FPC Blog


From Pig Valves to Stem Cells – The Exciting Evolution of Regenerative Medicine

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Introduction: 

Regenerative medicine is rapidly emerging as one of the most transformational and economically impactful healthcare advances in decades. While techniques for tissue engineering and molecular medicine have been a part of surgical care for decades, the options for modifying human cells, tissues and organs have exploded. Regenerative medicine has extended from surgical recovery to genetic disease, traumatic brain injury, joint therapy, autoimmune, and organ recovery. 

According to a report by Precedence Research, the global regenerative medicine market size is projected to be worth around USD 37.92 billion by 2030 and is expanding growth at a CAGR of 16.2% from 2021 to 20301 The report also highlights that one of the major factors driving the regenerative medicine market growth is the rising prevalence of genetic and chronic disorders.2 This growth in new treatment technologies stands poised to not only improve patient outcomes, but also drastically reduce the billions of dollars per year America spends on joint replacement surgeries and post-surgical care. 

As the population ages, more and more Americans are affected by joint degeneration and arthritis. Seeking to avoid risky surgeries and addictive opioids, many are turning to regenerative medicine as a revolutionary alternative. Groundbreaking case studies, like the one we will explore here, provide intriguing evidence that regenerative techniques can reverse joint damage naturally – no scalpels or prescription pills required. 

The implications for the US healthcare system and economy could be staggering if these emerging biological technologies live up to their promise, with some analysts projecting over 50% reductions in surgical costs.3 Follow along as we discuss this exciting medical frontier. The treatments described here may soon be saving millions from unnecessary suffering and society from massive costs. Our exploration of regenerative joint recovery provides a glimpse into the future of medicine in America. A future that patients, providers, and policymakers alike have reason to eagerly anticipate. 

Problem Identification: 

Consider using bone-on-bone disease as an example for how this new approach to medicine will change the entire therapeutic landscape. As 2012 Nobel winner Shinya Yamanaka has explained, a vast array of diseases is “easy” to solve, all with a similar cellular replacement approach.4 Yamanaka makes clear the underlying clinical problem is the same with the cartilage of a joint, the brain cells in Parkinson’s disease, and in muscle cells of the injured heart – the attenuated or reduced cells simply need to be replaced.5 

Knee Rescue 

A recent 60-year-old patient in our center demonstrated the new paradigm brilliantly. Each knee had failed to improve with surgical meniscus removal, medications, and supplements. The patient had the 2 cardiovascular fitness of a 25-year-old but looked like an 80-year-old as he tried to run or jump. Employing several regenerative techniques in a single treatment session, the patient became pain free with both knees and able to jump without pain. A knee replacement is no longer a consideration as he has resumed his amateur cyclist training schedule. 

Shoulder Reversal 

But the knees are not the only joint that responds to these new technologies. A “frozen shoulder” (adhesive capsulitis) patient had a classic onset of shoulder pain and loss of range of motion. A single regenerative treatment was aimed at improving the course of this well-described unrelenting joint condition. Incredibly, the patient presented the NEXT day with full pain-free movement. 4-weeks later the same patient reported the apparent reversal of a 20-year long serious continuous “low blood pressure” condition, requiring him previously to stop taking a daily drug on which he had depended for two decades. A case like this intrigues some profit-minded executives and entrepreneurs, but also stokes fear for others. Are we faced with a new kind of medicine that reaches across the body to simultaneously repair a host of cellular dysfunctions? 

Hands Relief 

Hand arthritis is a common affliction that impacts millions. Preliminary data from at least one small international safety trial showed a dramatic sustained improvement using regenerative medicine. There were no treatment failures in this study. In our center we have likewise seen a high degree of long-term pain reversal with hand arthritis. 

Our patient said: “I have deformed fingers from intense daily job use. A single injection has made me pain-free for more than a year.” The Arthritis Foundation represents that women are afflicted at a rate twice the rate of men. 50% of women who reach age 85 will struggle with stiffness and dysfunction of the joint of their fingers.6 Steroid injections have been the mainstay intervention of moderate to severe arthritis. Currently the industry tolerates the regular therapeutic use of oral medications that promote risk for deadly adverse events. There is excellent data to suggest that regenerative medicine can avoid these adverse effects and supply long-term relief with a single regenerative deployment. 

