Innovations at Cleveland Clinic · Medical Innovation Summit Recognition ... 2018 ANNUAL REPORT 2....

Innovations at Cleveland ClinicA N N U A L R E P O R T | 2 0 1 8

Welcome Letters

Scorecard

Technology/IP Highlights

TechnologiesDeviceHITTxDxDelivery Solutions

Ventures

Innovation Centers

External InnovationHealthcare Innovations AllianceBusiness SolutionsMedical Innovation Summit

Recognition

Table of Contents

3

4

6

89141924

25

30

33353740

44

INNOVATIONS AT CLEVELAND CLINIC2018 ANNUAL REPORT

2

Dear Colleagues,Innovation is a cornerstone at Cleveland Clinic – established by our visionary founding leaders. As one of six core values, the ideal is woven through the organization, allowing us to welcome change, encourage invention, and continually seek better, more efficient ways to achieve our goals. Throughout our history, Cleveland Clinic has shown its innovative colors with revolutionary discoveries and procedures to move patient care forward. From the first coronary angiography in 1958, to the first partial and total face transplants five and six decades later, we have maintained and matured the innovative spirit. Just this year we celebrate the 50th H.E.A.R.T.® license, the pilot and license of the Surgical Cooling Vest, and near full integration of the eHospital monitoring system. We celebrate the patients treated with life changing Enspire DBS, and the hundreds of future patients apnea-free with the Enhale neurostimulation system. Through our work, Innovation at Cleveland Clinic lives on, feeding the entrepreneurial culture while never losing sight of clinician and patient issues.

Cleveland Clinic Innovations was founded in 2000 to transform the way technology is transferred from an academic institution to market. Since the turn of the century, we’ve logged 18 years of hard work to remain dedicated to the objective: translate the innovations and inventions of our caregivers into commercial products for the benefit of patients everywhere. With emphasis on inventor engagement, invention protection, and product development, we’ve enhanced and minted drugs, devices, technologies, and solutions – growing the portfolio and bringing countless innovators’ solutions to life.

But with growth comes change as we realized a missing piece in the innovation puzzle – the ability to quickly and fully bring solutions to market through creation of standalone, investible companies. Cleveland Clinic Ventures (CCV) was formed in 2017 to make investments in emerging healthcare companies that deliver financial returns to Cleveland Clinic while advancing its mission, vision and values. As a team of professional, return-driven, early stage investors, CCV brings venture capital expertise bringing Cleveland Clinic’s most backable solutions to market.

In tandem, our entities spearhead Innovation at Cleveland Clinic. Embodying the core value, we channel the creative forces of our caregivers to make progress in the medical space. We take inventions from idea to adoption, support emerging technologies and companies, and inspire action for improved outcomes. In this annual report, we highlight the inaugural integrated year, showing growth and collaboration to service our caregivers and our community like never before. Find within stories of progress, persistence, growth, and change to set the tone for many more years of healthcare innovation.

Jack MinerManaging Director, Cleveland Clinic Ventures

Pete O’NeillExecutive Director, Cleveland Clinic Innovations


3

Scorecard


4

Established in

2000 50+Staff Members

600+Licenses

85Spinoffs

25Monetized Spinoffs

$168M+in State Grants

1,372Jobs Created

$90M+Returned to Inventors

1,535Issued Patents

$1B+Follow On

Equity Investment


5

Technology/IP Highl ights


6

Invention Disclosures(2009-2018)

’10’09 ’11 ’12 ’14’13 ’15 ’16 ’17 ’180

50

100

150

200

250

300

Intellectual Property(2009-2018)

0

100

500

200

300

400

’09 ’11’10 ’12 ’13 ’14 ’15 ’16 ’17 ’18

Invention Domains(2018)

Medical Device

Therapeutic & Diagnostic

Health InformationTechnology

Delivery Solutions

Foreign Issued US IssuedForeign Filed US Filed Provisional

Quick Stats

43Transactions

348Total Inventors

163New Inventors


7

Device

Technologies

HIT

TxDx

Del ivery Solut ions


8

For Amit Bhatt, MD, 2018 was a good year – this endoscopist licensed not one, but two of his technologies to a major medical device manufacturer. These devices, the Dissecting Endocap and the Endoscopic Retraction Strip, are both used for Endoscopic Submucosal Dissection (ESD).

