MedTech Clinical and Data Science Leaders Come Together to Introduce 3Aware and a First-of-Its-Kind Solution for Post-Market Clinical Follow-Up

INDIANAPOLIS, June 9, 2023 - Company leaders today announced the launch of 3Aware, formed by leading scientists and technologists from the MedTech and HealthTech sectors. 3Aware is committed to enhancing the availability, safety and performance of medical devices while decreasing the time, cost and risk associated with post-market clinical follow-up (PMCF) and active surveillance.

Medical device manufacturers indicate costs associated with new post-market surveillance regulations in the EU will equal 5% or more of their annual market revenues. As other regulators adopt similar approaches, the annual $500B global medical device industry could see compliance spending increase by $25B above current levels over the next several years.

3Aware was created when a leading global medical device company, Cook Medical, recognized the need for an industry-wide solution to this unsustainable trend and sought out a leading HealthTech innovator, Health Cloud Ventures (HCV), to establish a new, independent company focused specifically on optimizing post-market clinical follow-up and active surveillance for MedTech companies.

Cook and HCV combined their respective expertise to set 3Aware on a path to revolutionize how MedTech companies leverage healthcare data, by longitudinally connecting specific patient outcomes to specific devices, across large populations—a new method called aiSurveillance™. This breakthrough approach is implemented within a seamless user experience designed to optimize the access, efficiencies and insights of clinical scientists.

"3Aware presents a tremendous opportunity to solve real-world business challenges for MedTech—to decrease costs, drive efficiency and simplify the challenges of PMCF reporting," said Rob Lyles, President of Cook Ventures and a 3Aware board member.

"3Aware is delivering a breakthrough in the application of Reinforcement Learning from Human Feedback (RLHF) artificial intelligence (AI) to power clinical interpretation and resulting insights that demonstrate real-world safety and performance—a game-changer for our industry," added Brad Bostic, Executive Chairman of 3Aware and CEO of Health Cloud Ventures.

3Aware aiSurveillance™—aided by Natural Language Processing (NLP)—facilitates regulatory compliance, as outlined by European Union Medical Device Regulation (EU MDR) and the International Medical Device Regulators Forum (IMDRF, which includes the FDA) Post-Market Clinical Follow-Up Studies. aiSurveillance™ will also help to accelerate MedTech market share growth, by enhancing market access, label expansion and product portfolio optimization.

3Aware is also pleased to announce the appointment of Chris Brown as its President & Chief Operating Officer (COO) to assume oversight of business operations and overall execution across the company. Brown is the former COO of hc1 and former VP of Customer Operations at Sprint Nextel. He has held a variety of leadership roles in sales operations, finance, customer care and strategic planning. Additionally, 3Aware has appointed Amelia Hufford, Ph.D., as Senior Vice President of Clinical & Regulatory Science Operations. Dr. Hufford brings a wealth of experience in scientific research, clinical and regulatory affairs, and MedTech post-market strategy.

About 3Aware

3Aware enables MedTech manufacturers to achieve compliance at a fraction of the time, cost and risk of status quo approaches—by enabling highly-efficient access to longitudinal patient-level data, including conditions, treatments, encounters, procedures and outcomes, directly related to the use of specifically identified medical devices.

• 3Aware data currently covers millions of patients, relative to tens of thousands of devices, and is consistently growing.
• Proven AI capabilities facilitate the mining, interpretation and structuring of critical information buried in unstructured provider notes.
• The 3Aware platform enables analysts to quickly and directly access the content they need to apply their expertise—in an environment optimized for Post-Market Clinical Follow-up.