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Innovations that improve & extend patients’ lives

"The technology being developed at Pulse has the potential to quickly, safely, painlessly and effectively remove skin lesions, including cancers, for both clinical and cosmetic purposes. It is tremendously exciting. We will be hugely proud to bring it to the public."

Bob Duggan

Overview

Pulse Biosciences is a bioelectric medicine company, developing innovations that improve and extend patients’ lives. Pulse’s groundbreaking Nano-Pulse Stimulation (NPS) technology is used to treat a variety of conditions that currently have no established optimal solution. The first planned commercial product, the CellFX System, uses NPS technology to address a range of dermatologic conditions.

NPS technology is based on nanosecond pulses of high-amplitude electrical energy that non-thermally clear targeted cells while sparing adjacent non-cellular tissue. It is a precise, drug‐free tissue treatment that directly affects cell membranes and intracellular structures to stimulate unique behavior in the cells. It initiates a regulated cell death process with minimal inflammatory response, thus improving healing outcomes. It supports the replacement of treated tissue cells with healthy tissue cells.

In cancerous lesions, NPS has been shown to induce immunogenic cell death (ICD), exposing the antigens of the treated cells to the immune system. A result is the generation of cytotoxic T cells and the mounting of an adaptive immune response targeted against those cells.

Pulse Biosciences is investigating a variety of applications for its technology, including immuno‐oncology, dermatology, and veterinary medicine.

Technology

Nano-Pulse Stimulation (NPS™) is a proprietary technology that delivers nanosecond pulses of high-amplitude electrical energy to non-thermally clear targeted cells while sparing adjacent non-cellular tissue.

These ultrafast electrical energy pulses have pulse durations from billionths up to a millionth of a second.

When applied to the targeted tissue, NPS energy pulses enter cells and alter the function of the internal cellular organelles, including the mitochondria and endoplasmic reticulum, without disrupting extracellular tissue. This leads to regulated cell death (RCD), a process exhibited by cells in the human body when they undergo stress and are unable to restore cellular homeostasis.

The CellFX System delivers pulses that directly affect the internal organelles of targeted cells but have no functional effect on non-cellular tissue, such as collagen (a proteinaceous tissue that forms the structural foundation of the skin). In short, it delivers a unique cell-focused effect to the internal structures of treated cells while preserving surrounding non-cellular tissue. This combination may lead to highly differentiated treatment applications.

The CellFX™ System is planned as a commercial product using NPS technology to create a non-toxic and non-thermal biophysical disruption of targeted cells, using tunable speed and amplitude of NPS pulses.

“Along with a team of qualified scientists, we have studied Pulse Biosciences’ core technology, the strength of leadership and management, patent portfolio, breadth of engineering and research talent, as well as our perceived long‐term sense of the robust potential of NPS technology in healthcare. We are impressed by what we have seen and with the experience, ability, and enthusiasm of the Pulse Biosciences team. We have previously worked closely with several members of the Pulse Biosciences management team, including Darrin Uecker, President, and CEO, and Dave Danitz and Edison Manuel, engineering and operations executives. Each of them were critical to our previous success at Computer Motion, Inc. (now part of Intuitive Surgical, Inc.) in launching computer-assisted robotics in the field of human surgery. We look forward to working with the Pulse Biosciences team on this important technology that we believe can impact healthcare in a meaningful and sustainable manner for the significant betterment of all,” Mr. Duggan and Dr. Zanganeh in a joint statement.

Key Dates

Presentation of clinical studies data to clear skin lesions at ASDS annual meeting

17 Oct 2019

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Promising non-thermal treatment for skin conditions

18 Sep 2019

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Pulse Biosciences CellFX™ system to be given podium presentation at major Aesthetic Procedures conference

06 Aug 2019

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Publication of dose-response study using PulseX system

02 Aug 2019

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Research program explores energy for lesion treatment

14 May 2019

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Presentations announced at 2019 American Society for Laser Medicine and Surgery annual conference

26 Mar 2019

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510(K) for CellFX™ submitted to FDA

28 Jan 2019

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Positive clinical results of Nano-Pulse Stimulation to treat patients with Sebaceous Hyperplasia Lesions on the face

07 Jan 2019

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Continued expansion of its clinical study programs in dermatology

11 Oct 2018

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Treats initial patient in its human study evaluating the effects of Nano-Pulse Stimulation in Basal Cell Carcinoma

30 Jul 2018

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ODU researchers are using electric pulses to kill cancer cells. And they say it’s working.

