Major Estimate Revision • May 21
Consensus EPS estimates upgraded to US$0.44 loss The consensus outlook for fiscal year 2026 has been updated. 2026 losses forecast to reduce from -US$0.878 to -US$0.437 per share. Revenue forecast unchanged from US$16.2m at last update. Medical Equipment industry in Australia expected to see average net income growth of 30% next year. Consensus price target down from AU$23.77 to AU$14.00. Share price fell 13% to AU$0.52 over the past week. New Risk • Mar 31
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: AU$26.1m (US$17.9m) This is considered a minor risk. Companies with a small market capitalization 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 Risk Less than 1 year of cash runway based on free cash flow trend (-US$57m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$29m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (US$1.6m revenue). Market cap is less than US$100m (AU$26.1m market cap, or US$17.9m). Recent Insider Transactions Derivative • Mar 28
President exercised options to buy AU$70k worth of stock. On the 24th of March, John McCutcheon exercised options to buy 109k shares at a strike price of around AU$0.79, costing a total of AU$86k. John now holds 109.10k shares directly in their own name. Company insiders have collectively bought AU$306k more than they sold, via options and on-market transactions, in the last 12 months. Major Estimate Revision • Mar 25
Consensus EPS estimates fall by 15% The consensus outlook for fiscal year 2026 has been updated. 2026 expected loss increased from -US$0.085 to -US$0.098 per share. Revenue forecast unchanged at US$16.0m. Medical Equipment industry in Australia expected to see average net income growth of 45% next year. Consensus price target down from AU$2.50 to AU$2.41. Share price fell 3.6% to AU$0.67 over the past week. New Risk • Mar 20
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: -US$57m 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 Risk Less than 1 year of cash runway based on free cash flow trend (-US$57m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$36m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (US$1.6m revenue). Aankondiging • Feb 12
EBR Systems, Inc., Annual General Meeting, May 07, 2026 EBR Systems, Inc., Annual General Meeting, May 07, 2026. Major Estimate Revision • Jan 13
Consensus revenue estimates increase by 17% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$1.13m to US$1.33m. EPS estimate unchanged from -US$0.12 at last update. Medical Equipment industry in Australia expected to see average net income growth of 32% next year. Consensus price target broadly unchanged at AU$2.59. Share price rose 19% to AU$1.05 over the past week. Major Estimate Revision • Nov 19
Consensus revenue estimates increase by 22% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$930.0k to US$1.13m. EPS estimate unchanged from -US$0.12 at last update. Medical Equipment industry in Australia expected to see average net income growth of 36% next year. Consensus price target up from AU$2.52 to AU$2.60. Share price fell 8.4% to AU$1.09 over the past week. Aankondiging • Nov 07
EBR Systems Achieves First Enrollments in the WiSE-Up Study for Heart Failure Patients EBR Systems, Inc. announced the first patient enrollments in the WiSE®? System Utilization & Performance (WiSE-UP) Study. The first two patients were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist. This milestone marks an important step forward in advancing cardiac resynchronization therapy (CRT) for patients with heart failure with the addition of LVEP. Sponsored by EBR Systems, the WiSE-UP Study is a prospective, observational post-approval study designed to evaluate real-world outcomes in patients treated with the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 patients across 50 centers over five years, generating both short- and long-term performance data to inform future clinical practice. Major Estimate Revision • Sep 15
Consensus revenue estimates fall by 14% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$930.0k to US$800.0k. Forecast losses increased from -US$0.109 to -US$0.11 per share. Medical Equipment industry in Australia expected to see average net income growth of 32% next year. Consensus price target broadly unchanged at AU$2.57. Share price was steady at AU$1.17 over the past week. Recent Insider Transactions Derivative • Aug 20
Independent Non-Executive Director exercised options to buy AU$245k worth of stock. On the 18th of August, Bronwyn Evans exercised options to buy 196k shares at a strike price of around AU$0.82, costing a total of AU$161k. This transaction amounted to 55% of their direct individual holding at the time of the trade. Since September 2024, Bronwyn's direct individual holding has increased from 167.41k shares to 355.78k. Company insiders have collectively bought AU$315k more than they sold, via options and on-market transactions, in the last 12 months. Major Estimate Revision • Aug 19
Consensus revenue estimates decrease by 28%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$1.28m to US$930.0k. EPS estimate increased from -US$0.115 to -US$0.109 per share. Medical Equipment industry in Australia expected to see average net income growth of 13% next year. Consensus price target broadly unchanged at AU$2.61. Share price fell 5.2% to AU$1.28 over the past week. Aankondiging • Jun 30
EBR Systems, Inc. Announces Executive Changes EBR Systems, Inc. announced that the company has appointed Mr. Kobe Li as the Australian Company Secretary, effective June 30, 2025. Mr. Brendan Case has resigned as Company Secretary. Kobe is an experienced company secretary for a number of ASX listed companies. He has previously worked at the ASX as a Senior Advisor in the Listings Compliance team and is a member of the Governance Institute of Australia. New Risk • May 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 39% 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 Earnings are forecast to decline by an average of 3.1% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (39% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$52m net loss in 2 years). Share price has been volatile over the past 3 months (14% average weekly change). Aankondiging • May 23
EBR Systems, Inc. has filed a Follow-on Equity Offering. EBR Systems, Inc. has filed a Follow-on Equity Offering.
