2020-07-010 - BSURE - Be Sure genetic test to determine dermal filler implant adverse reactions

A new non-invasive prognostic method based on genetic analysis to determine predisposition to late onset severe adverse effects in patients treated with dermal fillers. The presence of at least one human leukocyte antigen (HLA) HLA-B8 and HLA-DRB1*3 of the histocompatibility complex indicates a genetic predisposition to develop an adverse inmune reaction to dermal fillers and breast implants.

Acronim & Gínjol codes

Acronim

ACRONYM

BSURE

Gínjol codes

2020-07-010

Gínjol Status

Main technology offer

In short

Biomarker kit to determine the genetic predisposition to adverse lateonset adverse reactions to dermal fillers based on the presence of specific human leukocyte antígens of the major histocompatibility complex

Ownership

Barcelona, Spain

2002

Vall d’Hebron Institut de Recerca (VHIR)

Spin-off based on this technology

Barcelona, Spain

2020

BSURE MEDICAL SL

Public Partners

Centres CERCA List

Readiness Level

Availability

Updated on

TRL (Technology Readiness Level)

1-2 Research /
3-4 Experimental PoC /
5 Prototype /
6-7 MVP /
8 Industrialization /
9 Commercialization

MIN

1

2

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4

5

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7

8

9

10

MAX

IRL (Investment Readiness Level)

1-First Canvas / 2-Market Analysis / 3-First Validation / 4-MVP / 5-Market Fit / 6-Validate Sales / 7-Final MPV / 8-Validate Business Model / 9-Key Metrics

MIN

1

2

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6

7

8

9

10

MAX

BRL (Business Readiness Level)

1-Market hypothesis / 2-Basic Market / 3-PoC / 4-Target Customer / 5- Customer Validation / 6-Launchable MVP / 7-Customer feedback / 8-Scale product-service / 9-Sustainable business

MIN

1

2

3

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9

10

MAX

TRL Level

IRL Level

BRL Level

Impact: ESG & SDG Goals

Sustainable Development Goals (SDG)

Sustainable Development Goals

Market Data

Problem/Solution

In 3-5% of all implants, severe long-term side effects are observed in patients such as angioedema, sarcoidosis, granulomas, inflammatory nodules, Sjögren's syndome, etc. Other long-term or permanent functional deficits such as paresthesia, tissue necrosis and arteria occlusion might also appear in patients, causing important psychological sequelae. Currently, there is no product on the market to determine the predisposition of adverse reaction to injectables. For this reason, there is a need to develop new methods to anticipate and prevent the described side effects.

TAM (Total Available Market) (in M€)

50000000

SAM (Serviceable Available Market) (in M€)

0

SOM (Serviceable Obtainable Market) (in M€)

0

Business Model

B2B2B: strategic partnerships to sell tests through the distributors. B2B2C: collaboration with aesthetic clinics where the surgeons will act as prescribers. D2C: direct online sales to people who want to undergo treatment with dermal fillers or breast implants.

Market Need

There is currently no product on the market to determine the predisposition to adverse inmune reaction to dermal fillers and breast implants.

Target Market

EUA, Brasil and Europe

DeepTech Area

LoftOS Category

Funding

Needs

2025: 1st round €800K in 2025 2026: 2nd round €2M in 2026

We're looking for

2025: Consolidate EU + USA entrance (Filler & Breast) 2026: Expand Worldwide (Filler & Breast) Sales of company in 5 years' time

Milestones

Personnel hiring Marketing New products development Legal and Regulatory consultancy

Technology Status

Disruption

First and only DNA test in the world predicting the risk for severe complications for dermal fillers and breast implants (there are no competitors in the market).

Early barriers

To approach bureaucracy To find distributors Increase of regulation and control (Breast implants and fillers are Medical Devices Class III Risk Level MDR Compliance by 2028)

Roadmap

IP Status

Patent (EP11EP11715922.8) granted in Europe and validated in Belgium, Germany, Spain, France, Italy, Luxemburg, Netherlands and United Kingdom. Patent (112012027353-6) granted in Brasil.

Additional information