Small Changes Big Difference

September 01, 2015 0 Comments

At the Raider Project we are always excited to hear about new technologies that can help advance preventative medicines, therapies and treatment for veterans.  One of our own RaidersDerek Herrera, is asking for your help in supporting an amazing advancement for individuals living with paralysis. Please read this story and share with your friends and family.   Donate now.

The world's first semi-permanent, fully internal, smart catheter system for Neurogenic Bladder.

Dealing with Paralysis and SCI/D

I knew my life would change, but I didn't know that managing my bladder would be the most challenging task I faced on a daily basis.  As a individual living each day with paralysis resulting from spinal cord injury, I understand just how terrible the current standard of care can be for managing Neurogenic Bladder.  Every day, I have to insert small dispoable catheters into my body in order to relieve my bladder of urine.  These devices have changed very little over the past century and I believe it is time to innovate radically to improve the quality of life for people like me.  

This is expensive and unhealthy.  Urinary Tract Infections are the leading cause of rehospitalization for people with SCI/D and the current process of catheterization is archaic and medieval.  The plastic tube used to drain the bladder is essentially the same as any plastic straw.

Neurogenic Bladder

Neurogenic Bladder is a condition that affects millions of Americans every year.  It often leaves a person unable to sense the fullness of their bladder and unable to control the voiding process.  This means that users often go to the bathroom more than they need to, avoid drinking anything but water, totally dehydrate themselves before a car or plane ride, and resort to virtually anything that will prevent them from having an accident in public.  This condition doesn't just affect people who were traumatically injured, the truth is that if you live long enough you have a pretty high chance of developing some form of urinary incontinence.  Other conditions that may result in Neurogenic Bladder include:

  • Alzheimer's Disease
  • ALS
  • MS
  • Spinal Cord Injury and Disease
  • Dementia
  • Peripheral Nerve Damage
  • Stroke
  • Cerebral Palsy
  • Parkinsons

The main methods of management for Neurogenic Bladder all have significant drawbacks and issues.  The methods of management include:

Intermittent (Disposable) Catheters (L): Disposable catheters that are inserted 5-10x per day.  The risks associated with this method include infection, false passage (urethral trauma), and strictures.

Indwelling (Foley) Catheters (R): A semi-permanent catheter that connects to a urine collection bag on the leg or wheelchair of the user.  Risks associated include infections and trauma to the bladder wall from the tip of the catheter.

Suprapubic Catheters: The same as an Indwelling catheter but requires a surgical incision in the stomach for the catheter to access the bladder.  Also connects to a leg bag but comes out of the stomach.  


    The Solution = A "Smart" Catheter

    Although the Connected Catheter™ utilizes some highly innovative and advanced technologies, our team has taken a problem first approach to solving this issue and are trying to accomplish two primary objectives:

    • Tell me when my bladder is full
    • Let me empty it without inserting catheters into my body 5-10x per day

    In doing this we also have identified secondary aims that we know will create and capture value for providers and insurers.  We are committed to improving this experience for users, clinicians/providers and payers all at the same time.  We hope to improve patient outcomes while decreasing costs for any payers (supplies and costs of care).  

     

    The Technology

    The technology behind the Connected Catheter™ allows us to achieve the following key product features (many of which have never been incorporated into a product for users):

    Semi-Permanent - One Connected Catheter will last for approximately one month and may replace as many as 200 intermittent (disposable) catheters.

    Minimally-Invasive - The Connected Catheter is inserted and extracted through the urethra almost exactly the same way that intermittent and indwelling (Foley) catheters.

    Fully-Internal - The Connected Catheter is fully internal to the body.  The valve is positioned at the base of the penis and is easily actuated by the user.

    Quickly Inserted/Removed - Our insertion/extraction mechanism allows a clinician or user insert/remove the device so that it can be removed in the event of Autonomic Dysreflexia or any other issue.  

    Connected - Our device wirelessly relays pressure data to an external device that alerts a user when their bladder is full and about to void.  This also offers clinicians the opportunity to utilize predictive analytics and advanced software algorithms to make more informed decisions.  

    The Impact

    Many people don't realize just how debilitating the conditions associated with paralysis can be.  It is common for people to see a wheelchair and think "Oh man, that must be really tough because he/she can't walk."  I thought the same thing before my injury but what I learned was that the human body was not designed to spend the entire day in a seated position.  A variety of secondary conditions result from this issue that are often more troubling than the mobility issue.  

