Sunday, March 26, 2017 6:14:06 PM
USRM Garyst Very Good DD by Hungry Hippo
I keep reminding myself just be smart
You know darn Well big Pharma Could influence the FDA to REJECT USRM drug so they can buy usrm cheap look at that media smear campaign Last week
NEW DD: USRM Treating MANY CONDITIONS & DISEASES
DISCLAIMER: THIS IS MY PERSONAL RESEARCH. DO NOT BUY OR SELL BASED ON ANYTHING POSTED IN THIS POST. I AM NOT A STOCK ADVISOR, DO YOUR OWN DD.
Hippo:
From our Research, we can affirm that the commercialization of Myocell, is most likely the most valuable benefactor for USRM as a stock. The Myocell therapy- if commercialized- could provide USRM with major revenues and a much higher valuation on this stock. It would most likely- be highly sought out by big pharmaceutical companies as they would want to have this in their portfolio. The MyoCell therapy for Congestive Heart Failure, is considered most valuable because two main reasons:
A. It requires FDA approval, which is very difficult to achieve.
B. CHF (Chronic Heart Failure) is the Leading cost of Healthcare & Death worldwide, and no other therapy currently exist available for commercial use to regenerate the heart.
But what about all of the other treatments offered by U.S. Stem Cell Inc., what are they? where did they come from?, and how can our stock benefit from these in the form of bottom line revenues?
Quote from March 15, 2017 PR:
"Working with physician partners to offer over 30 protocols to patients, U.S. Stem Cell, Inc. is increasing business opportunities by expanding its services, treatments and therapies both inside and outside the United States."
Link:
http://us-stemcell.com/wp-content/uploads/2017/03/U.S.-STEM-CELL-RELEASES-POSITIVE-2016-FINANCIAL-RESULTS.pdf
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30 Protocols? What are those?
Wait a second, didn't we just announce a plan to open 10 new Stem Cell Clinics in the United States?
HMMMMMMM.....
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Quotes about the 10 U.S. Clinics:
we are also working with General American Capital Partners (GACP) to open 10 new clinics in the U.S. called Stem Cell Centers of Excellence. We are excited to help GACP provide stem cell services to new patients in a variety of metropolitan areas over the next three years.
"GACP has contractually agreed to invest an additional Two and a half Million Dollars ($2,500,000) to open ten (10) stem cell clinics in the United States within 3 years"
Two things we should read into these quotes from CEO about the 10 Stem Cell Clinics:
1. They are "helping" GACP to provide stem cell services.
2. They will be providing stem cell services in "metropolitan ares"
So, What is the plan, with these 10 new Stem Cell Clinics ?
What types of procedures or "protocols" are currently/or will be
- taking place at now/ and at Future US Stem Cell Clinics?
What therapies require FDA approval, and what therapies do not?
- For new investors in USRM, this can be a extremely large mass of DD to metastasize, but let the hippo tell you what he knows...
FDA approval is needed only if the stem cells are injected into another patient, or manipulated by being “expanded (cultured)” – treated with human growth factor and induced to reproduce in labs before being injected.
Myocell has to be "expanded" or "cultured" -therefore it requires FDA approval.
The treatment with MyoCell® involves taking a biopsy from the patient’s leg muscle, transporting that biopsy to Bioheart’s cell manufacturing facility, expanding the number of cells from the biopsy, and inducing the cells to regress to produce precursors to muscle cells called myoblasts. These cells know that they are muscle cells, but do not know which muscle. Once those precursor cells, or myoblasts, are present, they are segregated from the muscle cells and grown until they number over 1 billion cells. The myoblasts are then transported back to the patient’s treatment centre. Some are then injected into the patient’s heart with a needle tipped injection catheter. The modified cells are injected in the same manner into the patient’s heart. The modified myoblasts are created using an adenovirus vector or a non-viral vector. The myoblasts will release increased levels of the SDF-1 protein, which stimulates angiogenesis and regeneration of tissue.
we recently learned about a few patents held by the USRM insiders which prevents other companies in the United States from replicating this process without permission. A process which is essential to creating the MYOBLAST culture in my opinion.
Method of providing a dynamic cellular cardiac support
US 20020124855 A1
ABSTRACT:
The present invention provides a method for repairing damaged myocardium. The method comprises using a combination of cellular cardiomyoplasty and electrostimulation to synchronize the contractions of the transplanted cells with the cardiac cells. The method comprises the steps of obtaining myogenic cells from a donor and implanting the myogenic cells into the damaged myocardium. Electrical stimulation can be applied to the cells in vitro during culturing of the cells, after implantation of the cells into the myocardium or both.
https://www.google.es/patents/US20020124855?dq=cellular+cardiac+support&hl=en&sa=X&ved=0ahUKEwjg0Zint_PSAhVMOyYKHVd1BEQQ6AEIGjAA
Method of enhancing myogenesis by electrical stimulation
US 7483749 B2
RESUMEN
The present invention provides a method for enhancing regeneration of the myocardium. The method comprises the steps of applying electrical stimulation to an injury site in the myocardium. The method can be used in combination with implantation of myogenic cells into the injury site. The electrical stimulation may be applied before or after the implantation.
https://www.google.es/patents/US7483749
Method for inducing angiogenesis by electrical stimulation of muscles
US 6988004 B2
ABSTRACT
The present invention comprises a method for stimulating angiogenesis. The method comprises the steps of electrically stimulating muscle below the threshold for muscle contraction.
https://www.google.es/patents/US6988004?dq=NORTHSTAR+BIOTECH+GROUP,+LLC,+MINNESOTA&hl=en&sa=X&ved=0ahUKEwicp8SDx_PSAhXGQCYKHWm-BKQQ6AEIKjAC
Bioheart Awarded Patent for Method to Repair Heart Tissue by Combination of Cell-Based Therapy and Electrostimulation
http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=188642
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So Why did Bioheart Assign these patents to Northstar Biotech Group LLC (which are showing currently assigned as of May 2016?
I have my theory:
1. Protection from product liabilities associated with the product MyoCell
2. An assignee has the right to exclude others from using the patent. Considering that Northstar Biotech Group LLC is owned by:
1. Dr. William P. Murphy ( Current Chairman of the Board of USRM )
2. Gregory Knutson ( Board member w/ unknown relationship )
3. Samuel Ahn ( former board member, investor, and last known as a Scientific Advisory Board Member for USRM )
4. Kristin Comella ( Current CSO 5% owner of Northstar )
5. Mike Tomas ( Current CEO also 5% owner of Northstar )
and... Who else... Who else is an owner of Northstar Biotech Group LLC?
Noone has been able to figure it out, and it is HIGHLY private info.
I cannot prove this, but, it is of MY OPINION ONLY: that, since the effective date of the assignment of the patents to Northstar Biotech Group LLC, was 10/10/2012
THAT during that time; it would make sense that since these patents were assigned to Northstar;
because these two men- could also possibly (Speculation only:) be owners in Northstar Biotech Group LLC.
those two men being:
1. Howard L &
2. Juan C. Chachques, M.D., Ph.D.
After all they co-invented two of those patents currently assigned to northstar, - for a total of 3 assigned to Northstar (that I could find off initial searches). Why would they just assign it to Northstar without being members of Northstar? Why would Juan C. Chachques just give away his patent?
Did you all know that Dr. Chachques was also a member of the Scientific Advisory board for USRM and may possibly still be? If anyone has a current list of the SAB please post it...
2009 – Bioheart SAB Members Dr. Juan Chachques and Dr. Jorge Genovese publish world’s first results Cardiac pre-differentiation of human mesenchymal stem cells by electrostimulation Frontiers in Bioscience 14, 2996-3002, January 1, 2009
Quite the list of esteemed colleagues on this board. I wonder what the current Advisory board consist of... A well kept secret now-a-days...
(click on "show all 100 entries" to see total amount of board members)
http://us-stemcell.com/scientific-advisory-board/
In total Leonhar*dt Ventures and Howard Leonh*ardt have directly invested in or borrowed to Bioheart, Inc. over $6 million since its founding.
"Northstar Investments & Minnesota Biomed Partners mentioned here???"
Leonhardt Increases Stake in Bioheart, Inc.
https://www.prbuzz.com/business-entrepreneur/268787-leonhardt-increases-stake-in-bioheart-inc-1.html
We also know that he is a minority shareholder as of 2016:
http://leonhardtventures.com/news/
Just my speculation, but I think Howard and the French M.D. Chachques are both members of Northstar. Thus explaining the patents being assigned.
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USRM Quote from March 15, 2017 10k Annual Report:
"We own or hold licenses or sublicenses to an intellectual property portfolio consisting of numerous patents and patent applications in the United States, and in foreign countries, for use in the field of heart muscle regeneration"
Hippo:
So. They Put some of the patents into Northstar to protect them, and then LICENSED them to USRM.
What did Bioheart receive in return for Assignment of these patents?
Answer: Royalties.
In the 2012 forbearance agreement. It was agreed upon that in return for Northstar keeping up with the maintenance of the Patents, USRM will receive royalties from any revenues generated from the Northstar Biotech Group LLC that are related to "relicensing" of these patents.
https://www.lawinsider.com/contracts/3Z0nK04wwj23OiN5PnmQ1C/bioheart-inc/1388319/2014-11-07
Coincidently around the same time the forbearance agreement was formed, was around the name time the Patents were assigned. They formed Northstar to not only help the company out through tough times with loans, but also protect the patents.
Also in 2010:
Mike Tomas took over as CEO,
and Howard became Chairman of the Scientific Advisory Board
https://business.fiu.edu/pdf/PrintJune2010/Bioheart-Announces-Mike-Tomas-Appointed-CEO.pdf
Quote from filings:
"the Company granted Northstar a perpetual license on products as described for resale, relicensing and commercialization outside the United States. In connection with the granted license, Northstar shall pay the Company a royalty of up to 8% on revenues generated.