27 Jun 2018

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Positive results from its first study evaluating a clinical target at major scientific meeting

12 Apr 2018

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Bob Duggan has been appointed Chairman of the Board; Ken Clark, Dr. Thomas Fogarty and Manmeet S. Soni have been appointed as independent directors

02 Nov 2017

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Pulse Biosciences announces $30 million private placement

23 Sep 2017

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Withdrawal and resubmission of 510(K) application for PulseTx™ System

11 Sep 2017

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Treatment of first patient in study to evaluate Novel Nano-Pulse Stimulation for Seborrheic Keratosis Lesions

06 Jun 2017

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Pulse Biosciences submits 510(K)Application to FDA for PULSEX™ system

14 Mar 2017

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Bob Duggan and Dr. Maky Zanganeh acquire combined interest of 17.1% of Pulse Biosciences

09 Feb 2017

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Media

Emerging technology: a look at nano-pulse stimulation

19 Aug 2020

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Nano-pulse stimulation technology produces favorable results in several clinical studies presented at the 2020 ASLMS virtual annual conference

09 Jul 2020

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Pulse Biosciences, Inc.’s nano-pulse stimulation technology produces favorable results for warts and all

07 Jul 2020

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High amplitude electromagnetic fields: a new player in dermatology

06 Jul 2020

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New device treats nonmelanoma skin cancer

04 Jun 2020

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Pulse plans to seek $30m from investors

07 Apr 2020

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Decrease in the number of active acne lesions on the back 3 months after a single nano-pulse stimulation treatment —Mark S. Nestor, MD, PhD

25 Oct 2019

Go to link

This first human study of the treatment describes the use of nanosecond pulsed electric fields (nsPEF) on the skin

18 Sep 2019

Go to link

Nano-pulse stimulation represents novel technology for delivering cellular specific therapy that is being investigated for its potential to treat both benign and malignant dermatological lesions

14 May 2019

Go to link

"This is an incredibly exciting technology...There’s a whole world, both cosmetic and clinical, including skin cancer that’s going to be looked at continually as we go forward."

Mark S. Nestor

MD, PhD

Key Dates

Presentation of clinical studies data to clear skin lesions at ASDS annual meeting

17 Oct 2019

Promising non-thermal treatment for skin conditions

18 Sep 2019

Pulse Biosciences CellFX™ system to be given podium presentation at major Aesthetic Procedures conference

06 Aug 2019

Publication of dose-response study using PulseX system

02 Aug 2019

Research program explores energy for lesion treatment

14 May 2019

Presentations announced at 2019 American Society for Laser Medicine and Surgery annual conference

26 Mar 2019

510(K) for CellFX™ submitted to FDA

28 Jan 2019

Positive clinical results of Nano-Pulse Stimulation to treat patients with Sebaceous Hyperplasia Lesions on the face

07 Jan 2019

Continued expansion of its clinical study programs in dermatology

11 Oct 2018

Treats initial patient in its human study evaluating the effects of Nano-Pulse Stimulation in Basal Cell Carcinoma

30 Jul 2018

ODU researchers are using electric pulses to kill cancer cells. And they say it’s working.

27 Jun 2018

Positive results from its first study evaluating a clinical target at major scientific meeting

12 Apr 2018

Bob Duggan has been appointed Chairman of the Board; Ken Clark, Dr. Thomas Fogarty and Manmeet S. Soni have been appointed as independent directors

02 Nov 2017

Pulse Biosciences announces $30 million private placement

23 Sep 2017

Withdrawal and resubmission of 510(K) application for PulseTx™ System

11 Sep 2017

Treatment of first patient in study to evaluate Novel Nano-Pulse Stimulation for Seborrheic Keratosis Lesions

06 Jun 2017

Pulse Biosciences submits 510(K)Application to FDA for PULSEX™ system

14 Mar 2017

Bob Duggan and Dr. Maky Zanganeh acquire combined interest of 17.1% of Pulse Biosciences

09 Feb 2017

Media

Emerging technology: a look at nano-pulse stimulation

19 Aug 2020

Nano-pulse stimulation technology produces favorable results in several clinical studies presented at the 2020 ASLMS virtual annual conference

09 Jul 2020

Pulse Biosciences, Inc.’s nano-pulse stimulation technology produces favorable results for warts and all

07 Jul 2020

High amplitude electromagnetic fields: a new player in dermatology

06 Jul 2020

New device treats nonmelanoma skin cancer

04 Jun 2020

Pulse plans to seek $30m from investors

07 Apr 2020

Decrease in the number of active acne lesions on the back 3 months after a single nano-pulse stimulation treatment —Mark S. Nestor, MD, PhD

25 Oct 2019

This first human study of the treatment describes the use of nanosecond pulsed electric fields (nsPEF) on the skin

18 Sep 2019

Nano-pulse stimulation represents novel technology for delivering cellular specific therapy that is being investigated for its potential to treat both benign and malignant dermatological lesions

14 May 2019