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, multi-billion-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 well-known 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 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 space-wise and are now completing our facility expansion," Stewart said.
In the next 12 months, the business will need to more than double production again for the two materials. The original space will continue to be heavily research and 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.