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.

Announcing Virtual PitchRounds – Covid-19

 

Southeast Life Sciences, the organization behind 400 presentations, 790 funding transactions, and $5.2B in investments from 500 distinct investors is going virtual for a special edition of PitchRounds.

As the nation and globe battle Covid-19, innovators and early stage companies continue to attempt to address the worst pandemic in a century. In some cases they are, or will need to, pivot to position themselves to succeed as the industry including early stage investors adjusts.

The week of June 16 we will host a special PitchRounds competition for early-stage southeastern companies working on Covid-19 products. We are accepting applications until May 22 through the F6S application. We encourage southeast-based early stage medtech and life science companies in any aspect of healthcare – diagnostics, treatments, vaccines, telehealth technologies, devices and even hygienics and PPE to apply.

The inaugural virtual event will follow the same format as our in-person PitchRounds events. Selected companies will make 10-minute presentations followed by Q&A from our investor panel.

April 6 Covid-19 Newsletter

April 6 Covid-19 Newsletter

Introduction 

Today I am kicking off a weekly newsletter to track the progress of Covid-19 in the southeast and provide useful information from the region and nation. This is an effort to keep you informed on what’s going on in each of the states in the southeast, as well as provide interesting articles, data, and good news to help break the monotony.

I have found many resources, but if you have any suggestions please let me know and I’ll do my best to include it in future posts. At heart, I’m a data nerd, so data is especially welcome!

Stay Safe!  

Numbers for the Week

State
New Cases
New Deaths
Total Cases
Total Deaths
AL
848
22
1842
45
AR
314
5,609
12,350
221
FL
5,609
136
12,350
221
GA
2,625
94
6,742
219
KY
364
28
955
45
LA
7,773
238
13,010
477
MS
701
23
1,634
43
NC
1,127
30
2,677
39
SC
966
22
2,049
44
TN
1,244
21
2,637
44
VA
1,387
25
2,637
51
Total
22,958
647
42,282
1,244

Peak Resource Usage

State
Date
AL
April 20
AR
April 24
FL
April 14
GA
April 14
KY
May 10
LA
April 4
MS
April 21
NC
April 14
SC
April 29
TN
April 18
VA
April 18

Upcoming Free Content

BIO Webinar 2PM TODAY: BIO invites you to join us for a special webinar  to discuss the Payment Protection Program and what it means for your company. During the webinar we will discuss key items to know and understand in advance of applying for the program. 

 HIMSS Webinar 2PM Tuesday: Deploying Technology During COVID

 SCBIO Webinar 10AM Friday: Maintaining Cybersecurity in light of COVID-19

 Southeast Life Sciences Webinar 12PM Monday, April 13: Life science investors: Is the faucet still on?

Resources & Links

Health Connect South Resource Page: Our friends at HCS have put together a robust database on resources available and needed by state. Instead of reinventing the wheel, please check out their site for valuable information. 

 Biotechnology Innovation Organization Covid-19 Hub

 Worldmeters information on cases, deaths, and recoveries. 

 Healthdata.org projections for resources uses. 

 American Enterprise Institute action tracker 

 Covidtracking.com – tremendous database for tracking data and resources by state 

 

Paycheck Protection Program Starts today – April 3, 2020

Today the Treasury Department is launching the Payment Protection Program that was created as part of the CARES Act. The program authorizes up to $349 billion in forgivable loans, up to $10M per company, to small businesses to pay their employees during the COVID-19 crisis.

The program is intended to be a simple process that will be implemented through your banks. Below is more for your review.

SBA overview of the program
More Information

Find eligible lenders
More Information

Dept of Treasury Fact Sheet
More Information

 Application
The application process is meant to be easy – fill in the application and take it to your bank.
Application Link

Venture-backed companies
 Uncertainty remains whether venture-backed companies would be eligible for the program, however there is a commitment from Congress and the Treasury Department to fix this problem. Due to the “affiliation rule” that was intended for companies owned by private equity, there is concern that venture-backed companies would not be eligible for the program. According to senior leaders in Congress, this has been or will be clarified by the Department of Treasury and venture-backed companies will be eligible.
Read More

If you would like more information, the Washington Post has a comprehensive FAQ to the program. Unlike most Washington Post articles, this is not restricted behind a paywall.
Read More

 

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.

For founders and early stage innovators: How do you know when it’s time to hire executive leadership?

Knowing when to hire executive level leadership is a daunting challenge for medtech and life science innovators. How long should founders go it alone? What skill sets should they develop versus hire into the organization? Do you hire a technologist, generalist, someone with founding experience? The answer is yes. But it depends on precisely who you are, what you know, what you need and where you are in your pathway to commercialization.

