DARMA's Non-Invasive Heart Failure Monitoring Device Receives FDA Breakthrough Device Designation Ahead of IPO

Recently, Darma’s non-invasive cardiac filling pressure (NIFP) monitoring and management device was granted Breakthrough Device Designation (BDD) by the U.S. Food and Drug Administration (FDA). The device provides convenient, accurate, and non-invasive readings of cardiac filling pressure, thereby helping heart failure patients in both hospital and home settings better manage their condition, reduce the risk of heart failure-related hospitalizations, and improve survival rates.

Breakthrough Device Designation is an incentive policy implemented by the U.S. Food and Drug Administration (FDA). According to the criteria for this designation, a medical device must incorporate novel, first-of-its-kind technology globally and hold the potential to provide significant benefits in the treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. Upon receiving this designation,Darma’s NIFP device will benefit from priority and preferential policies from the FDA and the Centers for Medicare & Medicaid Services (CMS) in areas such as future regulatory approval, market access, and insurance reimbursement.。

This breakthrough designation is the first of its kind in China’s heart failure research field., which is also extremely rare internationally, will accelerate the review and market launch process for NIFP devices in the United States. Darma will also expedite its efforts, expecting to obtain FDA approval for the NIFP device in 2023 and officially bring it to market.

Digitalization in healthcare is a major trend. Remote management of heart failure represents one of the largest and most critical markets within digital telemedicine, making it a fiercely contested arena in the digital health sector, yet also one of the most technically challenging domains.

Targeting the trillion-yuan digital health market, DARMA’s ultimate goal is to build a comprehensive cardiovascular disease management platform centered on data and powered by its proprietary monitoring devices. This official recognition will propel the company forward with a solid step on its digital healthcare journey.

Heart failure, known as the final “battlefield” of cardiovascular disease, has become another hundred-billion-yuan market following coronary stents and artificial heart valves.

Heart failure is not a standalone disease but rather a syndrome that manifests in the late stages of various cardiac conditions when cardiac function declines to a certain degree. It is characterized by high prevalence, high mortality, and high readmission rates. In recent years, as the prevalence of cardiovascular diseases has risen worldwide, the prevalence of heart failure has also been steadily increasing.

Over the past 15 years, the prevalence of heart failure in China has increased by 44%. In 2021, there were 12 million patients with heart failure in China, significantly burdening society and healthcare insurance expenditures.Meanwhile, recurrent deterioration and repeated emergency hospitalizations impose significant suffering on patients with heart failure and place a substantial burden on their families. As end-stage heart failure is incurable, patients can only pin their hopes on heart transplantation or the implantation of an artificial heart.

By adopting the technical solution integrated with Darma’s monitoring technology, it is expected to control and delay the progression of heart failure, thereby delivering significant benefits to patients.

The heart is the organ responsible for supplying blood and providing power to the human body. During physical activity, the body requires increased blood supply, which can be met in healthy individuals by a modest increase in heart rate. However, in patients with heart failure characterized by reduced cardiac function, climbing three flights of stairs increases the body’s demand for blood flow. To meet this demand, the body must activate a compensatory mechanism, namely, increasing cardiac filling pressure to enable the heart to satisfy the body’s perfusion requirements.

However, elevated cardiac filling pressures can cause secondary injury to the heart, exacerbating cardiac damage. As cardiac filling pressures rise further, fluid leaks from the pulmonary capillaries into the lungs, resulting in pulmonary edema and causing dyspnea.

Unfortunately,Patients with heart failure often do not realize their condition is worsening until they experience dyspnea, by which time the elevation in cardiac filling pressure may have occurred days or even weeks earlier.. During this period of days to weeks, the patient missed the optimal window for intervention, leading to further irreversible deterioration of cardiac injury; emergency hospitalization is required, with a high probability of ICU admission.

Scenarios like this occur several times a year for patients with heart failure. Among the total annual medical costs for heart failure,Hospitalization costs for heart failure account for as high as 65%., patients and their families live in constant anxiety, unable to predict when the next deterioration will occur.

Abbott’s CardioMEMS device alleviates some of the concerns associated with home-based heart failure management. This product involves implanting a small pressure-sensing device into a blood vessel near the patient’s heart. It measures cardiac filling pressures once daily (taking approximately two minutes). When elevated pressures exceeding a predefined threshold are detected, the system automatically alerts the remote care team via the internet. Physicians then contact the patient to adjust medications, such as diuretics, helping to bring the filling pressures back within a target range.

Through this monitoring approach, patient deterioration is detected and controlled in a timely manner, leading to a significant reduction in hospitalization rates and substantial improvements in survival rates and quality of life.

The NIFP product developed by Darma also measures cardiac filling pressure, yetNo Implantable Devices Required, which measures the patient's cardiac filling pressure from the body surface through its unique technology. In this way,Patients can obtain filling pressure data to monitor their condition without undergoing the trauma of implantation surgery or bearing the risks and side effects associated with implanted device failure.. This new technology, with independent intellectual property rights worldwide, will bring hope to heart failure patients across the globe.

