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Learn about innovations at the intersection of dental, oral, craniofacial space and regenerative medicine
Network with others developing technologies and/or investing in this field
Explore strategies for generating clinical evidence that successfully translates into patient benefit
Entrepreneur Expo | About
Entrepreneur Expo showcases innovative technologies at the intersection of dental, oral, and craniofacial space and regenerative medicine, where attendees can connect with technology teams behind the latest innovations. The Expo offers attendees a unique opportunity to explore cutting-edge advancements,
engage with forward-thinking entrepreneurs, and discover the future of technology across various dental indications. Panelists and other members from industry will be reviewing the projects, and a winner for each of the the following categories will be announced at the Networking Reception.
Big Leap Forward – Biggest potential game changer
Capital Catch – Most Likely to Attract Investors
Ready for the Chair – Fastest Track to Clinical Adoption
Entrepreneur Expo is made possible by the Event Sponsors
Entrepreneur Expo | Presenting Projects
Patient-Specific Bone Graft Scaffolds for Oral Surgery
Prakash Kolli, PhD, PE (CEO/Co-founder, 3D Orthobiologic Solutions)
3D Orthobiologic Solutions is developing customizable, 3D-printed scaffolds for repairing and regenerating bone in oral and maxillofacial and orthopedic surgeries. Biocompatible materials and structures are optimized to efficiently and maximally enhance bone regrowth. 3DOS' platform will provide an easy-to-use and biodegradable scaffold that will be superior to existing products in speed and quality and offer a high-throughput option for surgeons.
Clinical Need
Oral and maxillofacial segmental bone defects are associated with cancer, trauma, periodontal disease, or other pathology, causing irreversible structural bone loss. Quality of life deficit with speech, mastication, and form is a significant clinical burden. However, lack of ideal bone volume impairs rehabilitation with prostheses or endosseous dental implant survival. It is estimated that > 50% of dental implants require bone grafting and current solutions often prevent a successful clinical outcome.
Solution
We are developing customizable, 3D-printed scaffolds for repairing and regenerating bone in oral and maxillofacial surgery. Biocompatible materials and structures are optimized to efficiently and maximally enhance bone regrowth. 3DOS' biodegradable scaffold provides an easy-to-use solution compared to existing products in speed and quality, offering a high-throughput option for surgeons.
Competitive Advantage
Our innovations are patient-specific devices made of a biodegradable, low-cost polymer composite and a full customization design methodology. Having an already customized device saves significant time in the operating room. A regenerative and biodegradable device significantly improves current clinical issues and the need for revisions.
Achievements
Achieved minimum viable product
Pre-clinical study protocol developed
Material proof-of-concept established in small animal model studies
Regulatory Path
510(k) anticipated; pre-submission meeting requested May 2025
Opportunities for Partnerships
Investment Opportunity: Currently seeking pre-Seed financing of $600k to initiate regulatory testing requirements
Seeking strategic partnership with global dental supply company and/or distributors
Key Publications & Patents
US11,213,394 Graft segment bone defect repair
PCT/US2023/071602 Systems, compositions, and methods for making and using implants
Tissue Tape™ & Tissure™: Adhesive Technologies for Dental and Surgical Applications
Robby Lane, MBA (CEO, Amend Surgical)
Amend Tissue Tape™ is a wound and barrier technology that forms long lasting ionic and covalent bonds that tightly interconnect the tough adhesive to biologic tissue, even in challenging wet environments like the oral cavity. A clinical assessment over extraction sockets will begin in summer-2025 and FDA clearance as a non-resorbable wound dressing is expected late-2025.
Substantial work has also been completed on a resorbable version of the product line. Amend is pursuing the resorbable technology as a suture-less connector and wrap option for peripheral nerve repair procedures. The brand name for our resorbable product is Tissure™.
Clinical Need
An intraoral wound overlay for soft tissue that is easy to apply, remains in place for the duration of wound healing, and can be removed without causing damage to underlying tissue. Current options for oral wound care are limited to difficult to use, uncomfortable, and largely ineffective glues and resins.
