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United States Patent 8,440,440
Victor May 14, 2013
Ultrasonic cavitation derived stromal or mesenchymal vascular extracts and cells derived therefrom obtained from adipose tissue and use thereof
Abstract
Methods of treating using adipose tissue using ultrasonic cavitation to dissociate the fat cells and blood vessels contained within adipose tissue and thereby obtain mesenchymal or stromal vascular fractions for use in human subjects are provided. These methods preferably do not include the use of any exogenous dissociating enzymes such as collagenase and result in increased numbers of the cells which constitute the mesenchymal or stromal vascular fractions (about 10-fold greater) than methods which use collagenase to isolate these cells.
Inventors: Victor; Steven (New York, NY)
Applicant:
Name City State Country Type
Victor; Steven
New York
NY
US
Assignee: Intellicell Biosciences Inc. (New York, NY)
Family ID: 46317059
Appl. No.: 13/323,030
Filed: December 12, 2011
The company also intends to explore combination therapies with patent pending bio-engineered products under development....he Company believes that the IntelliCell product is an efficient cellular delivery platform for a variety of therapeutic applications and will look to partner with technology developers...
www.sec.gov/Archives/edgar/data/1125280/000101376212000880/form10k.htm
In consideration for the grant of the exclusive license, the licensee agreed to pay us an up-front license fee of $1,000,000 payable as follows: (i) an initial installment of One Hundred Fifty Thousand Dollars ($150,000) upon execution of the agreement; (ii) One Hundred Thousand Dollars ($100,000) within three (3) days of the completion of the Lab Equipment (as defined in the agreement) having been delivered and installed (in accordance with applicable cGMP’s and cGTP’s of the US FDA) and the Lab Technician (as defined in the agreement) for the initial Laboratory Facility (as defined in the Thailand Agreement) having completed training; and (iii) the balance of Seven Hundred Fifty Thousand Dollars ($750,000) to be placed in escrow with counsel for the Company upon the payment of the second installment, with such funds to be held in escrow for a period of ninety (90) days, with such funds to be released upon satisfaction by the parties that the Lab Equipment is in working order and the Lab Technician has been adequately trained.
Thursday, June 20, 2013
www.wnd.com/markets/news/read/20356239/intellicell_biosciences_announces_the_licensing_of_its_proprietary_patent
Intellicell Biosciences, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC); (“Intellicell”) or the (“Company”), Intellicell has licensed its proprietary, patent, pending technology for the manufacture of stromal vascular fraction from adipose tissue to Cell-Innovations, Pty Limited a company headquartered in Sydney, Australia. The license calls for a one-time payment of $700,000 and a royalty stream of 12 ½ % of net of sales.
Intellicell’s process is a patent-pending non-enzymatic method for deriving stromal vascular fraction from 60cc’s of adipose tissue. This process dramatically increases the yield in manufacturing stromal vascular fraction compared to the present enzymatic methods in use today. Intellicell’s process generates between half billion - 1.4 billion SVFC cells from 60 ccs from a patient’s own adipose tissue. This is approximately 10-20 times greater than enzyme based methods. Dr. Steven Victor, CEO, said “we are extremely excited about our licensing partnership with Cell-Innovations, Inc. We believe they are one of the best positioned companies to market the Intellicell technology in Australia & New Zealand.
Cell-Innovations is an Australian company headquartered in Sydney servicing the burgeoning regenerative medicine market by providing innovative IntelliCell technology to the Australian and New Zealand marketplace. We believe that IntelliCell technology will be a “game-changer” in the regenerative medicine field making available stromal vascular fraction (SVF) treatment to the public. Cell-Innovations CEO is Dr. Wayne Thomas BSc PhD a founder of Australian Cell Technologies, a company introducing regenerative cellular products to the veterinary market. Dr. Thomas has 25 years experience in cell biology and developed kits for adipose SVF for the veterinary market. Dr. Thomas’ research contributions has been recognized by many publications and book chapters, and is a reviewer for both national and international granting bodies and journals; and, will be a scientific advisor for IntelliCell. Dr Ralph Bright MB ChB FFMACC is a director with Cell-Innovations and is a pioneer in stromal vascular fraction treatments in Australia, a Fellow and Member of many cosmetic medicine organizations including the Cosmetic Physicians Society of Australasia and the Australian College of Cosmetic Surgery. Dr Bright has been treating patients with adipose SVF since 2009 for osteoarthritis and degenerative neurological disease and is one of the most experienced physicians in Australia in the use of adipose SVF. “Cell-Innovations and IntelliCell will assist Macquarie Stem Cells to establish ‘Intellicell Centers of Excellence’ where doctors can treat their patient”
A study of IntelliCell’s technology by Millipore, a division of Merck AG of Germany, confirmed that it produced an average of 10 times the number of SVF cells containing adult adipose stem cells from less than which the company believes is used by any of its present competition that use enzymes in their process. The study also showed that the SVF cells produced by IntelliCell contain all of the viable cells that are manufactured by competing technologies that use enzymes, such as Cytori.
The Company is a pioneering regenerative medicine company focused on the expanding regenerative medical markets using stromal vascular fraction derived from adult adipose tissue. IntelliCell intends to initially focus on selling laboratory suites and licensing its technology to doctors for use in their offices for their patients.
