An official website of the United States government
Surgeons treat 15 million bone-related injuries and defects annually in the United States alone. However, the current standards of care involve complex and invasive procedures that often incur long recovery times and limited mobility for patients. In fact, the rate of complications is as high as 36%, and may complications require revision surgeries.
A regenerative, high-strength, injectable bone adhesive called Tetranite® provides surgeons a new capability to transform bone fixation and repair. Not only does Tetranite have immediate load-bearing strength, bonding bone to bone as well as bone to metal, it also reabsorbs and is replaced with new bone during the natural healing process. In fact, research indicates that the load-bearing material is osteopromotive, accelerating bone healing and remodeling. The use of this unique material will reduce the duration and complexity of orthopedic and dental procedures, allow for more minimally invasive surgeries, and improve patient outcomes by reducing pain and recovery time and the overall cost of care.
RevBio will be developing Tetranite products to address unmet needs across five markets: dental, cranial, trauma, spinal, and veterinary applications. The total addressable market in the United States and Europe for all applicable indications totals more than $10 billion.
Tetranite is the only patented, regenerative, synthetic, adhesive biomaterial that is load-bearing at application, promotes bone growth, and bonds bone to bone and bone to metal in a wet field. These indications were selected based on a strong value proposition of eliminating surgical steps, accelerating return to function, and/or reducing complications based on today’s standard of care. Tetranite is protected by 8 issued patents, along with more than 10 additional patents pending across both the United States and several key countries across the globe.
Company Milestones
Scientific and Clinical
- 2022/2023: Project to grow bone with the International Space Station
- 2022/2023: Clinical stage in dental, vet, and cranial trials
Food and Drug Administration (FDA) approval to initiate dental implant stabilization clinical trial - FDA approval to initiate cranial flap fixation clinical trial
- 2024: Achieve enrollment for dental clinical studies
- 2024: Achieve enrollment for cranial flap fixation pilot clinical studies
- 2024: Regulatory approvals to initiate adhesive dental bone scaffold clinical studies
- 2024: Regulatory approvals to initiate extremity fracture fixation clinical studies
- 2024: Initiate pivotal animal study for vertebral compression fracture repair
Business
- 2023: Received strategic investment from Pacific Dental Services
- 2023: Raised $5 million in convertible notes
- 2023: Achieved ISO) 13485 certification of manufacturing and quality systems
- 2023: Won a $2 million adhesive dental bone scaffold research and development (R&D) grant
- 2023: Won a $2 million adhesive pain therapeutics delivery R&D grant
- 2023: Won a $3.4 million adhesive for fracture fixation grant for R&D and a clinical trial
- Q2 2024: Raise $25 million in a Series A round
- Q4 2024: Commercialize the veterinary alveolar fill product
Financial Overview
RevBio has raised $42,000,000 (investor and grant funding), including $17,000,000 of non-dilutive Small Business Innovation Research grants. A $5 million convertible note recently closed. RevBio’s current goal is to raise $25 million in a Series A round by Q2 2024. For future funding, the company hopes to raise $30 million in a Series B round in Year 3 of 5. Activities include commercialization, clinical trials, human regulatory applications, pre-clinical testing, regulatory support, and intellectual property protection.
Intellectual Property
RevBio has an exclusive, worldwide license from Stryker to six issued patent families covering the bone adhesive technology and all fields of use. All of the issued patent families expire between 2029 and 2033. RevBio also has the right to manage the ongoing prosecution of both domestic and international patent filings, as well as the right to secure patents for derivative formulations and inventions associated with the patented adhesive technology. Since 2016, RevBio has filed 12 patient care technology patent applications, three of which have recently issued, that will expand the patent estate and coverage period to at least 2037.
Product Development and Regulatory Strategy
FDA has designated Tetranite as a device or device-led combination product with therapeutic bone regeneration claims. The device will be either Class I risk, for indications that allow for a de novo pathway pursued for bone regeneration or adhesive augmentation claims with approval in approximately two to three years, or Class III, for indications that will follow the premarket approval pathway for standalone use load-bearing claims, which takes approximately four to five years. RevBio has led more than 15 Q-submission meetings with FDA to define pathways and testing plans for the various indications and has now had three investigational device exemption applications approved, allowing human studies for the Tetranite bone adhesive technology for assessment in dental and cranial indications.
Commercialization Strategy
RevBio’s platform rollout strategy exploits R&D synergies and parallel markets to capture as much of the $10 billion total addressable clinical market opportunities as possible. The company expects its first Tetranite product to launch to market as a veterinary dental bone adhesive by the end of 2024 and the first two Tetranite products to launch for human use in dental and cranial applications by mid-2026.
Company Details
Lowell, MA
Industry: Therapeutics
Management Team:
- Chief executive officer and founder: Brian Hess, M.B.A.
- Chief financial officer, chief operations officer, and co-founder: D. Grayson Allen, M.B.A.
- Chief science officer: George Kay, D.M.D., M.M.Sc.
- Chief medical officer: Kevin Foley, M.D.
- Vice president of R&D: Mike Brown, M.S.
Point of Contact:
Brian Hess
bhess@revbio.com
(617) 460-6675
SBIR