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https://www.medgadget.com/2021/10/wristband-to-detect-strokes-interview-with-sandra-saldana-ceo-of-alva-health.html

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Alva Health, a medtech startup based in Connecticut, is developing a wristband that can detect the signs of stroke and promptly alert the wearer and/or healthcare staff. The technology is intended for those at high risk of stroke, such as stroke survivors and those diagnosed with transient ischemic attack.

Strokes cause a huge level of patient morbidity every year, with many suffering debilitating symptoms that are life changing. Early diagnosis and prompt treatment are very important, but in many cases the early symptoms of a stroke are subtle and are easily missed. These issues have inspired this startup to develop a stroke monitor for high-risk patients.

The system consists of a wrist band that looks for signs of paralysis on one side of the body, a hallmark of stroke. The company was recently announced as the winner of the MedTech Innovator 2021 $350,000 global grand prize for their innovation.

See a video below that explains the wearable developed by Alva Health.

Medgadget had the opportunity to speak with Sandra Saldana, CEO & Co-Founder of Alva Health about the firm's technology.
Medgadget: How is stroke currently diagnosed/monitored, and why is this suboptimal?

Sandra Saldana: IV tissue plasminogen activator (tPA) has been an FDA approved therapy since 1995, yet only 5-10% of eligible patients receive this therapy due to delays in initiating the emergency response. Currently, stroke diagnosis can only be performed by a clinical team in the hospital or through telemedicine delivered on a mobile stroke unit. The diagnostic workup consists of a physical exam and neurological assessment, combined with brain imaging including a CT scan, MRI scan, carotid ultrasound, cerebral angiogram, and/or echocardiogram. The purpose of diagnosis is to rule out other conditions and to assess whether the patient is having an ischemic or a hemorrhagic stroke, which informs the type of treatment that is administered. However, in order for a patient to undergo this battery of tests and ultimately receive treatment, they must first recognize their symptoms as stroke symptoms, call 911, and arrive in an emergency room that is equipped to treat stroke patients. Because most people are not trained to recognize stroke symptoms quickly, and stroke symptoms can be subtle, patients do not immediately recognize the symptoms as stroke, and as a result they delay in seeking medical attention.
Medgadget: Please give us an overview of the importance of early diagnosis and treatment for stroke patients.
Sandra Saldana: It has been well documented that timely arrival in the emergency room after stroke symptom onset is directly associated with better outcomes for tPA treatment and endovascular therapy, specifically 4.5 hours and 8 hours, respectively. Early diagnosis and early treatment can prevent long term disability and save lives. It can mean the difference between living independently and needing assistance to perform the most basic functions. However, despite massive public health campaigns, identifying symptoms of stroke and activating emergency response systems has remained a major challenge over the years.
Medgadget: What inspired you to develop the technology inside the ALVA wristband? How did the idea come about?
Sandra Saldana: Alva Health's mission is to develop a wearable medical grade solution to effectively monitor ischemic stroke and to allow for the initiation of emergency response in a timely manner. Once deployed, our solution will dramatically improve stroke emergency response and increase the number of patients receiving IV tPA and other reperfusion therapies in the acute setting. The idea came about from the personal experience of one of our founders, Dr. Kevin Sheth, a practicing stroke neurologist and faculty at the Yale School of Medicine, after he observed that stroke symptom recognition and delayed emergency response was a persistent problem that has seen very little improvement over the years. We were inspired to develop this technology after doing substantial customer discovery interviews with stroke neurologists, nurses, stroke survivors, caregivers, payers, and many other stakeholders along the stroke patient's journey. After countless conversations, we were convinced that there is a significant clinical unmet need for people living with high risk of stroke and no marketed solutions available to monitor stroke symptoms outside of a hospital setting.
Medgadget: How do you envisage this wearable working? What are the signs of stroke that a wearable could monitor?
Sandra Saldana: We monitor stroke onset through wrist-worn wearables, a mobile app, and cloud-based analysis using machine learning algorithms. The solution monitors the onset of paralysis on only one side of the body that is one of the defining hallmarks of stroke, also known as hemiparesis. When the system detects stroke, the device notifies the user immediately. If there is no response from the user within two minutes, we will automatically connect them with trained personnel who will assess the user's condition over the phone, call 911, and notify the user's emergency contacts. Our initial users will consist of stroke survivors and people diagnosed with Transient Ischemic Attack, because both of these populations are known to have a high risk of recurrence within 90 days of the initial event. The wristbands will be worn around the clock throughout the entire high risk window.
Medgadget: What stage of the development process is the company at? Do you have a prototype device?
Sandra Saldana: We have developed a prototype device that will be deployed in the clinic with stroke survivors starting in the first half of 2022. Our next steps are to demonstrate proof of concept of continuous, long term monitoring of patients at home using our custom wearable devices, to gather additional clinical evidence for algorithm improvement, and to obtain usability data from our patients that we can incorporate into the design and development of the final product. We also plan to meet with the FDA in the first quarter of next year in order to outline our path to FDA clearance, and we are initiating conversations with payers to get an understanding of the evidence requirements for reimbursement decisions.
Medgadget: Congratulations on winning the 2021 Medtech Innovator Global Competition. How do you intend to spend the prize money?
Sandra Saldana: We are thrilled to have been recognized in this year's MedTech Innovator global competition, and we look forward to accelerating our development timeline with the prize money. The funds will allow us to expand our team, accelerate the development of our cloud based software solution, and fund part of our clinical study in stroke survivors that is launching next year. The award is an important milestone in Alva Health's journey that will enable us to accelerate our path toward bringing our long-term, continuous stroke monitoring solution to the millions of people living with high risk of stroke.