Solution
Amend Tissue Tape™ is a hydrogel-based adhesive comprised of two primary elements. The hydrogel consists of an interpenetrating network of alginate and polyacrylamide. The adhesive is composed of chitosan, which forms covalent bonds across the interface. When used together, the hydrogel and adhesive adhere to wet tissue and provide over five times the adhesion energy of cyanoacrylate while also providing a long duration mechanical barrier for the wound and flexibility to stretch with the wound without damaging the underlying tissue.
Competitive Advantage
There are limited products available that will safely adhere to sutured or nonsutured oral wounds. Periacryl, a cyanoacrylate-based product indicated as a dental cement, is often used off-label for wound closure. It requires a dry environment to fully set and is rigid, not stretching to accommodate movement or swelling. Amend Tissue Tape™ adheres to tissue in a wet environment, stretches with the wound, and stays in place for up to one week. This facilitates wound healing and the regenerative process.
Achievements
Qualifications and validation complete
Production ready
In 2024/25, raised over $1,400,000 in private equity funding
Regulatory Path
File 510(k) late summer/early fall 2025
Opportunities for Partnerships
Continue to pursue strategic partner: distribution, R&D
Key Publications & Patents
Li et al. Tough adhesives for diverse wet surfaces. Science 2017
PCT/US2019/055779 Bio-Inspired Degradable Tough Adhesives for Diverse Wet Environments
Drug Repurposing Combination Therapy for Enhanced Tooth Repair
Camila Sabatini, DDS, MS, PhD (Associate Professor, University at Buffalo)/ Techung Lee, PhD (Associate Professor, University at Buffalo)
We are harnessing the regenerative power of dental pulp stem cells (DPSCs) with an innovative combination of two clinically proven compounds—dexamethasone and poly(I:C). Together, they can stimulate enhanced repair of the pulp-dentin complex. While dexamethasone promotes DPSC differentiation into multiple cell types, RNA mimetic poly(I:C) triggers DPSCs release of a broad spectrum of growth factors necessary for tooth repair. With both compounds already in clinical use, we anticipate rapid adoption of this innovative therapy, pending successful testing in a ferret model. With promising results in preclinical testing, our approach aims to revolutionize the future of dental therapies.
Clinical Need
The standard treatment for pulp exposures uses MTA and calcium silicate-based materials, which are limited to small defects and have issues like discoloration, long setting times, and intra-canal calcifications, often leading to failure. Recurrent, progressively larger interventions lead to early tooth loss and several associated complications. Currently, no therapies leverage the regenerative potential of dental pulp stem cells (DPSCs) to repair the pulp-dentin complex.
Solution
Identifying molecular signatures to harness the regenerative power of DPSCs could exponentially enhance the healing of the pulp-dentin complex, promoting reparative dentin formation, pulp sensory innervation, and revascularization. This approach brings us closer to the goals of tooth healing and preservation and represents the future of regenerative dental therapies.
Competitive Advantage
We have identified a promising combination therapy based on dexamethasone and poly(I:C), two clinically proven compounds that stimulate pulp-dentin complex repair. Dexamethasone promotes DPSC differentiation into multiple cell types, while poly(I:C) triggers growth factor release for tooth repair. With preclinical success and clinical readiness, this innovative therapy could transform dental treatments.
Achievements
2 in vitro studies and 1 small animal confirmatory study concluded | GMP manufacturing started
Large animal study started | IRB protocol for Ph I/II pilot clinical trial in development
Seed round ongoing
Regulatory Path
Drug repurposing strategy: both compounds already in clinical use. Anti-inflammatory drug dexamethasone is widely used for many conditions; poly(I:C) is under investigation for its immune boosting function in cancer therapy trials. We need assistance in determining regulatory paths and required studies to secure IND approval.
Opportunities for Partnerships
Seeking strategic partnerships with industry, associations and/or academic centers for the advancement of this work.
Key Publications & Patents
Sabatini et al. The proneural transcription factor Atoh1 promotes odontogenic differentiation in human dental pulp stem cells (DPSCs). BMC Mol Cell Biol 2025
Sabatini et al. Dental Pulp Cell Conditioning through Polyinosinic-Polycytidylic Acid Activation of Toll-like Receptor 3 for Amplification of Trophic Factors. J Endod 2022
Targeted Remineralization Treatment Using Mineral Loaded Starch Nanoparticles
Steven Bloembergen, PhD (CEO, GreenMark Biomedical Inc.)