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Law:
An assignment being a conveyance of title in a patent that is permanent and irrevocable, an assignee that fails to pay royalties does not risk the loss of rights in relation to the patent, since the assignee owns the patent unconditionally.
The failure to comply with the future royalty obligations, while actionable with the recovery of damages for non payment, does not put at risk the intellectual property rights which have been irrevocably transferred.
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So besides Bioheart getting royalties, and owning Licenses to numerous patents, some known and some unknown, what other protections does USRM have for protecting rights to MyoCell?
1. U.S. Drug Price Competition and Patent Term Restoration Act of 1984
This act provided drug innovators protections in two ways. First, a new kind of market exclusivity was introduced, by means of a new five year period of data exclusivity awarded when the FDA approves marketed of a drug that is a new chemical entity; during that period the FDA cannot approve a generic version of the drug.
This provides market exclusivity for the drug innovator outside of any patent rights.[3] The Act also allowed the life of patents covering a drug to be extended by a portion of the time the drug is under regulatory review by the FDA, ensuring innovator companies that regulatory review will not unduly consume patent life.
In most cases, patents are non-renewable. An exception exists for some pharmaceutical inventions. If pending FDA approval holds up marketing, Congress sometimes extends the expiration date of the product's patent. The extension is usually equal to the time of the delay.
Patent life determination depends on the date of filing of the application or the date of patent issuance and other factors as promulgated under the patent laws. Under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984, as amended, a patent which claims a product, use or method of manufacture covering drugs and certain other products, including biologic products, may be extended for up to five years to compensate the patent holder for a portion of the time required for research and FDA review of the product. Only one patent applicable to an approved drug or biologic product is eligible for a patent term extension. This law also establishes a period of time following approval of a drug or biologic product during which the FDA may not accept or approve applications for certain similar or identical drugs or biologic products from other sponsors unless those sponsors provide their own safety and efficacy data.
2. The Patient Protection and Affordable Care Act, or Affordable Care Act, signed into law on March 23, 2010, included a subtitle called the Biologics Price Competition and Innovation Act of 2009
, or BPCI Act, which created an abbreviated approval pathway for biological products shown to be highly similar to, or interchangeable with, an FDA-licensed reference biological product. This is conceptually similar to the established process for generic drug approval in that it attempts to minimize duplicative testing. Biosimilarity, which requires that there be no differences in conditions of use, route of administration, dosage form, and strength and there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, must be shown through analytical studies, animal studies, and at least one clinical study, absent a waiver by the Secretary.
Interchangeability requires that a product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. No biosimilar or interchangeable products have been approved under the BPCIA to date. Complexities associated with the larger and often more complex structures of biological products, as well as the process by which such products are manufactured, pose significant hurdles to implementation that are still being worked out by the FDA.
A reference biologic is granted twelve years of exclusivity from the time of first licensure of the reference product, and no application for a biosimilar can be submitted for four years from the date of licensure of the reference product. The first biologic product submitted under the abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity against other biologics submitting under the abbreviated approval pathway for the same condition for the lesser of (i) one year after first commercial marketing of the first interchangeable biosimilar, (ii) eighteen months after the first interchangeable biosimilar is approved if there is no legal challenge, (iii) 18 months after the resolution in the first interchangeable applicant’s favor of a lawsuit challenging the reference biologics’ patents, or (iv) 42 months after the first interchangeable biosimilar’s application has been approved if a lawsuit is ongoing within the 42 month period.
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We know we want the FDA to approve MYOCELL for Fast Tracking, so we can sell it at Stem Cell clinics, and around the world right?
We know Northstar Biotech Group LLC is receiving 10% of international sales right?
It also seems that Northstar is licensing patents to USRM right?
So what exactly are they intending on selling at the Clinics in the U.S., and Worldwide?
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Hippo:
So, according to what I can tell, it seems USRM has had, and still has dealings with the Ageless Regenerative Institute, back in 2012 to do multiple testing on 22 different conditions and diseases:
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Ageless Regenerative Institute granted Bioheart exclusive, worldwide rights to LipiCell adipose-derived stem cell technology to treat heart attack and heart failure
http://bciq.biocentury.com/companies/ageless_regenerative_institute_llc
The Lipi-cell agreement was canceled according to what I have read, but... there are others.
I have found others folks.. many many others... related to Kristin Comella which have most likely been collaborated with the Regenerative Institute of Mexico.
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As seen on TV: http://drsharonmcquillan.com/?utm_source=google&utm_medium=ppc&gclid=COzBzJXy89ICFYdAhgodbxcN8Q
Dr. McQuillan formed the Ageless Regenerative Institute in conjunction with a team of experts in stem cell therapies from the medical, legal, biotechnical, and manufacturing arenas. This expert team has developed an approved method and protocol for the harvesting and isolation of adipose derived stem cells for autologous reimplantation.
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Dr. McQuillan attended The Ohio State University College of Medicine where she graduated with honors and was elected to the Alpha Omega Alpha Medical Honor Society.
Ms. Comella has over ten years of cell culturing experience including building and managing the stem cell laboratory at Tulane University's Center for Gene Therapy. She also developed stem cell therapies for osteoarthritis at Osiris Therapeutics. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.
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Who is on that expert team?
1. Kristin Comella, Chief Science Officer of Bioheart, CEO of Stemlogix, Chief Scientific Officer of the Ageless Regenerative Institute
andddd.. GUESS WHO: 2. BIOHEART INC.
McQuillan’s Aventura clinic and Bioheart Inc., a stem cell center in Sunrise, are sending U.S. patients to the Tijuana institute as subjects in research projects using fat and bone marrow stem cells to fight 22 diseases — congestive heart failure, critical limb ischemia (arterial blockage in the legs), emphysemia, retinitis pigmentosa (an eye condition that can lead to blindness), liver failure, type II diabetes, erectile dysfunction, frailty syndrome, renal failure, leukemia, MS, lupus, rheumatoid arthritis, MS, Parkinson’s, Alzheimer’s, stroke, cerebral palsy, autism, osteoarthritis, hip, knee and shoulder degeneration and post mastectomy breast reconstruction.
McQuillan and Kristin Comella, Bioheart’s chief scientific officer, are board members of the Tijuana institute. The research has been going on for about two years. (Since 2011 that I can find)
Regenerative Institute of Tijuana Mexico:
http://www.regenerativemedicine.mx/index.php/portal/medical
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Hippo:
So just How credible is this research?, and is it acceptable to the FDA for evidence used in the process of commercialization use in the United States of America?
Abstract:
There are many justifiable reasons for running clinical trials across multiple countries and indeed continents, or even only in sites that are not in the sponsor's location. Some countries are able to recruit participants faster than others for varied and valid reasons. The trial could be for a rare health event, such as dengue fever or traumatic cerebral hemorrhage, and for these trials it is necessary to recruit many centers in diverse locations, each site perhaps recruiting just a few patients to avoid prolonging the duration of the trial and increasing the wait for lifesaving new interventions. It is also true that some regions of the globe are vastly more expensive than others to conduct trials. For example, a clinical trial in India can cost one-tenth of the price that it would cost in the US [5]. Since clinical trials costs are largely driven by labour, much of these savings are from lower salaries to physicians, nurses, and trial coordinators. The time and cost of developing drugs or vaccine influences the final product cost and return on investment, so the logic of reducing trial costs is clear and reasonable.
FDA Law and Guidelines:
FDA recognizes that sponsors may choose to conduct multinational clinical studies under a variety of scenarios. Multinational studies may include domestic sites conducted under an IND, foreign sites conducted under an IND, and/or foreign sites not conducted under an IND. Sponsors may decide to use the data that is obtained from non-IND foreign sites to support clinical investigations and/or marketing approval(s) in the United States. Some sponsors may even seek to rely solely on foreign clinical data as support for an IND or application for marketing approval in the U.S.
Under 21 CFR 312.120, FDA will accept a well-designed, well-conducted, non-IND foreign study as support for an IND or application for marketing approval if the study was conducted in accordance with GCP and if FDA is able to validate the data from the study through an onsite inspection, if necessary. (GCP=Good Clinical Practices)
FDA rules on Clinical trials conducted outside the US:
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf
In conjunction with both the Regenerative Medicine Institute (RMI) and Bioheart, Inc., The Ageless Regenerative Institute (ARI), is conducting patient sponsored clinical trials for many degenerative diseases using ADSCs. There are approximately 30 protocols that have been approved by the Institutional Review Board of Hospital Angeles Tijuana, a JAHCO certified, state-of-the-art, private specialties hospital providing high quality chronic disease treatments with a patient centric focus. Many of these protocols can be found at www.clinicaltrials.gov and include pulmonary, cardiac, neurodegenerative, orthopedic, ophthalmic and autoimmune diseases, etc....
Regenerative Medicine Institute of Mexico: and Good Clinical Practices
As one of the only hospitals in Mexico certified by the Secretary of Health to perform stem cell procedures, the clinic was also the first in the world to participate in the International Cellular Medicine Society (ICMS) stem cell clinic accreditation program. All treatment protocols, as well as patient informed consent and patient candidacy documentation are evaluated by the institutional review board of the ICMS.
“This accreditation process is unique,” said David Audley, executive director of ICMS. “This is the only program to bring the best global practice standards to cell based medical clinics. It is an important step for this emerging field of medicine, and a critical step for patient safety.”
As part of the accreditation process, the ICMS has investigated every aspect of the clinic’s practices, processes and protocols. Patient candidacy protocols; informed consent processes; and cell collection, processing and implantation practices have all been examined for compliance according to the ICMS Best Practice Guidelines. Additionally, all patients treated with stem cells are entered into the ICMS Treatment Registry for outcome and complication tracking.