 

We hope you find this Q&A with Evan McClure MD, a Partner in the Healthcare and Life Sciences practice with global executive search firm Odgers Berndtson, useful. Evan describes his work as senior level executive and board search for healthcare and life sciences companies of all shapes and sizes, from preclinical biotech and medtech startups to global multibillion-dollar organizations. He can be reached at evan.mcclure@odgersberndtson.com.

 

How does an engineer, clinician or researcher innovating know when it’s time to hire executive leadership?

“Executive hires for growing companies tend to happen around periods of transition, so begin with the end in mind. What are your goals in the immediate, near and mid-term? Do you need to take a new Class I device into the clinic? Do you need to raise a series B or prepare for an IPO? Do you need to open up a new geography or client segment? Identify the capability gaps relative to your milestones, then work backward to identify the actions you’ll take to shore up your management team. Try to be brutally honest with yourself.

 

“Bringing on new leaders without a clearly articulated need can lead founders and young companies to get “out over their skis.’ You might find a great commercial leader, but if an upcoming trial doesn’t go as expected, you may still be years away from having something you can market. Of course, you also don’t want to wait until your FDA approval letter to think about commercial or market access strategy, so there’s a balance here.

 

“Founders and young life science organizations need to ensure they are accurately identify their needs to get to the next milestone. They should articulate these in a concrete way and translate them into discrete sets of responsibilities that complement one another. Make these plans and specifications as concrete and specific as possible, and you’ll find this makes things much easier when you start to compare real people against your rubric.

 

“A common scenario is a scientific founder growing the enterprise to the point where a broader skill set is needed at the top, such as needing to hire a CEO who has experience raising capital or building an executive team. Does the existing team have the capabilities and bandwidth to navigate the transition and come out of the other side successfully? Is the scientist-founder able, and have the time, to learn an essentially new kind of CEO job each time a company encounters a new phase? Can the gal with a finance background run BD? Can the guy with a sales background run HR? Perhaps – but it’s a risk.”  

 

From a hiring and recruiting standpoint, what are the most common mistakes young medtech & life science entrepreneurs make?

“There are two common scenarios found at ends of a spectrum. The first: hiring without a clearly defined need (e.g., I need to hire a CFO because that’s what companies do at our stage). Learn from others’ playbooks but don’t copy blindly. Every company has its own nuances and context. Make your talent strategy bespoke to your circumstances. Don’t get ahead of yourself.

 

“On the other side of that coin, some wait too long to hire executive leadership or expect the team to naturally adapt to meet a need. They think, ‘I’m smart. Why wouldn’t I [the founder] also be the CEO and Chairperson? I know the space and the technology. Certainly I can figure out how to organize and fund a clinical trial.’ Expect a de novo executive search to take several months. Look ahead and understand what your own network looks like in an area and the projected degree of difficulty in finding what you need. Consider that you’ll be in a better position to recruit a CMO, for example, if you can map out that need and start conversations several months before you need to hire.

 

“I’ll also comment on humility and the transferability of knowledge. I know doctors who are also pilots, but just because you are a top-tier physician key opinion leader doesn’t mean you can fly a plane. Or raise equity capital. Or design a market access strategy. Founders, especially engineers, scientists and clinicians – accomplished individuals in their fields – need to acknowledge their susceptibility to hubris as they venture to the edges of their spheres of expertise. Be realistic about your abilities, interests, and network. Plan ahead, talk to the right people and get out in front of the situation because the search, selection and hiring process takes time to execute and your windows of competitive opportunity may close quickly.

 

Having done the “homework” you described above, how does a young company get started in the search for the executive level talent they need? What about cost?

“Good executive search consultants are thought partners first and foremost. Those you’d want to work with are generally open to a discussion about your needs and willing to give advice. Many larger firms have minimum fees that are prohibitive to startups; some can make creative arrangements. Typically my own team has a $100,000 floor for a project, but I have certainly made exceptions and even (rarely) taken equity. I’m almost always open to a discussion with someone who is pragmatic and collaborative.

 

“Founders and young medtech or life science companies don’t need to presume they can’t talk to me because of a fee. We are information brokers, strategic partners, problem solvers. I’m happy to have an exploratory conversation that allows me to introduce the firm and get to know a young company, even and especially if they aren’t sure they need an executive search yet. We all make investments of time to establish and build relationships that don’t involve an invoice. If a search consultant won’t take the time to get to know you (or, alternatively, tries to sell you a search without understanding your business situation), that person is not likely very well-equipped to support your company and represent you to the talent market.”

