“Break a leg” may be what people say when they want to wish
someone luck, but breaking a leg is more than bad luck. That is especially true
for elderly people, who’s weaker bones often lead to severe fractures and
complications.
Thanks to the Israeli company Regenecure,
that may no longer be the case. Regenecure is developing what can be understood
as an intelligent wrapping paper that enables broken bones to heal faster, more
smoothly and even compensate bone loss.
In medical terminology, this wrapping paper is called
membrane implant. “Membranes in general are semi-selective materials. They
allow certain materials to get through, while others cannot,” CEO Moshe Tzabari
tells NoCamels.
When the Regenecure membrane is wrapped around the broken
bone, it allows fluids to get through, but prevents cells, vigor or soft tissue
from getting to the bone. This feature is crucial for the healing process.
“After a fracture there is a competition going on in the
human body between soft tissue and bone,” Tzabari explains. “If there is no
barrier, soft tissue will infiltrate the wound and stop the bone from growing
or make it grow in unintended ways.”
The membrane implant is a transparent, thin-yet-strong
material that looks like plastic wrap. However, the membrane is regenerative
and can be sutured, drilled and shaped into any geometrical form. Moreover, it
attracts stem cells to grow and populate along the membrane surface.
The material, which comes from Germany, has been used in the
past as a drug delivery system – to cover tablets that are not meant to
dissolve in the stomach but only to take effect later. Michael Friedman, Professor
at the Hebrew University in Jerusalem, discovered that the same material can be
used to enable guided bone growth after fractures. The membrane implant can
assist, and sometimes replace, traditional healing methods, he explains.
Comparative research has been done with sheep that suffered
from fractures with high bone loss. Treated with splints only, these fractures
never healed. With an additional bone-graft substitute, it took bones 28 weeks
to heal. When using the membrane implant instead of the bone-graft, it also
took 28 weeks, but Regencure says the growth proved to be more complete.
Finally, when the membrane implant was combined with bone-graft
substitute, complete healing took only 8-14 weeks.
“In short, the membrane implant can replace bone-graft
substitute for better healing or even halve the time of healing if used in
combination with bone craft substitute,” Tzabari says.
While Regenecure was only ever meant to be used in humans,
when vets heard about the membrane implant, they wanted in as well. In June of
this year, vets started using the product in dogs and sheep, as licensing
requirements on the veterinary market are lower than in human medicine.
A future in cranial reconstruction
Tzabari used to be a consultant for medical products before
he joint Regenecure. He sees the future of fracture treatment in the
combination of membrane implant with traditional approaches. According to him,
the market is in the billion dollar range. “This is not only less painful for
the patient, it also makes sense from an economical point of view. A second
operation after fractures to harvest bone costs between $2,000 and $3,000. Our
implant will be sold for $800.”
Regenecure’s first product for human medicine will be in the
dental market at the end of 2014. The membrane implant will enable bone growth
that is needed for teeth implants. The European Market will be approached
first. Once the product receives the European CE mark of approval, it will also
be allowed in most countries outside the European Union. The US market will
probably be entered last after gaining FDA approval. Regenecure will look to
enter the market of human fractures in mid-2015.
In an even more distant future, Tzabari hopes the
implant might even be used in cranial medicine for example, to reconstruct
face bones after serious accidents. The company is currently in the trial
period for this use.