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 Standard surgery eliminates that pain by removing the cartilage and
fusing the bones, but at the expense of mobility.
Cartiva Inc's implant - made of the same substance used in contact
lenses, called hydrogel - was approved for big-toe surgeries by the
U.S. Food and Drug Administration in July.
It is designed to mimic natural cartilage and can achieve the same
pain relief as surgery while retaining joint-mobility.
"It's reasonable to expect this could end up becoming the largest
procedure done on the foot and ankle in the United States," Chief
Executive Tim Patrick said in an interview.
Nearly 50,000 surgeries on the big toe will be conducted in the
United States this year, according to iData Research.
The condition, known as hallux rigidus, affects one in 45 Americans
over the age of 50, or about 2 million people. As the U.S.
population ages, these numbers are expected to grow.
Cartilage provides a smooth, gliding surface for joint motion and
acts as a cushion between bones.
In patients with osteoarthritis, which affects about 27 million
Americans, the cartilage breaks down, causing pain and inflammation
and limiting motion. Osteoarthritis can affect any joint, but occurs
most often in knees, hips, hands and big toe.
Unlike bone and other connective tissue, cartilage has little or no
ability to repair itself.
If drugs, braces, physical therapy, weight loss and activity
restrictions don't work, the next step is usually surgery.
The most common procedure, called fusion, uses plates and/or screws
to join the bones. That can limit activities such as playing sports
or wearing high-heels, and requires a recovery period of up to
twelve weeks.
Two years of data on Cartiva's implant, Cartiva SCI, showed that
patients experienced a faster recovery compared with fusion patients
and comparable pain relief.
Privately held Cartiva, a 20-employee company based in Alpharetta,
Georgia, expects to capture about 40 percent of the U.S. market
within five years, Patrick said.
DURABILITY QUESTIONED
While Cartiva's product has advantages, some experts wonder about
its durability, noting that older implants made of silicone, plastic
and metal have limited clinical evidence and tend to degrade over
time often due to particulate accumulation.
"It's a good thing for prolonging a joint's use without doing
something more drastic, like a total joint replacement ... but
nobody knows how long this hydrogel will last," said Dr. Arthur
Coury, a professor of chemical engineering at Northeastern
University in Boston.
"There are some horror stories of hydrogels degrading in the body
and what they have done, when they're meant to be long-lasting."
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Data from a small study tracking Cartiva patients for five years
after implantation showed that more than 90 percent of those
evaluated retained normal or near-normal joint function.
"I think Cartiva's product needs to be validated over a much longer
period of time before fusion is replaced to a major degree," Coury
told Reuters.
The advantage of Cartiva's technology is that the patient can still
opt for fusion if necessary.
In the study used to win FDA approval, the re-operation rate for
Cartiva SCI patients was 12 percent, about the same as for those who
underwent fusion.
Cartiva's implant is priced between $3,500 and $4,000.
A fusion of the big toe, excluding a metal implant, costs between
$4,000 to $6,000, said James Laskaris, an emerging-technologies
analyst with MD Buyline, which provides clinical and financial
information to hospitals.
The price climbs to about $10,000 including the metal implant,
Laskaris said.
Cartilage regeneration, which uses the patient's own cells and is
typically used in the knee, costs between $20,000 and $30,000 and
works best in younger patients, Laskaris said.
Cartiva's implant has been approved in Europe since 2002 for damage
that involves both the cartilage and underlying bone. The company
has since won similar approvals in Canada and Brazil.
The FDA, though, requires separate trials for each joint.
Cartiva SCI is currently being tested for a joint at the base of the
thumb. The company is years away from testing it for hips, Patrick
said.
(Reporting by Natalie Grover in Bengaluru; Editing by Ted Kerr)
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