Amniox Medical this month touted a reimbursement win from Palmetto Medicare as well as a 2-year cryopreserved lifespan for its Neox Cord 1k as it attempts to position itself as a market leader in wound care.
The Atlanta, Ga.-based company said that Palmetto Medicare recently included Amniox’s Neox Cord 1k and Neox 100 would allografts in a new skin substitute reimbursement policy, growing the product reach to more than 70% of Medicare patients.
The policy shift will allow for skin substitute applications that are medically necessary and follow proper billing guidelines, the company said.
“We now have coverage for virtually 70% of the coverage Medicare allows, with our most recent decisions being Palmetto and WPS. What we’ve done is, through our direct sales organization, we’ve place our people in the areas where we have coverage to grow our direct sales organization,” CEO Thomas Dugan told MassDevice.com in an interview.
Dugan said that the company is focused on wound care, seeing it as an under-penetrated market with room for growth. But the company isn’t limiting itself to only wound care, and is using independent sales groups to expand into the orthopedic sphere.
“In orthopedics we focus on foot and ankle – we believe we’re the market leader in foot and ankle. It’s where we started, it’s been our heritage and we’re doing very well in that market. Our products work well with foot and ankle surgery – if you think about it, if a patient’s torn a tendon or they have plantar fasciitis or various other things, you want to minimize the amount of inflammation and scarring that occurs to maximize motion,” Dugan said.
The ability of the allografts to reduce scarring and inflamation make it a good candidate for other uses, such as knees, hips, shoulders, hands and more, Dugan said, which is allowing the company to expand further into the orthopedic market.
The company said its CryoTek Cool Storage tech is now able to preserve its umbilical cord allografts for up to 2 years without compromising the structure of the tissue. Dugan said that the improvement in cryopreservation gives the company’s allografts a foot-up on dehydrated.
“Dehydrated products have longer shelf lives because the dehydration process, but you lose a lot of what’s good about the tissue,” Dugan told us. “We have scientific evidence that validates that. Other cryopreserved products are required to be in a deep freezer, where as our product can be stored in a refrigerator and the room temperature thaw is much quicker.”
Dugan added that the strength of the company, aside from a powerful direct sales force, comprehensive medicare coverage and long-shelf life products are the amount of time they’ve been in the game, as well as their approach which promotes a strong base of clinical evidence.
“Our company is really the pioneer in amniotic tissues. We take a scientific approach to how we do things. In addition to a number of new product iterations that are coming out in the foreseeable future, we’re also investing very heavily in critical evidence. In this market, which is changing very rapidly, the FDA is looking much more closely at given the number of companies entering the space. For us, building a solid base of clinical evidence is critical, so we’re making some significant investments in it. I think that’s going to bode well for us in the future as the landscape changes,” Dugan said.