Addressing Plastic Surgery | Orthopedics | Urology | Obstetrics-Gynecology specialties with the help of both regular and innovative techniques such as those using progenitor cells (PC).

In this respect, the clinic will utilize a cellular mechanical isolation technology patented by Rigenera in Italy.

It will be the first ever Romanian private human tissue entity carrying both the import & distribution accreditation.

Banked tissues will include cornea, bone, blood vessels, tendons and diverse cellular extracts & concentrates that are to be stored either in cryopreservation conditions or at the room temperature.

× The status quo is to import tissue from other EU countries. Romania has a close to baseline tissue collections from brain-dead patients therefore a virgin but needy market in this respect.

× Romanian human tissue legislation can suffer improvements. Therefore, in order to transplant a cornea (f.e.) you need to import and distribute as if RO in not an E.U. country. Doctor MiT Clinic BioBank will serve as the missing link.

× There is a large grey market as, until now, the entirely legal structure for import and distribution was not available. Unfortunately, statistics are unreliable in Romania, as the vast majority of these procedures are underreported because of lack of legal framework. There is a consensus that the clinics protect themselves by omitting to report.

× Doctor MiT Clinic Biobank is to apply and obtain an import & distribution accreditation by A.N.T. (Agentia Nationala de Transplant – National Transplant Agency) for own use and further distribution to other clinics.

× Rigenera is used in dozens of countries for this purpose as well as in scientific research such as in the case of E.S.A. (European Space Agency) for the study of tissue regeneration in microgravity environments or at the Excellency Center for Translational Medicine within Fundeni Institute with the purpose to create brand new liver tissue.

× Progenitor cells are easy to isolate with Rigenera through a mechanical process that allows for the filtration of cells with a diameter of 50 μm, in contrast with enzymatic procedures where reagents are used and various culture periods are needed.

× Micrografts are tissue particles or individual progenitor cells (PCs), which are descendants of stem cells that can differentiate into specialized cells belonging to the same type of tissue.

× The treatment of tissue with progenitor cells allows for quick wound healing with a rapid and minimally invasive chair-side technique.

× Various techniques exist to harvest PC. Since 2018, this treatment is available from the Spanish-Italian company HBW Rigenera, with Doctor MiT Center S.R.L. acting as the exclusive importer and distributor in Romania for numerous clinics offering treatment.

× These partners are successful, face a supply-demand imbalance, and are largely not present in the capital, Bucharest. Furthermore, none of the current Rigenera clients in Romania focus on tissue regeneration. The addressable market is much larger, via hospitals using other techniques.

Human tissue bank

There is no import-distribution human tissue bank so far in Romania. It is needed in order to unlock the national private transplants market. It will address every downside:

+ Importing tissue for transplants ===> time and additional cost

+ Perfectable legislation

+ The Romanian market (except for IVF) is “grey”, as lacking the legal structures (such as an import/distribution entity) to bring in tissues from other European tissue banks

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This results in creating an unnecessary brake on patient tissue transplants.

Rigenera within the medical practice

Rigenera represents the only specific cellular treatment of any kind compared to the below list of other treatments:

+ Enzymatic: specific, long process & affected cellular grafting success rate, expensive.

+ Platelet-Rich Plasma (PRP): non-specific, long process, many recurring treatments.

+ Lipogems: non-specific, long procedure, requesting authorized surgeons, expensive.

+ Ozone therapy: non-specific, cheap, many recurring treatments

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Alternative treatments are more invasive, more expensive or less effective.

Dr. Dragos Zamfirescu – plastic surgeon:
“Rigenera reaches more than 90% grafting success.“

Dr. Diana Serban Scurtu – obstetrics-gynecologist:
“Rigenera is the straight forward option for true cellular vaginal rejuvenation.”

Dr. Mihai Rascu – traumatalogy and orthopedics surgeon:
“More than 90% of my arthritic patients are happy with Rigenera results.“

Dr. Daniela Catanas - intensive care & dermatology :
“There is no patient that does not positively respond to Rigenera treatment for alopecia.”

