Beware of Foreign Platlet-rich Plasma Company Spreading Misinformation to Deceive Physcians and Consumers, Smear Their Competitors, and Limit Access to Affordable Care
PUBLIC HEALTH NOTIFICATION: Foreign medical device distributors are now launching unfounded smear campaigns against well-established, FDA registered, US-based regenerative medical device companies in an effort to disrupt the global supply chain and access to safe, effective, and affordable healthcare and therapies.
March 5, 2020 (FPRC) -- Regenerative Medicine is defined by the American Association of Blood Banks® as “the process of replacing or regenerating human cells, tissues or organs to restore or establish normal function”.1 Within the field of regenerative medicine there are potential treatments that are harvested from a patient’s own body, called autologous therapies, which are “(of cells or tissues) obtained from the same individual”. Autologous therapies are renowned for the fact that they are safe, effective, relatively easy to perform, and affordable options to risky and often costly alternatives such as surgery.
One such autologous therapy is Platelet-Rich Plasma, or PRP for short. This therapy works by harvesting whole blood from the patient and processing it to extract the blood platelets, growth factors, plasma and other naturally occurring components utilized by the body to respond to injury and repair tissue damage. PRP has been extensively studied by the medical community and has proven to effectively treat a variety of conditions ranging from degenerative musculoskeletal conditions, such as, Osteoarthritis of the knee, to aesthetic concerns such as androgenetic alopecia, which is also known as “male pattern baldness”. In fact, PRP therapy is so safe and effective that over 11,632 clinical research studies have been published in the US National Library of Medicine by The National Institutes of Health without a single adverse event or serious side-effect ever reported!2
To properly harvest and prepare Platelet-Rich Plasma, a licensed healthcare provider often uses a medical device called a “PRP Kit” to aide in this process. While there are many types of PRP Kits offered for sale to healthcare providers both domestically and abroad, not all of these medical devices are created equal. Many manufactures, distributors, and marketing companies the world over present often complex “solutions” in the form of their PRP kits to healthcare providers under the guise that their device is in some way superior to other products available in the marketplace. While this is true to a degree, some companies have produced adulterated “scientific research”, falsified lab reports, flashy sales collateral or websites and other misinformation to confuse and mislead both healthcare providers and the general public as it relates to the field of autologous regenerative medicine, and more specifically to PRP Kits themselves. One could argue that certain companies are over complicating the process to present their device as the only solution and charging a premium price point to the healthcare providers that they have duped with their “bought and paid for” evidence. This in turn raises the cost of these often life-changing treatment options to the patients that so desperately need access to safe and effective alternatives to drugs, surgeries, or simply being told they have to live with the pain, loss of function, or the gradual deterioration of their once youthful and healthy appearance.
One such company that has resorted to predatory and deceptive tactics such as this, is Regen Lab™. In a February 12th, 2020 email-blast titled “RegenLab USA LLC, a growing company with new facility and new organization!”, many false claims and attacks were levied against various competitors of Regen Lab™, while also touting their “new facility located in Brooklyn”, “with works starting in January 2020 and hopefully with production of RegenPRP® made in USA in September 2020”. This email, that was in all reality a thinly vailed “hit piece”, attacked various other manufacturers as being “non-conforming”, or manufactured outside of the USA. The real irony of this deceptive promotional email distributed to various healthcare providers in the United States, is that Regen Lab itself is a foreign based corporation that attempted to profit from use of the term “made in USA”, when it does not yet in fact make it’s own products in the USA as self-admitted within the email itself.
One of the companies attacked in the above referenced email is Estar Medical™, an Israel based company that markets a competitive product to RegenLab™ labeled Tropocells® PRP Kits. Within the email many derogatory claims about Estar Medical™ are made, and an “article” is referenced as the source of these claims. However, when one follows the link to this supposed news article3 it turns out to be a paid website for publishing press releases https://prdistributionco.com/ where for “Only $85” anyone can purchase an “Internet Presence & SEO Package” which includes: “1 Professionally Written Press Release+Revisions, Your Press Release will be distributed to 20+ Social Media websites, Published to PRD Newswire”.4 While the term “Fake News” has been oft overused and thrown around with reckless abandon in our domestic news media of late, this sure appears to be one very good example of a real case of bought and paid for “Fake News”.
If you dig a little further, you can discover that Regen Lab™ may not be the reputable source for information as it relates to their competitors, as they may want you to believe… In fact, maybe there is an ulterior motive to this email and its “news” content, maybe it is actually revenge? You see, in a 2019 legal ruling the “UK High Court Refuses to Grant Regen Lab Permission to Appeal the PRP Patent Revocation Judgement and Orders Regen Lab to Pay Hundreds of Thousands of Pounds to Estar Medical”.5 The plot thickens and maybe the content of this predatory email is purposefully misleading, especially considering it was sent from Antoine Turzi, founder and CEO of RegenLab SA, who was cited by the UK Patent’s court as being quote: "not a reliable witness".
To further unravel this piece of “Fake News”, numerous other “bombshell” claims are levied against more competitors of RegenLab™, such as Healeon Medical and their HD PRP™ system. They claim that “there was a recall of products reported to the US-FDA”, including the HD PRP™ kit and other products. But a quick search of the 1,224 medical device product recalls previously and currently issued by the US Food and Drug Administration6 reveals there was never a recall issued of this device, or brand. A further search for the other brand names listed within the predatory and deceptive email as having USFDA recalls issued against them including “Juventix Medical PRP Kit, Suneva Medical HD PRP, Integrity PRP kit, Medshift PRP, Prizmah PRP and CellTherapy PRP kit” also all come back without any previous, current, or pending recalls issued by the FDA.
