HVR Cardio Files Prospectus for IPO Following €10.7M Series B Funding to Advance Proprietary Helical Ring Technology for Mitral Regurgitation

According to the "Annual Report of China's Structural Heart Disease Industry 2020," an epidemiological study of the American community population showed that the overall prevalence of moderate or severe mitral regurgitation (MR) was 1.7%, four times that of aortic stenosis, and the prevalence rate increased with age. It is estimated that among the 4.1 million patients with mitral regurgitation in the United States, 1.67 million require surgical treatment, but only 2% (30,000 cases) underwent surgery. Forty-nine percent of patients with mitral regurgitation did not undergo surgery due to high-risk factors such as low cardiac function, multiple comorbidities, and old age, and another 49% did not visit the hospital or receive treatment. In the field of mitral regurgitation, there remains a significant unmet medical need.

The Mitral Valve: An Important Valve in the Heart

HVR Cardio is a cardiovascular device company founded in 2009, headquartered in Espoo, Finland. Its vision is to develop faster, easier-to-use, and less invasive mitral valve interventional treatment solutions without compromising clinical efficacy.

The company uses patented technology, minimally invasive surgery, and catheter-based therapies to extend the treatment of mitral valve disease to patients who cannot receive effective treatment due to old age or other illnesses. Based on its patented helical annuloplasty ring technology, HVR Cardio has developed its core product, MAR.^®and CathHELIX^®. They are surgical and transcatheter mitral valve repair devices, designed to address the effects of mitral regurgitation or valve leakage.

HVR Cardio's patented Helical Ring Technology can be applied to interventional cardiology treatments and cardiac surgeries, mimicking and adapting to the geometry of the mitral valve. The helical ring consists of two metal coils, one above and one below the mitral valve annulus, which can rotate from the posterior commissure (the area where the mitral valve leaflets connect on the annulus) to the target position. It achieves repair without damaging the mitral valve leaflets or chordae tendineae.

Compared with traditional annular implants, the helical ring of HVR Cardio can be rotated around the mitral annulus for adjustment, better fitting the shape of the mitral valve and contracting it to a normal size. The helical ring can maintain the natural movement and morphology of the mitral valve as much as possible, not only overcoming the drawbacks of traditional artificial annuloplasty rings or valves that mismatch with cardiac structures, affecting heart function and normal blood flow, but also improving the durability of mitral valve function.

Based on its helical loop technology, HVR Cardio has developed two mitral valve repair devices, namely CathHELIX.^®and MAR^®Depending on the severity of the patient's mitral regurgitation and the appropriate surgical method, they respectively target different patient groups and clinical needs to provide better treatment options and outcomes.

CathHELIX^®It is a transcatheter device that can enter the heart through a catheter from the femoral artery to reduce the enlarged mitral valve annulus. MAR^®HVR Cardio's new annuloplasty ring for cardiac valve repair can achieve the same effect by suturing the helical ring onto the mitral valve annulus through open-heart surgery.

Mitral regurgitation is divided into two types: primary and secondary. Among them, primary mitral regurgitation accounts for only a small portion, and the vast majority of patients have secondary mitral regurgitation.

Secondary mitral regurgitation is caused by diseases in the heart itself or the supporting structures of the valve, with mitral insufficiency due to left ventricular enlargement or deformation being a typical case. In this scenario, the patient's heart bears the dual burden of blood backflow from incomplete mitral valve closure and impaired cardiac function resulting from left ventricular deformation. Therefore, they require a treatment method that can simultaneously address both mitral valve and left ventricular pathologies. This approach should not only facilitate normal mitral valve opening and closing but also halt or even reverse the cardiac remodeling process where the left ventricle becomes deformed and weakened due to excessive load.

As for MAR^®is expected to meet this huge clinical demand. Compared with traditional annuloplasty rings, MAR^®Not only can it achieve fast and easy implantation, but it also enables reverse remodeling of the left ventricle. By reducing the diameter of the mitral valve annulus and alleviating the severity of mitral regurgitation, MAR® can decrease the load on the left ventricle and promote uniform distribution of stress on the left ventricular wall. This effectively prevents left ventricular dilation and functional deterioration while promoting the recovery of left ventricular systolic function and improving hemodynamics.

When using MAR^®During mitral valve surgery, the helical ring is delivered to the target position through minimally invasive or open-chest surgery. Next, the clinician sutures the helical ring onto the mitral valve annulus and contracts it to the appropriate size, finally securing the ring with sutures. In MAR^®During the implantation process, "anatomical guidance" can reduce friction between the catheter and the vessel wall, avoid damage to the vascular endothelium or structures around the mitral valve annulus, and will not alter the shape or size of the vessel. Therefore, it does not limit the patient's future options for transcatheter treatments.

