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BUSINESS PLAN Section 1: Executive Summary We are asking for $117,000 to create the ImmERge Virtual Reality Sudden Cardiac Arrest (SCA) training system, which will change the paradigm of cardiopulmonary resuscitation (CPR) training and improve bystander response and outcomes from SCA.ImmERge will be set up as an LLC company where equity can be shared between the founders, the University, and the funders. In the US, over 350,000 people experience a SCA annually, and survival is low, just 8%.1-4 Bystander CPR can double the chance of survival, yet only 3 out of 10 people who have a sudden cardiac arrest will receive this life-saving intervention.1 The chances of survival decrease 10% every minute that goes by without receiving CPR. In Philadelphia, on average, 3 SCA events happen every day. Studies have shown that bystanders do not perform CPR either because they do not know what to do or because they are afraid to do it. Currently standard CPR training classes take place in a classroom setting with trainees practicing their CPR skills on a plastic manikin. This type of training environment does not simulate the stress and emotion of a real emergency. That is why virtual reality is so powerful. It can simulate rare-occurring events in a safe, dynamic and realistic environment on a platform which “has an extraordinary capacity to convey the kinds of feelings of presence and place, that creates a visceral emotion of being immersed in a whole new world”.5 Combining a virtual reality device that includes a head mounted wearable such as the Oculus Rift along with data gloves, a tracking device and a CPR manikin, we will program a virtual environment that can prepare bystanders for these high-stress emergencies in as close to a real-life setting as virtually possible, so they are not just prepared with the skills to perform hands-on CPR, but emotionally and mentally prepared to step up and act when needed. The ImmERge system will be programmed to accurately illustrate any number of neighborhoods where trainees can walk among their virtual neighbors, go inside buildings to look for an automated external defibrillator (AED), acquire assistance from simulated bystanders, call 911 and perform CPR. The module will include a virtual CPR instructor that follows the trainee throughout the scenario and will be interactive, programmed to answer questions and to alert trainees when they are not performing CPR according to guidelines. Our financial projections are based on the following assumptions: The average cost per CPR training course is $85 for lay providers; there are approximately 75 American Heart Association and American Red Cross CPR training Centers in Philadelphia and over 200 in Southeastern Pennsylvania alone; on average there are 8 CPR trainings available per month at each training center that accommodate 20 participants per class.

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Each virtual reality system costs approximately five-thousand dollars; assuming ImmERge rents the devices to the CPR training centers for 20% of the cost of the system, which would be $6000 per device rental fee, and ImmERge keeps 10% of the $85 CPR training cost, we can expect to scale up, covering Philadelphia and expanding to Southeastern Pennsylvania (SEPA) and be revenue generating by year 2. Additionally, CPR instructors in the standard CPR training courses are paid, on average, $80,000 annually. Using the ImmERge virtual reality system, there is a potential cost savings for the centers by removing the need for a CPR instructor at each training. If the sudden cardiac arrest module is successful, one could envision a suite of emergency response modules such as mass casualty, first aid, fire safety etc. In additional, there is a large market for healthcare provider training with ImmERge. The close to 4 million RNs and 1 million MDs, along with over 800,000 EMS personnel, need to be CPR trained at some point in their career, if not on a continual basis. ImmERge has the potential to be funded through a granting agency or as a private LLC company through Penn StartUp, where equity from surplus revenue is shared between the University of Pennsylvania, the founders of ImmERge and investors. Section 2: About Your Organization The ImmERge team is embedded within the nationally-ranked University of Pennsylvania (Penn).6 Penn’s community includes over 1,000 faculty, more than 1,000 postdoctoral fellows, more than 3,000 PhD students, and more than 5,000 professional, administrative, and support staff, with a budget in excess of half a billion dollars annually. Penn Nursing, which is the co-home to our primary team member, has the highest grant funding in the country among all Nursing schools and is heavily invested in healthcare innovation.7 The Center for Resuscitation Science (CRS) at the University of Pennsylvania, which will be the organizational home for the ImmERge Virtual Reality modules, was established in 2006 to serve as a focal point for multidisciplinary research across the full spectrum of resuscitation science from bench to bedside.7 The CRS has developed a broad multidisciplinary team on resuscitation therapies, education and care, including scientists from the medical sciences and engineering, scientists and clinicians with backgrounds in biochemistry, cellular physiology, medicine, pediatrics, emergency medicine, anesthesia, surgery, trauma, critical care, neuroscience, mechanical engineering, bioengineering, nursing, veterinary medicine, and others. The mission of the CRS is to advance research, education and training to save lives from SCA. Section 2a: Sudden Cardiac Arrest Approximately 350,000 out-of-hospital and 200,000 in-hospital cardiac arrest events occur each year in the US with a mortality rate >80%.1-4 A cardiac arrest occurs when a