Link: Alva Health homepage..

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Wristband to Detect Strokes: Interview with Sandra Saldana, CEO of Alva Health

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Alva Health, a medtech startup based in Connecticut, is developing a wristband that can detect the signs of stroke and promptly alert the wearer and/or healthcare staff. The technology is intended for those at high risk of stroke, such as stroke survivors and those diagnosed with transient ischemic attack.

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Alva Health - One Minute Video Competition

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Author: Conn Hastings, PhD
Organization: Medgadget

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October 18th, 2021

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A startup Medtech company, Alva Health, could be changing the way we detect strokes. The Connecticut based company has created a prototype wristband that has the capability to detect strokes in patients. The article includes an interview with the CEO of Alva Health, Sandra Saldana, who describes this technology as a way to dramatically improve the lives of patients and stroke survivors who are at risk for stroke. The user is required to wear two wristbands which are linked to a mobileapp and cloud-based system. The wristbands monitor for one of the hallmark signs of stroke, hemiparesis. When hemiparesis is detected, it will notify the user. If there is no response from the user the wristband can alert the users emergency contacts and dial 911. With this innovative healthcare technology, stroke symptoms can be identified at a faster rate which allows for patients to seek medical attention faster (Hastings, 2021)

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·      Small and lightweight to device to wear

·      Can detect a major sign of stroke: hemiparesis

·      Can alert emergency contacts and call 911 if wristband detects no response from user

·      Symptom onset is key in determining if patients can receive tPA, the wristband allows for immediate notification of hemiparesis

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·      Only monitors for hemiparesis (there are several other signs of stroke such as vision difficulty, facial drooping and slurred speech)

·      Needs to be charged which would require user to remove wristband

·      Does not state if wristband is waterproof, if user must remove during a shower, this puts the user at risk for having an undetected stroke
·      Required to wear two wristbands, one on each wrist. This might be bothersome to some users, especially if one already wears a device such as an Apple-watch or Fitbit

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The idea of having a stroke detecting wristband is a great idea in the works. The thought that a wristband that can detect hemiparesis in a patient is an innovating piece of technology that could change the way we detect strokes. The fact that these wrist bands can also alert emergency personal is a huge benefit to using the device as well. However, I think this technology is not going to be as impacting as one may think it will be.

