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Investors Relations

CYTO365 is a startup company from Sweden that is already ten years old. The company holds a ISO13485 medical manufacturing certificate. The company has global ambitions and it’s component RondelO™ has the potential to become a new standard for infusion treatment where drugs are to be given in sequence, such as for Chemotherapy but also in other areas.

It is an aim that RondelO™ will become the new standard component within infusion therapy for drugs that should be given in sequence, such as cytostatic drugs. The development phase has come to an end and CYTO365 have started to deliver components to customers. Join us to change the way infusion therapy is delivered.

 

THE PROBLEM

Drug incompatibilities are frequent, accounting for 20% of all medication errors and up to 89% of administration errors (A). 90% of those treated at hospital get some sort of infusion treatment (B) which is an effective treatment where drugs are entering the patients bloodstream. 74% of the drugs given within infusion therapy should not be mixed (C). 26% of the drugs are potentially life threatening in case they are mixed (D). And a study we have found shows that 46 % of nurses have witnessed drug incompatibility 3-10 times within a month (E), clearly demonstrating the problem with drug incompatibility and the need for flushing fluid in between drugs.  

However, this effective method is vulnerable to adverse event for medical error. Often many drugs are to be given to a patient, but rarely at the same time, rather they should be given in serial with flushing fluid in-between that separates the drugs from reacting with each other that causes drug incompatibility. The main problem addressed is accidental mixing of drugs within infusion therapy causing drug incompatibility.

Furthermore there are 7.3 million nurses in Europe are exposed to hazardous drugs (F) and with RondelO™ it is possible to reduce the exposure. Connect to the inlets of RondelO™, and leave connected to reduce risk of occupational exposure for the nurse.

THE SOLUTION

RondelO™ developed by CYTO365 is a medical stopcock with multiple inlets, able to receive up to 6 drugs where only ONE can be flowing to the patient at the same time, thereby continues drug incompatibility of the connected drugs are eliminated. Flushing fluid is made available between each drug administration by design. RondelO™ is filling the gap for the unmet need of serial administration of incompatible drugs. 

 

Source:

A. https://www.infusesafety.com/medication-errors–drug-incompatibility

B. Multiple Intravenous Infusions Phase 1b https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3377572/

C. The Rate of Physicochemical Incompatibilities, Administration Errors. Factors Correlating with Nurses ̓ Errors https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4499430/pdf/ijpr-14-087.pdf

D. Hanifah S., Ball P. & Kennedy R.A. Medication incompatibility in intravenous lines in a Paediatric intensive care unit (PICU) of Indonesian hospital. Crit. Care Shock 2018;21(3):114-123

E. Tissot E., Cornette P., Demoly M., Jacquet m., Barale F & Capellier G. Medication errors at the administration stage in and intensive care unit. Intensive Care Med. 1999;25(4):353-359

F. https://www.theparliamentmagazine.eu/news/article/preventing-the-exposure-of-nurses-and-health-professionals-to-hazardous-drugs

RondelO has a setup prepared to become a global standard for any infusion therapy requiring two or more infusion drugs to be given in a sequence.

90%

of patients recieves infusion treatments

 

 

74%

of drugs are

incompatible

 

 

26%

are potentional

life threatening

 

 

46%

of nurses have witnessed

drug incompatibility 3-10

times in a month.

 

 

Market and business model

Our business focus is to be experts on manufacturing the RondelO™ as a component, and produce it in many millions per year and become a subcontractor. We have recently got a grant from the EIC to build an automation to produce 20 Million RondelO™ per year. That is just the start, there are estimated 2 Billion standard stopcocks sold annually worldwide. With multiple distribution agreements in place, and a long leads list, we finally now are delivering to our customers. The IP is strong, with +100 patents and 91 patents approved to date, and trademarks in key markets (AU, CA, CN, EU, IN, JP, UK, US).

The gross margin for the component sales of RondelO™ is high, up to 88%. For Final Device (IV-set), the gross margin will be 0-50%. To make adoption happen we are launching in Nov 2023 at Medica/Compamed CE approved IV-sets with RondelO integrated, to be sold via Distributors to Hospitals.

The future revenue is estimated 70% from Component and 30% from Final Device.

Market share and gross margin

Global IV therapy market is valued 7Bn USD (2020) and estimate to grow to a 4,29% CAGR (11,7Bn USD in 2027). Disposable medical stopcock market is valued at 841 Mn USD (2020) with CAGR of 4,1%. Market share of the stopcock market is estimated to be around modest 0,2% in 2027 assuming there is 2Bn medical stopcocks sold yearly, which is of course only scratching on the surface. If we reach the goal of becoming a new infusion therapy standard we may see much larger sales in range of (10-20% market share) before patent lifetime expires in 2036.

