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INTERview





Permanent Eye Color Change Becoming a Reality at Stroma Medical


Doug Daniels

Chief Executive Officer


Stroma Medical

www.stromamedical.com


Contact:

Douglas J. Daniels

949-207-3312 x10

Ddaniels@stromamedical.com


Interview conducted by:

Lynn Fosse, Senior Editor

CEOCFO Magazine


Published – March 23, 2020


CEOCFO: Mr. Daniels, what is Stroma Medical®?

Mr. Daniels: Stroma Medical is a clinical phase medical device company located in Irvine, California. We have designed, developed and patented, a transformational, laser-based system that creates options for patients to safely and effectively change the color their eye color from dark colors to light creating a natural radiance in the treated eyes. Stroma Medical is a company that is creating options for patients who want to change the eye color and opportunities for the physicians performing the procedure to expand their practice.  


CEOCFO: How does the process work?  

Mr. Daniels: Stroma has completed years of scientific, animal and human testing to develop a process that is safe, efficient and effective at changing eye color for patients looking to achieve a natural radiance in their eye color without the discomfort and un-natural look of colored contact lenses. The way the Stroma Laser System works is that we combine eye mapping and eye tracking with a highly divergent beam laser to trigger a natural body response to remove the pigment from the front of the iris. The Stroma Laser System is driven by proprietary software that allows the ophthalmic surgeon to provide a non-surgically invasive procedure that takes under a minute to perform, and effectively treats the eye to create a natural looking eye color after a full treatment cycle.


The mapping system captures an image of the eye and targets the pigment in the front portion of the iris. The mapping system blocks out segments of the eye, to protect all the other areas surrounding the iris and only allows treatment in the selected treatment area. During the procedure the system actively tracks the surface of the iris that has been mapped out, which allows us to complete the procedure very efficiently and safely. We can generally complete a procedure in under a minute. We use an Nd: Yag laser with a divergent beam to only impact the pigment on the front of the iris. Our procedure provides an experience that is easy for the patient to tolerate and very easy for the doctor to do. The Stroma Laser System is very precise, so it maintains the safety profile that we really need for doing a procedure like this and maintain both safety and gain the aesthetic results patients desire.  


CEOCFO: What allows the pigment to change? How does the laser make the color change?  

Mr. Daniels: The laser triggers a process called photo-thermolysis. This process heats up and cools down the pigment that sits on the anterior portion of the iris. The process triggers the cytokines in your body to recruit macrophages, which eventually carry the pigment that resides in the anterior portion of the iris, away from the iris and exposes the grey stroma fibers. This allows for light to shine through the stroma fibers and be absorbed in the back of the eye. Only the shortest band of color, the blue color, bends back and produces a blue eye color. So, there is no blue in a blue eye, it is the shortest band of light, the blue, bending back and creating a blue eye color.


The process to change eye color is gradual. The more we treat the iris, the more the color tends towards blue or green. The technology is both controllable and adaptable. For example, we may have a patients that wants to change from a black eye color to a brown color, from a brown color to a hazel color from a hazel color to a grey blue and then finally to a blue color. Our system allows the ophthalmologist doing the procedure to control the results and adapt the color that the patient wants within limits. We can create the options that patients want.    


CEOCFO: Why do people want to change their eye color? Why would people go through a medical procedure to change the eye color? What is the research about the market for this procedure?  

Mr. Daniels: Most people, are very satisfied with their eye color. However, there are many people who, for one reason or another would like to have the radiance that a lighter eye color provides. Their reason for wanting to change their eye color is often personal and somewhat historical as far as beauty is concerned. In other words, some people may have had a close relative who was complimented on their eye color or it may be as simple as some cultures have equated lighter eye colors with certain class or aesthetic benefits. Lighter eye colors are clearly a preference based on the color of the contact lenses sold worldwide. We are creating a safe way for providing the options for the patient who will feel more confident about their appearance with a lighter, more radiant eye color.


There are almost thirty million people, worldwide, that wear colored contact lenses each day to enhance their appearance. And, as it is in many areas of aesthetics, the change is appearance almost always starts off as a temporary solution and it evolves to a permanent fix. For example, people who used teeth whiteners eventually may move to teeth veneers. People who wore toupees eventually moved to hair replacements. People that used push-up bras eventually moved to breast implants. Almost every area of aesthetics starts off as a temporary solution, and then evolves into to some type of permanent fix, and, moving to a permanent change of eye color is really what we are doing. We are moving the market from what was a temporary solution in the colored contact lens and evolving it into a permanent eye color change that creates a natural looking color while avoiding the eye irritation and infections of the existing method.  


CEOCFO: Where are you in development of the procedure?  

Mr. Daniels: Right now, we are completing our pilot clinical trial on the full iris. Some of our actual patient results are now available on our Facebook page and we are happy to share that with the market at this point.   


CEOCFO: What have you learned through early testing?  

Mr. Daniels: The biggest thing that I think we found is that patients want the option to change their eye color to a lighter eye color and not necessarily a blue eye color or a green eye color. People are looking to give themselves a look that creates a natural appearance given their hair and or skin color. For some people, that is moving from a black eye to a brown eye or from a brown eye to a hazel eye or from a hazel eye to a grey eye. It is very personal. Therefore, what we have found is that our job is to optimize our technology to create the choices for the patient and not necessarily just targeting a specific eye color.  


