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With their “Batteries in a Bandage” Technology Procellera, Vomaris is Jumpstarting Wounds to Begin the Natural Healing Process Using a Low-Level Microcurrent

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Company Profile:

Vomaris Innovations, Inc. is a medical device company specializing in emerging bioelectrical field generating technologies for the wound care market. Its products and technologies are developed with sound principles, quality manufacturing and are supported by documented, reproducible data from scientific, biologic and clinical research.

Product Overview
Procellera is a bioelectric, antimicrobial device for partial and full-thickness wounds that consists of a multi-array matrix of biocompatible microcells. In the presence of a conductive fluid, such as wound exudate or normal saline, the device activates to generate a sustained microcurrent at its surface. This technology is based on a unique biophysical mechanism of action resulting from low levels of electrical energy produced within the device.

Michael Nagel
President and Chief Executive Officer

Michael Nagel joined Vomaris Innovations as President and CEO in February 2012. Nagel brings more than 26 years of sales and marketing experience in the medical device industry. Prior to Vomaris, Nagel served as Chief Commercial Officer at Neomend and oversaw the commercial launch of PMA device ProGEL. While at Neomend, Nagel guided ProGEL to rapid sales growth to over 1,200 hospitals. Nagel also served as co–founder and Vice President of Worldwide Sales and Marketing at Vascular Solutions (VASC). He helped take Vascular Solutions from inception to IPO within 39 months and led the launch of a novel, biological vascular closure device in the interventional marketplace. Nagel also served as Vice President of Sales and Marketing at Incisive Surgical. Nagel holds an MBA and BA from the University of St. Thomas.

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – September 3, 2012

CEOCFO: Mr. Nagel, you have been CEO for a relatively short time, what attracted you to Vomaris?

Mr. Nagel: First off, the technology was very unique, exciting, compelling, and within a very large market space that is obviously in need of innovation. The wound care market, by most estimates, is between $15 billion and $20 billion. The second biggest factor was the fact that Paul Foster, who is the Chairman of the Board and heads up Franklin Mountain Investments, came in as a key investor at about this time last year to recapitalize and get the company going in a forward moving direction. These were the two big factors, then there is the enabling technology.

CEOCFO: Would you tell us about the technology?

Mr. Nagel: Simply put, we have batteries in a bandage. It is a very unique and revolutionary technology. We are the only one in the world now that has this. We have a proprietary method of producing biocompatible microcell batteries on a material surface, which, as a wound device, is a woven polyester fabric. We essentially apply, with our patented and proprietary process, microcell batteries comprised of silver and zinc. When Procellera comes in contact with conductive fluid, such as wound exudate, saline or hydrogel, the batteries are activated. The batteries in our wound device provide a low-level microcurrent at the surface and provide antimicrobial (infection prevention) protection. Our bodies are made up of tons of electrical connections and when we have a wound on the skin, whether it be an acute wound or something chronic in nature, those microcurrents on our skin are active. Microcurrents in a healthy, healing wound are ways that the body sends anti-inflammatory signals and required healing cells to the site. There are all sorts of things that are going on in a cellular level which allow the wound to naturally heal. Procellera essentially creates an environment that helps it heal. What really happens to a lot of wounds that are infected or are stalled out, as we say in the business, is basically the microcurrents are interrupted or ceasing to flow in that area of the wound. We are essentially jumpstarting that wound to begin a natural healing process. By the nature of our technology, which utilizes silver and zinc, a strong antimicrobial action is present. Silver is a very well known antimicrobial, and in the presence of a microcurrent, research has shown that the antimicrobial effect is augmented. So, in the presence of microcurrents, it provides even more antimicrobial action than just silver itself, so you get several benefits in the technology. There is no other technology in wound care presently that provides this type of option to manage a wound.

CEOCFO: Has anything similar been tried in the past?