Pioneered in Japan, ESD was largely used for gastric cancers but has now been adapted to diseases more common in the West, like esophageal cancer and colon polyps. Dr. Bhatt recognized the beauty and precision of this procedure during his gastroenterology fellowship and won grants to study in Japan. In the time he was learning this complex procedure, he saw the precise, time-consuming work that Japanese endoscopists were performing to admirable results: patients were getting curative resection, while keeping their native organs allowing them to preserve their quality of life. He also realized that the procedure needed to be improved for ease and reduced time, and his devices were born.

The first device, the Dissecting Endocap, was created in collaboration with colleagues in Japan. The Endocap allows for placement of the blade in the proper dissection plane throughout the procedure, while protecting the muscle layer from perforation. When Dr. Bhatt returned to Cleveland Clinic, he took this idea to Cleveland Clinic Innovations and Medical Device Solutions and began to sketch ideas for how to tackle the problem of resection.

In open surgery, surgeons have two hands to work with; endoscopists only have the endoscope and the tools attached to it. The Retraction Strip is placed on the lesion and allows the endoscopist to cut underneath the tumor, while giving dynamic retraction and can act as a “second hand” for the doctor. These products can be used separately, or together in endoscopic procedures.

Before ESD was a mainstay procedure in the United States, Dr. Bhatt was working on a solution to this problem giving him and CCI a unique advantage when it came to shopping the devices to companies: the technology was mature when companies were ready to enter a new market segment. The team already had a funded prototype that had been tested in over 100 animal models, allowing them to present a full picture.

While there are beginning to be similar products on the market, they are cumbersome and not necessarily more efficient. Cleveland Clinic’s devices offer the simplest, most efficient way of facilitating the procedure, reducing the time for ESD by about 50 percent and providing better outcomes.

Since the deal was inked, Cleveland Clinic has been involved in further development of the product. They are testing the device in other centers, and bringing the refinements back to Cleveland Clinic for Dr. Bhatt’s input. This is something rather unique and due, in part, to the relationships that Dr. Bhatt has fostered.

Dr. Bhatt hopes to continue his success by identifying the next great clinical need and utilizing the resources available to him to create his next product.

Innovating and Iterating to Make EndoscopicSubmucosal Dissection Easier

INVENTORAmit Bhatt, MD


9

Jill Byrne, RN, MSN, knows a thing or two about persistence. Since 2010, she has been working diligently – and doggedly – to bring her invention to life.

The Surgical Cooling Vest was developed by Cleveland Clinic Innovations in 2014 after Byrne had already spent years tackling the challenge of surgeons overheating in the operating room. She began this endeavor by finishing her day as a nurse at Hillcrest Hospital and going home to sew prototypes of her vest. All on her own time and dime. Fitting underneath a caregiver’s protective clothing, each vest has six strategically placed pockets for cooling packs to maximize comfort. After a “pilot” of sharing her vest with a surgeon she worked with regularly, Byrne knew she had something special on her hands.

Since disclosing the idea to CCI in 2014, she has been working with Innovation Manager Ryan Nowicki to bring the cooling vest to market. “Other, similar products were available,” said Nowicki. “But Byrne’s vest had advantages in that it was less cumbersome and did not have to be tethered to a pump. Byrne also researched the ideal weight of the cooling packs, and anatomical locations on the body that cool the fastest.” In 2017, a commercialization partner came into the picture. With their help, a validation study was conducted at Cleveland Clinic garnering feedback from more than 40 physicians.

