Wound care company Uluru (OTCQB:ULUR) Thursday provided an update on its worldwide clinical and commercial activities for Altrazeal, saying it plans to expand an ongoing clinical evaluation study to include 500 patients at 15 clinical centres, including a leading hospital in New Zealand.
Initially, the company planned to conduct a 60 patient study at 5 clinical centres to support the launch of Altrazeal in Australia and New Zealand.
The company also said it will expand its key objectives of the study, based on positive results it has seen from the initial response to the product in these countries.
Altrazeal is a scientifically engineered product, which is based on Uluru's NanoFlex proprietary technology.
It is a sterile powder that when applied to a moist wound, interacts with bodily fluids and hydrates. The NanoFlex powder then aggregates and creates a moist wound dressing that conforms to the surface of the wound and seals it - helping to reduce pain.
The result is an engineered advanced material designed to provide specific properties to enhance healing and support tissue repair.
The dressing, which is composed of biocompatible materials used in several medical devices, is a micro-porous, skin-like film that is intended as a primary treatment for chronic wounds, such as leg ulcers, and diabetic ulcers, and acute wounds, trauma and burns.
"The initial response received in Australia and New Zealand has been outstanding," said Uluru president and CEO Kerry P. Gray.
"The results from this clinical evaluation and the proposed publications will be invaluable support of our global marketing activities.
"The overall cost benefit that Altrazeal offers in the treatment of wounds is an extremely important feature for the Australian market as cost containment and improved clinical outcomes have for many years been a high priority in Australia's health care system."
The company said it will expand the objectives of the clinical evaluation to include development of key opinion leader support for Altrazeal to influence doctors and nurses throughout Australia and New Zealand.
It also plans to develop clinical evaluations to support contracts and hospital approvals, and to work with wound care universities to build brand support.
In addition, objectives will include building broad clinical experience and usage in the "most influential hospitals", and conducting clinical studies that will be published in wound care journals.
Uluru also said that its European partner will conduct a 150 patient comparative study in Europe to support price reimbursement.
The study will compare the total treatment cost of Altrazeal relative to the current clinical practice, said the company.
Uluru said it believes that in addition to the product features, the benefit of once-weekly dressing changes offers a major economic benefit to various health care systems.
"This pharmaco-economic study will be instrumental in justifying premium pricing for Altrazeal in Europe," said Gray.
"The comparative study will also be extremely beneficial to support marketing activities globally. A cost analysis for sixty days of treatment for a home health patient in the United States indicates the potential for cost savings of greater than 50 percent."
Altrazeal is already approved in the US, Australia, New Zealand and all throughout Europe.
Gray said that markets such as Germany, Australia and New Zealand are "extremely attractive" due to their emphasis on saving costs within the health care system, which is a major product advantage of Altrazeal.
Uluru is also working with its existing licensee to secure the necessary product approval in China - targeted for around mid-2012 - as well as additional Asian markets.
Indeed, bolstering Altrazeal's international presence is important as the advanced wound care segment of the global wound care market is estimated at $6.5 billion, said Uluru.
The company is in ongoing talks with strategic partners to market the product in the US, as well as in Canada and Mexico - where approval is still necessary.
Plans are also in place for the launch of the wound care product in the near future into the veterinary market - where Novartis Animal Health is its worldwide partner.