MED Institute Joins Novelna’s PULSE Consortium to Advance Wearable Biosensing Technology for Post-Heart Attack Monitoring
MED Institute has joined Novelna Inc. and its consortium partners in the development of the Proactive Unified Longitudinal Sensing Ecosystem (PULSE), a next-generation wearable biosensing platform selected by the Advanced Research Projects Agency for Health (ARPA-H) under its Delphi program. The collaboration aims to advance continuous molecular monitoring technology, initially focusing on inflammation following myocardial infarction, commonly known as a heart attack.
Under the partnership, MED Institute will contribute its expertise in in vivo biosensor testing, regulatory strategy and clinical study services to support the development and evaluation of the PULSE platform. The company’s involvement is intended to help the consortium address key technical, regulatory and clinical development requirements as it works to move the technology closer to potential patient use.
The PULSE initiative is designed to develop a wearable biosensing system capable of continuously measuring molecular markers in interstitial fluid, the fluid found in the spaces between cells beneath the skin. By enabling ongoing measurement of selected biological markers, the platform aims to provide a new approach to monitoring physiological changes over time.
The initial application will focus on inflammation after myocardial infarction, a critical area of cardiovascular care in which patients may require continued monitoring after the immediate emergency has passed. The consortium’s longer-term objective is to advance a sensing platform that could support more personalized approaches to monitoring health and detecting changes in biological processes.
The project is being conducted under ARPA-H’s Delphi program, which is led by Program Manager Leonard Tender, Ph.D. ARPA-H has committed funding of up to $117.4 million over 4.5 years for the program, supporting the development of next-generation personalized biosensing technologies.
PULSE Aims to Advance Continuous Molecular Monitoring
Wearable health technologies have expanded the possibilities for monitoring physiological parameters outside traditional clinical environments. Devices that measure signals such as heart rate, temperature and activity can provide information about a person’s health over time. However, many biological processes involve molecular changes that cannot be assessed directly through conventional consumer wearables.
The PULSE platform seeks to address this challenge by developing a system that continuously measures molecular markers in interstitial fluid beneath the skin.
Interstitial fluid contains biological information that may help researchers assess changes in the body’s physiological state. Developing sensors capable of reliably detecting selected molecular markers in this fluid could expand the range of biological information available through wearable monitoring systems.
Unlike approaches that rely exclusively on occasional measurements taken during clinic visits, a continuous sensing platform could potentially provide longitudinal data that captures changes over time. Such information may help researchers better understand how biological processes evolve and how individual patients respond during recovery or treatment.
However, developing a wearable molecular biosensor involves several technical challenges, including sensor performance, measurement reliability, biocompatibility, data interpretation and the ability to maintain accurate readings during real-world use.
The PULSE consortium brings together organizations with complementary expertise to address these development requirements. MED Institute’s contribution will focus on in vivo testing, regulatory support and clinical study services, providing capabilities relevant to evaluating the technology as it progresses through development.
The initial focus on inflammation following myocardial infarction gives the project a defined clinical application in which the potential value of continuous molecular monitoring can be investigated.
Targeting Inflammation After Myocardial Infarction
A myocardial infarction occurs when blood flow to part of the heart muscle is severely reduced or blocked, resulting in damage to cardiac tissue. Treatment focuses on restoring blood flow, limiting heart muscle injury and managing complications. Recovery may require ongoing clinical assessment, medication management and lifestyle changes.
Inflammation is an important component of the body’s response to a heart attack. Following the initial injury, inflammatory processes contribute to the removal of damaged tissue and the subsequent healing process. The timing, intensity and resolution of these processes are relevant to cardiac recovery.
Monitoring inflammation over time could therefore provide useful information for researchers investigating post-heart attack recovery. A wearable biosensing platform designed to measure relevant molecular markers may offer a way to examine biological changes between conventional clinical assessments.
PULSE is intended to investigate this opportunity by developing a system that continuously measures selected molecular markers in interstitial fluid.