In September 2018, a license agreement was finalized with a large medical device manufacturer to bring the Surgical Cooling Vest to life. As part of this deal, they are now manufacturing the vest to the exact specifications that Byrne has been honing for years. In a show of commitment to the product, the device manufacturer brought their entire sales staff to CCI’s office in December to train them on the product.

Byrne’s story is one of perseverance. Her desire to create a better surgical environment kept her going through the long process of commercializing a product. In that time, she has completed her masters in nursing, and completed three years of a PhD program at Case Western Reserve University, with a focus on heat stress. She was also awarded the Outstanding Innovator in Delivery Solutions award at the Annual Innovator Awards Reception, held by Innovations, in 2017.

Byrne’s hard work and dedication to those she serves prove that hard work truly does pay off.

A Story of Sweat and Perseverance

INVENTORJill Byrne, RN, MSN


10

BJ Dupps, MD, PhD, ophthalmology staff at the Cole Eye Institute, came to Cleveland with a background in bioengineering and a deep interest in applying it to clinical problems in corneal disease and refractive surgery. When Dr. Dupps pitched a project to Andrew Rollins, PhD, a biophotonics expert at Case Western Reserve University, he met graduate student Matt Ford, now a Senior Research Engineer at Cole, and a team was forged. Thirteen years later, the team has just completed a five year NIH grant that aimed to develop and translate optical coherence elastography (OCE).

OCE is based conceptually on a dynamic ultrasound technology that allows clinicians and researchers to measure the biomechanical properties of tissue during deformation in applications such as mammography. The goal of elastography is to characterize tissue elasticity features in 3D space that might be more predictive of disease than static structural images. Dr. Dupps adopted this approach using a ubiquitous technology in the ophthalmology world, optical coherence tomography (OCT), and applied it to the problem of measuring corneal biomechanical properties.

OCE provides unique elasticity imaging capabilities that may help detect early forms of keratoconus, a condition where the cornea bulges forward, creating distorted vision. OCE is expected to be especially helpful in screening exams for refractive surgery procedures such as LASIK. Early keratoconus often goes undetected and can lead to further weakening of the cornea, leading to unpredictable or unstable refractive surgery outcomes. OCE can also be used to assess the biomechanical effects of corneal cross-linking treatments designed to strengthen the keratoconic cornea and to more directly assess the structural impact of LASIK, PRK and SMILE procedures in individual patients.

In the first four years of their grant, Dr. Dupps and Ford worked to prove they could translate the technology to practice. They spent this time developing a clinically suitable corneal perturbation device that delivered an automated but gentle force to the corneal surface, collecting data in human donor eyes, and reducing the system from a massive benchtop instrument down to a device that fits right in among other ophthalmology instruments. In 2018, the final year of the grant, the team measured 73 patients and published the field’s first-ever live human OCE results.

In the five years, they were able to go from a concept and benchtop system to clinical measurement and deep insights into the nature of keratoconus and the biomechanical impact of different refractive surgery procedures.

Dr. Dupps credits the resources available at Cleveland Clinic to the success of their project. “Things move really quickly in terms of innovation and our infrastructure encourages it,” he said. “Cleveland Clinic Innovations offers resources that allowed us to take it much further than we could have on our own.”

With the completion of the first round of research funding, the team is applying for a renewal grant to extend the approach to full 3D imaging and to integrate the elasticity measurements into predictive models that can be used to simulate the results of an individual patient’s response to corneal refractive procedures. Their hope for a final product is a device that can be freestanding or incorporated into existing OCT technologies and coupled with surgical planning software to leverage these complimentary technologies for better, more personalized visual outcomes.

From Concept to Benchtop Instrument:Using OCT to Study Keratokonus

INVENTORSBJ Dupps, MD, PhDMatthew Ford


11

When it comes to your medical treatment, custom is usually better. You want to know that your treatment is specific to you and your needs. Tom Gildea, MD, Section Head of Bronchoscopy, knows this better than most. As a pulmonologist, Dr. Gildea sees many patients who need airway stents due to tumors, inflammation, or a mass. And though the narrowed airway almost always requires intervention, no two patient conditions are alike, and the opportunity for total customization can provide hope in some of the most extreme cases.