The company is also setting up Centers of Excellence where doctors can treat their patients. In addition, IntelliCell BioScience in exploring storing the stromal vascular fraction in cryostorage for future uses. The company is also starting FDA IND clinical trials at major medical centers for clinical indication approval.
IntelliCell intends to pursue expansion to secondary markets and beyond the U.S. through a combination of company-owned and licensed clinical facilities.
In today's challenging healthcare sales market, biotechnology companies face many hurdles when trying to commercialize their products. Now, New York-based IntelliCell BioSciences has announced it has cleared a key roadblock to process its regenerative medicine technology.
The company said it has been notified by the Food and Drug Administration (FDA) that its facility in New York is now registered to recover, process package, store and label human cells and tissues for future development.
"The IntelliCell processing technology is designed to allow physicians to treat their patients during a same day and same procedure basis much the same way that bone marrow transplants and IVF treatments are performed today," Dr. Steven Victor, IntelliCell's chairman and chief executive officer, stated. "This is a significant step for the Company as it continues its mission to be a leading regenerative medicine company."
Although it's unclear whether the facility registration will allow the company to add more biotech sales jobs, it did say it was moving forward with plans for in-human clinical studies, including one for lower limb ischemia, which is a vascular disease that affects the arteries supplying blood to the legs. According to the National Institutes of Health, the condition often leads to amputation.
The IntelliCell process, branded IntelliSonics, is similar to the Cytori process in that they both use lipoaspirate. But the IntelliCell process produces a different cellular population because, with its sonification [ultrasound] process, the blood components are not washed out[/color]. The stromal vascular fraction of IntelliCell contains the hematopoietic cells. The final product is quality-controlled, checked for any contamination and cell viability is measured.
IntelliCell BioSciences has completed the preclinical protocols in anticipation of beginning a clinical trial for osteoarthritis of the knee under an FDA investigational new drug application in mid-2013. The company provides product today to ReGen Medical, and in doing so is building fantastic database of patient experience that will be used to focus on clinical applications.
Dr. Steven Victor, is also the founder of ReGen Medical. ReGen Medical is a state-of-the-art hospital in midtown Manhattan that provides stromal vascular fraction cellular therapy, which contains stem cells, to patients today. The hospital is a beautiful, brand-new facility that treats high-end patients.
NEW YORK--(BUSINESS WIRE)--IntelliCell BioScience, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC); (“IntelliCell”) or the (“Company”), A full page Daily News article, titled “Stem Sells” written by Sean Brennan published February 19, 2012,
http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.nydailynews.com%2Fsports%2Fcollege%2Fmanhattan-basketball-torgrim-sommerfeldt-turned-stem-cell-treatment-back-court-article-1.1025227&esheet=50175526&lan=en-US&anchor=http%3A%2F%2Fwww.nydailynews.com%2Fsports%2Fcollege%2Fmanhattan-basketball-torgrim-sommerfeldt-turned-stem-cell-treatment-back-court-article-1.1025227&index=1&md5=7bdd5c8be9c9c87aec20536648c5d3ec
...describes how Torgrim Summerfeldt’s budding basketball career was saved through Dr. Anthony Maddalo’s treatment using IntelliCell BioSciences proprietary SVF Cells (Stem Cell Therapy). Mr. Summerfeldts, a former star player for the Norwegian National Basketball Team, had undergone six knee surgeries and lived in constant pain. He had forfeited his Wake Forest basketball scholarship. Manhattan College took a chance on him and invited him to join their team. Due solely to the two IntelliCell SVF (Stem Cell) treatments in New York City by Dr. Maddalo near the end of 2010 and the beginning of 2011, he started his first game for Manhattan College pain free on January 20, 2012.
Dr. Steven Victor, CEO of IntelliCell BioSciences, said “We are very proud that our proprietary technology used by Dr. Maddalo was able to rehabilitate Torgims’s knees and alleviate his pain. Sports related injuries are a predominate focus for our Company. Doctors using our proprietary technology have treated several professional and college athletes with excellent results. Patients have seen cartilage regrow in the knee. We are about to start a multi-center study for several sports injury indications at major centers. We are fortunate to have several top orthopedic surgeons on our advisory board such as; Dr. Andrews, Dr. Hackel, Dr. Dugas and Dr. Nicola. We believe the 2012–2013 years will see significant revenues from the use of our technology to treat athletes. We believe that this is a $1.3 billion market opportunity just in the United States.
The Winthrop Wound Healing Center is currently investigating a promising new regenerative medicine approach that uses the patient’s own stromal vascular fraction (SVF) cells—a blood component rich in adult stem cells, which can help stimulate the regeneration of healthy tissue. The SVF cells we will be using are obtained from blood vessels in the patient’s adipose (fat) tissue through a process that uses high-frequency ultrasound to break up the fat tissue, then separates out the SVF cells using a centrifuge.
Our wound center is currently working on plans to launch a clinical trial that will evaulate the benefits of using SVF cells to treat non-healing diabetic foot ulcers. In the trial, which will utilize SVF cells supplied by IntelliCell Biosciences, the stem-cell therapy will be administered to patients through a combination of intravenous infusion and topical injection into the wound site. The healing of DFUs and other chronic wounds is just one potential application for SVC-stem cell therapy: It is also being investigated as a possible treatment for osteoarthritis, gum cavity degeneration and multiple sclerosis.