This technology would only be targeting a very specific population of stroke patients which would be ischemic strokes with severe hemiparesis. In this case that would indicate a stroke in MCA territory (Doria & Forgacs, 2019). Yes, hemiparesis is a sign of stroke, but there are several other common signs of stroke such as vision loss, facial drooping, and slurred speech. Not to mention the major sign of a hemorrhagic stroke is a sudden onset of a severe headache. So really this wrist band is only targeting a very specific symptom which not everyone will experience when having a stroke. I worked on an acute stroke unit for three years and yes hemiparesis is one of the major signs of ischemic stroke, however there are many patients who only experience minor numbness in one extremity such as their right leg or toes. This is a great start to an innovating health care technological advancement; however, I feel there needs to be a larger population evaluated.

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Alice (Achiever)- Having Alice on this team would give the team a leader. Someone needs to lead by example and have a strong work ethic to keep the team going. Alice’s work hard mentality will motivate others to work hard and be productive. Creating a stroke detecting wristband will require a lot of time and energy, however with Alice, the team will be led by a strong work ethic which will motivate all team members to work hard.

Angelica (Analytical)- She will be the research and back bone to creating the wristbands. Using her ability to think about all the factors and how they will affect situations will help the team tremendously. She will provide the best practice and research to support the project. Data and research are needed to support the creation of a new product. No one will trust the product if there is no evidence or research to support it.

Carter (Communication)- The ability to put thoughts into words is what Carter will contribute to this team. Having a strong communicator helps the team to have a clear understanding of roles and expectations. If no one communicates, then no work will get done. Carter’s easy ability to talk to will guide the team to know what to do during each step of the process.

Rachel (Restorative)- Being able to figure out what is wrong and how to resolve issues is how Rachel will contribute to this team. Any problems or conflicts that occur, Rachel will be able to troubleshoot and help find improvements or solutions. With any new technology like stroke detecting wrist bands, there are issues that will be presented, and Rachel will be able to help resolve the issue.

Pablo (Positivity)- Having someone who is consistently positive and enthusiastic helps to keep team members harmonized. Every team needs someone who can hype each other up and create an energetic environment. Pablo will keep the team motivated and interested in the creation of the stroke detecting wristbands.

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Arranger- Organization is a key aspect in the creation of a new product. With any new product there are lots of pieces and resources that need to be connected and arranged. Being able to organize thoughts and create timelines will help to keep the team on track to success.

Discipline- Being discipline can help the team be highly productive and accurate. This happens due to their ability to promote efficiency and analyze large ideas. Having structure is also something that can be utilized which promotes team success.

Empathy- This is a vital strength to carry for a team. Being able to build trust among team members is necessary for success. Sensing others’ emotions and being able to connect with team members will create a strong lasting relationship. There will be times of conflict and having the empathy as a strength can help make sure everyone’s voices are being heard.

Responsibility- Loyalty and honesty are key factors that help a team create success. Having someone who is responsible will keep all team members accountable for their work. The responsible person will also make sure that the work is ethical and that we are doing the right thing for the stroke population.

Harmony- People who have harmony as their strength look for areas of agreement. Because we don’t enjoy conflict, we would be the one to look for consensus. We would not want to waste time on imposing ideas on one another, instead we would find mutual agreement.

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Doria, J. W., & Forgacs, P. B. (2019). Incidence, implications, and management of seizures following ischemic and hemorrhagic stroke. Current neurology and neuroscience reports, 19(7), 37. https://doi.org/10.1007/s11910-019-0957-4

Hastings, C. (2021, October 18). Wristband to detect strokes: interview with Sandra Saldana, CEO of Alva Health. Medgadget. https://www.medgadget.com/2021/10/wristband-to-detect-strokes-interview-with-sandra-saldana-ceo-of-alva-health.html