Security Name: Cash Depository Interest
Security Type: Depositary Receipt (Common Stock) Aankondiging • May 22
EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 55.9 million. EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 55.9 million.
Security Name: Cash Depository Interest
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 55,900,000
Price\Range: AUD 1
Discount Per Security: AUD 0.04 New Risk • May 15
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: -US$45m 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 (-US$45m free cash flow). Earnings are forecast to decline by an average of 3.1% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$49m net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). New Risk • Apr 22
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 Australian stocks, typically moving 13% 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 Earnings are forecast to decline by an average of 3.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$45m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Aankondiging • Apr 17
FDA Approves WiSE System, World's First and Only Leadless Left Ventricular Endocardial Pacing (LVEP) Device for CRT EBR Systems, Inc. has received FDA approval of the WiSE®? System, which marks a significant leap forward in the treatment of heart failure. Unlike conventional CRT, the WiSE System is the first and only to deliver leadless left ventricular endocardial pacing (LVEP), that closely aligns with the heart's natural conduction pathway. The endocardial approach represents a more physiological method of resynchronization and allows electrophysiologists to treat patients that are not able to receive lead-based devices. This advancement offers a pioneering treatment option for patients who have limited access to conventional CRT therapies. Conventional CRT leaves too many heart failure patients behind. The WiSE System was designed for them. It allows physicians to help these key patient populations: Patients with challenging anatomy where the LV lead could not be implanted; Patients with acute or chronic LV lead failure; Patients with high procedural risk for LV lead placement; Patients with leadless pacemakers who need CRT, yet are often poor candidates for conventional upgrades. In short: WiSE brings CRT to more patients than ever before. Backed by Data. Reimagining Delivery of CRT. The SOLVE-CRT trial has delivered promising results for heart failure patients. The WiSE System offers hope to those who have tried other therapies without success and were told no further options existed-- until now; 16.4% reduction in LV end-systolic volume (LVESV--a key marker of reverse remodeling (p=0.003); Shorter QRS durations by an average of 39ms-- an indicator of electrical resynchronization; Over 55% improved at least one NYHA class and another 40% remained stable. The WiSE System syncs with existing pacing devices--pacemakers, ICDs, or CRTs--using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted in the LV. No leads. No lead navigation. Just endocardial pacing that's more physiologic, from the inside out. Aankondiging • Apr 15
EBR Systems, Inc. Announces US Food and Drug Administration Approval of EBR's WiSE CRT System EBR Systems, Inc. announced the US Food and Drug Administration (FDA) approval of EBR's WiSE cardiac resynchronisation therapy ("CRT") System. The FDA has issued an approval letter authorizing the commercial marketing of EBR's WiSE CRT System in the US. The FDA approval of the WiSE CRT System was supported by the submission of five comprehensive modules as part of the Premarket Approval ("PMA") application, the completion of a Pre-Approval Inspection (PAI) of EBR's manufacturing facilities in January 2025 with no form FDA 483 observations, and the resolution of any queries that arose from the FDA's review of the submitted modules. Securing FDA approval for the WiSE CRT System is a transformative moment, marking transition from clinical development to commercialization. With FDA approval in hand, EBR is well-positioned to bring innovative solution to market, delivering real impact to patients and servicing a significant unmet need. The FDA approved indications for use are as follows: The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy (CRT), have an existing implanted right ventricular pacing system, and are in one of the following two categories: Patients in whom previous coronary sinus lead implantation was unsuccessful or where an implanted lead has been turned off - referred to as "pre previously untreatable." Patients with previously implanted pacemakers or ICD's in whom standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation, referred to as "high-risk upgrades." EBR SYSTEMS, INC. Chronic lead failure: patients with inactive