Lasers and optics for personalized medicine and better life.

Dr. Petteri Uusimaa, VP & CTO3rd Jan 2020

Laser solutions for medical applications

fModulight, Inc.❑ The only vertically integrated PDT

laser manufacturer in the world❑ Profitable privately held company

with 19 years track record❑ Exclusive supplier to 10+ pharmas

& world leading cancer centers in USA & Europe

❑ Long track record of making all kinds of semiconductor lasers & pumps (400–2000 nm)

❑ Certified ISO13485 QMS in 2011, ISO9001 & 14001 in 2002

❑ Co-branded & OEM products currently shipping to all continents except Antarctica

❑ 600 000 pcs of 9xx-nm pulsed lasers in 2015 for LIDAR

Custom & industrial Services

Regulatory & engineering • Lifecycle support

Life sciences❑ Medical laser systems

❑ Oncology

❑ Ophthalmology

Subsystems for challenging optics & electronics • Processing

❑ Optogenetics

❑ Pharmaceutical safety & testing

Worldwide laser markets €15B

Medical laser markets €1.2B (GAGR 10%)

Surgical, therapy and ophthalmic laser markets €400M

Source: Strategies Unlimited

Growth drivers for medical lasers

Wider acceptance of laser based cosmetics and disposable based business models

Compact size and cost efficiency of diode based medical laser technology →handhelds, handset inregration, home use

Health monitoring lifestyle with various optical sensors, increase of outpatient treatment and mobile hospitals

Aging population in welfare countries increases demand for ophthalmics, oncology and other late age illnesses

Hip surgery

Actinic keratosis

PerkinElmerPlate reader

❑ Small / medium (10s/100s / 1000s) + High volume partnerships

❑ Regulatory support / FDA visits / 3rd party customer audits support + Vigilance reporting

❑ Sell-out reporting & customer intimacy analytics

❑ Example: PerkinElmer plate reader❑ GDPR / HIPAA: Yes

STANFORDPEDIATRICCARDIAC

NeuroOpthalmic solutions

Laser Induced

Skull surgery

DISCOVERY & INNOVATION

❑ Optical pacing / Optogenetics❑ Nerve stimulation / Ischemic

stroke – accelerated FDA track❑ Light activated drug release

liposomes❑ Example: Stanford pediatric

cardiac project

PROTOTYPING

❑ Novel opthalmictreatment❑ MRSA / Hip surgery (UCL)❑ Light activated skull pin

fixation ❑ In-vivo illumination kits❑ Actinic keratosis❑ Surgical lasers❑ Non-invasive glucose

monitoring,

PRODUCTIZATION❑ Design for manufacturing❑ Example: Glioblastoma❑ Data collection, Cloud monitoring of

clinical trials, future sell-out monitoring, Efficacy improvement & analytics, pre-emptive maintenance

❑ Phase 3 simultaneously or after❑ GDPR / HIPAA: Yes❑ Modulight as production partner

TESTING / CONCEPT VALIDATION❑ Validate business idea /

product / clinical trial / efficacy

❑ Product improvement❑ Example: Uveal melanoma

case Aura❑ Data collection & analysis❑ GDPR / HIPAA: Often yes

LIFE CYCLE MGMT

❑ Post market support❑ Vigilance reporting❑ Warranty & service❑ Calibrations❑ EXAMPLE:

Visudyne/Photofrin/ PerkinElmer Envision

❑ Online / cloud materials and user support

PRODUCTION

Ophtalmiccancer

treatment laser

Infra structure Capabilities❑ In-house laser production & design

– come and see❑ True supply chain control❑ Independence from third party

decisions ❑ Full traceability to the level not

available from competing laser companies

❑ MADE IN FINLAND - quality controlled and ethical work place

❑ Premises and factory all owned by Modulight

❑ Comprehensive regulatory, lifecycle & field support

❑ Demonstrated capability to develop numerous laser related products and exceed customer expectations – talk to us for more!

