BioCellgraft Launches First Injectable Tissue Therapy for Dentists

Introduction of OraFyl to the Dental Community

BioCellgraft, Inc., a New York-based company specializing in regenerative therapies for oral healthcare, has commenced the delivery of OraFyl, the world’s first injectable regenerative tissue advancement therapeutic, to select dental professionals across the United States. This innovative product is now being utilized by periodontists, prosthodontists, oral surgeons, and some general practitioners, who have reported promising outcomes in its application.

OraFyl is designed to address a range of dental conditions, including gum recession, papilla loss (commonly known as “black triangles”), alveolar socket management for dental implants, and even more complex cases like osteonecrosis of the jaw (ONJ). Its introduction marks a significant step forward in addressing unmet needs within the field of tissue regeneration.

BioCellgraft has informally partnered with one of the leading dental implant companies, referred to as “The Company,” to document the efficacy and versatility of OraFyl. According to BioCellgraft, this collaboration aims to evaluate the product’s performance across diverse clinical scenarios. The partnership underscores the potential of OraFyl as a tool that could simplify treatment protocols while enhancing patient outcomes.

Exclusive Partnership Discussions Underway

The distribution of OraFyl to a select group of dental experts was not random. Both BioCellgraft and “The Company” employed specific selection criteria to identify practitioners who could provide valuable feedback on the product’s performance. These case studies are expected to form the foundation for broader discussions regarding an exclusive marketing and distribution agreement between the two entities.

Under the terms of their current arrangement, BioCellgraft has granted “The Company” a “No Shop” period during which it will refrain from engaging with other dental implant product providers. This exclusivity allows both parties ample time to assess the feasibility of a long-term partnership. Upon the expiration of this period, BioCellgraft plans to explore opportunities with other manufacturers and distributors globally.

“BioCellgraft has already conducted many cases confirming the significant efficacy OraFyl offers in dentistry vs today’s ‘Gold Standard’ therapies for soft and hard tissue-related conditions,” stated a representative from the company.

Clinical Success and Growing Demand

Early adopters of OraFyl have highlighted its ability to enhance the body’s natural healing processes through the use of a human connective tissue matrix. This unique formulation has demonstrated success in promoting tissue regeneration, reducing recovery times, and lowering costs for patients. For instance, individuals facing extensive procedures and high expenses associated with traditional treatments may now benefit from OraFyl’s streamlined approach.

Demand for the product has surged among dental specialists familiar with its applications. BioCellgraft is currently accepting direct orders for future delivery, building a backlog ahead of the formal commercial launch scheduled for Q2 2025. The company emphasizes that both BioCellgraft and its manufacturing partner remain committed to meeting practitioner demand without compromising quality or timeliness.

At present, OraFyl is being provided to a limited number of oral surgeons and dental experts who have contributed to refining its application guidelines. These efforts aim to ensure optimal results when the product becomes widely available.

About BioCellgraft, Inc.

BioCellgraft positions itself as a leader in the development and commercialization of regenerative therapies tailored to oral healthcare. The company addresses critical gaps in the treatment of soft and hard tissue conditions, such as degenerating gums, thin biotypes, and gum recession.

Central to BioCellgraft’s innovation is its use of the Human Connective Tissue Matrix (HCTM), sourced through a partnership with Celularity, Inc., a publicly traded company listed on NASDAQ under the symbol CELU. Through this collaboration, BioCellgraft has secured exclusive rights to utilize Celularity’s placental-derived HCTM, branded as Interfyl, for oral and maxillofacial applications.

By leveraging advanced biomaterials, BioCellgraft seeks to transform the landscape of oral healthcare, offering solutions where conventional therapies fall short.

Forward-Looking Statements

This announcement includes forward-looking statements that reflect BioCellgraft’s expectations regarding the future availability and impact of OraFyl. However, these projections are subject to uncertainties and risks that could alter timelines or outcomes.

BioCellgraft disclaims any obligation to update or revise these statements unless required by law. Readers are advised to consider the context of these forward-looking statements and recognize that actual results may differ materially from current projections.

As the dental community awaits the full-scale launch of OraFyl, early indications suggest that this regenerative therapy could play a pivotal role in reshaping treatment paradigms across various specialties within oral healthcare.