Medical Device Daily

DENVER – While Colorado's biggest city sprawls out on a flat plain, the rest of the state can boast of some of the most attractive scenery on the planet: 14,000 ft.-plus “Fourteener” mountains offering beautiful vistas, great hiking and, of course, just about the best skiing anywhere. But the mountains also make some areas, well . . . let's say a bit hard to get to.

Take, for instance, winter sports haven Telluride, and the home of TheraTogs (Telluride). Essentially there is only one main highway in, only one out, and in the winter especially clogged with skiers, snowboarders and the general glut of tourists.

But that out-of-the-way location hasn't daunted Beverly “Billi” Cusick and husband Lee Taylor in establishing their small business of just eight employees, to create what they call “wearable hugs,” or preventing TheraTogs from growing into the bigger business that it is positioned to become.

“We like the mountains,” says Cusik, citing the primary personal reason for the company's location, though also acknowledging plans for eventually relocating some functions elsewhere, but still firmly in Colorado.

TheraTogs makes orthotic garments for children, their architecture intended to correct mobility or postural problem, functional disabilities and neuromotor difficulties. Coming in all sorts of configurations to match the patient's particular needs, the garments offer rehabilitative treatment outside the parameters of the physical therapy office and the short-term assistance work with a therapist provides.

The fabrics used to make these garments are foam-lined, providing a comfortable inner feel, while at the same time providing a tightening grip – the “hug” – that provides corrective force to key points of the body. In use, a clinician first fits the garment to the patient and then provides further evaluation in order to position straps that supply added corrective force.

Taylor, company president, says that TheraTogs has focused initially on the pediatric market for several reasons.

In particular, he notes that “this is where Billi's experience and global reputation is” as a therapist, thus offering a word-of-mouth platform for first sales.

A “more deliberate” reason for the pediatric focus, he says, is the opportunity for “more long-lasting benefit – if we can do what we do for them when they're children, and help them grow into improved states, we head off all manner of difficulties when they're older.”

TheraTogs, he adds, “are not simply palliative, not simply just support without improving dysfunction. They help train the patient out of a dysfunction or prevent compensatory dysfunctions.

“In plain terms, if we can fix a child's internal leg rotation, we can save a child's knee when they're a teenager,” he says, as an example.

TheraTogs are part of the FDA's database of Class I exempt products that don't require clinical trial validation, which Taylor notes as “our good fortune,” thus speeding products to the market – though the product required a five-year development period. And he says that TheraTogs “appeals to a client base of clinicians perfectly willing and interested in experimenting” with its products.

Founded in 1997, growth has been “steady and organic, Taylor says, the company hitting its first $1 million in cumulative sales in March of last year and then nailing the $2.5 million mark 15 months later.

Though the State of Colorado has been traditionally hesitant to provide traditional tax breaks to the healthcare industry, TheraTogs in March received initial seed funding of $100,000 from Colorado Fund I, and it has received Fund I commitments of another $1 million upon achievement of four milestones, two already realized. Additionally, Taylor has his sights set on additional equity rounds to bring its A-round funding to about $1.8 million.

Acknowledging Telluride as being “remote,” he praises the location for its strong sense of community and tremendous resources for children” (as well as a great place for satisfying his own snowboarding habit, which he noted as a passion when we met him at BioWest 2006).

Cusick says that the concept for TheraTogs came out of her frustration as pediatric therapist, having to end a therapy session and wanting “to cut my hands off and send them home with every child because I didn't have enough time with them.”

Over a 35-year career in the field, she says she has “learned very effective handling and treatment techniques for manually helping children to activate muscles” that failed to work correctly. The result, she said, was to see them “bloom under your hands,” and wanting “to sustain those changes between therapy sessions, a skill level that most parents don't have.”

She first began experimenting with orthopedic tapes to maintain mechanical alignment but that most people “don't tolerate tape very well.” The next breakthrough was the discovery of an Australian firm that made “total body suits” used in orthotics, and seeing this as a way to extend the taping strategy.

The final step was the discovery of some unique materials: foam-lined, composite fabrics both elasticized and latex-free, used primarily for insulating electrodes. Named NuStim and ProWrap, these materials are provided exclusively to TheraTogs for use in its orthotic systems. They are characterized by their strong gripping ability but thin, hand-washable and readily ventilating body heat and moisture.

Cusik says the garments work via “several layers of events.”

Simply putting on wearing one of the suits helps the child “become more aware of the corporal self,” she says, making it “easier to recruit muscles.” This “recruitment” ranges from “shortening long and underused muscles” to changing “postural alignment.” Then there is what she calls “neuromotor reeducation,” encouraging changes in the way the wearer uses bones and muscles.

TheraTogs is growing via its national and international presence and its founders state two key goals.

Taylor is pointing to reach the $20 million mark in sales, while Cusick expresses the ultimate clinical goal.

“I want TheraTogs to be a standard of care for neuromotor dysfunction as a humane and conservative way,” she says, “rather than [patients] being operated on. I think that by getting there early enough with kids in trouble with neuromotor development – getting them togged and into appropriate movement – we will have remediated those difficulties.”