NeuroPrex Inc.

 

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June 27, 2016 Issue

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rTMS Non-invasive Therapeutic Device for Treating Major Depression in Drug Resistant Patients for Clinical and Homecare Markets Offering Greater Safety with Deeper Penetration

 

 

Dr. Janice Huang

CEO & Founder

 

NeuroPrex Inc.

www.neuroprexinc.com

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June 27, 2016

 

CEOCFO: Dr. Huang, what is the idea behind NeuroPrex?

Dr. Huang: NeuroPrex is developing an rTMS device, which can be used for treating major depression in drug resistant patients. The US has 30 million depression patients, and 30% of them are drug resistant. Europe also has many such patients. Our initial device will be for clinical use but we will quickly release a low-cost mobile connected home care device that can be used regularly by patients at home and other locations outside of the clinic. We have patents issued in the US and Taiwan, as well as several patents pending in Europe, Japan and China. We also believe rTMS can be used for other neurological disorders including PTSD.

 

CEOCFO: How does the device work?

Dr. Huang: rTMS is a Repetitive Transcranial Magnetic Stimulation device. It is a safe, non-invasive therapeutic method. In our device, because we have a proprietary design of coils and a very unique, one of a kind patient protection system, the device can generate strong magnetic fields penetration through the charged electromagnetic coils. Thereby, it would induce eddy currents ranged from 0.5 to 5 Standard Motor Threshold units [one SMT is 130 volt/meter] inside the targeted tissue, which either activate or suppress nerve activities at the cellular level, to bring into a positive modulation outcome. The device will provide a strong healing effect with reduced side effects, create new synaptic connections, increase oxygen uptake and metabolism rates, modulate cellular function and trigger anti-inflammatory effects. That is why it will be so effective at treating depression, because depression is a disorder with certain types of nerve activities in the brain.

 

CEOCFO: What differentiates your rTMS device from others on the market?

Dr. Huang: Our technological advantage over competitive products is that our device low-cost and more effective, with a longer lasting treatment effect. The other rTMS devices are capital intensive big equipments with cost ranging from $70,000 to $160,000. Therefore, it is not affordable for small clinics to have one of these devices. That is one of the reasons why most of the patients that could be helped by these devices do not have access to them. Technology wise what differentiates our device is that our coils can deliver deeper energy more efficiently and we have more protection that allows for stronger energy that can go deeper without harming the surface tissue. We have another aspect in our design that has shield protection where there is a divided layer that can produce turbulence currents on the surface of head to prevent around 25% to 30% of the unwanted energy without affecting the deeper energy at lesion areas of brain. In patients with depression, the lesion side is the left brain, which is the motor cortex area and inside around the 5 to 6 centimeter depth. Therefore, you can see that we only want to target the 5 to 6 centimeter site. We do not want normal tissue to be affected by the energy because the energy is very strong. Several hundred volts of eddy current will be induced inside the brain, which is the beauty of the technology of our device. The other aspect is our design, where we have both sophistication and streamlining. We have downsized the equipment to a portable size for home use, where the patient connects to a mobile system. Once we get required funding we will do an App design, which will be in combination with some other therapeutic method such as music, and instant online support from a specialist or psychiatrist. In addition, we will have some light healing from detection to monitor for other neurological indications. This will allow us to provide an overall service for patients. Our competitors’ equipments are very expensive, much like MRI equipment, and there is a strong need for patients to be able to use the device at home for more repetitive treatments.

 

CEOCFO: Is the medical and patient community comfortable with the stimulation? Is it accepted or is there still some education needed to explain why and how this would work?

