BIOFEST INVEST APPLICANT
Advanced TeleSensors Inc.
- 5114 Balcones Woods Dr. Suite 307-472, Austin, Texas 78759, US
- https://cardio.io
Company Contact:
Legal Entity Type: C-Corp
Company Type: Medical Device
Company Stage: Commercialized
No. of Employees: 5
Desired Financial Amount: We are raising a convertible note of $1M with a 20% discount and 12% interest per annum with a 3-year term. We have raised $110K to date on this convertible note.
Background
Company Background
Advanced TeleSensors (ATS) was founded to commercialize radar-based Vitals Monitoring which was originally developed by NASA’s Jet Propulsion Laboratory (JPL). The technology is a combination of low-cost radar sensors used in the automotive industry and proprietary DSP and AI/ML algorithms that extract information from signals detected by the heart and respiratory system.
This makes it possible to continuously read the heart and respiratory information from across the room without the need for physical contact with the patient. It will work through clothing, bedding, and lighting to make the monitoring fully touchless and unobtrusive for the patient. This approach allows for a fixed networked sensor that eliminated the major issues with wearables- battery life, comfort, cost, and the need to be worn.
The project for contactless proof of life sensing was funded under a $6M US government contract with NASA (JPL) and Caltech. After the technology was developed and deployed, the US government transitioned the technology for commercial use in 2009. The five engineers who worked on the project at JPL founded ATS. Caltech incubated the company to develop a proof of concept for testing and validation. Caltech transferred the Intellectual Property (IP) and patents for remote sensing exclusively to ATS.
The team transitioned to a commercialization effort led by Sajol Ghoshal in 2018. The initial prototype for Wellness applications and pilot testing was completed in 2022.
ATS raised the first seed round of $2M in 2018 for commercializing the product on a 24GHz platform that is scalable for consumer and industrial applications. Product efficacy has been tested against an ECG on 20 adults (ages 18-85), 18 babies (ages 0-5 years), as well as 5 equines in rehabilitation. Market validation of Cardi/o®️ started in 2021 with Tier #1 customers doing beta testing for design-in projects. ATS has been conducting real-world testing in a cloud-connected IoT framework, where we’ve also been able to generate early sales for the Health & Wellness product via the cardio.io website.
Management
The management team is multi-disciplined and focused at this time. It is led by Sajol Ghoshal, CEO and CTO who provides the necessary direction and trade-offs needed to develop the product that is able to penetrate key customers. Sajol is a serial entrepreneur with multiple companies having successful exits: Level One Communications acquired by Intel in 1999 for $2.2B, Agere acquired by Lucent Technologies in 2001 for $450M and TAOS acquired by AMS AG in 2010 for $350M. Sajol has a Master’s in Electrical Engineering from Notre Dame and has over 40 patents.
Kristin Norton, PhD is a cardiovascular scientist and CEO of Greenroom Technologies, a health technology consulting firm. Kristin advises Advanced TeleSensors on product market fit, market acceptance, and business development initiatives with additional input on product strategy. She has been instrumental in understanding consumer needs and her team has created flyers, pitch decks, and other marketing materials for outreach.
David Sorensen leads the marketing efforts. He brings 30 years of experience in bringing new products to market at Broadcom, AMD, LSI, and Micron, and has cofounded five startups. Additionally, he has a strong background in working with government regulators and standards organizations.
Dr. Eric Farrell M.D. Chief Medical Officer and UCLA Medical Center Orthopedic Trauma Surgeon, and Assistant Professor at UCLA Trauma Center. Board Certificated Orthopedic Medicine. Eric has been instrumental is steering the company’s cardiac sensing technology toward measurable cardiac performance. Eric has been crucial in validating the efficacy of the product and evangelizing the need for Heart Rate Variability (HRV) in elders and babies.