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patient’s heart stops beating unexpectedly; time sensitive and complex actions, including provision of CPR by either a lay bystander or a healthcare provider, are

required within minutes of arrest to avoid death. For every minute that goes by without someone performing CPR, the chance of survival decreases by 10%.1 Bystander CPR can double the chance of survival for a victim yet only 3 out of 10 people who have a SCA will receive this life-saving intervention.1 There is great potential to improve SCA survival with innovative solutions that enhance currently existing therapies that are poorly disseminated. Improving survival from SCA is a significant public health concern that has been emphasized by both the Institute of Medicine (IOM) and the American Heart Association (AHA) just recently. The IOM is a division of the National Academies of Sciences, Engineering, and Medicine. The IOM’s aim is to help those in government and the private sector make informed health decisions by providing evidence upon which they can rely. In the IOM’s report Strategies to Improve Cardiac Arrest Survival: A Time to Act, they acknowledged that efforts to improve outcomes from SCA in the US are falling short. They discussed evidence-based recommendations to improve outcomes, one of which focused on improvement of public response with the need for immediate recognition and activation of 911 and high-quality bystander CPR and use of AEDs. The IOM stressed that SCA treatment “is a community issue and it is treatable and survivable but local personnel including lay bystanders, must provide high-quality care to save lives of community members.”9 Further, the updated American Heart Association (AHA) CPR and Emergency Cardiovascular Care Guidelines released in 2015, which are directed at out-of-hospital providers such as Emergency Medical Services (EMS) personnel, in-hospital providers and the lay public, focused on empowering the lay bystander to take action to help save a life during a SCA. Additionally, a new recommendation in the 2015 Guidelines included the need to increase innovative solutions for improving bystander training and response, stating: "quick action, proper training, use of technology and coordinated efforts can increase survival from cardiac arrest." 10

Section 2a: Virtual Reality Virtual Reality is a computer programed 3D environment where users can interact with alternate realities11. Virtual Reality has “an extraordinary capacity to convey the kinds of feelings of presence and place, which creates a visceral emotion of being immersed in a whole new world.”5 Pseudo-virtual reality programs on less dynamic platforms such as

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computers with simulated manikins are currently used for CPR trainings by our competitors such as the American Heart Association and the American Red Cross. These courses entail watching a video and then potentially practicing on a manikin with no emotional connection, creating a potential bystander who is completely apathetic and disengaged from the purpose and emotion of the training. Our market research suggests that lay providers want trainings that are immersive, allowing for a real-life experience. They want to feel what it is like to be in that situation, performing CPR; they are done with the standard components of traditional CPR classes that are always the same. The use of wearable technology has increased rapidly over the past few years. Using an immersive Virtual Reality wearable such as the Oculus Rift or HTC Vive, which allows people to experience anything, anywhere, at any time – along with a Laerdal CPR Manikin, data gloves and a tracking device, we can create a SCA module to train lay bystanders, in an environment that replicates “real life” as close as possible. Using Google Maps street view along with the MyHeartMap AED project data from Penn, which crowdsourced AEDs in Philadelphia12, we will create a dynamic environment that can more accurately illustrate any number of neighborhoods where participants can walk among their virtual neighbors, go inside buildings to look for an automated external defibrillator (AED), acquire assistance from simulated bystanders, call 911 and perform CPR. The module will include a virtual CPR instructor that follows the trainee throughout the scenario and will be interactive, programmed to answer questions and to alert trainees when they are not performing CPR according to guidelines. The ImmERge module will create an entirely new CPR training paradigm, removing the need for the classroom-instructor setting. Virtual reality immersion proof of concept A meta-analysis of clinical trials that used virtual reality exposure therapy (VRET) found that “patients undergoing VRET did significantly better on behavioral assessments following treatment than before treatment.” This study concluded that using virtual reality immersion can significantly change behavior in real-life situations.13 A case report published recently on the use of VRET on veterans called virtual Iraq, used VRET to treat veterans with post-traumatic stress disorder, found that following brief sessions with virtual reality immersion, there was statistically significant improvement in PTSD symptoms per validated PTSD scales.14

