Caeruleum Biotechnologies
The LunaFlex synthetic meniscus, a translucent C-shaped implant with peripheral suture strands and a porous metal fixation bridge, standing on a circular plinth.

A synthetic meniscal replacement system LunaFlex Get back to unstoppable.

Caeruleum Biotechnologies, INC.

Caeruleum Biotechnologies, Inc. is a preclinical orthopaedic medical device company. The LunaFlex Meniscus is a fiber-reinforced, patient-matched synthetic meniscus, engineered to replace meniscal tissue rather than remove it.

  • Preclinical – no FDA clearance
  • US Patent 11,147,677
  • Founded 2022
Two LunaFlex implants side by side, one configured for the medial meniscus and one for the lateral, each with peripheral suture strands and a fixation bridge.
Medial and lateral configurations Design render

The device

A total replacement for the medial or lateral meniscus

Most meniscal surgery removes tissue. LunaFlex is designed to replace it – a durable composite implant engineered to restore load distribution across the joint and to stay there for the long term.

It is being developed for the meniscus-deficient knee: patients whose meniscal tissue cannot be repaired or has already been removed, and whose remaining options are only pain management, resection, or allograft transplant.

See how it works

The problem

The tear is treatable.What follows is not.

Meniscal surgery is among the most common orthopaedic procedures in the U.S., and most of it removes tissue rather than restoring it.

850,000+ Meniscal procedures are performed in the U.S. each year, and most remove damaged tissue rather than replace it.
78% Of approximately 3.9 million symptomatic patients each year, most never receive surgical treatment for the injury.
~50% Ten-year meniscectomy failure approaches 50% in patients 40 and older, who account for roughly 70% of procedures.
3 in 4 Three in four patients go on to develop osteoarthritis after treatment under today’s tissue-removing standard of care.

No durable, joint-preserving option currently exists to break this cycle.

StatPearls, Knee Meniscal Tears, 2023 · Baker et al., Am J Sports Med, 1985 · National ACL Injury Coalition, 2023 · Sihvonen et al., FIDELITY, NEJM, 2013 · Reito et al., Acta Orthop 2022 · Roos et al., Arthritis Rheum 1998.

Work with us

Three ways to go further

Follow Us

Caeruleum is preclinical. We share development milestones with people tracking the category.

Get updates

Partner

For corporate and business development teams weighing meniscal replacement as a category.

Start a conversation

Advise

We are recruiting orthopaedic surgeons to a clinical advisory board for the LunaFlex program.

Express interest