Healing Balm
Little Rock-based BeluMed X Unveils an Innovative New Wound-Care Therapy
by Lisa Broadwater
It was a brisk November day. Annie's Sister Ida, a 2-year-old Thoroughbred filly, was on her way to Oaklawn from training in Indiana in preparation for her first racing season when the trailer accident happened. Ida had kicked the trailer and ended up with a massive cut deep wound on the inside of her right rear hock.
When the owners, Kathy and Mike Ward, saw the injury many hours later, they were told Ida's racing career was over.
"I figured she was done," remembers Kathy Ward. "A racehorse has to have all four legs absolutely healthy because there's so much weight pounding and going at the speed they go. And it was her hind leg, so she was going to have to be breaking from the gate, and most of their power comes from their back legs. We didn't think there was any hope."
So when the Wards' vet mentioned the horse might be a candidate for a wound-therapy study involving catastrophic injuries that Dr. David Jolly was conducting at his Step Ahead Farms in Hot Springs, the Wards agreed to give it a shot.
"I figured, 'We've got nothing to lose; we've got to do something," Mike Ward says. "So we loaded her up and brought her to Dr. Jolly."
Nine months later, Ida is in training again.
"She's been in training for 60 or 70 days," says Jolly, who also runs a Thoroughbred training center at Step Ahead. "She goes to the track every day except Sunday and gallops two laps, and we've been breaking her out of the starting gate, which is the last strain we're going to put on her. And she's having no problems. The gallop boy cannot feel any difference."
"If everything goes well, she'll probably start at the Fair Grounds [race track in New Orleans] around Thanksgiving," Mike Ward says. "We're hoping she'll still be the class of horse she was."
"We're keeping our fingers crossed," Kathy adds with a broad smile.
As for Dr. Jolly, "I expect her to be real solid," he says. "In three weeks, she may be solid all the way."
The Birth of BeluMed X
How Ida got from near death to racing shape is the story of a new wound-healing therapy developed by a Little Rock-based company called BeluMed X. The centerpiece is a product called Lacerum, a blood-based solution applied topically to a wound that works in combination with the horse's body to promote healing and produce normal healthy skin tissue.
Administered by a vet, Lacerum is used in combination with another BeluMed X product, RemX, an equine protein wash solution that also assists in the healing of wound and, BeluMed X claims, reduces the healing time and complications associated with a lengthy healing process and reduces scarring with no change in hair color or skin pigmentation. The products are based on the principle that certain blood cells contain natural proteins (growth factors) that, when applied to a wound, stimulate the horses body to heal from within.
Charles Worden, research director for BeluMed X and the creator of Lacerum, got the idea after developing AuTolo-Gel, a wound healant used successfully to treat people suffering from foot ulcers and other non-healing wounds associated with diabetes, several years ago. Back then, Dennis Hendren was working for one of the largest wound-care companies in the world, Curative Health Services, which had developed something similar. After realizing they both had similar goals, the two joined forces and created their own wound-care company, which did well and went public a year later. After the two were forced to relinquish control of their company, they temporarily went their separate ways before founding BeluMed X.
The duo made the transition from wound-healing in humans to wound healing in equines, in part, because of a chance meeting at a Chinese restaurant.
"One Monday, my wife and I were having dinner at Fu Lin," Worden remembers. "Dennis and his wife were there, and we started talking. He asked me, 'Have you thought about doing this [wound therapy] in equines?' He had been thinking about it on his own and had done some work traveling around, visiting with veterinarians about the possibility of using this technology."
The two made that leap from man to mammal, says Hendren, "probably because of the anecdotal information wed had when I was at Curative. They had taken outdated human material and treated some animals and had some good outcomes. It looked like there would be a good transition."
Focusing on the equine was a logical decision, Worden says, because "The therapy does work on other animals, but the equine when wounded is very similar to the diabetic human: You have poor circulation in the lower extremities, and when they get wounded in that area, they dont heal well. So most of the time, when they have a catastrophic wound in that area, because they dont heal well, they're just put down. So I decided I would start trying to heal some of those horses."
That wasn't his only motivation, however.
"The reason we got into this," Worden says, "is that the veterinary industry has changed little from the time my grandfather was treating his horses for wounds and my father was treating his horses for wounds. Here I am pushing 70 years of age, and youve seen very little change in wound care, even though the human side of medicine has progressed steadily. Things being taught in the veterinary schools as excellent techniques were discarded by the human side of medicine 10 to 12 years ago as counterproductive to cellular healing.
"But youve got a lot of old men whove been in positions of power in the veterinary colleges and have not been attentive to the changes in the human side of medicine for the good of wound healing."
When it came time to choose a veterinarian to test his new wound-care therapy, Worden turned to Dr. David Jolly, who had been his vet for more than 40 years.
