In conversation with Praxis SCI Incubate cohort member Starling Medical

Starling Medical CEO Dr. Alex Arevalos and Director of Product Development Sylvie Kalikoff, MBE, on revolutionizing neurogenic bladder management with an AI and tech-enabled platform.

 

What was the deciding moment in starting the company?

Sylvie Kalikoff: Starling Medical began as a research project at Rice University in Houston, Texas between myself and the two other founding engineers, Hannah McKenney and Drew Hendricks.

We were part of the same small cohort in the Bioengineering Master’s program, which links engineers with clinicians. Our collaborators at Texas Children’s Hospital across the street brought our attention to the fact that individuals with neurogenic bladder dysfunction, including those living with a spinal cord injury (SCI), need a better way to empty their bladders on a day-to-day basis. Neurogenic bladder is the name given to a number of urinary conditions in people who lack bladder control due to a brain, spinal cord or nerve problem. Currently, patients use catheters five to eight times a day. This leads to a high rate of severe urinary tract infections, or UTIs, that require hospitalization.

Many people think the most significant issue facing those with an SCI is lack of mobility since that is the most visible thing. They don’t think about the biological functions they take for granted, like the ability to pee. The mortality rate of UTIs in the SCI population is as high as 10 to 15 percent.

The problem statement instantly motivated me. My younger sister, Natalie, is severely disabled by cerebral palsy and was born with a neurogenic bladder. She has dealt with the current standard of care methods and catheterization her entire life.

The Starling Medical team and prototype.

As Hannah, Drew and myself looked into this further, we realized not only was there a large, widespread, and largely underserved clinical need affecting millions worldwide, but there was a significant value proposition. By harnessing artificial intelligence to better diagnose UTIs, we could lower hospitalization rates and decrease costs while increasing the quality of life of these patients and even save lives.

Tell us about your customers and potential customers?

Alex Arevalos: There are over 30 million patients in the US – let alone the rest of the world – who suffer from neurogenic bladders. This includes people who had a stroke, have a disease like Parkinson’s, Alzheimer’s, dementia, or multiple sclerosis, have neural tube defects, or are living with a spinal cord injury.

As Sylvie mentioned, the current standard of care is not ideal. Patients must undergo clean intermittent catheterization to drain their bladders many times a day. They also need to take medication to relax their constantly overactive muscles. The catheterization can be painful, time consuming and expensive. It’s also does not fully do the job. Many patients still have leakages, despite being on a regular schedule.

Yet the biggest challenge is catheterization increases the risk of a UTI. Compared to the general population, patients with severe neurogenic bladder are 51 times more likely to be admitted to a hospital for a UTI, and the mortality rate resulting from the bacteria overreaction is too high. These patients aren’t able to feel traditional early signs of a UTI, such as a persistent urge to urinate or a burning sensation when urinating. Urologists are left with subjective screening criteria, which can be difficult for patients and caregivers to adequately assess.

Sylvie: At the individual level, a device like this would be transformative for someone like my sister Natalie. In her case, she can’t walk or talk, but she likes to be out in the world and around people. She is 23 years old and would ordinarily attend a special day program. Because she needs to be catheterized so often, she requires special nursing care. If she had a better solution, she wouldn’t be so isolated.

What specific solution is your company providing?

Sylvie: Our UrinControl System is a temporary urinary prosthesis that is anchored once a month into a patient’s urinary sphincter. The prosthesis is wirelessly driven and has an internal pumping mechanism to drain the bladder at the push of a button. The device also has a pressure relief valve to prevent reflux. This holds continence between bathroom visits but automatically releases when the pressure goes above a certain level.

The patient controls the system through their smartphone using the UrinControl app. Information is sent between the prosthesis and their phone with radio frequency powered circuitry. Patients can check the fullness of their bladder, track their urinary output and receive objective, early warnings about the presence of a UTI. They can also lower the bacterial load in the catheter through UV-based active sterilization.

The data is automatically uploaded through the cloud to Starling Medical’s connected databases and telehealth portal. We generate daily alerts and monthly collated reports for each patient and their urologists. It is important to note that this sensitive patient information is protected. We have partnered with a firm called Galen Data, whose portal is in compliance with the US Health Insurance Portability and Accountability Act. Data is encrypted in transmission and de-identified in the database.

If the machine learning algorithms detect changes that could signify a UTI, the app triggers a process to further assess the patient. If the patient is deemed at risk, the app warns them and their urologist. This allows them to be treated early in a non-emergent, out-patient setting rather than the life-threatening, costly, and multi-week hospital situation that is currently happening. The artificial intelligence learning loop also means the system is continually improving.

What differentiates your company from the competition?

Alex: In our case, our competition is one of our best assets. Our main competitor is an FDA-cleared device that just got medical distribution and national-wide coverage. They have proven the medicine works with published results.

We are quickly following in their footsteps. We are building on their foundation to see if we can make the technology even better. For example, the competitor’s device is only made for females and is very large – many patients cannot tolerate its size. We are trying to develop our device for both men and women and to evolve it further into a product patient want to use.

We’re also making the value proposition to medical institutions and care providers that this device will reduce costs. The setup allows remote monitoring to be reimbursable under existing telehealth codes. In other words, every time a medical professional checks the information from our platform, it counts as a reimbursable event. By adopting our technology, urologists could generate over $250 per patient per month in recurring revenue – and a high-volume practice could generate over $1 million in revenue without a large time commitment.

If you dive further into the numbers, implementing the UrinControl System will lower the net costs to the healthcare system associated with managing neurogenic bladders by about $12 billion. Meanwhile, Starling Medical creates a $15 billion initial total addressable market. It is a compelling value proposition.

What do you hope to get out of SCI Incubate?

Sylvie: We want to learn from consumers how the device, app and whole system fits into their daily lives. The timing is perfect. We are still in the early stages of development – though we expect consumer discovery will be a long-term part of our development process. We want to learn the good and the bad so we can optimize the platform. The features need to be customizable but not overwhelming.

We have big ambitions. We want to revolutionize how the world manages neurogenic bladders. Current methods are unsafe, costly and archaic. Benjamin Franklin in the 1700s used catheterization with boiled river reeds to relieve his benign prostatic hyperplasia symptoms. Catheters now are made from silicone and sterilized in single-use packages, but the process is essentially the same. It is long overdue that those living with a SCI, as well as others who experience neurogenetic bladders, have a modern solution. We want to improve their independence and alleviate them from ever worrying about dying from going to the bathroom again – and we want to do this while also improving healthcare economics.

Learn more about the Praxis SCI Incubate Program.