Development of a novel bone adhesive scaffold to accelerate bone regeneration and improve ridge height maintenance for the treatment of patients with residual ridge resorption

Ended Project Grant Awarded Last action

Award ID
R44DE032564
Recipient
Awarding agency
Obligated
$3,991,320

Award facts

Assistance listing
93.121 Oral Diseases and Disorders Research
Completion date
Place of performance
Massachusetts, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Over 50% of US adults over the age of 45 have missing teeth. Following tooth loss, the alveolar portion of the jaw will atrophy in a process known as residual ridge resorption. While dental implant-supported crowns have become the standard of care, market research indicates that 70% of patients must undergo a ridge augmentation procedure to provide adequate bony structure to accept implant placement. The market for bone grafts is highly fragmented, indicating that the ideal material meeting user needs does not exist. Most dentists remain dissatisfied with existing bone grafts due to their challenging handling properties and poor predictability. Due to the lack of structural integrity, they typically require extra costs and steps to place ancillary containment devices to prevent graft migration and fibrous tissue ingrowth that impedes bone regeneration. As a result, a secondary augmentation procedure is required in 30% of cases to ensure sufficient volume for implant placement. Revbio, INC. Has developed a highly porous, regenerative bone graft biomaterial with adhesive properties called tetranite® adhesive dental bone scaffold (TN-adbs). Unlike currently available graft materials, TN-adbs is cohesive during application and its unique adhesive properties allow IT to maintain form, eliminating the need for ancillary fixation or containment devices. TN-adbs is comprised of o-phospho-l-serine (opls), which in part makes IT uniquely adhesive to bone and studies have also found opls during its resorption and local release to be osteopromotive, lending this product to yield a more predictable and efficacious product. Prior funding from the NIH-michigan pittsburgh wyss regenerative medicine resource center has been used to: (a) develop TN-adbs, (b) evaluate its performance in user handling trials, (c) develop a canine model with a mandibular critical-sized defect, and (d) conduct preliminary efficacy studies in this model. Based on FDA feedback, TN-adbs will be regulated as a device-led combination product, where opls is the drug constituent promoting bone regeneration. The following proposed phase II grant application is designed per recent FDA feedback to address the following two specific aims: (1) to assess the local/systemic effects of TN-adbs (opls) and pharmacokinetics/pharmacodynamics (PK/PD) under maximal use conditions in a new zealand white rabbit model and (2) to demonstrate the safety and efficacy of TN-adbs in a pivotal animal study for the intended clinical use to augment deficient jaw bone by (i) showing local or systemic adverse effects of TN-adbs treated defects are non-inferior to controls and (II) by showing superior ridge height maintenance throughout the course of bone substitution in comparison to controls (p

Transactions

Action Obligated Date
Amendment $0
Amendment $730,212
Amendment $730,212
Amendment $1,265,448
Original award $1,265,448

Quick answers

Who received award R44DE032564?

R44DE032564 was awarded to Revbio, Inc. by National Institute of Dental and Craniofacial Research (National Institutes of Health) on June 1, 2023.

How much is award R44DE032564 worth?

$3,991,320 has been obligated on R44DE032564.

On GovTribe

See this award's full record

  • Every transaction and subaward
  • The recipient's other awards and teaming partners
  • Similar grant awards
  • Ask GovTribe AI about this award
Try for free Login