Pulse Biosciences Q4 2019 Earnings Report
Key Takeaways
Pulse Biosciences reported a net loss of $13.8 million for the fourth quarter ended December 31, 2019. The company's cash, cash equivalents, and investments totaled $25.4 million as of December 31, 2019. Operating expenses for the quarter were $13.9 million.
Nano-Pulse Stimulation™ (NPS™) technology was highlighted in three clinical study presentations demonstrating its high clearance rates of benign skin lesions.
Data was presented from a study evaluating the clinical and histologic response of NPS technology in treating challenging cases of nodular Basal Cell Carcinoma.
Enrollment was completed in the Company’s CellFX Warts Pivotal Study.
The company obtained ISO-13485:2016 Quality System Management Certification to begin preparations for international commercialization of the CellFX System.
Pulse Biosciences
Pulse Biosciences
Forward Guidance
Pulse Biosciences is focused on obtaining FDA clearance for the CellFX System in aesthetic dermatology and is generating additional data to support a new 510(k) submission.
Positive Outlook
- The company is focused on generating and providing additional data that will support a new 510(k) submission for what we believe will be a general dermatologic indication.
- Confidence in the technology continues to grow.
- FDA meeting is expected to take place in May.
- Developing innovative health products.
- The CellFX System is intended to offer customer value with a utilization-based revenue model across an expanding spectrum of clinical applications.
Challenges Ahead
- The company received a Not Substantially Equivalent Letter from the U.S. Food and Drug Administration (FDA) on its previous 510(k) submission.
- The company remains engaged with the FDA to determine the regulatory path forward for the CellFX System.
- The company recently requested a formal Q-submission meeting with FDA to discuss requirements for a new 510(k) submission.
- The CellFX System and Nano-Pulse Stimulation (NPS) technology are for investigational use only.
- The company is pursuing a rights offering seeking to raise $30 million in net proceeds.