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 orthopedic 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 resection, allograft transplant, or waiting for a knee replacement.

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 United States every year, most of which remove tissue.
78% Of roughly 3.9M symptomatic patients each year, the large majority are never treated surgically.
~50% Ten-year failure rate for meniscectomy in patients 40 and over; allograft transplant runs to about 55%.
3 in 4 Patients go on to develop osteoarthritis after treatment under the current 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 · Zaffagnini et al., Arthroscopy 2019 · Sihvonen FIDELITY, NEJM · Roos et al., Arthritis Rheum 1998.

Work with us

Three ways to go further

Invest

We are preclinical and raising to take LunaFlex through design verification.

Request materials

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.

Express interest