Generally, clinical measurement of cardiac filling pressures requires right heart catheterization. A small incision is made in a blood vessel in the neck to insert a catheter into the heart and adjacent vessels, allowing for the measurement of pulmonary capillary wedge pressure (PCWP). Although this technique is considered the gold standard in current clinical medicine, it is not used as a routine measurement method due to its surgical and invasive nature.

Meanwhile, high-end cardiac ultrasound equipment can also provide a rough estimation or assessment of cardiac filling pressures; however, it requires operation by experienced physicians and is highly time-consuming. Patients face long waiting times at large hospitals, while such equipment is unavailable at smaller hospitals and primary care facilities, making it impossible for patients to monitor their condition daily at home.

andThe NIFP device is non-invasive, accurate, and user-friendly. It can be operated by nurses, patients, and their families, with each test taking only 2 minutes., suitable for use in emergency departments, outpatient clinics, ICUs, inpatient wards, nursing homes, and home monitoring. Compared with invasive catheter-based measurements,NIFP Device Accuracy Reaches 89%, surpassing echocardiographic assessment and also exceeding the average level achievable by senior physicians relying on clinical experience.

In addition to cardiac filling pressure,Darma’s next-generation NIFP devices and technology platform, currently under development, will also assess cardiac systolic function, diastolic function, valvular function, myocardial function, and integrated cardiopulmonary function, thereby evolving into a multifunctional cardiopulmonary assessment platform., it can be popularized at the grassroots and community levels, as well as in vast developing regions.

“The core essence of NIFP devices is to enhance the ability of most primary care physicians and ordinary patients to perform self-screening for cardiovascular diseases, enabling them to conduct disease diagnosis and management at primary care institutions or at home—tasks that previously required hospital visits. Compared with electrocardiograms (ECGs), which are more commonly used in home settings, NIFP devices can capture more parameters and detect a wider variety of conditions. Meanwhile, compared with ultrasound examinations in hospital settings, NIFP devices are easier to operate, do not require experienced physicians, and have a lower cost per use,” said Hu Junhao, founder of Darma.

The NIFP device’s receipt of the BDD designation serves as an endorsement of its innovative nature and will also propel the NIFP device onto the “fast track” of development.

Under the BDD policy, the FDA will assign a liaison officer to assist companies in developing robust clinical protocols and accelerating the regulatory approval process. More importantly,BDD Products Gaining U.S. Approval Can Achieve Insurance Coverage More Rapidly, both the U.S. Centers for Medicare & Medicaid Services (CMS) and the FDA have established special reimbursement policies specifically for products granted Breakthrough Device Designation (BDD), which will facilitate the future market entry and promotion of NIFP devices in the United States.

The NIFP device has obtained BDD clearance, marking a solid step forward for Darma in its journey of digital health management. For a company daring to enter the trillion-yuan digital healthcare market, this is merely the first step.DARMA aims to build a comprehensive digital health management platform centered on medical-grade data and based on vital signs monitoring devices.

Darma implements a “three-step strategy.” The first phase focuses on the independent sales of monitoring devices. The second phase aims to create a comprehensive home-based cardiovascular solution by establishing a SaaS (Software as a Service) platform to enable integrated management of various cardiovascular diseases. The third phase involves expanding the range of payers; leveraging medical-grade data captured by its monitoring devices, Darma provides clinical enrollment and management solutions for pharmaceutical companies. At the core of this “three-step strategy” is data.

In the first phase, the company’s smart vital signs monitoring mat has obtained dual certification from the NMPA and the FDA. It can measure users’ vital sign data through a four-layer mattress (50 cm thick), with accuracy fully equivalent to that of medical-grade monitors.

Currently,The company has entered Phase II and is developing a cardiovascular and other chronic disease diagnosis and remote patient monitoring platform based on NIFP devices.. By wirelessly integrating data from multiple vital signs monitoring devices, the system analyzes patients' health status in real time, establishes personalized data models for each patient, and employs intelligent algorithms for anomaly detection to identify potential health risks. When a health risk is detected, the system automatically alerts healthcare professionals to intervene and provide personalized medical care.

If the development stage represents a company’s assessment of its core competencies and market environment, then the choice of region tests its ability to adapt strategies to local conditions.

Affected by the pandemic, populations in Europe and the United States have shifted to remote work and face challenges in accessing hospital care, which has driven the gradual development of home-based health management and monitoring. Moreover, the mature U.S. healthcare insurance system provides robust coverage for innovative technologies.

Currently, digital health management in China is still in its early stages of development, and health insurance coverage has not yet become widespread; therefore, the market remains in its nascent phase. However, China boasts rapid R&D speed, mature hardware manufacturing capabilities, richer clinical resources, and a larger patient population, resulting in faster R&D and production iteration cycles compared to the United States.

In light of the current state of digital health development both domestically and internationally, Darma has decided to focus its R&D efforts in China. In addition to strengthening its position in the domestic market, it also regards the U.S. market as a key strategic frontier.