The Paradigm Shift: 

The “Ah Ha” moment awaits us all as it relates to any paradigm shift. Simon Senek represents that psychology dictates a natural resistance to the acceptance of change. Few can accept world-changing technology before its acceptance by 15-18% of the population7. The author was an attendee of a 2017 scientific presentation that presented data that doctors could completely recover a damaged organ. At the time I jumped up and down like I was at a modern rave. I did not understand why others were just sitting. Such an advancement is the thing that medical students dream. I have continued to pump my fist in the air as financial interests seem to have buried the organ recovery data and the device behind the outcome. Maybe executives understand that regulatory capture will resist such a disruptive advance? But the human spirit flourishes with the wind of capitalism at its back. 

Capitalism Finds a Way: 

The quash of innovation can include reasons that range from legitimate to sinister. In a Marxist environment the “goodies” are routinely held aside for the elites alone. But in a free market economy, the seed of value will germinate for all even under adversarial conditions. The triad of resistance to regenerative medicine is ego, ignorance, and the economic opportunism of the old “disease model.” Our entire medical delivery system has insulated itself from market forces for generations. The system is currently collapsing under its own morbid weight. An arc that trends so long towards inefficiency, must finally bend toward value. Capitalism comes to the rescue in the form of clinical medicine champions and corporate pragmatists. 

Medicine Champions 

Doctors will find a way to care for their patients, and those clinicians who are also entrepreneurial will create and scale innovation. The existing institutions of payors, networks, and providers over the last two decades have implemented treatments which are only incrementally improved. A host of chronic diseases and acute injuries remain unrelenting in effect. There are many mechanisms built into our system which impede innovative care. But I have capitalist-minded colleagues who are finding ways to step around mediocrity. One of my colleagues demonstrated a regenerative technology able to triple the rate of full recovery after traumatic brain injury. We don’t know if the old regulatory systems can accommodate advances like this. But her data has already made its way to corporate players who do not have the appetite to tolerate a 1970’s regulatory system in the age of AI. 

Innovative Financial and Corporate Landscape 

The investment and corporate sectors are increasingly vocal about their dissatisfaction with the escalating costs of healthcare. As detailed in industry analyses like those from Investopedia, the financial burden borne by companies is substantial. It is reported that businesses cover as much as 73% of the typical $22,463 annual healthcare cost for a family of four. Furthermore, a significant majority of employees, about 65%, are enrolled in health plans primarily funded by their employers. 

This growing financial strain is not merely a matter of corporate balance sheets; it represents a turning point in the approach to healthcare. The drive for innovation is not expected to stem from traditional governmental avenues but rather from strategic collaborations between forward-thinking companies and venture capitalists. These entities are not content with status quo solutions and are ready to offer advanced alternatives for self-funded employee health insurance. 

Embracing a full-risk model, these visionaries are rejecting the outdated, one-size-fits-all healthcare approach. They are spearheading the development of networks dedicated to integrative and regenerative medicine. As this innovative healthcare model matures, it is poised to utilize data-driven strategies, potentially expanding into areas like medical tourism for select procedures, thereby meeting a diverse array of healthcare needs more effectively.” 

Solution Presentation: 

We are using the presented severe knee degenerative arthritis in a 60-year-old cyclist as an example of how regenerative medicine might intervene in similar fashion for an array of reversible tissue conditions. In this case we are demonstrating how the patient might avoid joint replacement. Regenerative injections offer a promising alternative. Three actionable tactics were considered for the patient include: 

  • Platelet-rich plasma (PRP) injections to stimulate cartilage regeneration. Treatment involves a blood draw to process and isolate the patient’s own concentrated platelets. This blood component is rich in factors that impact inflammation and pain. Injections involve a simple office procedure. Orthobiologics companies like Biomet and Arthrex have PRP kits starting under $1,000. 
  • Bone marrow concentrate (BMC) injections to restore cartilage and bone health. Arthrex Angel and Regenexx systems provide treatments which range from $1,500-$10,000. Isolation of the patient’s own bone marrow cells has become a routine office procedure. A single joint deployment might provide relief for months to years. 
  • Adipose-derived stem cell injections to reduce inflammation and promote healing. Cells and structural components are separated from the patient’s fatty tissue with specialized equipment and prepared for injection using systems from companies like Lipogems and AdiStem. Kits start around $5,000. 

