PressureStim is designed to be the first bioelectric blood pressure control device based in part on precisely controlled protein expressions. The company’s primary product is a wrist, ear lobe and ankle stimulator combination product but it also has developed a brain cap for use in more severe cases.
Background: The unavailability of promising treatment options with fewer side effects and
complications associated with uncontrolled high blood pressure are compelling
governments to call out to industry to find a better solution.
Individuals with hypertension are estimated to face nearly $2000 higher annual healthcare expenditure compared with their nonhypertensive peers. This trend has been relatively stable over 12 years. Healthcare costs associated with hypertension account for about $131 billion (2014). This warrants intense effort toward development of less costly and more effective hypertension prevention and management products with less side effects.
Some common side effects of high blood pressure medicines include:
Diarrhea or constipation
Dizziness or lightheadedness
Feeling tired, weak, drowsy, or a lack of energy
Nausea or vomiting
Weight loss or gain without trying
Update on Progress: PressureStim this month launched a pilot clinical study in Brazil with its latest product design. We are working with a team that previously completed on their own a successful pilot similar feasibility study. The PressureStim has completed thousands of bioelectric protein expression studies in it labs and has filed over 500 bioelectric protein expression patent claims. PressureStim via the Schuler exclusive license has issued pioneering U.S. patents dating back to 2004. PressureStim is in discussions for collaboration with independent researchers that have completed over 150 patients with successful results in bioelectric treatment of blood pressure with wrist and ankle stimulation (which we believe followed our patent claims). Our bench top stimulator produced by Mettler Electronics in Anaheim, CA has FDA 510K market clearance for improving blood circulation and other indications of use. With this same OEM ISO and cGMPG certified manufacturing team we have developed a new portable palm sized stimulator with auto sequencing of up 6 bioelectric signals and safety shut off features. We have separately sourced wrist and ankle bands that we are adapting with electrodes and micro stimulators which may be used in future product designs. We have sourced ear lobe electrodes that have already been successfully used in a number of auricular vagus nerve studies.
Expected Advantages Over Other Blood Pressure Control Products – Designed To Intended To (confirmation pending full scale controlled studies)
Combination wrist, ankle and ear lobe stimulation is expected to be superior to wrist alone.
Only known bioelectric blood pressure system with patent pending signals to improve elastic properties of peripheral vascular arteries especially the aorta.
Method combines the best learned from thousands of years of acupuncture research with the new field of bioelectric medicine.
Less side effects than blood pressure control drugs.
Substantially less costly long term than blood pressure control drugs. We claim:
Our pioneering 2005 patent claim 1…
1. A method for modulating blood pressure comprising the steps of:
a. selecting from a storage area one or more waveforms representative of waveforms generated in the body and carried by neurons in the body;
b. transmitting or conducting the selected waveforms to a treatment member in contact with the body; and
c. broadcasting the selected waveforms from the treatment member to a target zone in the body.
Implantable method to regulate blood pressure by means of coded nerve signals
Patent number: 6957106
Abstract: A method and device for modulating blood pressure. The method comprises selecting waveforms from a storage area that are representative of body organ function. The selected waveforms are then transmitted to a treatment member, which is in direct contact with the body, and which then broadcasts the waveforms to a blood pressure regulatory points within the body to modulate blood pressure. A control module is provided for transmission to the treatment member. The control module contains the waveforms which are selected and transmitted to the treatment member, and computer storage can be provided for greater storage capacity and manipulation of the waveforms.
Filed: February 18, 2004
Date of Patent: October 18, 2005
1. A method for modulating blood pressure in a body, comprising the steps of:
providing a treatment member, said treatment member being adapted to be in communication with the body;
providing a plurality of waveform signals representative of waveform signals generated in the body and carried by neurons in the body, said plurality of waveform signals including first waveform signals operative in the control of blood pressure, said plurality of waveform signals being stored in a storage medium;
selecting from said storage medium said first waveform signals;
transmitting said first waveform to said treatment member; and
broadcasting said first waveform signals from said treatment member directly to a blood pressure regulatory point in the body.
Executive Management & Key Advisors
Howard J. Leonhardt
Executive Chairman & CEO
Has brought multiple cardiovascular products to leadership since 1986.
Dr. Leslie Miller
Chief Medical Officer
*241 peer reviewed publications, 80+ clinical trials, former Chairman Cardiovascular Medicine U of Minnesota for over a decade.
Chief Financial Advisor
33 years MedTech experience
Chief FDA Regulatory Compliance Advisor
Over 20 years FDA Examiner device section.
Dr. Jorge Genovese
VP Bioelectric Research
25 years experience
Alex Richardson Chief
Technology Officer, Vice President Engineering & Product Development
Over 30 years experience developing medical devices many serving Alfred Mann Cos.
VP Strategic Alliances
30 years experience
Dr. Brett Burton
Vice President R&D
*PhD. Bioengineering, 7 years experience.