Dr. Huang: This is a very good question. The FDA guidelines and standards are very high. This type of treatment has been used in Europe for more than 30 years, where its use started in England with Dr. Barker [published at The Lancet in May 11 of 1985]. In that environment, Europeans will accept this device being used, even for non-medical use. However, this type of treatment was not permitted in the US, until 2008 when the first rTMS was permitted in this market by the FDA for drug resistant depression. Then in 2012, Medicare started to reimburse for this therapy, but only for use in drug resistant patients. Therefore, this treatment has to be prescribed by a doctor when they conclude that a patient cannot be effectively treated by one or two antidepressant drugs. Then they would allow reimbursement by this treatment method. It will take some time in the US to obtain FDA clearance for other uses. We have observed that this method is very safe and non-invasive, although it is hundreds volts per meter of Eddy currents that will be induced inside the tissue. The patient is not being exposed to direct current. The current is automatically and neutrally generated inside of the tissue. From physical point, the eddy currents can be localized in the closed loops along the magnetic fields, spread through high or low impedance of lesion tissue [which generates heat] providing a natural healing effect.

 

CEOCFO: What is the patient able to control at home so that they do not overuse the therapy?

Dr. Huang: We have carefully considered patient safety and that is why we have developed our own interface using Windows Surface-Pro System. Under our standard process, the patient would go to the clinic the first time, where a doctor will determine a hot spot on the lesion site, because different patients have different hot spots. The doctor would locate the position and then customize the shield layer with embedded coils, which we simply call the Cap and the patient can bring home. In addition, the treatment conditions will be pre-programmed by the doctor at the clinic. In standard TMS treatments, the FDA allows 30 times and each time is 38 minutes continuously within a 6-week period for the completion of one course. Therefore, currently the patient would have to go the hospital 30 times over a 6-week period for treatment. This involves a great deal of travel time for the patient, which is very difficult for someone who is already depressed or is disabled. Each time the patient comes in the doctor has to properly position the device again. With our designed software, the patient only has to press a button to start the treatment. In addition, for security, we have facial recognition for identification so the device cannot be used by any individual other than the patient.

 

CEOCFO: Is the investment community aware of what you are doing? Are they excited about the prospects?

Dr. Huang: Currently most of the medical VC industry is primarily investing into digital health. They are aware that our device can bring improved performance to the current therapies. We have some angel funding but we are currently looking for non-dilutive funding. We recently received approval for the first phase of a EU Grant. We also want to submit a research proposal to the DoD for treatment of PTSD. Once we get more funding, we will finish development and do more marketing.

 

CEOCFO: Would you tell us about your acceptance to present at the upcoming National Academy of Neuropsychology Conference?

Dr. Huang: The Company’s submission entitled “Star-Shaped Coils and Shield Show Potential to Mitigate the Adverse Effects of Conventional Repetitive Transcranial Magnetic Stimulation Devices: Results Obtained by Feasibility Tests on Benchmark Prototype” was accepted to present at the National Academy of Neuropsychology 36th Annual Conference, on October 19-22 in Seattle, WA.

 

CEOCFO: Why is NeuroPrex such a breakthrough and so important?

Dr. Huang: NeuroPrex is important because we have not seen a method that is as effective in treating drug resistant depression. The lower cost and home care device will make treatment available to many more patients both in the US and Europe. We have reviewed many medical publications and understand the US has 30 million depression patients and 30% of them are drug resistant. Europe is also a large market. The market is huge, so once our device is more known to the medical industry as well as the doctors, we can release the device in the US. Doctors need more consideration, as they have to understand the device and see how effective it is, which will require some education. In addition, we can provide our device for their research and experiments, which would be another way to bring awareness and encourage more use of our device.



 

“Our technological advantage over competitive products is that our device low-cost and more effective, with a longer lasting treatment effect… The patient is not being exposed to direct current. The current is automatically and neutrally generated inside of the tissue. From physical point, the eddy currents can be localized in the closed loops along the magnetic fields, spread through high or low impedance of lesion tissue [which generates heat] providing a natural healing effect.” - Dr. Janice Huang


 

NeuroPrex Inc.

www.neuroprexinc.com

 

Contact:
Janice Huang

408-252-2925

janice@neuroprexinc.com



 



 

 


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