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(Incorporated in Minnesota)
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 percent 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. See “Business — Government Regulation” and “Risk Factors — Risks related to Regulation.”
Our FDA trial is currently under way 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. See “Risk Factors.”
Note: Net loss and revenue are for the 12 months that ended Sept. 30, 2025.
(Note: Encore Medical Inc. is offering 3 million shares at an assumed IPO price of $5.00 to raise $15 million in its IPO, according to its SEC filings. This is an NYSE-American Exchange listing.)
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