NEW YORK, Sept. 13, 2012 /PRNewswire/ -- IntelliCell BioSciences, Inc. ("Company") (OTCQB: SVFC) announced today that it will be initiating a groundbreaking in-human clinical study to treat people who suffer from diabetic induced critical limb ischemia wounds. IntelliCell has developed a proprietary treatment methodology using its autologous (your own) cellular therapy that includes adult stem cells that have demonstrated regenerative capabilities in anecdotal studies of patients treated. According to the American Diabetes Association, there are "over 65,000 lower limb amputations performed in the United States" as a direct consequence of diabetes and hundreds of thousands of diabetes related amputations globally.
Dr. Steven Victor, Chairman and CEO of IntelliCell stated, "Diabetes is a growing problem in the United States and around the world. We hope to show that our unique autologous cellular therapy may make a contribution to those who suffer from this terrible disease and reduce the number of people that undergo amputations from non-healing wounds in their legs and other extremities."
Robert Sexauer, VP of Clinical Development added, "Regenerative Medicine is progressing to the point whereby we can begin to truly offer personalized medicine based on each patients unique needs. IntelliCell has developed a novel treatment methodology that may impact a number of disease states with significant unmet clinical needs."
The company's (SVFC) expansion plan is to acquire cash flow positive ambulatory surgery centers in major US markets beginning in 2013 with a target of operating 20 centers by 2016. Each center will generate between $10M to $30M of revenue per annum in traditional surgical procedures such as orthopedics, aesthetic plastic surgery, urology, etc.
IntelliCell will place a cGTP compliant cellular processing laboratory in each surgical facility and offer regenerative medical procedures in addition to the surgical procedures. The company believes an additional $10M to $15M can be generated per annum from the cellular therapies at an average gross profit of 70% from the cellular procedures.
The financial model target is to reach over $600m in combined revenues by 2018
Anna Rhodes <arhodes@intellicellbiosciences.com>
3:49 PM (4 minutes ago)
to me
Hi xxxx,
Thank you for your interest in IntelliCell BioSciences. The transfer agent for the company is Continental and the float is approximately 27M. There are 500M authorized shares and the outstanding shares after full dilution is upwards of 150M with 39M in warrants.
I hope this information is helpful to you.
Best regards,
Anna
Anna Rhodes
Executive Vice President of Operations
IntelliCell BioSciences, Inc.
460 Park Ave., 17th Floor
New York, NY 10022
T: 646.576.8710
C: 917.209.6636
F: 212.249.1482
E: arhodes@intellicellbiosciences.com
www.intellicellbiosciences.com
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Dr. Steven Victor, founder and CEO of IntelliCell has been at the forefront of clinical product and process development for over 20 years. The patent pending process that Dr. Victor has developed for IntelliCell™ has been in research for over 4 years. In addition to developing clinical products that are used nationally and internationally in the medical aesthetics field, Dr. Victor is a practicing dermatologist in New York City. Dr. Victor's interest in regenerative medicine began well over a decade ago with the clinical use of autologous fibroblast cells for the purpose of dermal regeneration. Dr. Victor received his medical degree from New York college and a Bachelor of Arts degree from New York University and has held hospital based teaching positions. He has been a sought after national figure for teaching physicians new clinical techniques worldwide for over 20 years. Dr. Victor has also been featured in national and local media as a clinical subject matter expert in regenerative medicine, medical aesthetics, and dermatology
In addition, teaching appointments to Beth Israel Medical Center ("Beth Israel") and Lenox Hill Hospital ("Lenox Hill") have significantly added to his experience as a teacher and a doctor.
Other rewarding positions include his appointments as the consulting dermatologist for Elizabeth Arden, Clarins, Pierre Cardin, as well as Angio Medical Corporation, Medicis Pharmaceuticals, and the Orentreich Foundation for the Advancement of Science. In addition Dr. Victor has had the opportunity to give numerous newspaper, magazine and television interviews, and is honored to have been named one of New York Magazine's "Best Doctors in New York," Woodward and White's "Best Doctors in America," and Town & Country's "Best Cosmetic Surgeons." He has pioneered, perfected and delivered some of the most ground breaking and highly effective skin rejuvenation treatments that exist today. Beginning in 1982, he helped develop the first true cosmeceutical. In 1988, he introduced the first professional peeling formula to the aesthetician and plastic surgery worlds. In 2001, he formulated a full line of cosmeceutical treatments. Other highlights have included bringing Botox to Paris, and Restylane from Europe to the United States. In 1992 he was featured by the New York Times for bringing Mesotherapy to the United States.
In 2002, his first book, "Ageless Beauty, A Dermatologist's Secrets to Looking Younger Without Surgery" was published. Today his practice continues to grow with both new patients and long-term patients for more than 30 years, many of them in the worlds of modeling, show business and society. These include a number of celebrities and household names.