The gross margin for the component sales of RondelO™ is high, up to 88%. For Final Device (IV-set), the gross margin is 0-50%. To make adoption happen we are launching in Nov 2023 at Medica/Compamed CE approved IV-sets with RondelO integrated, to be sold via Distributors to Hospitals.

 

 


Financial outlook

EUR

2023

2024

2025

2026

2027

 seed    

Revenue

353 639

3 514 982

10 104 404

    18 323 321

    23 515 782

EBITDA

-652 282

9 940

4 773 009

11 433 628

14 460 791

Gross Margin

RondelO Component

30%

84%

84%

88%

88%

Gross Margin

RondelO Component + Final Devices

27%

47%

69%

75%

74%

Enterprise Value (EV)

31 000 000

  

343 008 836

433 823 720

Headcount FTE (consultants)

7(3)

11(3)

15(3)

17(3)

24

Fund need (secured)

5,9 (3,9)

    

Marketshare
Volume RondelO sold vs. IV-sets Global

0,00%

0,02%

0,09%

0,16%

0,22%

Marketshare
Volume RondelO sold vs. Chemo IV-sets Global

0,14%

0,71%

2,86%

5,18%

7,21%

Potential EXIT STRATEGY

TRADESALE
(EV = 30 x EBITDA)

 

Data driven info

Sources (work in progress):

(A) 3,7 M cancer incidents Europa https://www.euro.who.int/en/health-topics/noncommunicable-diseases/cancer/data-and-statistics

(A) 4M cancer incidents Europe https//www.ncbi.nlm.nih.gov/pmc/articles/PMC8568058/ 

(B) 1,7 M cancer incidents USA, 85% receiving chemotherapy https://www.atlanticmarketresearch.com/disposable-infusion-sets-market  + 442 / 100 000 = 0,44% https://www.cancer.gov/about-cancer/understanding/statistics

B) 1,8 M cancer incidents USA www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2020.html

(C) 17 M cancer incidents globally of which 9,8 M require Chemotherapy 57,7% https://archive.cancerworld.net/news/more-than-50-percent-rise-in-chemotherapy-demand-by-2040/

(D) 9 M anticancer compunds are administered / year in France with a incident rate of  423 000 ger 7.1 cykler https://www.biolog-id.com/biolog-oncology
6-9 cykler bekräftas av https://www.sbu.se/en/publications/sbu-assesses/chemotherapy-for-cancer/ 

(E) Kända upphandlingar lågt pris för 3 inlet IV-set

(E) Blandningsaggregat Oncology 4-way, 62SEK=6EUR

 https://www.onemed.se/products/I0001688/blandningsaggregat-cyto-ad-z

(F) 400 M Primary IV-set Europa derived from 137 M Pump sets https://idataresearch.com/product/infusion-therapy-market-europe/,
1/3 are pump IV-sets in Europe https://idataresearch.com/pump-infusions-projected-to-take-over-the-european-market/

(G) 230 M Primary Iv-set https://www.entrepreneurindia.co/blog-description/10292/business+ideas+in+production+of+disposable+iv+set  

(H) 5,9 B IV-set globally https://idataresearch.com/product/infusion-therapy-market/

 

Funding situation

Total funding need is 5,9 MEUR 2023. We have recently got awarded blended finance from the EIC accelerator of 1.9MEUR grant + additional 4MEUR in equity where the European Investment Bank will co-invest 2MEUR with qualified investor(s).

Tranch 1: 2MEUR (closing 30 Sept 2023).

Seeking 1MEUR to be co-invested with EIB 1MEUR (25% discount on 31 MEUR pre-money)

Tranch 2: 2MEUR

Seeking 1MEUR to be co-invested with EIB 1MEUR (31MEUR pre-money)

 

Tranch 1

Tranch 1 closing 30 Sept 2023. Please enter your email address if interested, our CEO Micael will contact you. 

500 000 EUR
50%
250 000 EUR
12.5%
125 000 EUR
12,5%
125 000 EUR
12,5 %


The team and board members

Micael Törnblom

CEO & Founder

Ida Virtala 

Project Manager

Monique Feikes de Groot

QA Manager

Patrik Gerenmark

R&D Specialist

Fredrik Hansson Alkbrand

CFO

Anna Rydberg

CMO

Nina Vahér Dahlström

Logistics & sales coordinator

Mats Dörring

Chairman of the Board

Arne Nilsson

Board Member

Olle Nilsson

Board Member

Håkan Svanberg

Board member

Fredrik Lüning

Board Member

Linda Berndtsson

RA / Board Member

Investors Relations Contact

Micael Törnblom

Micael Törnblom, CEO & Founder

+46 (0) 709 64 66 73

micael@cyto365.com.

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