The main indications for Rigenera (except for the big burns) address a Romanian pool of patients numbered in hundred of thousands:

Arthritis + Alopecia + Vaginal rejuvenation + Vitiligo + Diabetic foot

Size / distribution of Rigenera distribution in RO up-to-date:
+ a total of 400 Rigenera treatments | 60% outside Bucharest | 160 treatments done on Doctor MiT generated patients.

TOTAL ADDRESSABLE MARKET (TAM)

+ Cornea

1,500 transplants / year RO potential; declared 1,016 since ever. Germany reports 7,000 transplants / year (D population is 4.5 larger than RO population)

+ Bone: 6,600 transplants / year RO potential; declared 699 since ever. Germany reports 30,000 transplants / year (D population is 4.5 larger than RO population)

+ Tendons: no figures for RO

+ Blood vessels: no figures for RO

+ Other (cell derived patches aso.): no figures for RO

Doctor MiT Clinic patient's services (B2C)
+ People suffering from any addressable disease with: Rigenera / Any other technology that will be acquired
+ Expecting women
+ People looking to improve their cosmetic appearance
+ Current Stem Sure database: Existing customers / Future customers

BioBank human tissue import / distribution (B2B)
+ Medical clinics that have surgery rooms for: Plastic surgery / Dermatology

The business mode is pretty straight forward. Doctor MiT Clinic BioBank provides the space, back-office and laboratory resources, for hand-picked consulting doctors for consult and for treatments as B2C business model.

The biobanking side of the business is a B2B that follows the B2B model.

+ (B2C) patients are being provided:

• By Doctor MiT Clinic BioBank marketing campaign
• By collaborating physicians

+ (B2B) customers are being provided:

• By Stem Sure sales team (their sales commission is accounted within the financial forecast)

Dr. Bogdan Ivanescu is the host of:

+ Doctor MiT TV-show that reaches more than 1,3M tele-spectators / month.

+ Biocode documentary produced by DIGI World – the first Romanian biotechnology documentary

+ Co-host of DIGIPEDIA Stiinta together with prof. Alexandru Mironov aired by DIGI World Romania

Dr. Ivanescu is the medical editor of Stiinta&Tehnica Magazine, the most respected science publication in Romania. He has also co-authored several research studies and scientifical papers.

Bogdan Ivanescu is the coordinator of the sole stem cells transplant programm in Romania, destined to treating autism in children aged 3-7 years.

As the only public person in Romania to produce 2 science TV-shows, dr. Bogdan Ivanescu’s media platform, Doctor MiT, reaches 1,3M Romanians every month via his communications channels. At least half of this monthly reach will bear Doctor MiT Clinic BioBank’s advertisement.

Yr 1 / Yr 2 / Yr 3:

+ 15 / 30 / 40 patient consults per day out of 44 (conservative) patient consults daily capacity

+ 1 / 3 / 6 Rigenera treatments / day out of 12 treatments daily capacity

Yr 1 / Yr 2 / Yr 3:

+ 2 / 6 / 10 tissue units released / day

+ €46K / €406K / €856K target profitability

BioBank's development by:

+ Proving cells isolation for Romanian stem cells banks based on a patented processing procedure that is to start trials on December 2022

+ Storing Stem Sure’s stem cells (with year 2027)

Clinic's development by:

Scaling up the number of clinics in Romania to 3 similar clinics by the end of year 3

Entering CRO programs and developing research programs

+ Revenues
+ COGS
+ Gross Margin
+ (S)G&A
+ Marketing cost
+ Profit

+ Seeking: 160 000 €

+ For 10% of the equity = initial offering 1.6M €

+ Breakeven in one year

+ 5 year equity value = 455 000 €

+ Participate in a novel medical clinic led by a proven business leader.

I have asked BALTO to provide investment counseling and financial guidance for the start of Doctor MiT Clinic BioBank as it is such an unique enterprise.

Grab this opportunity, as BALTO did, no later than 31st of December of the current year!

You are welcome!