June - 2021

The HSB Blog

7 min

Untangling the Intricate World of Digital Health Regulation-The HSB Blog 6/28/21

Our Take: The current regulatory landscape for digital health tools is complex and doesn’t lend itself to easily determining where digital health tools belong or how they should be regulated. As a result it is not clear how to design these tools within regulatory guidelines and what process they should or may need to follow for approval. This can risk the health and safety of patients as well as slow the pace of development of innovative products to market. Furthermore, it ri

4 min

Scouting Report-Cleerly: Applying AI for Early Detection and Treatment of Coronary Disease

The Driver: New York-based Cleerly secured $43 million in series B funding providing a cutting-edge digital health platform with machine learning capabilities for early detection and treatment of coronary disease and heart attacks. The Series B funding was led by Vensana Capital, with additional backing from LRVHealth, New Leaf Venture Partners, DigiTx Partners, the American College of Cardiology, and Cigna Ventures. Founded in 2017 by Dr. James K. Min, a cardiologist and dir

5 min

How Can Healthtechs Navigate the FDA and CMS Regulatory Maze?-The HSB Blog 6/21/21

Healthtech companies have to navigate a complex regulatory process to bring products to market and it’s important they understand the role of different agencies and what they look for. Perhaps the two most important aspects that companies have to deal with are regulatory approval and financial reimbursement which fall under the purview of the Food and Drug Administration and the Center for Medicare and Medicaid Services (CMS). Navigating the regulatory process should be manag

4 min

Scouting Report-Sempre Health: Incentivizing Prescription Adherence with Dynamic Pricing

The Driver: On June 15th, San Francisco based startup Sempre Health announced that it had raised $15M in a Series B round led by Blue Venture Fund with UPMC Enterprises, Rethink Impact, and LifeForce Capital and Industry Ventures joining the round. Founded in 2015, the company offers behavioral-based discounts on drug copays. The company currently offers discounts on drugs for diabetes, cardiovascular and respiratory conditions. The company plans for use the proceeds to attem

8 min

Healthcare Startups: Common Mistakes and Lessons Learned-The HSB Blog 6/14/21

Our Take: Telehealth usage is increasing at a rapid pace as are the number of startups who are commercializing the use of telemedicine and digital healthcare tools. There are common mistakes that these startups can avoid as they begin to operationalize these tools. Some of the most common mistakes pointed out by Forbes and our recent presentation in collaboration with Georgia Bio include lack of diverse leadership teams, improper networking, unfocused go-to-market plans, and

4 min

Scouting Report-NUE Life Health: Taking Ketamine from Party Drug to Effective Depression Treatment

The Driver: NUE Life Health, a telemental wellness platform, raised $3.3 M in funding from investors including Jack Abraham, Shervin Pishevar, Martin Varsavsky, Jon Oringer, James Bailey, and Christina Getty. Founded in Miami, NUE Life uses the oral form of ketamine, Esketamine which was approved by the FDA in March and is given as a nasal spray. NUE Life has operations in California, Texas, and Florida and aims to expand its services with the new funding. The Takeaways: Alth

5 min

Biden’s Plan to End Cancer Won’t Succeed Without Social Infrastructure-The HSB Blog 6/7/21

Our Take: Though President Biden’s proposed new biomedical research agency (Advanced Research Projects Agency for Health or ARPA-H, modeled on DARPA (which is credited with creating the internet) can provide “cutting edge solutions” unless healthcare’s underlying social infrastructure issues are addressed first, the initiative will not succeed. While President Biden has proposed this initiative to potentially eradicate major diseases such as cancer, Alzheimer’s disease, and

4 min

Scouting Report-Clearing: Addressing Non-Addictive Pain Management

The Driver: Clearing is developing a digital healthcare platform for chronic pain sufferers looking for non-opioid pain relief. According to Crunchbase News the New-York based company recently raised $20 million in a seed round led by Bessemer Venture Partners and Founders Fund with additional backing by Flatiron Health, Curology, Hims & Hers, Seamless, Grubhub, and Forward Health. With the funding, Clearing plans to address the chronic pain market’s shortage of pain speciali