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?

Important News

 

Good News

 

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.

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.
MORE INFORMATION
APPLY FOR PITCHROUNDS

Southeastern Medical Device Association and Southeast BIO Merge to Form Southeast Life Sciences

Southeastern Medical Device Association and Southeast BIO Merge to Form Southeast Life Sciences

Atlanta – February 20, 2020 – Representatives from the Southeastern Medical Device Association (SEMDA) and Southeast BIO (SEBIO) have announced that the two organizations have officially merged to form Southeast Life Sciences. The merger provides a single platform for medtech and bioscience innovation, partnering and investor relations in the region.

“The convergence of medical technologies, including devices, with bioscience technologies including drugs, data, digital and combination products necessitates the convergence of these entities,” former SEMDA Executive Director and now Southeast Life Science Executive Director Jason Rupp says. “In order to respond to the combined needs of stakeholders in both ecosystems, the time has arrived for SEBIO and SEMDA to come together under one roof.”

Combining individuals, corporations, universities and other entities in one regional industry organization mitigates “death by one thousand conferences,” ensuring more efficient use of time and resources, Rupp says.

New technologies like nanoparticles and microneedles for drug delivery coming out of the Wallace H. Coulter Department of Biomedical Engineering, a joint program of Emory University and Georgia Tech, are tangible examples of the potential for innovation when multiple scientific disciplines connect.

“With the advent of devices like Cardiomems that blend device with data and devices that deliver pharmaceutical therapies, close connectivity between medical device and bioscience innovators is advantageous to regional stakeholders, especially investors,” Rupp says.

“Because clients span the entirety of medtech innovation including devices, pharmaceutical therapies and combination devices, many companies like ours needed to support both organizations,” says former SEMDA Chair Tiffany Wilson, CEO of the Global Center for Medical Innovation (GCMI). “Financially, this meant telling them, ‘We have this amount of funding support for you. You have to figure out how to divvy it up.’ While both SEBIO and SEMDA flagship conferences had value, bringing them under the same roof brings connectivity, educational and financial efficiency gains for all concerned that should lift medtech and life science innovation and investment across the board.”

The inaugural ADVANSE Life Science Conference, Southeast Life Science’s flagship event will be May 28-29, 2020 in Charleston, SC. Organizers expect to convene more than 500 attendees, including a significant number of investors, highlighting innovations from 50 early stage medtech and bioscience companies over the two-day conference.

David Day, Executive Director of Southeast BIO, added, “Southeast BIO and SEMDA have been operating as sister organizations for medtech and life science stakeholders in the southeast. The resulting merger will provide a critical mass of innovation that will be more than the sum of its parts.”

###

Contact
Jason Rupp
Executive Director, Southeast Life Sciences
jrupp@semda.net

Spotlight interview: SEMDA PitchRounds winner RCE Technologies

Around 18 percent of all heart attack victims will wind up readmitted to the hospital within thirty days. For twenty-five percent of all heart attack victims, it is not their first experience with myocardial infarction (MI). This is costly to all concerned, most vitally the at risk patients, but also to the economic health of the hospitals that care for them who are at risk for being penalized for readmission rates over certain levels.

RCE Technologies, winner of the 2019 SEMDA PitchRounds competition, is following a commercialization pathway to reduce those events and costs via remote monitoring that “non-invasively detect[s] protein biomarkers in the blood, and extract[s] a 3D representation of the electrical conductivity of the heart. Continuous streams of critical data points wirelessly enable our cloud based AI models in detecting characteristic learned patterns of heart morphology changes, that affords the cardiologist in making an instant early assessment and proactive intervention”

RCE Technologies’ CEO Atandra Burman

“We have shown high velocity bringing concept to product in nine months, viable clinical alignment and a needed, reimbursement ready opportunity, RCE Technologies’ CEO Atandra Burman told Write2Market VP of Healthcare Paul Snyder. “We believe we have a very clear path forward to de-risking and commercializing our technology.”

Atandra shared with us a few of the insights gained from SEMDA 2019 and some pieces of advice for other early stage medtech innovators and company leaders.

Beyond the “win” what was most valuable about your participation in SEMDA PitchRounds?