MAR^®Applicable to patients who require surgical mitral valve repair. Generally, these patients suffer from moderate to severe mitral regurgitation along with symptoms such as heart failure or arrhythmia. It is also suitable for patients with mild mitral regurgitation but in need of other types of cardiac surgery. MAR^®The implantation surgery can be performed simultaneously with other types of cardiac surgeries, such as coronary artery bypass surgery or aortic valve replacement surgery, to address multiple cardiac issues in patients.

Currently, the statistical analysis of the HVR Cardio proof-of-concept study has been completed. The analysis results indicate that through MAR^®After mitral valve repair, the cardiac condition of all patients improved. At the end of a two-year follow-up, the hearts of the patients in the study group remained in good condition, fully demonstrating the effectiveness of MAR.^®Good long-term tolerance.

Currently, the traditional therapies for mitral regurgitation mainly include medication, surgical procedures, and transcatheter interventions. Among these, medication primarily aims to alleviate symptoms and prevent complications, but it cannot achieve a "cure."

Surgical repair or replacement of the damaged mitral valve can be performed, but it requires open-heart surgery under cardiopulmonary bypass. For most patients, this is a high-risk treatment option.

On the one hand, undergoing open-heart surgery means that the patient needs to have their chest opened. This type of surgery carries high risks, requires general anesthesia, takes a long time, and may lead to serious complications such as bleeding, infection, stroke, and kidney failure. On the other hand, most patients with mitral valve disease are elderly and often suffer from other conditions like coronary heart disease and hypertension, which further increases the risks and complexity of the surgery. Moreover, patients who undergo surgical treatment may need to take anticoagulant medications for life to prevent vascular embolism, and some may also require regular replacement of biological valves.

In contrast, transcatheter intervention may be a better option. CathHELIX^®The fact that it stands out also proves this point.

CathHELIX^®It is a catheter-based mitral valve repair system suitable for the vast majority of patients who are unable to undergo surgical procedures due to high-risk factors such as low heart function, multiple comorbidities, and advanced age. It provides a safer and less invasive cardiac intervention therapy for patients with mitral regurgitation. Meanwhile, CathHELIX^®Still retains the clinical efficacy of surgical mitral valve repair, which is the current gold standard for treating mitral valve disease.

CathHELIX^®Can enter the heart through the femoral vein and place the helical ring on the mitral valve annulus under transesophageal echocardiography (TEE) guidance. TEE can scan and examine from behind the heart, without interference from the chest wall structure and intrapulmonary gas. At the same time, TEE can monitor CathHELIX in real time.^®The placement and orientation, guide its proper deployment, and promptly identify other complications, such as paravalvular leakage, aortic dissection, and coronary artery obstruction.

During the specific treatment process, a constrictor catheter is first introduced into the coronary sinus through femoral vein puncture. The constrictor catheter can release an adjustable balloon within the coronary sinus, which temporarily reduces the size of the mitral valve annulus by applying pressure, creating space for subsequent steps. Then, a helical ring is advanced along the catheter to the posterior side of the mitral valve annulus, where the helical ring is released and self-anchored. Finally, the position and effect of the helical ring are checked using X-ray and ultrasound, and further adjustments can be made based on actual conditions.

CathHELIX^®The advantage is that it can be performed without damaging the native mitral valve, avoiding complications such as leaflet detachment or blood flow obstruction that may result from edge-to-edge techniques. Additionally, it can mimic annuloplasty techniques used in surgical procedures to restore the normal shape and function of the mitral valve annulus.

On January 11, 2023, HVR Cardio announced the completion of a €10.7 million Series B financing round. The round was led by Innovestor and Tesi (Suomen Teollisuussijoitus), marking one of the largest financing rounds in this field in Finland. The proceeds will be used to further advance CathHELIX.^®Clinical trials and expand its team.

In this round of financing, the company also announced the appointment of new directors. Tom Fleming, who has served as the CEO of HVR Cardio, has more than 20 years of experience working with world-leading cardiac surgery equipment manufacturers such as Boston Scientific and over 30 years of experience in the medical device field. Dr. Tim Girton was appointed as the Chief Technology Officer, bringing 24 years of experience at Boston Scientific, where he served as the technical leader for large global projects and as Vice President of R&D.

HVR Cardio has a strong intellectual property portfolio, with its CathHELIX^®、MAR^®And the helical ring technology has been protected by more than 50 applied patent families. Currently, MAR^®The safety and effectiveness of the helical loop technology have been studied and verified in clinical trials involving 11 patients. CathHELIX^®A 90-day study was also conducted in an animal model of mitral regurgitation, demonstrating excellent efficacy and safety results.

CathHELIX^®It has obtained FDA Breakthrough Device Designation and is currently in the late preclinical trial stage, with the potential to become the first transcatheter mitral valve repair device. Next, HVR Cardio will focus on advancing CathHELIX.^®The First Human Trial and MAR^®Market approval, and explore the potential application of its helical ring technology in other areas of heart valve disease.