AtriCure Stock

AtriCure, Inc. (AtriCure) operates as an innovator in treatments for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management.

The company’s cardiac ablation and left atrial appendage management (LAAM) products are used by physicians during open-heart and minimally invasive surgical procedures. In open-heart procedures, the physician is performing heart surgery for other conditions, such as a mitral valve repair or a coronary artery bypass; and the company’s products are used in conjunction with (‘concomitant’ to) such a procedure. Minimally invasive procedures are performed on a standalone basis, and often include multi-disciplinary or ‘hybrid’ approaches, combining surgical procedures using AtriCure ablation and AtriCure LAAM products with catheter ablation performed by an electrophysiologist.

The company’s pain management solutions are used by physicians to freeze nerves during cardiothoracic or thoracic surgical procedures. Recovery from cardiothoracic and thoracic surgery can be complicated and painful. Many surgeons use multi-modal pain management strategies that include oral delivery of opioid and non-opioid pain medications. The company’s cryoICE cryoSPHERE probe for pain management (Cryo Nerve Block) provides temporary relief of post-operative pain, allowing the patient's body to heal after surgery while the nerves regenerate and sensation is regained.

The company sells its products to medical centers through its direct sales force in the United States, Germany, France, the United Kingdom, the Benelux region, Canada, and Australia. The company also sells its products through distributors who in turn sell its products to medical centers in other international markets. The company’s business is primarily transacted in the U.S. Dollars; and direct sales transactions outside the United States are transacted in Euros, British Pounds, Canadian Dollars or Australian Dollars. The company depends on independent third-party distributors to sell its products in certain markets outside of the United States.

AtriCure Solutions and Products

The company is the market leader in the surgical treatment of Afib and left atrial appendage management, and pioneers of the application of Cryo Nerve Block in thoracic procedures. The company anticipates that substantially all its revenue for the foreseeable future will relate to products the company sells or is in the process of developing. The company’s products enable cardiothoracic surgeons to perform surgical ablation procedures with faster, less invasive and less technically challenging approaches. The company has completed, and continues to invest in, clinical studies for the use of the company’s ablation and LAAM products to treat Afib and reduce stroke. Leading cardiothoracic surgeons and electrophysiologists, including those who serve or who have served as consultants to the company, have published results of preclinical and clinical studies utilizing the company’s devices. The results of these studies have assessed efficacy, ease of use and safety endpoints.

Products for cardiac tissue ablation include those that create scar tissue using radio frequency (RF) energy or cryothermic modalities. The company’s ablation products are part of platforms each consisting of disposable hand pieces which connect to either a RF generator or a cryothermic generator. The company generally place this capital equipment with the company’s direct customers and sell to the company’s distributors.

Products for open and minimally invasive ablation:

Isolator Synergy Clamps: The company’s Isolator Synergy Ablation System clamps are single-use disposable RF products with jaws that close in a parallel fashion. The company sells multiple configurations of its Isolator Synergy clamps. The various configurations provide the user with options to address patient specific procedure requirements or anatomy; however, all the clamps provide consistent performance using the same core technology. The parallel closure evenly compresses tissue and evacuates the blood and fluids from the energy pathway to make the ablation more effective. The Isolator Synergy Ablation System has been studied in multiple FDA approved clinical trials, including the previously completed ABLATE clinical trial which supported a pre-market approval (PMA) in 2011, as well as the ongoing DEEP AF IDE and HEAL-IST clinical trials.

The company’s Isolator Synergy Ablation System includes multiple configurations approved by the United States Food and Drug Administration (FDA) for the treatment of persistent and long-standing persistent Afib concomitant to other open-heart surgical procedures. Certain products of the company’s Isolator Synergy clamps bear the CE mark and may be commercially distributed throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive. These products are available for sale in a number of other countries globally.

In April 2022, the company launched its most recent configuration, the ENCOMPASS clamp, following 510(k) clearance in July 2021. The ENCOMPASS clamp is indicated for cardiac soft tissue ablation. The configuration is designed to make concomitant surgical ablations more efficient and is expected to drive deeper penetration of cardiac surgery procedures.

Multifunctional Pens and Linear Ablation Devices: These devices are single-use disposable RF products that come in multiple configurations. The MAX Pen devices enable surgeons to evaluate cardiac arrhythmias, perform temporary cardiac pacing, sensing and stimulation and ablate cardiac tissue with the same device. Surgeons can readily toggle back and forth between these functions. The device comes in multiple configurations that have unique tissue contacting and shaft lengths. The Coolrail device enables the user to make longer linear lines of ablation. Surgeons generally use one or more of the company’s pen and linear devices in combination with Isolator Synergy clamps.