In the beginning, the no-nonsense Jolly who has specialized in treating racehorses for the past 15 years was asked simply to try the product on a few of his patients.
"They wanted me to give them my opinion on whether it had application on horses," he says. "I said to Charles, 'I'm not much of a cheerleader. I'll try it. If it's worth a damn, it'll fly on its own. If it's not, it'll die a natural death, and you won't have to worry about it.' "
At first, Jolly wasn't exactly bowled over.
"I treated the first horse three times and sent him home," he recalls. "It was an 8-week-old wound the horse had burned the back side of his pastern, and he wasn't getting any better. I treated it three times, and then the owner said that was all he wanted to put into it, and he took the horse home.
"I didn't see that much [about Lacerum] that impressed me at that point. But there was one thing that did interest me: The edges of the wound got good epithelial growth [healthy regenerated skin] around them.
"So they went and photographed this horse, along with three other horses, 25 days later, after they'd all gone home. That was the first thing that really impressed me: They had continued to heal after they went home. And they had healed beyond my expectations."
There was another reason Jolly was drawn to the wound-care study. He shares Worden's frustration with his profession.
"I don't feel like the veterinary profession has made many strides forward in the last 30 years in terms of wound care," he says. "There are thousands of products out there, yet we haven't made much progress in terms of successfully treating catastrophic wounds."
That's the case, Jolly says, because "Veterinarians haven't been able to make any money with it, so they don't fool with it. It's that simple. I'm talking about catastrophic wound care, which is long-term, day-by-day treatment of wounds. Plus, the products that have been available have been just as useful in the hands of the owners as they have the veterinarians, so the veterinarians essentially haven't gotten involved.
"And," he adds, "some of the ideas in the journals and textbooks on how you should be handling these types of wounds are just not practical. If you've got to put a $50 bandage on a horse's leg that needs to be rebandaged every third day, about the second week, that's over with for the owner, the horse, the veterinarian. Because the owner is going to say goodbye."
In the past year, Jolly has documented 56 case studies, all involving serious wounds; all but one of the horses has recovered.
"We had a horse that was brought to us from Oklahoma that had been hit by a truck and basically succumbed to the injuries," Hendren says of the one fatality. "There is a limit to what we can do, from a catastrophic nature. We dont claim to be God; we say were going to provide you with some tools."
Just about every case is a Cinderella story. Consider Alibi, the 10-year-old Quarter horse mare that Teresa Harrington brought in 10 1/2 months after the horse had severed the flexor tendon in a back leg.
"When she was first injured, a different veterinarian took her to his facility, treated her for two weeks and pretty much told me to make the decision whether or not to put her down," Harrington remembers. "He didn't feel like she was going to be functional at any level at all. So we brought her home and did dressing changes every day for the first three months, then every other day and then every third day. After about six months of diligent care, the proud flesh [excessive tissue often created by a wound] had proliferated so much that we felt we needed to go further, so we had it removed for the first time. That was unsuccessful; it grew back. And she started chewing on that area."
Before the accident, Alibi had been a Western Pleasure show horse, and Harrington was hoping her teenage daughter, Tyler Witham, eventually would be able to show her again.
"At that point, Alibi could walk and trot but she'd carry her leg," Harrington says. "I had tried to work with her on a longe line and thought maybe I could build her back up. I worked her one day, and the next day I came out and the end of the tendon had stuck straight out of the wound. So I thought, 'This is really not good.'
"A few weeks earlier, I had met Dr. Jolly at the State Show. I called him the next day and had her up there that afternoon. We immediately removed the lower part of the extender tendon. He started the wound treatment that day, and within a week the area where we had excised the tendon was completely filled. I came to see her every other week, and it was amazing how quickly she turned around.
"She was sound within a week. There was such a dramatic change in the shape of the wound and the shape of the leg. When I brought her, it looked like a small soccer ball was stuck up underneath her skin. Her wound was huge."
Jolly learned a valuable lesson while treating Alibi.
"At the time, I didn't know how to keep the granulation tissue [proud flesh] under control," he explains. "When it gets above the skin line, skin won't grow over it. So I put copper sulfate on there; that produces a drawn effect, which is a result of the copper sulfate killing the elastic tissue in the skin.
"We've learned since then how to control the granulation tissue without using a caustic agent on it or anything to destroy the granulation bed, which is what copper sulfate does. There are about 10 different treatments, which all do essentially the same thing destroy the blood vessels going to the granulation tissue. When you do that, you destroy the ability to grow healthy new skin.
"So we've overcome that in our treatment. We do it now by bandaging. Because this horse's injury is right at joint level, we're constantly stretching and straining the tissue that's trying to heal. Eventually, we'll get a granulation bed there that's willing to accommodate the amount of strain she's putting on it.
