When Kristi Pelegrin gave birth to her son Cooper, she thought her son’s father was joking when he said the baby was healthy with 10 fingers and 12 toes. He wasn’t kidding.
She was even more shocked, she said, when she heard about the usual procedure to remove the extra digits: tying a silk string around the base of the toes to restrict blood flow, then waiting up to 10 days for the tissue to “blacken, die and fall off.”
“It seems so barbaric,” Pelegrin said. “I don’t think I could have gone through with it. I would have left without getting the toes removed and researched other options.”
Instead, Dr. Juan Roig treated Cooper at the Munroe Regional Medical Center in Ocala in November 2011 with the XDG Clamp — a device he invented and is marketing with business partner Carlos Hondal to treat polydactyly — the formal name for the condition of extra digits — and skin tags.
“When you see a simple, elegant solution to health issues that affect millions of people worldwide, you have to take notice,” said John Fleming of Biztegra and a Challenge judge. “The XDG device could greatly improve the standard of care for children born with extra fingers or toes and for people suffering with skin tags. The company’s founders demonstrate the ingenuity and passion for creating products that can positively change people's lives.”
Using local anesthetic and aseptic, the medical professional uses both stainless steel reusable clamps and disposable plastic clamps to remove extra digits and skin tags — extra clumps of skin that grow on the body — in 10 minutes. A high-compression procedure fuses the skin together so there is no need for sutures or further treatment.
“There was no blood, no irritability, and [my son] didn’t even cry,” Pelegrin said. “He healed beautifully, and today there is zero sensitivity.”
Polydactyly occurs in about one in every 143 newborns in the United States — more than 20,000 cases annually — according to Roig, medical director of neonatal intensive care at Munroe Regional Medical Center. He said these babies become “hot potatoes.”
“The pediatricians become insecure in dealing with these babies,” Roig said. “With the string method, the babies will cry and the procedure isn’t uniform. The string can be tied too tight or too loose, and there’s typically a poor outcome. Pediatricians are just as uncomfortable performing the procedure as the parents are having their babies undergo it.”
Roig thinks the clamp will empower primary doctors to perform the procedure and eliminate complications like sensitive scarring and neuromas that can be difficult and expensive to treat in the future.
Though the string method gets a 75 percent success rate, Roig says that figure is high because complications are underreported.
“These people live with discomfort the rest of their lives because they don’t know there’s any other option,” Roig said. “They’ve settled for a life that’s less than great.”
Roig, who is also an associate professor of medicine at the University of Florida’s Department of Pediatrics’ Division of Neonatology, uses the clamp at both UF’s Health Science Center’s Shands Hospital in Gainesville and Munroe Regional Medical Center.
He has performed about a hundred procedures, which have all been successful, he said.
XDG is working to publish a new standard of care for polydactyly and develop webinars and a mobile app to train nurses, midwives, pediatricians, family practitioners and dermatologists to use the clamp.
It also plans to capitalize on skin tag removal — a commercial tactic.
“We want to get this into the hands of doctors as soon as we can,” said Hondal, founder and principal of CMH Advisors LLC, who received his master’s in accounting from FIU. “Skin tag removal is a much broader market and will add value to our company so that we can support our efforts to treat polydactyly,” he said.
Skin tags occur in about 46 percent of the adult population, according to Roig.
Like polydactyly, removal can involve pain, bleeding, scarring and multiple office visits. The clamp can remove a skin tag in 10 minutes without these complications.
The business plan: to sell 9,000 to 10,000 pairs in 2015 and 15,000 to 20,000 pairs in 2016 for less than $800 each through a distribution network to domestic hospitals, pediatricians, dermatologists, and general practice physicians and clinics, with expansion into international markets.
Roig and Hondal plan to sign a letter of intent with a distributor this summer.
Medical centers in Ocala, Gainesville, Orlando, Jacksonville and Panama City will have Institutional Review Board documentation filed when the prototype is finalized, Roig said.
XDG is considered an early-stage company under a provisional patent shared with UF with the U.S. Patent and Trademark Office, and the device is undergoing approval from the Food and Drug Administration.
Roig thinks the “fancy clamp” will be classified as a Class I General Surgical Tool.
“It’s a simple solution to old problems,” he said.