    In peer-reviewed research, a doctor asked paraplegics and quadriplegics what function they would choose to return if they had the option and paraplegics reported Trunk Stability, Sexual Function, and Bowel/Bladder Function all as more important than the ability to walk.  This is similar for quadriplegics except that they also would rather regain Hand/Arm function ahead of walking in addition to the Trunk Stability, Sexual Function, and Bowel/Bladder function.  This is the truth that most people don't see and prefer not to talk about (because it can be embarrassing).

    The Impact our product can have is vast.  One Urologist with over two decades of experience treating Neurogenic Bladder said,

    "Imagine the improvement in quality of life for the millions  of patients who wear permanent indwelling urinary catheters or do intermittent catheterizations...  As someone who has managed thousands of patients with neurogenic bladder and urine retention who need the assistance of a catheter to maintain renal function, this device  could be revolutionary in its impact."

    The Team

    We have assembled a talented team of engineers and clinicians to develop this product.  Currently, there are two full-time employees (1 MBA, 1 PHD), two part-time consultants (2 PHD), and a large network of advisors (financial, clinical, regulatory, reimbursement, product development, federal grant writing).

    In the past few months we have been successful in local business plan competitions and were accepted to a highly-competitive virtual accelerator this past summer.  

    First Place at UCLA Anderson School of Management, Knapp Business Plan Competition - http://blogs.anderson.ucla.edu/anderson/2015/05/judges-tap-spinal-singularity-first-prize-knapp-venture-competition.html

    First place at UCLA Institute for Technology Advancement (ITA) Student Engineering Venture Competition - http://www.venturecapital.ucla.edu/blog/spinal-singularity-wins-last-week-s-ucla-ita-venture-competition

    Derek presenting at the Wilson, Sonsini, Goodrich, Rosati Medical Device Conference as a semi-finalist in the MedTech Innovator Accelerator program -http://medtechinnovator.com/company/spinalsingularity

    In addition to these recent accolades, our team has been involved in many other aspects of medical technology, some of which have been publicized widely.  One example of this is when our CEO and founder, Derek, became the first person in the USA to own a personal ExoSkeleton (a device that allows paraplegics to stand and walk).  With this device Derek was able to stand and walk to be awarded the Bronze Star medal (with V) at his retirement ceremony this past November.  

    Our team has made many other contributions to advancing science and supporting world-leading medical research.  If you are interested in learning more about our experience please feel free to email us and we would be happy to talk more about this in a separate forum.  

     

    Risks & Challenges

    This is a HUGE undertaking.  Traditionally, medical devices that are regulated by the US FDA (like ours will be) and other regulatory agencies abroad don't fare well on crowdfunding websites because it is such a complex and challenging landscape to navigate.  The reason we have chosen to launch this campaign is because we HAVE to generate support.  The momentum from this campaign will raise money (which is essential for our success) but will also show any potential investors that this is a significant issue.  If you are unable to donate any money, please support us by leaving a note of encouragement, sharing our story with friends, or by giving any sort of feedback (positive or negative).  The only way we can be successful is with your help.  

    Additionally, we have analyzed the risks associated with this project thoroughly and have noted the following key components which we will address continually throughout the development and fielding of our product:

    Engineering: We have identified and are hiring a world-class team of engineers to assist in developing this product.  We also have identified external consultants that will be critical in supporting our engineering processes.  

    Regulatory: We have worked diligently to identify and address any potential risks throughout our design process.  We will continue to ensure the product meets the highest levels of safety and testing standards as set forth by applicable US FDA and other regulatory agencies (in applicable geographies).

    Market Adoption: We have talked with thousands of stakeholders.  For the past few years of my life I have made myself an expert on paralysis and met so many people who have confirmed the same problems and complaints that I experience.  Our team has spent time with world-leading clinicians to ensure that we can design a product to meet the complex needs of our target population.  

    Thank you!

    The entire Spinal Singularity team would like to personally thank you for visiting this page.  We have been continually humbled by the support and generosity we have received.  If you are unable to donate any funds please help us in one of the following ways:

    Share our story on Facebook!

    Tell us about your Neurogenic Bladder Experience!

    Leave a comment or email us any feedback!!




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