We are empowering no-drill dental care in a modern world through biomimetics, targeted delivery, and preventive products. GreenMark is aiming to transform the dental experience by providing dentists, hygienists, and patients non-invasive products that combine treatment for dental sensitivity with proactive oral health management. By redefining dental care standards to treat sensitivity and better manage caries disease, GreenMark is making painless, natural repair possible.
Clinical Need
Dental caries is the most prevalent chronic disease worldwide. The unmet clinical need is noninvasive treatment through subsurface remineralization of enamel, as current fluoride toothpastes & varnishes incompletely repair caries lesions. Our professional-use and direct-to-consumer products treat both dental hypersensitivity and early-stage caries, to reduce discomfort, preserve precious enamel and improve oral health.
Solution
We produce tiny positively charged, mineral-loaded starch particles, to target and release inside negatively charged tooth subsurfaces. In-situ degradation forms hydroxyapatite crystals, occluding dentinal tubules and enamel porosities. Our products, CrystLCare™ Biorestorative, Fluoride-Free and Fluoride-Plus, are easy-to-use dissolvable dental strips that release the targeted mineral-loaded particles when placed onto teeth.
Competitive Advantage
Current fluoride products merely seal the extreme upper surface layer of enamel lesions, but targeting the subsurface enables non-surgical treatment of early-stage caries as well as sensitivity relief. Localized concentration of minerals and fluoride facilitates tooth structure regeneration through targeted formation of apatite crystals, yielding superior treatment compared to currently available products.
Achievements
Built intellectual property with broad patents extended globally
Medical device manufacturing and Quality Management in place | Manufacturing scaled to 100,000 doses
Developed a suite of CrystLCare™ Biorestorative products
Third-party in vitro performance validation published | Clinical study protocol developed
Regulatory Path
CrystLCare Fluoride Free (CC FF) sensitivity product: Class I Medical Device FDA-registered (April 2023)
CrystLCare Fluoride Plus (CC FP) Pro in-office sensitivity product: Class II 510(k) FDA Clearance (January 2025)
CC FP OTC product for caries prevention under Fluoride Monograph (Launch targeted Q2 2025)
CC FP/FF De Novo application for “Enamel Mineral Regeneration” after completion of clinical studies (2025-6)
Opportunities for Partnerships
Seeking strategic partnerships with global dental supply companies and/or distributors
Raising $4.0 million Series A equity investment round
Key Publications & Patents
Jones et al. Targeted Enamel Remineralization with Mineral-loaded Starch Particles. JADA Found Sci 2024
Jones et al. Nanoparticle-based targeting and detection of microcavities. Adv Healthc Mater 2017
Amaechi et al. Evaluation of a Novel Caries Detecting Oral Rinse. BDJ Open 2023
US10,987,434 Detection and Treatment of Caries and Microcavities with Nanoparticles
Non-Viral Aquaporin-1 Gene Therapy to Restore Salivary Flow
Isabelle Lombaert, PhD (Associate Professor, University of Michigan)
We provide a non-viral gene therapy approach to treat head and neck cancer patients suffering from radiation-induced xerostomia.
Clinical Need
Radiotherapy is commonly used to treat head-and-neck cancers. Because of the anatomical proximity, salivary glands often receive secondary radiation damage, resulting in xerostomia. While intensity-modulated radiotherapy significantly reduces the incidence of radiation-induced xerostomia, a need still exists for patients suffering from xerostomia.
Solution
Ultrasound-assisted gene transfer is based on sonoporation generated by ultrasound, enabling gene transfer into cells. The delivery of a water channel to glands in a large animal model restored salivary flow post-radiation to pre-treatment levels, demonstrating efficacy of our non-viral gene transfer approach.
Competitive Advantage
While a recent clinical trial using a viral-based AQP1 gene delivery demonstrated an increase in saliva production, this approach has not advanced beyond Phase I/II trial due to side-effects generated by the adenovirus vector. With our non-viral based approach, it is anticipated that enhanced safety is provided in patients with AQP1 gene therapy throughout their lifetime.
