OUR MARKETS(PLATELETS,RED CELLS,CONTAMINATES,NO WASHING,NEW - - PowerPoint PPT Presentation

OUR MARKETS(PLATELETS,RED CELLS,CONTAMINATES,NO WASHING,NEW PROTECTANT

ELIMINA MINATION ON OF BLOOD D SHOR ORTAGES GES GLOBA BALL LLY Resea search and disco scovered ed in the sixtie ies s under er Militar itary Contr tract t with h Un Union

• n Car

arbi bide e to elimin minat ate e shelf lf life e of Red d Cells. lls. Since e then we have e taken en it from

• m Red

d Cell lls to Platele elets (shelf elf life e 5-6 days and d $30-50 50B B Market), ), White e Cells, ls, and Plasm sma. a. We can an impl mpleme ement t the Platele elet t market with thin in months hs using the existin sting cryo-protec ectant tant for bloo

• od/s

d/stem em cells. lls. Introd

• ducin

ing a new w Cryo-protec ectan tant t that is alread ady FDA approved d for ot

• ther

er consu sumab mable le produc

• ducts.

s. This s new w Cryo-Protec ectant tant will ll elimin minat ate e the need ed to be remo moved ed prior

• r to use.

. The wa wash shing ing is an expen ensiv sive e toxic ic proc

• cess

ess whic ich will ll save e hospital itals/ s/blo blood

• d centers

s millio lions. s. Our proc

• cess

ss will ll also so elimin minat ate e most st if not

• t all contamin

taminat ates es in bloo

• od/s

d/stem em cells, lls, i.e. . bac acter eria ia, parasit asites, es, HeP A-C, C, and Viruse ses. . We will ll strea eam m line e the whole

• le donatio

ation and managem agement t proc

• cess

ss. . All you do is donat ate e bloo

• od.

d. No separ arate e proc

• cess

ss to extr trac act t Platele elets, ts, White e Cells lls, , or Plasm sma.

• a. Significa

icant t savi vings to hospital ital/b /bloo lood d cen enter ers. s.

Strategic partnering will be with companies like: Zipline.com. They use Drones for delivery

• f blood in Africa within minutes vs hours and days.

Fremont Scientific has a device and inventory management system and a portable device (cost approx. &5K) that is no water base and portable. In most if not all cases the customer has the required freezers thereby eliminating any major capital investment to implement our technology. Thereby saving millions in re-curing costs. This is game changing technology that will change blood management as we know it today.

CURRENT MARKET ECONOMICS

The markets which the process will have a major impact on:

• 1. Elimination of shelf life for all blood components: currently a $5.0B

market

• 2. Elimination of shelf of platelets: currently a $3.0B market
• 3. Elimination of washing of cryoprotectant from blood and stem cells:

potentially a $5B market

5 YEAR FINANCIAL PROJECTIONS

C-Levelclone Financial Statement (Platelets) Platelets.New Protectant) ($000’s) 2018 2019 2020 2021 2022 Revenue 296,345,67 325,980,23 358,578,26 394,436,087 433,879,69 CC/G/S 88,903,701 97,794,071 107,573,47 118,330,826 130,163,90 Gross Margins 207,441,96 228,186,16 251,004,78 276,105,261 303,715,78 Operating Income Expenses 2,569,234 2,826,157 3,108,772 3,419,649.00 3,761,615 Profit Before Taxes 204,872,73 225,360,00 247,896,01 272,685,612.0 299,954,17

MARKE KET T SIZE ZE

MODEL EL A PLATEL TELETS ETS UNITS TS DISOP SOPOSED OSED OF US (2011) ) 650,000 00 FMV of each h unit ($625) Value e of dispos

• sed

d units( s(20 2011) 1) $406, 6,25 250, 0,00 000 Global al Market t $4,062, 2,500, 00,000 00 Global al Market t forward value ue 2018 18 ( growth th @ 2.5%PA) A) $482,903 03,587, 7,000 Assume ume 25% of Market

MA MARKE KET T SIZE ZE

MODE DEL L A PLATELE TELETS TS

Assume ume CL CLC C @25% of the market et $1, 1,121,05 059, 9,96 967 Royalty ty @10% $112,105, 05,997

Market et size e Model el B New w Prot

• tecta

ctant nt Becker’s Hospital Review Hospit ital al rankings ngs by size ize # 1 w/ 2272 beds $74,248, 8,36 366 #100 w/674 4 beds ds $22,026, 26,144 #27 w/Joh

• hn

n Hopkins ns w/918 beds $ 30,000, 0,00 000 Mean n budge get t (1 and 100) $ 48,13 137, 7,255 55 US Blood