ICMS International Cellular Medicine Society:
READ ABOUT HOW THIS ORGANIZATION HELPS CLINICAL TRIALS MEET FDA STANDARDS:
http://www.cellmedicinesociety.org/icms-guidelines/guidelines
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Ageless & Bioheart:
In terms of Institutional Review Board (IRB) clinical trials being conducted by our physician network group at our offshore facility in Mexico, early results are promising for chronic obstructive pulmonary disease (COPD), congestive heart failure and ischemic limbs.
Outcome measurements for the COPD study include safety (number and frequency of adverse events), pulmonary function tests, exercise capability (six minute walk test), and quality of life assessment. Ten patients received intravenous stem cells treatments. Thus far results demonstrate an average increase of 23 points on the St. George Respiratory Questionnaire, as well as an increase of 70 meters in the six minute walk test at three months when compared to baseline (Figures 1 and 2).
All of these results are also substantiated by positive patient testimonial and 83% statistically significant improvement in quality of life. This represents a potential new breakthrough for COPD Patients who often suffer a progressive decline in health after diagnosis.
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Hippo:
So, what research has been done? How much of it is eligible for RMAT designation?
Folks, I think you have been underestimating our gal Kristin Comella...She has experience beyond our comprehension and intimate knowledge about every single one of these:
https://clinicaltrials.gov/ct2/results?term=Ageless+Regenerative+Institute&Search=Search
This Study, was published in the Journal of Translation medicine in 2016:
Here are 3 more studies, that also list Kristin Comella as the main contact:
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Abstract:
The license Bioheart bought from the Aventura-based Ageless Regenerative Institute covers the process used to extract the adipose stem cells, ...
“The Ageless adipose stem cell technology will allow us to broaden our portfolio of product candidates for cardiac patients,” Bioheart President and CEO Mike Tomas said in a news release. “We have successfully treated patients in Mexico, and now we are ready to expand into the U.S.”
Terms of Bioheart’s deal with the Ageless Regenerative Institute were not disclosed. The medical group mostly focuses on training physicians to extract adipose stem cells for use in cosmetic surgery.
Hippo:
So it looks like they found out that there was many more uses for adipose (fat-derived) stem cells than just cardiac patients, and some may say "oh what if the license expired," or "they didn't do a new deal with ageless, then maybe they don't have access to these"
I think Kristin is well connected with Dr. McQuillian and there is most likely an agreement there for some of these, however... it doesn't matter. and let me tell you why:
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Why? Because the FDA can't regulate these adipose stem cell therapies, because they are not "cultured" or "expanded"
Abstract from Kristin Comella:
What are your views on the recent FDA draft guidances including on adipose in which the FDA suggested that SVF is a biological drug?
Comella: The FDA has recently released a draft guidance document regarding the use of human cell and tissue products used during the same surgical procedure from adipose tissue and has requested comments from the public on this guidance. Please note that guidance documents represent the FDA’s “current thinking on the scope” of the topic. “FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.”
We do not believe that the current draft guidance document will affect our ability to offer in-clinic cell therapy from fat to our patients. We understand that the FDA’s draft document has elicited much resistance from the public and highly respected organizations such as AABB Center for Cellular Therapies and The Academy of Regenerative Medicine have voiced their opposition.
https://ipscell.com/2015/04/kristin-comella/
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Hippo:
So whether or not they still maintain a license with Dr. McQuillan, doesn't matter, because as it stands, the FDA cannot stop them from selling adipose (fat derived stem cell) therapies.
But, what is a positive from McQuillan is that Bioheart partnered with them on numerous trials, and our CSO Kristin Comella, knows how to implement everyone of those procedures.
From the USRM filing:
Bioheart has successfully completed various trials using adipose stem cells. In August 2013, the Company canceled its license agreement with the Ageless Regenerative Institute for adipose derived stem cells called LipiCell.
Hippo:
Why did they cancel it? Because they don't need it? Maybe Lipicell was ineffective as a treatment? Maybe there was a better option (MyoCell obviously better)? Lipicell was for heart treatment, but what about all the other treatments: diabetes copd auto immune etc.. Comella's Paper on SVF for Ischemic Heart Failure therapy was published in the Journal of Translational Medicine long after this fact (Angel Trial)
Seems to me Bioheart just developed their own procedures based on knowledge from Comella since the FDA doesn't require "approval" for some of these adipose procedures. but I did find another license related to adipose (fat derived stem cells)
From USRM:
Bioheart has entered into a term sheet agreement with Invitrx to License their adipose derived stem cell products. Bioheart has changed its adipose derived stem cell product name to AdipoCell.
The team at Invitrx has been working with adipose derived stem cells for over 10 years and this experience can contribute to the development and commercialization of AdipoCell (Bioheart's adipose stem cell product).
"We are looking forward to expanding the Angel trial and incorporating some of the newly licensed techniques," said Mike Tomas, CEO of Bioheart , Inc.
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So USRM has their OWN adipose stem cell product. called AdipoCell: Which they have also have been able to use the Adipose/SVF procedure on patients with congestive heart failure, and THEN - they used a combination of Adipose and MyoCell, to treat a patient in Honduras...
From USRM filing:
AdipoCell
U.S. Stem Cell has successfully completed various trials using adipose stem cells. We have completed the Phase 1 Angel Trial for AdipoCell (adipose derived stem cells) in congestive heart failure patients. Five patients were enrolled and treated in the second quarter of 2013. At the twelve (12) month time point, patients demonstrated a statistically significant average improvement in ejection fraction (“EF”) by echocardiogram.
At the three (3) month time point, 100% of the patients demonstrated either improvement or stayed the same. After three (3) months, patients showed an average absolute improvement of 3 percentage points in EF. The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p=0.01) and at the 12 month follow up patients showed this same level of improvement (p=0.01).
These trials were expanded to include a total of 28 patients. The patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the akinetic myocardial scar region using a transendocardial delivery system (MyoCath®) in patients who had experienced a previous myocardial infarct. The subjects were then monitored for adverse events, ejection fraction via echocardiogram and 6-minute walk test (6MWT) over a period of 6 months.
The average EF was 29% at baseline and significantly increased to 35% at both 3 and 6 months. Patients walked an average of 349 meters at baseline and demonstrated a statistically significant improvement at 3 and 6 months’ post treatment of more than 80 meters. Overall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy.
The adipose cells have also been utilized in a phase I trial in Europe for critical limb ischemia (n=20). Patients enrolled in the trial were already on the list for amputation. The cells were directly injected into the affected limbs in an effort to prevent the amputation. Seventy-five percent of the patients were able to avoid amputation and progressed to wound healing. No adverse events or complications were reported or linked to the cell therapy.
We have also initiated several Institutional Review Board studies in 2013 using adipose derived stem cells for various indications including dry macular degeneration, degenerative disc disease (DDD), erectile dysfunction (ED) and chronic obstructive pulmonary disease (COPD). We have discontinued any studies with macular degeneration. We are continuing to see patients in the clinic for various indications including ED and COPD. We have completed a published the study of DDD.
In the DDD trial, a total of 15 patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the disc nucleus of patients with degenerative disc disease. The subjects were then monitored for adverse events, range of motion, visual analog scale (VAS), present pain intensity (PPI), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Dallas Pain Questionnaire and Short Form (SF)-12 scores over a period of 6 months. Safety events were followed for 12 months.
No severe adverse events (SAEs) were reported during a 12 month follow up period with no incidences of infection. Patients demonstrated statistically significant improvements in several parameters including flexion, pain ratings, VAS, PPI, and short form questionnaires. In addition, both ODI and BDI data was trending positive and a majority of patients reported improvements in their Dallas Pain Questionnaire scores. Overall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy.
In the second quarter of 2014, we announced the treatment of a patient in Honduras with congestive heart failure using AdipoCell and MyoCell. We believe that this was the first patient treated in the world using a combination of stem cells.
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So this is what they have listed on the clinic's website as treatments offered:
http://usstemcellclinic.com/en/neurological/
http://usstemcellclinic.com/en/autoimmune/
http://usstemcellclinic.com/en/orthopedic/
http://usstemcellclinic.com/en/degenerative/
30 different protocols, MULTIPLE DISEASES being treated, LEGALLY.
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Hippo:
What some do not understand is that Multiple clinical trials can be used to give to the FDA to help them render a decision on a specific single drug. This does not apply to some Adipocell procedures (since these are fat derived stem cells), but it does apply to MyoCell.
And we have ALOT OF DATA on MyoCell folks.
Look at all the Research Related to Myocell:
http://www.zoominfo.com/CachedPage/?archive_id=0&page_id=176407920&page_url=//www.bioheartinc.com/resources.php&page_last_updated=2010-01-07T23:57:31&firstName=Tatsuya&lastName=Shimizu
Final Data From the Bioheart Seismic Trial Suggest Safety, Efficacy of Autologous Stem-Cell Therapy for Treating Congestive Heart Failure
http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=169268
Catheter-Based intramyocardial injection of autologous skeletal myoblasts as a primary treatment of ischemic heart failure ?: Clinical experience with Six-Month Follow-Up:
http://www.sciencedirect.com/science/article/pii/S0735109703012762
MARVEL part 1 Data:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=129741828
95.7 TO 52 BIOHEART MYOCELL BEATS MESOBLAST MPCS IN SIDE BY SIDE PHASE II/III CLINICAL TRIAL PERFORMANCE IN THE PRIMARY END POINT MEASURE OF EXERCISE CAPACITY IMPROVEMENT IN HEART FAILURE PATIENTS VIA 6 MIN. WALK TESTING.
MESOBLAST, INC. IS VALUED AT OVER $2 BILLION WHICH BY COMPARATIVE PERFORMANCE MEASURE STANDARDS SHOULD VALUE BIOHEART WELL ABOVE THAT. BIOHEART IS FURTHER ALONG IN CLINICAL TRIALS THAN MESOBLAST AND HAS A DEEPER PATENT PORTFOLIO.
