lumeden

27-28 May 2013 © Lumeden 2011-13, all rights reserved.

an

wireless Womens’ healthcare

Skolkovo Startup Village Investor Pitch Deck

© Lumeden 2011-13, all rights reserved.

wireless Product lines


Lumescope™ wireless Cervical examination

Fullterm™ wireless Pregnancy management

HIGH RISK/NORMAL PREGNANCY MANAGEMENT

EU/US/BRIC addressable market € 22.8 B+/ year Priced @ € 1900/ € 500

First in woman Q2, 2014 CE Mark, Q4, 2014

European Sales Q4, 2014, US Sales 2015

Cost savings at < 1 additional day of gestation

Improved newborn outcomeEasy to use mobile application &

device sensorDiscussions now with major

customers including UK NHS for roll out

ROUTINE CERVICAL EXAMINATION

EU/US/BRIC addressable market € 1.36 B/ year Priced @ € 995

CE Marked, 1st International September, 2011

Distributors in EU (AU, DN, NL, UK, BG, SL) MO, TK, GR, CN, PK, CH & BR < 1/3 the cost of traditional devices> 50% reduction in patient

examination timeLumescope™ iPro™ Generation Two

introduction October 2013

“The key challenge in pregnancy monitoring is to replace current hospital-based monitoring systems by alternatives that are non-invasive, sufficiently reliable, comfortable, and applicable for continuous mobile monitoring throughout the pregnancy.” http://www.sps.ele.tue.nl/members/M.J.Rooijakkers/ funded by Philips Healthcare

http://www.sps.ele.tue.nl/members/M.J.Rooijakkers/




















Sir Prof. Arulkumaran Sabaratnam Academic Clinician, Head of Obstetrics & Gynecology, St. George’s, University of London (London, United Kingdom), In Clinical Obstetrics and R&D for 37 Years

“If you take a women at high risk, she has to travel to the hospital…it takes physician time, to examine and sent her back, and there is cost involved…if she can use this device well, and get the information back in 5 minutes, it saves money, patient and physician time, so overall it will save time, money and energy”

Prof. Jacques S. Abramowicz MD, FACOG, FAIUM Chair, Illinois Section of AGOS, Frances T. and Lester B. Knight Professor, Department of Obstetrics and Gynecology, Co-Director, Rush Fetal and Neonatal Medicine Center Rush University Medical Center (Chicago, USA), In Clinical Obstetrics for 26 Years

“It is extremely important…that the patient is involved in her care…we are empowering her [with the FULLTERM technology]….she becomes part of the team…to help us see what is appearing…being able to see these changes early [cervical effacement and os dilation] is a tremendous advantage.“


wireless Women’s healthcare

KOL Independent Opinions

“Report found that almost three-quarters (74%) of the physicians surveyed use a smart phone for professional purposes, a 9% increase year-over-year.” April 30, 2013, www.healthwatch.com

“Report finds pregnancy apps morepopular than fitness apps.”

http://mobihealthnews.com/20333/report-finds-pregnancy-apps-more-popular-than-

fitness-apps/


wireless Pregnancy management

The Problem: High Risk Pregnancy → Premature Birth

Solution: FULLTERM™ wireless Pregnancy Management

Premature Birthcauses life long debilitation,or death for 15 MILLION newborns every year

BUT Premature Birth can be MANAGED with on time therapies or on time, right location newborn delivery at a hospital with a NICU

IF clinicians get early warning of the patient’s CERVICAL EFFACEMENT and CERVICAL os DILATION with FULLTERM™ wireless pregnancy management

“Our ability to predict preterm birth remains sub-optimal … Even with a detailed history and physical exam, we remain largely unable to tell pregnant women when their baby will deliver. And because we can't tell who will deliver early, we have little opportunity to try to intervene before labor starts.“ Dr. Erin Clark, Assistant Professor of Obstetrics and Gynecology, University of Utah Health Sciences Center (July, 2012)

“Premature babies are more likely to survive when they are born in high-level neonatal intensive care units (NICUs) than in hospitals without such facilities”

√ Because cervical effacement is the first indicator of premature birth

√ Because cervical os (opening to the uterus) dilation is the second indicator of premature birth

√ Current methods don’t work and are not efficient

Not “enough” time or clinical information for doctor to intervene, e.g. prior to effacement and dilation proceeding beyond the “point of no return”



Why Cervical Effacement and os Dilation?

