CLEVELAND, OHIO-S4 Medical, a medical device company focused on protecting the esophagus from damage during catheter ablation procedures for atrial fibrillation (AF), announces that the US Food and Drug Administration (FDA) has approved its Investigatory Device Exemption (IDE) for a human clinical study of the ESOLUTION esophageal catheter. The study is a prospective, multi-center, randomized controlled, single-blinded clinical study to assess a reduction of esophageal lesions attributable to catheter ablation treatment of AF.
Dr. Raul Weiss, MD, FACC, Professor of Clinical Medicine and Director of the Electrophysiology Fellowship Program at The Ohio State University Medical Center, will serve as principal investigator of the study. "This is an interesting study as it will provide the first FDA randomized study of a device for protecting the esophagus from injury by ablation energy. This device also uses vacuum suction to hold the esophagus and then moves the entire segment, solving the issue with the trailing edge. Finally, the device is designed to provide for controllable degrees of bidirectional deflection," says Dr. Weiss.
The chief medical officer and co-inventor of the device, Emile Daoud, MD, Electrophysiology Section Chief at The Ohio State University, is equally enthusiastic: "It has taken some time, but we have developed a simple but clever way to safely and successfully deviate the esophagus. If successful, this will be well received by electrophysiologists as an added benefit for managing patients undergoing AF ablation."
Since its founding in 2017, S4 has achieved several exciting milestones towards bringing the ESOLUTION device to market, including a successful first in a human study, an issued patent, and now this IDE approval. "We are delighted the FDA has granted this IDE and excited to kick off this study and evaluate the ESOLUTION device in a larger study. This IDE is proof of the excellent progress we've made at S4," says co-founder and CEO William Fuller.
About S4: S4 Medical Corp. is a medical device company focused on innovative solutions for cardiac procedures. The company's primary focus is a simple, yet comprehensive solution for reducing complications to the esophagus during catheter ablation treatment for atrial fibrillation. S4's team is motivated by providing advanced solutions for superior healthcare. For more information, visit S4 at www.S4medical.com on LinkedIn and Twitter.
The COVID-19 pandemic has forced many business sectors under water, and has paused fundraising activity due to uncertainty of the market. A recent study by Israel’s customer research firm Wizer concluded that more than half of participating investors are cutting back on startup funding, or holding off on investments entirely. Another 47% of investors believe the aftermath of the pandemic will last a minimum of another six months to a year.
It is true that the market has shifted greatly and companies have moved from focusing on growth to focusing on survival and profitability. Even more challenging, venture capital firms have cut back on funding opportunities due to the market’s uncertainty. But despite these stats, there are still ways and new avenues for unrelenting startups to raise capital for their firms. It will certainty take a pivot in strategy and a reconsideration of how a company approaches business, but it is possible. Here’s what you should consider:
Prepare a strong financial strategy, and have cash burn under control
One quality that investors may seek out when approached by startups for funding is a founder with good burn mechanics. Startups should be prepared to showcase a sound financial strategy that prioritizes reducing higher cost line items over the next two years.
Agility and nimbleness are key in this business landscape
Companies that are able to showcase how they can diligently and successfully adapt to the business landscape shaped by the pandemic may catch the eyes of potential investors. VCs still willing to invest are looking at companies that can successfully respond to the pandemic and maintain, or even increase, their profitability. Wizer also reported that 40% of VC respondents recommend startups leverage the COVID-19 pandemic creatively, react, and adapt accordingly. VCs are considering companies that (when applicable) can swiftly move their businesses to digital platforms, and leverage new possibilities.
Learn from other startups
Not quite sure where to start, or simply need inspiration to revise your VC pitch? Check out what other startup companies are doing, and learn from them. Now more than ever is the time to network, and the networking scene has moved to online options. One option is tuning into The Startup of the Year Online Pitch Event, where U.S. veteran-led companies will compete for funding in front of a panel.
An important point to remember is that earning venture capital funding and seeing it through the full process to eventual exit is a long game. According to MIT, the time frame for successful companies is typically 10 – 15 years. There aren’t “quick schemes,” or fast tracks, and VC funding requires dedication to your company, grit, and patience. Just like the time it takes to develop a funding package, it will take time to create and strengthen a relationship with a potential VC. Don’t lose sight of your goals during the pandemic – this is a testament to your entrepreneurship. Keep pushing forward, and create new approaches to the challenges at hand.
The COVID-19 pandemic is not the first time the world has experienced a health crisis, nor does it mark the first time the business industry has been affected by an epidemic. From the Spanish Flu to SARS, we have had to shift with changing times due to a health crisis, and have learned several business lessons that are still applicable today (and to the current pandemic.) Let’s take a look at previous epidemics, some business lessons learned, and pandemic inventions and startups that are still in business today.
The 1918 Spanish Flu
The 1918 Spanish Flu pandemic devastated the world, infecting about 500 million people worldwide and claiming 50 million lives including 675,000 Americans. While there was mass suffrage, this pandemic offered entrepreneurs and businesses ways to create impact for their societies. The Spanish Flu shared a vital business lesson: provide solutions to the world’s current needs. During this time of distress, Walter and Lydia Deubener of New York City recognized a need for a durable way to carry groceries as the “cash and carry” method began to grow in grocery sales. In 1918, the grocery bag was invented.
SARS, or severe acute respiratory syndrome, caused by one of seven COVID-19, spread to 26 countries and infected over 8,000 people worldwide between 2002 and 2003. Although short-lived, the SARS pandemic sent shock waves into businesses, disrupted the travel industry, work, and the economy. The 2003 SARS pandemic shared a sharp reminder and lesson for companies: ensure emergency preparedness. Proactive communication is a large part of emergency response, as well as internal communications.
2009 Swine Flu
In 2008, a new influenza emerged, infecting approximately 60.8 million people in the United States. Although the Swine Flu created a shock wave across the world, it came to us during the digital age and transformed the way we track and combat the Flu through the use of technology at our fingertips. The 2009 Swine Flu pandemic shared with us this great insight: think locally and act globally. Collaboration and information sharing not only served us well in combating the epidemic but also within business. Despite the economic recession, Uber, a ride-sharing company built on real-time collaboration and digital technology, was founded in 2009.
Business isn’t doomed during health crises, and not all pandemics lead to recessions. With critical learning from history, and the rapid advancement of technology, nimble startups and companies can navigate the current landscape to achieve success. Be sure to keep in mind now and for the future, “Those that cannot remember the past are condemned to repeat it.” – George Santayana