Dr. Jason Zagrodzky M.D. Jason is a cardiologist and electrophysiologist at the Texas Cardiac Arrythmia. Jason is one of the most respected physicians in the field of electrophysiology in Texas and has had a fascination with electrophysiology and the science of the heart. Dr. Zagrodzky has devoted his entire career to studying and applying complex technology to the treatment of rhythm disorders of the heart, with the simple goal of getting people back to good health. After graduating first in his class at the University of Texas Southwestern Medical School in Dallas, Dr. Zagrodzky completed an internship and residency training in internal medicine at Massachusetts General Hospital in Boston. He then returned to UT Southwestern to complete his fellowship training in cardiology and electrophysiology.
Elisa Maldonado-Holmertz is responsible for FDA regulatory affairs and quality assurance. Elisa has 25 years of leadership experience in the multinational biopharma and medical device industries. She has worked and lived in emerging and established markets including the USA, Belgium, Sweden, and the P.R. China. She successfully contributed at PPDI, Pfizer, Aerocrine, and Emergo Group, with responsibilities in pre-clinical, clinical, regulatory and quality functions. Elisa earned a BA from University of Texas at Austin, and has completed graduate work in Business Management and Health Economics.
Board of directors
Our board of advisors comprises of members from the Caltech/JPL group and new technology seasoned investors. We have 5 board members.
Jack Syage from Caltech is Founder, CEO of ImmunogenX which addresses the critical needs of individuals with diagnosed Celiac disease. He was also the Founder & CEO of Syagen Technology which had a successful exit in 2011 to the $18B French company Safran. Jack has 30 U.S. patents & was a postdoctoral fellow at Caltech under Nobel Laureate Ahmed Zewail.
With the new investment from KLDC Partners, Kirk Laney and Jacob Jacobsson startup veterans joined the board in 2018. Kirk Laney, CEO of TAOS (Texas Advanced Optical Solutions) in Dallas drove an $350M acquisition by Austria Microsystems (AMS) and as CEO of AMS grew the company to a billion dollars in 4 years. Jacob Jacobsson, CEO of SES an RFID company that was sold to Texas Instruments and had other successful exits.
Jason Zagrodzky M.D. cardiologist and electrophysiologist joined the board in 2021. Jason would like to see this technology applied to the treatment of rhythm disorders of the heart.
Sajol Ghoshal, CEO of Advanced TeleSensors Inc.
Product / Service
disease area / application
Cardi/o provides the early detection of episodic cardiac events – episodic events are precursors to possible cardiovascular diseases (CAD) like Afib, Stroke, and Heart Failure. With continuous cardiac telemetry and built-in alerts, nurses and medical professionals can get alerted to fast heart rates or arrhythmias. Patients with Afib are five times more likely to suffer a stroke, three times more likely to have heart failure, and two times more likely to die of cardiac death. Afib is two to three times higher in the US compared to the rest of the world and is likely to double in the next decade, so early detection is paramount. Afib generally starts as intermittent rapid heart rate, 15% of new cases are asymptomatic – surgeons have indicated that clots can start in your heart five minutes after the onset of Afib. Recent published literature and clinical data indicate that long-term cardiac monitoring provides the best outcomes (earlier detection and lowest cost). Cardi/o can identify potential issues early and allow for prompt treatment, reducing the risk of serious complications. Additionally, continuous cardiac monitoring can also help to monitor patients with chronic conditions, such as heart failure, and provide valuable information to healthcare providers for adjusting their treatment plans. Existing solutions (ECG patches) suffer from high false positives and poor patient compliance. This is primarily due to the need for a robust, and comfortable, physical connections to the patient. Wearable solutions further suffer from issues with battery life, lack of data storage, and increasing support requirements. Cardi/o removes the issues with the physical attachment, by eliminating it. Its operating radius allows it to be fixed with continual power and network connections. has an economic advantage over wearables in both OPEX and CAPEX, and is better suited for provider ownership as it contains no consumables and is not subject to patient abuse.
product / Service
Cardi/o® provides effortless touchless cardiac telemetry for in-patient care without the patient wearing any wearable or patches thus minimizing any maintenance overhead on nurses. Cardi/o is wall mounted, operates from AC power, and provides continuous, real-time sensing of the heart rate, respiratory rate, heart rate variability [HRV], and motion, up to a distance of 10 feet from the patient.