Achievements
Securing non-diluted funding to support GLP Toxicology studies
Regulatory Path
IND submission anticipated in 2025
Opportunities for Partnerships
Obtaining funds to initiate first-in-human trial
Key Publications & Patents
Wang et al. Ultrasound-assisted nonviral gene transfer of AQP1 to the irradiated minipig parotid gland restores fluid secretion. Gene Ther 2015
Regenerative Approaches to Oral Wound Healing Leveraging the Immune System
Steven Goudy, MD, MBA (CEO/Founder, Oridivus)
Oridivus is a biotechnology company that is focused on developing the first FDA-approved oral wound healing therapy. Oral wound healing complications are frequent and associated with significant pain and Oridivus has developed a drug-device topical therapy that improves mucosal wound healing and reduces pain through immunomodulation. Currently Oridivus is scaling their drug-device combination in large animals and developing a regulatory route towards clinical trials and commercialization.
Clinical Need
More than 50 million oral surgeries are performed in the US every year. Up to 50% of these surgeries experience poor wound healing or wound healing complications including dry sockets and oronasal fistulas. Unfortunately, there are currently no FDA-approved treatments for injury to the oral mucosa. Clinicians frequently use off-label products such as platelet-rich plasma which carry disease transmission risks and do not have demonstrated efficacy in meta-analyses. Thus, there is an unmet need for an FDA-approved, safe, and effective treatment specifically for oral injuries.
Solution
Oridivus has developed a drug/device combination treatment specifically designed to treat oral wounds. It is based on the immunomodulatory FDA-approved drug FTY720 encapsulated in PLGA/PCL electro-spun polymer nanofibers. Our technology works by repurposing the immunomodulatory effects of FTY720 to control the inflammatory process in the injured tissue and harness the body’s innate regenerative capacity to accelerate healing. Studies in mice have shown our technology can produce almost complete oral wound healing and reduced pain compared to minimal healing of untreated oral injuries. Reducing pain associated with oral wound healing is important to society as it will reduce the need for narcotic prescriptions and therefore narcotic dependence.
Competitive Advantage
There are currently no FDA-approved treatments for injury to the oral mucosa. Clinicians frequently use off-label products including platelet-rich plasma, acellularized dermis, and amniotic membranes. However, these products carry the risk of disease transmission (e.g. HIV and prions). Further, meta-analyses have not demonstrated benefit or cost efficacy from PRP or acellularized dermis. Our FTY720-nanofiber is able to control the inflammatory component of wound healing and expedite wound healing.
Achievements
Phase 1 STTR grant awarded in 2024
Preclinical pig studies in progress
Regulatory Path
Preparing for pre-IND meeting with FDA in Q2 2025
IND submission planned for Q3 2025
GLP manufacturing and QMS Q3 2025
FIH trials planned for Q4 2025
Opportunities for Partnerships
Raising seed round to support FIH trials for Q4 2025
Key Publications & Patents
Toma et al. Accelerating Oral Wound Healing Using Bilayer Biomaterial Delivery of FTY720 Immunotherapy. Adv Healthc Mater 2024
RegendoGEL: A Bioinspired Hydrogel System for Endodontic Therapy
Pamela C. Yelick, PhD (CSO, RegendoDent Inc.)
RegendoDent Inc. is working to create products to regenerate dental tissues including dental pulp and dentin. We anticipate that these therapies will be highly superior to currently used, nondegradable endodontic therapies.
Clinical Need
Dental caries is the most common non-transmissible infectious disease in the world. If untreated, caries lesions will progress to the dental pulp, exposing it to infection. Standard of care techniques involve removing infected pulp and capping the defect with inert material, or root canal therapy. Currently, there are no clinically available materials that regenerate the pulp-dentin complex.
Solution
A team led by Luiz Bertassoni, DDS, PhD and Pamela Yelick, PhD has developed a novel material, RegendoGEL, intended to be the first-of-its-kind clinical product to promote vital pulp and dentin regeneration. RegendoGEL contains key bioactive molecules present in healthy teeth that naturally promote dental pulp and dentin regeneration and may be used for pulpotomies.
Competitive Advantage
Compared to non-degradable silicate/calcium hydroxide-based products currently used for endodontic treatments, RegendoGEL is a soft, biodegradable hydrogel material. RegendoGEL stimulates cells to migrate into the defect site and regenerate living dental pulp tissue and dentin in 5 days. RegendoGEL is designed as a ready-to-use product that can easily be applied using routine dental procedures.