Combining multiple regenerative techniques allows for greater efficacy than any approach alone. Astute investors could target the companies with best-in-class technology in this rapidly growing market. According to the 2021 Annual Report, there were 2,244,587 hip and knee arthroplasty procedures performed between 2012 and 2020.8 Regenerative injections present a multi-billion dollar opportunity to heal joints and restore quality of life non-surgically. 

With declining costs and rapid innovation, regenerative medicine could transform healthcare. Getting in early on companies commercializing leading-edge cell and gene therapies may offer investors substantial upside. *Investments carry inherent risks. The writer of this blog is not dispensing individual advice nor endorsements through this commentary. All readers are responsible for thorough personal due diligence and consultation with financial advisors before making investment decisions. 

Here are some example companies that investors could target as promising investment opportunities in the emerging regenerative medicine space:

  • Athersys (ATHX – NASDAQ) – Developing off-the-shelf stem cell treatments including MultiStem for treating inflammatory conditions and stimulating tissue repair. Recently received FDA RMAT designation for expedited consideration for treating the lung condition ARDS. 
  • Tissue Tech, Inc – A leader in the space of placenta-based regenerative tissue. Currently enjoys FDA RMAT designation for expedited consideration for TTAX02 as a device for the surgical intervention for intrauterine spina bifida. 
  • Mesoblast (MESO – NASDAQ) – Their allogeneic cell therapy remestemcel-L showed strong Phase 3 results for treating steroid-refractory acute graft versus host disease. Also pursuing treatments for back pain and heart failure. 
  • Sangamo Therapeutics (SGMO – NASDAQ) – Pioneering gene editing and cell therapy technology with promising treatments for hemophilia, lysosomal storage disorders, and autoimmune diseases. Partners include Biogen, Pfizer, and Novartis. 
  • Fate Therapeutics (FATE – NASDAQ) – Producing off-the-shelf, programmed cellular immunotherapies for cancer and immune disorders. Robust pipeline of NK cell and T cell candidates for solid tumors. 
  • Replimune Group (REPL – NASDAQ) – Developing oncolytic immunotherapies designed to selectively attack cancer while triggering anti-tumor immunity. Recently entered a global license with Janssen. 
  • T2 Biosystems (TTOO – NASDAQ) – Their technology rapidly identifies sepsis-causing pathogens to enable targeted, pathogen-specific sepsis treatment. Also developing tests for Lyme disease and other conditions. 

Conclusion  

The Financial Policy Council (FPC) challenges you to wake up and confront the seismic shift that regenerative medicine is unleashing in healthcare. This isn’t just another advancement; it’s a full-blown upheaval of the status quo. While the complacent may linger in the comfort of outdated methods, we urge you to break free and spearhead this revolution. Traditional healthcare systems are not just evolving; they are being overtaken. We’re not asking you to merely adapt; we’re urging you to lead the charge. The potential of this disruptive force is not a distant dream—it’s a concrete reality reshaping healthcare as we know it. 

Innovative doctors and trailblazing entrepreneurs aren’t just experimenting with regenerative medicine; they’re using it to rewrite the rules of healing and health. Corporate leaders are not just noticing; they’re acting, recognizing the immense opportunity to overhaul employee health insurance for the better, slashing costs, and vastly improving lives. This goes beyond optimism; it’s a battle cry for change. 

We stand at a pivotal moment in healthcare history, a chance to alleviate suffering, dramatically cut medical expenses, and elevate the human condition. But what good is this revolution if you remain a bystander? How will your family and your finances reap the benefits if you don’t actively engage? The transition from conventional treatments to the forefront of regenerative medicine is laden with opportunities, but only for the audacious, the disruptors, the contrarians who understand that the future is not tomorrow—it’s today. 

The future of healthcare is here, demanding not just your attention but your active participation. It’s time to challenge the old guard, to be the maverick in this new era. Will you merely watch from the sidelines, or will you lead the charge? The choice is yours but make no mistake: the revolution won’t wait. 

