Wound Healing & Measuring Solutions
Wound Healing & Measuring Solutions
BRH-A2 Wound Healing System *
Understanding that the expectations and demands from physicians and the healthcare system are greater than ever, BRH Medical believes in innovative software and data solutions in order to maintain quality, efficiency and excellence.
The BRH-A2 system has a patent protected *
measuring software to measure the ulcer size, even though the edges of chronic ulcers are not clearly defined due to loss of tissue.
The system also features a state of the art user friendly interface and stores clinical data of thousands of patients on an individual patient’s filing system and data base.
* Potential feature developement
BRH Product
- Multilingual Interface * - Easy to use, user-defined language configuration. The system currently supports English , German , Italian , Polish, Turkish and Chinese languages.
- Calculation of multiple wounds * - The system is now able to measure wounds that are separated into two or more secondary wounds . Measures the area of each sub-wound individually and shows the relevant change. The system will then calculate a total of all the individual areas combined and present the overall change in area.
- Improved GUI * - The user interface program (GUI) has undergone a upgrade and significant changes allow a more intuitive user friendly working method.
* Potential feature developement
The BRH-A2 is a non-invasive, portable device that has been intended to heal chronic ulcers, reduce lesion size and wound pain, and accelerate tissue regrowth.
The BRH-A2 combines the benefits of therapeutic ultrasound with electrostimulation and modulates them both individually and in combination during the treatment period. This mode of operation is designed to create a “micro-circulation” effect, a massage-like process within the tissues and blood vessels of the impacted medium, increasing the blood flow to significantly increase the healing rate.
The advanced BRH-A2 includes proprietary software for patient record storage and highly accurate wound measurement, assuring that all record-keeping is accurate and compliant with documentation requirements.
Technology
The BRH-A2 device implements a unique combination of therapeutic ultrasound and electrostimulation in modulating cycles of independent and joint activity. Determining the most effective levels of stimulation for optimal treatment parameters are the result of hundreds of hours of scientific experimentation and laboratory simulations.
The BRH-A2 device combines the two modalities, and modulates them both individually and in combination during the treatment period. The result of this unique activity alters the overall effect on the cellular structures and also modifies the directions of cellular and subcellular aggregation.
A proven effect of ultrasound is to stimulate fibroblasts to create collagen, and also to lay the new collagen in a more ordered pattern, resulting in a better weave for epithelialization. Electrostimulation is known to pull taut the fibroblasts and resultant collagen, yielding a stronger weave. The end result of using the two technologies is a more ordered and tighter collagen weave.
For more information on the BRH-A2 technology, please see our white paper here.
- Any wound requires more blood than normal in order to heal. If that extra blood is not forthcoming, the wound can never heal properly, moreover necrotic tissue may form. The BRH system combines two non-invasive technologies that affect blood circulation.
- This combination of Ultrasound & Electric Current Fields varied over the course of the treatment (frequency+ intensity), causes mechanical movement below the wound bed and encourages increased blood circulation in the wounded area.
- The mechanical movement generates a “micro circulation” effect, creating a massage-like effect within the tissues and blood vessels of the wound area, resulting in increased blood flow thus enhancing the healing rate significantly.
- When ultrasonic waves enter the skin, they cause the tissues to vibrate and to mollify, releasing and moving around fluids within the tissues, including blood from within blood vessels.
- The system has a patent protected measuring software to measure the ulcer size, even though the edges of chronic ulcer are not clearly defined due to loss of tissue.
Regulatory and Quality
Israel AMAR
Received
ISO 13485/2003
Received
CE Mark
Received
Australia TGA
Received
Singapore HSA
Received
FDA 510K
Received
Chinese FDA
Submitted
Software for Storing Clinical Data and Measuring *
* Potential feature developement
BRH Medical believes in providing advanced technology solutions to all aspects of the clinical practice. An advanced software and data solution is incorporated in the product in order to efficiently store patient data and results.
The BRH-A2 system features unique, user-friendly, state-of-the-art and patent-protected measuring and documentation software. Detailed patient data, including specific data regarding the location, type and characteristics of specific wounds is saved for improved patient management. Using algorithms, the device can accurately measure ulcer size, even while the edges may not be clearly defined due to loss of tissue.
The system also features a user-friendly interactive interface and can store individual clinical data on thousands of patients for efficient treatment and follow-up procedures.
Customer Support
Please contact your local distributor for all instances of customer support. Please see the list of distributors here.
Using the system
FAQs for Product
Is there a pattern on electrode placement or is it just random around the wound?
The electrodes must be placed as close to the wound as possible, but not touching the wound edges, being sure to leave a sufficient area for the transducer to be operated around the wound.
Is polarisation important for the electrode placement?
Yes
How large is the market for wound healing products?
The market for wound healing products is huge. In the USA alone, over 6.5 million people suffer from some type of chronic wound. About 7 % of the US health budget is spent on the wound care market. This market is highly fragmented and lacks a gold standard.
Is the wound care market a challenging and difficult one?
Until now, there is no one product that is proven to cure all chronic wounds for all people. and no proven treatment solutions for hard-to-heal wounds. Chronic wounds are an immense clinical problem that causes great suffering to patients, and are a growing economic burden on hospitals, clinics and health systems around the globe. Even though this problem is large and widespread, no proven effective solution has been developed. This is one of the reasons that can make it easier for new technologies to penetrate and try to prove themselves.
What is unique about the BRH technology?
The BRH patented technology combines therapeutic ultrasound and electric fields. Many studies have identified ultrasound and electric fields as causing acceleration of blood flow. The FDA also confirms the fact that ultrasound and electrical fields are capable of accelerating blood flow. To date, studies and companies have been trying to seek the specific combination of a fixed frequency and intensity but have failed to find the effective combination. Their results do not meet the expectations. While it is true that a fixed frequency and intensity will lead to blood flow values’ acceleration, these will be very minor and for a very short period of time, which is not enough to cure hard-to-heal wounds effectively. The BRH device implements a unique patented technology that combines therapeutic ultrasound waves with electric fields. The technology implements a proprietary algorithm for the two technologies simultaneously, while continuously changing frequencies and intensities of the waves during the entire treatment process, resonating the affected tissue and accelerating the blood flow.
Is the combination of electric fields and ultrasound effective?
It is, but only if the frequencies and intensities change continuously based on the unique algorithm. This is the ‘BRH Effect’.
How many treatments have been performed until now ?
So far, we have performed almost 10,000 treatments in sites around the world. We are currently active in the following countries:
• Israel
• USA
• UK
• Australia
• Italy
• Ireland
• South Africa
• Singapore
What is the regulatory status of the device?
The device has the following approvals
• FDA
• CE mark
• TGA (Australia)
• HSA (Singapore)
• AMAR (Israel)
Will these studies / data be sufficient for the US reimbursement system?
These studies are the basis for future studies to come. This clinical base should be sufficient to convince the decision makers to carry out clinical trials together with BRH medical as it has done with other companies in the past.
How can I operate the device after a power outage?
After a power outage, perform the following steps:
1. Open File Explorer
2. Delete D:\BRH_Data\Settings\Settings.xml 3. Delete D:\BRH_Data\Backup\Settings\Settings.xml
4. Reboot
Can I perform the treatment myself?
No. The ActiVessel & Actiwound systems must be operated by a trained professional in a medical clinic.
Treatment duration: The actual treatment is between 15-40 minutes long, however, you can expect that the whole procedure may take up to 30-45 minutes including the time it takes to remove all bandaging and then redress the wound. In case of pain, it may be shorter.