With the help of CT scans and the advent and continual improvement of 3D printing, Dr. Gildea is able to create experimental custom printed airway stents for a small, cohort of his patients who meet certain clinical requirements. With this innovation, under FDA compassionate use, he has taken something that used to be changed monthly, to something that need only be changed once a year.“We’ve had great support from the FDA and they are beginning to understand how to work with patient-specific products,” Dr. Gildea said during the annual Medical Innovation Summit.

Due to this incredible bout of innovation, Dr. Gildea was the recipient of the Outstanding Innovation in Medical Device award at the annual Inventor Awards Reception held by CCI in May 2018.

Pioneering Patient-Specific Devices Using 3D Printing

INVENTORTom Gildea, MD


12

George Muschler, MD, is a cell biologist and orthopedic surgeon by trade and an engineer at heart. Not long after coming to Cleveland Clinic 30 years ago, he realized he needed to engineer the solutions to his research problem. The problem? How to regrow bone and cartilage. Over the course of the last 30 years, Dr. Muschler has slowly, but surely, been advancing his technology down the road to commercialization.

Cell X is a technology comprised of a high-powered microscope with a mechanical stage and fluidics management system housed in a sterile, environmentally controlled casing. With this machine, researchers can analyze cell colonies, pick sections based on standardized analysis, and expose them to media. This system has been developed over the course of years by Dr. Muschler and Kim Powell, PhD, who has expertise in image analysis, and it ensures that colonies are counted and analyzed in a standardized fashion that removes the element of human error. The goal is to define what you are looking for, pick the proper selection, show how you did it, and know how to reproduce the results.

To grow new bone, or any other type of tissue, you need to have the right kind of cells. Cell X enables selection of the right cells. “Think of it like a garden,” Dr. Muschler explains. “If you want to grow corn, but only have soybean and nettle seeds, you’ll never get corn.” With Cell X, researchers can analyze a cell colony and make sure they are selecting the right “seeds,” or cells.

Disclosed to Cleveland Clinic Innovations in 2009, Cell X was developed in collaboration with Parker Hannifin. The first sale of the product came in 2016 to a university where retinal cell research is being done for children with mutations of the rhodopsin gene; a light-sensitive receptor protein. In 2018, Cell X was formed as a spinoff company of Cleveland Clinic and saw the sale of another unit to the same university to further their research. 2018 also saw Dr. Muschler speaking to the National Academies of Science, Engineering and Medicine on the subject of cell formation, as well as a collaboration with the FDA to study the effects of immune modulation.

“We put the tools in the hands of people that who can use it,” said Dr. Muschler. He went on to explain the myriad of uses for Cell X beyond what his own lab is doing to regrow bone and cartilage.

The road to commercial success can be a long one – the first patents related to this device date back to 1995. It is also a road that sometimes demands you to wait while other technologies catch up to your needs. Imaging resolution and analysis had to grow up to meet the original ideas of Drs. Muschler and Powell. However, when the right partners come along, it can allow for the road to open up and for a product to finally get in the fast lane.

Define, Pick, Show, Know:Growing New Bone with Cell X

INVENTORGeorge Muschler, MD


13

A new era has begun in head-mounted display (HMDs) technology for augmented and virtual reality (AR and VR) fueled by giants such as Microsoft, Google, and Facebook. With this mega-trend, researchers Karl West, Director, Medical Device Solutions and Jeffrey Yanof, PhD, Department of Biomedical Engineering, Lerner Research Institute, recognized that this can help address unmet needs in minimally-invasive surgical visualization, not just gaming and education applications. The present standard-of-care for surgical image-guidance is viewing 2D images on a flat screen; this suggested a need to develop applications for the HMDs that enable true 3D (360 degree) visualization. True 3D can lead to improved safety and effectiveness for planning, executing, and collaborating on surgical procedures.