The project is still focused on technology development, and its potential clinical benefits will need to be established through appropriate testing and research. The announcement does not identify the specific molecular markers that the platform will measure or establish that the system has demonstrated clinical effectiveness in patients recovering from a heart attack.
Nevertheless, the initial indication provides a framework for evaluating whether continuous molecular sensing can generate reliable information relevant to post-myocardial infarction inflammation.
If successfully developed and validated, technologies of this type could contribute to future approaches for monitoring biological changes over time. Their ultimate role in clinical care would depend on sensor accuracy, clinical evidence, regulatory requirements and demonstrations that the resulting information can meaningfully support healthcare decisions.
MED Institute to Provide Testing, Regulatory and Clinical Expertise
MED Institute will support the PULSE consortium through three principal areas of expertise: in vivo biosensor testing, regulatory support and clinical study services.
In vivo testing involves evaluating technologies in living biological systems. For biosensors, this type of testing can help investigators assess how a device performs under biological conditions and identify issues that may not be fully captured through laboratory testing alone.
Such evaluation can be important for wearable technologies designed to interact with biological fluids and generate measurements over extended periods. Researchers need to understand how a sensor performs under relevant conditions and whether its measurements are sufficiently reliable for the intended application.
MED Institute’s regulatory expertise will also support the development process. Medical technologies must be evaluated against applicable safety, performance and regulatory requirements before they can be authorized for clinical use. Regulatory planning can help developers determine what evidence is needed, identify relevant testing requirements and structure development activities around the product’s intended use.
Clinical study services represent another important component of MED Institute’s contribution. Clinical research is necessary to evaluate how medical technologies perform in intended populations and settings. Depending on the product and its stage of development, studies may assess safety, technical performance, measurement reliability and other outcomes needed to support further development.
By combining these capabilities, MED Institute will contribute experience across several stages of medical product development as the PULSE consortium advances its wearable biosensing platform.
Steve Charlebois, president of MED Institute, emphasized the value of collaboration between organizations with specialized expertise.
“Programs like Delphi succeed because many partners each bring deep expertise to a shared goal,” Charlebois said. “We’re excited to apply our strengths in in vivo testing, regulatory strategy, and clinical study design and execution to help move this technology toward patients. We also welcome the opportunity to support other innovators pursuing bold ideas in biosensing and beyond.”
His comments highlight MED Institute’s role in helping translate a developing technology into a product that can undergo appropriate scientific, clinical and regulatory evaluation.
Novelna Leads a Multidisciplinary Consortium
Novelna Inc. serves as the prime awardee and principal investigator organization for the PULSE initiative. The company is leading a consortium that includes partners specializing in microelectronics, secure communications, biosensing and clinical development.
This multidisciplinary structure reflects the range of capabilities required to develop a wearable platform that measures molecular markers and delivers useful biological information.
Microelectronics expertise can contribute to the development of sensing components and the electronic systems needed to collect and process measurements. Biosensing capabilities are central to detecting the molecular targets of interest, while secure communications expertise can support the transmission and handling of sensitive data.
Clinical development capabilities are also important because a sensor must ultimately be evaluated in the context of its intended use. Technical performance alone is not sufficient to establish that a device provides reliable and clinically meaningful information.
MED Institute’s addition strengthens the consortium’s access to product development, testing, regulatory and clinical study services.
The partners will need to coordinate these different areas of expertise as they work through the technical and scientific challenges associated with continuous molecular sensing.
For a platform intended to measure biological markers over time, the development process must address not only the sensor itself but also the reliability of its measurements, the interpretation of the resulting data and the evidence required to support its intended clinical application.
The consortium model provides a structure for bringing these capabilities together within a coordinated research and development effort.
ARPA-H’s Delphi Program Supports Next-Generation Biosensing
The PULSE platform was selected under ARPA-H’s Delphi program, which is intended to advance next-generation personalized biosensing technologies.
