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OPHTHALMIC MEDICAL DEVICE
OVERVIEW - GLAUCOMA
GLAUCOMA is the leading cause of
irreversible blindness
UNMET NEED due to high failure rates of glaucoma surgery
Glaucoma is optic nerve damage caused by HIGH
INTRAOCULAR PRESSURE (IOP)
UNMET NEED§ Glaucoma treatment:
§ For mild glaucoma: eye drops
§ For moderate to severe glaucoma: drainage surgery is the standard of care
§ Glaucoma drainage surgery has an unacceptably high complication rate
§ Approaching 50% failure by 3 years
§ Nearly half of patients undergoing this surgery going blind
Data: Market Scope, presented by Keith Barton MD, at Ophthalmology Futures Forum
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%
GLAUCOMA
RETINA
OCULOPLASTY
CATARACT
REFRACTIVE
RELATIVE COMPLICATION RATES BY SUBSPECIALITY AT 3 YEARS
NEARLY HALF OF PATIENTS UNDERGOING THIS SURGERY FAIL AND SUFFER PROGRESSIVE VISION LOSS (BLINDNESS)
UNMET NEED TRABECULECTOMY Trabeculectomy is the gold standard surgery to lower IOP.
The surgery creates a fistula or “trapdoor” to let the fluid drain to a reservoir under the conjunctiva called a “bleb”.
TRANS-SCLERAL MIGS Market challenger: “Minimally Invasive Glaucoma Surgery”
Minimally invasive placement of micro, flow-controlled shunt devices
As in trabeculectomy, blebs provide the outflow reservoir
THE PROBLEM GLAUCOMA DRAINAGE SURGERY HAS AN UNACCEPTABLY HIGH FAILURE RATE
Healing response triggered at the surgical
site
By 3 years, 50% of surgeries are no longer effective as the bleb has scarred the fistula shut
Scarring leads to surgical failure
Functioning Bleb Scarred Bleb
Low IOP
Elevated IOP Scarring Blindness
RADIANCE THERAPEUTICS SOLUTION § Beta brachytherapy:
§ anti-scarring therapy
§ Sealed Source Radioisotope§ (Strontium-90)
§ Beta therapy is proven in 4 randomized controlled trials (RCTs) n=788 to deliver significantly better results than the current standard of care; and with improved workflow
§ 4 Randomized Controlled Trials completed (n=788)
§ Patients currently being treated at Moorfields Eye Hospital
CLINICAL EXPERIENCE
RANDOMIZED CONTROLLED TRIALS
DHALLA ET AL. COOK ET AL. EL MAZAR ET AL. KIRWAN ET AL.
PROVEN SUPERIORITYKIRWAN ET AL.
5% FAIL BETA30% FAIL PLACEBO
~10% FAIL BETA~ 50% FAIL PLACEBO
320 PATIENTS
156 PLACEBO
164 BETA
THERAPY
Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomized controlled trial
James F Kirwan, Simon Cousens, Lynette Venter, Colin Cook, Andries Stulting, Paul Roux, Ian Murdoch
BMJ, doi:10.1136/bmj.38971.395301.7C
BETA
Prob
abilit
y of
ble
b su
rviv
al
PROVEN SUPERIORITYCOOK ET AL. 117
PATIENTS
56MMC
61 BETA
THERAPY
BETA THERAPY EYES:
§ 3.2 TIMES more likely to have a functioning bleb versus MMC treated eyes (p=0.009)
§ 5.6 TIMES more likely to have an intraocular pressure (IOP) less than 16mmHg ON NO MEDICAL TREATMENTversus MMC treated eyes (p=0.008)
§ On average, at one year beta therapy eyes have an IOP of 4mmHg LOWER than MMC treated eyes
ODDS RATIOS AT ONE YEAR
SA OPHTHALMOLOGY JOURNAL ▪ SPRING 2018 ▪ VOL 13 NO 4
Randomized clinical trial of trabeculectomy with mitomycin-c versus trabeculectomy with beta radiation
Colin Cook, Andrew Perrot, Hamzah Mustak, Paul Courtright, Julie Wetter, Nagib Du Toit
TOPICAL APPLICATION OF BETA THERAPY
EASY TO USE, INTUITIVE, NON-INVASIVE
THE RADIANCETX SOLUTION Beta therapy is the use of a sealed radioisotope brachytherapy source (RBS) that provides therapeutic energy
Device is held on the surface of the conjunctival bleb for 30 seconds
QUICK, 30 SECOND APPLICATION
NEXT GENERATION DEVICE
RAZOR/ RAZOR BLADE BUSINESS MODEL
STERILE-PACKED, SINGLE USE HANDLE AND CAP
REUSABLE BETA THERAPY SOURCE
§ CPT C2699: “codes are available for for payment of new brachytherapy sources for which source codes have not yet been established”
§ CPT 77789/ 77790/ 77300: “surface application of radiation source” pays up to $775 to doctor. ”S” code on top of DRG
BOARD OF DIRECTORS
MARC SANDROFF CHAIRMAN
Principal, Cadre Partners (PE)
Founder and MD, Essex Woodlands Ventures
Allstate Insurance: Venture Capital Division
.
LAURENCE MARSTELLERFOUNDER, CEO AND
DIRECTOR
Founder and CEO Salutaris Medical
Devices, Inc.