Director of Marketing
Over 12 years experience
Dr. Cristiane Carboni
Research Coordinator Brazil
Marketing Consultant & Technical Writer
25 years experience
$10 billion +
Nearest Valuation Comparable – Competition and Comments
Pressao Irvine, CA
New patent pending…
1. A method of using a bioelectric stimulator to control blood pressure in a subject, wherein the bioelectric stimulator comprises: a power source and means for delivering an electrical signal to a subject’s tissue, wherein the bioelectric stimulator utilizes the electrical signal to precisely control protein expression in the tissue on demand to control blood pressure in a subject, the method comprising:
physically associating the bioelectric stimulator with the subject; and
delivering selected bioelectric signals to the subject’s tissue from the bioelectric stimulator so as to control the release and/or expression of proteins, wherein the proteins comprise stromal cell-derived factor 1 (“SDF1”), vascular endothelial growth factor (“VEGF”), insulin-like growth factor 1 (“IGF1”), platelet-derived growth factor (“PDGF”), tropoelastin, and hepatocyte growth factor (“HGF”).
6. A method of controlling blood pressure in a subject, the method comprising:
delivering selected bioelectric signals to the subject’s tissue so as to enhance the release and/or expression of proteins, wherein the proteins comprise stromal cell-derived factor 1 (“SDF1”), vascular endothelial growth factor (“VEGF”), insulin-like growth factor 1 (“IGF1”), platelet-derived growth factor (“PDGF”), tropoelastin, and hepatocyte growth factor (“HGF”).
- Completed lab pre-clinical bioelectric protein expression studies.
- Tested a variety of electrodes and electro acupunctures needles.
- Sourced ear lob electrodes.
- Developed portable palm size stimulator with 6 auto bioelectrical sequences and safety shut off.
- Developed PressureStim web site.
- Exclusive license to pioneering the Schuler bioelectric blood pressure control patent estate dating back to 2004.
- Filed additional new patents claims for bioelectric protein expression based blood pressure control.
- Met with independent research team in California that has completed 150 patients with success and working to conclude a research and commercialization collaboration. PressureStim believes this team followed our patent claims in their work.
- Launched pilot clinical study in Brazil.
Expected Upcoming Milestones
- Completion of pilot clinical study in Brazil.
- Potential completion of collaboration agreement which IF successful would add 150 successful patients to our clinical study total and additional IP on electrode placement positions.
- Updated enhanced web site.
- Completion of Executive Summary.
- Completion of animation video.
- Completion of slide decks for scientists and investors.
Market Size Sources:
Hypertension https://www.grandviewresearch.com/press-release/global-pulmonary-arterial-hypertension-pah-market-size-report + https://www.prnewswire.com/news-releases/the-global-pulmonary-arterial-hypertension-market-size-is-expected-to-reach-usd-9-3-billion-by-2026–300858633.html.
Overall hypertension cost to healthcare $131 billion 2014 – https://www.ahajournals.org/doi/10.1161/JAHA.118.008731
Electrical stimulation for blood pressure device market – https://www.marketwatch.com/press-release/electrical-stimulation-blood-pressure-treatment-devices-market-is-expected-to-register-the-highest-cagr-according-to-market-forecasts-to-2026-2019-12-10?mod=mw_quote_news
(1) Interferential electrical stimulation improves peripheral vasodilatation in healthy individuals http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1413-35552013000300281
(2) Non-invasive Vagus Nerve Stimulation Acutely Improves Blood Pressure Control in a Placebo Controlled Study https://www.fasebj.org/doi/abs/10.1096/fasebj.31.1_supplement.848.8
(3) Long-Lasting Reduction of Blood Pressure by Electroacupuncture in Patients with Hypertension: Randomized Controlled Trial https://www.ncbi.nlm.nih.gov/pubmed/26392838
(4) Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial https://www.ncbi.nlm.nih.gov/pubmed/27026087
One or more of these blood pressure medicines are often used to treat high blood pressure:
- Diuretics are also called water pills. They help your kidneys remove some salt (sodium) from your body. As a result, your blood vessels do not have to hold as much fluid and your blood pressure goes down.
- Beta-blockers make the heart beat at a slower rate and with less force.
- Angiotensin-converting enzyme inhibitors (also called ACE inhibitors) relax your blood vessels, which lowers your blood pressure.
- Angiotensin II receptor blockers (also called ARBs) work in about the same way as angiotensin-converting enzyme inhibitors.
- Calcium channel blockers relax blood vessels by reducing calcium entering cells.
An investment in PressureStim LTP and its parent accelerator Cal-X Stars Business Accelerator, Inc. DBA Leonhardt’s Launchpads must be considered to be a very high-risk investment. PressureStim LTP is a development stage innovation in formative stages as startup within the Cal-X Stars Business Accelerator, Inc. DBA Leonhardt’s Launchpads innovation and startup launch accelerator and currently has no FDA approved products in its portfolio. Early indications of efficacy from pre-clinical studies and early clinical feasibility studies may not necessarily translate into positive long term clinical results or financial success. Second Heart Assist, Inc. may be unable to obtain sufficient capital to fund planned development programs. There are substantial high regulatory risks associated with the development of these device and Second Heart Assist, Inc. may not receive FDA approval for its two product candidates despite significant time and financial investments. Regulatory approval to market and sell a medical device does not guarantee that the device will penetrate the market, and sales may not meet expectations. Patents issued, licensed, optioned or pending may not be maintained or may be found to be invalid due to prior art. The company may be found to be infringing patents of others. The company is highly dependent on outside suppliers, which are not under control of the company, which may not meet timelines or other needed requirements for product development or regulatory compliance. The company in general is under staffed and under funded compared to historical data on other companies developing similar products. This may result in substantial delays or failures in the development cycle.