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What is Regenerative Medicine?

Regenerative Medicine is a rapidly expanding, multidisciplinary set of innovative medical technologies that enable the body to repair, replace, restore and regenerate damaged or diseased cells, tissues and organs. The technologies enabling Regenerative Medicine (RM) are based on more than 50 years of research in stem cell biology, molecular biology, engineering, advanced materials, immunology and genomics. Together these RM technologies are transforming healthcare.

The RM field has taken a quantum leap forward with the introduction into the clinic of cell and gene-based therapies, which can cure underlying disease, rather than simply manage symptoms or slow disease progression. RM technologies, with their power to restore and regenerate regardless of the underlying medical indication (e.g. aging, cancer, trauma), are transforming the therapeutic landscape in much the same way as antibiotics and biotech did in previous decades. Antibiotics transformed the treatment of bacterial infections in the 1940s, and in the process created the big pharma industry. Recombinant proteins and monoclonal antibodies produced the next industry step change, and launched the biotech sector.

RM technologies, like cell and gene therapies, are the next major advancement in healthcare, and represent an enormous commercial opportunity. Proteus and its team have been at the forefront of the commercialisation of regenerative medicine technologies for over a decade and have deep domain knowledge of all its constituent parts including:

  • Cell Therapy – the use of living cells as therapies
  • Gene therapy – the therapeutic manipulation of genetic code
  • Stem cell biology to discover and develop new drugs that promote regeneration
  • Tissue engineering – using advanced materials and nanomaterials combined with cells to produce functional tissues and organs
  • Bio-aesthetic medicine: medical therapies that generate new and aesthetically appealing tissues
  • Stratified medicine – the ability to sub-divide patient populations into responders and non-responders and thus only treat patients that can benefit from the specific therapy
  • Underpinning technologies – the tools & devices required to enable the above RM technologies e.g. cost-effective and scalable manufacturing equipment, gene editing technologies and clinical cell implantation devices

In clinical trials, therapies based on RM technologies have been demonstrated to transform, or cure, a wide range of medical indications including:

 Cell Therapy

  • Advanced leukemias – T cell-based immunotherapies for acute lymphoblastic and chronic lymphocytic leukemias e.g. UPenn/Novartis; Juno Therapeutics
  • Cartilage regeneration in the knee e.g. Carticel, Aastrom Biopharmaceuticals; ChondroCelect, TiGenix
  • Cardiac disease – Chronic heart failure e.g. Adult stem cells Mesoblast/Teva Pharmaceuticals

Gene Therapy

  • Hemophilia – Factor 9 deficiency e.g. St. Jude’s/University College London; Spark Therapeutics
  • Inherited metabolic disease - familial lipoprotein lipase deficiency, Glybera, uniQure
  • Inherited immunology disorders e.g. Severe combined immune-deficiency (SCID) – GlaxoSmithKline/Molmed

Tissue Engineering

  • Chronic venous leg ulcers – Tissue-engineered skin replacement, Apligraf, Organogenesis, Dermagraft, Organogenesis
  • Diabetic foot ulcers - Tissue-engineered skin replacement, Apligraf, Organogenesis
  • Corneal blindness – Adult stem cell-based therapy e.g. Holoclar, Chiesi
  • Severe burns – Tissue-engineered skin – Epicel, Aastrom Biopharmaceuticals

Bio-aesthetic Medicine

  • Gum regeneration – tissue-engineered soft tissue to restore healthy gums, GINTUIT, Organogenesis

Combined these therapies have treated in excess of a million patients.

These represent only a small fraction of the RM technologies in development. Globally, there are several hundred thousand peer-reviewed publications, 10,000+ issued/pending patents and a weighty amount of industrial know-how directly relating to RM technologies. Currently there are well over a 100 programs in leading academic centers and several billion dollars in funding for research and translation spread across North America, Europe and Asia. This funding is confidently expected to increase over the coming decade as governments fiercely compete to create RM industrial clusters that generate significant health and wealth benefits.

RM is a sector with major commercial and investment opportunities. To date, less than 20 cell and gene-based therapies have received regulatory approval in North America, Europe and Japan, however, several hundred are currently in the later stages of development many of which have demonstrated significant proof of concept. This, in turn, has led to a proliferation of patient advocacy groups rightfully demanding a shift in medical treatment paradigms from traditional "band-aid therapies" to prevention, cure, rejuvenation, restoration, and replacement. Savvy entrepreneurs and passionate physicians and scientists are joining forces to take on the challenge of translating this innovative research into revolutionary medical therapies capable of alleviating the tremendous healthcare burden experienced by developed and developing countries. Globally here now over 700 private and over 60 public companies (combined market cap of over $10B) in the RM sector. With DHHS predicting the market for RM will reach $300B by 2020 it's no surprise that many analysts feel the sector is now entering into a significant inflection phase.

It is the mission of Proteus is to transform healthcare through RM technologies, capitalizing on the convergence of key market factors including: an ever-aging population, increasing patient expectations, diminishing Big Pharma pipelines, and significant corporate investment by the majority of the Big Pharma’s including GlaxoSmithKline, J&J, Novartis, and Pfizer, In this quest towards commercialization, Proteus has assembled the brightest minds in the field and built an elite team capable of providing the capital, scientific insight, and business leadership to launch and support the most successful RM companies in the world. Proteus will execute its mission by employing its unique in-house expertise, international network, proprietary deal flow and due diligence algorithms, an active management philosophy, and sector-specific exit strategy experience through licensing, M&A transactions, and public offerings.