Xinling Med Completes China's Longest-Ever pVAD Animal Trial, Submits IPO Prospectus

In mid-June 2022, China successfully conducted long-term animal trials of a percutaneous ventricular assist device (pVAD). Currently, the animal trial has been successfully completed with the pVAD being removed after 10 days of continuous operation (designed for 5 days), effectively verifying the safety, reliability, and efficacy of this pVAD product during prolonged operation in vivo. Meanwhile, all test results from this animal trial have met or even exceeded the expected goals.

(HearHill pVAD Operating in Animal)

This is the first publicly reported long-term animal trial of a percutaneous ventricular assist device (pVAD) in China, and the pVAD product used in this animal trial was independently developed by the Chinese innovative enterprise HearHill.。

Data shows that pVAD refers to a small blood pump that can be implanted into the ventricle through minimally invasive intervention, partially or fully replacing the heart's pumping function and maintaining the body's blood circulation. pVAD products can be applied to indications such as cardiogenic shock, high-risk PCI surgery protection, and heart failure, helping to improve the survival rate of patients in critical conditions.

The success of this animal trial not only means that the domestically produced original percutaneous ventricular assist device (pVAD) is one step closer to clinical application, but also signifies another advancement in China's high-end medical device innovation within the medical device industry.

According to the introduction, the indication for this animal trial of HearHill's pVAD product is cardiogenic shock. The animal trial is designed to last for 5 days, with the aim of verifying the safety, reliability, and effectiveness of the product during prolonged operation in living bodies.

HearHill stated: "In animal trials, trained animal surgeons completed the correct placement of pVAD from vascular access to crossing the aortic valve into the left ventricle in just 5 minutes. Post-surgery, the animals recovered well with stable vital signs and normal indicators. Subsequently, the pVAD product operated in the test animals for double the designed experimental duration (i.e., 10 days), providing support for observing various data metrics of pVAD in vivo, while also offering sufficient design margin for pVAD."

(HearHill pVAD Removal Process)

Test results show:First, the pVAD product begins working immediately after being placed in the target location within the animal's body, providing 4-5 liters of blood flow per minute, effectively reducing the heart's preload; Second, the pVAD product operated safely and effectively for 10 days within the animal, with excellent results in hemolysis testing.Third, this pVAD has a short learning curve and can be operated smoothly after simple training, greatly reducing the operation time.

It is reported that there are two main technical routes for pVAD products: one is the built-in motor route, and the other is the external motor route. The pVAD product used in this animal trial adopts the built-in motor technical route.

In principle, pVAD products adopting the built-in motor route have shorter transmission distances and less vibration. This results in such pVAD products causing less damage to the myocardium and heart valves, providing more stable fluid flow, generating fewer vortices, inflicting less damage on blood cells, and presenting a lower risk of hemolysis and tissue injury, making them more conducive to long-term stable operation within the body.

In fact, surgical heart pumps for diseases such as heart failure are already available in the Chinese market. However, these products are designed for surgical use, requiring open-chest placement, which involves significant trauma and demands high levels of surgical experience from doctors as well as advanced medical facilities. Currently, implantation surgeries for surgical heart pumps are only performed at top-tier tertiary hospitals in first-tier cities in China.

Compared with surgical heart pumps, pVAD products are placed through percutaneous puncture or vascular incision, resulting in less trauma, faster patient recovery, and a shorter learning curve for operators. For instance, the veterinarian performing this experimental surgery was able to conduct the procedure independently after receiving training in January 2022. In this surgery, the placement of the pVAD took only about 5 minutes, demonstrating simple and rapid operation.

It should be noted that the reason why pVAD products have the above advantages is because of their smaller size. Providing a blood flow of 4-5 liters per minute at a smaller size imposes extremely high requirements on the rotational speed of pVAD products, which needs to reach tens of thousands of revolutions per minute. Additionally, continuous operation in animal bodies for 10 days requires pVAD products to maintain hundreds of millions of stable rotations.