Mr. Leonard L. Mazur Co-founded Triax Pharmaceuticals, LLC and serves as its Chief Operating Officer. Mr. Mazur also Co-Founded Akrimax Pharmaceuticals in 2007. Mr. Mazur began his pharmaceutical career with Cooper Laboratories in 1971, where he served as a Product Manager for ophthalmology, dermatology and other products. He was responsible for creating and growing the business that was sold to Pierre Fabre, a French dermatology company, in 2002. In 1995, he founded Genesis Pharmaceutical, Inc., and served as its Chairman, Chief Executive Officer from 1995 to 2005 and President. In 1989, he became one of the first employees of Medicis Pharmaceuticals, a start-up dermatology pharmaceuticals company. Mr. Mazur was responsible for acquiring brands, as well as sales and marketing. He was promoted to Marketing Manager with responsibility for the ethical OTC division where he managed sales and licensing. In 1984, he joined ICN Pharmaceuticals as Vice President of Marketing and Sales, and managed all aspects of the US pharmaceuticals group, including marketing, sales, licensing, and acquisitions. In 1981, he joined Knoll Pharmaceuticals as Director of Product Management. After a 2-year transition period, Mr. Mazur joined Krivulka in founding Triax. He serves as a Vice Chairman of Akrimax Pharmaceuticals. Llc. He has been a Director of PhotoMedex, Inc. since May, 2009.
Mr. Myron Z. Holubiak serves as a Senior Partner of 1-800-Doctors.com Inc. and has been its President since May 2007. Mr. Holubiak serves as a Senior Executive with a broad background in the pharmaceutical industry and healthcare companies. He was a Partner of HealthSTAR Communications Inc., since 2002 and served as its Group President and Chief Operating Officer from November 2003 to April 2007 and also served as its Group President, Field Level Marketing Group from August 2002 to October 2003. Mr. Holubiak is an accomplished biotech and pharmaceutical senior executive with over 30 years of industry experience including directing Roche Laboratories. From August 2001 to June 2002, Mr. Holubiak served as the President and Chief Operating Officer of iPhysician Net Inc. From December 1998 to August 2001, Mr. Holubiak served as the President of Roche Laboratories, USA and was responsible for all U.S. operations including oversight of the development and launch of the obesity product Xenical (R). Previously, he spent 19 years in a variety of marketing, sales and executive positions with Roche Laboratories. Mr. Holubiak co-founded Emron Inc., and served as its Chief Executive Officer. He has been Chairman of the Board at BioScrip Inc. since April 18, 2012. He has been a Director of BioScrip Inc., since March 2005, and of Ventrus Biosciences Inc., since July 2010. He has been Director of IntelliCell BioSciences, Inc since October 2012. He serves as a Director of US Wellness Inc. and 1-800-Doctors.com. Mr. Holubiak served as a Director of Chronimed, LLC (also known as Chronimed Inc.), since October 28, 2002. He served as a Director of iPhysician Net Inc., from August 2001 to June 2002. He served as a Director of MDRNA Inc. (now, Marina Biotech, Inc.) since June 2004. He serves as a Director of the Children of Chernobyl Relief Foundation. Mr. Holubiak was a Trustee of the Robert Wood Johnson Hospital Foundation from 2000 to 2001. He was a Founding Member of the Academy of Managed Care Pharmacy, the professional society of managed care pharmacists. Mr. Holubiak holds a BS in Molecular Biology and Biophysics from the University of Pittsburgh in 1969 and a graduation in Biophysics from the University of Pittsburgh in 1970 and has completed medical training.
Michael Hershman is an internationally recognized expert on matters relating to transparency, accountability, governance, litigation and security. The Fairfax Group, founded in 1983, has been retained by governments, corporations, law firms and international financial institutions to assist on matters relating to the conduct of senior-level officials and/or the entities with which they do business.
Mr. Hershman has been called upon repeatedly to respond in times of crisis by governments, public and private companies, law firms and individuals. In high profile controversies, criminal prosecutions and civil litigation, Fairfax has participated in some of the most prominent disputes around the world for the last twenty-eight years. From high profile events, like the Olympics and Super Bowls, to targeted terrorist attacks, Fairfax has responded to provide assistance to individuals and entities facing serious, wide-spread threats against their persons and property. Fairfax has provided litigation support, state-of-the-art digital forensics and security measures, crisis monitoring and response, and advice to corporate boards and executives and governments in the midst of some of the most contentious situations.
In December 2006, for example, Mr. Hershman was appointed as the independent compliance advisor to the board of directors of Siemens AG, a company with more than 400,000 employees. Similarly, The Fairfax Group has assisted governments from India to Chile on ethics matters, and has served as the appointed monitor of companies that have violated laws, rules or regulations.
Mr. Hershman began his career in intelligence and investigations in Europe during the late 1960s as a special agent with U.S. Military Intelligence, specializing in counter-terrorism. After leaving the military, he moved to investigations of government misconduct and financial fraud for the New York State Attorney General's Office and the Office of the Mayor of New York City.
Later, Mr. Hershman served as a senior staff investigator for the Senate Watergate Committee, and as chief investigator for a joint Presidential and Congressional commission, reviewing state and federal laws on wiretapping and electronic surveillance. After the wiretap commission hearings, Mr. Hershman joined the Federal Election Commission as chief investigator, where he was responsible for audits and investigations of candidates and their campaign committees.
Mr. Hershman then served as deputy staff director for the Subcommittee on International Organizations of the U.S. House of Representatives, which was responsible for legislation and oversight relating to international banks and other U.S. supported international organizations, such as the United Nations.
Immediately prior to founding the Fairfax Group, Mr. Hershman served as deputy auditor general for the Foreign Assistance Program of the U.S. Agency for International Development (AID), where he led investigations and audits of major U.S. funded projects overseas, and was responsible for worldwide security at all foreign AID missions. Mr. Hershman was awarded the Superior Honor Medal for his service at AID.