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One study out of Italy examined the use of immersive virtual reality for CPR training and found that healthcare providers rated the experience easy for use and high for realism and immersion.15 Section 3: Personal and Organizational History Marion Leary, MPH MSN RN (PI), is the Assistant Director of Clinical Research for the Penn Center for Resuscitation Science (CRS) at the University of Pennsylvania.8 Ms. Leary serves on the Science Subcommittee of the AHA Emergency Cardiovascular Care Committee and the AHA Cardiovascular Nursing Membership and Communication Sub-committee. Ms. Leary participated in the 2010 International Liaison on Consensus on Resuscitation (ILCOR) Guidelines process and on the 2015 ILCOR/AHA Guidelines process. Ms. Leary has been an author on over 30 scholarly publications pertaining to CPR and resuscitation science, including a recent AHA scientific statement on CPR quality. Ms. Leary currently has two grant awards examining cardiac arrest care. Ms. Leary and Ms. Blewer have experience with a resuscitation start-up, Resuscor, LLC, created through the Penn Center for Innovation in 2012. Additionally, Ms. Leary founded and ran a non-profit organization, Sink or Swim, Inc., whose mission was to help people who were uninsured or underinsured raise funds to pay for medical expenses using social media and crowdfunding. Ms. Leary currently teaches Public Health Methods in the Penn Master of Public Health program and is the Course Director for their research residency program at the Penn School of Nursing. In addition, Ms. Leary is a Senior Fellow for the Center for Public Health Initiatives and an International Fellow for the American Heart Association. 27 Audrey L. Blewer, MPH, is the Assistant Director of Education for the Center for Resuscitation Science (CRS)8 and a PhD candidate in Epidemiology in the Department of Epidemiology and Biostatistics at the University of Pennsylvania. Ms. Blewer has established herself as a promising young investigator in the field of implementation and resuscitation science, having authored studies on the implementation of CPR training, among other works. She serves on the Citizen CPR Foundation’s Emergency Cardiovascular Care Update committee, and has served as the coordinator of a highly successful national CME course pertaining to resuscitation science, hosted at Penn. Marc Rigas, PhD, Managing Director of the Institute for Biomedical Informatics (IBI), Idea Lab.16 Biomedical informatics is the interdisciplinary field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving and decision making, motivated by efforts to improve human health. Before coming to Penn, Dr. Rigas served as a program director for interdisciplinary activities within the Directorate for Computer and Information Science and Engineering at the National Science Foundation. He also spent seven years building new bioengineering and computational biology grant programs at the National Institutes of Health.

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Section 4: Your Strategy Working with the Penn Idea’s Lab, we will program the ImmERge virtual reality SCA training module. The module will be coupled with the existing CPR training manikins to incorporate the hands-on tactile component of the traditional classroom trainings. Ms. Leary and Ms. Blewer have established working relationships with Laerdal Medical, the company that manufactures the CPR training manikins and with the American Heart Association and the American Red Cross, who are the biggest competitors in the area of CPR training. Phase 1 of ImmERge will focus on purchasing the virtual reality devices, working with the Penn Idea’s Lab to program the sudden cardiac arrest module, testing, research, & development and then expansion of the system to established CPR training centers. Ms. Leary and Ms. Blewer will approach the American Heart Association and the American Red Cross to discuss a partnership to enhance their standard classroom trainings, in turn enhancing the student’s level of preparedness. Phase 2 will focus on increasing the number of people who are trained in CPR. In the US only 2% of the population are CPR certified and 17% CPR trained. Furthermore, rates of bystander CPR are significantly lower in low SES communities, even though sudden cardiac arrest incidence is two times higher, highlighting glaring disparities in care. Virtual Reality kiosks could be installed at the public libraries, medical offices, etc. to increase access to these life-saving trainings to segments of the population who may not otherwise have access or training. If the sudden cardiac arrest module is successful, one could envision a suite of emergency response modules such as first aid, fire safety, chocking etc., with wide scale dissemination of these products. Finally, there is a large market for healthcare provider training with ImmERge as all of the close to 4 million RNs and 1 million MDs, along with over 800,000 EMS personnel,need to be CPR certified at some point in their career, if not on a continual basis.17-19 Section 5: Marketing In the US, only 2.5% of people are CPR certified and locally, in Philadelphia, only 15% of the population are CPR trained.17-18 There is a large market to increase bystander CPR training and in turn increase bystander response and survival from SCA using innovative approaches.

