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H&P Medical Research (“we”, “us”, the “Company”, “H&P”) is a privately held medical technology company focused on developing and marketing proprietary technology and products for use in wound healing, pain management and tissue repair. They have a granted patent on a new and improved technology that tailors to the wound requirements and provides a solution to a lot of problems with the existing devices in the market. They are currently building prototypes and plan to bring the product to the market within 6 months.
H&P Medical Research was a Nevada S-Corporation founded on August 22, 2006, primarily as a research and business consulting firm. It is relocated to Arizona in February 2014 as the founder is domiciled in Arizona and intends to conduct business here. Also, the state of Arizona offers the similar indemnification to officers and directors of the Company as the state of Nevada does. Sensing the market opportunity for a patient-friendly, portable and less expensive device for wound healing, Dr. Pandelisev decided to bring his patented idea to life. The technology behind the device is proven and a number of devices used for electromagnetic therapy have been approved by the FDA earlier (discussed in the sections below). Thus, we believe that the device would receive approval without much difficulty. However, there are several advantages of this device over the existing systems in the market which are discussed in the upcoming sections.
Pulsed radio frequency electromagnetic field therapy (PRFE) has a long history in treating medical conditions such as pain and edema, chronic wounds and bone repair. It is a non-invasive therapy that delivers electromagnetic energy into soft tissue generating an electric field which is thought to mediate the therapeutic effects. In 1947 the Federal Communications Commission assigned three frequencies at the short end of the RF band for medical use (40.68 MHz, 13.56 MHz and 27.12 MHz). The frequency of 27.12 MHz is the most widely used in clinical practice. The first PRFE device, the Diapulse (Diapulse Corporation, NY) was commercially available in the 1950’s, and was followed by other commercially available machines.
However, the devices that are currently available in the market are bulky and costly devices which are not user-friendly. They have no control over the field strength over the treated area and there are no feedback sensors of any kind. Skin heating and burning remains an issue and the irradiated area is either too large or too small for the wound heated. New and improved technology that tailors to the wound can treat more than one wound on the body at the same time, and resolve the issues mentioned. H&P Medical Research through its granted patent brings the latest technology to its device making it patient-friendly, flexible, portable, and less expensive.
U.S. Food and Drug Administration (FDA)
A number of devices used for electromagnetic therapy have been approved by the FDA through the 510(k) approval process. When used to treat wounds the FDA considers these devices as Class III devices which require a premarket approval. Some of these devices have been cleared by the FDA more specifically as short-wave diathermy devices or radiofrequency stimulation devices (e.g., Provant Wound Closure System [Regenesis® Biomedical, Scottsdale, AZ]); Diapulse® [Diapulse Corporation of America, Great Neck, NY]; SofPulse® [Electropharmacology, Inc., Alachoa, FL]). Several of the devices are intended for the treatment of postoperative pain and edema in superficial tissue and not specifically for wound treatment. Approval for the use of these devices specifically for the treatment of chronic wounds was not found on the FDA site.
About H&P Medical Research Inc,
H&P Medical Research, Inc. is a privately held medical technology company focused on developing and marketing proprietary technology and products for use in wound healing, pain management and tissue repair.
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