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EXECUTIVE SUMMARY – Q3/2019 Light Line Medical, Inc.’s (LLM or the Company, based in Salt Lake City, UT), novel, patented Light Line Phototherapy™ visible light technology is positioned to create a game-changing, global shift in prevention (and eventually treatment) of catheter associated infections (CAIs). Without relying on drugs, other chemicals, or harmful UV light, LLM’s technology will contribute to averting an antibiotic-resistant (AR) world where infection prevention and treatment becomes more challenging. CAIs are a major part of the growing AR “apocalypse”, one of the world’s most pressing public health threats. LLM’s WW revenue estimate for effective prevention and treatment of all CAIs is $1.0B 6 years from its first product launch and $2.2B 11 years from launch. LLM Technology LLM estimates significant revenue opportunities with the Company’s patented technology. The Company’s targeted indications are: 1. Peritoneal dialysis (PD) catheter infection prevention. 2. Catheter associated urinary tract infections (CAUTI). Unlike other hospital acquired infections, CAUTIs have not decreased in decades despite compliance with industry standards. Hospitals continue to be severely economically penalized for these infections. After validating the technology in PD and CAUTI, LLM’s technology will be translatable to: 3. Respiratory endotracheal tube infections (RETI) 4. Vascular catheter infections (VCI). LLM has generated de-risking proof of concept in vitro and animal data, showing the technology works to prevent microbes intraluminally and extraluminally in both silicone Foley and PD catheters. Revenue Potential The table to the right shows LLM’s estimates of market share and related revenue for the targeted indications. A 510(k)-regulatory pathway has been established for LLM’s first- generation PD and CAUTI-prevention products. Two core patent covering freedom to operate in catheter infection prevention, with potential for blocking competition, have issued. One more is issueing shortly and additional filings are being prosecuted to ensure patent exclusivity in multiple fields the Company is pursuing. The Company just closed its bridge round of $1M to complete its working PD Gen-1 prototype. It is currently seeking Series A of $3.5-$5M in two trances: Series A-1 ($1M) and Series A-2 ($2.5- 4M) which will fund its Gen-1 PD product through FDA 510(k)-premarket clearance, followed by the launch of ts products to prevent CAUTIs and RETIs or VCIs. Approval and commercial launch for only the initial indication, with a first generation PD catheter launch expected 12 months from funding, will represent a potential exit point or strategic partnership opportunity. The Company has a 3 year distribution agreement in North America for its CAUTI-prevention product with its seed investor Medline Industries, Inc., the largest privately held manufacturer and distributor of medical supplies ($10B in annual revenue). LLM’s strategic investor Merit Medical System’s, Inc., a leader in development, manufacturing and commercialization of interventional cardiology and endoscopy medical devices ($760M in annual revenue), anticipates participating in the Series A. I. Market Opportunity Preventing and reducing PD and CAUTI infections with a non-antibiotic platform technology will be the first major advancement in decades. Although it is recognized that PD (performed in the home) provides a better quality of life and is clinically superior to and less expensive than hemodialysis (HD) (performed in a clinic), 89% of all dialysis patients in the U.S. elect HD over PD - due to threat of infection. However, 93% of all dialysis patients are PD eligible. Solving the PD infection problem will create the opportunity to shift HD patients to PD. LLM’s technology will immediately prevent avoidable patient morbidity and mortality, improve patient care and quality of life, and reduce hospital stays and readmissions, saving billions of dollars in costs worldwide. As this technology develops in other areas, including respiratory and vascular indications, it will represent a viable solution to a drug resistant world where infection prevention and treatment are becoming more and more difficult. The WW five core markets for the Company’s platform technology (PD, Drainage, Urinary, Respiratory, Vascular) will drive LLM’s revenue opportunity for infection prevention alone to over $1.0B annually 6 years from the launch of its first product and to $2.2B by 11 years from launch. Year 6 Year 11 Indication Share Rev. ($M) Share Rev. ($M) PD 30% $ 572 55% $ 1,000 CAUTI 13% $ 256 24% $ 528 RETI 4% $ 67 9% $ 158 VCI 2% $ 123 6% $ 486 Worldwide US Only

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  • EXECUTIVE SUMMARY – Q3/2019

    Light Line Medical, Inc.’s (LLM or the Company, based in Salt Lake City, UT), novel, patented Light Line Phototherapy™ visible light technology is positioned to create a game-changing, global shift in prevention (and eventually treatment) of catheter associated infections (CAIs). Without relying on drugs, other chemicals, or harmful UV light, LLM’s technology will contribute to averting an antibiotic-resistant (AR) world where infection prevention and treatment becomes more challenging. CAIs are a major part of the growing AR “apocalypse”, one of the world’s most pressing public health threats. LLM’s WW revenue estimate for effective prevention and treatment of all CAIs is $1.0B 6 years from its first product launch and $2.2B 11 years from launch.

