m in revenue. Total revenue: €900k (US$1.0m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€12m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€22m net loss in 2 years). Revenue is less than US$5m (€900k revenue, or US$1.0m). New Risk • Mar 05
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 0.0007% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€15m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (0.0007% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (€23m net loss in 2 years). Price Target Changed • Mar 05
Price target increased by 7.6% to €3.88 Up from €3.60, the current price target is an average from 4 analysts. New target price is 16% above last closing price of €3.35. Stock is up 136% over the past year. The company is forecast to post a net loss per share of €0.59 next year compared to a net loss per share of €0.41 last year. New Risk • Feb 22
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 4.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€15m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings are forecast to decline by an average of 4.1% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (€19m net loss in 2 years). Announcement • Feb 03
Affluent Medical Announces Appointment of Alain Chevallier as Board Member Affluent Medical at its Combined Shareholders’ Meeting held on January 30, 2026 ratified the appointment of Mr. Alain Chevallier as a Board member. Reported Earnings • Oct 06
First half 2025 earnings released First half 2025 results: Net loss: €9.37m (flat on 1H 2024). Revenue is expected to decline by 12% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in France are expected to grow by 6.2%. Price Target Changed • Oct 01
Price target decreased by 14% to €3.60 Down from €4.17, the current price target is an average from 3 analysts. New target price is 147% above last closing price of €1.46. Stock is down 19% over the past year. The company is forecast to post a net loss per share of €0.47 next year compared to a net loss per share of €0.41 last year. New Risk • Sep 26
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 6.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€11m free cash flow). Earnings are forecast to decline by an average of 26% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€27m net loss in 2 years). Share price has been volatile over the past 3 months (6.7% average weekly change). Market cap is less than US$100m (€60.0m market cap, or US$70.0m). New Risk • Sep 06
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€11m free cash flow). Earnings are forecast to decline by an average of 26% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€27m net loss in 2 years). Market cap is less than US$100m (€57.1m market cap, or US$66.8m). Announcement • May 15
Affluent Medical SA, Annual General Meeting, Jun 11, 2025 Affluent Medical SA, Annual General Meeting, Jun 11, 2025. Location: 320 avenue archimede, les pleiades iii batiment b, aix en provence France Announcement • Apr 17
Affluent Medical Announces Progress Toward European Clinical Study of Artificial Sphincter Artus for the Treatment of Urinary Stress Incontinence in Women Affluent Medical announced progress toward its upcoming SPHINX clinical study. The study, which is set to launch across Europe, in the second half of 2025, will assess the safety and performance of the Artus artificial urinary sphincter in female patients at leading medical centers in France, Spain and Belgium. This marks a significant step in expanding treatment options for women suffering from stress urinary incontinence (SUI). In preparation for the launch of the SPHINX study, Affluent Medical successfully completed the first implantation of its Artus device in a female anatomy model. The procedure was led by Professor Veronique Phe, a leading European urologist from Tenon Hospital in Paris, and evaluated the surgical approach in women. Utilizing the Da Vinci robotic-assisted laparoscopy system, it was confirmed that the device can be implanted with precision and ease, demonstrating its suitability for minimally invasive surgery. Severe Urinary incontinence is a widespread condition that significantly affects quality of life, with women accounting for approximately 80% of the more than 400 million individuals affected globally. Artus is designed to treat moderate to severe SUI through a fully implantable, adjustable device that patients can easily operate via remote control. The technology offers a minimally invasive and effective alternative to existing treatment options and has demonstrated promising results in male patients from the recently completed DRY pilot study. Announcement • Mar 12