It is more cost-effective than ECG patch based cardiac monitors or Holter monitors, providing real-time cardiac telemetry as opposed to event-based or store and forward monitors. It does not require any physical contact with the patient, no wearable patches needed. Cardi/o® leverages AI to provide early warnings when deterioration in cardiac health is occurring. With Cardi/o’s tailored alerts, nurses can get early warnings for any episodic events, like abnormal or irregular or rapid heart rates, elevated or depressed respiratory rates, thus allowing them to confidently provide the best care on a timely basis for all their patients, improving patient outcomes and reducing healthcare costs by reducing readmissions
technology / ip
The key to our vision is a revolutionary non-intrusive cardiac monitor based on radar technology for detecting biometrics without the use of any wearables, developed by NASA’s Jet Propulsion Laboratory (JPL) scientists. Taking RF innovation out of the lab and designing it into a form factor that balances performance and commercial viability requires deep RF knowledge and algorithmic understanding of micro-doppler signal detection expertise. It’s this rare blend of world-class expertise in both RF signal processing AND algorithmic & AI based machine learning design that defines our core competence and gives ATS the leadership advantage in the cardiac vitals monitor market.
The engineers who worked who worked on the NASA’s Mars Rover project at JPL founded ATS and Caltech transferred the Intellectual Property (IP) and patents exclusively to ATS. The company was incubated at Caltech to develop a proof of concept using a 10Ghz radar chipset from ADI, enabling customers could start to test and validating the performance of the device.
After the technology was validated by customers in the automotive arena, the team transitioned to a commercialization team lead by Sajol Ghoshal in 2018. Based on proven commercial technology, we re-purposed the low-cost 24Ghz radar sensors used in your everyday Toyota/Chevy for anti-collision or lane-change detection from detecting vehicles to detecting humans, and developed the commercial product for Wellness applications and started pilot testing in 2022.
The core technology is protected by 6 patents, 3 of which are granted.
distribution channels
The initial deployment for Cardi/o is in Skilled Nursing Facilities (SNFs). These nursing facilities focus on a number of medical rehabilitation care, and care for post-heart failure patients benefit significantly with continuous cardiac monitoring. As of 2021, there were approximately 15,000 skilled nursing facilities (SNFs) in the United States, according to the Centers for Medicare & Medicaid Services (CMS), with the median number of licensed beds in a skilled nursing facility (SNF) being 96 beds.
Continuous cardiac monitoring can be useful in skilled nursing facilities. This technology allows healthcare providers to monitor the heart function of patients in real-time, even when they are not physically present. This can help detect changes in heart rate and rhythm that might indicate an underlying medical condition, allowing for prompt and appropriate intervention. Continuous cardiac monitoring can also improve communication between healthcare providers and reduce the need for repeated in-person assessments, which can be particularly important for residents with mobility issues or other limitations.
Typically, Medicare coverage for cardiac monitoring includes services such as electrocardiogram (ECG or EKG), Holter monitoring, event monitoring, and implantable cardiac devices such as pacemakers or implantable cardioverter-defibrillators (ICDs). Medical professionals may bill Medicare for reimbursements for application under CPT code 93242 for greater than 48 hours and up to 7 days, or 93246 for greater than 7 days up to 15 days and for the final interpretation of the results CPT code 93244 for greater than 48 hours and up to 7 days, or 93248 for greater than 7 days up to 15 days. Vendors of cardiac monitors can bill the patient’s insurance for the technical component, CPT code 93243 for greater than 48 hours and up to 7 days, or 93247 for greater than 7 days up to 15 days.
