Call 888-776-0942 from 8 a.m. to 10 p.m. Eastern Time
Seoul, South Korea, October 28, 2021/PRNewswire/ - In 1941, the second most abundant inorganic mineral in bones, "Marcasite", was named Herbert Whitlock, the curator of minerals and gems at the American Museum of Natural History Name the history of New York. Whitlockite is a unique form of tricalcium magnesium phosphate, with excellent bioactive regeneration and reconstruction properties and excellent biocompatibility, making it an ideal biomaterial for implants in fractures or bone defects. In 2018, a Korean bio-venture company was established based on the manufacturing and mass production technology of "high-purity Whitrokite" that mimics the structure of inorganic substances in human bones. Osfirm was established in the Medical Innovation Center of Seoul National University Bundang Hospital, one of the most prestigious medical institutions in Korea.
The CEO, Professor Chan Yeong Heo, is also the head of the Center for Regenerative Medicine at Bundang Hospital, Seoul National University.
The product line is diversified, from 3D printed customizable implants to absorbable composite bone splice plates and screws
Regarding the legal issue of patents, the substance itself may not be patentable, but its manufacturing process is eligible to be patented. So far, Osfirm has 7 patents on various methods of manufacturing muscovite, and has completed the registration of the substance with the American Chemical Society.
A patented technology involves the development of a synthetic bone graft based on marcasite. For example, in dentistry, it is a material used to securely fix the implant by implanting the implant at the implantation site.
Synthetic bone based on marcasite is an innovative alternative that can replace allogeneic bone from human cadavers, which is expensive and considered barbaric by many patients, while heterogeneous bone from animal recipients exists. The risk of allograft rejection and infection.
The existing synthetic bone graft materials using hydroxyapatite and tricalcium phosphate are relatively cheap, but have limitations in bone regeneration and reconstruction capabilities. For this reason, the medical profession began to search for different substances and found marcasite.
Osfirm is preparing to submit an application to the Korean Ministry of Food and Drug Safety before 2022 to approve the IND for marcasite-based bone implants. If approved, it is expected to start clinical trials in 2023. Investigation results on the efficacy of marcasite A synthetic bone graft material is currently waiting to be published as an original article in an internationally recognized medical journal.
In addition, 3D printing technology has been combined to create "patient-specific bone implants" based on marcasite synthetic materials. In this case, CT scans are used to simulate bone structure. With sufficient bone imaging databases, manufacturing time is expected to be shortened. It is possible to produce standard off-the-shelf products with reduced costs and manufacturing time. The therapeutic effect of these implants is significantly affected by the accurate alignment and position of the implants, the operation time and the patient's recovery period. Osfirm hopes to solve the shortcomings of existing products on the market by using new technologies.
Osfirm's medical devices are expanding their product line by combining various materials such as schifflite with polymers, titanium, and hyaluronic acid as basic materials.
One of their products are plates and screws used to connect and fix fractured bones. It is a product made by mixing marcasite and biodegradable polymer. "A biodegradable material means that after bones and other human tissues are regenerated and completely rebuilt, the substance will naturally degrade and be absorbed into human tissues within 6 months to 2 years," Osfirm CEO Chan Yeong Heo said. He continued, “These plates and screws will stabilize and support the fractured bone until the fracture heals and will dissolve on its own within 2 years.”
In the past, titanium-based plates and screws were used to treat fractures. However, a second operation is necessary to remove them. Osfirm's biodegradable bone plates and screws not only enhance bone regeneration by adding marcasite, but also provide complete biodegradability.
Excellent research and development capabilities have led to the development of Whitlockite-based beauty and oral care products
The company's product line includes marcasite-based cosmetic surgery and oral care products. South Korea, the birthplace of the K-beauty trend, is becoming the center of the global cosmetic surgery market, especially facial plastic surgery, such as double jaw surgery.
Osfirm is currently developing two products, a synthetic thread to improve facial wrinkles, and a dermal filler to increase facial volume. They take advantage of the properties provided by marcasite nanoparticles and aim to be marketed in 2025 .
In addition, with the intensification of population aging and higher requirements for improving living standards, the oral care market such as whitening products and implants is also growing rapidly. Chief Executive Chan Yeong Heo stated: “Osfirm concentrates a large part of its corporate activities on research and development.” “We invest in research and development to ensure the safety of new technologies, and continue to receive government project funding as they are successfully implemented.” He added: "An important aspect of a company is its competitiveness in the global market, including the US market."
Osfirm plans to enter the US market while entering domestic clinical trials in 2023. The goal is to obtain 6 clinical trial approvals and 3 product approvals by 2026. Although the main pipeline currently focuses on the development of medical devices, cell therapy related to bone diseases is also being prepared. The company's strategic business development is undergoing revision, but it is expected that by 2022, it will ensure R&D capabilities consistent with our business plan.
The clinical network provided by CEO Chan Yeong Heo is a valuable asset that supports the company's grand vision and action plan. "With a wealth of clinical experience, it is easier to understand the needs of the medical community, such as products that doctors need, which are indispensable for patients," he said. "Over the past two decades, we have been committed to establishing a healthcare business platform with hospitals, pharmaceutical companies and biotech start-ups as the market players. The platform will increase the success rate of commercialization by promoting the interaction between medical care, research and industry. ."
Chan Yeong Heo, MD., PhD. (CEO) Tel) 82)-10-3079-7222 Email) [email protected] / [email protected] Homepage) www.osfirm.co.kr
Cision Distribution 888-776-0942 8 a.m. to 9 p.m. Eastern Time