Watching the late stage companies gave us a clearer view of our roadmap unfolding. What’s needed to weather the first, or next, round of challenges? Clinical studies and demos. All of the late stage PitchRounds companies had a clear path on reimbursement strategy, regulatory pathways and channel partnerships identified along with optimized operations for production and distribution. One hinted at a clear exit strategy. This I thought was most valuable, because it gives you the end goal, and helps you work backwards from that – time and cost wise, and those are important variables for me as an operator to run a startup and hit within time and budget.

What did you hear from prospective investors?

Are there other markets or monitoring product reimbursement codes for our technology? What we heard inferred a high level of synergy. Our technology is viable and multiple supporting elements exist.

What are the top questions young medtech & device companies need to answer?

Has there been any kind of clinical validation done? This assumes the technology works and the product functions as anticipated towards better patient outcomes. Next, understand your health economics. How will you get paid? Is the hospital paying, is there a reimbursement code? Basically, think beyond the bench. Think economics, exit path and ROI potential at an early point in your journey. That enables a better gauge on a MVP path to market.

What advice would you give young companies considering applying for SEMDA PitchRounds next year?

While working on functionality, you must also work on payer economics. You must be able to explain how your technology is going to make money in time. Furnishing an exit strategy is another important aspect, that keeps young companies focussed, and on target for what is needed. Expect curveballs from investors and strategics. You need to be on top of it to give perspective on how it will work.

We hear more and more that investors, particularly large strategics, are more frequently requiring products in which they invest be 100% de-risked? How accurate is that?

If you are revenue positive and cost effective, that shows some level of viability for strategics to bet on startups/early stage. Sometimes, we might see them engage in M&A with companies in pre-commercialization and clinical trials. An example is Boston Scientific’s acquisition of Millipede for $325 million in structural heart. Millipede has accomplished a great deal on their pathway to commercialization, but haven’t finished their clinical trials. But then, Boston Scientific’s strategy is clear towards innovation in cardiovascular devices, and if there are ones that have clinical viability, commercialization can be addressed effectively by these large strategics.

What’s next for RCE? 

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.

What do you need?

As a fast moving business, 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.

In parallel, we are evaluating channel partners, and contract manufacturers, to bring our at scale costs down enabling production lines for goto market.

Congratulations again to RCE Technologies. We look forward to seeing how far you’ve come by the SEMDA 2020 Medtech Conference.

MedTech startups and innovators, this one’s for you. What Avanos looks for in an investable young MedTech company.

With Shyam Parekh, Ph.D., Director, Strategy & Business Development, Avanos Medical. Inc..

Shyam Parekh, Ph.D., Director, Strategy & Business Development, Avanos Medical. Inc.

Shyam Parekh’s role, as part of the Avanos’s corporate strategy group is to support the senior leaders in their strategic alliances and technology acquisitions needs. In other words, this gentleman would play a leading role on the team evaluating the value and suitability of your MedTech innovation if you wanted to sell it, or your company, to Avanos.

Shyam describes his role as focused more on open innovation and pre-revenue opportunities. Here’s what Shyam told Write2Market VP of Healthcare Paul Snyder during a recent visit to Avanos’ Alpharetta, Ga., headquarters.

Has your perception of what makes a young medtech company ‘investable’ changed recently?

“Not significantly. The strength of your IP, the quality of your people, your credibility, and the presence of other reputable investors all increase investability in young companies. Now, in the early-stage exploratory work we do, human data is another significant advantage.

“A key question for us is whether a company has sufficiently considered available versus addressable versus currently served market. If a startup tells us, ‘It’s a billion dollars market opportunity,’ they can lose credibility fast. Credible investors will do their own diligence. Those financial data will never be, and do not need to be, anywhere near as precise as any claims. Any market potential numbers will be taken as guidance only. They need to be ‘directionally correct and precisely inaccurate.’

“Also, be prepared to validate your addressable market. This needs appropriate exposure to considerations a large strategic [MedTech company] has. When you say health economic impact is in the tens of billions of dollars for diabetics on injectable insulin regimens, that is not a questionable number. If your widget is automated and portable, then what’s the addressable market? Just as important, how large is the available market versus the market already being served?”

Where are your top areas of innovation interest?

“Pain management and nutrition delivery. We look at investment or acquisition opportunities two ways. Is it a procedural enhancement or is it outcomes improving? From a procedural standpoint, where can technology help with placement confirmation, short of direct visualization for nasal gastric tubes, for example?

