Next Science Limited announced the launch of topical collagen products (Collagen) to complement the company's BlastXTM product. To take this product to market more effectively, the company has established itself as, and been licensed and accredited by US Medicare as, a Durable Medical Equipment (DME) provider based in the State of Florida, USA. Biofilms are the major underlying problem in chronic, difficult to treat wounds.
The company's XBioTM technology-derived products disrupt biofilms in wounds and are at the core of its mission to heal patients and save lives. One product at the heart of this commitment is BlastXTM, developed for the management of wounds including various forms of chronic non-healing ulcers as well as other general and surgical wound infections. As part of its research and development program, the company continually explore how BlastXTM can complement and strengthen traditional wound healing support.
An example at the forefront of this program is the use of Collagen with BlastXTM to enhance patient outcomes. Combining BlastX TM with Collagen: The company is developing technology to combine BlastXTM with Collagen in both powder and sheet forms (the forms in which it is currently administered for wound care). The technology, which will fully preserve the efficacy of both BlastXTM and Collagen, is continuing through development towards submitting a FDA 510k application for an integrated BlastXTM Collagen product.
After much investigation, Next Science has determined that the most efficient and competitive way for a BlastXTM Collagen product to enter the market will be via the US DME structure, explained further below. The Company announces that it has completed the application process and received full accreditation to operate, and be reimbursed through US Medicare, as a DME provider based in the State of Florida, USA. This means that the Company is licensed to bill Medicare /Medicaid for the supply of approved products direct to patients and is now also holding a National Provider Identifier with Medicare.
The Medicare registration gives Next Science a licence to sell in 40 US States. The company will now review the process for registration in the remaining 10 States. BlastX TM /Collagen User Study: The company announces that commencing immediately, and simultaneously with the ongoing development of the integrated BlastXTM /Collagen product and the 510(k) application process, it will be distributing a Collagen product through the DME structure and undertake a user study on the combination of BlastXTM with Collagen.
The user study will provide strong clinical evidence for the combined use of the two wound care technologies. BlastXTM will be provided to patients enrolled in the user study who are prescribed Collagen treatment in order to add proven infection control to their healing strategy. Short series case studies have shown that augmenting Collagen treatment with BlastXTM will push a stalled surgical wound or unhealed pressure ulcer back to healing with wound closure shown to occur at between two and four weeks.
Standard wound care healing usually takes between twelve and sixteen weeks. In supplementing its portfolio with Collagen, the company is providing a complementary product to advance the healing of chronic wounds and at the same time, improving its wound care business economics as the use of Collagen materials is eligible for reimbursement. This means the company will receive a significant contribution towards marketing, sales, distribution and administration costs for BlastXTM.