After a painful process that took nearly a year, Atlanta-based MMJ Labs has received relief in its effort to take the sting out of shots in Taiwan.
A stamped approval letter from the island’s Food and Drug Administration has opened a market of more than 23 million people for Buzzy, a bee-shaped handheld device that combines cold and vibration to decrease minor sharp pains naturally.
MMJ founder Amy Baxter, a pediatrician and pain researcher, conceived of Buzzy after her son had a bad needle experience at the doctor that left him scared to return. She knew that millions of other kids shared this anxiety and saw a “blind spot” in society when it came to treating their pain.
Since 2009, Buzzy has entered the United Kingdom, Australia and a few Latin American countries without a lot of regulatory hurdles. That wasn’t the case in Taiwan.
“The approval process is very rigorous, and frankly we almost had given up. We were completely discouraged,” said Jennifer Tipping, director of business development.
The company holds multiple patents, and the regulatory agency wanted the company to disclose so much information that its executives had to draw the line.
“We told our distributor, Tricon International Corp., that we gave them more information than we wanted to and we weren’t going to give them any more even if if killed the deal, but somehow they made it happen,” Dr. Baxter said. “Of course we were worried about knockoffs, but it’s not that easy to copy.”
Although children were targeted initially, other potential users are the 25 percent of adults who fear needles, as well as those who use needles on a daily basis, such as diabetics. Currently Buzzy is used by more than 1,200 hospitals in the U.S. Buzzy has been used in dentistry and plastic surgery, as well as for neck and back pain relief.
Dr. Baxter’s recent appearance on ABC’s “Shark Tank” has built considerable buzz for Buzzy globally. She was offered $500,000 for a 20 percent stake in the company, valuing it at $2.5 million. She declined, pointing out that sales are projected to more than double to $2.5 million in 2014.
Assistance from the Georgia Department of Economic Development has helped the company with the nuts and bolts of entering new markets abroad, Ms. Tipping said.
“They give us a lot of data as well as insights about potential distributors and partners,” including evaluations of the financial health of a potential partner as well as their performance and credit history, she said.
Dr. Baxter believes the experience in Taiwan will be instructive in the next international markets it hopes to conquer: Canada and Brazil, which both have strict regulatory agencies.
“Both of those countries are great markets for us, but the regulatory process will be long and very rigorous,” she said. “In fact, we’re having Canadians cross the border to buy Buzzy, which is a nice change of Americans going to Canada to buy drugs.”