“For outcomes improvements, how can devices reduce the number of days a patient stays on a ventilator? Then, once in the home care environment, how can medical technology reduce, or improve, underlying conditions or exacerbations that accompany COPD, chronic bronchitis or emphysema for example?”

How many investments might you make this year in young companies?

“We have publicly stated we are open to innovation acquisitions and are looking for disruptive solutions that are consistent with our value proposition in acute and chronic pain management and digestive health.”

What advice would you give a young company when preparing for an event like SEMDA?

“Keep your pitch crisp.

“Provide a high level of clarity on what are you doing and why is it better.

“Know your audience. Are you talking with true investors or am I talking with intermediaries? Are the people in the audience technology scouts or are they actually investors? In many cases, innovators will find themselves presenting to marketers, researchers or associates of a corporate innovation entity.

“Another question is, how are you changing my health economic equation? We look at that closely. If that isn’t the case and the story isn’t crisp, a pitch for investment in a young medtech company or startup does not score high.”

Does a device have to generate data to be investible?

“Data is becoming central to all, but if data doesn’t change outcomes or drive decisions, data for the sake of data has no bearing, particularly when looking at a quick procedural intervention.

“If you are leveraging diagnoses as evidence generation for reimbursement support, those data are valuable.”

The SEMDA 2019 Medtech Conference – where the Southeast Medtech Ecosystem Connects

The SEMDA 2019 Medtech Conference is April 8 – 10 in Alpharetta, Georgia. Register today to join hundreds of investors, entrepreneurs, researchers and representatives from large strategic companies like Avanos whose CEO, Joe Woody, will deliver the opening keynote on Tuesday, April 9 at 9:30 a.m.

Follow SEMDA on Twitter and LinkedIn for the latest.

On the frontline of connecting patients to their providers via blockchain: a quick catch up with Patientory Founder and CEO Chrissa McFarlane

As we recently recognized in a conversation with Florence Hudson, there is a LOT to unpack when it comes to blockchain in health care. But the industry has definitely taken notice of Patientory, whose team and distributed ledger technology is starting to revolutionize EHRs and the way doctors and patients interact with each other and their data.

You may recall Patientory was the winner of the 2018 SEMDA Medtech Conference PitchRounds competition.

After raising $7.2 million in mid-2017 through its ICO (initial coin offering), Patientory launched its consumer-facing app in late 2018. But what’s needed to accelerate blockchain technology deployment in the healthcare continuum?

“We need brave, forward looking health systems for use cases in large patient populations,” Patientory founder and CEO Chrissa McFarlane told us. “We need to see an adoption by a large company on a day-to-day basis that includes 1 million covered lives. The space is filled with great startups, but adoption and implementation is the next mountain to climb.”

Beyond an individual’s EHR, blockchain for healthcare can improve processes in supply chain management of medical devices or opioids or even claims processing and adjudication. But large scale adoption in highly centralized provider IT networks is unlikely in the short term given clinical workflow disruption and technical proficiency ramp up requirements.

“There are payer and provider CIOs or IT architecture leads fluent in blockchain, but very few of them,” McFarlane says. “Ultimately the end users, the patients, physicians and their bosses will drive systemic adoption of secure, distributed ledger technology that enables them to truly own and access individuals’ electronic health records. This is why the launch of our app was so important.”

As tech giants like Google and Apple wade deeper into the healthcare pool collecting more and more personal health data, will blockchain be the technology that carriers and secures it?

“It’s inevitable,” McFarlane says. “Blockchain’s potential spans the entirety of the continuum, which tends to cloud its greatest value potential: securely placing patient data in the right hands at the right time to improve outcomes while reducing cost.”

What’s next for Patientory?

“We remain focused on our core deliverables from our 2017 product roadmap including the enterprise distributed application solution and the PTOYNet storage network,” McFarlane says. “We are also eager to analyze the results from our ongoing pilot programs to learn what works, what doesn’t and what’s needed next to place millions of lives under care through the Patientory platform. Do they have a long term tech strategy to incorporate distributed ledger technology into their stack?

“We need more market validation and to learn more about health systems’ financial structures and operations along with their perception of the emerging opportunities and potential for blockchain in healthcare.”

Ms. McFarlane will share further thoughts on the future of blockchain in healthcare during a panel conversation following Florence Hudson’s keynote on Wednesday, April 9th at the 2019 SEMDA Medtech Conference. Register today!