ARPA-H is a U.S. government research agency focused on supporting ambitious health research and development projects. Its programs seek to accelerate innovative approaches that could address important healthcare challenges.
The Delphi program is led by Program Manager Leonard Tender, Ph.D., and carries an agency commitment of up to $117.4 million over 4.5 years.
The scale and duration of the program provide a framework for supporting the development of advanced biosensing technologies that may require substantial technical work, interdisciplinary collaboration and clinical evaluation.
Continuous molecular monitoring represents a different level of ambition from conventional wearable devices that primarily measure physical or physiological signals. Molecular sensing introduces additional challenges involving biological sample access, detection sensitivity, sensor stability and the interpretation of measurements over time.
Projects such as PULSE seek to advance the technology needed to address these challenges and explore how continuous biological measurements might eventually support more personalized healthcare.
The program’s support also underscores the importance of collaboration among technology developers, medical product specialists and clinical researchers in moving emerging biosensing concepts toward practical applications.
Further information about the program is available through the official ARPA-H announcement: ARPA-H advances next-generation personalized biosensors.
Additional details about the PULSE initiative are available through Novelna’s announcement.
MED Institute Brings Decades of Medical Product Development Experience
MED Institute said its participation in PULSE builds on more than four decades of experience supporting the development of medical products.
The company reports more than 40 years of medical product development experience and over 100 premarket submissions across all U.S. Food and Drug Administration regulatory pathways.
Premarket submissions are an important part of medical product development because they provide the information regulators need to evaluate a product under the applicable regulatory framework. The evidence requirements vary according to factors such as the technology, its intended use and the regulatory pathway involved.
MED Institute also reports ISO/IEC 17025 accreditation, ISO 13485 certification, compliance with ISO 14155 and capabilities for conducting Good Laboratory Practice (GLP)-compliant studies.
These quality and operational frameworks address different aspects of testing, medical device quality management, clinical investigation and laboratory study conduct. Their relevance depends on the specific activities being performed and the requirements applicable to each study or product.
In clinical research, MED Institute reports experience managing trials involving more than 2,500 patients across over 50 sites in 10 countries.
This experience provides a foundation for supporting the clinical development activities associated with emerging medical technologies. Clinical studies can involve coordination among investigators, research sites, study participants and other stakeholders, as well as the collection and management of data needed to evaluate product performance.
For the PULSE consortium, MED Institute’s background in testing, regulatory strategy and clinical study execution is intended to support the transition from technology development toward evaluation in clinically relevant settings.
Advancing Wearable Biosensing Toward Future Patient Applications
The addition of MED Institute to Novelna’s PULSE consortium represents a collaboration focused on advancing wearable molecular sensing technology and evaluating its potential application in cardiovascular care.
The initiative will initially examine post-myocardial infarction inflammation through a platform designed to continuously measure molecular markers in interstitial fluid beneath the skin. MED Institute will contribute in vivo biosensor testing, regulatory support and clinical study services, while Novelna leads a consortium spanning microelectronics, secure communications, biosensing and clinical development.
Supported through ARPA-H’s Delphi program, which carries an agency commitment of up to $117.4 million over 4.5 years, the project reflects a broader effort to develop next-generation personalized biosensing technologies.
The PULSE platform’s potential value will ultimately depend on whether it can deliver reliable measurements, demonstrate appropriate performance under relevant conditions and generate information that is meaningful for clinical use. Additional development and clinical evaluation will be needed before its role in patient monitoring can be established.
Through its participation, MED Institute will apply its medical product development experience to help address the testing, regulatory and clinical requirements associated with the platform.
The collaboration brings together specialized organizations with a shared objective: advancing continuous biosensing technology and exploring whether molecular monitoring can contribute to future approaches for tracking health and recovery after a heart attack.
About MED Institute: MED Institute is dedicated to bringing new medical products to market that are safe and effective for patients. MED supports entrepreneurs, consultants, developers, and manufacturers of medical products through the entire product life cycle, providing services as needed from initial concept through product approval to post market needs.