Recently, NextBioMedical announced that its absorbable embolic microsphere, Nexsphere-F, has been awarded the "Breakthrough Device" designation by the FDA.

At present, Nexsphere-F has been approved for CE, and it is worth mentioning that this product is also the only CE approved microsphere for the treatment of musculoskeletal pain embolism.

Innovative technology, breaking through traditional boundaries
The Nexsphere-F, which was awarded the breakthrough device this time, is an embolic microsphere with a size of 100-300 μ m that can be quickly absorbed by patients. Its indication is for the treatment of knee osteoarthritis pain in patients who do not respond adequately to conservative non pharmacological treatment and/or analgesics.

It is worth mentioning that this product integrates innovative absorbable microsphere technology. When Nexsphere-F is delivered to the patient's target blood vessel through a 1.7Fr microcatheter, the microspheres will absorb water and expand, thereby achieving precise blockage of the target blood vessel and temporarily cutting off the blood supply to the tissue. These microspheres will dissolve within 2 to 6 hours, leading to pain induced neuronal necrosis and providing rapid and effective pain relief. Once the microspheres dissolve, they will be fully absorbed by the body.

From the perspective of usage, the application method of Nexsphere-F is roughly the same as that of traditional embolization microspheres, but the effect is quite different. The unique absorbability of Nexsphere-F can significantly reduce the occurrence of complications caused by traditional embolization surgery.

NextBioMedical is an innovative medical device company in South Korea that focuses on developing innovative therapeutic materials using advanced drug delivery systems and developing and manufacturing customized drug device combinations specifically designed to address major clinical unmet needs.

According to a search in the Medicine Intelligence Medical Device Database, the company already has one product on the market in the United States - Nexpowder. This product is a new type of powder hemostatic technology under digestive endoscopy, consisting of hemostatic powder, delivery handle, and spray catheter. Among them, powder is the core technology of the company.

It is understood that Nexpowder's hemostatic powder not only reacts to blood, but also to moisture, which is fundamentally different from hemostatic powders on the market. This characteristic also allows the hemostatic powder to become a binder, promoting its adhesion to the bleeding area and accelerating healing.

In addition, Nexpowder has also undergone a series of upgrades at the delivery handle, which has its own unique delivery mechanism to avoid blockages in the machine, equipment, or visual effects for doctors. Currently, Medtronic is the sole agent for this product.

Open a new door to treatment in the vast market
Knee osteoarthritis refers to a bone and joint disease characterized by joint pain, stiffness, and functional impairment caused by various factors leading to erosion and degeneration of knee cartilage, varying degrees of chondrocyte hypertrophy, and imbalance in subchondral bone reconstruction.

With the comprehensive impact of aging population and increasing obesity, its incidence rate has increased year by year. It has been listed as the fastest growing major health problem by the World Health Organization and the second major disability disease. At present, there are a wide range of patients with knee osteoarthritis, with over 650 million patients worldwide, and the incidence rate among people aged 65 and above exceeds 50%.

Previously, the main treatment methods for knee osteoarthritis were conservative treatment and arthroscopic minimally invasive treatment, both aimed at relieving pain, and their long-term clinical benefits were very limited. With the further development of technology, the emergence of Siemens' Embozene microspheres and Meriton's Embosphere microspheres, two embolic microsphere products, has opened a new door for the treatment of knee osteoarthritis.
As a minimally invasive surgery, embolization microspheres can selectively reduce blood flow to the knee area with abundant blood vessels, and clinical studies have shown that they help alleviate pain and inflammation associated with knee osteoarthritis. It is precisely because of the excellent clinical results of knee joint arterial embolization that Siemens and Meriton's two products have successively been awarded the title of "breakthrough device" by the FDA.

Siemens Embozene microspheres
It is reported that Siemens' Embozene microsphere has the characteristics of accurate calibration, compression and firmness. It is made of nonabsorbable hydrogel coated with Polyzene-F polymer, and has a range of sizes from 40 to 1300 µ m. And, the product has been uniquely color coded, which helps with size confirmation and ease of use within its range.

Mairuitong Ebosphere Microspheres
The Embosphere microspheres of Mairuitong are made of acrylic polymer microspheres and 3% gelatin, stored in a sodium chloride solution. The diameter range of the microsphere is 40-1200 µ m, and it is divided into different specifications according to the size and loading capacity of the microsphere.

Conclusion
The absorbable microsphere technology provides a new treatment option for knee osteoarthritis, and with the further approval of Nexsphere-F, it will benefit a large number of knee osteoarthritis patients.

Source: https://news.yaozh.com/archive/45122.html