"That's one of the things we've learned in this study. We started turning out this mare after we'd had her here for two months, exercising her so she wouldn't just continue to grow tissue and then tear it open. The routine way of healing a joint like this is to immobilize it. But when you do that, you never get it healed."
As for Alibi, "She was at [Jolly's] farm for 99 days," Harrington says. "We picked her up, and within a week we took her on a long ride, and she's never been unsound since. We started showing her in March, and she's been very successful. She's never had any complications."
"This leg is one-third the size it was when it was brought here," adds Jolly. "We've gone from a horse that maybe should have been put to sleep to one that maybe could be kept alive to one that's going to the State Show."
That's right: Harrington's daughter qualified for the State Show in three events: Walk-Trot, Buckaroo Horsemanship and Girl's Western Pleasure.
The dramatic tenor of these case studies certainly isn't lost on Jolly.
"A brood mare was brought in last night by a man; she had run a pipe up into her shoulder, about five inches deep," he says. "We only had to treat her three times. It was a puncture wound, and that's one of the things this drug works the best on puncture wounds that cannot drain. I treated several horses with a similar problem and never made a case study of any of them because there's nothing to show. You put the treatment in there, protect the surface, and in two weeks, they're finished."
Without the therapy, "You don't know what will happen," Jolly says. "Most of the time you get a drainage that goes on and on, and you flush it with antibiotics. I've found this drug, because it's a blood-based product, I'm sure, to be much more effective in dealing with infection than I would antibiotics put right at the surface of the wound.
"And my heart has gotten a lot bigger in the size of the problems I've been willing to tackle," he adds. "The longer I worked on these cases and the worst the cases got that were brought in, the more I began to realize there is a different way to treat these horses than what we've been doing for 30 years, in terms of managing granulation tissue and what the cost of materials should be.
"For example, do you use Elasticon, which costs $4 a roll, or can you use VetRap and duct tape? Duct tape costs 50 cents a roll; VetRap costs $1.37. So I developed a $2.47 wrap that would stay on a hock for seven days, as opposed to one that's going to cost maybe $12 or $14.
"That was an important part of the therapy: How do you develop bandaging that's an asset in controlling granulation tissue that's also cost efficient and can be changed without the cost becoming prohibitive?"
A Self-Sustaining Study
For a while, most of the cases were referred by Dr. James Powell of Hope.
"He referred maybe the first eight or nine," Jolly says. "One horse had a very severe burn. It got its leg caught in a panel, and the trainer had to cut the horse out with a torch, and the heat ran down the pipe and burned the horse. It had burned the tissue to where you could see the tendon.
"Dr. Powell continued to send horses here for the next four months. And the owners always went back and were very positive about the results they were getting and the therapy that was being done. Also, when they would come here, they would see the other horses that were being treated. So it became self-sustaining: The owners would come about every three weeks to look at their horses, and eventually we would have maybe 20 people out at the barn."
Now, rather than referring patients, Powell is using the therapy himself.
"That's our goal: to get veterinarians to do this," Jolly says. "I don't want to treat all the horses in Arkansas. But we're reluctant to put the product in the hands of veterinarians who are not familiar with it who might have something bad happen and then they'd say it doesn't work. Then we'd be fighting two wars."
The guys at BeluMed X agree.
"Its not our intent to have all the horses come to Dr. Jolly," Hendren says. "Our intent is to have other veterinarians and other states involved and train them in the use of the technique."
So far, 10 vets in four states are providing the therapy, including four in Arkansas: Jolly, Powell, Nancy Bonhoff in Fayetteville and Mike Pallone in Rose Bud. Although the BeluMed X hopes to convince more vets to use the therapy, they aren't targeting all of them.
"Most country-practitioner veterinarians have their own regimes set up as to how they like to work on these types of problems. And they are slow to change," Jolly says. "As a result, we aren't trying to get every veterinarian to use this product. We are trying to get enough veterinarians in a given area to set up wound-therapy centers so that people who want to get this type of therapy done can get it done.
"If we get four or five wound therapy centers in a given area where people have an opportunity to get the treatment, we're happy. The fact that some veterinarians are never going to do this is not a problem for us.
"I think the important thing for the veterinary profession to realize," Jolly says, "is that there are people out there who want these horses treated, and the public appears to be a little ahead of where the profession is. The profession doesn't believe people want this done. What we're doing here is living proof that they do."
The reason some vets are hesitant to try Lacerum, Worden says, is "theyve never been taught this. But once they are and they understand the science behind it, they grasp it very readily.
"We had a veterinarian last week who was very hesitant to use our product. The owner wanted it used on a colt. It was a Missouri Foxtrotter, and the mare had something like 13 championships and the stallion was a national champion. This colt was on the ground, was about 90 days old and got caught in an electrical fence and cut its tendon.