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We performed market research via social media and found that close to 70% of those surveyed preferred an immersive virtual reality platform or combination training over the standard classroom style CPR trainings currently available. One study out of Italy on using immersive virtual reality for CPR training and found that healthcare providers rated the experience easy for use and high for realism and immersion.19 Section 6: Measure Your Social Impact The City of Philadelphia has a population of over 1.5 million people. The poverty rate in Philadelphia is 26.5% and the racial and ethnic make-up includes: 45% White, 44% Black, 7% Asian, with 14% identifying as Hispanic/Latino.20 Alarmingly, bystander CPR rates are less than the national average of 35%. Though CPR has been shown to increase survival dramatically, most SCA victims in Philadelphia are not receiving this life-saving intervention. Furthermore, though responses to a SCA should be the same for all patients who suffer a cardiac arrest, it has been show that different segments of the populations receive lower rates of this crucial life sustaining therapy which leads to lower overall rates of survival. Rates of bystander CPR are significantly lower in low SES communities, though sudden cardiac arrest incidence is two times higher, highlighting glaring disparities in the SCA care. 21-23 A study recently published in the New England Journal of Medicine specifically looked at disparities in care related to cardiac arrest. They analyzed data from 29 US sites and found that low-income Blacks were less likely to receive bystander CPR when compared to their high-income White counterparts. In another recent study examining outcome differences between Blacks and Whites who had suffered a SCA requiring defibrillation, survival to hospital discharge was worse for Blacks compared to Whites (30% v 33%, p<0.001).21 In addition, a recent study presented by Penn faculty at the Society for Academic Emergency Medicine found that in Philadelphia, there was a delay in time to defibrillate in Blacks versus Whites (27.3% vs. 34.4%, p<0.001) and even more troubling, that Black patients had a lesser chance of regaining their pulse than Whites (14.7% v 17.1%, p=0.04).22-23 These studies highlight the importance of bystander CPR and the problem with the lack of knowledge around SCA care in the Black community.21-23 There is great potential to decrease these disparities in SCA response with a self-contained, easy to implement program such as ImmERge. Implementing the ImmERge program with wide scale dissemination of this product via Virtual Reality kiosks installed at the public libraries or medical offices in low SES communities could have huge social policy, training and outcomes implications.

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Section 7: Funding Nationally there are approximately 3,500-3,800 American Heart Association (AHA) and 170 American Red Cross (ARC) CPR training centers. Other for-profit and non-profit organizations exist that perform CPR training and certification, though the AHA and ARC are the major training centers in the US. In Philadelphia, there are approximately 75 AHA CPR training centers and 1 ARC CPR training center. In SEPA there are 100 AHA CPR training Centers and 3 ARC CPR training centers. On average, CPR courses average $85 - $100 for lay provider Heartsafe CPR and AED certification trainings. In any given month there are on average 8 CPR training courses available at each training center. Assuming ImmERge keeps 25% of the $85 cost ($20) and assuming 20 participants per class, the following revenue would be generated (see below for financial spreadsheet screenshot): Year 1 revenue would be: $20 x 20 participants x 8 CPR trainings per month per center x 3 centers x 6 months. We are assuming a 6 month pilot test of CPR trainings via the ImmERge module at 3 CPR training centers in the last half of the first year. Year 2 would be expanded to all of the training centers in Philadelphia, totaling ~76 training centers. Revenue is based on the following assumptions: $20 x 20 participants x 8 CPR courses a month per training center x 76 CPR training centers x 12 months. Year 3 would expand to all of SEPA CPR training centers, a total of 103 training centers. Revenue is based on the following assumptions: $20 x 20 participants x 8 CPR courses a month per training center x 103 CPR training centers x 12 months. Currently, Year 4 captures the same CPR training centers in SEPA from Year 3 but includes 10 replacement units under expenses. Preferably, Year 4 could be expanded further nationally or a model would be determined to price and sell the ImmERge system to one of the CPR device manufacturers such as Laerdal Medical.

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Section 8: References

1. Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322.

2. McNally B, Robb R, Mehta M, Vellano K, Valderrama AL, Yoon PW, Sasson C,

Crouch A, Perez AB, Merritt R, Kellermann A. Out-of-Hospital Cardiac Arrest Surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005--December 31, 2010. Surveillance Summaries. 60(SS08);1-19.

3. Kantamineni P1, Emani V, Saini A, Rai H, Duggal A. Cardiopulmonary

resuscitation in the hospitalized patient: impact of system-based variables on outcomes in cardiac arrest.Am J Med Sci. 2014 Nov;348(5):377-81.

4. Merchant RM1, Berg RA, Yang L, Becker LB, Groeneveld PW, Chan PS;

American Heart Association's Get With the Guidelines-Resuscitation Investigators. Hospital variation in survival after in-hospital cardiac arrest. J Am Heart Assoc. 2014 Jan 31;3(1):e000400.

5. New York Times, Where Virtual Reality Takes Us, January 21, 2016. Accessed from: http://www.nytimes.com/2016/01/21/opinion/sundance-new-frontiers-virtual-reality.html?_r=0.

