Kosel Medical Files IPO Prospectus: Pioneering Domestic Umbrella IVC Filter and Platform Strategy in Vascular Intervention

Seven years of R&D broke the domestic空白 for umbrella-shaped vena cava filters; nine years of积累, with a product line covering peripheral intervention, coronary intervention, and cardiac electrophysiology. Every step Kossel Medtech takes is in line with the company's long-term development strategy, not only entering the market with individual niche products but also providing systematic solutions.

Since its establishment in 2013, Kossel's Octoparms®️ vena cava filter has obtained registration through the National Medical Products Administration’s innovation channel and successfully commercialized. It won the bid as the top candidate in Group A during the high-value medical consumables bulk procurement by the Shanxi-Hebei-Shandong-Henan Alliance. Meanwhile, Kossel's coronary balloon products have been awarded bids in the bulk procurement across 22 provinces (autonomous regions and municipalities) in China, and have gained global certification, entering mainstream markets such as Japan, South Korea, and Europe.

In 2014, Kossel Medtech officially launched the research and development of the umbrella-shaped vena cava filter. After 7 years, the Octoparms®️ Vena Cava Filter was approved for marketing by the National Medical Products Administration in 2021.

Caval vein filters are used to capture detached thrombi in the venous system, preventing fatal pulmonary embolism (PE). Pulmonary embolism is insidious in onset and lacks specific symptoms, making it prone to misdiagnosis or missed diagnosis in clinical practice. It is the third leading cause of cardiovascular death after coronary heart disease and stroke, highlighting the critical importance of early screening, prevention, and treatment.

Deep Vein Thrombosis (DVT) and Pulmonary Embolism are collectively referred to as Venous Thromboembolism (VTE). Most pulmonary embolisms are caused by the detachment of deep vein thrombosis in the legs, so clinically, vena cava filters are often placed to treat deep vein thrombosis and thus prevent pulmonary embolism.

Caval Filters Can Be Divided into Umbrella-shaped Filters and Spindle-shaped Filters. Umbrella-shaped filters have a longer retrieval period but are prone to tilting, displacement, and perforation within the body. Spindle-shaped filters, on the other hand, have a shorter retrieval period, typically around 14 days, but are less likely to tilt or become displaced.

The ideal vena cava filter should not only safely and effectively intercept thrombi but also have a longer retrieval period. According to the recommendation of the U.S. FDA, considering the patient's risk/benefit situation, the optimal retrieval window for vena cava filters is 29 to 54 days after placement.

Some retrievable caval filters miss the retrieval window, and forced retrieval may cause damage to human blood vessels. However, if left in the body for a long time, patients still need anticoagulation therapy and face risks of complications such as filter fracture or thrombosis. Therefore, proper postoperative management of the filter is the primary clinical task. The most direct advantage of umbrella-shaped caval filters is their extended retrieval window, offering more options for clinical practice, enabling timely retrieval when necessary, and improving filter retrieval rates.

Octoparms®️ Umbrella-shaped Vena Cava Filter consists of a filter and a delivery system. The filter is composed of balancing arms and support rods, manufactured from a nickel-titanium alloy tube through complex and precise processes such as laser cutting, heat treatment shaping, sandblasting, and electrochemical polishing. The delivery system comprises a delivery sheath, introducer, and pusher rod. The filter is preloaded within the introducer, which is marked with "jugular," "femoral" labels and arrows, allowing the filter to be inserted via the jugular or femoral vein, providing doctors with flexibility to choose and operate based on clinical needs.

Octoparms®️ Vena Cava Filter not only effectively intercepts thrombi but also features a long retrieval period of 3 months with minimal vascular damage. The delivery system of the Octoparms®️ Vena Cava Filter is designed with an Over-The-Wire (OTW) system, enabling precise deployment without jumping or tilting when accessed via the femoral or jugular route. High stability during filter placement ensures a high success rate for subsequent retrieval.

Currently, China is promoting the construction of VTE Prevention and Treatment Centers. In 2021, the National Health Commission issued the "2021 National Medical Quality and Safety Improvement Goals," with the fifth goal explicitly stating the need to increase the standardized prevention rate of venous thromboembolism (VTE). VTE prevention and treatment require intra-hospital coordination to improve early screening rates and standardize treatment procedures. The promotion of the VTE prevention and treatment system will boost growth in the related device market and further drive the adoption of inferior vena cava filters.

Octoparms®️ Vena Cava Filter, as the first umbrella-shaped filter approved for marketing in China, currentlyWinning bids in over 20 provinces, ranked first in Group A (with a recovery period of more than 30 days) in the volume-based procurement of the Shanxi-Hebei-Shandong-Henan Alliance.。

In recent years, various regions in China have successively carried out the centralized procurement of high-value medical consumables, leading to significant price reductions. The issue of profit margins and business survival has become a pain point of concern within the industry. Regarding this, Hu Qing, founder and CEO of Kossel Medtech, stated: "In the short term, the centralized procurement policy has had a huge impact on enterprises, but..."In the long term, centralized procurement exchanges volume for price. Although the unit price drops significantly, the volume of clinical surgeries increases, allowing companies to quickly gain 'entry tickets' into hospitals and focus on R&D and production.。”

Centralized procurement allows domestic companies to quickly gain hospital entry qualifications and simplifies the entry process, enabling products to be implemented in hospitals more rapidly. At the same time, price reductions from centralized procurement are driving domestic companies to reduce costs and improve efficiency. From a broader perspective, centralized procurement of high-value consumables will become the norm in the medical device field. Currently, centralized procurement has been successively carried out in coronary intervention, neurointervention, and peripheral intervention. Companies need to adapt to this trend by strengthening their R&D and manufacturing capabilities and diversifying their product pipelines.