In 1993, along with Peter Eigen, Mr. Hershman co-founded Transparency International, the largest independent, not-for-profit coalition promoting transparency and accountability in business and in government. For the past 6 years he has served Interpol as a member of the International Group of Experts on Corruption, and for the past 12 years, he has sat on the board of the International Anti-Corruption Conference Committee.
Mr. Hershman is a member of the board of directors of the U.S. Chamber of Commerce Foundation, and advises the Chamber on corporate compliance issues. Since 2007, Mr. Hershman has been a member of the board of directors and the executive committee of the Center for International Private Enterprise.
For the past 12 years he has been a member of Interpol’s International Group of Experts on Corruption and now serves as Vice Chairman. He is also on the board of the International Anti-Corruption Conference Committee. He also serves on the Financial Coalition against Child Pornography, a project of the National Center for Missing and Exploited Children. Additionally, he is a member of the Advisory Council of the George Mason University School of Information Technology and Engineering.
Since 2008, he has been named every consecutive year to the Ethisphere Institute’s list of the top 100 most influential people in business ethics worldwide.
Michael Hershman has given hundreds of speeches throughout the world on issues related to transparency and accountability and has provided commentary on ABC, CBS, NBC, PBS, CNN, CNBC, MSNBC and the Fox News Channel as well as countless national radio shows. For five years he was the co-host of the Public Radio Law Show. He has been quoted and published in the Wall Street Journal, the New York Times, the New York Post, the Washington Post, USA Today, the Financial Times, the National Law Journal and other print media.
Dr. Caplan is a Professor of Biology & General Medical Sciences and Director of the Skeletal Research Center at Case Western Reserve University in Cleveland, Ohio. Professor Caplan has published over 300 manuscripts and articles in peer reviewed journals. Dr. Caplan has been Chief Scientific Officer at OrthoCyte Corporation since 2010. Dr. Caplan co-founded Cell Targeting Inc. and has served as President of Skeletech, Inc. as its founder. He served as Chief Scientific and founder of Osiris Therapeutics, Inc. He has served as Director of BioMetic Pharmaceuticals, Inc. and Carbylan Biosurgery. Also, he has been a Director of Biomimetics Pharmaceuticals, Inc. Dr. Caplan has served as a Member of the Scientific Advisory Board at IsoTis Orthobiologics. He is the recipient of several honors and awards from the orthopedic research community. Dr. Caplan holds a Ph. D. from John Hopkins University Medical School and a B.S. in chemistry from the Illinois Institute of Technology.[/quote]
Born in Africa, Dr Khalpey completed his medical education in the UK and studied and worked extensively throughout Europe and the United States before deciding to pursue his organ transplantation research at the University of Arizona, the birthplace of the Total Artificial Heart.
In addition to his clinical work at The University of Arizona Medical Center, where he recently was appointed director of the internationally renowned heart transplant program and mechanical circulatory support, Khalpey is involved in numerous research activities, focused mainly in three key areas: bridge to regeneration, organ reconditioning and organogenesis, or the creation of new organs.
The first area, bridge to regeneration, focuses on reducing the number of people who require heart transplants by improving stem cell treatments for failing hearts.
In patients requiring heart transplants, mechanical devices known as ventricular assist devices often are used to keep their failing hearts functioning while they wait for donor organs. The devices act as "a bridge to transplant." Khalpey would like to use those same devices instead as "a bridge to regeneration," as he aims to regenerate failing hearts with stem cell injections.
To date, clinical trials involving stem cell therapies for failing hearts have had limited success. Khalpey is involved in a series of clinical trials and studies exploring ways to improve the process. Among his efforts, he's working on transforming the cells from being pluripotent - able to differentiate into essentially any part of the body - to being multipotent - tailored to differentiate into only certain areas, such as the heart.
Khalpey's second research area, organ reconditioning, focuses on increasing the pool of donor lungs for patients requiring a lung transplant by taking donor lungs that would be thrown away and making them suitable for transplant.
He is currently developing the UA's Ex Vivo Lung Program, which will explore new ways to recondition lungs from DCD (donation after cardiac death) donors, using mechanical devices and designer drugs to manipulate the metabolism of the organs and optimize them for transplantation.
This summer, the UA will serve as a national trial site for the Expand trial, comparing the survival of DCD lungs resuscitated on a mobile ex vivo circuit versus normal lungs transplanted.
In the event that an organ can't be reconditioned, Khalpey hopes it can still be put to use in his third area of research - organogenesis, which aims to grow new organs by combining an otherwise unusable donor organ with a transplant patient's own stem cells.
The idea is that a donor heart or lung could be put into detergent and decellularized so that nothing but the organ's matrix - essentially its skeleton - remains. The organ would then be seeded with the stem cells of a patient awaiting transplant and left to grow inside a special bioreactor, developed by Khalpey and his former colleagues at Harvard and Harvard Bioscience in Boston.
Khalpey and his colleagues have already used the bioreactor to successfully grow a new pig heart and lungs and they now are experimenting with human organs. The Donor Network of Arizona has pledged all the hearts and lungs it would normally throw away to help with the research efforts. With the organs that can't be reconditioned, Khalpey plans to create a "biofarm" of frozen organ cytoskeletons for use in future organogenesis research.