 

What’s the smartest decision – of any kind – you’ve seen a young medtech or life science company make?

“I recently worked with a very exciting young biotech whose name can stay private, though I suspect it will be very well-known in the coming years. It’s a classic story of a scientific founder CEO who discovers a great technology but needs capital to scale.

 

The uncommon piece is that this founder readily acknowledged that a $50mm venture raise would be new to him, and that his skills were better suited to a Chief Technical/Scientific Officer type role than a growth-stage CEO position. He had the humility to say ‘I’m happy to try this, but my top priority is to ensure the success of the company and its ability to save lives, and I think a professional CEO would be better-equipped.’ He put aside his need for the CEO title in the interest of meeting the company’s goals. That’s not always the case, and I have also recruited CEOs to replace scientific founders against their wishes and at the request of their Boards, which is much harder for everyone.

 

“It takes humility and foresight to transition out of the CEO role, or any senior role, in the interest of the company. In this case, there are others available in the market who have done this before, earned their scars, and are more likely to anticipate the normal potholes of company-building and emerge with the funding required to initiate human trials. We’re at the offer stage with a tremendous candidate who complements the founder-CEO and has all our boxes checked (with a slate of additional candidates at the ready if required). It’s our expectation that this scientific founder will find himself and the company in a much better spot in 12 months than if he had tried to take that on himself.

 

“A more concise answer to your question: Know when someone else is a better fit for your needs. Your ego may object initially, but it will thank you later when that leader takes your company in a direction, or at a pace, that you might not have been able to. Dig the well before you’re thirsty, and look to establish relationships with talent partners who can be your advocates for the long term.”

 

Thank you, Evan for sharing your insights with us! Connect with Evan on LinkedIn.

Request for Supplies from National Association of Manufacturers

March 18, 2020

Forwarded Correspondence from Jay Timmons, President, National Association of Manufacturers

Please note this deadline is COB TODAY (March 18), but if you miss the deadline, please fill out the survey when you can.

Please complete this survey, if you possibly can. Tonight, the White House asked us to “reach out to our members” to identify their capabilities to step up and help the United States during this all-hands-on-deck crisis. The administration is seeking volunteers who can donate and provide and/or produce within two weeks large-scale quantities of critical supplies to help the nation respond to the COVID-19 pandemic.

If you have any questions about this survey or other COVID-19-related issues, please email the NAM’s COVID-19 response team at responseteam@nam.org.

Thank you once again for your partnership and support.

Jay

Jay Timmons
President and CEO
National Association of Manufacturers

Southeast Life Sciences Postpones the AdvanSE Life Sciences Conference

March 18, 2020

We have continued to follow the Covid-19 updates closely and want to announce that we will be postponing the AdvanSE Life Sciences Conference originally scheduled for May 27-28. We have not yet determined a new date, but we are working through the available options and will follow up as quickly as we can.

The last week has seen an incredible change in the situation, from WHO declaring a global pandemic, to the US declaring a state of emergency, and individual states, counties, and cities implementing strict limits on group gatherings.
These changes would make it impossible to hold the conference, but even without these measures, the safety and welfare of our attendees, their families, and the larger community warrants a postponement.

All of that being said, among our primary mission is to bring together constituents to nurture the deal flow in the Southeast, resulting in new products to the market and an improved human condition. We are actively consulting with our state partners, investor firms, and others how we might still fill this function during the intervening period until the conference is rescheduled. If you have thoughts along these lines, we would very much like to hear from you.

If you have any questions, please contact Jason Rupp or David Day.

Thank you for all of your support!
Jason & David

Apply for SE PitchRounds

The inaugural AdvanSE Life Sciences Conference is May 26 – 28, 2020, in Isle of Palms, SC. A highlight of the event is SE PitchRounds, our small company program.
We are looking for the best companies in the southeast in biopharma, medical devices, digital health, and diagnostics to present during the conference.
The deadline to apply is April 10. We accept applications from companies at any stage – from an idea on a napkin to profitable companies looking for expansion capital. Companies selected for PitchRounds will receive benefits including:
  • Two significantly discounted (more than 25%) off early-bird registration
  • In-depth workshops on topics such as Go-To-Market, Valuation, and Persuasive Pitch coaching
  • Mentoring with a team of investors, entrepreneurs, regulatory and reimbursement professionals, etc.
  • And more!
For more information or to apply, follow the links below.