EBRCZ

EBR Systems, Inc.

OTC · HEALTH CARE · SURGICAL & MEDICAL INSTRUMENTS & APPARATUS

0.11

+0.00 +0.00%

USD · close Oct 23

A free account adds a watchlist, alerts when insiders, Congress or short sellers move on your tickers, and a morning brief. Sign up

Work order

FLAG · shorts 0

Insiders, 90 days

no open-market filings in 90 days

Congress, 90 days

0 / 0

no disclosures naming it

Big money

0 / 15

none of the tracked funds disclose it

Calls on record

nobody we score has called it yet

MKT CAP $8.6MP/E —DIV YIELD —FCF YIELD -861.47%REV TTM $6.4MNET INCOME −$60.8MNET CASH $17.6M52W 0.11 – 1.20SEC XBRL · TTM TO Invalid Date

How EBRCZ rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

58%

of sentences unchanged

Added

264

new sentences

Dropped

376

sentences removed

Length

−3,985

words, now 42,046

New in FY2025

Business Overview EBR is a U.S. based medical device company that developed the WiSE CRT System (“WiSE”), an implantable cardiac pacing system able to provide stimulation to endocardial heart tissue for the correction of heart rhythm conditions without requiring the use of leads.
That implantable device is part of a cardiac resynchronization therapy (“CRT”), offering endocardial heart tissue stimulation without the complications associated with traditional lead-based systems.
Cardiac rhythm management (“CRM”) systems use leads to conduct electricity from an implantable pulse generator (“IPG”) to electrodes that deliver therapeutic electric pulses to heart tissue.
We initially developed WiSE for use in conjunction with another implanted pacemaker to provide CRT to patients who are unable to receive CRT from a traditional lead-based system or are at high risk of complications from an upgrade procedure.
WiSE CRT technology is engineered to benefit patients who have not seen success with conventional CRT or face high complication risks.
On April 11, 2025, we received notification that the Center for Devices and Radiological Health (“CDRH”) of the Food and Drug Administration (“FDA”) had completed its review of our premarket approval application (“PMA”) for WiSE and approved WiSE for commercial distribution in the U.S. for adult patients who are at least 22 years of age, are indicated for CRT, have an existing or are eligible for an implanted right ventricular pacing system, and are in one of the following two categories: 1) patients in whom previous coronary sinus (“CS”) lead implantation was unsuccessful, or where an implanted lead has been turned off, referred to as "previously untreatable"; or 2) patients with previously implanted pacemakers or Implantable Cardioverter-Defibrillators (“ICDs”) 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".
We have launched WiSE with the focus on driving adoption of WiSE at key, high-volume, hospitals or medical facilities within the U.S. to be followed by select, high-volume hospitals or medical facilities in markets outside the U.S.
(“OUS”) that we would target after evaluating regulatory and reimbursement considerations.
The growth of our business depends on our ability to successfully commercialize WiSE and gain wide acceptance of WiSE by continuing to make physicians and other hospital staff aware of the benefits of WiSE to generate increased demand and frequency of use and thus increase sales to our hospital customers.
Our ability to grow our business will also depend on our ability to expand our customer base in existing or new target markets.
The rate at which we grow our sales force and the speed at which newly hired salespeople become effective can impact our revenue growth or our costs incurred in anticipation of such growth.
We intend to make significant investments in our sales and marketing organization by increasing the number of U.S. sales representatives and expanding our international marketing programs to help facilitate further adoption among existing hospital accounts as well as broaden awareness of our products to new hospital accounts.
Products The WiSE CRT System, our only product, is an implantable cardiac pacing system capable of delivering pacing level energy to the heart without using a lead/ wire.
The technology used to achieve this leadless pacing is based on converting ultrasound energy into electrical energy.
Components of the WiSE CRT System include the Delivery Sheath and Electrode Catheter which delivers the Electrode, the Pulse Generator (Transmitter and Battery), and the Programmer (Figure 1.1 below).
