Study Designed to Further Confirm Safety, Efficacy and Patient Benefit of BladderCell Non-Invasive Bioelectric Stimulation Treatment for Bladder Dysfunction Incontinence
Porto Alegre, Brazil and Irvine, California, October 23rd, 2020 (PR Distribution) — BladderCell, an emerging leader in the development of technologies for treating bladder dysfunction, today announced it is launching a new clinical study on the heels of its previous positive pilot early feasibility study shared earlier this year https://publishedpr.com/news/bladdercell-completes-landmark-first-in-human-clinical-study-2.html
“The BladderCell non-invasive therapy showed promising results in both safety and efficacy in our previous pilot study, this new study adds pelvic stimulation intended to reinforce and further improve treatment in patients with bladder dysfunction” said Dr. Alexandre Fornari, Principal Investigator for the study and Urologist at Moinhos de Vento hospital, Porto Alegre, Brazil. “We hope the results of the study will lead to larger scale studies to properly prove out this potential therapy designed to help patients suffering from incontinence.” further states Dr. Leslie Miller, Chief Medical Officer
Study Name: Bioelectric Stimulation for treatment of Bladder Incontinence
Study Sponsor: BladderCell, a subsidiary of Leonhardt Ventures, LLC
Principle Investigator: Cristiane Carboni, MSC, PhD, Director Pelvic Floor World Clinic
Number of Study Sites: 1-3
Study Locations: Pelvic Floor Dysfunction Clinic, Porte Allegre, Brazil
Study Design: Prospective, Randomized, 2 Arm, Open Label, Pilot Trial
Number of Subjects: 30
Number of Treatment Arms: 2
Duration of Each Treatment: 30 minutes
Frequency of Treatments: 2 x’s/week for two months
Number of Treatments: 16
Stimulator to be Used: CE Mark and FDA 510K market cleared BladderCell Mettler model 240 manufactured in Anaheim, California (cleared for improving blood circulation, pain relief, improvement of muscle motion, muscle recovery)
The present study aims to evaluate the benefit of BES at two different nerve stimulation locations on the improving bladder function and LTUS and frequency of incontinence using questionaires and clinical patient assessment as study end points.
“By initiating these studies, BladderCell moves to a higher stage of development our patented and patent pending bioelectric and biologics therapies for bladder recovery,” said Howard J. Leonhardt, Executive Chairman and CEO and primary inventor of the device along with Dr. Jorge Genovese. “Our team published our first biologics therapy study in 1989 and our first bioelectric therapy study in 1999 more than 31 years ago, and the BladderCell product development is the culmination of an unparalleled amount of research involving over 300 researchers over many years. We believe we are developing what will be the new gold standard in bladder treatment via bioelectric controlled regenerative protein expressions and biologics that address nerve (includes neuro-bladder communication regeneration), muscle, blood flow and elasticity regeneration. We believe our BladderCell technology is set apart from all other bladder dysfunction treatment devices and methods by addressing ALL the underlying causes (muscle, nerve, elasticity, blood flow, neuro connections) via a comprehensive regeneration platform.”
The study will conducted in Porto Alegre, Brazil led by Dr. Cristiane Carboni and Urologist Dr. Alexandre Fornari, Moinhos de Vento hospital
Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 87 million adults in the United States and Europe. The BladderCell bioelectric therapy is the first treatment to address bladder regeneration via stem cell homing, angiogenesis, muscle and nerve regeneration controlled protein expressions. Electrical stimulation in general has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for bioelectric bladder treatment is well established in the United States and is a covered service in Europe, Canada, and Australia. Many sufferers limit their lives socially, professionally, and personally; however, as many as 45% who suffer from symptoms do not seek treatment.
BladderCell, based in Irvine, California is focused on the development of (1) non-invasive and (2) implantable bioelectric stimulation devices including added repeat deliveries of biologics for treating the most severe advanced cases.
BladderCell has series of three products in development that are intended to be applied to patients based on the severity of their bladder dysfunction:
- BladderCell is a non-invasive bioelectric stimulation only system for mild to moderate bladder dysfunction.
- BladderCell Plus Lite Biologics is bioelectric + PRF and regenerative fluid therapy for moderate to severe patients.
- BladderCell Plus Full Biologics utilizes patented bioelectric stimulation via an implantable micro stimulator, our BC-15 multi-component composition and a re-fillable under skin implantable micro infusion pump intended for use in treating advanced very severe bladder dysfunction. The slow infusion micro pump is intended to re-filled daily with 2mls of the BC-15 bladder regeneration composition.
Bioelectric stimulators in development intended to deliver our patented signals to the target organ include bench top, palm size portable and implantable micro stimulator models. The bench top stimulator was utilized in this pilot feasibility study.