Affluent Medical SA Announces Management Appointments Affluent Medical SA announced three key leadership appointments. These strategic additions aim to accelerate the company’s progress towards market access for its advanced product pipeline. New Chief Medical Officers to Drive Specialized Platforms: The company has appointed Dr. Howard C. Herrmann as strategic Chief Medical Officer (CMO) for its Structural Heart Platform and Pr. Nicolas Barry Delongchamps as strategic CMO for its Urology Platform. These key appointments underscore Affluent Medical commitment to enhancing its clinical expertise and driving innovation as it advances its devices, including mitral ring KALIOSTM, mitral valve EPYGON and artificial urinary sphincter ARTUS. Dr. Howard C. Herrmann, a renowned interventional cardiologist, is Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania and Director of Interventional Cardiology at the Hospital of the University of Pennsylvania, Philadelphia. With over three decades of experience in transcatheter device therapies for valvular and structural heart diseases, he has authored over 500 publications and served as President of the Pennsylvania Chapter of the American College of Cardiology. His profound expertise in structural heart care will guide the development of Affluent’s next-generation structural heart devices. Pr. Nicolas Barry Delongchamps, a distinguished urologist and professor at Paris-Cité University, brings extensive expertise in minimally invasive surgery for benign prostatic hyperplasia and urinary incontinence. His knowledge and experience with urinary incontinence will support Affluent Medical’s strategy in urology, driving innovation in this critical area. Expanding Operational Expertise with New Director of Clinical Operations: Further bolstering its operational capabilities, Affluent Medical has named Federica Azzimonti as Director of Clinical Operations. With close to 25 years of experience in managing international clinical studies across cardiovascular and other medical specialties, Federica brings a wealth of expertise in trial optimization and execution. In collaboration with both strategic CMOs, she will lead the operational aspects of Affluent Medical clinical trials, ensuring streamlined execution as the company prepares for pivotal stages. Announcement • Feb 26
Affluent Medical Appoints Liane Teplitsky as New Member of its Board of Directors Affluent Medical announced it has coopted Liane Teplitsky as a new Board member. Recently appointed CEO of Artedrone, the first autonomous robotic solution for Mechanical Thrombectomy, Liane Teplitsky is a successful seasoned senior executive in the medical device with achievements in building, leading, and growing innovative businesses that elevate the standard of patient care. With an extensive background in R&D and a passion for advancing intelligent and life-changing medical technologies, Liane has cultivated an expertise in leading business strategy, clinical data development and commercialization for multimillion-dollar global medical technology franchises. Additionally, Liane has demonstrated excellence in building and leading highly functioning, highly engaged teams. Most recently she was President, Global Robotics, Technology & Data Solutions at Zimmer Biomet where she led the global growth and development of the company’s portfolio of robotics and digital health technologies. Prior to Zimmer Biomet, Liane spent nearly a decade in executive leadership roles at Abbott as Vice President Sales & Division Vice President Marketing for Cardiac Arrhythmia & Heart Failure division and at St Jude Medical, with different strategic roles across multiple product and sales divisions. Liane holds a Master of Science in Biomedical Engineering from Duke University and a Bachelor of Science in Electrical Engineering and a Bachelor of Science in Physiology from the University of Saskatchewan – Canada. New Risk • Nov 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 6.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 33% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€30m net loss in 2 years). Share price has been volatile over the past 3 months (6.5% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Revenue is less than US$5m (€1.3m revenue, or US$1.4m). Market cap is less than US$100m (€62.2m market cap, or US$65.6m). New Risk • May 21
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 7.3% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€12m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 30% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€28m net loss in 2 years). Shareholders have been diluted in the past year (7.3% increase in shares outstanding). Revenue is less than US$5m (€1.2m revenue, or US$1.3m). Market cap is less than US$100m (€55.7m market cap, or US$60.4m). Announcement • May 20
Affluent Medical SA, Annual General Meeting, Jun 24, 2024 Affluent Medical SA, Annual General Meeting, Jun 24, 2024. Location: 320 avenue archimede, les pleiades iii batiment b, aix en provence France New Risk • Nov 30
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 22% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€13m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€22m net loss in 2 years). Revenue is less than US$5m (€1.2m revenue, or US$1.3m). Market cap is less than US$100m (€38.9m market cap, or US$42.5m). New Risk • Jun 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 70% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€11m free cash flow). Earnings have declined by 7.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Minor Risks Revenue is less than US$5m (€1.3m revenue, or US$1.5m). Market cap is less than US$100m (€38.3m market cap, or US$41.9m). Board Change • Nov 16
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 11 experienced directors. No highly experienced directors. 3 independent directors (6 non-independent directors). CEO & Chairman Michel Finance was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 7 non-independent directors. Chairman & CEO Michel Finance was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. 