Mr. Nagel: Not the way we approach the opportunity. There have been many publications on electrical simulation in wounds; in fact, it started in the fifties with an author named Robert Becker, M.D., who studied a substantial amount on the effects of the microcurrents. Many of his observations, and those of subsequent others, form the foundation of our technology. Current technology has cords, wires, plugs, external batteries and everything else. If you notice with Procellera, when you look at it, it is just a piece of fabric that is flexible and conformable. You can cut it to size, and you do not have to worry about cords and wires. Electrical stimulation is a very well known phenomenon in wounds, but nothing like this has been tried before.

CEOCFO: For skeptics or people concerned, what are the possible side-effects?

Mr. Nagel: The benefit of this technology is there is not much of a downside. Obviously, if you have an allergic reaction to silver or zinc you would not want to use the product. The voltage that is present at the device surface is less than one volt of potential energy, similar to the natural electrical field at a wounded skin surface. The current produced by the device is far below the threshold of feeling, so people cannot feel or sense it. If someone is undergoing an energy-based procedure, the physician should decide whether Procellera should be removed during the procedure. So, you can see that there is not much of a downside to Procellera, and that is the beauty of the product.

CEOCFO: Is the medical community aware of your approach?

Mr. Nagel: Somewhat. The company has been around for a while. It got an auspicious start like many medical device companies that start with great technology. Jeffry Skiba, who is our Chief Technology Officer and founder, started the company. He got the passion and came up with the process and invented the technology. He is a brilliant guy. As he went out to raise money and run a new company, he ran into the same issues as many other brilliant inventors have: that inventing and coming up with a technology offers very different demands than running a company. The technology to the wound care marketplace has never really been fully utilized up until now because the company had lacked the resources to be able to market and do the necessary clinical studies. That is why Mr. Foster’s involvement was so important; he came in last year and recapitalized the company. Then they subsequently found me through a search and I joined the company in February. In the wound care marketplace, there are a growing number of people who are aware of Procellera and have had very impressive results. There are already about nineteen or twenty articles that are in various forms of publication regarding Procellera. We have a recently published study in the Journal of Burn Care Research. But, I would say that, in general, most of the wound care community has not had an experience to try the product.

CEOCFO: How will you reach the appropriate people?

Mr. Nagel: With Procellera, we have many available avenues to reach our target markets. Procellera has an over-the-counter indication as well as a professional indication; these are two very large markets that we look to serve. Right now we are launching our own sales and distribution network to sell and market Procellera, and as we get further into the marketplace, we will always look at various strategic options for both getting Procellera to patients who need it, and for serving our shareholders. We will always be looking at various distribution options because there are all sorts of avenues of distribution that the wound care market offers, such as the hospital market, the long-term care market, the over-the-counter market, the home market. It makes it challenging for small companies because you have so many different directions to go to fully supply the market.

CEOCFO: Is the cost a major factor or is it negligible compared to what you can do?

Mr. Nagel: There are documented articles out that current costs to treat various conditions like diabetic ulcers range between $8 thousand to $40 thousand. Wound management is very expensive. Healing is the ultimate goal that everyone should be after because at the end of the day, if you heal the wound, the patients can lead active lives and they are no longer in the healthcare system. For any therapy which can reduce the amount of healing time needed and can reduce the readmission rate or a potential infection, the cost of the product is generally negligible when you are looking at the cost to the healthcare system. The cost for hospitals to acquire Procellera is very low. They can order various sizes and we are cost competitive with most advanced wound care products on the market today.

CEOCFO: What is in your background that makes you the right person to handle all of this?

