Innovations

Discover the exclusive innovations of our current partners

EPIFLO – USA

France and international status:

  • FDA and CE approved for venous statis, decubitus and diabetic foot
  • More than 1000 units sold in Europe in 2011
  • France : in validation process.

EPIFLO is a 3 ounce, portable oxygen generator

 

It has no moving parts, does not store oxygen, and does not require the use of water.  It is the smallest advanced medical device for treating chronic wounds which we know of.  It is the size of a beeper and delivers oxygen directly to the wound through a canula.  The installation takes no more than a few minutes and the patient’s wound is treated with oxygen around the clock for the duration of the treatment.  The case studies in our database generate some interesting statistics:

 

  • The average wound duration prior to EPIFLO is about 6 months
  • The treatments which failed to achieve healing prior to EPIFLO include Moist Wound Therapy, NPWT, HBOT, grafts, and many others.
  • The average difficult wound heals in about 7 weeks, average wounds heal in less time.
  • EPIFLO has healed 78% of the wounds treated.
  • Excellent results have been achieved with Diabetic Foot Ulcers, Venous Stasis, and Pressure (decubitus) ulcers.
  • There is a small but growing evidence base that shows continuous oxygen is also effective on other wounds including Sickle Cell, Coumadin Necrosis, and PAD (Peripheral Arterial Disease) and in many cases has been shown to reduce pain associated with these wounds.

Case #1: 69 year old female.  Diabetic with history of delayed healing

Week 0: Pre-EPIFLO® treatment

Week 7: Wound healed with epitheliazation

 

The benefits of EPIFLO : Part of Inno3Med Commitment 

Inno3Med commits to promoting innovations benefiting to both patients and healthcare professionnals,  with a global cost-efficiency.

  • Patients : EPIFLO allows normal daily activity to continue without inconvenience while the wound is healing
  • Healthcare professionnals : The installation process is very simple and involves placing the oxygen delivery cannula over the center of the wound, covering the wound and cannula with a primary absorbent dressing and covering that with a clear plastic thin film dressing or multi-layer compression wrap to keep the oxygen from dissipating.
  • Cost-efficiency : EPIFLO avoids repetitive, time consuming trips by your patients and they no longer need be tethered to heavy and cumbersome Negative Pressure Wound Therapy (NPWT) vacuum pumps for months on end

 

 

How it works

The EPIFLO® device provides a continuous supply of oxygen to the patient’s wound in a small disposable system that allows the patient to be treated anywhere and to remain ambulatory. It is delivered topically at a rate of 3 ml per hour; and the continuous oxygen delivery increases oxygen tissue levels. Some clinicians suggest that EPIFLO® Transdermal Oxygen delivery mimics the bloodstream in delivering the necessary metabolic energy to oxygen starved cells. Oxygen provided by EPIFLO® energizes ischemic cells and triggers a response which initiates the natural healing of the wound

 

The EPIFLO® unit weighs just 3 ounces and sits in a pocket or attaches to a waistband while in use.  During the treatment, patients often go for up to 15 days between office visits.  During the first week, increased drainage is commonly seen which indicates the wound has begun to heal. The EPIFLO® unit is disposable and is replaced with a new unit every 15 days.  The EPIFLO® device uses a patented, state-of-the-art fuel cell technology to extract atmospheric oxygen, concentrate it to near 100 percent, and delivers it via a thin cannula directly to the wound.  See Above Figure  for an explanation of the technology.  The end of the cannula is simply placed over the wound and covered with an absorbent and semi occlusive dressing of the doctor’s choice.  The oxygen is delivered at a low flow rate to maintain the correct environment for moist wound healing.

 

 

 

Case Study #2: 59 year old diabetic male.  Inpatient 1 week NPWT; Outpatient 12 weeks NPWT, had severe circulatory impairment; NPWT after 13 weeks with initial reduction in size but wound became ‘stuck’ at 10 weeks and would not improve.


Week 0: After debridement

Week 5 after EPIFLO®: fully remodeled/ ephitheliazed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Efficacy

An analysis of our internal data suggests that EPIFLO is effective on approximately 78% of diabetic ulcers, venous leg ulcers and decubitus ulcers.  The following  patients had mean open wound duration of 67.3 weeks with standard of care wound treatment prior to EPICLO.  The mean wound size was 14.22 sq. cm. with the associated healing rate for these wounds calculated at 1.55 sq. cm. per week. The mean time to healing, for the 58% of subjects (n=37) whose wounds closed was 7.05 weeks. This compares with a 67.3 week mean wound duration prior to treatment with TCOT for these healed subjects

 

 

 

Upon further analysis of the data it was determined that the patients with diabetic foot ulcers healed at a rate of 61 percent at 7 weeks nearly double the healing rate of 31 percent for standard of care after 20 weeks of treatment.

In a case study series from Canada, similar impressive healing results were found when the EPIFLO device was used.  11 patients with 14 ulcers participated in the study.   The mean age of the wound prior to delivery of Transdermal Continuous Oxygen Therapy via the EPIFLO device was 19.1 weeks.    12 of the 14 ulcers healed, or 86 percent, completely healed within, on average, 46 days or 6.5 weeks.  This case study was published in Advanced Skin and Woundcare (Dec 2012).

Other published articles and wound conference posters can be found here OGENIX

FDA and CE Approved Indications

The EPIFLO device has FDA and CE approval to be used on a number of other indications including:

  • Skin  ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions Decubitus Ulcers (bedsores, pressure sores)
  • Amputations and infected stumps
  • Skin grafts
  • Burns
  • Frostbite

As noted above, Ogenix is aware that EPIFLO has also been successfully used off label on Sickle Cell disease, Peripheral Arterial Disease, Osteomyelitis and other indications.

 

 

For more information:

Download EPIFLO brochure

Contact Inno3Med