or malfunctioning left-heart CRT leads High-risk upgrade: patients who have existing pacing systems, including leadless pacemakers, who need an upgrade to biventricular pacing due to heart failure progression and are not candidates for CRT coronary sinus lead placement. Medtronic's Micra leadless pacemaker has been qualified for use with WiSE CRT. The FDA approval letter was received by EBR via email at 10:47am PDT on 11 April 2025 (3:47am AEST on 12 April 2025) in line with the Company's expectation of obtaining approval on or before 13 April 2025. With FDA approval secured, EBR will launch the WiSE CRT System in phases. A limited market release is planned for 2025, with sales expected during the second half of the year, ramping towards full commercial distribution during 2026. The initial phase of the rollout will concentrate on high-volume centers, specifically those involved in previous clinical trials, aimed at gathering early user experience and facilitating wider adoption. The company will concurrently conduct a post-approval study, which is an FDA requirement as a condition of approval. As a result of the FDA's Breakthrough Device Designation, EBR expects to qualify for two reimbursement schemes: New Technology Add-on Payment (NTAP - inpat patients) and Transitional Pass-Through payment (TPT - outpatients). This strategic rollout ensures the WiSE CRT System are introduced with the right clinical support, training, and infrastructure in place. New Risk • Apr 10
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 3.3% 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 (-US$42m free cash flow). Earnings are forecast to decline by an average of 3.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$45m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Major Estimate Revision • Mar 31
Consensus revenue estimates decrease by 42% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$2.13m to US$1.23m. EPS estimate unchanged from -US$0.12 per share at last update. Medical Equipment industry in Australia expected to see average net income growth of 17% next year. Consensus price target up from AU$2.38 to AU$2.81. Share price fell 11% to AU$1.75 over the past week. New Risk • Mar 28
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: -US$42m 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 (-US$42m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$39m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). New Risk • Mar 18
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 4.0% 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 Earnings are forecast to decline by an average of 4.0% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$50m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). New Risk • Mar 06
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 Australian stocks, typically moving 12% 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 Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$41m net loss in 2 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Aankondiging • Feb 19
EBR Systems, Inc., Annual General Meeting, May 29, 2025 EBR Systems, Inc., Annual General Meeting, May 29, 2025. Recent Insider Transactions Derivative • Nov 27
Independent Non-Executive Director exercised options to buy AU$133k worth of stock. On the 25th of November, Bronwyn Evans exercised options to buy 150k shares at a strike price of around AU$0.68, costing a total of AU$102k. This transaction amounted to 85% of their direct individual holding at the time of the trade. Since December 2023, Bronwyn's direct individual holding has increased from 127.97k shares to 175.78k. Company insiders have collectively bought AU$139k more than they sold, via options and on-market transactions, in the last 12 months. New Risk • Nov 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.8% 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 Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$41m net loss in 2 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Board Change • Nov 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Bronwyn Evans was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Oct 25
EBR Systems, Inc. to Report Q3, 2024 Results on Nov 13, 2024 EBR Systems, Inc. announced that they will report Q3, 2024 results Pre-Market on Nov 13, 2024 New Risk • Sep 30
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% 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 Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$42m net loss in 2 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Aankondiging • Sep 20
EBR Systems, Inc. has filed a Follow-on Equity Offering in the amount of AUD 50.002187 million. EBR Systems, Inc. has filed a Follow-on Equity Offering in the amount of AUD 50.002187 million.
