Company Description

Encore Medical is a structural heart device company dedicated to the transcatheter closure of certain cardiac defects. The Company, though founded in 2017, builds on over two decades of experience, including more than 35,000 successful transcatheter defect closure implants, providing a significant foundation of expertise and clinical confidence. We offer closure devices that include features such as multi-element frame construction that adapts to varied anatomies, high closure rates, low arrhythmia incidence, and anatomical adaptability. Our delivery system enhances procedural control and safety, enabling retrievability and intuitive deployment. We develop, manufacture, and market septal occlusion products, which are small, implantable devices delivered through a catheter inserted into a major blood vessel to permanently repair certain cardiac defects. Our devices include patented technology that has been in use extensively outside of the U.S. Procedures are performed in a cardiac catheterization lab and reduce the need for open heart surgery or a lifetime of drug therapy, which are currently the primary alternative methods for treating these defects. We have developed devices capable of providing effective, nonsurgical methods of correcting a variety of cardiac defects in both adults and children. We have obtained CE Mark approval for our products, which is a prerequisite for the general sale of medical devices in the European Union (the “EU”) and are currently marketing and selling our septal occlusion devices for the closure of certain cardiac defects through distribution partners in countries outside of the United States. Our primary closure device is designed to repair a cardiac defect known as a patent foramen ovale (“PFO”). PFO is an abnormal passage or flap-like hole between the atrial chambers of the heart that can enable embolic material (clots) to travel from the right to left chambers and potentially cause a stroke. PFO is generally detected during adulthood. An estimated 25% of the population has a PFO, yet most people have no adverse effects and are unaware that they have a PFO. However, 50% of patients who suffer a cryptogenic (from an unknown cause) stroke also have a PFO. In the U.S., this represents approximately 139,000 patients annually, and at an assumed average sales price of $11,000 for each of our products, the potential annual market for our PFO products for stroke prevention may exceed $1.5 billion. Previous clinical experiences indicate that in patients with migraine headaches and a PFO, closure of the PFO may eliminate or greatly reduce the occurrence of migraines. According to the Association of Migraine Disorders (Migrainedisorders.org), 13,000,000 people in the United States who have a PFO suffer from migraine headaches. We believe we have a superior closure device for treating PFO defects. Our device features ease of deployment, low metal mass, low profile, conformity to the septal wall, accessibility upon reintervention, and a low incidence of post-implant arrythmia. Our PFO closure device addresses both the stroke and migraine markets. We also currently market and sell septal occlusion devices for the transcatheter closure of atrial septal defects (“ASD”). The ASD defect is generally described as a hole in the atrial septum that divides the right and left atria and is primarily a pediatric defect. The ASD market is a small market and is not a primary focus of our activities. To date, our septal occlusion devices have been implanted in approximately 35,000 patients, all of whom reside in countries outside the United States, primarily for the purpose of treating PFO. We currently do not have regulatory approval to sell our products in the United States, but the FDA has granted us an Investigational Device Exemption (IDE) approval to conduct our clinical trial to obtain market clearance for our PFO septal occlusion device for stroke. Such FDA approval, if obtained, would enable us to market our products throughout the United States. Our FDA trial is currently underway and we estimate it will take approximately two years to complete. If we successfully complete this clinical trial, we would be required to submit an FDA PMA application for final FDA approval to begin marketing in the United States. There can be no assurance that we will not experience delays in this process or that the FDA will ultimately find our submission satisfactory. Even if we satisfactorily complete our clinical trial, there can be no assurance that the trial will yield sufficient results and data to allow commercial sales to be made in the United States Our sales and marketing focus has been on the European market and other countries where we maintain the CE Mark and other certifications necessary to market our products. We market our products through a network of 11 international distributors to many countries, including Germany, the Czech Republic, Italy, Portugal, Spain, France, Switzerland, Austria, Lithuania, Hungary, Turkey, Mexico, and various countries in Central and South America. We are also adding independent distributors in countries in Central Asia, Central and South America. In the United States, the Company intends to develop and utilize a direct sales and marketing team, once our PFO device is approved for sale. We are currently using cash flow from the sale of our products outside of the U.S. to help support our daily operations and have commenced this offering primarily to finance our U.S. clinical trials for the stroke and migraine indications. Key Features of Our Devices • Two Decades of Proven Design Encore is built on over 20 years of experience and 35,000+ global implantations using the same core technology platform, resulting in a device informed by extensive real-world use. • Ease of Implantability & Full Retrievability Encore devices are engineered for smooth deployment, and are able to be fully retrieved or repositioned before final release if placement is not ideal. • Effective Defect Closure & Tissue Preservation Encore devices provide high closure rates with minimal residual shunting. They have low metallic surface area, which helps minimize thrombosis risk. The device also includes soft radiopaque discs that conform well to atrial anatomy, minimizing stress on tissue and preserving future trans-septal access to the left atrium. • Low Disturbance & Minimal Arrhythmias Encore devices were designed to minimize disruption to normal blood flow and reduce force exerted on atrial walls, potentially resulting in a lower incidence of post-implant arrhythmias compared to competing devices. • Anatomical Conformance & Self-Centering Design The flexible, multi-element frame of Encore devices adapts in multiple dimensions to patient anatomy. The Company’s ASD device is self-centering for optimal alignment, improving fit and reducing complications related to malpositioning. • Delivery System Optimized for Safety and Control Encore’s delivery system features J-shaped sheaths, radiopaque tips, a positive locking mechanism, and hemostasis introducers — tools carefully tailored to ease device deployment and enhance procedural control. --- Encore Medical, Inc. was incorporated as a Minnesota corporation on September 26, 2017. Our corporate offices are located at 2975 Lone Oak Drive, Suite 140, Eagan, Minnesota 55121, and our telephone number is 651-797-0913. Our website address is https://www.encore-medical.com.