The wound care market – characterized by Celleration (Eden Prairie, Minnesota) President and CEO Kevin Nickels as “mostly goops and gauzes and fairly low technology products“ – has seen very little innovation.
So when Celleration introduced a new active therapy into the market – the first non-contact ultrasound wound treatment system – it was “like a Star Trek technology,“ Nickels told Medical Device Daily. “It is so advanced, such a modern technology.“
The goal of the early-stage firm, formed in 1999 to commercialize its therapeutic ultrasound platform technology originated in Russia, was to “establish truly a medically efficacious technology in the market,“ Nickels said. “And we've done that,“ with the MIST Therapy System 5.0, which produces a low-intensity, ultrasound-generated mist used to promote wound healing.
Ultrasound has long been known to cause cellular stimulation, Nickels said. In contrast to the more familiar diagnostic ultrasound, which uses sound waves to create an image, the therapeutic ultrasound in the MIST device uses sound waves as the treatment mechanism.
The company's founder, Eliaz Babaev, PhD, “figured out a way to create the therapeutic effects of contact ultrasound in a very unique, highly robust and patient friendly vehicle in this MIST treatment,“ Nickels said.
The MIST system delivers therapeutic ultrasound to the wound bed without direct contact of the device to the body, thereby virtually eliminating concerns associated with wound cross-contamination and tissue injury.
Babaev, Nickels explained, “figured out how to create a mist that has such a high content of fluid between the source of the ultrasound and the body, that [it is] able to transmit enough energy to the surface of the wound. So it basically creates the couple but in the form of a mist,“ as opposed to a gel or solution. And, he added, “it actually is being shown to reduce the pain – it has an analgesic effect. And there's no thermal effect, so people actually like the feeling of it being applied.“
The device, used to wash a wound three to four times a week during dressing changes, consists of an ultrasonic power supply, a transducer (handset), and a single-use applicator that holds a pre-packaged saline bottle. The generator is compact, lightweight, portable and adaptable to standard power sources.
The system generates and propels the therapeutic mist towards the tissue. The saline solution is directed to the tip surface and is atomized through the vibration of the tip surface. This surface creates atomization of the fluid, breaking it apart into small particles of uniform size. Once the particles of fluid are released from the tip, acoustic pressure wave drives them toward the wound.
“This is creating a very gentle washing of the wound surface,“ Nickels explained.
The MIST Therapy System 5.0 was FDA-cleared in 2004 for wound cleansing and maintenance debridement as well as the removal of bacteria. The company received an additional clearance in 2005 for an expanded claim that the device can “promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.“ (See sidebar, page 6).
“What's exciting about that is we're one of the few companies that have the words 'to promote' – not 'may promote',“ Nickels emphasized. There also is no narrowing wound-specific terminology in Celleration's claim, he pointed out, meaning that MIST Therapy can be used on a broad range of wounds, including acute, traumatic, chronic and dehisced wounds.
“And we have a number of doctors who are playing with it with many other dermatological and acute wound problems, because in theory, all wounds would appreciate having cleansing and cellular stimulation,“ Nickels said.
Celleration's technology is being used in hospitals, outpatient clinics, long-term acute care centers, skilled nursing facilities and nursing homes. The treatment is covered by Medicare and most health insurance plans.
Critical to the company's strategy is ongoing clinical and scientific research to provide evidence supporting the new technology's efficacy.
Celleration has completed a multicenter, double-blinded, sham controlled randomized trial intended to demonstrate the effectiveness of MIST Therapy in healing chronic diabetic foot ulcers in comparison to standard of care wound treatment. And the company is conducting a randomized, blinded, sham-based control trial for pain reduction and narcotic reduction, which Nickels expects to be completed next year.
Nickels said the ongoing trial is based on “the perception that because the technology reduces the bio-burden – the bacterial colonization level on the surface of the wound – so rapidly, that the inflammation phase subsides very quickly and the patient basically is able to start to report substantial reduction of pain.“
The company plans to “continue to application-mine“ the technology, he said. “We want to start trying to exploit, appropriately within our FDA guidelines, other applications. We could spend a lot of time building a great company in the chronic [wound] market. There are obviously some opportunities in the acute market, there's probably even some opportunities in the dermatological market. And there's also an opportunity to put a drug on board.“
The privately held company's last cash infusion was in November 2005, when it raised $20.6 million in a Series C financing. Nickels said there are no current plans for additional financing.
“We believe we're actually set to get the company to cash flow,“ he said.
And with an aging population and the prevalence of health conditions such as diabetes and obesity, “there's a 6 million patient population driving almost $20 billion of costs to the healthcare system tied to chronic wounds,“ Nickels noted. “Delivering value to the healthcare system is really what this company is all about.“