In a second attempt to sow dissent, misinformation, and chaos to damage the business interests of their competitors Regen Lab™ distributed another predatory email on Tuesday March 3rd, 2020 entitled “Non-Conforming Chinese Medical Devices Are Placing Consumers & Patients At Considerable Risk”. They attacked a host of their competitors, again referencing an article disguised as “news” which was a paid press-release distribution by a for-hire company7. They even included a picture designed to make it appear as if there was a safety recall issued against their competitors headlined “The Medical Community Should Avoid If They Come Across These Products: There Is An Urgent Alert On These Items ----- Confiscate & Notify Authorities:”
So why does the deceptive behavior of one “bad actor” in the regenerative medical community matter to physicians, to consumers, and to those of you reading this article? Because misinformation such as this is a danger to competition, to the development of advanced technology and more efficient solutions, and above all behavior like this puts at risk access to care offered by affordable, safe, and effective medical devices and solutions.
One such medical device company that was unscrupulously attacked by these false claims levied against it is Juventix Regenerative Medical, LLC. Unlike Regen Labs™, Juventix is actually a US based corporation, owned by US citizens, that employs other US citizens, who pay their taxes and contribute to their local communities. Additionally, Juventix Regenerative Medical, LLC is registered with the US Food and Drug Administration holding the registration number 3015942805, which is confirmed by the FDA through their public online “Establishment Registration & Device Listing” database.9
Additionally, Regen Labs™ incorrectly claims that Juventix line of PRP Kits is manufactured by a Chinese based company Beijing Hanbaihan Medical Devices Co. Ltd. (HBH), and that this company “has been shut down by the Chinese CFDA”. Both claims are categorically false. A quick email to one of HBH’s employees was returned confirming they are still open and operational, even despite the recent Coronavirus outbreak in mainland China, and a search of the Chinese FDA’s website for adverse actions against their company and products returned no results8, just as the USFDA search also returned no adverse findings. In reality, the Juventix Medical PRP Kits have been issued an FDA 510(K) clearance under the Premarket Submission Number: BK170136, which verifies that their products “demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.” The same degree of registration and clearance afforded to other reputable Class II medical devices in the USA.
While the true motives of Regen Labs™ and the misleading emails and “bought-and-paid-for” press releases they have splashed across the internet these past few weeks cannot be ascertained, one can’t help but wonder if this was an effort to unfairly compete with their peers that produce safe, effective, and above all affordable devices made available to US physicians and by extension, their patients? This hypothesis speaks to the heart of why this press release was drafted, because the founder of Juventix Regenerative Medical, LLC actually went into business to compete with the existing PRP Kit manufacturers, distributors and marketers that operated in the global marketplace because he had seen first-hand as an end-user how expensive, complicated to use, and time consuming other platelet-rich plasma processing kits could be. His goal was to develop and source manufacturing channels for a product that could be prepared in less time, with less complexity, and at a lower cost than current devices – in other words, he was trying to disrupt the market, and as a result place access to quality care at more affordable prices into the hands of US and world consumers. Based upon that fact that their competitors have resorted to efforts of defamation and slander, Juventix can be confident that they have in fact disrupted the marketplace, and are placing increased pressure on their peers to improve their own operations to remain relevant and competitive with the current US based platelet-rich plasma market leader.
That’s why we are happy to report that since our inception Juventix Regenerative Medical, LLC has a strong history of positive clinical outcomes reported by their physician clients and by extension their patients, while maintaining the highest quality standards resulting in ZERO complaints filed by patients, physicians, entities or organizations to date! Despite false and misleading smear efforts by competitors Juventix will remain true to its founding principle and commitment to always offer the highest quality regenerative medical devices, supplies, and advanced technologies to the healthcare community so that they may better care for their patients, improve their quality of life, and minimize the financial burden to access the latest and greatest treatment options available to them!
To join the growing ranks of physicians and healthcare clinics utilizing the Juventix Regenerative Medical line of PRP Kits and accessories please visit www.Juventix.com, email email@example.com, or call (866) 693-4PRP today!
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Contact: Lance Liberti
Juventix Regenerative Medical, LLC
Phone: (866) 693-4777
About Juventix Regenerative Medical, LLC:
Juventix Regenerative Medical is a corporation dedicated to innovation in novel non-surgical alternative products and techniques to combat the problems of aging. More than a decade ago Juventix began as an effort by its founder Lance Liberti, to develop a simple to use, clinically effective, and cost-effective alternative to the complicated, time consuming, and expensive Platelet Rich Plasma (PRP) processing kits of the late-2000’s. Years of research and trial lead to the launch of Juventix flagship Medical PRP Kit in 2017. In the years since, Juventix continues to be a leader in the field of regenerative medical enhancement offering the first pre-titrated medical kits for the preparation of PRP and Hyaluronic Acid (HA) facial filler and skin rejuvenation, as well as PRP and Biotin (B7) for hair restoration therapy. Juventix also participates in and hosts various advanced clinical training symposiums in collaboration with renowned organizations and institutes such as the USF Health Center for Advanced Medical Learning and Simulation (CAMLS). To learn more about Lance Liberti and Juventix Regenerative Medical please visit: www.Juventix.com
For more information contact Lance Liberti of Juventix Regenerative Medical, LLC (http://www.juventix.com)
Juventix, RegenLab, Antoine Turzi
You can read this press release online at: http://www.free-press-release-center.info/pr00000000000000403691.html