All the company’s pen and linear ablation devices are cleared for sale in the United States under FDA 510(k) clearances, with indications for the ablation of cardiac tissue and/or the treatment of cardiac arrhythmias. The company’s Isolator Synergy pens bear the CE mark, and most configurations may be commercially distributed throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive. These products are available for sale in a number of other countries globally.

Products for open ablation:

cryoICE Cryoablation System: The cryoICE cryoablation system is used in both open ablation procedures and cryoanalgesia. The system consists of the cryoICE BOX generator along with a variety of single-use disposable probes. The primary differences between these cryoablation probes are the form of the tissue-contacting distal end. The cryoICE devices enable the user to make linear ablations of varied lengths. Surgeons may utilize the cryoICE devices in combination with Isolator Synergy clamps or independently.

The company’s cryoablation devices are cleared for sale in the United States under FDA 510(k) clearances, bear the CE mark for commercial distribution throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive. These products are available for sale in a number of other countries globally.

The ICE-AFIB clinical trial is studying the safety and efficacy of the cryoICE system for persistent and long-standing persistent Afib treatment during concomitant on-pump cardiac surgery.

Products for minimally invasive ablation:

EPi-Sense Systems. The EPi-Sense Guided Coagulation System with VisiTrax technology and the new EPi-Sense ST Guided Coagulation System utilize monopolar RF energy for the coagulation of tissue. The company’s EPi-Sense devices are single-use disposable ablation devices capable of intraoperative cardiac signal sensing and recording when connected to an external recording device.

The company’s EPi-Sense System was studied through the CONVERGE clinical trial and was subsequently approved in 2021 by FDA for the treatment of patients with systemic, drug refractory, long-standing persistent Afib when augmented with an endocardial ablation catheter. The company’s EPi-Sense ST Guided Coagulation System was approved via PMA supplement in late 2022. Hybrid AF Therapy is the only FDA-approved minimally invasive procedure to treat patients with long-standing persistent Afib and represents a proven option for patients with advanced disease.

The EPi-Sense System bears the CE mark and is commercially distributed throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive. This system is available for sale in a number of other countries globally.

Products for pain management:

cryoSPHERE Probe: The cryoSPHERE probe is used to apply cryothermic energy to targeted intercostal peripheral nerves in the ribcage in order to provide temporary pain relief. This technique, called Cryo Nerve Block, is applied intraoperatively by cardiothoracic or thoracic surgeons and results in temporary pain relief for up to 90 days after the procedure. Sensation typically returns to the affected region of the chest after this period. Scientific data that has been published on the effects of Cryo Nerve Block has generally shown a significant reduction in prescription of opioids, significantly reduced length of stay for patients in the hospital and other benefits.

The cryoSPHERE probe is 510(k) cleared for managing pain by temporarily ablating peripheral nerves and bears the CE mark for commercial distribution throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive.

Products for appendage management:

AtriClip System: The AtriClip LAA Exclusion System includes various combinations of an implantable device (AtriClip) coupled to a single-use disposable applier. The AtriClip device is designed to exclude the left atrial appendage by mechanically clamping the appendage from the outside of the heart. The left atrial appendage has been shown to be a source of arrhythmias. The exclusion of the LAA eliminates blood flow between the left atrial appendage and the atrium while avoiding contact with circulating blood and provides electrical isolation benefits after placement. The AtriClip system is potentially safer, more effective and easier to use than other techniques for permanently excluding the left atrial appendage. The device comes in two geometries (a rectangular configuration which encircles the targeted tissue and ‘V’ shape which allows for an alternative lateral access) and a variety of lengths, which are matched to each patient's anatomy. The appliers come in multiple forms tailored to specific procedural needs depending on the type of surgery and how the surgeon is accessing the heart.

In the United States, the company’s AtriClip LAA Exclusion System products are 510(k)-cleared with an indication for the exclusion of the LAA, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon can see the heart directly, with or without assistance from a camera, endoscope or other appropriate viewing technologies. Certain products of the company’s AtriClip LAA Exclusion System bear the CE mark for commercial distribution throughout the member states of the European Union and other countries that comply with or mirror the Medical Device Directive. These products are available for sale in a number of other countries globally.

The AtriClip LAA Exclusion System is being evaluated under the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) IDE clinical trial.

