Market Research Report: RevBio, Inc.

Company Overview

• Name: RevBio, Inc.

• Mission: To end medicine's 50-year search for a biocompatible bone adhesive.

• Founded: 2014 by Brian Hess.

• Key People:

• Brian Hess, MBA: Chief Executive Officer, Founder

• D. Grayson Allen, MBA: Chief Operations Officer & CFO

• George Kay, DMD: Chief Scientific Officer

• Headquarters: Lowell, MA

• Number of Employees: No information is available

• Revenue: No information is available

• What is the company known for: Developing TETRANITE®, a revolutionary bone adhesive biomaterial.

Products

TETRANITE®

• High Level Description:

• TETRANITE is a synthetic bone adhesive bioengineered from the sandcastle worm's secreted protein. It consists of mineral-organic compounds that transform from a pliable putty to a cement-like adhesive scaffold in wet conditions.

• Key Features:

• Wet Field Performance: Effective bonding in wet surgical environments.

• Multi-Surface Bonding: Adheres to both bone and metal surfaces.

• Mechanical Stability: Rapid mechanical stability, with tensile and shear bond stresses as high as 3 MPa.

• Controlled Biodegradability: Gradually dissolves and is replaced by new bone, maintaining mechanical integrity.

• Cost-Effective: Can be produced in large quantities at a low cost due to its synthetic nature.

Recent Developments

• New Products Launched:

• No information is available

• New Features Added:

• No information is available

• New Partnerships:

• RevBio has developed a broad base of research partners and collaborators, including university-based research teams and leading clinical research organizations.

Recent Press Releases

• December 8, 2023: RevBio receives FDA approval to conduct the first-in-human clinical trial for cranial flap fixation using TETRANITE®.

• October 25, 2023: Awarded a $2 million NIH grant to reduce opioid use and addiction with TETRANITE®.

• October 6, 2023: Awarded a $3.4 million NIH grant for treating complex fractures.

• August 1, 2023: Receives FDA approval for a clinical trial for dental implant stabilization.

• June 7, 2023: Awarded a $2 million grant for developing its dental adhesive bone scaffold product.

• May 22, 2023: Receives ISO certification for its quality management systems.

• February 14, 2023: Receives a strategic investment from Pacific Dental Services for ongoing clinical trials.

• January 18, 2023: Receives approval to start a dental clinical trial in Italy.

Publications

• Bone Glue—The Final Frontier for Fracture Stabilization and Implantable Device Stabilization—M.R. Norton, G. Kay, M. Brown, D.L. Cochran.

• Pivotal Animal Study for Cranial Flap Fixation—Foley, Kevin T., et al. “Cranial flap fixation in sheep using a resorbable bone adhesive.” Journal of Neurosurgery (2020).

• Bioinspired Mineral–Organic Bioresorbable Bone Adhesive—Alina Kirillova, et al.

Pipeline Applications

Dental Stabilization

• Market Size: Combined U.S. and European market estimated at $1.5B.

• Procedure Simplification: Reduces the current 12-month multi-visit procedure to potentially two visits over six months or less.

• Market Need: 50% of the U.S. population over 45 has missing teeth, with only 2% treated due to complex procedures.

Dental Bone Graft

• Market Size: Estimated at $700M in the U.S. and Europe.

• Need for Innovations: High failure rate (31%) of existing procedures creates a demand for a product that does not require ancillary fixation or containment devices.

Cranial Flap Fixation

• Market Size: $500M combined market in the U.S. and Europe.

• Advantages: Enhances bone healing, reduces infection rates, and improves cosmetic outcomes by eliminating metal fixation hardware.

Fracture Fixation

• Market Size: $500M in the U.S.

• Market Opportunity: TETRANITE for distal radius fractures could reduce complications (currently 36%) from existing fixation techniques.

Dental Animal Health

• Market Size: $950M for filling sockets following tooth extractions.

• Market Opportunity: High rates of periodontal disease in pets and expensive surgeries drive the need for improved dental and orthopaedic solutions.

Conclusion

RevBio is poised to revolutionize bone repair with TETRANITE®, addressing diverse market needs within orthopaedics, dental, and animal health sectors. The company continues to receive significant grants and regulatory approvals, validating the transformative potential of its technology.