When we spoke last year RCE CEO Atandra Burman told us, “Our goal in 2019 is clinical validation and submit to FDA this fall. As our pilots materialize towards key insights, we look forward to setting up 2020 for commercialization efforts. we are currently raising $800k to support our immediate needs in completing our compliance testing and FDA sub, as well as supporting clinical pilots for 2019.”
RCE Technologies is following a commercialization pathway to reduce major adverse cardiovascular events and healthcare costs via instant risk stratification and remote monitoring via “non-invasively detection of cardiac protein biomarkers. Continuous streams of these early clinical data points enable our cloud based AI models in detecting characteristic learned patterns of early changes in the heart, thereby empowering clinicians in making an instant early assessment and proactive intervention”
How did the balance of the year unfold for the 2019 SEMDA PitchRounds winner? Atandra recently shared an update with us.
“2019 was a successful year for RCE in product innovation both with the ECG wearable vest and Non-invasive protein sensor,” Atandra said. “We successfully completed our pilot studies for the ECG wearable vest along with product certification requirements. We also demonstrated early feasibility of our non-invasive protein sensor in cardiac biomarker measurements.
“On the funding side, we completed a round of promissory notes enabling us to fast track our clinical feasibility track.”
What have you learned in the past 12 months about fundraising?
“Our focus on physician investors has been highly productive. It seems the market has been waiting for this innovation for years. Many physicians we have spoken to, including our investors, expressed some surprise this hadn’t been done yet.
“Our studies have demonstrated positive outcomes, allowing those physicians to extrapolate the clinical and economic value propositions by using our technology in present workflows. We intend to publish some of those outcomes data by year’s end.”
Have you shifted course at all?
“Not fundamentally. We solved the first problem, which was wearables to collect non-invasive biomarkers. Now we are solving our second problem, to conduct clinical validation efforts and collect data from diverse demographics for accurate AI prediction models.”
“The feedback from the clinical pilots has been well received by key opinion leaders who have told us they have not seen anything like it. We are able to demonstrate early feasibility of our non-invasive protein sensor in measurement of cardiac biomarkers allowing risk stratification of chest pain patients. We see the market in point of care diagnostics in the hospitals and urgent care clinics.
“We are currently conducting multi-site clinical trials of the non-invasive protein sensor. We expect those trials to conclude in September. We reinforced our lean product development and kept our focal efforts on track towards our vision. We are much closer to ‘product market fit’ than we were 12 months ago.”
What is the current status of your FDA submission and market entry?
“We are currently working closely with the FDA on both of our submissions this year, including fast tracking the non-invasive device submission this year. We will use a combination of partnerships and salesforce for hospital and outpatient clinic device sales.
“Employing a partnership model drives initial revenue with lower investment in salesforce out the gates. This allows us to assess the market segments to establish a product market before scaling. This also justifies spend on data collection efforts for our AI models that are core to our value provision and mission.”
What does the balance of 2020 hold for RCE?
“We will continue clinical validation and market development efforts for our wearables, AI data collection efforts, and formalizing our regulatory pathways with anticipated product launch in 2021.”
What is particularly advantageous about innovating in the southeast, particularly Atlanta?
“There is outstanding access to “voice of the customer” and patient populations for clinical trials through the robust networks of hospitals, health systems and research institutions like Emory University, and Wellstar Health System. Advancing our technology requires significant time spent with both patients and physicians. Georgia Tech’s ATDC facilities, and access to highly qualified local services in product prototyping and quality verification has been advantageous as well. Lastly, low cost of operations here compared to places like Boston and San Diego, extends the capital runway, and the opportunity to accomplish more with less.”