BIOHEART’S BOARD AND MANAGEMENT TEAM HAS BROUGHT NUMEROUS CARDIOVASCULAR RELATED PRODUCTS FROM CONCEPT TO MARKET LEADERSHIP IN THE PAST.
95.7 TO 53 BIOHEART MYOCELL BEATS CARDIO3 C-CURE CARDIAC STEM CELLS IN SIDE BY SIDE COMPARISON – 6 MIN. WALK.
95.7 TO 53 BIOHEART MYOCELL BEATS CAPRICOR CARDIAC STEM CELLS IN SIMILAR CLINICAL STUDIES – 6 MIN. WALK.
95.7 TO 10 BIOHEART MYOCELL BEAT OSIRIS/HARE ALLOGENEIC BONE MARROW DERIVED STEM CELLS IN SIMILAR CLINICAL STUDIES – 6 MIN. WALK.
BIOHEART MYOCELL (IMMATURE MYOBLASTS) ARE THE ONLY CELL TYPE KNOWN TO BE ABLE TO FORM NEW CONTRACTILE MUSCLE IN THE DEPTHS OF HEART SCAR TISSUE.
OVER 400 PATIENTS HAVE BEEN ENROLLED IN MYOBLAST CLINICAL TRIALS SINCE JUNE OF 2000.
SINCE 2000 84% OF MYOBLAST TREATED PATIENTS HAVE IMPROVED ONLY 16% HAVE WORSENED. OVER 69% OF CONTROL OR PLACEBO PATIENTS WORSENED.
BIOHEART, INC. HAS RAISED OVER $107 MILLION TO DATE SINCE 1999 THAT HAS ALLOWED THE COMPANY TO ADVANCE FURTHER IN CLINICAL TRIALS THAN ANY OTHER STEM CELL COMPANY FOCUSED ON GROWING NEW CONTRACTILE MUSCLE IN HEART SCAR TISSUE – PHASE II/III MARVEL APPROVED TO ENROLL AT UP TO 35 SITES IN THE USA.
BIOHEART BEAT IT’S PRIMARY END POINT GOAL IN THE MARVEL PHASE II/III CLINICAL STUDY BY 500%! 95.7 TO 16 IN EXERCISE CAPACITY IMPROVEMENT.
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"These data support the need for a randomized, double-blind, placebo-controlled study involving the MyoCell technology," said Prof. Serruys. "We look forward to applying our learning from this trial to the larger, more comprehensive MARVEL Trial currently underway in the U.S. and Europe."
The MARVEL Trial will further study the safety and efficacy of the minimally invasive MyoCell autologous stem-cell therapy in the treatment of congestive heart failure delivered via a MyoStar(TM) injection catheter(3), in combination with the NOGA® XP Cardiac Navigation System.
(MYOSTAR catheter and NOGA cardiac mapping technology coming from CORDIS CORPORATION (Dr. Murphy current chairman of the USRM board))
The Principal Investigator for the MARVEL Trial is Warren Sherman, MD, Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, New York.
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Hippo:
So what do we know about the trials related to MyoCell? imo. here is the status:
MARVEL: Has reached phase 3 (ongoing or finished, not sure)
MIRROR: Has reached phase 3 (but on hold supposedly)
SEISMIC: Has reached phase 3 (ongoing or finished, not sure)
European Clinical Trials site (showing Seismic as on-going):
https://www.clinicaltrialsregister.eu/ctr-search/search?query=bioheart
Marvel (This study is ongoing, but not recruiting participants):
https://clinicaltrials.gov/ct2/show/NCT00526253?term=bioheart&rank=3
It is unknown whether or not these are still ongoing, or have been completed, other than what we know from clinical trials sites, and from the SEC filings which imo. shows a lot of out of date material. These would seem to have all reached phase 3 according to what I have found. But that doesn't matter because:
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U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation.
BUT. NOW. That the 21st Century Cures act is in place... We won't need to complete these phase 3 trials if we are accepted for Fast Track Designation of MyoCell:
On regulatory news, following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation. Thanks to the REGROW component of the Cures Act, The FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. We believe that our MyoCell® product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL Phase II/III trial. If RAT designation is granted, this could expedite the approval process with the FDA. More information on the FDA’s new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
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Hippo:
So what treatments are we going to be offering at U.S. Stem Cell Clinics?
Products
1. MyoCell
2. MyoCell (also with SDF-1)
3. AdipoCell
http://us-stemcell.com/en/products/
Conditions and Diseases Treated Currently listed on US Stem Cell Clinic Website:
Parkinson’s Disease
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis (ALS)
Stroke
Traumatic Brain Injury
Multiple Sclerosis (MS)
Rheumatoid Arthritis (RA)
Scleroderma
Orthopedic (Osteoarthritis & Injuries)
Degenerative Disc Disease
Chronic Obstructive Pulmonary Disease (COPD)
Diabetes
Congestive Heart Failure
Kidney Disease
Liver Disease
Some of these treated with AdipoCell
(Fat Derived Stem Cells and SVF procedure- No FDA approval needed if minimally manipulated, if grown in culture (in-vitro) then they will need FDA approval.)
Read about FDA guidance on Adipose tissue stem cells here:
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm427795.htm#HCT_QUESTION
There are other Clinical trials out there that I am still searching for- related to all these and Bioheart. There are a few trials in Europe still to be discovered. Perhaps co-sponsors not revealed for some reason?
Here is another agreement we should be looking at for evidence of more clinical trials:
http://us-stemcell.com/wp-content/uploads/2015/05/Globalstemcell.pdf
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Also Important: MyoCath
"We recognized revenues of $729,813 for the three months ended September 30, 2016. These revenues were generated from the sales of kits and equipment, services, MyoCath Catheters, AdipoCell, and laboratory services."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=129569790&txt2find=noga
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Hippo:
Needless to say, The potential for Big Profit is there, The potential for Buyout is there with MyoCell imo. The insiders are set up, protected, and holding their cards tight. And either one of these paths for this company will result in positive gains for USRM common shareholders imo. With so many Conditions and Diseases being treatable at our clinics, we should all be excited about the direction this company is heading. With FDA Fast Track Approval Pending, if MyoCell is approved, we could be valued in MULTI-DOLLARS with a MULTI-MILLION dollar valuation, possibly even BILLIONS, in my opinion. I have just presented more evidence on how MyoCell is the HIGHEST interest of USRM shareholders, but also that there are other conditions and diseases that will generate revenues for this stock, and I am feeling confident about the probability of MyoCell being Fast Tracked and USRM achieving that HUGE HUGE VALUATION, and possibly being bought out or partnering with Big Pharma! I expect the Quarter over Quarter and Year over Year increases in revenue to continue to be the trend here.
From USRM most recent 10k:
Today, we contend that U.S. Stem Cell is a combination of opportunistic business enterprises. We estimate that the products and services we offer through US Stem Cell Training, Vetbiologics, and US Stem Cell Clinics has the potential, although we cannot provide assurances as to if and when it will be accomplished, to drive up to $100 million dollars in cumulative peak annual revenues. What we are establishing is a foundation of value in the products and services we are selling and plan to sell from US Stem Cell Training, Vetbiologics, and US Stem Cell clinics. Our strategy is to expand the revenues generated from each of these operating divisions and to reinvest the profits we generate into our U.S. Stem Cell clinical development pipeline.
Our cardiovascular and vascular product candidates have been streamlined, putting our best opportunities at the forefront of our efforts. The MYOCELL and MYOCELL SDF-1 candidates will, in our opinion, advance forward in the treatment of chronic heart failure (CHF). We are in active prospective partnering discussion for the MYOCELL SDF-1 program. Partnering, we contend, will enhance our capabilities, reduce our development cost through cost sharing and potentially accelerate our time to approval and commercialization. We will continue to apply our ADIPOCELL technology to the treatment of patients in clinic at the point of care. We believe that updating and diversifying our clinical development programs increases the probability of our success, brings operational and fiscal clarity to our Company, and will ultimately enhance shareholder value.
U.S. Stem Cell markets several products to physicians for in clinic regenerative medicine use. These products include equipment (centrifuges, heating block, laminar hood, autoclave) necessary to separate and obtain cellular medicine therapies. We are also providing a variety of materials necessary to obtain fat and/or bone marrow including cannulas, trocars, syringes and other supplies. U.S. Stem Cell also supplies laboratory kits for processing adipose and bone marrow tissue to obtain a mixture of cells for use in clinic. These kits include disposables and reagents and are prepared according to FDA cGMPs. U.S. Stem Cell also provides banking services to patients interested in storing their fat or bone marrow and the cells from this tissue. U.S. Stem Cell is a registered FDA tissue bank in good standing.
Vetbiologics is focused on providing regenerative medicine therapies to veterinarians for use in both small and large animals. We provide a complete regenerative medicine package which includes training, equipment and supplies necessary for in clinic cell therapy. We sell kits for isolating stem cells from bone marrow and fat. We also provide kits for isolating platelet rich plasma. The kits include all of the disposables and reagents necessary and are produced according to FDA cGMPs. Vetbiologics is also working on several off the shelf type products including an allogeneic stem cell source.
Financial highlights from 2016 include:
Revenue up by 38% from $2.2M in 2015 to $3.03M in 2016
Current liabilities down by $1.9M or 23.8% from $8.0M in 2015 to $6.1M in 2016
Operating Expenses down 16.5% (or $631,825) from 3.82M in 2015 to $3.19M in 2016
Net loss improved 136% from $2.6M (gain) in 2015 to $1.15M in 2016
And for the first time in the company’s history, U.S Stem Cell, Inc. ended the year on a cash positive note: $108,596 cash positive as a result of operations in 2016 compared to $844,690 cash negative from operations in 2015
I keep reminding myself just be smart
You know darn Well big Pharma Could influence the FDA to REJECT USRM drug so they can buy usrm cheap look at that media smear campaign Last week
NEW DD: USRM Treating MANY CONDITIONS & DISEASES
DISCLAIMER: THIS IS MY PERSONAL RESEARCH. DO NOT BUY OR SELL BASED ON ANYTHING POSTED IN THIS POST. I AM NOT A STOCK ADVISOR, DO YOUR OWN DD.