    LLM Technology LLM estimates significant revenue opportunities with the Company’s patented technology. The Company’s targeted indications are:

    1. Peritoneal dialysis (PD) catheter infection prevention. 2. Catheter associated urinary tract infections (CAUTI). Unlike other

    hospital acquired infections, CAUTIs have not decreased in decades despite compliance with industry standards. Hospitals continue to be severely economically penalized for these infections.

    After validating the technology in PD and CAUTI, LLM’s technology will be translatable to: 3. Respiratory endotracheal tube infections (RETI) 4. Vascular catheter infections (VCI).

    LLM has generated de-risking proof of concept in vitro and animal data, showing the technology works to prevent microbes intraluminally and extraluminally in both silicone Foley and PD catheters.

    Revenue Potential The table to the right shows LLM’s estimates of market share and related revenue for the targeted indications.

    A 510(k)-regulatory pathway has been established for LLM’s first-generation PD and CAUTI-prevention products. Two core patent covering freedom to operate in catheter infection prevention, with potential for blocking competition, have issued. One more is issueing shortly and additional filings are being prosecuted to ensure patent exclusivity in multiple fields the Company is pursuing.

    The Company just closed its bridge round of $1M to complete its working PD Gen-1 prototype. It is currently seeking Series A of $3.5-$5M in two trances: Series A-1 ($1M) and Series A-2 ($2.5-4M) which will fund its Gen-1 PD product through FDA 510(k)-premarket clearance, followed by the launch of ts products to prevent CAUTIs and RETIs or VCIs. Approval and commercial launch for only the initial indication, with a first generation PD catheter launch expected 12 months from funding, will represent a potential exit point or strategic partnership opportunity. The Company has a 3 year distribution agreement in North America for its CAUTI-prevention product with its seed investor Medline Industries, Inc., the largest privately held manufacturer and distributor of medical supplies ($10B in annual revenue). LLM’s strategic investor Merit Medical System’s, Inc., a leader in development, manufacturing and commercialization of interventional cardiology and endoscopy medical devices ($760M in annual revenue), anticipates participating in the Series A.

    I. Market Opportunity Preventing and reducing PD and CAUTI infections with a non-antibiotic platform technology will be the first major advancement in decades. Although it is recognized that PD (performed in the home) provides a better quality of life and is clinically superior to and less expensive than hemodialysis (HD) (performed in a clinic), 89% of all dialysis patients in the U.S. elect HD over PD - due to threat of infection. However, 93% of all dialysis patients are PD eligible. Solving the PD infection problem will create the opportunity to shift HD patients to PD. LLM’s technology will immediately prevent avoidable patient morbidity and mortality, improve patient care and quality of life, and reduce hospital stays and readmissions, saving billions of dollars in costs worldwide. As this technology develops in other areas, including respiratory and vascular indications, it will represent a viable solution to a drug resistant world where infection prevention and treatment are becoming more and more difficult. The WW five core markets for the Company’s platform technology (PD, Drainage, Urinary, Respiratory, Vascular) will drive LLM’s revenue opportunity for infection prevention alone to over $1.0B annually 6 years from the launch of its first product and to $2.2B by 11 years from launch.

    Year 6 Year 11 Indication Share Rev. ($M) Share Rev. ($M) PD 30% $ 572 55% $ 1,000 CAUTI 13% $ 256 24% $ 528 RETI 4% $ 67 9% $ 158 VCI 2% $ 123 6% $ 486 Worldwide US Only

  • Appendix

    II. Technology Validation LLM has established proof of concept in both PD and Foley catheters. Specifically, it has generated in vitro and animal data (swine) establishing that its visible light therapy system kills microbes that cause peritonitis and CAUTI both intraluminally and extraluminally on PD and Foley catheters, respectively. Significantly, microbes on the PD catheter cuffs (dacron) were killed by visible light, indicative of its ability to treat existing infections. The Appendix summarizes these data.

    Light Line TM Foley Light LineTM PD Catheter

    III. Competitive Overview LLM is the first company to use visible light phototherapy and to develop a patented light-delivery system to uniformly irradiate internal and external surfaces of a catheter in situ, preventing PD and CAUTI infections long term while avoiding AR issues. To LLM’s knowledge, no company is actively developing a visible light method to prevent PD and CAUTI infections. As far as the Company’s management knows, while Teleflex published a paper evaluating visible light for preventing CAUTI, its IP covers only UV light (which is harmful to tissue exposure). Significantly, LLM has priority and issued patents on its visible light phototherapy system in catheters covering hospital acquired infection devices.