HOW CAN WE REDUCE €40+B IN COSTS AND IMPROVE PREMATURE

NEWBORN OUTCOMES?

KEEP NEWBORNS “IN WOMB” FOR DEVELOPMENT USING FULLTERM™

Daily NICU costs exceed $3500/newborn

Each day of “in womb” development time

decreases neonatal NICU time by 1.6

days increases survival rates by 2-3 percent



Premature Birth is a Major Healthcare Cost

Lumeden Reduces Cost

FULLTERM™ pays for itself with one day additional “in womb”

development time and improves newborn outcomes

“The telemedicine group had a significantly later mean gestational age at delivery (38.2±1.4 vs. 35.3±3.8), higher mean birth weight (3224±588 vs. 2554±911), fewer mean total nursery days (2.4±1.8 vs. 14.9±26.4), and less frequent admission to the neonatal intensive care unit (6.7 percent vs. 40 percent) than the control group (all P<0.005). The total mean cost per pregnancy was $7,225 for the telemedicine group and $21,684 for the control group. This represented average savings of $14,459 per pregnancy using telemedicine services.”

“Early identification of preterm labor, prior to advanced cervical dilation, allows for more successful treatment of the condition and a continuation of the in-utero fetal maturation process. Often preterm labor is recurrent. Therefore, a patient who has already experienced preterm labor must be carefully followed. Comprehensive follow-up care is often achieved through case management, more frequent physician visits, and/or home nursing services with or without home uterine activity monitoring.”



FULLTERM™: Our Product

√ doctor/nurse manages many

patientsvia Internet

√ automated patient care and

billing

√ no additional capital purchase

required

Patient prescribed

FULLTERM™

mobile app to medical

professional

Bluetooth™ tampon sized device (IMD) used 2 minutes each day

+single pregnancy

management mobile app via Internet to patient

√ preterm (high risk) or

√ fullterm (normal)



Global Patents

intravaginal monitoring device

tampon sized, wireless, ultrasound

and CMOS sensor

abdominal smart patch

bandage sized, wireless, fetal heart rate and maternal contraction rate sensor

mobile phone/ internet network

patient smartphone, application software, lumeden

server, post processing software

mobile app smart phoneapplication software

PCT/US10/50329, entitled “Intravaginal Monitoring Device and Network”

U.S. Ser. No. 12/890,743, entitled “Intravaginal Monitoring Device”

U.S. Ser. No. 12/890,811, entitled “Intravaginal Therapy Device”

U.S. Ser. No. 12/890,830, entitled “Intravaginal Dimensioning System”

U.S. Ser. No. 12/890,847, entitled “Intravaginal Optics Targeting System”

U.S. Ser. No. 12/890,750, entitled “Network Supporting Intravaginal Monitoring Device”

U.S. Ser. No. 12/890,764, entitled “Analysis Engine within a Network Supporting Intravaginal Monitoring”

U.S. Ser. No. 12/890,805, entitled “Intravaginal Monitoring Support Architecture”

U.S. Provisional Patent Application, Ser. No. 61/3500, entitled “Disposables for External, Handheld, Self Powered, Wireless Medical Imaging Assembly, Netowork and Methods Related Thereto”

National/Regional Patents filed: Brazil, Russia (Eurasian Patent Office), India, China, European Patent Office (EU Countries), Mexico, US and Canada

3rd Party Valuation of IP Estate:1.9 Million Euro

April 8, 2013 News Release Philips Healthcare Website: “Philips started a study of a new design concept to support women

during labor. The study is conducted in close collaboration with the family centered mother and childcare center at the Máxima Medical Center in Veldhoven, the Netherlands. The concept could be the foundation for future solutions that improve the delivery experience for mothers. The .. concept consists of two main elements, which are interconnected in the delivery room:

The first is a smart phone application that helps women to practice and prepare different labor breathing techniques prior to delivery. [] The app also enables the woman to personalize the environment in the delivery room.The second element of the concept is an interactive visual animation projected on the wall of the delivery room that grows and changes in response to the progress of the birth. Based on the data from monitoring contractions, it gives the woman and her partner a simple and attractive visual impression of progress. There are currently two different themes – nature and abstract – which the woman can choose using the smart phone app. The animation on the wall switches to the breathing coach when a contraction occurs. The visualization of the delivery, which is unique to the birth, is stored in the smart phone app (as an image and a movie) and serves as a special memento of the experience.”

http://www.design.philips.com/philips/sites/philipsdesign/about/design/designportfolio/design_for_healthcare/labor_and_delivery_experience_concept.page



New Competing Product

Professor Dr. Guid Oei, Gynaecologist Máxima Medical Center

“It’s a wonderful concept. It can be very motivating for a woman to be able to see the

results of her efforts during the delivery. In addition, research shows that distraction and

relaxation can positively influence the birth of a child.”

