Page 33 - OxyBand Research Background

# OxyBand Technologies: Local oxygen therapy and wound healing Contact information:
A Franklin PhD
OxyBand Technologies Inc.
amie.franklin@oxyband.com
7616 Currell Boulevard
Amie Franklin, PhD 3 , and Patrick J. Parks, MD, PhD 1,2 Suite 249
Woodbury, MN, 55125
1 University of Minnesota, Minneapolis, MN, USA; 2 3M Company, St. Paul, MN, USA, 3 OxyBand Technologies, Woodbury, MN, USA 651 264 3095 (Office)
651 286 0911(Fax)
415 302 9713 (Cell)
www.oxyband.com
Abstract Results: Preclinical studies Next steps: Technology selection
BACKGROUND: Hyperbaric oxygen has been shown to be effective in improving
healing in selected clinical conditions. Similarly, local oxygen delivery has been shown
to provide a stimulus to healing in a manner similar to hyperbaric oxygen. The exact
mechanism of effect remains an open question for both technologies. Chronic wounds
represent a significant problem for both patients and health care delivery systems, and
the changing demographics of most developed societies imply that a dramatic increase
in the incidence of chronic wounds will soon appear. The absence of a single
therapeutic target in chronic wounds has made the treatment of these conditions almost
entirely empiric in nature. It is common to develop a technology for chronic wounds and Preclinical studies were carried out using a porcine full thickness wound model (left
to test the efficacy in patients suffering burn injury. It is only recently that a conceptual image). Oxygen delivery using one of the OxyBand configurations was carried out
link has been developed to describe how burns and chronic wounds may be sufficiently into the wounds (center image). Oxygen measurements were made in situ for each Porcine vaginal mucosal
tissue explants.
similar in nature to allow for the transfer of knowledge on therapies to occur between wound as a function of time.(right image above, graph below)
what would otherwise be considered conceptually distinct disease processes. That link
is the presence of biofilms in both types of lesions. Recent data indicate that anaerobic
bacteria are significant components of biofilms in both chronic wounds and burns. Local
oxygen therapy carries the potential benefit of not only providing oxygen to allow for
cellular migration into an otherwise non-healing area, but also presents a treatment that
will be toxic to the bacteria largely responsible for the biofilms that inhibit healing. Methods: Patented technology platforms include a variety of designs and production
AIM: Develop a practical oxygen delivery system that is independent of any active methods. Correlation with outcomes represents a logical next sequence in technology
source of oxygen and illustrate its ability to improve wound healing. The delivery system enhancement.
is an FDA approved (510k) device.
MATERIALS: All studies (in vitro, preclinical, clinical) used the FDA approved device Summary
(510k approval number K043063). The description of the device is taken from the
approval:”OxyBand is a multilayer wound dressing that keeps out water, dirt and germs, Clinical Results • In vitro data indicate that the technology provides oxygen in a continuous fashion for up
and supplies oxygen to the wound. It is designed to be applied directly over clean skin to 5 days.
or wounds for up to 5 days. A study has shown that upon attaching the dressing over a Randomized trial Case series • Microbiological assays in vitro demonstrate enhanced antimicrobial effect of silver
test plate, oxygen levels rise steadily over the device area for the first few hours
and then maintain at elevated levels through 5 days as long as the dressing by the use of the OxyBand technology.
remains intact and secure around the perimeter.” • Preclinical studies illustrate an enhanced delivery of oxygen in vivo after hyperbaric
METHODS: (Detailed information on each method is available from OxyBand and oxygen in a porcine model.
contact information appears above.) Briefly, clinical case series studies were carried out • OxyBand was associated with successful treatment of recalcitrant wounds in a case
at Univ Calif San Diego on recalcitrant wounds. A second clinical trial on laser induced series of lesions of varied etiologies.
injury and healing was carried out on 19 patients each receiving two wounds measuring • A randomized acute wound study using laser induced lesions resulted in earlier re-
1x1 inch in size and 100 microns in depth. Each patient received both placebo and epithelialization of induced wounds with decreased exudate and decreased pain with
OxyBand in a randomized pattern. Preclinical testing was performed according to OxyBand vs placebo.
accepted guidelines using a porcine model with real-time oxygen measures. Full Conclusion
thickness wounds were used (as illustrated, next column) and the combination of
hyperbaric oxygen and local oxygen delivery were monitored using standard oxygen The in vitro and ex vivo evidence derived from these data indicate that local
measures. In vitro analysis (not illustrated) of the role of local oxygen delivery on Comparative oxygen levels as a function of
enhanced bacterial killing by silver was measured using standard culture methods local oxygen delivery oxygen delivery can be beneficial by interacting with biochemical
against multiple strains of MRSA and Pseudomonas species. sequences involved in healing while interfering with bacteria capable of
RESULTS: The results indicate that the use of the OxyBand Dressing was associated In a series of 19 patients, two wounds, each 1x1 causing biofilms.
with healing in patients with longstanding lower limb ulcers. Re-epithelialization inch and 100 microns deep were produced by
occurred in less than one month in all patients. Laser induced injury showed less pain, laser and monitored for re-epithelialization (solid Representative References
less erythema, and shorter healing times than placebo controls. Preclinical data support lines above) and exudate production (ordinal
the concept of sustained delivery seen in vitro. Bacteria commonly associated with scale, solid bars above). Exudate production Goldman RJ. Hyperbaric oxygen therapy for wound healing and limb
biofilm formation, i.e., Pseudomonas species and Methicillin resistant Staphylococcus ended sooner for OxyBand and the rate of re- Med Rehab (2009) 1:471-489.
epithelialization was greater at 6 days for
aureus, demonstrate enhanced destruction by silver in the presence of local oxygen OxyBand than Placebo. Wolcott RD, Cox SB, Dowd SE. Healing and healing rates of chronic wounds in the age
delivery. of molecular pathogen diagnostics. J Wound Care (2010) 19:272-280.