MED Institute Joins Novelna’s ARPA-H Funded PULSE Consortium to Advance Wearable Biosensing

Personalized Biosensors / ARPA-H Delphi Program

WEST LAFAYETTE, Ind.--(BUSINESS WIRE)--MED Institute has joined Novelna Inc. and its consortium partners on Proactive Unified Longitudinal Sensing Ecosystem (PULSE), a wearable biosensing platform selected by the Advanced Research Projects Agency for Health (ARPA-H) under its Delphi program. MED Institute will support PULSE with in vivo biosensor testing, regulatory support, and clinical study services.

Through PULSE, Novelna and its consortium partners will develop a wearable biosensing platform that continuously measures molecular markers in interstitial fluid beneath the skin. The initial target is post-myocardial infarction inflammation to help monitor patients after a heart attack.

The Delphi program is led by ARPA-H Program Manager Leonard Tender, Ph.D., with an agency commitment of up to $117.4 million over 4.5 years. For more details, read the ARPA-H announcement and the Novelna announcement.

Novelna, the prime awardee and principal investigator organization, leads a consortium with partners in microelectronics, secure communications, biosensing, and clinical development. MED Institute is pleased to contribute its end-to-end product development expertise to this collaborative effort.

"Programs like Delphi succeed because many partners each bring deep expertise to a shared goal,” said Steve Charlebois, President of MED Institute. “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."

MED Institute brings decades of experience advancing novel medical products from concept to market, including:

• 40+ years of medical product development experience and 100+ premarket submissions across all FDA pathways.
• ISO/IEC 17025 accreditation, ISO 13485 certification, ISO 14155 compliance, and GLP-compliant study capabilities.
• Clinical trial management experience spanning 2,500+ patients, 50+ sites, in 10 countries.

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.

This research is funded, in part, by the Advanced Research Projects Agency for Health (ARPA-H). The views and conclusions contained herein are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the U.S. Government.