A business plast for establishing "PROMETHEUS", a Regenerative Medicine Center in Cyprus

1. REGENERATIVE MEDICINE
Dr STAVROS A. ALEVROGIANNIS,MD, MsC(Orth.), PhD
SENIOR CONSULTANT ORTHOPAEDIC SURGEON/ MEDICAL DIRECTOR IN REGENERATIVE & RECONSTRUCTIVE ORTHOPAEDIC DEPT.
IASO GENERAL HOSPITAL/ATHENS/GREECE

2. OUR VISION- PROMETHEUS
Establish a European Regenerative Orthopaedic Center (E.O.R.C) in Cyprus for domestic
use & Medical Tourism.
● Prometheus is going to be a "Center of Excellence" in Regenerative Orthopaedics dedicated to
patients they wish to treat their hip & knee arthritis, as well as lower back pain, using their own
stem cells (MSC’s) and avoid major operations, such as joint replacements .
● It's main target, using a toolbox of life sciences, is a unique combination of economic
effectiveness, global reconnaissance, scientific competition and life expectancy elongation.
● Working together with our biotechnology company we constantly follow the scientific trends and
we strive to improve patients' lives by developing and employing safe and effective novel
cell therapies, therapeutic tools and technologies that hold the promise for better treatments.

3. PREVALENCE OF OSTEOARTHRITIS

5. HOW COMMON IS THE PROBLEM OF HIP & KNEE ARTHRITIS ?
Arthritis in the United States
3

6. Economically Detrimental
Direct + Indirect Costs
>$100 billion

7. Arthritis will continue to climb..

9. Reality
for 10 million
Americans
Desire
Golden Years?

10. NSAID’S TOXICITY

11. WHY NOT A TOTAL JOINT REPLACEMENT,
AS THE SUCCESSFUL RATE IS VERY HIGH?
● Lengthy period of hospitalization
● Lengthy period of downtime
● Painful rehabilitation
● Major trauma
● Blood loss
● Major complications

13. Regenerative Medicine/Orthopaedics
● Process of creating living, functional tissues to repair or replace tissue or
organ function lost due to age, disease, damage, or congenital defects
● It helps to produce extended healthy longevity
● Regenerative Orthopaedics :
a sub-division of Regenerative Medicine, dealing with biologic treatment of
most common orthopaedic injuries and chronic diseases, using Advanced
cellular Therapies (adult stem cells). Future trend to regenerate
musculoskeletal organs

14. Potential of Adult Stem Cells

15. ADVANCED CELLULAR THERAPIES (A.C.T)
Why someone to undergo a stem cell therapy for hip & knee
arthritis?
● A non-invasive method
● No hospitalization needed (O.D.C procedure)
● No blood loss
● No blood transfusion
● The patient can walk immediately, without any external aid
● Not extended physiotherapy protocols
● Minimal complication rates

16. Human Cells, Tissues, and Cellular and Tissue-Based Products 1 (HCT/Ps) from Adipose Tissue:
FDA Regulatory Considerations
Under FDA’s risk-based HCT/P regulatory framework, which is set forth in 21 CFR Part 1271, certain HCT/Ps are regulated solely under section 361
of the PHS Act and the regulations under
21 CFR Part 1271; no premarket review is required for these HCT/Ps. In 21 CFR 1271.10, the regulations identify the criteria for regulation solely
under section 361 of the PHS Act and
21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and
21 CFR Part 1271 if it meets all of the following criteria (21 CFR 1271.10(a)):
1) The HCT/P is minimally manipulated;
2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective
intent;
3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a
sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not
raise new clinical safety concerns with respect to the HCT/P; and
4) Either:
i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
a) Is for autologous use
b) Is for allogeneic use in a first-degree or second-degree blood relative; or
c) Is for reproductive use.
Apart from the above a hospital exemption is apparent

17. Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception
DRAFT GUIDANCE
Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice
announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in
the Federal Register.
Additional copies of this guidance are available from the Office of Communication, Outreach, and Development (OCOD), 10903
New Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002 or by calling 1-800-835-4709 or 240-402-7800, or
email ocod@fda.hhs.gov, or from
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
October 2014

18. Medical Tourism: not a new phenomenon
● Renowned centres / physicians have always attracted patients
from afar
 Healing shrines
 Spas
 Pilgrimages
● Wealthy citizens of countries with limited health resources
travelling to access care / expertise that cannot be obtained
locally
● Desperate patients with incurable conditions seeking miracle
cures

19. Medical Tourism Destinations
Source: Grail Research, 2009

20. Statistics …
● $60 billion / yr industry*
● USA 2006: >½ million people travelled overseas for care
● Thailand 2006: 36.4 million baht (USD: 1.15 million)
● Israel 2006: $40 million, 15,000 health tourists
● Singapore 2005: 374,000 health tourists
● India: 2005: >150,000 medical tourists
● Costa Rica 1993: (CMAJ)
 14% tourists came for medical reasons
 10% of hospital beds in 1 private hospital occupied by foreigners
*Crone, Academic Medicine, Vol 83, No 2, Feb 2008, 117-121

21. WHY CYPRUS FOR MEDICAL TOURISM?
● Geopolitical position
● English as a native language
● Transportation Possibilities to the Medical Tourism Destinations of Cyprus
● Many airlines companies have flights to Cyprus.
● Coastal communication with many countries in the South-East
● The abolition of visas with many countries.

22. Replacement/ Repair Regeneration
Regeneration Process

23. The Future is Cellular!
LET YOUR CELLS
BE
THE MEDICINE