Hippo:
From our Research, we can affirm that the commercialization of Myocell, is most likely the most valuable benefactor for USRM as a stock. The Myocell therapy- if commercialized- could provide USRM with major revenues and a much higher valuation on this stock. It would most likely- be highly sought out by big pharmaceutical companies as they would want to have this in their portfolio. The MyoCell therapy for Congestive Heart Failure, is considered most valuable because two main reasons:
A. It requires FDA approval, which is very difficult to achieve.
B. CHF (Chronic Heart Failure) is the Leading cost of Healthcare & Death worldwide, and no other therapy currently exist available for commercial use to regenerate the heart.
But what about all of the other treatments offered by U.S. Stem Cell Inc., what are they? where did they come from?, and how can our stock benefit from these in the form of bottom line revenues?
Quote from March 15, 2017 PR:
"Working with physician partners to offer over 30 protocols to patients, U.S. Stem Cell, Inc. is increasing business opportunities by expanding its services, treatments and therapies both inside and outside the United States."
Link:
http://us-stemcell.com/wp-content/uploads/2017/03/U.S.-STEM-CELL-RELEASES-POSITIVE-2016-FINANCIAL-RESULTS.pdf
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30 Protocols? What are those?
Wait a second, didn't we just announce a plan to open 10 new Stem Cell Clinics in the United States?
HMMMMMMM.....
___________________________________________________________________________
Quotes about the 10 U.S. Clinics:
we are also working with General American Capital Partners (GACP) to open 10 new clinics in the U.S. called Stem Cell Centers of Excellence. We are excited to help GACP provide stem cell services to new patients in a variety of metropolitan areas over the next three years.
"GACP has contractually agreed to invest an additional Two and a half Million Dollars ($2,500,000) to open ten (10) stem cell clinics in the United States within 3 years"
Two things we should read into these quotes from CEO about the 10 Stem Cell Clinics:
1. They are "helping" GACP to provide stem cell services.
2. They will be providing stem cell services in "metropolitan ares"
So, What is the plan, with these 10 new Stem Cell Clinics ?
What types of procedures or "protocols" are currently/or will be
- taking place at now/ and at Future US Stem Cell Clinics?
What therapies require FDA approval, and what therapies do not?
- For new investors in USRM, this can be a extremely large mass of DD to metastasize, but let the hippo tell you what he knows...
FDA approval is needed only if the stem cells are injected into another patient, or manipulated by being “expanded (cultured)” – treated with human growth factor and induced to reproduce in labs before being injected.
Myocell has to be "expanded" or "cultured" -therefore it requires FDA approval.
The treatment with MyoCell® involves taking a biopsy from the patient’s leg muscle, transporting that biopsy to Bioheart’s cell manufacturing facility, expanding the number of cells from the biopsy, and inducing the cells to regress to produce precursors to muscle cells called myoblasts. These cells know that they are muscle cells, but do not know which muscle. Once those precursor cells, or myoblasts, are present, they are segregated from the muscle cells and grown until they number over 1 billion cells. The myoblasts are then transported back to the patient’s treatment centre. Some are then injected into the patient’s heart with a needle tipped injection catheter. The modified cells are injected in the same manner into the patient’s heart. The modified myoblasts are created using an adenovirus vector or a non-viral vector. The myoblasts will release increased levels of the SDF-1 protein, which stimulates angiogenesis and regeneration of tissue.
we recently learned about a few patents held by the USRM insiders which prevents other companies in the United States from replicating this process without permission. A process which is essential to creating the MYOBLAST culture in my opinion.
Method of providing a dynamic cellular cardiac support
US 20020124855 A1
ABSTRACT:
The present invention provides a method for repairing damaged myocardium. The method comprises using a combination of cellular cardiomyoplasty and electrostimulation to synchronize the contractions of the transplanted cells with the cardiac cells. The method comprises the steps of obtaining myogenic cells from a donor and implanting the myogenic cells into the damaged myocardium. Electrical stimulation can be applied to the cells in vitro during culturing of the cells, after implantation of the cells into the myocardium or both.
https://www.google.es/patents/US20020124855?dq=cellular+cardiac+support&hl=en&sa=X&ved=0ahUKEwjg0Zint_PSAhVMOyYKHVd1BEQQ6AEIGjAA
Method of enhancing myogenesis by electrical stimulation
US 7483749 B2
RESUMEN
The present invention provides a method for enhancing regeneration of the myocardium. The method comprises the steps of applying electrical stimulation to an injury site in the myocardium. The method can be used in combination with implantation of myogenic cells into the injury site. The electrical stimulation may be applied before or after the implantation.
https://www.google.es/patents/US7483749
Method for inducing angiogenesis by electrical stimulation of muscles
US 6988004 B2
ABSTRACT
The present invention comprises a method for stimulating angiogenesis. The method comprises the steps of electrically stimulating muscle below the threshold for muscle contraction.
https://www.google.es/patents/US6988004?dq=NORTHSTAR+BIOTECH+GROUP,+LLC,+MINNESOTA&hl=en&sa=X&ved=0ahUKEwicp8SDx_PSAhXGQCYKHWm-BKQQ6AEIKjAC
Bioheart Awarded Patent for Method to Repair Heart Tissue by Combination of Cell-Based Therapy and Electrostimulation
http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=188642
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So Why did Bioheart Assign these patents to Northstar Biotech Group LLC (which are showing currently assigned as of May 2016?
I have my theory:
1. Protection from product liabilities associated with the product MyoCell
2. An assignee has the right to exclude others from using the patent. Considering that Northstar Biotech Group LLC is owned by:
1. Dr. William P. Murphy ( Current Chairman of the Board of USRM )
2. Gregory Knutson ( Board member w/ unknown relationship )
3. Samuel Ahn ( former board member, investor, and last known as a Scientific Advisory Board Member for USRM )
4. Kristin Comella ( Current CSO 5% owner of Northstar )
5. Mike Tomas ( Current CEO also 5% owner of Northstar )
and... Who else... Who else is an owner of Northstar Biotech Group LLC?
Noone has been able to figure it out, and it is HIGHLY private info.
I cannot prove this, but, it is of MY OPINION ONLY: that, since the effective date of the assignment of the patents to Northstar Biotech Group LLC, was 10/10/2012
THAT during that time; it would make sense that since these patents were assigned to Northstar;
because these two men- could also possibly (Speculation only:) be owners in Northstar Biotech Group LLC.
those two men being:
1. Howard L &
2. Juan C. Chachques, M.D., Ph.D.
After all they co-invented two of those patents currently assigned to northstar, - for a total of 3 assigned to Northstar (that I could find off initial searches). Why would they just assign it to Northstar without being members of Northstar? Why would Juan C. Chachques just give away his patent?
Did you all know that Dr. Chachques was also a member of the Scientific Advisory board for USRM and may possibly still be? If anyone has a current list of the SAB please post it...
2009 – Bioheart SAB Members Dr. Juan Chachques and Dr. Jorge Genovese publish world’s first results Cardiac pre-differentiation of human mesenchymal stem cells by electrostimulation Frontiers in Bioscience 14, 2996-3002, January 1, 2009
Quite the list of esteemed colleagues on this board. I wonder what the current Advisory board consist of... A well kept secret now-a-days...
(click on "show all 100 entries" to see total amount of board members)
http://us-stemcell.com/scientific-advisory-board/
In total Leonhar*dt Ventures and Howard Leonh*ardt have directly invested in or borrowed to Bioheart, Inc. over $6 million since its founding.
"Northstar Investments & Minnesota Biomed Partners mentioned here???"
Leonhardt Increases Stake in Bioheart, Inc.
https://www.prbuzz.com/business-entrepreneur/268787-leonhardt-increases-stake-in-bioheart-inc-1.html
We also know that he is a minority shareholder as of 2016:
http://leonhardtventures.com/news/
Just my speculation, but I think Howard and the French M.D. Chachques are both members of Northstar. Thus explaining the patents being assigned.
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USRM Quote from March 15, 2017 10k Annual Report:
"We own or hold licenses or sublicenses to an intellectual property portfolio consisting of numerous patents and patent applications in the United States, and in foreign countries, for use in the field of heart muscle regeneration"
Hippo:
So. They Put some of the patents into Northstar to protect them, and then LICENSED them to USRM.
What did Bioheart receive in return for Assignment of these patents?
Answer: Royalties.
In the 2012 forbearance agreement. It was agreed upon that in return for Northstar keeping up with the maintenance of the Patents, USRM will receive royalties from any revenues generated from the Northstar Biotech Group LLC that are related to "relicensing" of these patents.
https://www.lawinsider.com/contracts/3Z0nK04wwj23OiN5PnmQ1C/bioheart-inc/1388319/2014-11-07
Coincidently around the same time the forbearance agreement was formed, was around the name time the Patents were assigned. They formed Northstar to not only help the company out through tough times with loans, but also protect the patents.
Also in 2010:
Mike Tomas took over as CEO,
and Howard became Chairman of the Scientific Advisory Board
https://business.fiu.edu/pdf/PrintJune2010/Bioheart-Announces-Mike-Tomas-Appointed-CEO.pdf
Quote from filings:
"the Company granted Northstar a perpetual license on products as described for resale, relicensing and commercialization outside the United States. In connection with the granted license, Northstar shall pay the Company a royalty of up to 8% on revenues generated.