We will need a sales group to sell medical devices to skilled nursing facilities, requiring building relationships, understanding their needs and budgets, and offering value-added services that help differentiate our products from competitors or fill a gap that they need. As we get referrable engagements with SNFs we can work with VARs like Diversatek Healthcare, Medline, AMD Global Telemedicine… who can provide relationships with SNFs and delive value-added services to grow the business.
market size
The overall TAM for Remote Patient monitoring is $31B in 2028 with a 41% CAGR. This growth was accelerated by COVID, however even post-Covid we see sustained growth and interest in telemedicine and remote patient monitoring. Remote patient monitoring has been doubling and will reach 70 million patients by 2025. In 2017, the estimated total cost of HF in the US was approximately $31 billion, with hospitalizations accounting for the largest portion of these costs. Studies have shown that remote monitoring can improve the early detection of arrhythmias, such as atrial fibrillation, and reduce the number of hospital readmissions for patients with heart conditions, thus reducing overall healthcare costs.
It’s important to note that these costs are likely to increase in the future, given the aging population and the growing burden of HF in the United States. Therefore, it’s critical to focus on strategies that can reduce the cost of HF, such as early diagnosis and effective management of the disease, as well as the promotion of heart-healthy lifestyle behaviors.
1. The target market (SAM) for ATS’ Cardi/o cardiac monitor is Skilled Nursing Facilities (SNFs) which has 1.3 million beds in the US alone. Skilled nursing facilities (SNFs), provide a wide range of services for individuals who require a higher level of medical care, especially in post-cardiac care for a patient discharged from hospital stays for stroke, Afib, or heart failure. SNFs can help individuals manage chronic conditions such as hypertension, diabetes, and high cholesterol, which can contribute to cardiac disease. Most SNFs usually have nurses that monitor patients every 4-6 hours leaving them vulnerable to episodic events that can occur suddenly between checks. Some SNFs may offer continuous cardiac monitoring to track heart rate, rhythm, and other vital signs, but these services are expensive and limited to about 10-15% of the overall beds in the facility. Cardi/o’s goal is to provide a low-cost cardiac telemetry service to all beds in a SNFs that would monitor a patient continuously in real-time providing alerts to the nursing staff if it detects any abnormal heart activity.
2. Once we have established traction in the SNF, we can apply the same model to pursue deployment in nursing homes. There are 1.7 million nursing homes in the US alone, most without any vitals telemetry. Cardi/o can provide a low-cost cardiac telemetry that can be scaled to all beds and can provide optional ON/OFF capability to minimize costs.
3. The 3rd growth market is Home Health with over 35M patients who will require cardiac monitoring at home. CMS will reimburse health care providers for Remote Patient Monitoring with CPT codes billing codes to reimbursing costs associated with RPM technology to manage patient care needs. Centers for Medicare & Medicaid Services (CMS) introduced several CPT codes for remote patient monitoring services, including CPT codes 99457 and 99458, which are specifically intended for use in skilled nursing facilities. These codes allow providers to bill for remote monitoring of patients with at least one chronic condition that is expected to last at least three months.
competition
There are 2 types of competitors, wearable ECG patches from iRythmn, BioTelemetry, Cardea Solo etc. and Virtual Patient Sitter like Caremerge, Tapestry Telehealth, TeleHealth Solution…
ECG Patch technology took the industry in stride when it was first released and many doctors were on board for quick ECG monitoring. However, any removal of the patch disrupts the test, the patient has to wear the patch for up to 14 days straight, and results take almost a month to receive. Unfortunately, patches provide only a partially augmented image of the patient’s ECG with the algorithm reducing what it thinks is redundant data. The patch technology relies on algorithms, recording only pieces of your patient’s arrhythmias. The algorithm takes the ECG in pieces, separating it into sections as it records. When an arrhythmia occurs, the algorithm pieces the ECG back together at a very low resolution in an attempt to provide a glimpse of what the algorithm caught. Although ECG patches detect 38% more arrhythmia events than a Holter monitor, it still detects barely 10-15% of arrhythmia overall in studies that have been performed. Patches also require patient compliance, in keeping it on and need trained staff to maintain the monitor. Finally, patches are disposable and for one-time use making them very expensive at $854 per patient.
