Plastics News - May 20, 2019 - 5

Plastics News, May 20, 2019 * 5

Silicon Valley firm adds production for orthodontic material
By Catherine Kavanaugh
Plastics News Staff
Fremont, Calif.-based Bay Materials LLC is more than doubling
the size of its headquarters and
manufacturing plant to meet increased demand for rigid polyurethane orthodontic materials used
to fabricate clear aligners and retainers.
Founded in Silicon Valley in
1999, the company says it has a
new thermoformable material,
branded Zendura FLX, that is appealing to mass manufacturers,
orthodontists, orthodontic labs
and consumers in the fast-growing, multibillion-dollar industry
known as clear aligner therapy.
In its early days, Bay Materials developed and supplied the
first-generation material used to
produce Invisalign-brand aligners,
which pioneered invisible and removable orthodontics for teeth
straightening. The most wellknown product, Invisalign, made
by Align Technology, now uses its
own patented material.
"We first developed transparent, high-strength thermoformable polyurethanes to replace
previously used polyester materials," Bay Materials founder
and CEO Ray Stewart said in an
email. "Those materials helped
spark the clear aligner revolution.
As the market has grown there is
increasing demand for advanced
materials requiring a challenging
combination of mechanical, optical and biocompatability properties."
Twenty years after opening, Bay
Materials says it has met a new
performance standard for clear
aligner materials with Zendura
FLX, which was designed to maximize tooth-moving force while
reducing the initial pressure on
the patient's teeth. The material
comes in three-layer sheets with
the inner shell designed to grip
teeth, an outer shell that acts as
a tough barrier and a central elastomeric layer to apply gentle yet
consistent pressure to move teeth
predictably.
"This highly elastic material allows customers to manufacture
dual-shell aligners with enhanced
processabilility, greater patient
comfort and faster tooth movement so patients can smile faster,"
Stewart said.
The material's other properties
include crack resistance, stress
retention, stain resistance and
optical clarity. To increase production of Zendura FLX, the Fremont facility expansion is underway with a tight schedule to grow
from 12,000 square feet to 26,000
square feet in about three months.
"We must move fast. The clear
aligner therapy market has exploded, and it will continue to
do so," Bay Materials marketing
spokesman Chip Hennen said in
a phone interview. "Today it represents 20-22 percent of all orthodontics worldwide, and within 4-5
years that will grow to 40-50 percent of all orthodontics. It's growing all over the world. I just talked
to a distributor in Morocco."
Clear align therapy has gained
worldwide consumer acceptance,
Hennen added, because it is more
convenient for patients than wire
brackets, more profitable for the

orthodontist because it involves
about half the chair time and
better suited for treating a wider
range of complicated cases.
To meet demand for the plastic sheets, Bay Materials says it
doubled production volume in
2018 for Zendura FLX and another
product called Zendura A, which
is used primarily for post-treatment retainers that keep newly
straightened teeth in position.
"As we expanded our product
line 300 percent over the last 12
months and added new customers, we ran into a wall spacewise
and are now completing our facility expansion," Stewart said.
In the next 12 months, the busi-

'We first developed transparent, high-strength thermoformable
polyurethanes to replace previously used polyester materials.
Those materials helped spark the clear aligner revolution.'
Ray Stewart
Bay Materials LLC
ness will need to more than double production again for the two
materials. The original space will
continue to be heavily researchand development-focused with
polymer synthesis, compounding,
small scale extrusion, formulation
and physical and chemical testing
under one roof. The new space
will be primarily manufacturing,

warehousing, fulfillment, customer service and technical support.
"We're investing heavily in the
people, equipment and other resources required to help better
meet the unique plastic material
needs of the fast-growing orthodontic clear aligner therapy market," Stewart said. "Our production capacity and our employee

base all need to keep pace with
this rapid growth for demand for
our products."
Bay Materials moved its headquarters and plant to its current
Fremont location in 2015. The
company also serves the medical
device, electronics, food packaging, aviation and consumer product industries.

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Plastics News - May 20, 2019

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