Osfirm to Launch Novel Implantable Biomaterial Whitlockite with Excellent Biodegradability and Bone Regenerative and Reconstructive Properties into Global Market by the Year 2023

SEOUL,South Korea,Oct. 28,2021 -- In 1941,"whitlockite," the second most abundant inorganic mineral of the bone was named in honor of Herbert Whitlockite,Curator of Minerals and Gems in the American Museum of Natural History in New York. Whitlockite is a unique form of magnesium tricalcium phosphate that has shown superior bioactive regenerative and reconstructive properties and excellent biocompatibility,making it an ideal biomaterial for implant use on sites of fracture or bone defects. In 2018,a Korean bio-venture company was founded based on the manufacturing and mass production technology of 'high-purity Whitrokite' that mimetics the structure of inorganic substances present in human bones. Osfirm was established within the Healthcare 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 Regenerative Medical Center at Seoul National University Bundang Hospital.

Product Line Diversity Ranging from 3D Printing Customizable Implant to Absorbable Composite Bone Bonding Plates and Screws

With regard to the legal issues on patents,the substance itself may not be patentable but its manufacturing process is eligible for patents. Osfirm holds 7 patents to this day on the various methods for manufacturing whitlockite and has completed registry of the substance with the American Chemical Society.

One patented technology involves the development of synthetic bone graft based on whitlockite. For example,in dentistry,it is a material used to firmly fix the implant by implanting it in the implant site.

whitlockite based synthetic bone is an innovative alternative to allograft bone from a human cadaver which is both costly and considered barbaric by many patients and xenograft bone from animal recipients which presents risks of allograft rejection and infection.

And the existent synthetic bone graft materials using hydroxyapatite and tricalcium beta phosphate are relatively inexpensive but present limitations in bone regenerative and reconstructive abilities. For this reason,the medical community began to seek different substances leading to the discovery of whitlockite.

Osfirm is preparing to submit applications to the Korean Ministry of Food and Drug Safety by 2022 for approval of IND on whitlockite-based bone implants,and if approved,is expecting to begin the clinical trials by year 2023. Findings on the efficacy of whitlockite as a synthetic bone graft material is currently awaiting publication as an original article in an internationally recognized medical journal.

Additionally,3D printing technology have been incorporated to create "patient-specific bone implants" based on whitlockite synthetic material. In such cases,CT scans are used to model the bone structures. With sufficiently accrued database for bone imaging,manufacturing time is expected to be curtailed. It may be possible to generate standard ready-made products at reduced cost and manufacturing time. The therapeutic effect of these implants is significantly influenced by accurate alignment and position of implants,operation time and recovery period of the patients. With the use of novel technologies,Osfirm expects to address drawbacks to currently available products in the market.

The medical devices being developed by Osfirm are expanding the product line by combining whitlockite with various materials such as polymers,titanium,and hyaluronic acid as a basic material.

One of their products is the plate and screw for attaching and fixing fractured bones. It is a product made by mixing whitrokite with a biodegradable polymer. "A biodegradable material implies that after the human tissue such as the bone is regenerated and fully reconstructed,the substance will naturally degrade and absorb into the human tissue over a period of 6 months to 2 years," said Chan Yeong Heo,CEO of Osfirm. He continued,"These plates and screws will stabilize and support the fractured bones until the break heals and will dissolve on its own within 2 years."

In the past,plates and screws based on titanium were used for treatment fracture. However,secondary operation was necessary to have them removed. Osfirm's biodegradable plates and screws offer complete biodegradability in addition to enhanced bone regenerative effects with the addition of whitlockite.

Outstanding R&D Capacity Leads to Development of Whitlockite-Based Beauty and Oral Care Products

The company pipeline includes whitlockite-based cosmetic surgery and oral care products. S. Korea,home to the ever-growing K-beauty trend,is becoming world's center for cosmetic surgery market especially facial plastic surgery such as the double jaw surgery.

Osfirm is currently developing two products,a synthetic thread for improving facial wrinkles,and a dermal filler for augmenting the volume of the face,that takes advantage of the properties which the nanosized particles of whitlockite offer with the goal of being marketed in 2025.

In addition,oral care market such as whitening products and implants are rapidly growing with the expanding aging population and higher demand for improved living standards. CEO Chan Yeong Heo claimed,"Osfirm is concentrating a significant part of its corporate activities on R&D." "We are securing new technologies by investing in R&D,and with its successful implementation,continuing to receive government funds for projects." He added,"The important aspect of a company is its competitiveness in the global market including the US market."

Osfirm is preparing to enter the US market at the same time as its entry into domestic clinical trials in 2023. The goal is to obtain 6 clinical trial approvals and 3 product approvals by 2026. Although the current primary pipelines are concentrated on medical equipment development,bone disease-related cell therapy is being prepared alongside. The company's strategic business development is undergoing amends,but the R&D capabilities to align with our business plans are expected to be secured by 2022.

The clinical network offered by CEO Chan Yeong Heo is a valuable asset that underpins the company's grand vision and action plan. "With extensive clinical experience,it is easier to understand the needs of the medical community such as the products required by doctors and are essential to patients," he said. "For twenty years have been devoted to establishing a healthcare business platform with hospital,pharmaceutical companies and biotech startups as the main players in the market. This platform will make possible the increased success rate of commercialization through the facilitated interaction between medical,research and industrial sites."

Chan Yeong Heo M.D.,PhD. (CEO)

Tel) +82)-10-3079-7222

Email) ceo@osfirm.co.kr / jhshim@osfirm.co.kr

Homepage) www.osfirm.co.kr

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