    C. R. Bard and Teleflex are the current Foley market leaders with 85% of the U.S. market collectively, but do not have effective CAUTI-prevention antibiotic resistant Foleys. Even the aggressively marketed, widely utilized, Bardex® silver alloy coated Foley claims only that it may minimize the dosage of antibiotics, not that it is antibiotic resistant. While there are photodynamic therapies on the market and in development, as well as cancer treatments that use UV light, there is currently no non-UV light-based technology on the market to prevent infections caused by a catheter in situ. This is mainly because the properties of UV light greatly limit its usefulness and ability to deliver the light inside the body.

    IV. Intellectual Property LLM has a robust patent portfolio and three issued patents covering its core technology: Methods and Apparatus to Inactivate Infectious Agents on a Catheter Residing in a Body Cavity, U.S. Serial No. 9,808,647, issued 11.7.17; U.S. Serial No.10,238,890, issued 3.26.19); US Serieal No. 10,307,612 issue 6.4.19. The Company has also paid the issue fee on U.S. Serial No. 16/276,459, which will issue shortly. Fourteen (14) pending applications cover various aspects of the device and methods of use. A freedom to operate opinion has been obtained for the Light Line FoleyÔ and the Light Line PD Disinfection SystemÔ.

    V. Management The Company has extensive industry, hospital, and R&D experience. • Vicki Farrar, CEO, former Founder/CEO of Catheter Connections (infection control company recently acquired by Merit

    Medical Systems, Inc.), has 40+ years of pharmaceutical and med- tech IP and commercialization experience. • Perry Croll, Chief Engineering Officer, a medical device veteran with 20 years of commercialization and successful exits,

    is overseeing product development. Mr. Croll’s most recent exits were Olive Medical acquisition by Johnson & Johnson and AbViser Medical acquisition by ConvaTec.

    VI. Board of Directors:

    • Dinesh Patel (Executive Chairman) was the former managing director of vSpring Capital and the Founder/CEO of TheraTech which was acquired for $350 million.

    • Kelly Powers has 30+ years of medical industry expertise (former VP of R&D, Bard Access; recently retired as VP Science & Technology at CR Bard).

    • Greg Fredde, EVP Business Development, Merit Medical, has led multiple M&A transactions and has expertise in evaluating competitive markets and new technologies.

    • Mitchell Barneck, MD, a co-founder and co-inventor, is an emergency medicine physician. • Mark Ehlert, 40+ years medical device exertise (Cardinal, Baxter, Hospira), deep peritoneal dialysis experience. • Vicki Farrar, CEO of LLM, is also on the Board.

    VII. Awards: LLM has received many prestigious awards: AMA Innovation; NASA; USPTO; USTAR; and Utah Innovation.

  • Appendix

    Preliminary animal & In vitro testing of the Light Line Disinfecting Systemä (PD & Foley)

    Animal Model: A pre-pilot, multi-day, mini-animal study was conducted in female swine to evaluate this model for functionality, manageability, and clinical relevance. This study demonstrated safety and efficacy of LLM’s light-based sterilization technology in a silicone Foley catheter inoculated with infectious levels of E. coli. Images were obtained following gross necropsy and microbiology quantification and extra-luminal SEM imaging were completed on catheter samples retrieved post necropsy.

    Preliminary Gross Pathological Findings:

    Bacterial Infection process is observed below No gross evidence of an ongoing infectious process

    No Light = Infected Bladder No Light = Infected Bladder Light Treated = No Infection Light Treated = No Infection (Extra-luminal catheter surface) (Extra-luminal catheter surface)

    Foley Catheter and Peritoneal Dialysis Catheter In vitro Testing: Silicone Foley catheter extra-luminal surfaces were inoculated with infectious levels of Staph aureus and successfully treated with visible light through simulated urine and silicone. Silicone PD catheters were fixed in petri dishes filled with agar with infectious levels of Staph epidermidis and Staph aureus. PD catheters were successfully treated with visible light through dialysate fluid and silicone.

    Light Line Foley in vitro SEM Images (Extra-luminal Catheter Surface) Staph aureus Inoculated Foley Catheters

    Light Treated = No Bacteria No Light = Bacteria & Biofilm

    PD Catheter:

    Kill Zone Created by Visible Light (S. epidermidis) PD Catheter:

    Kill Zone Created by Visible Light (S. aureus)

    Light Exposure Visible Light Kill Zone Light Exposure Visible Light Kill Zone