Security Name: CHESS Depositary Insterests
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 45,568,852
Price\Range: AUD 0.82
Discount Per Security: AUD 0.0492
Security Name: CHESS Depositary Insterests
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 15,409,424
Price\Range: AUD 0.82
Discount Per Security: AUD 0.0492
Transaction Features: Rights Offering; Subsequent Direct Listing Aankondiging • Sep 05
EBR Systems, Inc. 1 CDI TO 1 SHARE OF COM STK to be Deleted from OTC Equity EBR Systems, Inc. 1 CDI TO 1 SHARE OF COM STK will be deleted from OTC Equity effective September 04, 2024, due to inactive security. New Risk • Sep 04
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.8% 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 Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$42m net loss in 2 years). Buy Or Sell Opportunity • Aug 05
Now 23% undervalued after recent price drop Over the last 90 days, the stock has fallen 6.4% to AU$1.02. The fair value is estimated to be AU$1.33, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Buy Or Sell Opportunity • Apr 24
Now 22% overvalued after recent price rise Over the last 90 days, the stock has risen 24% to AU$0.91. The fair value is estimated to be AU$0.74, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Buy Or Sell Opportunity • Apr 05
Now 27% overvalued after recent price rise Over the last 90 days, the stock has risen 45% to AU$0.92. The fair value is estimated to be AU$0.73, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Aankondiging • Feb 13
EBR Systems, Inc., Annual General Meeting, May 29, 2024 EBR Systems, Inc., Annual General Meeting, May 29, 2024, at 16:00 Pacific Daylight. Aankondiging • Oct 26
EBR Systems, Inc. Announces Positive Results from First-In-Human Fully Leadless CRT in the US, Published in the Journal of the American College of Cardiology EBR Systems, Inc. announced that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States have been published in The Journal of the American College of Cardiology (JACC). The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE®? CRT Electrode in the left ventricle of the heart. At 12-months, the patient showed improved heart failure symptoms (NYHA Class III to II), no recurrent heart failure-related hospitalization, a reduction in QRS duration, and an improvement in left ventricle from 30% to 65%. This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR. The initial addressable market of $2.6 billion is focused on treating patients who had previously failed CRT and by treating new CRT patients, the addressable market could increase to $6.8 billion. Based on the patient's health complications and risks, the implantation of EBR's investigational Wi SE CRT System alongside Medtronic's Micra received requisite approval from the Institutional Review Board (IRB) and U.S. Food and Drug Administration (FDA) on compassionate grounds. The Journal of theAmerican College of Cardiology (J ACC) is a prestigious, peer-reviewed medical journal dedicated to the field of cardiology. As a leading publication in the cardiovascular sciences, JACC provides a platform for the dissemination of research, clinical studies, and breakthroughs in cardiovascular medicine. The WiSE®? CRT System has the potential to offer a new treatment option for patients including the 3 million heart failure patients worldwide who were previously untreatable by conventional CRT, and potentially, the 64 million heart failure patients across the globe. Aankondiging • Sep 13
Ebr Systems, Inc. Announces Chief Financial Officer Changes EBR Systems, Inc. announced the appointment of Mr. Gary Doherty as Chief Financial Officer of the Company, effective as of 11 September 2023. Mr. Doherty will replace EBR's current CFO, Frank Hettmann, and will help drive the Company forward with proven international experience across technology, healthcare, finance, and operations. Gary has a proven track record of developing high performing finance functions in international medical device corporations across his 30-year career. Prior to joining EBR, Mr. Doherty was the Chief Financial Officer at Acutus Medical, a medical technology company specialising in cardiac arrhythmia and atrial fibrillation treatment. He was responsible not only for the financial operations of the business which included leading a successful public offering but also played a pivotal role securing distribution agreements with strategic partners to accelerate global expansion and drive commercialisation. Before that, Gary served as Group Plant Controller for 12 years for Volcano Corporation (Nasdaq:VOLC), a company specialising in the development, manufacture, and distribution of medical products. Gary holds a Bachelor of Science degree in Business Administration from the San Diego State University. Current CFO, Frank Hettmann, has agreed to stay with the Company until 30 November 2023, to help Gary transition to the CFO role. New Risk • Jul 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 11% 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 Earnings are forecast to decline by an average of 6.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$39m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). Aankondiging • Jul 07
EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 30 million. EBR Systems, Inc. has completed a Follow-on Equity Offering in the amount of AUD 30 million.
Security Name: CHESS Depositary Interest
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 5,494,506
Price\Range: AUD 0.91
Discount Per Security: AUD 0
Security Name: CHESS Depositary Interest
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 27,472,527
Price\Range: AUD 0.91
Discount Per Security: AUD 0.0546
Transaction Features: Subsequent Direct Listing Aankondiging • May 23
