PRINCETON, N.J.--(BUSINESS WIRE)--Microdermis Corporation, a privately held life sciences company, announced today that its new antiseptic product, Provodine®, which incorporates a novel drug-dermal delivery system, has been adopted and will be deployed by the US Army in the fight against Ebola virus in West Africa.
Preliminary testing by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has demonstrated that Provodine® provides superior antiseptic protection within 30 seconds of exposure with a > 99% kill-rate against Ebola virus particles. The duration of the killing effect, also known as "active kill," was initially tested at time points of up to two hours. This week, further testing is underway by USAMRIID under a Material Transfer Agreement (MTA) to confirm the active kill up to nine hours.The antiseptic skin product, Provodine®, is being applied as a final "molecular barrier" to viral exposure for healthcare workers and emergency responders using traditional layers of protective equipment. To date a total of 335 relief workers have died while fighting to prevent the transmission of Ebola virus infections in West Africa. Skin coverage is an issue. Unlike most branded antiseptic products – which are contra-indicated for eye, mucosal surfaces (nose and mouth), ear and genitals – Provodine® can be safely used on the most sensitive areas of the body.
In September 2014, the US Army's Central Command deployed military personnel to provide medical and logistical support for the West Africa Ebola response. This week, Central Command confirmed the deployment of an additional 9,000 medical-logistical personnel to the region.
In addition to the US Army, Microdermis is prepared to make Provodine® available to other agencies and non-government organizations working with US military forces in western Africa based on the following results from the initial testing of Provodine:
• Complete eradication of Ebola virus particles at maximal concentrations achievable in the laboratory;
• No virus recovered after treatment with Provodine from any of the replicates at the three incubation times — 30 seconds, 2 minutes and 5 minutes;
• The virus tested was Ebola Zaire-95, similar to the strain that is causing the current outbreak in western Africa.
"A large part of the problem," according to Hal M. Hornburg (General, US Air Force, retired, and Microdermis Board Director), "is not the deficiency in the CDC's or anyone else's procedures and protocols – it's that there have not been anti-infective products that are effective enough."
"The fight against Ebola has proven to be a tough one. Now Microdermis is bringing Provodine, a novel and critical weapon against Ebola and many other infectious diseases," said Dr. Lester, Martinez-Lopez, the former head of the US Army's Medical Research and Materiel Command (2002-05) at Ft. Detrick, who has guided much of Microdermis' strategic initiative.
Microdermis' decision to have the product tested at USAMRIID is the culmination of four years of product development and clinical studies creating a portfolio of next-generation products which will address the control of the worst infectious disease threats abroad, along with the prevention of US hospital-acquired infections that are attributable to the most virulent pathogenic threats such as C. difficile, methicillin-resistant staphylococcus aureus (MRSA), vancomycin resistant enterococcus (VRE), acinetobacter and other multi-drug resistant organisms that have become increasingly problematic in traditional healthcare settings.
"Given the public health crisis, Microdermis has committed significant resources – not the least of which is its expert medical and scientific 'bench' – to support the Ebola outbreak response," said Mac Sweeney, Chief Executive Officer of Microdermis. The company advanced its manufacturing goals seven months ahead of schedule to supply the initial deliveries for the military's planned response, according to Sweeney. "Several members of the Microdermis team, including Major General (MG) Elder Granger, bring decades of military medical experience; hence they enable us to be responsive in support of the troops and healthcare workers in harm's way," Mr. Sweeney added. MG Granger oversaw the US military's largest field hospital force since Vietnam.
The company's mission is rooted in Military Medicine, which has been at the forefront of infectious disease prevention.
"Microdermis has the finest collection of General Officer talent I have seen," said Edward A. Rice, Jr. (General, US Air Force, retired), head of Microdermis' Military Council. "Unquestionably we have benefited from the leadership of two former Surgeons General from both the USAF and the Navy. Each today celebrates with me that Microdermis was able to turn production around so efficiently and get initial product shipments to West Africa to meet the Army's requirements," he added.
According to the company's lead director, former CEO of Amylin Pharmaceuticals, Daniel M. Bradbury, "The combination of drug with delivery system gives Microdermis significant, breakthrough formulation advantages in the creation of solutions for a variety of infectious disease threats, including anthrax, as well as for products currently in development for both healthcare and personal care uses. Our clinical trials program with several leading U.S. laboratories and hospitals supports that value proposition," Bradbury added.
USAMRIID's mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. Research conducted at USAMRIID leads to medical solutions—vaccines, drugs, diagnostics, and information—that benefit both military personnel and civilians. The Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency's Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.www.usamriid.army.mil
Microdermis, an emerging life sciences company focused on the prevention and control of infectious diseases, was founded in 2010 when new management recapitalized and restructured a collection of decades-old, research- based enterprises which had developed the technology upon which the next-generation antiseptic, Provodine®, is based. Provodine® meets or exceeds FDA requirements for use as a Surgical Scrub, Pre-Operative Skin Preparation, Healthcare Personnel Hand Wash, and First Aid Antiseptic. It uses a proven active ingredient, Povidone-Iodine (PVP- Iodine), but with significantly improved performance due to its patented multi-layered Amidermal® delivery platform. Microdermis' unique Amidermal® technology powers the enhanced antiseptic effectiveness, killing many of the planet's most dangerous or exotic viruses, fungi and bacteria. Provodine does not require water, making it especially valuable for deployment in challenging environments, and there are currently no known resistant strains to Provodine®, making it an antiseptic-of-choice within environments characterized by an unknown mix of infection sources. www.microdermis.com/