Strong Evidence of Healing - 95% Mean Wound Size Reduction with 71% of Wounds Achieving Complete Healing in 12 Weeks
NORTHVALE, N.J., Oct. 26, 2017 /PRNewswire/ -- ADM Tronics Unlimited, Inc. (OTCQB - ADMT) announced today that its client Origin, Inc., a Princeton, NJ based clinical-stage wound care company ("Origin") has today announced positive interim results from its "GENESIS" US-based dose-ranging Phase IIb trial in the treatment of Diabetic Foot Ulcers ("DFUs") utilizing a proprietary plasma technology. ADMT has been providing a full complement of engineering, regulatory and production services to Origin in the development of the technology and produced the units used in the GENESIS trial. The Origin proprietary technology for the first time, generates and delivers therapeutic quantities of plasma-generated nitric oxide (NO) into the tissue, potentially addressing a wide range of unmet medical needs.
Key interim results from GENESIS include 95% average wound-size reduction at 12 weeks with 71% of wounds achieving complete closure (12-minute dose of NO treated 4 times per week, along with standard of care). The GENESIS trial is designed to demonstrate healing and optimize the treatment regimen for chronic DFUs.
"These are excellent early results. They suggest that our NO therapy compares favorably to the average 55% closure rate of a number of other approved advanced wound products," said Michael Preston, Chairman and CEO of Origin. "A comparison of our results with data available from other studies suggests that our strongest performing arm healed chronic DFUs better than almost all currently available or well-publicized products."
"ADM Tronics has been, and continues to be, an integral partner with us in the advancement of our plasma therapeutic technologies," stated Mr. Preston. "ADM Tronics has assisted us greatly with their engineering, intellectual property and regulatory expertise in their work for our specialized plasma therapeutics, which we believe have worldwide applications in many medical specialties. We look forward to continuing to work closely with ADMT as we bring our medical technologies to market."
"Plasma-generated NO has the potential to offer a safe and effective wound closure treatment, particularly for patients with Diabetic Foot Ulcers, where limb amputation is often the outcome. Because DFUs affect as many as 7 million people in the US and EU with diabetes (as high as 15% of the diabetic patient population), we believe that Origin's first targeted indication represents a large market opportunity," stated Mr. Preston.
Andre' DiMino, President of ADMT, commented, "We have a very close working relationship with Origin and we are excited to be working for them on their ground-breaking plasma-generated NO technology that has the potential to help so many."
As previously announced, in addition to utilizing ADMT's medical device development services, Origin made a direct investment into ADMT in August 2015.
ADMT is a diversified, technology-based developer and manufacturer of innovative technologies and products. Its core competency is its ability to conceptualize a technology, bring it through development, into manufacturing and commercialization, all in-house. ADMT has three areas of activity: Proprietary Electronic Medical Devices; Medical Device Design, Engineering, Regulatory and Manufacturing Services; and Eco-Friendly, Water-Based Formulations. ADMT's multi-disciplinary team of engineers, researchers and technologists utilize advanced technology infrastructure, for the research, development and commercialization of diversified technologies. Additional information is available at the Company's websites - admtronics.com and concepttoquantity.com.
Except for historical information contained herein, the matters set forth in this news release are "forward looking" statements (as defined in the Private Securities Litigation Reform Act of 1995), including statements regarding future revenue growth and performance. Although ADMT believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, there can be no assurance that its expectations will be realized. Forward looking statements involve risks and uncertainties that could cause actual results to differ materially from expectations. Factors that could contribute to such differences include those described from time to time in ADMT's filings with the SEC, news releases and other communications. The Company assumes no obligation to update the information contained in this news release.