Intelligent Needle for Safer and Faster Punctures€¦ · Usability & familiarity ... 3 FI univ...

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Intelligent Needle for Safer and Faster Punctures Dr. Tommi Rasila Chairman +358 40 750 8158 [email protected] Precision. Care. Confidence.

Transcript of Intelligent Needle for Safer and Faster Punctures€¦ · Usability & familiarity ... 3 FI univ...

Page 1: Intelligent Needle for Safer and Faster Punctures€¦ · Usability & familiarity ... 3 FI univ hospitals. CE with. TÜV SÜD. 4Q. Build-up of distributor network, KOLs, sales channels,

Intelligent Needle for Safer and Faster Punctures

Dr. Tommi RasilaChairman +358 40 750 [email protected]

Precision. Care. Confidence.

Page 2: Intelligent Needle for Safer and Faster Punctures€¦ · Usability & familiarity ... 3 FI univ hospitals. CE with. TÜV SÜD. 4Q. Build-up of distributor network, KOLs, sales channels,

Problem of a “blind puncture”

Uncertainty leads to trial-and-errorresulting in blood in CSF samples, raised risk of infections and post-operation headache to the patient

CHALLENGES IN MAKING A SAFE LUMBAR PUNCTURE

CSF - cerebrospinal fluid

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HYPODERMIC NEEDLE REINVENTED: IQ-TIP

Real-time bioimpedance guided lumbar puncture

No tissueAnalyzingAnalyzingCSF

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1ST APPLICATION: PEDIATRIC LUMBAR PUNCTURESAcute Lymphocytic Leukemia

• ~20 punctures within 30 months treatment period

Suspected Meningitis• most common acquired cause of newborn fatalities

18-35% of these punctures are traumatic, causing blood to leak in spinal channel increasing the risk of inferior outcome.

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VALIDATED CLINICAL NEED –LESS TRAUMATIC PUNCTURES

Right the first time with IQ-Tip

Unsuccessful punctures

Traumatic puncture

Optimal lumbar puncture

• Optimal puncture – Less trial-and-error

• Faster punctures with better success rate

• Reduce traumatic punctures for less tissue

damage and internal bleeding

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Existing needle manufacturers⎯ Traditional needles continue to be

widely used

WELL AHEAD OF COMPETITIONNo known direct competitors close to market entry.

Main competition

→ Outperformed by IQ-Tip in usability and performance

Other needle guidance method developers⎯ Guidance based on e.g.

ultrasound imaging, loss of resistance (LOR), laser reflection or x-ray

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BUSINESS MODEL

Sales through distributors who already aretargeting pediatric dpts ⏤ 400+ identified and

screened by Injeq, e.g. FR,ES,UK

Low capex razor & blade model. Analyzer and single-use needles and cables ⏤

Consumables for recurring revenue stream

Usability & familiarity ⏤ Smooth market adoption

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GO TO MARKET TIMELINE

1-2Q 2020

3-4Q 2021

3-4Q 2020

1-2Q 2021

Clinical trial report

Production processesvalidated 2Q

Clinicalinvestigation

3 FI univ hospitals

CE withTÜV SÜD

4Q

Build-up of distributor network, KOLs, sales channels, Tech/Product partnerships

1-2Q 2022

Initiate entry into US and other markets

Submissionto

NotifiedBody

(MDR)3Q

Sales start4Q 2020

New clean roomfacility 3Q

Pilot clinical trials (4)…-2018

3-4Q 2019

QMS 3Q

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Pediatric lumbar50M€

Caesarean section & Delivery anesthesia

150M€Other lumbarincl. cancer therapy and precision medication

300M€

IQ-TIP – THREE DIMENSIONS OF GROWTH

Injeq needle system market (EU only)

1. Lumbar puncture (EU)

2. New geographical areas

3. New applications→ Precision medication injections→ Delivery of DNA vaccines with

electroporation → Other challenging punctures→ Biopsies of internal organs→ Veterinary medicine

Global ~2B€ → US→ JP, CN, SE Asia

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IPR PROTECTED –CURRENT AND FUTURE APPLICATIONS

Stylet and Electrode Concepts: EU grantedBioimpedance Sensor “IQ-Tip”: EU granted, US to grant (2020)Biopsy Needle: EU to grant (2020), US pendingBiopsy “Gun": EU pending

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THE TEAM WITH CAPABILITY TO DELIVER

RIITTA SEPPÄNEN-KAIJANSINKKOVice ChairmanMD, DDS, PhD,Prof

JARI HYTTINEN

Board Member Prof Biomedical Engineering

Board MemberDDS, MSc Eng.

KATJA PAASSILTA

TOMMIMAJAUS

Board Member MSc, CEO at Atrotech Ltd

JAN LINDGREN

Board Member MD, PhD

KARI JÄÄSKELÄINENBoard MemberEMBA, BBA

TOMMIRASILA

ChairmanDr.Tech.Serial entrepreneur

Kalle ÅströmAdvisor VC

JUHO KARI

Research Engineer

SANNA HALONEN

PETRI AHONENChief Manufacturing Officer

TIMO ELOMAA

COO

MANUELAVILLAREAL

Prod Specialist

CEO

ILARI ANTILA

EEVASELÄNPÄÄProduction Specialist

SEPPO LAUTAMÄKI

VP Sales

HARRI SIEVÄNENChief Scientific OfficerDr.Tech

KATJA SILLANPÄÄProduction Engineer

Research Engineer

Board & AdvisorsEmployees

JUSSI SEITSONENChief Quality Officer

PETRI POMMELINSenior Advisor,RegulatoryAffairsLic.Sc.

M&S - Product Management- Customer Support Production Specialist

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SERIES A FINANCING 2020

3,4 M€ in crowdfunding ’17 & ’19 for developmentNow raising 5M€ as venture capital or combination of VC and other financing instruments

• Faster expansion in EU• Scale up production• Initiate expansion to US

and other markets• Clinical investigations for

other applications • Strategic industrial

partnering projects

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IN PUNCTURES,THE QUALITY IS EVERYTHING.

“All the punctures should be made with this device”Deputy chief physician during the clinical trial

“I would have continued deeper with the puncture without this device. Truly helpful.”Senior clinician during the clinical trial

DISCLAIMER: All the presented benefits and features have not yet been verified in clinical trials. The product is not available on the market.

Injeq.com@iq_needle

Dr. Tommi RasilaChairman +358 40 750 [email protected]