Innovatie

Twente Medical Optics

Opschaling

We are bringing the first handheld laser perfusion imager to the market. It visualize the blood perfusion level under the tissue. Based on this, the surgeons in the microsurgery fields could make good judgement of the surgery outcome. It will prevent for necrosis and potential re-surgeries.

Medisch technologische innovaties

Regio Overijssel

Help ons versnellen

We would like to further collaborating with hospitals, optical experts, engineering partners and usability design partner.
Hospitals:
They are our end-users and customers. Understanding their opinions and current workflow will be essential for making our product adopted. Additionally, we would like to further conduct clinical studies and user tests at the partner hospitals.
Optical experts:
We use laser technology for diagnosis. Therefore we need optical experts to assist us on optimizing the optical systems.
Engineering partner:
We need a reliably engineering partner who is knowledgeable about medical product development, therefore understanding the stakes of quality and regulatory systems. We need them to help us further develop the product until pre-clinical dossier ready.
Usability design partner:
As we are bringing the first handheld laser perfusion imager to the market, usability is one of our USPs. We want to offer superior technology without interrupting the exiting workflow of the medical workers.

Kiki Liu

https://www.twentemedicaloptics.com/

Probleemstelling

Approximately 13.1 percent of women will be diagnosed with breast cancer at some point in their lifetime, and about 50% of them will undergo either partial resection or total mastectomy. Of these surgeries, around 20% result in necrosis when traditional clinical assessment techniques are used. Indocyanine Green (ICG) imaging can improve blood perfusion visualization, potentially reducing the necrosis rate to about 5%; however, it also comes with significant risks and costs. ICG is an invasive procedure that may trigger allergic reactions and other risks for patients. Additionally, its illumination is temporary, lasting about 45 minutes before it flushes out of the system and can be re-injected if necessary. The technique also relies on consumables, leading to high costs, and provides results that are more qualitative than quantitative.

Oplossing

We bring HAPI, the first handheld laser perfusion imaging technology to the market.
HAPI is completely contactless, handheld, grab-and-measure (meaning can be used whenever needed), quantitative device without consumable parts.
It is an ideal solution for blood perfusion validation (important indicator for surgery success).

VWS-missies

Our innovation contribute to both the central mission and sub-mission 1:
Women who have breast cancer and undergone a breast resection/ excision surgery have already experienced high level trauma. When they finally built up their courage and are willing to accept a new life with reconstructed breasts, they are hoping for a new life to begin.
Necrosis is seen as a second-time damage, which brings even more pain to them, not only physically, but also psychologically. This will destruct them and bring them back to an unhealthy life style.

Doelgroep

oncology surgeons, plastic reconstructive surgeons.
Almost every general hospital conduct mastectomy, and flap surgery is a very common accompanying surgery. The number of target group is very high (ca. 58,000 hospitals globally).

Verlaging zorgkosten

It saves surgery time, increase the surgery success rate, eliminate consumable costs.

Verdienmodel

The cost of the product will be ca. 60,000 euro per device. Lease and pay-per-use model is also applicable

Geïnvesteerd vermogen

€ 10-100 duizend

Concurrentie

There are three competitors in the laser-supported blood perfusion measurement sector: Moor Instruments, Perimed AB, RWD Life Science.
All of their devices are highly bulky and inflexible, that blocks them from entering the Operating Room for clinical usage.

Unieke kenmerken

We are the first handheld laser perfusion imager, which allows us to serve in the Operating Room. Comparing to the ICG technology that already used in the Operating Room, we are non-invasive, constant, completely safe, cost-saving.

Intellectueel eigendom

We have 2 patents (one granted and one under process), software algorism, and already three generations of prototypes.

Organisatie

Our organization will be implemented by team members with diverse background. The main roles should include engineers (optical, hardware, software, system, implementation), clinical specialists, regulatory specialists, business developers. After setting our team in the Netherlands, we will expand our team into USA and other countries.

Beschrijving pilotfase

We are currently collaborating with Radboudumc and ZGT hospitals for clinical studies, on both burn and flap surgery patients.
The surgeons believe that our technology could be potentially a good substitute of ICG, which is expensive, invasive, time-consuming non-quantitative and temperary.

Betrokken partners

Radboudumc and ZGT hospitals are our clinical partners. They provide locations, patients and relevant cases for our device to be tested on.

Aantal gebruikers pilot

0-10

Onderzoeksresultaten

They are on-going. The result is expected to be ground-breaking and show the potential of replacing the ICG.

Rapportage pilot

PIHC project description.pdf

Implementatiestrategie

First step: Connecting with surgeons (users) and convince them about the clinical benefits of the device
Second step: getting surgeons' support and submit the interest together to procurement department
Third step: background investigation from the procurement department
Fourth step: getting in process of setting up tender/ procurement project

Reeds in gebruik

Radboudumc hospital, ZGT hospital

Behaalde prestaties of gewonnen awards

PIHC grant
Turbo Grant
NWO Take-off Phase 1 grant
Final round Venture Challenge
Final round BBFH Challenge
Top Loan University Twente
Invited for National Wound Care Congress Serbia 2024
Invited for Radboudumc Investment day 2024

Productontwikkeling

Implement AI imaging study technology into wound diagnosis, decrease the time-to-diagnosis from 48h post injury to <24h

Internationale ambitie

We will get FDA earlier than CE, and include the American market into our development plan.
We are currently under discussion for collaboration with IDE group (specialized in medtech venture development and commercialization), who have offices in USA, Australia and the Netherlands.
With FDA 510(K) clearance, we can further expand our business in Middle East and Latin America.
After FDA and CE, our next step plan will be entering UK and Chinese markets.

Omzet

€ 0-10k