The core BladderCell technology platform and IP is based on precise bioelectric signaling sequences for stem cell homing via controlled expression of SDF1 and PDGF, new blood vessel growth via a full suite of angiogenic signals, muscle and elasticity regeneration via klotho, COL17A1, tropoelastin, LIM muscle and follistatin and nerve regeneration via IGF1, LIM muscle and sonic hedgehog. For treating highly severe cases we intend to include an implantable and re-fillable micro infusion pump re-filled daily with our proprietary BC-15 multi-component bladder regeneration mixed composition that may be comprised of any or all of these components in combination – hypoxia treated and klotho expressing genetically modified MSC stem cells, adipose tissue derived stromal fraction, endothelial progenitor cells, immature myoblasts, selected proteins and growth factors, selected exosomes, bioelecrically pre-treated PRF, amniotic fluid, nutrient hydrogel, selected alkaloids, Wharton’s Jelly, micro RNA gel, DNA methyltransferase 1 (Dnmt1) elastomers and bladder matrix.
BladderCell has over a 100 related patent claims https://patents.justia.com/inventor/howard-j-leonhardt issued and pending covering its one-of-a-kind technology platform. BladderCell research team members filed the first of our series of bioelectric urinary regulation patents in 2004 – https://patents.justia.com/patent/20050113879 and since then we have implemented numerous improvements with new patents issued August 13th, 2013 https://bladdercell.com/wp-content/uploads/2019/09/pat8509887_Schuler.pdf and May 12th, 2020 https://patents.justia.com/patent/10646644
The devices used in this study manufactured in Anaheim, California have FDA 510K https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113017.pdf market clearance for improving blood circulation, pain relief and muscle related healing including improvement of muscle motion and inflammation management. The specific microcurrent signaling programming for these studies falls within the cleared parameters for this device. Based on only the results of this small pilot study we are NOT making any claims that safety of efficacy has been proven for bladder dysfunction recovery at this time. New larger scale studies are forthcoming.
BladderCell is collaborating with a number of researchers that have completed independent electrical stimulation bladder recovery studies to improve our knowledge of how best to implement improvements forward. The product pipeline is still considered to be in development stage. If including these independent studies there is data available on over 150 patients to date.
BladderCell LTP http://www.bladdercell.comis a Licensable Technology Platform with the Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. innovation and startup launch accelerator headquartered in Irvine, California with subsidiary branches in Petaluma/Santa Rosa, Utah, Brazil, Pittsburgh, The Netherlands, Minneapolis and Australia. The BladderCell core research team began stem cell based biologics and bioelectrics research for organ regeneration and healing in the late 1980’s. In 2000 the team began filing the first of a long series of patents for both bioelectric and biologics based organ regeneration and healing. In 2001 the team treated their first organ regeneration clinical patient with muscle stem cells derived from skeletal muscle. The first bladder and urinary regulation specific patent claims were filed in 2004 and over 100 related patent claims since have been filed with improvements to the original bladder regeneration and urinary regulation technology platform. The BladderCell and innovation accelerator business model is to seek out a strategic partner for commercialization after first in human studies have been completed and patents have been issued. B-Alive www.b-alivestim.com is a subsidiary of BladderCell founded by women and managed by women to apply, tailor, modify , customize, distribute and market BladderCell inventions and products to the unique needs of women.
About Leonhardt’s Launchpads:
Leonhardt’s Launchpads http://www.leonhardtventures.com is the organ regeneration focused innovation and startup launch accelerator arm of Leonhardt Ventures LLC based in Corona Del Mar, California. The Leonhardt team has been developing medtech and biotech inventions and products since the mid 1980s. The innovation accelerator has over 600 patents claims issued, pending, optioned or exclusively licensed covering bioelectric and biologics based organ regeneration and healing including over 100 patent claims related to bladder regeneration directly or indirectly – https://patents.justia.com/inventor/howard-j-leonhardt
Warning and Disclaimers: Product(s) are not yet proven safe or effective. Patents pending may not be issued. Patents licensed or optioned may not be maintained. Patents issued may be invalidated or may not be maintained. Products are in early stage development. Forward looking statements may change without notice. As an investment these startups mentioned are in the highest risk category for total loss and only suitable for sophisticated experienced accredited investors. The company does not have on hand sufficient resources to bring these products through clinical studies and certainly not enough resources to bring them fully to market, and may not obtain these resources. The company is underinsured compared to comparable companies on our sector. The company is under staffed and under funded compared to most other participants in this space. Due to a small staff at the accelerator to maintain all web sites and other published materials across over 30 innovation developments they may not be fully up to date and there may be out date inaccurate information. If you have any questions on our products or our company please write us to ask.
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