Kossel Medtech is positioned as a platform enterprise with comprehensive R&D and production capabilities in vascular intervention, featuring a full range of technology platforms including balloon catheters, metal stents, drug coatings, cryoablation, and shock wave, covering both passive and active technologies. Its products span three major fields: peripheral intervention, cardiac electrophysiology, and coronary intervention.

China's peripheral interventional market is in its early stage of development, with a large number of patients suffering from venous diseases and peripheral arterial diseases. The number of patients with venous diseases exceeds 100 million. According to Frost & Sullivan, the number of patients with arterial diseases is expected to reach 55.96 million by 2023. However, due to the low mortality rate and lack of obvious symptoms, the treatment rate for peripheral diseases remains low, indicating significant potential in the interventional device market.

Kossel Medtech is committed to building a one-stop treatment system in the field of peripheral interventions. For peripheral venous diseases, in addition to inferior vena cava filters, the company is developing a series of products for debulking treatments; for peripheral arterial diseases, it is developing a series of products for treating arterial stenosis and arterial calcification lesions.

Among them, the shock wave balloon is used to treat lower limb arterial calcification lesions and can simultaneously address calcified plaques in the inner wall and middle layer of the artery. Vascular calcification has always been a clinical challenge, often accompanied by angulated and tortuous vascular lesions, with a lack of effective treatment methods in clinical practice, especially for deep calcification lesions.

Kossel's shockwave balloon integrates shockwaves and balloon functions, reducing balloon expansion pressure and minimizing vascular wall injury. The product has entered the type inspection phase and is expected to move into clinical trials next year.

Except for peripheral interventions,Kossel's subsidiary Haiyu Xincheng focuses on the field of cardiac electrophysiology, providing comprehensive solutions for the treatment of tachyarrhythmia. Its fixed-curve mapping catheter, adjustable-curve mapping catheter, and radiofrequency ablation catheter have been approved by the National Medical Products Administration. The company is currently developing a balloon-type cryoablation system and related access products.。

Cryotherapy ablation damages or kills abnormal myocardial cells in the target area through low temperatures. Compared with radiofrequency ablation, cryotherapy ablation is easier for doctors to operate, shortens the learning curve for operators, reduces operation time, and causes less pain for patients.

In June 2021, the U.S. FDA granted a new indication for cryoballoon ablation catheters, allowing them to be used as a first-line treatment for atrial fibrillation before the use of antiarrhythmic drugs. This is the first time the FDA has approved cryoablation as an initial rhythm control strategy, which will further drive the development of the cryoablation market.

Hu Qing believes: "The market for cardiac electrophysiology in China is huge, with foreign brands occupying more than 90% of the share. The technical difficulty is high and the threshold is steep, meaning domestic companies still have a long way to go. However, with the emergence of new technologies such as cryoablation and pulsed electric field ablation, the pace of domestically produced alternatives will accelerate. This is also the starting point for Kossel's entry into the electrophysiology market."

Another subsidiary of Kossel Medtech, Mison Medical, focuses on the field of coronary intervention and the transformation of overseas products and technologies. Its CTO (Chronic Total Occlusion) balloon, PTCA balloon, and coronary drug-eluting stents have already been marketed and sold.Among them, Selebrek®️ CTO Balloon, PTCA Balloon, and NC PTCA Balloon have obtained FDA certification.

In CTO lesions with complete or near-complete coronary occlusion, traditional balloons are difficult to pass through. However, the Selebrek®️ CTO Balloon features an extremely small entry diameter, making it easier to navigate through narrow lesions. It can closely follow the guidewire at nearly zero angle, offering excellent pushability and resistance to bending.

Kossel Medtech focuses on technology, products, talent, and other core elements, adhering to a long-term development strategy. The company has formulated its "Second Five-Year Plan" (2019–2023: to become a well-known innovator of medical devices in the vascular intervention field in China) and its "Third Five-Year Plan" (2024–2028: to become a leading innovator of medical devices in the vascular intervention field in China and gain global recognition).

From a founding team of a few people to the current team of more than 300, Kossel Medtech has built an experienced, pragmatic, and highly efficient talent pool and possesses a well-structured organizational framework. Meanwhile,Kossel Medtech actively promotes global patent layout, with 85 patents applied, including 48 invention patents. Its products have entered mainstream markets such as Japan, the United States, South Korea, and Europe.。

Kossel Medtech adheres to the concept of “derived from clinical practice, serving clinical practice” and has carried out fruitful research cooperation with many well-known hospitals, clinical departments, and universities in China. In addition, Kossel Medtech firmly implements an overseas expansion strategy, actively develops international business, upholds the principle of win-win cooperation, practices "going global and bringing in," and enhances the company's overall technical level.

Next, Kossel will continue to implement the "Second Five-Year Plan," making comprehensive efforts in innovative R&D, production and manufacturing, registration and certification, and channel development. At the same time, it will attract and cultivate more talent, striving to become a leading enterprise in the vascular intervention field.

Reference: "Jiang Peng: Selection and Retrieval Strategies for Caval Filters" —— New Horizons in Outpatient Care