BioCellgraft Inc. activities and particularly our flagship product OraFyl® are attracting the attention of an increasing number of our colleagues which are facing each day the following needs in regenerative dental medicine:
• Soft tissue management around implants, abutments and restorations (gaps filling),
• Gingival thin biotype, • Gingival recession,
• Interdental papilla loss or volume reduction (black triangle),
• Bioactivation of bone grafting material. It appeared very recently that this Human Placental Connective Tissue Matrix (HPCTM) extracted from the chorionic part of the placenta could be very useful to remodel
• Gingival invaginations in case of orthodontic space closure and to properly correct the biological situation in case of
• Osteonecrosis of the jaw (ONJ) by boosting the healing process through soft tissue enhancement while simplifying the surgical procedure.
In parallel to the intense work of our team in optimizing treatment procedures, new insights into the Mode Of Action were assessed how the support of OraFyl® can help accelerate the healing and regeneration process by attracting the essential cells through chemotaxis and stimulate growth factors synthesis. It appeared that after application (mainly injection inside the soft tissues) the common properties of a native extracellular matrix (including elasticity) are restored leading to a positive colonization balance in favour of M2 macrophages which are known to exhibit regenerative properties and to the migration and multiplication in situ of surrounding cells like fibroblasts and endothelial cells which synthesize de novo endogenous growth factors.
Confident in the clinical impact of the above pre-clinical results and in their interpretation which encourages the extension of the clinical indications, BioCellgraft announced the anticipated formalization of an agreement with Straumann USA, a division of Straumann Group Brands, headquartered in Basel, Switzerland. BioCellgraft will bring to market its regenerative therapy product, OraFyl®, gained from the chorionic part of the human placenta, making it the world’s first injectable regenerative soft and hard tissue advancement product along with human amniotic allograft membranes (OraFyl®M) to support the regeneration of alveolar socket extractions for implant procedures and other soft tissue applications, while also aiding in post-surgical patient compliance. The market size for OraFyl® and OraFyl®M applications exceeds $300 million per annum in North America alone. Currently, Straumann Group revenues exceed $2.4 billion (2023) making this company the largest and most successful dental implant company in the world with wholly owned subsidiaries such as Neodent, Anthogyr, Medentika and ClearConnect, The North American dental implant market is projected to grow from USD $1.4 billion 2024 to USD $3.5 billion 2032, exhibiting at least a yearly 10% growth rate during this time period. This initial stage of the BioCellgraft and Straumann Group preliminary venture consists of two parts, with the first being Straumann’s integrated selection process to recruit highly respected periodontists and oral surgeons for implantology. Once these specialists receive Biocellgraft’s OraFyl® and apply the proven and available regenerative therapy to patients of their choosing, Biocellgraft will have replicated the success of earlier results that the company has consistently achieved, while also receiving first-hand accounting to further document the attributes of OraFyl® that lend to the patient experience, which are of the highest importance due to the high level of usability reached by OraFyl® products line in its formulation, presentation and usage. Our Clinical Partners will maintain continued communication with patients receiving OraFyl® to hear their personal experience with OraFyl®’s administration pre and post procedure thus receiving their valuable feedback. Practitioners such as periodontists, implantologists, and oral surgeons as well as general practitioners within Straumann US distribution will soon become intimately familiar with the use and advantages, including ease of use in procedures as they strive to establish a more enhanced environment for tissue regeneration when applying the human placental-based biomaterials of which OraFyl® and OraFyl®M are manufactured from. Straumann Group, as a partner with BioCellgraft, together could soon be offering the first available injectable regenerative oral tissue therapeutic addressing multiple voids present in implant dentistry and overall dental procedures.
You can easily understand why the BioCellgraft, Inc. team is looking with great optimism into a bright future and all the co-workers join me with enthusiasm to wish all of you, loyal readers and partners a Merry Xmas and a healthy and prosperous year 2025!