Khalpley also serves as director of the department of surgery's CAPTURED Biobank. His goal is to create a bank of cardiac and thoracic tissue with a stem cell directory that could be used by medical researchers worldwide. Human stem cells would be harvested during operations, with patient consent, for future use in tissue engineered heart valves, lungs and other organs.
Finally, Khalpey also is looking at the long-range possibility of creating transplantable human hearts and lungs using a 3-D bioprinter.
Three-dimensional printing, which produces three-dimensional solid objects from digital models, has been used to create things such as architectural models, jewelry and dental crowns. Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, has used the technology to engineer a lab-grown human bladder that was successfully transplanted into a patient in 2007.
Khalpey envisions doing the same thing with hearts and lungs, seeding a printed collagen or elastic organ structure with human stem cells and putting it into the bioreactor to develop.
TUCSON, Ariz. – Zain Khalpey, MD, PhD, MRCS (Eng), has joined the University of Arizona Department of surgery as associate professor in the Division of Cardiothoracic Surgery. He has been appointed surgical director of the Heart Transplant and Mechanical Circulatory Support Program at The University of Arizona Medical Center – University Campus.
Specializing in heart surgery for adults and children, Dr. Khalpey comes to the UA from Columbia University in New York City, where he also has a tenure track appointment in cardiothoracic surgery. His surgical interests include adult and pediatric heart transplant, mechanical circulatory support (ventricular-assist devices and total artificial heart), ex vivo lung perfusion, minimally invasive treatments for valve disease, arrhythmia surgery and robotic mitral valve surgery.
In his research role at the UA, he is the director of the Ex Vivo Lung Program, clinical and translational research, and the Cardiopulmonary Stem Cell Bank. Dr. Khalpey also holds a position on the UA Institutional Review Board (IRB).
Dr. Khalpey’s research on translational tissue regeneration evolved from past basic science studies in metabolomics and cell survival. His laboratory at the UA focuses on basic and translational research on organogenesis (the formation and development of organs), organ preservation and tissue regeneration.
Dr. Khalpey is engaged in ex vivo reconditioning of marginal human hearts and lungs, which will generate functional lung and heart tissue that ultimately can be used for transplantation. This reconditioning process uses human cadaveric lungs that are decellularized (chemically stripped of its cells, leaving behind the extracellular tissue and lung scaffolds). That structure is “re-seeded” with autologous stem cells to rebuild the organ.
He also is involved in creating clinical “bridge-to-regeneration” trials, in which autologous stem cells will be injected into failing hearts with the hope of recovery in an era of limited hearts for transplantation.
Dr. Khalpey has published more than 100 manuscripts, abstracts and book chapters in heart and lung transplantation in basic science and clinical outcome studies. He is an American Heart Association reviewer and Early Career Reviewer for the National Institutes of Health (NIH). He has received numerous teaching and institutional awards, including the Hunterian Medal and Professorship of Surgery from Royal College of Surgeons, England; the Winston Churchill Medal, bestowed by HRH Queen Elizabeth II, Winston Churchill Memorial Trust, London, UK; Excellence in Teaching Award, Harvard University; United Nations Educational, Scientific and Cultural Organization (UNESCO) Fellowship from Switzerland and France; and the Solly Medal and Prize for Surgery from the University of London.
“The combined training, aptitude and skills of Dr. Khalpey represent the future of cardiac surgery,” said Robert Poston, MD, chief, Division of Cardiothoracic Surgery. “He has tremendous promise as a surgeon who successfully will bridge the gap between the theories of basic science research and practical innovation in clinical medicine and surgery. I am extremely excited to add him as a critical partner to our growing CT team.”
“We are very happy to have a surgeon and researcher of Dr. Khalpey’s caliber join the cardiothoracic team,” saidRainer W.G. Gruessner, MD, chairman, UA Department of Surgery. “The cardiac surgery program has a national reputation as a pioneer in heart transplantation, in developing new heart devices and for providing the highest levels of patient care for patients suffering from heart failure. The addition of Dr. Khalpey will serve to further strengthen this outstanding program for the residents of Tucson and beyond.”
Doctor James Andrews is one of the founding members of Andrews Sports Medicine and Orthopaedic Center in Birmingham, Alabama. He is also a founder of the American Sports Medicine Institute (ASMI) a non-profit institute dedicated to injury prevention, education and research in orthopaedics and sports medicine. This foundation is recognized as one of the world’s leaders in this field. Doctor Andrews is internationally known and recognized for his skills as an orthopaedic surgeon as well as his scientific and clinic research contributions in knee, shoulder and elbow injury prevention and treatment. In addition, he has made major presentations on every continent, and has authored numerous scientific articles and books.
Doctor Andrews graduated from Louisiana State University (LSU) in 1963, He completed LSU School of Medicine in 1967 and completed his orthopaedic residency at Tulane Medical School in 1972. He had surgical fellowships in sports medicine at the University of Virginia School of Medicine in 1972 with Doctor Frank McCue, III and at the University of Lyon, Lyon, France in 1972 with the late professor Albert Trillat, M.D., who is known as the Father of European Knee Surgery.
Doctor Andrews is a member of the American Board of Orthopaedic Surgery and the American Academy of Orthopaedic Surgeons. He is President-Elect of the American Orthopaedic Society for Sports Medicine and was Secretary of that Board from May 2004 to May 2005.
