Monday, January 4, 2016

Mark Standeford of Cardiovate on the Opportunity in Stem Cell Therapy

Cardiovate’s technology provides a structure for a patient’s own cells to form new tissue, replacing damaged blood vessels.

 Originally from Indiana, Mark Standeford of Cardiovate started working in medical device R&D and moved to Texas 9 years ago.  Through his work he traveled significantly and always enjoyed Texas in terms of its climate, culture and of course the people.  He performed his undergraduate degree at Ball State University.  As he was studying for his BS degree in Engineering Technology he found several courses in Computer Integration that he enjoyed and ended up taking the extra courses during his 4 years to complete an A.S. along with my B.S degree.  After working for a few years he attended University of Texas at Dallas to complete an MBA.

Cardiovate provides tissue regeneration

Cardiovate is a medical technology company targeting transformational opportunities in tissue regeneration and repair through the development of novel products.  The core technology provides a structure for a patient’s own cells to form new tissue, replacing damaged and diseased blood vessels.

The idea came from research that was collaborated by the University of Texas San Antonio and the University of Texas Health Science Center San Antonio.  The body’s vascular system is complex with a key component of that system being the interior tissue that lines the system which is known as the endovascular lining and is comprised of endothelial tissue.  The idea is to help the body regenerate its own endovascular tissue after surgery by using a bioabsorbable material that dissolves after use.

Vascular disease can cause restrictions to occur which will impede a person’s blood flow.  This reduced blood flow causes damage to the body’s systems and tissue that depend on the blood.  Over time as the blood flow decreases, severe complications can occur which can lead to loss of limbs (amputation) or even death.  Even less severe complications can be detrimental to a person’s quality of life if they have severe pain in their limbs due to poor blood flow.

When blood flow complications become severe, surgical intervention is required in order to establish good flow.  Often times this surgical procedure utilizes a synthetic tube to replace a damaged blood vessel.  Over time the body reacts to this synthetic tube and blood flow is again restricted as the tube becomes clogged.  The underlying issue is that the synthetic tube does not have an endothelial lining as your natural blood vessel does which causes the body to react and clot. 

The technology targets the poor performance of the current synthetic tubes by creating a structure or scaffold that the body can rebuild a new endothelial lining with, and then our material absorbs and leaves the body with just its own natural new tissue, thus reducing the response to clot.  This reduced response by the body will provide for improved clinical outcomes which in turn will reduce the number of surgeries a patient has to go through and the cost of treating vascular disease.

Cardiovate’s device is for vascular surgeons and interventional radiologist who treat patients with peripheral vascular disease.  They will utilize our synthetic device instead of existing devices along with their current surgical techniques.  By using the product the overall cost of treatment will be reduced which will provide value to hospitals and payers who choose this over existing products.

Challenges ahead

The most challenging aspect has been aligning resources with development tasks that create value as we move forward.   The technology has a lot of potential applications which is exciting but can be distracting at the same time. 

In this field, data driven analysis is key to supporting a solid business strategy so Cardiovate must continue to create data that supports the value proposition.  The next steps are to complete a set of product builds and use the devices in planned animal studies. The studies will inform on the initial blood vessel tissue generation with our latest design.  Cardiovate is also collaborating with a stem cell company to see if their product on our device will facilitate even better tissue generation than our device alone. 

Lessons for entrepreneurs

No matter what your product or service, make sure to first test the business model.  It is easy to get excited about a new technology or service but that is the invention phase which does not tell if you have a good business opportunity.  The entrepreneur should be focused on how you create a sustainable business for the new technology or service.  Often times I have seen new inventions raise excitement and funding but fail to test the market opportunity before moving heavily into development and fail.

In most cases you can test the model early and cost effectively as long as you know (1) what the problem you are trying to solve is, (2) who your target customer is, (3) the target market including its dynamics, and (4) how you get paid for your product or service.

Resources for entrepreneurs

Experienced mentors and knowledge experts familiar with your industry are extremely valuable.  Use their knowledge to assist you in planning your strategy and execution.  Everyone needs others to bounce things off of and using experienced people that are open to new approaches but can ground an entrepreneur in avoiding known pitfalls is priceless.  Often times these experts are not someone you need to hire or have equity in the company because without any financial interest they can be unbiased in there help and provide the support you need to make the best decisions.

To learn more about fundraising through TEN click here: TEN Site

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