Today, the BioCellgraft team proudly announces that our esteemed Clinical Partners—highly skilled and respected experts in oral care—are increasingly utilizing OraFyl® (Human Placenta Connective Tissue Matrix, HPCTM) to significantly advance the quality and volume of soft tissue and bone regeneration in deficient areas within the oral cavity.
Our collaborative experiences with these clinicians have allowed us to refine the indications for OraFyl®, categorizing them based on the method of application: injectable or mixable.
Injectable Applications:
- Soft tissue management around implants, abutments, and restorations (emergence profile shaping or gap filling), particularly keratinized tissue augmentation.
- Transformation of gingival thin biotype to a thick biotype via injection.
- Treatment of gingival recession using gingival extension procedures or pedicle graft.
- Addressing interdental papilla loss or volume reduction (black triangle).
- Repair at free-gingiva palatal graft retrieval sites.
- Correction of gingival invaginations following orthodontic space closures.
- Lip reshaping and augmentation.
Mixable Applications:
- Bioactivation of bone graft materials for alveolar socket or supra-alveolar regeneration and ridge augmentation via putty shaping.
- Bioactivation of autogenous free gingival palatal grafts or allogenic soft tissue substitutes through soaking.
- Treatment of bone dehiscence at teeth or implants by defect filling with a putty.
- Management of osteonecrosis of the jaw (ONJ).
- Repair in cleft-palate surgeries.
Our Clinical Partners have highlighted the particular benefits of OraFyl®, including:
- Exceptional purity following the decellularization process, without chemical cross-linkers.
- Fully preserved elasticity, maintaining a youthful collagen matrix after saline reconstitution, enabling adjustable viscosity and controlled mechanical stress beneficial for cellular metabolism.
- Lyophilized form with an extended shelf life at room temperature for up to 10 years.
- High versatility to tailor specific surgical techniques to clinical needs.
- Ease of use, requiring minimal training for medical professionals due to its straightforward application, which typically involves injection into gingival tissue without flap elevation, or gentle mixing with bone substitute materials.
Moreover, we recently reached a significant milestone by submitting a manuscript to a prominent international peer-reviewed journal in early May. The manuscript, titled “Soft Tissue Regeneration of Extraction Socket Sites via Adjunction of Flowable Decellularized Human Placental Extract: A Proof of Concept,” has been authored by leading specialists in the field, including Bachar Husseini, Ronald Younes, Nabil Ghosn, Robert Hariri, Patrick El Sayegh, Robert Miller, and Michel Dard.
The study clinically and digitally investigated outcomes from inserting a mixed flowable decellularized Human Placental Connective Tissue Matrix (HPCTM) combined with allograft bone substitutes for alveolar ridge preservation. Ten patients, each presenting two compromised teeth in different quadrants, were included. Their sockets were divided into test and control sites, evaluated using intra-oral scans and clinical photographs at baseline and post-operatively on days 10, 21, and 30 to monitor healing kinetics and quantify soft tissue changes. Cone beam computed tomography (CBCT) scans were also taken pre-extraction and 4 months post-operative to assess and compare volumetric bone resorption patterns. Statistical analysis revealed significantly reduced bone resorption and soft tissue shrinkage at test sites compared to control sites, demonstrating enhanced healing capabilities when utilizing flowable HPCTM.
This innovative approach positions flowable HPCTM as an advantageous adjunctive agent in alveolar ridge preservation, significantly enhancing healing outcomes and minimizing hard and soft tissue loss. The successful confirmation of OraFyl®’s remarkable ease of use and efficacy will catalyze its commercial launch initially in the United States, followed swiftly by global availability. OraFyl® is poised to become a pivotal tool for practitioners committed to elevating care standards for patients requiring soft and hard tissue regeneration.
We express profound gratitude to all our supporters and dedicated Fellows, whose passion drives continuous improvements in patient care.
Thank you for being an essential part of the OraFyl® journey!
Founder, CEO