CEOCFO: Are there several treatments involved in getting to the final change or is it a onetime situation?  

Mr. Daniels: In most cases it will take three to four treatments in order to create the optimal color for the patients who want to lighten their eye color. The lighter the eye color to start with the less that you treat, the more that you establish the grey stroma fibers, and the more pigment that you release from the iris, the more likely you are going to get a color that is bluer color. We can remove as much pigment or, as little pigment as patients wants and we can create an eye color that looks best for them given their personal preference.


CEOCFO: Would you be introducing this in the US, in Europe? What are your plans? Where do you see the most/best opportunities?  

Mr. Daniels: The best possibilities are going to be in those areas that already have a colored contact lens business established. There is also a very good market for any areas that have a high rate of aesthetic procedures. Therefore, we believe that the first markets we will be entering are in the southern European markets, across to the Middle East and then into Asia, Central and South America and eventually into the United States, China and Brazil.    


CEOCFO: Has anything similar been attempted?  How can people currently changing their eye color?  

Mr. Daniels: For years, people have been using colored contact lenses, a market that continues to grow. Now, there are sites who are trying to use just a free hand laser in order to change eye color. In order to be as precise as necessary to really change eye color, the energy generated on the front of the eye has to be focused on an area that is roughly the thickness of a business card. For Stroma, the key aspects of our technology development have been just defining exactly what is necessary to treat the pigmented area and do no harm to the rest of the eye. That is almost impossible to do safely and efficiently with a free hand laser. What we have been able to do is figure out the exact combination of laser treatment perimeters with the right amount energy that is necessary to photo disrupt the pigment combined with safety features to do the procedure safely and with optimal clinical results. And, then as a business, patent those aspects of the treatment to protect a sustainable competitive advantage in our vertical.


CEOCFO: What type of training would a surgeon or an ophthalmologist need?  

Mr. Daniels: An ophthalmologist is always going to have the patient’s eye health as the most important thing he or she could protect. The specific training that is going to be necessary is going to be on the unit and, making sure the physicians and their staff have identified the right patients up front, screened both physically and psychologically. Then, it would just be a matter of using the system as intended. The system is easy to adapt to for physicians who are used to doing refractive or Lasik eye procedures. Therefore, the training that is necessary is going to be easily adapted.   


CEOCFO: We came upon Stroma Medical as you were at the Emerging Med Tech conference. What type of response have you had from the medical community and also at conferences?  

Mr. Daniels: The response from the market five years ago, was very skeptical, and rightfully so with any new technology in the aesthetic arena. I think that many ophthalmologists were concerned about things like intraocular pressure, damage to the cornea or vision and perhaps even damage to the pupillary muscle response. What we found was that over time we have been able to really identify and clinically test the specific areas of the science that make the doctors comfortable, that in fact that Stroma is creating a very safe and effective procedure that is going to be done very efficiently over the long haul.  


CEOCFO: Are you funded for your next steps? Are you seeking investment or partnerships?  

Mr. Daniels: Right now, we are in the process of raising a Series B of $30 million. We are now actively speaking to investor groups, family offices, and venture funds from around the world to provide the capital for the company to get through to profitability in the next three years. We plan to be able to close on the round in the next few months and welcome the opportunity now to speak with investors interested in the company.  


CEOCFO: Given your considerable history, what have you learned from your past experience about new medical devices or procedures and bringing products to market?

Mr. Daniels: I think the key thing that I have learned over the years is that if you can define a big need or desire, and develop a technology that is more effective and less costly to the alternative, you can generally fund and develop a successful company that is good for the market and profitable for investors. If you invent or discover new technology, it always takes considerably longer than it first appears. Therefore, what I have learned over the years is that it is important to define where you want to end up, and to define metrics or steps that help you to determine success points along the way that keep you on track for success. Building a company requires a symbiotic relationship between the idea, the need in the market, the customers, and the investors and the market. Those things must be in place to be a successful business.


CEOCFO: There are so many new ideas, products and services. Why pay attention to Stroma Medical?  

Mr. Daniels: Stroma has a truly transformational technology. We are pursuing a large unmet need in our market, that creates options for patients, and opportunities for doctors. We have a great team to achieve success. And, this is an opportunity for investors to get a great for a positive return on their investment. Our system combines technology that is really very unique in that it is able to map effectively, track during an actual procedure and then treat, which gives it a very unique ability to treat very precisely and very efficiently which are key elements for many future opportunities to treat patients with greater speed and safety while improving clinical outcomes.

The Stroma technology is something that is going to be very special. It starts off with a market, eye color change, and an opportunity that is really underserved at this point. But, it will be used in many areas of ophthalmics and aesthetics in the future. Our technology will provide the helping hand that physicians need in order to do many procedures much more efficiently.


Therefore, this technology is going to have some unique advantages in the long haul, so we have to be able to capitalize on it, not only for the eye color change market and this opportunity, but for additional markets and opportunities down the road.


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“Stroma Medical is a company that is creating options for patients who want to change the eye color and opportunities for the physicians performing the procedure to expand their practice.”- Doug Daniels

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