Virtual Patient Sitters have staff remotely watching cameras that are located in the patient rooms in Skilled Nursing Facilities. People are hired to watch 16 cameras at a time on a computer screen for 8 hours a day in 3 shifts. This is useful to make sure a patient does not get out of bed or fall down, but provides no vitals monitoring. It is also very expensive and costs approximately $540K per year for a 100-room facility (or $450 per month per room)
Financials
Desired financial amount
We are raising a convertible note of $1M with a 20% discount and 12% interest per annum with a 3-year term. We have raised $110K to date on this convertible note.
previous funding
We have raised $5.7M to date. The company was started with a seed round of $175K and raised $500K in seed convertible notes to develop a proof of concept. The company then raised its 1st equity round of $2M in July 2018 for a post valuation of $5.26M to develop a prototype to validate with customers. We then raised $2.7M in convertible notes to develop the commercial product and pilot testing has started.
current financials
We are currently operating under a tight budget with no salaries being paid to the team. The burn rate is in the $15K/month range. The typical burn rate last year was $70K/month. We currently have approximately $70K in cash and at the reduced burn rate can get us to June of this year, where we expect to close funding on the convertible note.
financial use
We are raising a $1M convertible note to bridge us to FDA compliance before we raise our Series A equity round for growth. We expect to close this convertible note in the next 4 months.
We have established a predicate device and expect to get FDA “Cleared” in 2023. In addition to this milestone, we are working with the partners at UT Health San Antonio, School of Nursing, Texas Cardiac Arrythmia and Baylor Scott & White Rehab Clinic (SNF) to start validating our product in parallel with FDA compliance.
revenue
The Medicare reimbursement strategy: Medicare provides coverage for cardiac monitoring includes services such as electrocardiogram (ECG or EKG), Holter monitoring, event monitoring, and implantable cardiac devices such as pacemakers or implantable cardioverter-defibrillators (ICDs). Medical professionals can bill Medicare for reimbursements for cardiac monitoring application under CPT code 93242 for greater than 48 hours and up to 7 days, or 93246 for greater than 7 days up to 15 days and for the final interpretation of the results CPT code 93244 for greater than 48 hours and up to 7 days, or 93248 for greater than 7 days up to 15 days. Vendors of cardiac monitors can bill the patient’s insurance for the technical component, CPT code 93243 for greater than 48 hours and up to 7 days, or 93247 for greater than 7 days up to 15 days.
Our revenue in 2019 was $103,982, however due to the impact of Covid and significant manufacturing component delays revenue declined in 2020-22. Revenue in 2020 was $22,081 and zero in 2021. In 2022 our revenue was $29,010.
exit strategy
A potential exit for Advanced TeleSensors would be an M&A acquisition. The remote patient monitoring market is growing rapidly, a 41% CAGR. This is fueled by Covid, which made patients and doctors comfortable with remote monitoring and supported by Medicare’s reimbursement CPT codes being introduced in 2020, 2021 and 2022.
2021 acquisitions of Digital Health Remote Monitoring companies: Philips’s acquired BioTelemetry for $2.8B, Hillrom announced a $375M deal for Bardy Diagnostics, and Boston Scientific shared plans to snap up Preventice Solutions for $925M. All three acquired companies offer connected patch devices to monitor and diagnose heart rhythm disorders.
In 2021 Venture capitalists invested $9.5 billion in digital health, including remote patient monitoring – Top 7 RPM Startups Raised $228M
“There aren’t many startups remaining in the remote ECG market. More broadly, it’s clear that remote patient monitoring is going to be the standard of care for patients with heart rhythms disorders.” – Rock Health 1/25/2021