"This was a foundation foal for the stable, and the owner wanted that fixed. The veterinarian didnt know Dr. Jolly, didnt know of our product and was hesitant to use it. We took the time to teach her the science while we were treating the animal, and now shes going to be one of our biggest advocates. She can understand whats behind this healing mechanism. Its not just another one of the smoke-and-mirror products out there that people, out of desperation, grasp off the shelf and pay $25 or $30 for and hope its going to heal the problem."
Showing rather than telling is the modus operandi for Jolly, too.
"When people come here and ask me about treating their horse, I find out what their problem is and then I show them a tape of a horse I've treated with a similar problem," he says. "Because people don't believe you when you talk to them anymore; they've seen too much stuff that isn't true. In the horse business, everybody's got a cure for everything. So why should they believe us?
"So I don't talk. I'll turn the tape on and go in the barn and start doing my work. And when they're finished, they'll come out and say, 'Oh, this is a lot worse than the one we have. If you can heal that, you can heal our horse.' And I'll say, 'We can treat your horse, and I feel like it's going to be fine based on my experience. You come back in three weeks, and I'll show you the results.' "
Details, Details
So, just how expensive is the treatment?
"Its relative to the type of wound," Hendren says. "We've priced it such that per application its about $60 to the veterinarian; we provide the material to do at least five to six weeks treatment for about $400. In some cases, that will heal the wound; in other cases, itll only make a small dent depending on the catastrophic nature of the wound."
So far, BeluMed X's products haven't received any official medical endorsement, which Worden blames in part on the fact that they haven't published a study of the therapy yet.
"This material is going to be published later in the fall, probably several different journals, including veterinarian journals, cellular biology journals and things of that nature," Hendren says. "Because it has some broad-reaching effects. It has been used on the human model. All weve done is transfer it over to the equine model."
"Everything weve said we can back up with science," Worden adds. "We dont make claims that we cannot back up."
Not that the two haven't attempted to get industry approval. However, Worden says, "So far, the regulatory bodies Ive contacted and that our consultants have contacted have said, 'We dont want to regulate it.' "
The problem, Hendren says, is that "the technology is novel enough that its hard for the regulatory agencies to decide how to regulate it. We have a regulatory consultant whos a veterinarian as well. The only concern he has is that were able to document any claims we might make on the labels or in the literature. The basic questions are safety and efficacy. Safety there has been no downside. Efficacy we can show you case studies and tissue studies that show this is much more efficacious than conventional therapy.
"The FDA regulates anything that goes into the food chain (thats ingested, like feed supplements). They dont care about products for wounds, especially if theyre not in the food chain. Theyve got so much to do that they dont want to regulate someone like us. We dont require FDA approval because were not injecting anything; were topically putting platelets on the wound area.
"One of our longer-term goals is to become a recognized standard of care in the industry and get insurance endorsement and approval so it will be paid for as a modality for treatment on a catastrophic wound.
"Im sure that an insurance company, rather than paying out a policy for an animal to be put down that might be the cost of that animal would be far more willing to pay $1,000 or so to have that animal returned to a functional level."
Future Plans
In the meantime, BeluMed X is about to tackle the mass market with a line of products designed for use by horse owners. The first is Eclipse, a product similar to Lacerum (only in a diluted form) that's designed to heal superficial wounds.
"Our initial focus was on the catastrophic wound," Hendren explains, "but as we have gone out and talked with horse owners, invariably they would say, 'OK I can see the merit of going through the veterinarian for the catastrophic wound, but what do you have for the everyday superficial things?' And thats what has motivated us to develop this material. Weve realized that its going to be a longer period of time to educate and change the market for the professional material. Its going to be a much shorter period for the over-the-counter material.
"When a [case study] horse goes home, 90 percent of the time, theyre being worked and ridden but the wound hasnt closed," Worden adds. "Eclipse is what Dr. Jolly sends home with the owner so they can feel like theyre contributing to the healing process."
With any luck, the Eclipse ointment will be on the market this month; it's scheduled to be followed by a complete line of Eclipse horse care products everything from shampoo and mane and tail conditioner to hoof shine and fly spray.
"Dennis and I have been in front of maybe 300,000 horse owners in the last six months," Worden says, "talking to them and getting their input into our products (at horse shows in Arkansas, Tennessee, Indiana, Wisconsin, Texas and Minnesota). We listen to what horse owners say they need for this industry. Right now, the biggest thing I think they have in their craw is products that make false claims, especially in the fly spray area. For example, My fly spray will work for seven days. Theyre lucky if in seven minutes it works.
"When we came into this industry, we said, Were not going to put a product out unless weve tested it. Were going to put some credibility come kickin, scratchin or screamin into this industry, which it does not have at this time. Thats our sole purpose.
"If you buy one of our products, youre going to know its been tested and it works. We intend to own the market nationally. And we intend to do it within a short period of time."