Intelligent Needle for Safer and Faster Punctures€¦ · Usability & familiarity ... 3 FI univ...
Transcript of Intelligent Needle for Safer and Faster Punctures€¦ · Usability & familiarity ... 3 FI univ...
Intelligent Needle for Safer and Faster Punctures
Dr. Tommi RasilaChairman +358 40 750 [email protected]
Precision. Care. Confidence.
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
HYPODERMIC NEEDLE REINVENTED: IQ-TIP
Real-time bioimpedance guided lumbar puncture
No tissueAnalyzingAnalyzingCSF
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.
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
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
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
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
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
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
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
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
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]