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Law:
An assignment being a conveyance of title in a patent that is permanent and irrevocable, an assignee that fails to pay royalties does not risk the loss of rights in relation to the patent, since the assignee owns the patent unconditionally.
The failure to comply with the future royalty obligations, while actionable with the recovery of damages for non payment, does not put at risk the intellectual property rights which have been irrevocably transferred.
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So besides Bioheart getting royalties, and owning Licenses to numerous patents, some known and some unknown, what other protections does USRM have for protecting rights to MyoCell?
1. U.S. Drug Price Competition and Patent Term Restoration Act of 1984
This act provided drug innovators protections in two ways. First, a new kind of market exclusivity was introduced, by means of a new five year period of data exclusivity awarded when the FDA approves marketed of a drug that is a new chemical entity; during that period the FDA cannot approve a generic version of the drug.
This provides market exclusivity for the drug innovator outside of any patent rights.[3] The Act also allowed the life of patents covering a drug to be extended by a portion of the time the drug is under regulatory review by the FDA, ensuring innovator companies that regulatory review will not unduly consume patent life.
In most cases, patents are non-renewable. An exception exists for some pharmaceutical inventions. If pending FDA approval holds up marketing, Congress sometimes extends the expiration date of the product's patent. The extension is usually equal to the time of the delay.
Patent life determination depends on the date of filing of the application or the date of patent issuance and other factors as promulgated under the patent laws. Under the U.S. Drug Price Competition and Patent Term Restoration Act of 1984, as amended, a patent which claims a product, use or method of manufacture covering drugs and certain other products, including biologic products, may be extended for up to five years to compensate the patent holder for a portion of the time required for research and FDA review of the product. Only one patent applicable to an approved drug or biologic product is eligible for a patent term extension. This law also establishes a period of time following approval of a drug or biologic product during which the FDA may not accept or approve applications for certain similar or identical drugs or biologic products from other sponsors unless those sponsors provide their own safety and efficacy data.
2. The Patient Protection and Affordable Care Act, or Affordable Care Act, signed into law on March 23, 2010, included a subtitle called the Biologics Price Competition and Innovation Act of 2009
, or BPCI Act, which created an abbreviated approval pathway for biological products shown to be highly similar to, or interchangeable with, an FDA-licensed reference biological product. This is conceptually similar to the established process for generic drug approval in that it attempts to minimize duplicative testing. Biosimilarity, which requires that there be no differences in conditions of use, route of administration, dosage form, and strength and there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, must be shown through analytical studies, animal studies, and at least one clinical study, absent a waiver by the Secretary.
Interchangeability requires that a product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. No biosimilar or interchangeable products have been approved under the BPCIA to date. Complexities associated with the larger and often more complex structures of biological products, as well as the process by which such products are manufactured, pose significant hurdles to implementation that are still being worked out by the FDA.
A reference biologic is granted twelve years of exclusivity from the time of first licensure of the reference product, and no application for a biosimilar can be submitted for four years from the date of licensure of the reference product. The first biologic product submitted under the abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity against other biologics submitting under the abbreviated approval pathway for the same condition for the lesser of (i) one year after first commercial marketing of the first interchangeable biosimilar, (ii) eighteen months after the first interchangeable biosimilar is approved if there is no legal challenge, (iii) 18 months after the resolution in the first interchangeable applicant’s favor of a lawsuit challenging the reference biologics’ patents, or (iv) 42 months after the first interchangeable biosimilar’s application has been approved if a lawsuit is ongoing within the 42 month period.
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We know we want the FDA to approve MYOCELL for Fast Tracking, so we can sell it at Stem Cell clinics, and around the world right?
We know Northstar Biotech Group LLC is receiving 10% of international sales right?
It also seems that Northstar is licensing patents to USRM right?
So what exactly are they intending on selling at the Clinics in the U.S., and Worldwide?
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Hippo:
So, according to what I can tell, it seems USRM has had, and still has dealings with the Ageless Regenerative Institute, back in 2012 to do multiple testing on 22 different conditions and diseases:
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Ageless Regenerative Institute granted Bioheart exclusive, worldwide rights to LipiCell adipose-derived stem cell technology to treat heart attack and heart failure
http://bciq.biocentury.com/companies/ageless_regenerative_institute_llc
The Lipi-cell agreement was canceled according to what I have read, but... there are others.
I have found others folks.. many many others... related to Kristin Comella which have most likely been collaborated with the Regenerative Institute of Mexico.
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As seen on TV: http://drsharonmcquillan.com/?utm_source=google&utm_medium=ppc&gclid=COzBzJXy89ICFYdAhgodbxcN8Q
Dr. McQuillan formed the Ageless Regenerative Institute in conjunction with a team of experts in stem cell therapies from the medical, legal, biotechnical, and manufacturing arenas. This expert team has developed an approved method and protocol for the harvesting and isolation of adipose derived stem cells for autologous reimplantation.
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Dr. McQuillan attended The Ohio State University College of Medicine where she graduated with honors and was elected to the Alpha Omega Alpha Medical Honor Society.
Ms. Comella has over ten years of cell culturing experience including building and managing the stem cell laboratory at Tulane University's Center for Gene Therapy. She also developed stem cell therapies for osteoarthritis at Osiris Therapeutics. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.
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Who is on that expert team?
1. Kristin Comella, Chief Science Officer of Bioheart, CEO of Stemlogix, Chief Scientific Officer of the Ageless Regenerative Institute
andddd.. GUESS WHO: 2. BIOHEART INC.
McQuillan’s Aventura clinic and Bioheart Inc., a stem cell center in Sunrise, are sending U.S. patients to the Tijuana institute as subjects in research projects using fat and bone marrow stem cells to fight 22 diseases — congestive heart failure, critical limb ischemia (arterial blockage in the legs), emphysemia, retinitis pigmentosa (an eye condition that can lead to blindness), liver failure, type II diabetes, erectile dysfunction, frailty syndrome, renal failure, leukemia, MS, lupus, rheumatoid arthritis, MS, Parkinson’s, Alzheimer’s, stroke, cerebral palsy, autism, osteoarthritis, hip, knee and shoulder degeneration and post mastectomy breast reconstruction.
McQuillan and Kristin Comella, Bioheart’s chief scientific officer, are board members of the Tijuana institute. The research has been going on for about two years. (Since 2011 that I can find)
Regenerative Institute of Tijuana Mexico:
http://www.regenerativemedicine.mx/index.php/portal/medical
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Hippo:
So just How credible is this research?, and is it acceptable to the FDA for evidence used in the process of commercialization use in the United States of America?
Abstract:
There are many justifiable reasons for running clinical trials across multiple countries and indeed continents, or even only in sites that are not in the sponsor's location. Some countries are able to recruit participants faster than others for varied and valid reasons. The trial could be for a rare health event, such as dengue fever or traumatic cerebral hemorrhage, and for these trials it is necessary to recruit many centers in diverse locations, each site perhaps recruiting just a few patients to avoid prolonging the duration of the trial and increasing the wait for lifesaving new interventions. It is also true that some regions of the globe are vastly more expensive than others to conduct trials. For example, a clinical trial in India can cost one-tenth of the price that it would cost in the US [5]. Since clinical trials costs are largely driven by labour, much of these savings are from lower salaries to physicians, nurses, and trial coordinators. The time and cost of developing drugs or vaccine influences the final product cost and return on investment, so the logic of reducing trial costs is clear and reasonable.
FDA Law and Guidelines:
FDA recognizes that sponsors may choose to conduct multinational clinical studies under a variety of scenarios. Multinational studies may include domestic sites conducted under an IND, foreign sites conducted under an IND, and/or foreign sites not conducted under an IND. Sponsors may decide to use the data that is obtained from non-IND foreign sites to support clinical investigations and/or marketing approval(s) in the United States. Some sponsors may even seek to rely solely on foreign clinical data as support for an IND or application for marketing approval in the U.S.
Under 21 CFR 312.120, FDA will accept a well-designed, well-conducted, non-IND foreign study as support for an IND or application for marketing approval if the study was conducted in accordance with GCP and if FDA is able to validate the data from the study through an onsite inspection, if necessary. (GCP=Good Clinical Practices)
FDA rules on Clinical trials conducted outside the US:
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf
In conjunction with both the Regenerative Medicine Institute (RMI) and Bioheart, Inc., The Ageless Regenerative Institute (ARI), is conducting patient sponsored clinical trials for many degenerative diseases using ADSCs. There are approximately 30 protocols that have been approved by the Institutional Review Board of Hospital Angeles Tijuana, a JAHCO certified, state-of-the-art, private specialties hospital providing high quality chronic disease treatments with a patient centric focus. Many of these protocols can be found at www.clinicaltrials.gov and include pulmonary, cardiac, neurodegenerative, orthopedic, ophthalmic and autoimmune diseases, etc....
Regenerative Medicine Institute of Mexico: and Good Clinical Practices
As one of the only hospitals in Mexico certified by the Secretary of Health to perform stem cell procedures, the clinic was also the first in the world to participate in the International Cellular Medicine Society (ICMS) stem cell clinic accreditation program. All treatment protocols, as well as patient informed consent and patient candidacy documentation are evaluated by the institutional review board of the ICMS.
“This accreditation process is unique,” said David Audley, executive director of ICMS. “This is the only program to bring the best global practice standards to cell based medical clinics. It is an important step for this emerging field of medicine, and a critical step for patient safety.”
As part of the accreditation process, the ICMS has investigated every aspect of the clinic’s practices, processes and protocols. Patient candidacy protocols; informed consent processes; and cell collection, processing and implantation practices have all been examined for compliance according to the ICMS Best Practice Guidelines. Additionally, all patients treated with stem cells are entered into the ICMS Treatment Registry for outcome and complication tracking.