The company sells additional products and enabling technologies that hold 510(k) approvals and/or bear the CE mark. The LARIAT System is a solution for soft-tissue closure that includes a suture loop coupled to a single-use disposable applier. The Lumitip dissector is used by surgeons to separate tissues to provide access to key anatomical structures that are targeted for ablation. Other enabling technologies include the company’s Glidepath guides for placement of its clamps, Subtle Cannula’s to support access for the company’s EPi-Sense catheters and a line of reusable cardiac surgery instruments.

Business Strategy

The company is passionately focused on healing the lives of patients affected by Afib and pain after surgery. The company’s strategy is to expand the treatment options for patients who suffer from Afib, have a high risk of stroke, or who suffer from post-operative pain, through the continued development of the company’s technologies and expansion of its product offerings, clinical science investments and global commercial expansion.

The key elements of the company’s strategy include new product and procedure innovation; investments in clinical science; building physician and societal relationships; providing training and education; and evaluating acquisition opportunities.

Research and Product Development

The company’s ongoing research and development activities support the company’s business strategy to expand treatment options and increase awareness in the company’s markets, as well as enabling expansion into adjacent markets. The company is engaged in developing and researching new and existing products or concepts, preclinical studies, clinical trials and other regulatory activities.

The company is conducting several clinical trials to validate the long-term results of procedures using the company’s products and to support applications to regulatory agencies for expanded indications. In addition, the company conducts various studies to gather clinical data regarding the company’s products. Key trials and studies are:

LeAAPS. In April 2022, FDA approved the protocol for the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) IDE clinical trial. The trial is designed to evaluate the effectiveness of prophylactic LAA exclusion using the AtriClip LAA Exclusion System for the prevention of ischemic stroke or systemic arterial embolism in cardiac surgery patients without pre-operative AF diagnosis who are at risk for these events. This prospective, multicenter, randomized trial evaluates safety at 30 days post-procedure to demonstrate no increased risk with LAA exclusion during cardiac surgery and effectiveness with a minimum follow-up of five years post procedure for all subjects. The trial provides for enrollment of up to 6,500 subjects at up to 250 sites worldwide. In January 2023, the company enrolled its first patient; site initiation and enrollment is ongoing.

HEAL-IST. In February 2022, FDA approved the protocol for the Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (IST) clinical trial (HEAL-IST). The HEAL-IST clinical trial is designed to study the safety and efficacy of a hybrid sinus node sparing ablation procedure using the Isolator Synergy Surgical Ablation System for the treatment of symptomatic, drug refractory or drug intolerant IST. The trial is a prospective, multicenter, single arm trial that evaluates safety 30 days post-procedure and evaluates primary effectiveness of freedom from IST (as specified) at 12 months post-procedure. The trial provides for enrollment of up to 142 patients at up to 40 sites in the United States, the United Kingdom and European Union. The first patient enrollment in the trial occurred in June 2022; site initiation and enrollment is ongoing.

CONVERGE. The CONVERGE IDE clinical trial proved the safety and efficacy of the EPi-Sense System to treat symptomatic persistent and long-standing persistent Afib patients who are refractory or intolerant to at least one Class I and/or III anti-arrhythmic drug. In April 2021, the company announced the PMA approval of the EPi-Sense System for the treatment of symptomatic, drug-refractory, long-standing persistent atrial fibrillation, when augmented with an endocardial ablation catheter. The Convergent procedure, or Hybrid AF therapy, provides the only compelling treatment option for a large and vastly underpenetrated population of Afib patients. The CONVERGE trial demonstrated superiority in the hybrid therapy arm compared to endocardial catheter ablation alone. In patients diagnosed with long-standing persistent Afib, the therapy arm showed a 29% absolute difference in efficacy at 12 months (78% relative improvement) and an absolute difference of 35% at 18 months (110% relative improvement). There was also a 33% absolute difference in Afib burden reduction in favor of the Hybrid AF therapy at 12 months, which increased to 37% at 18 months. In April 2021, the company also received approval from FDA to conduct the CONVERGE Post Approval Study (PAS). This study allows for 325 patients to be enrolled at up to 50 sites. The first patient enrollment in the trial occurred in June 2022; site initiation and enrollment is ongoing.