Figure 1.1 How WiSE CRT System Provides Leadless Cardiac Pacing SOLVE-CRT Clinical Trial The SOLVE-CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) investigational device exemption (“IDE”) study was a prospective, multicenter trial consisting of an initial randomized, double-blind part and a subsequent single-arm part.
The SOLVE-CRT study demonstrated that leadless left ventricular endocardial pacing (“LVEP”) with the novel WiSE CRT System is feasible, safe, and effective for delivering CRT in patients with advanced HF.
FDA Approval On April 11, 2025, the Center for Devices and Radiological Health of the FDA completed its review of and approved our premarket approval application for the WiSE CRT System.
The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy, have an existing or are eligible for an implanted right ventricular pacing system and are in one of the following two categories: (a) patients in whom previous coronary sinus lead implantation was unsuccessful, or where an implanted lead has been turned off, referred to as “previously untreatable”; and (b) patients with previously implanted pacemakers or Implantable Cardioverter-Defibrillators in whom standard CRT upgrade is not advisable due to know relative contraindications for CS lead or CRT device implantation, referred to as “high risk upgrades”.
Post-approval Study To help assure the continued safety and effectiveness of the WiSE CRT System, the FDA has required a post-approval study (“PAS”) as a condition of approval under 21 CFR 814.82(a)(2).
As part of our PMA approval, we agreed with the FDA to conduct a PAS, with a goal to enroll approximately 320 patients such that 250 implanted patients will reach the 12-month follow-up for the primary endpoint.
Participants will be enrolled, implanted, and followed at one month, six months, and annually thereafter for the duration of the study through 5 years follow-up.
The primary endpoint is to evaluate the safety of the WiSE CRT System by assessing the rate of device- or procedure- related serious adverse events.
The study will also measure: (i) procedural success; (ii) CRT response assessment; (iii) Heart Failure Clinical Composite Score; (iv) New York Heart Association Functional Classification; (v) QRS duration; (vi) 6-minute walk test; (vii) events assessment; (viii) mortality; (ix) Patient Global Assessment; and (x) device longevity and battery performance.
We are required to submit an interim PMA PAS Report every six months until subject enrollment has been completed, and annually thereafter, from the date of the PMA approval.
In the fourth quarter of 2025, we enrolled four patients in the post-approval study, known as WiSE System Utilization and Performance Registry (“WiSE-UP’).
The first three procedures were performed in November 2025 at St.
Bernards heart and Vascular Center by globally respected electrophysiologist Dr.
In December 2025, one additional patient was successfully enrolled by Dr.
Dinesh Sharma, at Naples Comprehensive Health (NCH).
Reimbursement The process for determining whether a payor will provide coverage for a product is typically separate from the process for setting the reimbursement rate that the payor will pay for the product.
A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be available.
Some products may not be reimbursed separately but their cost may instead be bundled as part of the payment received by the provider for the procedure only.
Separate reimbursement for the product itself or the treatment or procedure in which a product is used may not be available.
Commercial third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies but also have their own methods and approval process apart from Medicare coverage and reimbursement determinations.
As such, one third-party payor’s determination to provide coverage for a product does not ensure that other payors will also provide coverage for the product.
As a result of its breakthrough device designation, our WiSE CRT technology is eligible for incremental payment coverage in the U.S. for up to three years following FDA approval.
The Centers for Medicare & Medicaid Services (“CMS”) approved of the New Technology Add-On Payment (“NTAP”) for WiSE.
The program commenced on October 1, 2025.
The NTAP is designed to bridge the financial gap between the costs of innovative technologies and the standard Medicare severity Diagnosis Related Groups (“MS-DRG” or “DRG”) payment structure in place, while encouraging early adoption of the breakthrough medical advancements used in the inpatient setting for Medicare patients.