ICMS International Cellular Medicine Society:
READ ABOUT HOW THIS ORGANIZATION HELPS CLINICAL TRIALS MEET FDA STANDARDS:
http://www.cellmedicinesociety.org/icms-guidelines/guidelines
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Ageless & Bioheart:
In terms of Institutional Review Board (IRB) clinical trials being conducted by our physician network group at our offshore facility in Mexico, early results are promising for chronic obstructive pulmonary disease (COPD), congestive heart failure and ischemic limbs.
Outcome measurements for the COPD study include safety (number and frequency of adverse events), pulmonary function tests, exercise capability (six minute walk test), and quality of life assessment. Ten patients received intravenous stem cells treatments. Thus far results demonstrate an average increase of 23 points on the St. George Respiratory Questionnaire, as well as an increase of 70 meters in the six minute walk test at three months when compared to baseline (Figures 1 and 2).
All of these results are also substantiated by positive patient testimonial and 83% statistically significant improvement in quality of life. This represents a potential new breakthrough for COPD Patients who often suffer a progressive decline in health after diagnosis.
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Hippo:
So, what research has been done? How much of it is eligible for RMAT designation?
Folks, I think you have been underestimating our gal Kristin Comella...She has experience beyond our comprehension and intimate knowledge about every single one of these:
https://clinicaltrials.gov/ct2/results?term=Ageless+Regenerative+Institute&Search=Search
This Study, was published in the Journal of Translation medicine in 2016:
Here are 3 more studies, that also list Kristin Comella as the main contact:
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Abstract:
The license Bioheart bought from the Aventura-based Ageless Regenerative Institute covers the process used to extract the adipose stem cells, ...
“The Ageless adipose stem cell technology will allow us to broaden our portfolio of product candidates for cardiac patients,” Bioheart President and CEO Mike Tomas said in a news release. “We have successfully treated patients in Mexico, and now we are ready to expand into the U.S.”
Terms of Bioheart’s deal with the Ageless Regenerative Institute were not disclosed. The medical group mostly focuses on training physicians to extract adipose stem cells for use in cosmetic surgery.
Hippo:
So it looks like they found out that there was many more uses for adipose (fat-derived) stem cells than just cardiac patients, and some may say "oh what if the license expired," or "they didn't do a new deal with ageless, then maybe they don't have access to these"
I think Kristin is well connected with Dr. McQuillian and there is most likely an agreement there for some of these, however... it doesn't matter. and let me tell you why:
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Why? Because the FDA can't regulate these adipose stem cell therapies, because they are not "cultured" or "expanded"
Abstract from Kristin Comella:
What are your views on the recent FDA draft guidances including on adipose in which the FDA suggested that SVF is a biological drug?
Comella: The FDA has recently released a draft guidance document regarding the use of human cell and tissue products used during the same surgical procedure from adipose tissue and has requested comments from the public on this guidance. Please note that guidance documents represent the FDA’s “current thinking on the scope” of the topic. “FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.”
We do not believe that the current draft guidance document will affect our ability to offer in-clinic cell therapy from fat to our patients. We understand that the FDA’s draft document has elicited much resistance from the public and highly respected organizations such as AABB Center for Cellular Therapies and The Academy of Regenerative Medicine have voiced their opposition.
https://ipscell.com/2015/04/kristin-comella/
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Hippo:
So whether or not they still maintain a license with Dr. McQuillan, doesn't matter, because as it stands, the FDA cannot stop them from selling adipose (fat derived stem cell) therapies.
But, what is a positive from McQuillan is that Bioheart partnered with them on numerous trials, and our CSO Kristin Comella, knows how to implement everyone of those procedures.
From the USRM filing:
Bioheart has successfully completed various trials using adipose stem cells. In August 2013, the Company canceled its license agreement with the Ageless Regenerative Institute for adipose derived stem cells called LipiCell.
Hippo:
Why did they cancel it? Because they don't need it? Maybe Lipicell was ineffective as a treatment? Maybe there was a better option (MyoCell obviously better)? Lipicell was for heart treatment, but what about all the other treatments: diabetes copd auto immune etc.. Comella's Paper on SVF for Ischemic Heart Failure therapy was published in the Journal of Translational Medicine long after this fact (Angel Trial)
Seems to me Bioheart just developed their own procedures based on knowledge from Comella since the FDA doesn't require "approval" for some of these adipose procedures. but I did find another license related to adipose (fat derived stem cells)
From USRM:
Bioheart has entered into a term sheet agreement with Invitrx to License their adipose derived stem cell products. Bioheart has changed its adipose derived stem cell product name to AdipoCell.
The team at Invitrx has been working with adipose derived stem cells for over 10 years and this experience can contribute to the development and commercialization of AdipoCell (Bioheart's adipose stem cell product).
"We are looking forward to expanding the Angel trial and incorporating some of the newly licensed techniques," said Mike Tomas, CEO of Bioheart , Inc.
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So USRM has their OWN adipose stem cell product. called AdipoCell: Which they have also have been able to use the Adipose/SVF procedure on patients with congestive heart failure, and THEN - they used a combination of Adipose and MyoCell, to treat a patient in Honduras...
From USRM filing:
AdipoCell
U.S. Stem Cell has successfully completed various trials using adipose stem cells. We have completed the Phase 1 Angel Trial for AdipoCell (adipose derived stem cells) in congestive heart failure patients. Five patients were enrolled and treated in the second quarter of 2013. At the twelve (12) month time point, patients demonstrated a statistically significant average improvement in ejection fraction (“EF”) by echocardiogram.
At the three (3) month time point, 100% of the patients demonstrated either improvement or stayed the same. After three (3) months, patients showed an average absolute improvement of 3 percentage points in EF. The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p=0.01) and at the 12 month follow up patients showed this same level of improvement (p=0.01).
These trials were expanded to include a total of 28 patients. The patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the akinetic myocardial scar region using a transendocardial delivery system (MyoCath®) in patients who had experienced a previous myocardial infarct. The subjects were then monitored for adverse events, ejection fraction via echocardiogram and 6-minute walk test (6MWT) over a period of 6 months.
The average EF was 29% at baseline and significantly increased to 35% at both 3 and 6 months. Patients walked an average of 349 meters at baseline and demonstrated a statistically significant improvement at 3 and 6 months’ post treatment of more than 80 meters. Overall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy.
The adipose cells have also been utilized in a phase I trial in Europe for critical limb ischemia (n=20). Patients enrolled in the trial were already on the list for amputation. The cells were directly injected into the affected limbs in an effort to prevent the amputation. Seventy-five percent of the patients were able to avoid amputation and progressed to wound healing. No adverse events or complications were reported or linked to the cell therapy.
We have also initiated several Institutional Review Board studies in 2013 using adipose derived stem cells for various indications including dry macular degeneration, degenerative disc disease (DDD), erectile dysfunction (ED) and chronic obstructive pulmonary disease (COPD). We have discontinued any studies with macular degeneration. We are continuing to see patients in the clinic for various indications including ED and COPD. We have completed a published the study of DDD.
In the DDD trial, a total of 15 patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the disc nucleus of patients with degenerative disc disease. The subjects were then monitored for adverse events, range of motion, visual analog scale (VAS), present pain intensity (PPI), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Dallas Pain Questionnaire and Short Form (SF)-12 scores over a period of 6 months. Safety events were followed for 12 months.
No severe adverse events (SAEs) were reported during a 12 month follow up period with no incidences of infection. Patients demonstrated statistically significant improvements in several parameters including flexion, pain ratings, VAS, PPI, and short form questionnaires. In addition, both ODI and BDI data was trending positive and a majority of patients reported improvements in their Dallas Pain Questionnaire scores. Overall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy.
In the second quarter of 2014, we announced the treatment of a patient in Honduras with congestive heart failure using AdipoCell and MyoCell. We believe that this was the first patient treated in the world using a combination of stem cells.
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So this is what they have listed on the clinic's website as treatments offered:
http://usstemcellclinic.com/en/neurological/
http://usstemcellclinic.com/en/autoimmune/
http://usstemcellclinic.com/en/orthopedic/
http://usstemcellclinic.com/en/degenerative/
30 different protocols, MULTIPLE DISEASES being treated, LEGALLY.
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Hippo:
What some do not understand is that Multiple clinical trials can be used to give to the FDA to help them render a decision on a specific single drug. This does not apply to some Adipocell procedures (since these are fat derived stem cells), but it does apply to MyoCell.
And we have ALOT OF DATA on MyoCell folks.
Look at all the Research Related to Myocell:
http://www.zoominfo.com/CachedPage/?archive_id=0&page_id=176407920&page_url=//www.bioheartinc.com/resources.php&page_last_updated=2010-01-07T23:57:31&firstName=Tatsuya&lastName=Shimizu
Final Data From the Bioheart Seismic Trial Suggest Safety, Efficacy of Autologous Stem-Cell Therapy for Treating Congestive Heart Failure
http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=169268
Catheter-Based intramyocardial injection of autologous skeletal myoblasts as a primary treatment of ischemic heart failure ?: Clinical experience with Six-Month Follow-Up:
http://www.sciencedirect.com/science/article/pii/S0735109703012762
MARVEL part 1 Data:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=129741828
95.7 TO 52 BIOHEART MYOCELL BEATS MESOBLAST MPCS IN SIDE BY SIDE PHASE II/III CLINICAL TRIAL PERFORMANCE IN THE PRIMARY END POINT MEASURE OF EXERCISE CAPACITY IMPROVEMENT IN HEART FAILURE PATIENTS VIA 6 MIN. WALK TESTING.
MESOBLAST, INC. IS VALUED AT OVER $2 BILLION WHICH BY COMPARATIVE PERFORMANCE MEASURE STANDARDS SHOULD VALUE BIOHEART WELL ABOVE THAT. BIOHEART IS FURTHER ALONG IN CLINICAL TRIALS THAN MESOBLAST AND HAS A DEEPER PATENT PORTFOLIO.