Hundreds of millions, billions, and even tens of billions of stable operations impose higher requirements on the wear of pVAD product components, electrode sealing, and other technologies. This is also one of the R&D challenges for percutaneous ventricular assist devices.

However, up to now, HearHill has successfully completed the independent research and development of core components for its pVAD product, achieving excellent results in this animal trial. During this animal experiment, the HearHill team and the Animal Testing Center gained valuable post-operative maintenance experience. The next step for HearHill will be to gradually challenge its pVAD product to operate safely and stably in living bodies for 15 days, 20 days, and 30 days.

The percutaneous ventricular assist device (pVAD) targets diseases with extremely high mortality rates and currently lacks effective clinical solutions. In addition to cardiogenic shock, the indications for HearHill’s pVAD also include high-risk PCI procedures and heart failure. Currently, HearHill's pVAD products for high-risk PCI, cardiogenic shock, and heart failure have all entered the type inspection stage, and the FIM study is expected to commence soon.

Currently, the annual number of PCI procedures in China exceeds 1.2 million, of which about 30% are high-risk PCI, meaning there are at least 380,000 high-risk PCI patients each year. Broadly speaking, high-risk PCI patients should be comprehensively evaluated based on the complexity of the lesion, hemodynamic and anatomical characteristics, as well as other comorbidities. This group should also include patients who cannot tolerate surgery, have undergone CABG, or refuse surgery.

High-risk PCI patients can significantly improve their quality of life and reduce the risk of cardiovascular events through revascularization. The reasonable selection of mechanical circulatory support devices is recommended by guidelines and expert consensus. Moreover, pVAD products can increase aortic pressure, enhance coronary perfusion, reduce myocardial oxygen consumption, alleviate the burden on the left ventricle, improve left ventricular function, and ultimately ensure the safe conduct of PCI procedures.

As another indication for pVAD, cardiogenic shock refers to a clinical syndrome caused by insufficient cardiac output due to heart pump failure, leading to tissue ischemia, hypoxia, and further systemic circulatory disorders. Its mortality rate is extremely high. Currently, there are over 300,000 patients with cardiogenic shock in China.

In the past, treatment options for cardiogenic shock included medication, mechanical ventilation, IABP (Intra-Aortic Balloon Pump), VA-ECMO (Venous-Arterial Extracorporeal Membrane Oxygenation), etc. However, neither medication nor mechanical ventilation offers a curative solution; the blood flow provided by IABP to the coronary arteries is limited, and it has recently been downgraded to a Class III recommendation by the European Society of Cardiology (ESC); ECMO, on the other hand, is complex to use, carries high surgical risks, and only a few hospitals in China use it as a cardiac pumping assist device.

Nowadays, pVAD, as a minimally invasive interventional product with small trauma and clinically effective results, has been recommended by consensus and guidelines in multiple countries or regions. For instance, the "2018 Chinese Expert Consensus on Diagnosis and Treatment of Cardiogenic Shock" indicates that for patients with hemodynamically unstable cardiogenic shock, consideration should be given to the prompt insertion of mechanical assist devices, and hospitals with appropriate conditions may consider the implantation of percutaneous left ventricular assist devices.

Besides, pVAD also targets heart failure, known as the last battlefield in the cardiovascular field. The latest "China Cardiovascular Health and Disease Report 2021" shows that there are 330 million existing cardiovascular disease patients in China, of which 8.9 million are heart failure patients.

Currently, the commonly used treatment for heart failure patients is surgical intervention, but it comes with high risks, significant trauma, and high medical costs. The pVAD product, on the other hand, is safe and easy to operate, unlikely to cause embolism or bleeding, and is expected to become a new weapon in treating heart failure, extending the lives of patients.

Overall, high-risk PCI, cardiogenic shock, and heart failure are all diseases that remain unresolved in clinical practice or present numerous challenges. The emergence of pVAD will offer a new option for these patients, potentially becoming their new hope. The success of this animal trial has brought these patients one step closer to that hope.