The company has invested in other clinical trials to validate the long-term results of procedures using the company’s products and to support applications to regulatory agencies for expanded indications. The ICE-AFIB clinical trial is designed to study the safety and efficacy of the cryoICE system for persistent and long-standing persistent Afib treatment during concomitant on-pump cardiac surgery. The trial provides for enrollment of up to 150 patients at up to 20 sites in the United States, which was completed in May 2023. Patient follow-up for twelve months post ablation required by the study protocol remains ongoing. During the second quarter of 2023, results from the company’s CEASE-AF trial were presented at the European Heart Rhythm Association meeting and subsequently published in July 2023. CEASE-AF is a prospective, multi-center randomized control trial that demonstrated superior freedom from atrial arrhythmias for staged hybrid ablation compared to endocardial catheter ablation. During the fourth quarter of 2023, the 12-month follow-up results of enrolled patients from the DEEP AF Pivotal study were presented at the American Heart Association meeting. The DEEP AF IDE pivotal trial evaluated the safety and efficacy of the AtriCure Bipolar System when used in a staged approach where a minimally invasive surgical ablation procedure is first performed. The patient undergoes the endocardial catheter procedure approximately 91-120 days later. The results from this single arm study demonstrated superior freedom from atrial arrhythmias for staged hybrid ablation compared to a pre-specified performance goal. The company is in the process of analyzing additional trial data for publication, future development activities, or possible evaluation of label expansions.

Sales, Marketing and Medical Education

The company’s global sales and marketing efforts focus on educating physicians about its unique technologies and their clinical benefits. The company only promotes its products for uses described in their labeling as cleared or approved by relevant regulatory agencies, and train the company’s sales force on the use of its products to the extent the products are cleared or approved.

The company markets and sells its products in selected countries outside of the United States through a combination of independent distributors and direct sales personnel. The company’s international sales team includes approximately 60 employees focused on the company’s direct markets, such as Germany, France, the United Kingdom, the Benelux region, Canada and Australia. The company also maintains a network of distributors who market and sell its products in Asia and South America, as well as certain countries in Europe. The company continues to evaluate opportunities for further expansion into markets outside of the United States.

Competition

The company’s primary competitor in the cardiac surgery market is Medtronic, plc.

Government Regulation

The company’s products are medical devices and are subject to regulation in the United States by FDA and other federal agencies, and by comparable authorities in the European Union (EU) and other countries worldwide.

To obtain 510(k) clearance, the company must submit a notification to FDA demonstrating that the company’s proposed device is substantially equivalent to a predicate device, i.e., a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, for which FDA has not yet called for the submission of a PMA.

The company must conduct its clinical studies in compliance with state and federal privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). The company’s manufacturing facilities and processes are also subject to FDA inspections to ensure compliance with Quality System Regulations (QSR).

AtriCure is a member of the Advanced Medical Technology Association (AdvaMed), a voluntary United States trade association for medical device manufacturers. This association has established guidelines and protocols for medical device manufacturers in their relationships with healthcare professionals on matters, including research and development, product training and education, grants and charitable contributions, support of third-party educational conferences and consulting arrangements.

AtriCure is a member of MedTech Europe, a voluntary trade association for the medical technology industry, including diagnostics, medical devices and digital health. MedTech Europe and its members are committed to a high level of ethical business practices and have put in place strict guidelines to advise medical technology manufacturers on how to collaborate ethically with healthcare professionals (HCPs). These guidelines are set out in the MedTech Europe Code of Ethical Business Practice (MedTech Code), which regulates all aspects of the industry's relationships with HCPs and healthcare organizations (HCOs).

Consulting Relationships

The company has developed consulting relationships with scientists and physicians throughout the world to support the company’s research and development, clinical and training and education programs. The company works with these thought leaders to understand unmet needs and emerging applications for the treatment of Afib and other diseases and conditions.

Trademarks

The company owns or has the rights to use various trademarks, including Isolator Synergy clamp, EPi-Sense coagulation device, ENCOMPASS, AtriClip Flex·V, and cryoSPHERE probe, among others, and their respective logos.

Manufacturing

The company regularly audits its suppliers for compliance with its quality system requirements, the QSR and/or applicable International Organization of Standardization (ISO) standards. The company is an FDA-registered medical device manufacturer and certified to ISO 13485:2016. The company routinely conducts internal audits of its quality systems in accordance with various international standards. In addition, the company has successfully participated in the Medical Device Single Audit Program (MDSAP) and have been certified accordingly. The MDSAP program is recognized in Australia, Brazil, Canada, Japan, and the United States.

History

AtriCure, Inc. was founded in 2000. The company was incorporated in the state of Delaware in 2000.