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Pulse Biosciences Inc (NASDAQ:PLSE) Banking On FDA Approval

Written by

Jarrod Wesson

Published on

March 29, 2017

On March 14, 2017, medical technology Pulse Biosciences, Inc. (NASDAQ:PLSE) ("Pulse") submitted 510(k) to the FDA for its PulseTx™ System. The market expects that this company will make a lot of money if the product is successful, since the share price has not stopped climbing from the IPO. We also believe that if the FDA does not accept the PulseTx™ System, we will see a big correction take place in PLSE. Take a look at the chart. It's been nothing but vertical for the stock this year.

In this article, we will try to throw some light on Pulse Biosciences. We will provide you some information about the technology as well as information about what the insiders are doing. Once you read this information, it is up to you to decide.

The Technology

PulseTx™ System uses a "therapeutic tissue treatment platform based on Nano-Pulse Stimulation (NPS)". The company explained the "Nano-Pulse Stimulation" concept in the following terms:

"NPS is a non-thermal drug-free tissue treatment technology that can stimulate unique behaviors in cells by applying ultra-short nanosecond duration electrical pulses that affect the cell membrane and intracellular structures. NPS can be used for tissue removal by inducing cell death in tissue cells with minimal inflammatory response, which improves healing and supports the replacement of treated tissue cells with healthy tissue cells. In preclinical cancer studies, NPS has been shown to induce immunogenic cell death, a cell death process that destroys the treated cells and exposes the tumor cell antigens to the immune system, resulting in the generation of cytotoxic T-cells and the mounting of an adaptive immune response targeted against the tumor cells."

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I also found an explanatory video about this concept, filmed by Richard Nuccitelli, professor in the UC Davis College of Biological Sciences:

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The following is the poster that the research group of Pulse Biosciences presented to the Society of Immunotherapy of Cancer Annual Scientific Meeting in November 2016. This technology may be useful for the "treatment of tumor cell lines":

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In the following poster, the company shows that the Nano-Pulse Stimulation may be also useful for the treatment of "murine melanomas that initiates an immune response and inhibits metastasis":

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Finally, the company also presented a poster explaining "adaptive immune response to NPS":

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Past developments of the company

The company is quite young, which is something that investors need to take into account. Investing in new share issues is in most cases riskier than investing in matured companies. The IPO happened in May, 2016. The company offered 5,000,000 shares to the public at a price of just $4.00 per share. In addition to this offering, the company granted the underwriters 750,000 shares. The book runners included MDB Capital Group and Feltl and Company.

The company did not issue a lot of information in the first part of 2016 apart from the appointment of Mr. Edward Ebbers as Vice President and General Manager of its dermatology products, and Holly Hartman, Ph.D., J.D. as its Vice President, Business Development and Corporate Strategy. However, in October and November, 2016, Pulse presented new data and uses of the technology to the scientific community and it was from that time the stock commenced to climb.

The most relevant press release that we found in 2017 was the application to the FDA, which we have already mentioned, and the fact that two executives of the firm, Robert Duggan and Dr. Maky Zanganeh had acquired a large shareholder interest in the company.

Conclusion

Readers need to understand that this is a new technology and the FDA still needs to approve it. The stock returns are exceptional, but the company is in an early stage. Therefore, it is very difficult to predict what will happen in the future. PLSE is one that we are monitoring closely. We will be updating our subscribers as soon as we know more. For the latest updates on PLSE, sign up below!

Disclosure: We have no position in PLSE and have not been compensated for this article.