Mr. Nagel: I have been in healthcare for 26 years, so roughly half my life has been dedicated to medical devices. The key thing that you learn is the ability to focus, pick a few key markets and really drive the execution in that direction. We also have a great team of dedicated employees at the company, that is also key. A football coach once told me, any play will work if it is flawlessly executed. Secondly, I heard a line from the Apple CEO recently when he said something along the lines of “we are going to say no to a thousand different things and yes to a very few, and those few things we'll do very well”. That is our approach. The key starting point with Procellera has to be what I call the professional market and that is the wound care professionals who are located in hospitals or clinics. Once it is established there, and the clinical validity is established there, and clinical studies are done there, that then drives interest in what I call the peripheral markets: the over-the-counter markets, maybe the long-term care market, the home healthcare market, maybe the veterinary market. Those are all good markets but I think, from my background, that you really have to start in that professional market to really build the company’s credibility, and it is also a sizeable opportunity. In the professional market, you are not lacking in the number of wound care cases or you are not lacking that the business is not there; there is a substantial business in the 6,500 hospitals and the 550 or so wound care centers in the United States, so there is a substantial opportunity there. That is a good target to begin with.

CEOCFO: What is the plan of action over the next year or so?

Mr. Nagel: We are going to continue to build our clinical story with Procellera because we know that in the marketplace, this is one of the key elements that you need to have. You need a clinical story and you need an economic story or you do not have a story. To really penetrate into the hospital system now, you need those two things. You need to work together with new technology. The market is no longer compelled just by new technology, I mean you have to come into a market now and give a compelling reason besides just clinically. Now you have to do it economically, showing why they should consider your product. With that, we have to focus on a clinical story. We have some clinical development programs in progress now to help further our clinical message with some good retrospective studies. Secondly, those retrospective studies can be subsequent data that we will collect and will always have an economic bent to it. If we claim that Procellera works better, we have to put a number to that. As for what that means, if it means less time in the hospital, better healing rates, or less dressing changes, then we need to show what it equates to as far as cost savings. We are totally gearing our company now toward what is going to be required going forward for medical device companies to be successful. You have to have a clinical and an economic argument before you are going to get the widespread adoption of your technology.

CEOCFO: Is Vomaris Innovations funded to get through the next year of growth?

Mr. Nagel: Yes, we are adequately funded right now. Once we get done with our projects every year, we will look into the horizon and see what we need for additional funding. Franklin Mountain Investments funded the last round, and they have been a wonderful partner so far. We also have some angel investors who helped to fund the company in the beginning, and they are very important, as well.

CEOCFO: Why should investors pay attention to Vomaris Innovations?

Mr. Nagel: First of all, the wound care marketplace is a very substantial marketplace. If you look at the demographics of obesity and diabetes and just chronic wound conditions of the ageing population, it is a very large and substantial business. No one player is going to dominate. There are many modalities and different ways to treat wounds. Second, the technology is probably one of the most enabling technologies right now in wound care. Microbatteries applied on a flexible membrane to provide a low-level microcurrent is very technologically advanced, but also a very affordable product for hospitals to acquire. Third, we are going to continue to build a very good clinical story. We have all the legs of the stool. Potentially, it will be a very substantial company. We have a nice patent portfolio to which we have recently added. We have very good profit margins. We have a validated manufacturing system and a Quality System that is certified to ISO 13485. We have many things already done for us that most small companies struggle with. We are there.

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Healthcare
Regenerative Medicine
(Private)

Vomaris Innovations, Inc.
3100 W. Ray Rd., Suite 148
Chandler, AZ 85226
Phone: 480-921-4948
www.vomaris.com

Vomaris Innovations, Inc. Print Version

 

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Simply put, we have batteries in a bandage. It is a very unique and revolutionary technology. We are the only one in the world now that has this. We have a proprietary method of producing biocompatible microcell batteries on a material surface, which, as a wound device, is a woven polyester fabric. We essentially apply, with our patented and proprietary process, microcell batteries comprised of silver and zinc. When Procellera comes in contact with conductive fluid, such as wound exudate, saline or hydrogel, the batteries are activated. The batteries in our wound device provide a low-level microcurrent at the surface and provide antimicrobial (infection prevention) protection. - Michael Nagel