Covered by Lumeden Patent

Estate



Timeline

FULLTERM™ CE FDA & OEU Approvals

Series A Angel/VC /Strategic Series B M&A/IPO Exit FULLTERM™ Q2(First in Woman Milestone) €1.62 M €5.825 M FULLTERM™Q3-4 CE Approval €45.0M 2012 2013 2014 2015 2016 2017

Exit Points: € € € € € €

LUMESCOPE™ (CE Mark, 2009) OEU approvals including SFDA and FDA

Andrea Ziarno Chairman of the Board, CTO, Founder’s Representative23 year veteran of medtech and biotech sectors. Management level positions at The Sorin Group, Rohm & Haas Company, Third Wave Technologies, Inc. Lead inventor. Brought Lumescope™ product line to CE mark and EU market commercialization in 1.6 years. Early stage company strategy, operations and technology development from 2009 to present. Founded and sold Engate, Inc. (Real time court reporting technology company) to Thomson. University of Chicago ([email protected] Skype: andrea.ziarno)

Reed Prior CEO25 year veteran CEO for 11 biosciences companies, including iStat and Seragen. Led 3 companies to first FDA approvals & 1 company to

UK N.I.C.E. recommendation of CE marked product. Raised $180M in capital. Many corporate deals and M&A exits. Harvard MBA ([email protected] Skype: reedprior)

Pascal Genelot President Wireless Pregnancy Management Business Unit24 year veteran global business manager in medical imaging, remote patient management, telemedicine and consumer electronics multinationals, including The Sorin Group (tele-cardiology global business line manager), GE Healthcare and Philips Medical Systems. Extensive network of telecom (France Telecom, Tefonica, BT, Telecom Italia) and electronics partners. Built Sorin tele-cardiology business from “blank sheet of paper” for €150M cardiac rhythm management business unit, including > € 10M deal with Orange/France Telecom ([email protected] Skype: pascal.genelot)

Peter Milton VP Sales & Marketing, International23 year veteran medtech sales & marketing professional. Experience of driving sales, building and managing distributor networks, building brands and launching new products across multiple sectors, including imaging, diagnostics in primary care, patient monitoring, surgery and gynecology

Bruce Diamond VP Sales & Marketing, North America14 year veteran medtech sales & marketing professional. Experience driving North American and International sales, launching new products across multiple sectors, including obstetrics and cardiac monitoring. Worked for North American companies and US based multinationals including Airstrip Technologies, Boston Scientific and Medtronic

Anders Cederberg VP Research & Development, Europe

25+ year veteran medtech management and engineering professional. Founder & prior owner of Scalae AB. Product development expertise in medical devices, systems integration, project management and complete product lifecycles.



Management Team/Contact

mailto:[email protected]





Conclusion

How big is the addressable market? High risk pregnancy/premature birth is a large world wide market (30/15 M), standard pregnancy management is even larger (180 M)

How disruptive is Lumeden? Lumeden technology provides a game changing, first mover early warning solution for wireless Pregnancy management and first mover solutions for lost cost, point of care, wireless Cervical examination

Cost Reduction is a top priority for all healthcare payers: governments, insurance companies and individuals, and a major market driver for technology adoption

Improved operational efficiency: proactive, outcome improving mobile app based technology replaces current reactive hospital-based, bed side monitoring systems with non-invasive, reliable, comfortable, continuous mobile app based management throughout the pregnancy empowering women and the support team of medical professionals

2014 + Upside: targeted, captive mobile advertising business unit is a signficant plus

lumeden

Technology

pregnancy monitoring

physician time

pregnancy apps morepopular

wombdevelopment time

time therapiesor

neonatal nicu time

percent lumeden

yearbut premature birth