PressureStim Receives IRB Approval to Launch Bioelectric Hypertension Treatment Clinical Study
United States, California, Irvine - 12/21/2020 — Irvine, California and Porto Alegre, Brazil – PressureStim LTP, a privately held medical device startup within the Leonhardt's Launchpads innovation accelerator, focused on innovative bioelectric device-based solutions for treating high blood pressure (hypertension) today announced Ethics Committee (IRB) Approval from the Santa Casa Catholic Hospital in Porto Alegre, Brazil to begin enrolling the first patients in a controlled pilot clinical trial. The PressureStim I study is designed to establish the safety and efficacy of a novel bioelectric stimulation system for the treatment of hypertension. The specific stimulation protocol is designed to elevate the level of circulating Klotho in a patient’s bloodstream, as well as having a number of other potential therapeutic benefits. The PressureStim device is targeted in development to be a potential treatment most useful for drug-resistant hypertension, where patient options are diminished. The stimulator and electrodes to be used in the study already have FDA 510K and CE Mark clearance for improving peripheral blood circulation, one the known primary pillars for reducing high blood pressure.
Over 100 million people in the U.S., 58 million in Brazil, and over 1.1 billion people worldwide have hypertension, which is recognized as the most important single risk factor for cardiovascular morbidity and death. Existing pharmacological interventions are effective for some, but more than half of those treated with antihypertensive medications continue to have uncontrolled high blood pressure.
"We are optimistic that device-based treatments involving bioelectric stimulation to induce protein expression, such as the PressureStim device system, may be able to provide effective solutions for patients who have not benefited from drug-based treatments," stated in a joint statement Dr. Leslie Miller, Chief Medical Officer of PressureStim LTP and Dr. Rodrigo Plentz Principal Investigator for the study at the Santa Casa Hospital https://www.researchgate.net/profile/Rodrigo_Della_Mea_Plentz. “In my opinion, this may be the most intriguing new device being studied in the field of hypertension.” Dr. Miller further stated.
"Uncontrolled blood pressure is a serious condition which can lead to heart attack, stroke, heart failure, cognitive function decline, or death if not adequately treated. For some patients, medication and lifestyle changes do not sufficiently lower blood pressure to safe levels. Many patients have significant side effects from blood pressure medications including fatigue. Using properly controlled studies, we hope we can show that the PressureStim bioelectric stimulation technology can be at least equally effective as drug treatment with fewer side effects" stated Howard J. Leonhardt, lead inventor of the product and Executive Chairman and CEO of PressureStim LTP
“We are thrilled to offer patients the opportunity to participate in this new trial because the device combines the benefits demonstrated in previous electrical stimulation studies for treating high blood pressure, such as our own previous studies, with the unique new feature of circulating Klotho supplementation via bioelectric stimulation. Both of these have been shown in separate stand-alone studies to bring about a significant decrease in blood pressure." said Dr. Joci Schardong co-investigator on the study and rehabilitation specialist the Santa Casa Hospital in Porto Alegre, Brazil.
In other clinical studies for other applications of use the collaborative Leonhardt-Brazil research team has demonstrated a > 168% increase in circulating Klotho levels @ 12 weeks in patients with only approximately 35 minutes of stimulation 2X a week.
The research team in Brazil previously completed independently clinical evaluations with electrical stimulation technology for lowering blood pressure with some success but without these particular new patented and patent pending Leonhardt signaling sequences.
The Leonhardt's Launchpads core team has been working for over 33 years on therapies for helping heart failure patients recover. They believe there is likely a strong connection between myocardial ischemia and cardiac arrhythmia events in heart failure patients and hypertension. This is provoked by stress and the PressureStim treatment may potentially decrease the risk of these cardiac problems. It has been posited that arrhythmias and ischemia relate to an imbalance between the supply and demand of myocardial oxygen. This imbalance appears to be tied to increased autonomic nervous system sympathetic activity. Bioelectric stimulation is intended to inhibit the sympathetic nervous system, decrease blood pressure and, in turn, reduce the oxygen demand.
"The true 'holy grail' of hypertension management lies in a therapy that is both cost-effective and lacks the side effects and developed resistance associated with drug treatment. We believe this PressureStim treatment has the potential to be that answer." stated Dr. Jorge Genovese Vice President of Bioelectric Regeneration Research at Leonhardt's Launchpads in Irvine, California.
Persistent hypertension has been linked to hardening of arteries, aortic aneurysms, heart attacks and heart failure, brain damage including cognitive function decline, stroke, dementia, kidney failure, vision loss, sexual dysfunction and other ailments.
Reference Link: Klotho Supplementation Reduces Blood Pressure Pre-Clinical Study https://pubmed.ncbi.nlm.nih.gov/30251773/
About PressureStim:
PressureStim LTP is an early-stage startup innovation being developed within the Leonhardt's Launchpads by Cal-X Stars Business Accelerator, Inc. in Irvine, California. The technology is based on bioelectric stimulation-controlled protein expressions including promoting and increase of circulating klotho levels. See www.pressurestim.com for more information.
About Leonhardt's Launchpads:
Leonhardt's Launchpads by Cal-X Stars Business Accelerator, Inc. is the organ regeneration focused innovation accelerator arm of Leonhardt Ventures LLC founded in 1982 (formerly HJ Leonhardt & Co.) Leonhardt's Launchpads has research support branches in Utah, Pittsburgh, Santa Rosa, CA, Minneapolis, The Netherlands, Australia and Brazil. Leonhardt's Launchpads Brazil is fully supporting the launch and implementation of this study mentioned in this press release as well as a number of other bioelectric stimulation related studies in Brazil. See www.leonhardtventures.com for more information.
CAUTION: Investigational Device: The PressureStim device for treating hypertension is limited worldwide including the United States to investigational use only for this indication of use.
Warning: PressureStim is an early-stage development not yet proven to be either safe or effective for treating hypertension. Any patents or patents pending mentioned may not be issued or maintained. Any timelines mentioned may vary even by many years or decades. Company lacks sufficient resources in all categories at this time to bring this product to market.
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Media Contacts:
Company Name: PressureStim LTPFull Name: Howard J. Leonhardt
Phone: 424 291-2133
Email Address: Send Email
Website: www.pressurestim.com