At present, Doctor Andrews serves as Medical Director for Intercollegiate Sports at Auburn University; Senior Orthopaedic Consultant at the University of Alabama; and Orthopaedic Consultant for the athletic teams of Troy University, University of West Alabama, Tuskegee University and Grambling University. Doctor Andrews serves on the Medical and Safety Advisory Committee of USA Baseball and on the Board of Little League Baseball, Inc.
In the professional sports arena, Doctor Andrews is Senior Consultant for the Washington Redskins Professional Football team; Medical Director for the Tampa Bay Rays Professional Baseball Team; and team physician for the Birmingham Barons Double A Professional Baseball Team, an affiliate of the Chicago White Sox. Doctor Andrews is the Co-Medical Director of the Ladies Professional Golf Association.
Joshua G. Hackel, M.D.
Primary Care Sports Medicine
Andrews Primary Care Sports Medicine
Clinical Specialties
Primary Care Sports Medicine
Clinical Interests
Non-surgical Orthopaedics/Primary Care Sports Medicine; Musculoskeletal Ultrasound for diagnosis and treatment of orthopaedic injuries; Regenerative Medicine and Injection Therapy; Peripheral Joint Injections
Education
Medical School: American University of the Caribbean
Internship: Columbus Regional Medical Center
Residency: Columbus Regional Medical Center
Fellowships
American Sports Medicine Institute (ASMI) with Dr. James Andrews
Board Certifications
Sports Medicine, Family Practice
Research Specialties
Autologous Blood Injections (Platelet Rich Plasma Injections, PRP); Stem Cell regeneration
Current Research
Stem Cell Research and Platelet Rich Plasma (PRP)
Musculoskeletal Ultrasound
Hyaluronic Acid shoulder injections for glenohumeral osteoarthritis
Osteoarthritis of the knee
Major Publications
Hackel JG, Nicolais V, Adolescent with Rash, Photo Quiz. Am Fam Physician, August 2004
Hackel JG, Verma S, Syncope in Athletes: A Guide to Getting Them Back On Their Feet. The Journal of Family Practice, July 2007; 56(7):545-550.
Hackel JG, Asthma Overview. Athletic Therapy Today, 2004; 9(2):28-29.
Andrews JR, Hackel JG. The Thrower’s Exostosis Pathophysiology and Management. Techniques in Shoulder and Elbow Surgery, 2004; 5(1):44-50.
Scholarly Service and Honors
Fellow of the American Academy of Family Physicians
Current Academic Appointments
Director, Primary Care Sports Medicine Fellowship, Andrews Institute for Orthopaedics & Sports Medicine; Clinical Associate Professor, Florida State School of Medicine; Clinical Associate Professor, University of West Florida
Current Society Memberships
American Medical Society of Sports Medicine
American College of Sports Medicine
American Medical Association
Florida Medical Association
Current Team Affiliations
Booker T. Washington High : Team Physician
Northview High School: Team Physician
University of West Florida athletics: Team physician
Dr. Anthony V. Maddalo, Orthopedic Surgeon, NY Rangers..Joins INTELLICELL BIOSCIENCES...
http://www.hvbjsurgeons.com/surgeons/maddalo.htm
Anthony V. Maddalo, M.D.
Phelps Memorial Hospital Center, Sleepy Hollow, New York
Director of Surgery - 1996 - 2003
Vice-President of Medical Staff - 1999-2002
Board of Directors
St. Johns Riverside Hospital/Dobbs Ferry Pavilion, Yonkers, NY
Lenox Hill Hospital, New York, New York
NYU Langone Medical Center, New York, New York
Specialty: Orthopedic Surgery
Sub-Specialty: Sports Medicine
Certifications:
Fellow of American Academy of Orthopaedic Surgeons – 1989
Board Certified in Orthopaedic Surgery - 1988
Hospital Training:
Orthopaedic Residency
Lenox Hill Hospital, New York, NY
Education:
M.D., New York Medical College, Bronx, NY
B.S. Cum Laude, Manhattan College, New York
Beta Beta Beta Biology Honor Society
Sports Medicine Experience:
Assistant Team Physician for New York Rangers Hockey Club
1986 - Present
Team Physician Westchester Flames Soccer Club
1999 - Present
Member National Hockey League Physicians Association
1986 - Present
Advisory Board of National Academy of Sports Medicine
1985 - Present
Team Physician and Sponsor - U.S. Basketball League -
Westchester Wildfire
2003 - 2005
Team Resident, New York Jets Football Club
1985 - 1986
Team Resident, New York Cosmos Soccer Club
1986
Team and Pre-draft Physicals for New York Jets Football Club
1982 - 1985
Team Physician, Dalton High School Football Team, New York, NY 1982 - 1984
Publications:
Sports Injuries to the Lower Extremities by James A. Nicholas
Author of chapter on "Rehabilitation of the Foot and Ankle"
Orthopaedic consult for Sportshape by Helen Royce
Death in the Locker Room – co-author – "A Screening Self-Examination for the Male Athlete Taking Anabolic Steroids"
Muscle Training Illustrated – "Uses and Abuses of Anabolic
Steroids"
Guest Speaker on Anabolic Steroids:
Kids First Health Program – WABC-TV – August 1996
PBS "kids Mix Health Hour – May 1996
48 Hours / CBS-TV - 1993
ESPN Muscle Magazine – 1989
Coca-Cola High School Sportsweek on MSG Network – April 1988
American Medical Society of Alcoholism and Drug Abuse – April 1987
New York Jets Pre-Game Show – November 1985
Background
Employment History
President
Brazilian Society for Lasers
Position, Medicine and Surgery, South Region
Brazilian Society for Lasers
Medicine and Surgery - South Region Director
Mount Sinai School of Medicine
Medical Insight Inc
Board Memberships and Affiliations
Board Member
Clinica Goldman
Education
Alberto Goldman, M.D.