6. University of Pennsylvania. Accessed from: www.upenn.edu/.

7. Penn Nursing. Accessed from: www.nursing.upenn.edu/.

8. Center for Resuscitation Science. Accessed from: https://www.med.upenn.edu/resuscitation/.

9. Institutes of Medicine, Strategies to Improve Cardiac Arrest Survival: A Time To Act, June 30, 2015. Accessed from: http://www.nationalacademies.org/hmd/Reports/2015/Strategies-to-Improve-Cardiac-Arrest-Survival.aspx.

10. Kronick SL, Kurz MC, Lin S, Edelson DP, Berg RA, Billi JE, Cabanas JG, Cone DC, Diercks DB, Foster JJ, Meeks RA, Travers AH, Welsford M. Part 4: Systems of Care and Continuous Quality Improvement: 2015 American Heart Association

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Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S397-413.

11. Giraldi G, Silva R, deOliveira JC. Introduction to Virtual Reality. LNCC-National Laboratory for Scientific Visualization and Virtual Reality Laboratory. Accessed from: http://www.lncc.br/~jauvane/papers/RelatorioTecnicoLNCC-0603.pdf

12. Merchant RM, Asch DA, Hershey JC, Griffis HM, Hill S, Saynisch O, Leung AC, Asch JM, Lozada K, Nadkarni LD, Kilaru A, Branas CC, Stone EM, Starr L, Shofer F, Nichol G, Becker LB. A crowdsourcing innovation challenge to locate and map automated external defibrillators. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):229-36.

13. Morina N, Ijntema H, Meyerbröker K, Emmelkamp PM. Can virtual reality

exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. Behav Res Ther. 2015 Nov;74:18-24.

14. Jones F. Virtual reality worlds could soon be available on prescription. Mind,

News and Analysis. Accessed from: http://snip.ly/qtf33?utm_content=bufferaaff6&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer#https://health.spectator.co.uk/virtual-reality-worlds-could-soon-be-available-on-prescription/?utm_content=buffere39a8&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer

15. Semeraro F, Frisoli A, Bergamasco M, Cerchiari EL. Virtual reality enhanced

mannequin (VREM) that is well received by resuscitation experts. Resuscitation. 2009 Apr;80(4):489-92.

16. Penn Institute for Bioinformatics. Accessed from: upibi.org/.

17. Department of Health and Human Services. The US Nursing Workforce: Trends in Supply and Education. April, 2013. Accessed from: http://bhpr.hrsa.gov/healthworkforce/reports/nursingworkforce/nursingworkforcefullreport.pdf.

18. The Henry J. Kaiser Family Foundation. Total Professionally Active Physicians. January 2016. Accessed from: http://kff.org/other/state-indicator/total-active-physicians/.

19. NAEMT, EMT Statistics. Accessed from: http://www.naemt.org/about_ems/statistics.aspx.

20. Anderson ML, Cox M, Al-Khatib SM, Nichol G, Thomas KL, Chan PS, Saha-

Chaudhuri P, Fosbol EL, Eigel B, Clendenen B, Peterson ED. Rates of

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cardiopulmonary resuscitation training in the United States. JAMA Intern Med. 2014 Feb 1;174(2):194-201.

21. Blewer AL, Leary M, Ikeda D, Becker LB, Abella BS. The Majority of Laypersons Trained in CPR Do Not Maintain Current Certification or Training, Circulation. 2015;132:A16236.

22. United States Census Bureau. QuickFacts Philadelphia County, Pennsylvania.

July 1, 2015. Accessed from: http://www.census.gov/quickfacts/table/PST040214/42101.

23. Sasson C, Magid DJ, Chan P, Root ED, McNally BF, Kellermann AL, Haukoos

JS; CARES Surveillance Group. Association of neighborhood characteristics with bystander-initiated CPR. N Engl J Med. 2012 Oct 25;367(17):1607-15.

24. Wallace SK, Abella BS Shofer, FS, Leary M, Neumar RW, Mechem CC, Gaieski DF, Becker LB, Band RS. Racial Differences in Prehospital Care of Out-of-Hospital Cardiac Arrest. Society of Academic Emergency Medicine Annual Meeting. Chicago, IL, May 2012.

25. Demirovic J. Cardiopulmonary resuscitation programs revisited: results of a community study among older African Americans. Am J Geriatr Cardiol. 2004 Jul-Aug;13(4):182.

26. Vaillancourt C1, Lui A, De Maio VJ, Wells GA, Stiell IG. Socioeconomic status influences bystander CPR and survival rates for out-of-hospital cardiac arrest victims. Resuscitation. 2008 Dec;79(3):417-23.

27. Marion Leary Accessed from: http://marionleary.strikingly.com/