Achievements
2 confirmatory large-animal studies concluded
GMP manufacturing started
Seed round ongoing
Regulatory Path
IDE submission Q2 2025
FIH to be conducted upon FDA IDE approval
Opportunities for Partnerships
Funding for RegendoDent, Inc. to launch RegendoGEL and conduct a clinical trial
Key Publications & Patents
Cunha et al. 3D-printed microgels supplemented with dentin matrix molecules as a novel biomaterial for direct pulp capping. Clin Oral Investig 2023
PCT/US2018/035200 Dental pulp constructs
US11,278,474 Pulp regeneration compositions and methods of forming and using the same
Translating Regenerative Bone Adhesive Platform from Bench to Clinic
Rahul Jadia, PhD (R&D Manager, Technology Development, RevBio Inc.)
RevBio, Inc. (“RevBio”) is a clinical-stage medical device company developing a bone adhesive technology known as TETRANITE®. With this technology, RevBio has designed a synthetic, cohesive organic-mineral bone graft biomaterial with adhesive properties called TETRANITE® Adhesive Dental Bone Scaffold (TN-ADBS) specifically for ridge augmentation procedures. TN-ADBS is a self-setting, osteoconductive, bioactive, resorbable, volume-preserving scaffold intended to fill, augment, or reconstruct, alveolar bone defects of the oral and maxillofacial region through adhesion to surrounding bone. TN-ADBS excludes soft tissue ingrowth and promotes bone formation and regeneration without the need for containment devices or barrier membranes.
Clinical Need
Based on market research conducted by RevBio, almost half the patients that seek a dental implant supported crown suffer from chronic edentulism and require extensive bone grafting to rebuild their alveolar ridge. Over 30% of the time, these grafting procedures achieve suboptimal results and require some form of re-grafting adding to the overall cost, treatment time, and morbidity for these patients.
Solution
RevBio has developed Tetranite® Adhesive Dental Bone Scaffold (TN-ADBS), a synthetic, porous, cohesive organic-mineral bone scaffold with adhesive properties that resorbs and is replaced by bone on a timescale commensurate with existing graft materials but does not require ancillary fixation or containment devices.
Competitive Advantage
Currently available particulate bone grafting products require significant surgical skill to apply. In contrast, TN-ADBS is both cohesive and adhesive which makes it easy to use. The product will reduce the overall time necessary to perform ridge augmentation procedures, better maintain graft volume over time, and minimize the need for re-grafting.
Achievements
Received FDA approval to conduct and SBIR to fund a first-in-human clinical trial for cranial flap fixation, and enrolled 5 patients.
Regulatory Path
Device-led combination product; IDE submission scheduled for Q3 of 2024
Opportunities for Partnerships
Distribution of the product: Strong industry distribution partner that can represent the product globally
Investment opportunity: Currently seeking Series A financing of $20M to initiate multiple clinical studies
Key Publications & Patents
Kesseli et al. Identification of a calcium phosphoserine coordination network in an adhesive organo-apatitic bone cement system. Acta Biomater 2020
Kirillova et al. Bioinspired mineral–organic bioresorbable bone adhesive. Adv Healthc Mater 2018
US8,232,327 Tetra Calcium Phosphate Based Organophosphorus Compositions and Methods
US8,765,189 Organophosphorous & Multivalent Metal Compound Compositions and Methods
Dentin Regeneration Therapeutics
Il-Ho Jang, PhD (CEO, STEMDEN)
STEMDEN develops tissue regeneration therapeutics for dental applications. Using small molecule modalities, STEMDEN is testing the efficacy of tissue regeneration in human stem cells and animal models to optimize the final formulations for human clinical trials. STEMDEN is currently focusing on dentin-regenerating therapeutics for the treatment of dental caries in order to obtain regulatory approvals. A convergent product of the small molecule Compound P and collagen sponge, PNUT1, shows 90% efficacy for dentin regeneration in mini-pig models. STEMDEN therapeutics will revolutionize the dental industry by moving from the current replacement treatment to regenerative repair of dentin.