Design capabilities❑ Laser chip & structure❑ Electronics & software❑ Usability & regulatory❑ Field service & lifecycle support

E U R O P E U S A

REGULATORY SERVICE

MODULIGHT CE MARKModulight creates technical file and applies for CE mark on behalf of customer

PRIVATE LABEL CE MARKModulight provides technical content for CE mark submission

IND / IDEModulight assists with regulatory submission

510 (k)FDA approved device

PMAModulight has solid experience delivering fullFDA PMA regulatory submission file

PROCESS Product tested towardsCB certification

Modulight manages CE applicationprocess and initial factory audit

Subsequent factory audits and unannounced inspections

Modulight can ship products directly to end user

Modulight manages medical devicereporting and post-market surveillance

Registration with local healthauthorities (Clinical evaluation providedby customer)

Product tested towardsCB certification

Product manufactured according to customer specification under Modulight ISO 13485 certified quality system❑ Customer required to have certifications

for QMS, including post-market surveillance and medical devicereporting and registration with localhealth authorities, customer responsiblefor managing factory audits and unannounced inspections, and CE marking submission including clinicalevaluation

❑ Agreement with Modulight for allowingcustomer NB to audit Modulight as critical subcontractor

❑ Customer needs to have physicalprescence in Europe

Modulight provides limited technical fileas deliverable to customer

Product tested towards CB certification

Modulight applies for NRTL ATM, manages IFA and subsequent quarterly audits by theNRTL representative❑ Customer registers for IND / IDE,

required to report to FDA

Modulight provides technical file as devicemaster file (MAF) to FDA, customer refersto MAF in their applicationOR Modulight provides technical file as deliverable to customer

Product tested towards CB certification

CDRH submission and yearly reports byModulight (or customer)

Modulight applies for NRTL ATM, manages IFA and subsequent quarterly audits by theNRTL representative

Modulight (and/or customer) registered as manufacturer for the product at FDA

Modulight provides technical file as devicemaster file (MAF) to FDA, customer refersto MAF in their application

Modulight applies for NRTL ATM, manages IFA and subsequent quarterly audits by theNRTL representative

Modulight registered as manufacturer for the product at FDA❑ Modulight registered as manufacturer

for the product at FDA❑ Agreement with Modulight to provide

access to FDA for on-site inspection❑ CDRH submission and yearly reporting

by customer (Modulight providestechnical content)

QUALITY

MANAGEMENT

ISO 13485 certified93/42/EEC and 2007/47/EC requirements

ISO 13485 certified USFDA QSR requirements21 CFR 820 and 21 CFR 1040 requirements

USFDA QSR requirements21 CFR 820 and 21 CFR 1040 requirements

USFDA QSR requirements21 CFR 820 and 21 CFR 1040 requirements

DURATION months months months months months + xxx days

CASE

EXAMPLES MODULIGHT

ML7710

3

2

1

8 10+ 10 x 16

2

Regulatory knowhow and quality management services

3

2

1

2

3

2

1

2

3

2

1

2

3

2

1

2

University / hospital collaboration❑ We are about making lasers for

Doctor, Patient and Hospital❑ Many pharma customers come

to us through introduction from our customers

Ophthalmic treatment station

❑Modulight ML6710i laser with slit lamp adapter

❑Mountable to Zeiss SL120/SL130/SL115C and Haag Streit type slit lamps

❑ iPad control and remote treatment planning

❑ IP connectivity and cloud based data collection and AI driven medicine

Modulight as a medical device company

✓ Medical application knowhow from in vitro to clinical use and lifecycle support

✓ In-house product design and manufacturing from laser chip to connected medical devices to hospitals with true security of supply

✓ Proven knowhow on medical device design and regulatory documentation for pharmaceuticals and all medical approval

✓ Partnerships with leading medical and cancer centers globally

✓ Generic product platforms with user friendly GUI and connectivity technologies supporting cloud based business models and AI boosted medicine

Summary❑ Modulight has been >19 years in

business and is well profitable❑ Long history of quality driven

products and certifications❑ Exclusive provider of medical

lasers for 10+ pharmas❑ ISO9001 & 14001 in 2002 &

ISO13485 certification in 2011❑ CE approval in 2012 & FDA

approval in 2016❑ Wide, long expertise in

semiconductor lasers & solutions

Thank you!

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This presentation was presented at

EPIC World Photonics Technology Summit 2020

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