The Financial Policy Council 

As a member of the Fiscal Policy Council, I can affirm that the FPC is dedicated to a core mission of fostering sound public policy. We recognize the critical intersection of fiscal matters and healthcare policy in shaping the nation’s prosperity and well-being. 

The Council advocates for a healthcare landscape that mirrors the principles of liberty, prosperity, and independence. We see healthcare as an essential pillar of a thriving America, where the pursuit of health and economic growth go hand in hand. Our commitment is unwavering. We strive to achieve our mission through the following endeavors: 

EMPOWER: We empower entrepreneurs, investors, and the public to actively engage with policymakers, ensuring that their voices are heard in support of healthcare policy solutions that align with the broader principles of economic development. 

EDUCATE: We educate policymakers and the public alike, fostering an understanding of the significance of sound financial public policy within the context of a re-envisioned healthcare. We seek to enlighten individuals about the crucial concerns of entrepreneurs, investors, and the broader community regarding healthcare policy. 

BRIDGE: 

At the Financial Policy Council (FPC), we are committed to bridging the gap between real-world business experience and policymaking. Our mission is pursued through conducting timely and accurate research on key policy issues, and effectively disseminating these findings to crucial decision-makers. This includes key policymakers, the nation’s news media, and the academic and policy communities at large. 

We firmly believe in the importance of ensuring that individuals with hands-on experience in business and entrepreneurship, particularly those well-versed in the financial services industry, have a platform to project their voices. It is essential that their insights reach those making critical decisions impacting our nation’s fiscal health. 

Chaired by Ziad Abdelnour and governed by a Board of Directors with deep and relevant experience, the FPC operates as an autonomous, non-profit organization. Our work is supported by the general public, foundations, and business contributions. Adhering to our ideals of independence and freedom, the FPC does not accept government funds nor engage in contract work. We are a tax-exempt organization under section 501(c)(3) of the United States Internal Revenue Code. 

The FPC is a champion of sound public policy. Its experts, with practical expertise in business and entrepreneurship across various asset classes, contribute significantly to our mission. Our published findings serve as a call to action to key policymakers, the news media, the financial sector, and the academic and policy communities. 

Visit www.financialpolicycouncil.org to access blogs and resources focused on evidence-based healthcare policy solutions. Connect with legal, medical, and economic experts working to reform healthcare regulations and investment strategies aimed at accelerating development of regenerative treatments. 

Together we can support pragmatic ventures increasing patient access, lowering costs, and improving quality around revolutionary technologies like regenerative medicine – building the next generation of resilient and equitable medical advancement for all. 

Passionate citizens deserve governance and healthcare systems that work. While the path forward faces critics, progress depends on an activated public participating in solution-building. We ask readers compelled by the restorative possibilities of regenerative medicine to join the FPC contributor network as authors or volunteers to uplift ideas into action. For it is only through principled participation that we secure the blessings of life, liberty, and the pursuit of happiness for our post-pandemic world. 

#RegenMed #TissueEngineering #StemCells #CellTherapy #JointHealth #Biologics 

Footnotes: 

  1. https://www.globenewswire.com/news-release/2022/03/16/2404664/0/en/Regenerative-Medicine-Market-Size-Worth-Around-US-37-92-Bn-by-2030.html 
  2. https://www.aaos.org/aaos-home/newsroom/press-releases/american-joint-replacement-registry-releases-2021-annual-report/ 
  3. https://www.mckinsey.com/capabilities/mckinsey-digital/our-insights/how-the-bio-revolution-could-transform-the-competitive-landscape 
  4. https://www.nobelprize.org/prizes/medicine/2012/yamanaka/facts/ 
  5. https://www.bbc.com/news/health-19869673 
  6. https://www.arthritis.org/getmedia/73a9f02d-7f91-4084-91c3-0ed0b11c5814/abtn-2020-final.pdf 
  7. https://www.smartinsights.com/digital-marketing-strategy/online-value-proposition/start-with-why-creating-a-value-proposition-with-the-golden-circle-model/ 
  8. https://www.aaos.org/aaos-home/newsroom/press-releases/american-joint-replacement-registry-releases-2021-annual-report/ 

About the Author: 

Gregory Laurence, MD FAAFP, BC ABFM, ABLS, is a surgeon, innovator, and risk management consultant from Germantown, TN. 

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