Clinical Need
Dental treatment has relied heavily on replacement therapies using artificial materials. Considering that dental tissues are prone to regenerate with high potential of natural healing, it is ironic that regeneration therapy is not the norm to date. Restoring the damaged tissues to near natural and healthy status will have a significant impact on humanity in improving longevity and productivity. Treatment of dental caries by dentin regeneration will change the paradigm of clinical practice.
Solution
A small molecule drug that activates the differentiation of dental pulp stem cells is delivered in a collagen sponge. Compound P, 500 Da small molecule, promotes odontogenic differentiation in vitro culture. PNUT1, the final product of combining Compound P and collagen sponge, shows effective dentin regeneration in 3 months.
Competitive Advantage
Compared with pulp capping materials, including MTA, PNUT1 provides an unprecedented regeneration of dentin and an advantage in preserving healthy pulp. Compared with collagen sponge, PNUT1 provides an advantage in accelerating the regeneration of mineral tissue. The production cost of Compound P decreases with scale-up.
Achievements
Effective high-volume and high-density regeneration of dentin in mini-pig model
Low systemic-toxicity in rat tail vein injection and low topical-toxicity in mini-pig tooth histology
Regulatory Path
510(k)/PMA submission by April 2026
Opportunities for Partnerships
MOA and indication study
Investment
Key Publications & Patents
US12,090,166 Pharmaceutical Composition for Preventing or Treating Dentin-Dental Pulp Disease or Periodontal Disease, Containing LPAR2 Inhibitor
Revitalizing Pulp Therapy Implant for Children
Juan Taboas, PhD (Associate Professor, University of Pittsburgh)
Vital-Dent is an acellular drug-free obturation device indicated for root canal filling following pulpectomy, or for apexogenesis following pulpotomy. Dentist in the USA perform approximately five million endodontic procedures per year on the immature permanent teeth of children to remove inflamed, infected, and diseased pulp. Large animal studies confirm Vital-Dent's biopolymer-based hydrogel supports pulp revitalization and continued root growth, prolonging tooth survival and reducing the long-term treatment costs. Commercialization is at cGMP manufacturing for GLP biocompatibility testing with support from VIC Foundry, Delta Dental, the TRC, and the NIH.
Clinical Need
Approximately 5 million procedures are performed in the USA each year to treat pulpitis of permanent teeth in the pediatric population. Children are often subject to multiple procedures because the standard of care is to stabilize the tooth until more definitive treatment can be performed when the child’s growth stops. The outcomes are unideal, because the whole tooth is not revitalized after pulp removal, resulting in tooth discoloration, loss of tooth structure, and limited (if any) tooth growth.
Solution
Vital-Dent is an acellular, resorbable hydrogel scaffold intended for revitalization of tooth pulp and maintenance of tooth vitality in immature permanent teeth treated with endodontic therapies. It is supplied as a powder in a single-use kit with sterile saline. The powder is rehydrated at the chairside using kit tools to make a clear liquid. The liquid is inserted into the instrumented canal space as would conventional sealers and sets in three minutes with a dental curing lamp to form the colorless Vital-Dent hydrogel. The tooth is then sealed with a bioceramic and restored with conventional techniques.
Competitive Advantage
Unlike current obturating materials, Vital-Dent is resorbable and promotes continued development of immature teeth, pulp revitalization and regenerative dentin, root strengthening, and long-term survival of the tooth. Vital-Dent eliminates difficulties of the only available revitalization procedure, revascularization therapy, with more consistent outcomes including root development, and a better fit with conventional clinic workflows including no phlebotomy and faster delivery.
Achievements
SBIR awarded to VIC Foundry, based on ITP work
Regulatory Path
510(k)
Opportunities for Partnerships
Seeking academic partnership in studies that promote adoption and advance therapy development
Key Publications & Patents
Zaky et al. Effect of the periapical “inflammatory plug” on dental pulp regeneration: A histologic in vivo study. J Endod 2020
PCT/US2019/023132 Regeneration of Vital Tooth Pulp
Thank You Event Sponsors!
TRC would like to thank the following companies for their generous support of the 2025 TRC Networking Exchange
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TRC would like to recognize the following companies for their long-standing guidance and support
which have been instrumental in the growth of the TRC