Analyst, Lehman Brothers
Analyst, Morgan Stanley
HARRY GEORGE FOUNDER AND DIRECTOR
Solstice Capital (VC)
Director, Calimmune Inc., acquired by CSL Behring
Founder & CFO of Interleaf, acquired by BroadVision
KEN ABRAHAMS DIRECTOR
Principal, Cadre Partners (PE)
Founding Partner, Diamond Ventures
Extensive entrepreneurial
ventures
PENG KHAWFOUNDER AND DIRECTOR
Consultant Ophthalmic Surgeon
Professor of Glaucoma Studies and Wound Healing
Director of R&D and the NIHR Biomedical Research Centre at Moorfields Eye
Hospital/ University College London, UK
§ Serial medical device entrepreneur
§ Beta therapy innovator
§ Previously Founder, co-innovator and CEO of Salutaris Medical Devices, Inc.,
successful investment from HOYA (Market Cap $21B, $4.5B annual sales)
§ Physicist (Yale Graduate School)
§ Physician (U Arizona)
FOUNDING TEAM
PROFESSOR SIR PENG TEE KHAW, MD PHDFOUNDER AND DIRECTOR § Consultant Ophthalmic Surgeon, international thought-leader
§ Professor of Glaucoma Studies and Wound Healing, Director of R&D at theNIHR Biomedical Research Centre
§ Pioneer of antimetabolite therapy in glaucoma surgery, now standard of care
§ Pioneering beta therapy as better therapy
§ Pioneer of the 10-10-10 goal for glaucoma surgery
LAURENCE MARSTELLER, MD PHDFOUNDER AND CEO
* Varian MS Inc. JP Morgan HCC Presentation 2017
FOUNDING TEAM
§ Consultant glaucoma surgeon and epidemiologist
§ Lead author of 7 published papers investigating beta therapy, including outcomes from 2 RCTs
§ Pioneering beta therapy for glaucoma surgery, particularly underserved regions
IAN MURDOCH, MD PHDFOUNDER AND MEDICAL DIRECTOR
WENDELL LUTZ, PHDFOUNDER
§ Innovation leader in radiation oncology medical physics
§ At Harvard, invented stereotactic radiosurgery, now standardof care
§ Innovation leader in brachytherapy
§ Professor of Ophthalmology and Director of the Glaucoma Service, Stanford University School of Medicine§ United States FDA Advisory Committee on Ophthalmic Devices§ Author of over 250 published papers§ Past President, American Glaucoma Society§ Past Chair of the Board of Directors, Glaucoma Research Foundation§ Past Chief Executive, World Glaucoma Association§ Past Chair & Methodologist, Ophthalmic Technology Assessment Panel, American Academy of Ophthalmology
OPHTHALMOLOGY K.O.L. ADVISORS
KULDEV SINGH, MDStanford University
§ Glaucoma Consultant, Moorfields Eye Hospital§ Honorary Reader, University College London§ Steering Group Member and Co-Chair, various internationally renowned glaucoma surgical trials§ Author of over 100 published peer-reviewed papers and book chapters§ Editor in Chief, British Journal of Ophthalmology§ Chairman, International Glaucoma AssociationKEITH BARTON, MD
Moorfields Eye Hospital/ University College London
IKE AHMED, MDTrillium Health Partners
University of Toronto
§ Glaucoma surgeon and Division Head of Ophthalmology, Trillium Health Partners, Ontario, Canada§ Assistant Professor, University of Toronto§ Clinical Professor, University of Utah§ “The Father of MIGS”
IP 510(K) SUPPLY
Validated 510(k) FDA pathway. Experienced
team have achieved numerous 510(k)s
including for ophthalmic brachytherapy devices
Radiation supply chain and manufacturing with a
Fortune 500 partner
Patented&
10+ Patents Pending
“Core” Patent: strong claims of composition of
matter and methods.
PATHWAY TO SUCCESS
2021
EARLY MARKET READY
Q1
Q2
Q3
Q4
2022
Q1
Q2
Q3
Q4
2023
Q1
Q2
Q3
Q4
Device DesignISO13485 Compliant
Notified Body ISO13485 Audit
Manufactured RBS
1st Lot Release Manufactured Applicators
CE Mark Safety Study
CE Mark Submission
1st Lot Release Second Generation Applicators
US FDA 510(k) Clearance
2024
THE GLAUCOMA MARKET Glaucoma is the leading cause
(75%) of irreversible blindness worldwide: 80 million people suffer from glaucoma
Annual glaucoma product sales exceed $4.5B in the United States, Europe and Japan
40% annual growth rate in glaucoma medical devices is driven by innovation
Glaucoma is a big and growing market!
*Market Scope
$35MM
RADIANCETX MARKET OPPORTUNITYCURRENT ADDRESSABLE ANNUAL OECD MARKET* OF ~ $500MM
$100MM $108MM$200MM
USA80,000 Trabeculectomies
RTx @ $2500
JAPAN35,000 Trabeculectomies
RTx @ $1000
EUROPE94,000 Trabeculectomies
RTx @ $1000
2019 MIGS (GLOBAL)43,000 ab externo Procedures
RTx @ $2500
BILLION DOLLAR EXITS:§ GLAUKOS [NYSE: GKOS], a Minimally Invasive Glaucoma Device company, current Market Cap ~$3.5B on annual sales of approx. $212MM
§ Acquisitions pre-approval: § AQUESYS, acquired by Allergan for $300MM upfront plus milestones§ INNFOCUS, acquired by Santen for $225MM upfront plus milestones§ TRANSCEND MEDICAL, acquired by Alcon for $225MM upfront plus milestones
* Market Scope 2019 Data
RTX CHECKLIST FOR SUCCESSTherapy solves a significant medical problem
Validated regulatory pathway
Big market: $4.5B therapeutic category
Randomized Controlled Trial clinical data: 4 studies done
Manufacturing supply chain: ready and validated
Validated patent pending pathway for strong IP
