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Commercialization of an Improved Treatment of Extremity Fractures Using a Regenerative Bone Adhesive to Accelerate Bone Healing in Aging Patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1SB1AG085803-01
Agency Tracking Number: SB1AG085803
Amount: $1,746,739.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PAR20-130
Solicitation Year: 2020
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2026-08-31
Small Business Information
600 Suffolk Street, Suite 250
Lowell, MA 01854-3643
United States
DUNS: 068750201
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (617) 460-6675
Business Contact
Phone: (617) 947-6246
Research Institution

Project Abstract/Summary
In the U.S., about 2.1 million people experience a fragility fracture each year. This number is expected to double
or triple by 2040 as the population ages. Injuries in the upper and lower extremities equate to more than 40% of
fragility fractures, and experiencing a prior fracture is associated with an 86% increased risk of recurrence. Falls
from standing height and other low-energy trauma account for 87% of all orthopedic fractures among the elderly.
External fixation, percutaneous pinning, and open reduction internal fixation with locking plates are interventions
that are currently being used to treat extremity fractures. Despite advances in surgical technique and implant
design, nonunion, malunion, and hardware failure continue to remain a significant cause of revision surgery in
the elderly. Complication rates as high as 36% have been reported and involve onset of carpal tunnel syndrome,
complex regional pain syndrome, tendon irritation and rupture, and deep infection.
To address this problem, RevBio developed Tetranite® (TN), a novel bone adhesive that can fill gaps in bone,
fixate bone fragments, and accelerate healing through its osteoconductive effects. TN can be used as an adjunct
to traditional hardware fixation to provide immediate load sharing between the metal plate and screw systems,
and bone. It provides additional stability by enhancing fracture stabilization to achieve better healing and
prevents hardware failure. It can also be injected percutaneously a standalone method of fixation providing an
option to surgically treat fractures without the need for open reduction, metal hardware, or anesthesia.
Proposed work to treat extremity fractures in the elderly will bridge off existing late-stage development of TN
supported by a SBIR Phase II award from the National Institutes of Aging entitled, “Improved Treatment of Distal
Radius Fractures Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive” (R44 AG060881-
02). This grant enabled formulation optimization and conduction of user validation studies with surgeons (Aim 1)
and a pivotal animal study in sheep (Aim 2) to demonstrate safety and efficacy of TN. This project is focused on
a specific indication to treat distal radius fractures; however, based on discussions with FDA and surgeons, the
impact and value of the material could be expanded to a wider set of indications across all metaphyseal fractures
in the upper and lower extremities for this same patient population. Therefore, this grant would provide additional
funding to conduct market research and supplemental pre-clinical development costs to expand its use to these
additional anatomic regions. This funding would also enable completion of biocompatibility, sterilization,
packaging, and shelf-life validations to finish late-stage development, enabling RevBio to file an IDE, and execute
a clinical study with TN as an adjunct to hardware. The overarching goal of this program is to build off successful
Phase II research and to execute Aim 1 and Aim 2 to lead to product regulatory approval for commercialization.
Long term, RevBio’s mission is to commercialize TN in order to provide surgeons with a novel product that will
enhance fixation, accelerate healing, and reduce complications associated with extremity fractures in the elderly.

* Information listed above is at the time of submission. *

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