Ebr Systems' Pivotal Solve-Crt Trial Meets Endpoints EBR Systems, Inc. has met its primary safety and efficacy endpoints in its pivotal SOLVE-CRT trial of the WiSE®? Cardiac Resynchronization Therapy (CRT) System. EBR Systems' WiSE®? system is on track to submit a Premarket Approval (PMA) application to the Food and Drug Administration (FDA) in early 2024 after successfully achieving primary and secondary endpoints in its pivotal trial which ended early due to success. The FDA has granted the WiSE CRT System a Breakthrough Device designation, which supports a priority of the WiSE CRT System. SOLVE-CRT was an international, multicenter clinical trial designed to enrol up to 300 patients in randomized and single-arm parts. The study was conducted across 43 sites in the US, 10 in Australia, and 15 centers in the United Kingdom, Germany, France, Italy, and the Netherlands. SOLVE- CRT was powered for an interim analysis such that if the primary efficacy and safety were met with 183 patients at the 6-month follow-up, the study could be declined a success and be halted early. The study was led by Co-Principal Investigators, Drs Jagmeet P. Singh, MD, DPhil, Professor of Medicine at Harvard Medical School, Director, Massachusetts General Hospital, Boston, MA; and Mary Norine (Minnow) Walsh, MD, Medical Director, Ascension St. Vincent Heart Center, Indianapolis, IN. The SOLVE-CRT trial results were presented by Dr. Singh at the Heart Rhythm Society (HRS) 2023 annual meeting, the largest gathering of heart rhythm professionals globally. The inclusion of the presentation in the Late Breaking Clinical Trials session during the premier global electrophysiology conference underpins the importance of EBR's SOLVE-CRT study within the cardiovascular field, with the aim to materially improve patient outcomes. Aankondiging • Feb 01
EBR Systems, Inc., Annual General Meeting, May 23, 2023 EBR Systems, Inc., Annual General Meeting, May 23, 2023, at 09:00 AUS Eastern Standard Time. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • Oct 21
EBR Systems, Inc. Provides an Update Regarding the Wise System EBR Systems, Inc. provided an update regarding the WiSE® system. Following ongoing technical assessments, EBR has identified a potential increased rate of battery depletion affecting a small number of WiSE® systems. Preliminary analysis confirmed the cause as an insulation breach in the system's transmitter, which may result in the development of a leakage pathway, leading to the battery draining at a faster rate than normal. The issue has been clinically confirmed in 1 patient representing a device failure rate of 0.8%, with an additional 7 devices suspected of having a similar issue which could raise the failure rate to 6.3%. There have been no reported complications to patient health or safety as a result of this issue to date. EBR continues to investigate the issue further, however the Company believes that this will not affect the outcomes of the pivotal SOLVE-CRT ("SOLVE") trial and said devices will continue to function normally and deliver biventricular pacing until the battery is depleted. EBR remains committed to providing patients with the higher level of care and is working closely with the relevant regulatory bodies, physicians, clinical sites, and partner institutions to ensure that patient safety is maintained. In line with Company policy, EBR has issued a technical notification to customers highlighting patient management recommendations such as monitoring potential battery depletion and conducting routine tests for battery status. New patient implants have been paused until the issue has been rectified. The Company has already identified solutions involving manufacturing changes and is actively working to implement these changes. EBR does not expect this issue to impact headline data for the SOLVE trial, where the 183-patient interim enrolment was recently completed. EBR believes it will achieve the key primary endpoints of the SOLVE trial, as previous trials of WiSE exceeded the safety and efficacy endpoints required for SOLVE. As such, the Company remains confident it will release headline results in H1 2023. EBR is currently engaged in consultation with relevant regulatory authorities across key markets. In the US, EBR expects final PMA submission to the FDA in H2 2023. This submission will include the necessary changes to design and manufacturing processes to resolve this matter. The Company remains focused developing its unique and novel technology to help those suffering from heart failure, a major social and economic problem. EBR has a clear and targeted pathway to commercialisation in 2H 2024, with plans to initially target patients who cannot receive CRT from existing devices or are at high risk for conventional upgrades, with an initial annual addressable market of $2.5 billion. Aankondiging • Aug 11
EBR Systems, Inc. Announces Study of WiSE Published in Heart Rhythm Journal EBR Systems, Inc. announced that a scientific paper describing the use of leadless septal left ventricle (LV) pacing with the WiSE®-CRT system has been published in the leading peer-reviewed journal Heart Rhythm, the official journal of the Heart Rhythm Society, the Cardiac Electrophysiology Society and the Paediatric & Congenital Electrophysiology Society. Major Estimate Revision • May 01
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$370.0k to US$500.0k. EPS estimate unchanged from -US$0.11 at last update. Medical Equipment industry in Australia expected to see average net income decline 20% next year. Consensus price target down from AU$1.59 to AU$1.56. Share price was steady at AU$0.58 over the past week. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Bronwyn Evans was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Major Estimate Revision • Mar 03
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$900.0k to US$1.50m. EPS estimate fell from -US$0.10 to -US$0.12 per share. Medical Equipment industry in Australia expected to see average net income decline 20% next year. Consensus price target broadly unchanged at AU$1.54. Share price fell 2.2% to AU$0.66 over the past week. Aankondiging • Nov 24
EBR Systems, Inc. has completed an IPO in the amount of AUD 109.999999 million. EBR Systems, Inc. has completed an IPO in the amount of AUD 109.999999 million.
Security Name: CHESS Depositary Interests
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 101,851,851
Price\Range: AUD 1.08
Discount Per Security: AUD 0.0378 Board Change • Nov 24
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. Non-executive Director Bronwyn Evans 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.