and 224 more.

Gone since FY2024

Business Overview EBR Systems, Inc., a Delaware corporation incorporated in 2003, is a U.S. based medical device company that is developing the WiSE CRT System, an implantable cardiac pacing system able to provide stimulation to endocardial heart tissue for the correction of heart rhythm conditions without requiring the use of wires or leads.
This implantable, investigational device delivers left-ventricle endocardial pacing for cardiac resynchronization therapy (“CRT”), without the use of wires or leads going into the heart.
An investigational device is one that has not been cleared or approved for commercial use by the U.S.
Food and Drug Administration (the “FDA”).
The left ventricle (“LV”) is a chamber of the heart responsible for pumping blood through the aorta to the rest of the body, such that ‘left-ventricle endocardial’ pacing refers to electrical pacing delivered inside the left ventricle of the heart.
Conventional cardiac rhythm management (“CRM”) systems use leads to conduct electricity from an implantable pulse generator (“IPG”) to electrodes that deliver therapeutic electric pulses to heart tissue.
Our leadless system is designed to address this shortcoming.
Our proprietary WiSE CRT technology is engineered to benefit patients who have not seen success with conventional CRT or face high complication risks.
Conventional CRT has limitations related to the need for lead placement and complication risks of occlusion, infection or concurrent illness.
If approved by the FDA, our system would allow clinicians to provide CRT for patients where a LV lead has failed or is deemed high-risk by their doctor.
A patient in whom standard CRT upgrade is not advisable due to known relative contraindication to coronary sinus (“CS”) lead implant would be deemed high-risk by their doctor.
The initial focus of our WiSE CRT technology is to serve as an adjunct to existing implanted cardiac devices, providing CRT to those for whom traditional methods have failed or are not viable.
In support of capturing this opportunity, WiSE CRT has been granted a Breakthrough Device Designation (“BDD”) by the FDA, which provides us with greater access to the FDA during the premarket review phase, a prioritized review process, and potentially up to three years of favorable reimbursement coverage in the U.S. following such approval.
We completed a pivotal clinical study, SOLVE-CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) and submitted the final module of our modular pre-market approval (“PMA”) submission on August 28, 2024.
For a more comprehensive discussion of the SOLVE-CRT study, see “SOLVE-CRT Clinical Trial” below.
Products The WiSE CRT System, the Company’s only product candidate, is an implantable cardiac pacing system capable of delivering pacing level energy to the heart without using a lead/ wire.
The technology used to achieve this leadless pacing is based on converting ultrasound energy to electrical energy.
Components of the WiSE CRT System include the Delivery Sheath and Electrode Catheter which delivers the Electrode, the Pulse Generator (Transmitter and Battery), and the Programmer ( Figure 1.1 ).
Figure 1.1 How WiSE CRT System Provides Leadless Cardiac Pacing SOLVE-CRT Clinical Trial The SOLVE-CRT investigational device exemption (“IDE”) study is a prospective, multicenter trial consisting of an initial randomized, double-blind part and a subsequent single-arm part.
All versions of the study protocol were approved by relevant institutional review boards and the FDA under an IDE application.
All patients provided written informed consent.
We are seeking to demonstrate with the SOLVE-CRT study that leadless left ventricular endocardial pacing (“LVEP”) with the novel WiSE CRT System is feasible, safe, and effective for delivering CRT in patients with advanced HF.
Clinical Conclusion Subject to the review and determination by the FDA, we believe the performance and safety of the WiSE CRT System is supported by results of the SOLVE-CRT pivotal clinical trial, and peer-reviewed clinical literature.
The System has a high implant success rate and delivers significant benefit to moderate to severe HF patients, including improved clinical and functional status and reverse remodeling.
Further, complication rates observed with the WiSE CRT System are similar to those observed with other approaches to delivering CRT.
The risks associated with the use of the System are acceptable when weighed against the potential benefits to the indicated patient populations.
This is of particular importance as the patient populations treated in the EBR-sponsored studies have failed or not responded to conventional CRT and have a poor prognosis.
Providing clinical benefit to these high-risk patients shows that the WiSE CRT System can meet the identified unmet clinical need for novel approaches to delivering CRT for the treatment of HF.
Further, we believe the design strategy for the WiSE CRT System results in a leadless device that is 95% smaller by volume compared to commercially available leadless pacemakers, such as Medtronic’s Micra or Abbott’s Aveir.
Consequently, subject to approval by the FDA, we believe WiSE CRT will be the only therapy demonstrated in clinical study that can deliver LVEP and potentially broaden the spectrum of patients who could benefit from CRT.
Status of the FDA Review We submitted the final module of our PMA submission on August 28, 2024.
Under standard review, the FDA has 180 days to review the PMA.
In January 2025, the FDA completed the manufacturing site Pre-Approval Inspection (“PAI”) with no Form FDA 483 observations.
Thus, subject to FDA review and approval, and pre-commercial activities described under “Markets and Distribution” below, we expect to commercially launch the WiSE CRT System in the U.S. in 2025.
Markets and Distribution If approved by the FDA and other regulatory authorities, we intend to commercially launch WiSE with the focus on driving adoption of WiSE at key, high-volume, luminary sites within the U.S. to be followed by select, high-volume sites in markets outside the U.S.
Strategy We plan to implement a phased Limited Market Release (“LMR”), with the following phases: LMR Phase 1: Initial Target Accounts · Launch in target accounts from the SOLVE-CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) pivotal trial. · Leverage existing relationships with trial sites to streamline patient identification and device implantation.
LMR Phase 2: Expansion and Optimization · Strategically expand our field team to broaden our market presence into additional high-volume sites. · Focus on optimizing the customer training programs and enhancing EBR's business operations.
LMR Phase 3: Increase Implants Per Site · The field team will focus on increasing the number of cases per month per site by improving hospital implant workflows and familiarity with the technology.
Full Market Release · Expand market presence and maximize product adoption. · Utilize refined business operations and continue scaling the field team. · Focus on expanding into additional sites, leveraging the experience and efficiency gained from the LMR.
If approved, we anticipate our average selling price (“ASP”) in the U.S. will be approximately $45,000 per WiSE CRT system.

and 336 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch EBRCZ. Know when insiders buy.

One email the day a filing lands. Free.