Where are they now? We caught up with 2019 PitchRounds winner RCE Technology’s CEO Atandra Burman

Atandra and RCE will be presenting June 16 at 2:20 during the Southeast Life Sciences Virtual PitchRounds

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.”

Insights and full recording from our recent Southeast Life Science investor panel and webinar

On Tuesday, April 13, Southeast Life Sciences convened a panel of industry leading medtech and life science investors to discuss how activities have shifted and what the mid-long term ramifications will mean to early stage innovators. 

Bob Crutchfield moderated the discussion including insights from:

Gerry Brunk of Lumira Ventures, Joe Cook III of Mountain Group Partners and Kyparissia Sirinakis of Epidarex Capital.

A few of the top takeaways included:

  • There are, and will continue to be, significant disruptions in GLP preclinical work required to achieve an IND or entry into clinical trials. 
  • New medical technologies with ‘capex’ implications for hospital budgets will be at a significant funding and commercialization disadvantage for at least 12 to 24 months.
  • Telehealth and remote monitoring should be poised well for structural changes including adoption and reimbursement.
  • High net worth family offices have plenty of capital to invest. They will ‘lean in’ on increasing stakes in existing investments and in sectors or stages least likely to be impacted. The telehealth genie, for example, will not likely go ‘back into its lamp.’ Opportunity: What is going to really make it sing? 
  • Innovators need to adjust timelines to reflect new realities and resources required. Runway extension is the current name of the game, especially for technologies requiring clinical studies. Break up your pathway into ‘bite size’ milestones and discontinue using any pre-COVID-19 valuation and structure analogs.
  • Keep the conversation going. Investors are now considering technologies they may have passed on previously. They are continuing to do their due diligence. Many are focused more highly on solutions so transformative on patient benefit and cost reduction than they ever have been before. Early stage companies’ funding rounds will take longer, but great companies will always find funding.
  • The translational aspect of new medtech and life science innovations needs to be stronger than ever before.

We encourage everyone, especially early stage medtech and life science companies, to give the full session a watch or listen HERE.

Southeast Life Sciences signs coalition letter on behalf of small businesses with equity investors

This week, Southeast Life Sciences joined a national coalition to encourage the federal government to clarify that small businesses with equity investors will be included in the Keeping Workers Paid and Employed Act provision included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. 

The imminent fate of hundreds of thousands of jobs across the Southeast and America hinges on the implementation of these rules.  In order to survive, these companies must make difficult decisions over the course of the next several days. Rapid clarity on how these rules will be interpreted for purposes of the program can provide confidence to these vital small businesses that resources will be available and will mitigate the layoffs beginning to sweep across the startup ecosystem.

The Keeping Workers Paid and Employed Act is one of the most powerful small business recovery programs ever passed by the United States Congress.  This program will provide loans of up to $10 million dollars to small businesses up to 500 employees.  The benefits are carefully crafted to encourage the retention of middle-class jobs through the economic crisis caused by the COVID-19 pandemic.  If this is effective then millions of jobs across America will be preserved, potentially preventing the downward spiral in economic activity created by widespread layoffs.

Most American startups are below 500 employees and are not yet profitable.  Like other small businesses, these companies survive on a month-to-month basis, meaning their workforces are also particularly vulnerable in an economic downturn.  Startups commonly take equity financing, and in an economic crisis, that capital must be used to keep the entity in operation.  Companies must make difficult decisions fast on whether to lay off some of their workforce or run the risk of exhausting their available capital and destroying the business.  Every single one of these companies are currently looking through their books to better understand how far they can stretch their current available capital to preserve the entity through the economic crisis.  This timeline is often colloquially referred to as “runway.”  Because such a high percentage of the capital is spent on payroll, often the only way for startups to extend their runway is furloughs and layoffs.

Thankfully, Congress responded to the crisis with the Keeping American Workers Paid and Employed program that is designed to prevent mass layoffs at small businesses.  But how the Department of Treasury and the Small Business Administration (SBA) will apply the rules in upcoming guidance to implement the program is a central question to program access for startups and other small businesses with equity investors.  If the current SBA rules on affiliation are applied, they will create significant confusion about eligibility, delay the application process, render many small businesses ineligible, and cause many more to forego the process.  Each of these challenges will exacerbate layoffs.

In the last few days a brief survey of a cross-section of venture investors was conducted to gauge what the impact would be on their portfolio companies if they do not have access to the small business lending facility.  The responses were dramatic, with many companies considering layoffs between 25 and 50 percent of their workforce.  To provide a perspective of the impact of these layoffs on the workforce, about 34,000 companies in the United States have raised venture funding since 2015.  Of the approximately 20,000 of these companies for which the employee count is captured, 97% have fewer than 500 employees. 1   As noted above, about 2.27 million Americans work at these companies, with many more people employed in support roles at other companies.

Failure to provide clarity that small businesses with equity investors are eligible for the loan facility will cost jobs not only at startups, but at many of the independently owned service oriented small businesses in communities across America.  These startup workers, who include engineers, customer service representatives, and human resources professionals, are the very customers that service-oriented small businesses such as restaurants and coffee shops rely on for sales making an economic comeback post crisis even more difficult.

Finally, if the affiliation rules are not applied appropriately, our country will experience incalculable cost to our science and technology leadership.  Venture capital backs the world’s most innovative companies, but without support from the government hundreds of research projects across the country are at risk of being shelved.  This is potential progress that will pause overnight, and just as important, will set back American competitiveness in an increasingly global race for innovation leadership back by years.

Full Coalition Letter Here

About Southeast Life Sciences

Southeast Life Sciences is a regional non-profit organization dedicated to the growth of the life sciences industry. It was formed in 2019 through the merger of Southeast BIO and the Southeast Medical Device Association (SEMDA).

The mission of Southeast Life Sciences is to efficiently, effectively connect our industry’s innovators and entrepreneurs with the right investment and partners be they institutions, corporations, venture capitalists or angels.

We facilitate connections, conversations and capital investments through continuous networking, education and funding opportunities for life-science innovators of all shapes and sizes.