Darma’s founder, Hu Junhao, summarized: “We should make rational use of the different market and resource advantages in China and overseas, and boldly go global,”Say No to Involution。”

To achieve balanced development both domestically and internationally, it is essential to leverage Darma’s comprehensive R&D capabilities in integrated hardware and software solutions, along with its marketing prowess.

DARMA has built the world’s first medical-grade fiber-optic sensor diagnostic platform, capable of precisely monitoring vital signs, cardiac function, hemodynamics, and behavioral patterns. To date, the company has filed 92 patents, with 27 already granted; the majority of these patents have been filed simultaneously in both domestic and international jurisdictions.

DARMA’s founder holds a Ph.D. in Optoelectronics from the National University of Singapore. The team members largely come from major medical device companies, bringing extensive experience and technical expertise in the field. Additionally, its medical advisory board includes renowned cardiovascular experts from Europe, the United States, and China.

Since its founding in Silicon Valley, the United States, in 2014 and the relocation of its headquarters back to China in 2015, DARMA has been in operation for over eight years.The transition from a consumer electronics provider to a medical device company, with its vital signs monitoring mat receiving dual certification from the NMPA and the FDA, tested Darma’s comprehensive capabilities; this year, the NIFP device secured the first BDD in China’s heart failure sector, underscoring recognition of Darma’s breakthrough innovative monitoring technology.

The digital healthcare sector in which DARMA operates is a trillion-dollar market.

Globally, the digitalization of healthcare is a major trend. With the widespread adoption of biosensor technology and wearable devices, vital sign data can now be acquired remotely and non-invasively. Furthermore, through SaaS platforms established by enterprises, two-way interaction between doctors and patients is enabled, facilitating remote diagnosis and treatment.

The COVID-19 pandemic has served as a “catalyst” for the development of digital health, with telehealth emerging as a new focal point. Under the influence of the pandemic, remote digital vital signs monitoring, consultations, and rehabilitation have gradually gained traction.

Between 2020 and 2021, numerous foreign digital health companies secured substantial financing or were acquired. For instance, Biofourmis raised $143 million, Tytocare raised $156 million, Current Health was recently acquired by Best Buy for $400 million, Huma Health raised $130 million, Forward Health completed a $225 million Series D funding round, and Noom closed a $540 million Series F round (with participation from Sequoia Capital). All these companies are focused on digital health monitoring.

In January 2021, global medical device giant Boston Scientific agreed to acquire Preventice Solutions for $1.02 billion. The company specializes in mobile cardiac health solutions and has launched remote wearable cardiac monitors. Bardy Diagnostics, which also focuses on remote cardiac monitoring and ECG parameter tracking, was acquired by Hill-Rom for $376 million.

In the field of decentralized clinical trials, Medable has also completed a $300 million financing round, achieving a valuation of $2.1 billion. Medable extensively leverages home-based vital signs monitoring to help pharmaceutical companies enroll patients and monitor them remotely.

Meanwhile, global regulatory agencies are promoting the widespread adoption of remote digital healthcare, and relevant regulations in some countries are changing rapidly, with some of these changes likely to become permanently entrenched even after the pandemic ends.

The U.S. Medicare Program Has Added Reimbursement Codes for Telemedicine.The National Healthcare Security Administration and the National Health Commission of China jointly issued the “Guiding Opinions on Promoting ‘Internet+’ Healthcare Security Services During the Prevention and Control of the COVID-19 Pandemic,”"Internet Plus" Follow-up Consultation Services for Common and Chronic Diseases Can Be Included in the Scope of Medical Insurance Fund Payment. Telemedicine is poised to transition from a “special channel” during the pandemic to a normalized platform, providing patients with full-chain health management that integrates online and offline services into a closed loop.

Data is the core of remote digital healthcare. Both patient management and physician consultations require corresponding vital signs data, particularly in the field of cardiovascular disease, where patients’ disease monitoring parameters are critically important.Currently, a large number of digital health companies in the market leverage basic physiological data—such as electrocardiograms (ECG), heart rate, and blood pressure—obtained from traditional medical devices to deliver their own digital health services. The barrier to entry for data acquisition in this segment is relatively low.

In the digital healthcare market, the AI capabilities of domestic and international players are gradually converging. While platform capabilities and commercialization models continue to be explored, medically significant data with clinical guidance value is highly likely to become the core focus of future competition. Data lies at the heart of digitalization; if data volume is insufficient or lacks precision, companies will be unable to enhance their subsequent services.

As a relatively small enterprise, Darma deeply understands the importance of “building core competitiveness” and is committed to strengthening its data foundation.Leveraging its core fiber-optic sensing technology, DARMA’s product series achieves medical-grade accuracy, precisely monitoring vital signs, cardiac function, hemodynamics, and behavioral patterns, thereby delivering clinically validated, medical-grade data.

In the data-driven realm of digital healthcare, it will be exciting to see how Darma builds its industry foundation on data.