• d Mgt

t budg dget et top 100 hospi pita tals s US $4,813, 3,725, 25,490 90 (the e data for the Platele elets ts and d New Prot

• tecta

ctant nt taken en from the National ional Blood

• d Collecti

ection

• n Utilization

ization Repo port

Market t Size Discoun count t by 2/3 = reminder der 1/3 $ 1. 1.602, 2,970, 70,588 CLC process cess saving ng @ 15% $ 240,445, 45,588 88 Global alize ize @ 4 times es $961, 1,78 782, 2,35 352, 2,940 940 Process ess Royaltie alties s @7.5% % $ 72,13 133, 3,67 676 Tot

• tal

al Roya yalti ties es Annual ally y $18 184,23 239, 9,67 673

BLOOD STORAGE DURATION & ADVERSE OUTCOMES IN CARDIAC SURGERY

Clevela land nd clini nic c (Dr.Col Colle lenn nn Gorman n Koch) conduct ucted d the largest est blood storag

• rage

e study udy to date . They found nd blood stored red more than n 14 days s are most t likely y to suffer r post t operati tive comp mplica cati tion n https tps://ww //www.youtu utube.c .com/w m/watch? atch?v=0jF7k =0jF7kbIc6_ c6_M

KEY TAKE AWAYS

• The technology is patented
• The cryoprotectant used in the technology is currently FDA approved for other

“HUMAN –INGESTED” consumable products

• The cryoprotectant will replace DMSO/Glycerol which are the current standard

protectants in use, each with significant documented disadvantages

• The cryoprotectant is less expensive to purchase and the ratio of cryorotectant to be

used is dramatically less (we estimate a reduction 400X’s in the amount required over current protocol)

• Hospital and blood centers already have equipment to implement process. NO

ADDITIONAL CAPITAL OUTLAY

• Dramatic cost savings to hospital and blood centers

(Data taken from ARC/WHO and National Blood Collection and Utilization Survey Report)

NATURAL DISASTERS /STORMS ON BLOOD SUPPLY

Natural ral disast saster ers, s, storms

• rms have a m

major impact mpact on the supply pply ava vailable. Our technol nology gy will eliminat minate shelf f life https tps://ww //www.youtu utube.c .com/w m/watch? atch?v=Ze =Zet0vi t0viZ8a 8aVI

CREATING PLATELETS FROM BONE MARROW

It is expensiv nsive e comp mplicat cated d and not

• t alwa

ways ys ava vailable. Our process ess you just st donate e blood with th our patent nted d Heat/Transf nsfer er rate. e. https tps://ww //www.youtu utube.c .com/w m/watch? atch?v=ZX =ZXLLP LPWa9G 9Grg rg

CRYOPRESERVATION TECHNOLOGY

WHAT ARE THE KEY DIFFERENCES IN CLC’S PROCESS COMPARED TO THE CURRENT STANDARD PROTOCOL? The specialty cryoprotectant used in this patented process is fundamentally different than currently used organic cryoprotectants (Glycerol and DMSO) and has the following distinct and unique characteristics:

• It is a polymer, not organic, and therefore readily available and economically advantaged
• It works at dramatically reducing quantum’s – for example, 400 times less than the

currently used amount of Glycerol/DMSO

• Critically, unlike current cryoprotecants, it does not need to be “washed” from the blood

prior to transfusion, thereby eliminating an entire step in the commercial process of utilizing cryopreserved blood

Our Value e Proposi positi tion

• n

Eliminate shelf life of all components of blood Draw blood as usual no separate station for Platelets No Glycerol which must be washed before use No DMSO which must be washed out before use

:

New Protectant- Polyvinyl Alcohol(PVA) FDA approved for other consumable products and will not have to washed prior to use Store whole blood until ready for use Eliminate shortages for all components Globally

AMERIC RICAN N ACADE DEMY MY OF BLOOD OOD BANKING KING PUBLIS ISHED HED IN 12-25 25-2016

WHAT IS CLC’S PROPREIETARY TECHNOLOGY?

• Revolutionary advance in the science of cryopreservation of blood and its

component parts, including platelets, using a proprietary process that is commercially feasible and economically superior to methods currently used in the United States and Europe

• Significantly enhances the science of organ preservation and handling,

thereby vastly improving the process of transplantation

• Potentially broader and economic applicability to the current

commercially utilized preservation process of high-end foods

PLATELETS

• The preservation of platelets is extremely challenging
• Effective shelf life is only 4-6 days…even less when the actual

processing is taken into account

• CLC technology will permit the effective preservation of platelets

indefinitely

• Preliminary testing indicates that CLC’s unique process, together with

the use of the identified protectant, results in the efficacious preservation of platelets for periods far in excess of today’s standard shelf life

WHAT ARE THE EXPECTED COMMERCIAL APPLICATIONS FOR THE PROCESS?

