This $252,906 National Science Foundation project grant supports the development of scalable manufacturing methods for peptide amphiphile molecules by Amphix Bio Inc. The goal is to advance a safer and more affordable alternative to recombinant proteins currently used in spinal fusion surgeries. Over 500,000 such surgeries are performed annually in the U.S. to treat back and neck pain. While peptide amphiphiles show promise for reducing biological dose needs and offering consistent outcomes,...
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Cooperative Agreement award to Reselute, Inc. provides $998,921 to develop a novel implantable orthopedic medical device and procedure to reduce recovery duration and infection risks associated with severe traumatic fractures of the long bones. The project aims to advance a 3D-printed, antibiotic-releasing intramedullary nail to improve upon current standard-of-care implants that are prone to...
The National Institute of Dental and Craniofacial Research (NIDCR) awarded a $1,963,287 Project Grant (CFDA 93.121 - Oral Diseases and Disorders Research) to Cleveland State University to develop a multi-functional, 3D printed dental implant that can effectively prevent peri-implantitis, a common and challenging implant-related oral infection. The project aims to engineer a silver-doped, antibacterial and bioactive composite material called "Ultra-PEEK" that can be 3D printed into...
This Project Grant from the National Science Foundation's Technology, Innovation, and Partnerships program totaling $295,247 will support the development of an innovative medical technology for localized and sustained antibiotic treatment of periprosthetic joint infection. Specifically, the awardee Reselute will design, develop, and validate a proof of concept for an orthopedic spacer implant with a novel porous medium capable of controlled antibiotic elution over 180 days. The implantable...
This federal Project Grant award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), under CFDA Program 93.846 - Arthritis, Musculoskeletal and Skin Diseases Research, is for the development of a "Smart Cavity Creator Drill for Lumbar Interbody Fusion". The $830,712 award, effective from April 1, 2025 to March 31, 2027, aims to commercialize a novel lumbar interbody fusion technology that uses a small approach channel to create a large cavity in...
This National Science Foundation (NSF) Cooperative Agreement award under the NSF Technology, Innovation, and Partnerships (TIP) program (CFDA 47.084) provides $1,000,000 in funding to Amphix Bio Inc. to develop scalable manufacturing methods for a novel supramolecular polymer-based spinal implant. The project aims to enable safer, simpler, and lower-cost spinal fusion surgery by advancing this regenerative medicine technology. The key deliverables include scaling up the production of the...
The National Science Foundation (NSF) awarded a $273,563 Small Business Innovation Research (SBIR) Phase I grant to Medicarbone Inc. under the NSF Technology, Innovation, and Partnerships (CFDA 47.084) program. The objective of this 12-month project is to design, develop, and demonstrate the feasibility of a minimally-invasive intramedullary (IM) sleeve system with an in situ, photocurable, and removable polymeric bone cement for the treatment of orthopedic fractures. The project aims to address...
This Project Grant award from the National Science Foundation (NSF) Technology, Innovation, and Partnerships (TIP) program (CFDA 47.084) provides $305,000 to Magsorbeo Biomedical Corp to develop a bioabsorbable magnesium alloy for maxillofacial fixation. The project aims to create a magnesium-based implant that can temporarily fixate bones or stabilize tissues during recovery, while being gradually absorbed by the body, eliminating the need for secondary hardware removal surgeries. Key goals...
This $1,816,884 federal Project Grant award from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) under the Discovery and Applied Research for Technological Innovations to Improve Human Health program (CFDA 93.286) aims to develop, evaluate, and prepare regulatory paperwork for a new technique to guide implant placement in orthopedic surgery. The key products and services include: Developing a surgical navigation workstation to integrate a low-profile guidance robot with...
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Phase I Small Business Innovation Research (SBIR) project aims to develop a novel implantable system that leverages distraction osteogenesis as a treatment for diabetic foot ulcers (DFUs). The $295,000 award, effective from December 15, 2024 to August 31, 2025, supports the design and development of a low-profile implantable transverse tibial transport device. This device integrates an active mechanical...
