R43AR083299

Pre-clinical assessment of a minimally invasive meniscus implant to delay arthritis - Abstract

Meniscus tears are among the most common orthopedic injuries, with about 1 million occurring in the United States each year and growing at a rate of 5% annually. Shortcomings associated with the current standard of care leaves a clinical need for a new treatment option.

The meniscal tissue can only be repaired in limited cases due to its healing capacity, so the most common treatment for meniscal tears is removal of the damaged tissue, or a meniscectomy. The contact stress in the joint increases proportionally with the amount of meniscus tissue removed due to the decrease in contact area, and this increase in contact stress frequently leads to articular cartilage damage and the development of osteoarthritis (OA).

Once a patient damages their articular cartilage, which causes chronic pain and impacts knee function, the patient has few choices. Most patients must undergo a total knee replacement to relieve their symptoms, which is a very invasive surgery with permanently debilitating consequences. Since most meniscectomies are performed on patients under the age of 55, the patient is often too young to be considered for a total knee replacement and is in need of an alternative option.

OrthoPreserve, a small business of clinicians and engineers, is developing an artificial meniscus implant to fill the significant treatment gap for patients during the time between a meniscus injury and a knee replacement. There are currently no meniscus implants available on the consumer market in the United States, so this device has the potential to disrupt the orthopedic market and provide a breakthrough treatment option.

Previous studies on the implant have demonstrated its ability to restore the natural contact pressure distributions within the knee joint, and significant mechanical testing on the implant's composite material has shown that the material is strong and durable enough to withstand the forces that the meniscus experiences in the knee.

In Phase I, OrthoPreserve will demonstrate the feasibility of this meniscus implant to become a viable product in the treatment of meniscus injuries and delay of arthritis through three specific aims. Aim 1 will assess the safety and efficacy of the implant in an animal model. Aim 2 will refine a minimally invasive implantation method for the implant within human cadaver knees and provide insight into potential attachment redesigns. Aim 3 will show that size variations can allow the implant to restore function while also remaining securely fixed in the joint after cyclic use in various knee sizes.

A significant market opportunity exists for OrthoPreserve's meniscus implant, and this technology can enhance quality of life for millions of patients and reduce overall healthcare burden in meniscus injury and OA treatment.

Orthopreserve

THE NATIONAL INSTITUTE OF AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) MISSION IS TO SUPPORT RESEARCH INTO THE CAUSES, TREATMENT, AND PREVENTION OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES, TRAINING OF BASIC AND CLINICAL SCIENTISTS TO CARRY OUT THIS RESEARCH, AND DISSEMINATION OF INFORMATION ON RESEARCH PROGRESS IN THESE DISEASES. THE EXTRAMURAL PROGRAM PROMOTES AND SUPPORTS BASIC, TRANSLATIONAL, AND CLINICAL STUDIES OF SYSTEMIC RHEUMATIC AND AUTOIMMUNE DISEASES, SKIN BIOLOGY AND DISEASES, BONE BIOLOGY AND DISEASES, MUSCLE BIOLOGY AND DISEASES, AND JOINT BIOLOGY AND DISEASES AND ORTHOPAEDICS. NIAMS SYSTEMIC RHEUMATIC AND AUTOIMMUNE DISEASES PROGRAMS ADDRESS BASIC, TRANSLATIONAL, AND CLINICAL RESEARCH, INCLUDING CLINICAL TRIALS AND OBSERVATIONAL AND MECHANISTIC STUDIES, FOCUSED ON IMMUNE-MEDIATED ARTHRITIS AND AUTOIMMUNE-RELATED ACUTE AND CHRONIC DISORDERS IN ADULTS AND CHILDREN. NIAMS SKIN BIOLOGY AND DISEASES PROGRAMS SUPPORT BASIC, TRANSLATIONAL, AND CLINICAL RESEARCH IN SKIN, INCLUDING BOTH COMMON AND RARE SKIN DISEASES. THESE PROGRAMS INCLUDE INVESTIGATIONS OF THE BASIC MOLECULAR, CELLULAR, AND DEVELOPMENTAL BIOLOGY OF SKIN, AS WELL AS STUDIES OF SKIN AS AN IMMUNE, SENSORY, ENDOCRINE, AND METABOLIC ORGAN. NIAMS BONE BIOLOGY AND DISEASES PROGRAMS SUPPORT RESEARCH ON THE CONTROL OF BONE FORMATION, RESORPTION, AND MINERALIZATION AS WELL AS THE EFFECTS OF SIGNALING MOLECULES ON BONE CELLS. THEY SUPPORT CLINICAL STUDIES OF INTERVENTIONS TO PREVENT FRACTURES ASSOCIATED WITH OSTEOPOROSIS AND RESEARCH INTO LESS COMMON BONE DISEASES. NIAMS MUSCLE BIOLOGY AND DISEASES PROGRAMS ENCOURAGE RESEARCH ON MUSCLE DEVELOPMENTAL BIOLOGY, GROWTH, MAINTENANCE, AND HYPERTROPHY, PHYSIOLOGY OF CONTRACTION, STRUCTURAL BIOLOGY OF THE CONTRACTILE APPARATUS, DISEASE MECHANISMS, BIOMARKERS AND OUTCOME MEASURES, AND DEVELOPMENT AND CLINICAL TESTING OF THERAPIES FOR CONDITIONS INCLUDING THE MUSCULAR DYSTROPHIES. NIAMS JOINT BIOLOGY, DISEASES, AND ORTHOPAEDICS PROGRAMS SUPPORT A BROAD SPECTRUM OF RESEARCH CENTERED ON THE INTERPLAY AMONG THE BODY'S MUSCLES, BONES, AND CONNECTIVE TISSUES. THEY ENCOURAGE TISSUE ENGINEERING AND REGENERATIVE MEDICINE RESEARCH, MOLECULAR BIOLOGY, IMAGING, AND CLINICAL RESEARCH, AND THE TREATMENT AND PREVENTION OF ORTHOPAEDIC CONDITIONS. NIAMS PARTICIPATES IN THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS. THE SBIR PROGRAM IS INTENDED TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE STTR PROGRAM IS INTENDED TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.846 - Arthritis, Musculoskeletal and Skin Diseases Research

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) [HHS - NIH]

Georgia United States

State-Wide

Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed) (PAR-23-032)

Amendment Since initial award the End Date has been extended from 08/31/24 to 12/31/24.