Cushion impact
Absorbs shock as the knee bears weight
Understanding the meniscus and meniscal tears
The meniscus is an important part of how the knee cushions and distributes load. Caeruleum is developing LunaFlex, a synthetic meniscal replacement system for the meniscus-deficient knee.
The knee in plain language
What the meniscus does
Each knee has two menisci: firm, flexible pads of tissue between the thighbone (femur) and shinbone (tibia).
Together, they help the rounded end of the thighbone meet the flatter top of the shinbone as the knee bends, straightens, and bears weight.
Distribute weight
Spreads force across the top of the shinbone
Support stability
Helps the joint stay stable as it moves
A meniscal injury can happen suddenly or develop over time, and the symptoms and care needs differ from person to person.
A licensed healthcare professional can evaluate an individual knee and explain the care options that may be appropriate.
General education: AAOS OrthoInfo and MedlinePlus.
The problem with meniscal injuries
Why a tear can become a long-term joint problem
A torn meniscus does not heal uniformly. Much of its inner region has little or no direct blood supply, limiting the tissue’s ability to repair itself.
Healing capacity is limited
Tears near the vascular outer rim may have greater healing potential. Tears farther inward often receive less of the blood supply needed to support repair.
Tissue loss changes joint loading
When damaged tissue cannot be preserved, removing it may relieve symptoms but leaves less meniscus to cushion the knee and distribute force.
Cartilage bears the consequence
With less functional meniscus, contact stress can rise across the joint surface, contributing over time to cartilage damage and earlier osteoarthritis.
General education: AAOS OrthoInfo · Roos et al., Arthritis Rheum, 1998. Individual risks and treatment decisions vary and should be discussed with a licensed healthcare professional.
What “meniscus-deficient” means
A meniscus-deficient knee is one in which some or all functional meniscal tissue is absent.
It describes anatomy
The term describes the amount of functional meniscal tissue in the knee. It does not, by itself, explain someone’s symptoms.
It is not a treatment decision
Caeruleum uses the term to describe the development focus for LunaFlex – not to identify, screen, or advise individual patients.
How do we solve this?
What Caeruleum is developing
LunaFlex is designed to directly solve the issues that plagued previous synthetic meniscal replacements. Our thesis is rooted in three design concepts:
Native biomechanics performance
The implant is engineered to restore the meniscus’s load-distribution and stability functions across compression, rotation, and everyday joint motion.
Anatomic sizing & positioning
Patient-matched sizing and pre-operative planning are intended to support anatomic fit, alignment, and positioning within the individual knee.
Anchor durability
Central and peripheral fixation elements are being developed to maintain secure attachment through repeated loading and joint motion.
These are design features and development objectives, not established clinical benefits.
Explore the LunaFlex platformToday’s status
Where development stands
The work is preclinical. No treatment is being offered through this website.
Caeruleum is not evaluating individual cases, screening patients, or enrolling participants. Any future clinical study would begin only after the required regulatory and independent ethics reviews are complete.
Learn about investigational-device safeguards in the FDA’s IDE FAQs.
- Preclinical design and testing
- Current stage
- Clinical study enrollment
- Not underway
- Clinical availability
- Not available
Common questions
What patients and families often want to know
These answers describe the development program. They are not medical advice.
What is the LunaFlex?
The LunaFlex is a synthetic meniscal replacement system in preclinical development for the meniscus-deficient knee. It is a device-development program, not an available treatment.
What does “preclinical development” mean?
Preclinical development includes design and testing work performed before any potential clinical investigation in people. Preclinical work does not establish that a device is safe or effective for patients.
Is the LunaFlex FDA cleared or approved, or available now?
No. The LunaFlex has not received FDA clearance or approval and is not available for clinical use or sale. Its safety and effectiveness have not been established.
Who is the LunaFlex being developed for?
The development focus is the meniscus-deficient knee. Final indications, if any, would depend on future testing and regulatory review. Caeruleum is not using this website to determine whether a product in development may be appropriate for an individual.
Is Caeruleum recruiting or screening patients?
No. Caeruleum is not recruiting, enrolling, or screening patients through this website. Nothing here is an offer of treatment or an invitation to participate in research.
What should I do if I have knee pain or questions about my care?
Please speak with a licensed healthcare professional. Caeruleum cannot diagnose a condition, recommend treatment, interpret imaging, or advise whether a product in development may be appropriate for an individual.
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