3D PRINTED SILICON NITRIDE POROUS PEEK COMPOSITE SPINAL CAGES FOR ANTI-INFECTION - PROJECT SUMMARY SPINAL FUSION IS THE STANDARD TREATMENT FOR PERSISTENT NECK AND BACK PAIN, BUT THE HARDWARE USED TO STABILIZE THE FUSION CAN HARBOR OR EVEN PROMOTE BACTERIA THAT LEAD TO PERSISTENT, DIFFICULT-TO-TREAT INFECTIONS THAT ARE COSTLY AND DAMAGING TO PATIENT HEALTH. AMONG THE AVAILABLE MATERIALS FOR SPINAL FUSION, POLYETHER-ETHER-KETONE (PEEK) CAGES STAND OUT DUE TO THEIR STRENGTH, BIOCOMPATIBILITY, AND RADIOLUCENCY, BUT LIKE OTHER MATERIALS, THEY ARE SUSCEPTIBLE TO SPINAL INFECTIONS. SILICON NITRIDE (SI3N4) SPACERS HAVE BEEN USED IN OTHER SPINAL APPLICATIONS WHERE THEIR RATES OF REPORTABLE ADVERSE EVENTS DUE TO INFECTION ARE MUCH LOWER THAN INDUSTRY NORMS, BUT THEY ARE NOT IDEAL FOR STABILIZING SPINAL FUSIONS DUE TO THEIR POTENTIAL FOR SUBSIDENCE AND BRITTLE FRACTURE. TO ADDRESS THIS CHALLENGE, SINTX USED PHASE I SBIR FUNDING TO DEVELOP AND TEST A 3D-PRINTED SI3N4-PEEK MATERIAL THAT INCORPORATES THE ANTIMICROBIAL AND OSSEOINTEGRATIVE PROPERTIES OF SI3N4 WITH THE STRENGTH AND ELASTICITY OF PEEK. IN THIS PHASE II SBIR, SINTX PROPOSES TO USE THIS MATERIAL TO DEVELOP A 3D-PRINTED ANTI-MICROBIAL SPINAL FUSION CAGE THAT PROMOTES OSSEOINTEGRATION, WITHSTANDS IN VIVO LOADING, AND FACILITATES IMAGING. THE PROJECT INCLUDES LONG-TERM BIOMECHANICAL PERFORMANCE AND IN VIVO FUSION PROPERTY TESTING IN BOTH NORMAL AND CONTAMINATED OPERATIVE SCENARIOS. SUCCESSFUL COMPLETION OF THESE ACTIVITIES WILL POSITION SINTX TO PREPARE A 510(K) PREMARKET NOTIFICATION APPLICATION FOR FDA. SINTX ANTICIPATES FURTHER DEVELOPMENT AND COMMERCIALIZATION OF A 3D-PRINTED SI3N4-PEEK SPINAL FUSION CAGE WILL PROVIDE ORTHOPEDIC SURGEONS A HIGH-PERFORMANCE FUSION DEVICE THAT COULD GREATLY REDUCE THE INCIDENCE OF FUSION-ASSOCIATED INFECTIONS. AIM 1. MINIMIZE POTENTIAL DESIGN AND MANUFACTURING HAZARDS BY FORMAL DESIGN AND PROCESS RISK MANAGEMENT ANALYSES IN ACCORDANCE WITH ISO 14971. MILESTONE: COMPLETION OF THE DESIGN FMEA AND PROCESS FMEA PER ISO 14971 TO MINIMIZE RISKS ASSOCIATED WITH THE NOVEL CERVICAL CAGES AND DESIGN FREEZE. AIM 2. VERIFY THAT THE FINALIZED 3DP SI3N4-PEEK CERVICAL CAGE MEETS THE STATIC AND FATIGUE LOADING REQUIREMENTS OF ASTM F2077 AND SUBSIDENCE REQUIREMENTS OF ASTM F2267. MILESTONE: FOLLOWING THE DESIGN FREEZE IN AIM 1, DEMONSTRATE STATIC AND FATIGUE COMPRESSION, SHEAR, AND TORSION STRENGTH AND SUBSIDENCE RESISTANCE OF THE FINALIZED 3DP SI3N4-PEEK'S POROUS CAGE MEETS OR EXCEEDS THE GUIDELINES FOR CERVICAL CAGES ESTABLISHED BY ASTM F2077 AND ASTM F2267 AND BENCHMARKED FOR MANY CAGE MANUFACTURERS IN THE LITERATURE. AIM 3. DETERMINE ANTIMICROBIAL ACTIVITY (EXPERIMENTAL ARM) AND IN VIVO BIOCOMPATIBILITY AND OSTEOINTEGRATION (BIOCOMPATIBILITY GLP ARM) FOR A 3DP SI3N4-PEEK CERVICAL CAGE IN A CAPRINE MODEL OF CERVICAL SPINAL FUSION. MILESTONE: FINAL, PACKAGED, AND VALIDATED IMPLANTS WILL PASS REQUIREMENTS IN ISO 10993. 3DP SI3N4-PEEK IMPLANTS WILL HAVE BIOCOMPATIBILITY, BONE INGROWTH, FUSION, AND RESISTANCE TO INFECTION COMPARABLE TO OR BETTER THAN CONTROL 3DP PEEK SPINAL CAGES.