Identified Commercial Applications: 1. Cryopreservation of whole blood for periods far in excess of current protocols used by hospitals ,donation centers and organizations at remote trauma sites. This includes military excursions in remote locations, such as submarines and space stations, all using a commercially feasible process 2. Cryopreservation of platelets permitting the efficacious preservation of platelets beyond the current shelf life of 4-6 days 3. Cryopreservation of high-end specialty food items (e.g. sushi) to prevent all of the significant disadvantages inherent in freezing food items for extended periods 4. Other potential extended uses of technology under investigation, including stem cells advancement and better control of contaminants

FUNDIN DING G NEEDS 1) Platelets $ 6,450,000 2) 21st Century licensing of PVA $ 640.000 3) Re-Freezing of unused blood–research $ 2.100,000 4) Patent Attorney for current patents $ 125,000 5) Patent Attorney for additional patents $ 125,000 6) Stem Cells $ 3,500,000 7) New Blood Storage program $ 2,120,000 8) Elimination of Blood Washing $ 2,100,000 9) Sales and marketing for intro. $ 2,840,000

• Total $ 20,000,000

==========

Strategic Partners

In many parts of the world. Blood supply as well as efficient delivery is a challenge. ZIPLINE has the answer to that with the introduction of DRON ONES ES They can, in most cases deliver in most parts of Africa in 50 minutes versa several hours/days. As we also know that 60-70% of their donated blood is contaminated. In partnering with them we will be able to increase their supply as well as eliminated the contaminates https://www.ted.com/talks/keller_rinaudo_how_we_re_using_drones_to_deliver_b lood_and_save_lives

REJUVE UVENATED TED MEDIC DICINE As science nce has disco covered ered repleni nish shin ing g older blood

• d with

h younger ger blood

• d has

had re remarkable ble re results ts with destr troying ing diseases ses. . Our blood

• od can become

come stale ale and accepticle cepticle to many differen ent t type of diseas ases. es. Storin ring g our r blood

• od now and having

ing it availab vailable e when and if we are re diagno nosed sed with h a termin inal disea ease. se. See video: eo:http https://ww //www.ted.com/ d.com/ta talks/t ks/ton

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MEDICAL AL ADVISOR SORY BOARD RD FOR IMMEDIATE RELEASE…. C LEVEL CLONE ANNOUNCES THE FORMATION OF ITS MEDICAL ADVISORY BOARD AND THE APPOINTMENTS OF DR. WADIE F. BAHOU DR.LOREN WALENSKY TO SUCH BOARD. Boston, April 09, 2015…C- Level Clone is pleased to announce the formation of its Medical Advisory Board( hereinafter MAB). The MAB is to be comprised of recognized authorities in the medical and scientific fields with the role of providing strategic advice and counsel to the company in order to assist the company in the further development of its patented processes to improve all aspects of blood (and the key components thereof) management, preservation and efficacy, and to extend the functional utilization of traditional blood and blood component transfusions to non- traditional (ex hospital) situations. C Level Clone is also pleased to announce the appointments of its first two members to the MAB,

• Dr. Wadie F. Bahou, and Dr.Loren Walenski.

• Dr. Bahou received his Medical Degree from the University of Massachusetts Medical

School, and completed his specialty training in Hematology at the University of Michigan. He is currently Professor of Medicine at the Stony Brook University School of Medicine, specializing in Hematology. His career at Stony Brook has included professional positions including Chief of Hematology and Vice Dean for Research at the Medical School; he currently directs the Stony Brook Stem Cell Facility.

• Dr. Bahou is an internationally recognized expert in the field of Hematology, with

extensive research and publications related to blood cells, platelets, and human blood

• disorders. Since he has devoted his professional life to the advancement of the field of (

hematology ,his joining the MAB is a welcomed and important development for CLC.

Dr.Walensky is associate professor of pediatrics at Harvard Medical School. Dr. Walensky received his MD and PhD from John Hopkins University School of Medicine in 1997. He trained at the Boston Combined Residency Program in Pediatrics and then completed a fellowship in Pediatric-Hematology-Oncology at Dana Faber Cancer Institute (DFCI) and Children’s Hospital in 2003. He joined (DFCI) in 2003 and was named medical director of the new program in Cancer Chemical Biology in 2005. He is board certified in general pediatrics and pediatric hematology-oncology. We are extremely pleased to have Dr. Loren Walensky, join and bring his specialized knowledge and experience to the MAB in order to successfully achieve its mission.

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