BIOHEART’S BOARD AND MANAGEMENT TEAM HAS BROUGHT NUMEROUS CARDIOVASCULAR RELATED PRODUCTS FROM CONCEPT TO MARKET LEADERSHIP IN THE PAST.
95.7 TO 53 BIOHEART MYOCELL BEATS CARDIO3 C-CURE CARDIAC STEM CELLS IN SIDE BY SIDE COMPARISON – 6 MIN. WALK.
95.7 TO 53 BIOHEART MYOCELL BEATS CAPRICOR CARDIAC STEM CELLS IN SIMILAR CLINICAL STUDIES – 6 MIN. WALK.
95.7 TO 10 BIOHEART MYOCELL BEAT OSIRIS/HARE ALLOGENEIC BONE MARROW DERIVED STEM CELLS IN SIMILAR CLINICAL STUDIES – 6 MIN. WALK.
BIOHEART MYOCELL (IMMATURE MYOBLASTS) ARE THE ONLY CELL TYPE KNOWN TO BE ABLE TO FORM NEW CONTRACTILE MUSCLE IN THE DEPTHS OF HEART SCAR TISSUE.
OVER 400 PATIENTS HAVE BEEN ENROLLED IN MYOBLAST CLINICAL TRIALS SINCE JUNE OF 2000.
SINCE 2000 84% OF MYOBLAST TREATED PATIENTS HAVE IMPROVED ONLY 16% HAVE WORSENED. OVER 69% OF CONTROL OR PLACEBO PATIENTS WORSENED.
BIOHEART, INC. HAS RAISED OVER $107 MILLION TO DATE SINCE 1999 THAT HAS ALLOWED THE COMPANY TO ADVANCE FURTHER IN CLINICAL TRIALS THAN ANY OTHER STEM CELL COMPANY FOCUSED ON GROWING NEW CONTRACTILE MUSCLE IN HEART SCAR TISSUE – PHASE II/III MARVEL APPROVED TO ENROLL AT UP TO 35 SITES IN THE USA.
BIOHEART BEAT IT’S PRIMARY END POINT GOAL IN THE MARVEL PHASE II/III CLINICAL STUDY BY 500%! 95.7 TO 16 IN EXERCISE CAPACITY IMPROVEMENT.
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"These data support the need for a randomized, double-blind, placebo-controlled study involving the MyoCell technology," said Prof. Serruys. "We look forward to applying our learning from this trial to the larger, more comprehensive MARVEL Trial currently underway in the U.S. and Europe."
The MARVEL Trial will further study the safety and efficacy of the minimally invasive MyoCell autologous stem-cell therapy in the treatment of congestive heart failure delivered via a MyoStar(TM) injection catheter(3), in combination with the NOGA® XP Cardiac Navigation System.
(MYOSTAR catheter and NOGA cardiac mapping technology coming from CORDIS CORPORATION (Dr. Murphy current chairman of the USRM board))
The Principal Investigator for the MARVEL Trial is Warren Sherman, MD, Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, New York.
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Hippo:
So what do we know about the trials related to MyoCell? imo. here is the status:
MARVEL: Has reached phase 3 (ongoing or finished, not sure)
MIRROR: Has reached phase 3 (but on hold supposedly)
SEISMIC: Has reached phase 3 (ongoing or finished, not sure)
European Clinical Trials site (showing Seismic as on-going):
https://www.clinicaltrialsregister.eu/ctr-search/search?query=bioheart
Marvel (This study is ongoing, but not recruiting participants):
https://clinicaltrials.gov/ct2/show/NCT00526253?term=bioheart&rank=3
It is unknown whether or not these are still ongoing, or have been completed, other than what we know from clinical trials sites, and from the SEC filings which imo. shows a lot of out of date material. These would seem to have all reached phase 3 according to what I have found. But that doesn't matter because:
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U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation.
BUT. NOW. That the 21st Century Cures act is in place... We won't need to complete these phase 3 trials if we are accepted for Fast Track Designation of MyoCell:
On regulatory news, following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation. Thanks to the REGROW component of the Cures Act, The FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. We believe that our MyoCell® product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL Phase II/III trial. If RAT designation is granted, this could expedite the approval process with the FDA. More information on the FDA’s new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
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Hippo:
So what treatments are we going to be offering at U.S. Stem Cell Clinics?
Products
1. MyoCell
2. MyoCell (also with SDF-1)
3. AdipoCell
http://us-stemcell.com/en/products/
Conditions and Diseases Treated Currently listed on US Stem Cell Clinic Website:
Parkinson’s Disease
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis (ALS)
Stroke
Traumatic Brain Injury
Multiple Sclerosis (MS)
Rheumatoid Arthritis (RA)
Scleroderma
Orthopedic (Osteoarthritis & Injuries)
Degenerative Disc Disease
Chronic Obstructive Pulmonary Disease (COPD)
Diabetes
Congestive Heart Failure
Kidney Disease
Liver Disease
Some of these treated with AdipoCell
(Fat Derived Stem Cells and SVF procedure- No FDA approval needed if minimally manipulated, if grown in culture (in-vitro) then they will need FDA approval.)
Read about FDA guidance on Adipose tissue stem cells here:
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm427795.htm#HCT_QUESTION
There are other Clinical trials out there that I am still searching for- related to all these and Bioheart. There are a few trials in Europe still to be discovered. Perhaps co-sponsors not revealed for some reason?
Here is another agreement we should be looking at for evidence of more clinical trials:
http://us-stemcell.com/wp-content/uploads/2015/05/Globalstemcell.pdf
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Also Important: MyoCath
"We recognized revenues of $729,813 for the three months ended September 30, 2016. These revenues were generated from the sales of kits and equipment, services, MyoCath Catheters, AdipoCell, and laboratory services."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=129569790&txt2find=noga
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Hippo:
Needless to say, The potential for Big Profit is there, The potential for Buyout is there with MyoCell imo. The insiders are set up, protected, and holding their cards tight. And either one of these paths for this company will result in positive gains for USRM common shareholders imo. With so many Conditions and Diseases being treatable at our clinics, we should all be excited about the direction this company is heading. With FDA Fast Track Approval Pending, if MyoCell is approved, we could be valued in MULTI-DOLLARS with a MULTI-MILLION dollar valuation, possibly even BILLIONS, in my opinion. I have just presented more evidence on how MyoCell is the HIGHEST interest of USRM shareholders, but also that there are other conditions and diseases that will generate revenues for this stock, and I am feeling confident about the probability of MyoCell being Fast Tracked and USRM achieving that HUGE HUGE VALUATION, and possibly being bought out or partnering with Big Pharma! I expect the Quarter over Quarter and Year over Year increases in revenue to continue to be the trend here.
From USRM most recent 10k:
Today, we contend that U.S. Stem Cell is a combination of opportunistic business enterprises. We estimate that the products and services we offer through US Stem Cell Training, Vetbiologics, and US Stem Cell Clinics has the potential, although we cannot provide assurances as to if and when it will be accomplished, to drive up to $100 million dollars in cumulative peak annual revenues. What we are establishing is a foundation of value in the products and services we are selling and plan to sell from US Stem Cell Training, Vetbiologics, and US Stem Cell clinics. Our strategy is to expand the revenues generated from each of these operating divisions and to reinvest the profits we generate into our U.S. Stem Cell clinical development pipeline.
Our cardiovascular and vascular product candidates have been streamlined, putting our best opportunities at the forefront of our efforts. The MYOCELL and MYOCELL SDF-1 candidates will, in our opinion, advance forward in the treatment of chronic heart failure (CHF). We are in active prospective partnering discussion for the MYOCELL SDF-1 program. Partnering, we contend, will enhance our capabilities, reduce our development cost through cost sharing and potentially accelerate our time to approval and commercialization. We will continue to apply our ADIPOCELL technology to the treatment of patients in clinic at the point of care. We believe that updating and diversifying our clinical development programs increases the probability of our success, brings operational and fiscal clarity to our Company, and will ultimately enhance shareholder value.
U.S. Stem Cell markets several products to physicians for in clinic regenerative medicine use. These products include equipment (centrifuges, heating block, laminar hood, autoclave) necessary to separate and obtain cellular medicine therapies. We are also providing a variety of materials necessary to obtain fat and/or bone marrow including cannulas, trocars, syringes and other supplies. U.S. Stem Cell also supplies laboratory kits for processing adipose and bone marrow tissue to obtain a mixture of cells for use in clinic. These kits include disposables and reagents and are prepared according to FDA cGMPs. U.S. Stem Cell also provides banking services to patients interested in storing their fat or bone marrow and the cells from this tissue. U.S. Stem Cell is a registered FDA tissue bank in good standing.
Vetbiologics is focused on providing regenerative medicine therapies to veterinarians for use in both small and large animals. We provide a complete regenerative medicine package which includes training, equipment and supplies necessary for in clinic cell therapy. We sell kits for isolating stem cells from bone marrow and fat. We also provide kits for isolating platelet rich plasma. The kits include all of the disposables and reagents necessary and are produced according to FDA cGMPs. Vetbiologics is also working on several off the shelf type products including an allogeneic stem cell source.
Financial highlights from 2016 include:
Revenue up by 38% from $2.2M in 2015 to $3.03M in 2016
Current liabilities down by $1.9M or 23.8% from $8.0M in 2015 to $6.1M in 2016
Operating Expenses down 16.5% (or $631,825) from 3.82M in 2015 to $3.19M in 2016
Net loss improved 136% from $2.6M (gain) in 2015 to $1.15M in 2016
And for the first time in the company’s history, U.S Stem Cell, Inc. ended the year on a cash positive note: $108,596 cash positive as a result of operations in 2016 compared to $844,690 cash negative from operations in 2015
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