Dr. Goldman is a Brazilian board certified plastic surgeon who completed his training at Clinica Planas in Barcelona, Spain. He is a senior member of the Brazilian Society of Plastic Surgery and recently served as president of the Brazilian Society for Lasers in Medicine and Surgery, south region. Dr. Goldman, a leading authority in laser lipolysis and an internationally recognized laser expert, frequently teaches cosmetic surgery and laser liposuction courses for physicians and surgeons around the world. Dr. Goldman is a pioneer and author of the main publications about laser-assisted liposuction. He has authored many articles and book chapters and he is also the director of Clinica Goldman in Porto Alegre, Brazil.M.D.
Frederic G. Nicola, M.D.
Diplomate, American Board of Orthopaedic Surgery
Team Physician Oakland Raiders
Dr. Frederic Nicola is a Johns Hopkins Fellowship trained physician who is an experienced surgeon specializing in the fields of orthopedic surgery and sports medicine. His expertise in disorders of the knee joint and in advanced techniques for cartilage preservation using minimally invasive and FDA approved techniques is unsurpassed.
Having served as team physician for the Oakland/Los Angeles Raiders since 1983, Dr. Nicola still actively maintains that role for the Raiders, performing game-day, training camp, and NFL Combine duties. As a member of the National Football League Team Physician Society, Dr. Nicola has worked as team physician during two Super Bowls and two Pro Bowls. He is also an experienced Ringside Boxing Physician for the California State Athletic Commission. With more than 20 years of treating some of the top athletes in the nation, Dr. Nicola’s experience as an orthopedic surgeon and sports physician is unmatched.
The former chairman of orthopedics at Cedars Sinai Medical Center, Dr. Nicola is currently the director of the Knee and Hip Institute at DISC, where he continues to use minimally-invasive as well as the latest FDA approved techniques to treat disorders of the shoulder, elbow, hip, knee, and ankle. His other specialty lies in utilizing the technique of cartilage preservation to prolong the natural life of those joints. As an orthopedic surgeon, he is dedicated to relieving the pain caused by joint-related injuries and allowing his patients to enjoy the same active lifestyle they had prior to their injury.
Ludlow Research Issues Opinion on SVFCE Based on their Stem Cell Technology
Last Updated: June 26, 2013 - 8:00am EST
http://www.wallstreetnewscast.com/profile/svfc.html
(NEW YORK)--Intellicell Biosciences, Inc. (OTC:SVFCE), a developer of technology for the extraction of autologous stem cells for physicians in the area of regenerative medicine, was initialed research coverage based on their unique stem cell processing technology.
Report Highlights
- Unique Stem Cell Extraction Technology from Blood Vessels
- FDA Registered Facility in NYC
- One of few cGTP Cell Manufacturing Facilities in US
- Use of Ultrasonic Cavitation instead of Enzymes
- Patent for Stem Cell Extraction Process
- Appointment of Dr Zain Khalpey to Advisory Board
FDA Compliant Stem Cell Facility
In November 2012, the Company was notified according to the Federal Drug Administration (“FDA”) validation registration number 3009842420, that its new facility located at 460 Park Avenue, New York, NY 10022 is now registered to recover, process, package, store, and label human cells and tissue products (HCT/P’s), such as the IntelliCell autologous stromal vascular fraction cellular product.
IntelliCell's proprietary patented method for deriving blood vessel originated vascular cells from adipose (fat) tissue by use of ultrasonic cavitation. This technology is an innovative mechanical method for the separation of stromal vascular fraction without the use of enzymes. Ultrasonic cavitation is an innovative mechanical method of separating SVFCs from fat tissue. Vascular cells derived by IntelliCell's proprietary method are potentially useful in bringing the promise of regenerative medicine to many therapeutic and aesthetic procedures.
Open House Tour Event
Very rarely do we get the chance to tour a companies operation facilities. Since based in midtown Manhattan we had the chance to tour SVFC medical treatment facilities, and can say first hand that their facilities were very impressive. Not only were their people visiting for basic cosmetic treatments, which the company uses to generate revenue and offset operational costs, but the back-side treatment facilities were quit large and impressive. There were a number of completed clean and professional minimal surgical treatment rooms, offices, and very impressive and FDA compliant stem cell extraction processing room, which was managed by very experienced and professional personal.
The Company is working on conducting an open house event where shareholders, and institutional investors will be invited to tour their facilities on Park Avenue, and meet the executives from IntelliCell. An announcement of this upcoming open house could be released in the coming days, and to potentially attend this event in NYC you can register here to request more information.
All in all, SVFC isn't one of your regular penny stock, or run of the mill R&D stem cell stocks. SVFC has a very impressive treatment facility that will not only manufacture stem cells through their now patented process, but treat patients as well. This places SVFC as one of the very few stem cell treatment and manufacturers in the US, and they are always open to provide guided tours if you ever find yourself in New York City. This is definately one to watch.
08/23/23 8:27 AM
AI