They developed a first-of-its-kind medical AR platform by integrating medical imaging, mini-GPS tracking of surgical devices, and Microsoft HoloLens, a self-contained HMD with a holographic computer, light engines, and telecommunications equipment. The HMD 3D holographic images-- of the patient and tracked devices-- are projected in real-time on the patient, like x-ray vision, instead of a 2D monitor. Working side-by-side with clinicians at Cleveland Clinic, their medical AR platform accelerated translation of many AR applications from bench to pre-clinical or clinical evaluation, such as minimally invasive treatment of liver cancer, aortic aneurysms, and even planning for face transplant surgery. Most notably, Charles Martin,III, MD, Imaging Institute, led the first-in-human study which evaluated the HoloLens-based system for percutaneous ablation of liver tumors.

Since 2D displays are presently ubiquitous, their AR platform can lead to innovation for a broad range of medical applications, paving the way to significant benefits for healthcare.

True 3D Visualization Leads to New Reality for Surgery


14

eHospital’s Journey from Concept to Emerging Enterprise-wide Luminary

Innovation has long been one of the hallmarks of Cleveland Clinic. The innovations and medical “firsts” frequently attributed to Cleveland Clinic include surgical firsts, such as the world’s first coronary angiography, the first minimally invasive aortic heart valve surgery, and the first kidney surgery performed through a patient’s navel. But Cleveland Clinic’s expertise and innovations stretch far beyond the surgery suite.

eHospital is a leading example of Cleveland Clinic’s leadership in Health IT and is a comprehensive solution for in-patient monitoring. The multidisciplinary team responsible for creating it developed a game changing clinical playbook, clinical decision support, software platform, and command center that monitors patients enterprise-wide and prioritizes those patients needing attention.

“There’s just too much information for one caregiver or even a single machine to take in when taking care of a population of patients,” says Marc Petre, PhD, Executive Director of Clinical Engineering.


15

eHospital by the Numbers

eHospital Volume 2015-2018

Patient volume 122% increase

Admissions 1230% increase

Order volume 1817% increase

Monitored beds 222% increase

Intensive Care Unit (ICU)

Volume 2015-2018

Patient volume 122% increase

Admissions 1230% increase

Order volume 1817% increase

14% decrease in aggregate Length of Stay

18% decrease in the aggregate Standard Mortality Rate

*Cleveland Clinic Observations at regional Hospital compared to National Hospital data from APACHE Database

Central Monitoring Unit (CMU)88% increase in average daily census with no increase in FTEs

100% increase in patients monitored per tech with revised teaming approach

22% decrease in Cardiac Emergency Response Activations** (reduction in the census of monitored patients without an increase in cardiopulmonary arrest events)

Received 84% CMU Notification Prior to Emergency Response Activation (allowing for early intervention)

**Cantillon, et al JAMA 15-10101 Issued August 2016

The Road Ahead

Remote care in hospitals is leading to new ways of thinking and supporting clinicians complex decision making with a constant flow of actionable information. So far, the impact on both patient care and staffing has been extensive. Next up for eHospital: clinical consults, additional coverage areas, and expanded use of analytics.

The eHospital program’s primary purpose is to get the right information real-time to the right people to make great decisions resulting in optimal patient outcomes and reduced staff burnout. At the core of the program is the operations center that is staffed around the clock for telemetry and 12 hours daily for ICU. From this operations center, teams remotely monitor patients within the enterprise. eHospital clinicians intervene in critical situations, and they also provide support for routine activities. Even though it’s a process driven, technology-driven program, eHospital also contributes to delivering relationship-based care within the workflow.

The buzz about eHospital wasn’t created overnight. Rather it was a multi-year innovation journey that began in 2009 with a proposal to implement remote ICU monitoring using a commercial platform. During the search for existing platforms, the multidisciplinary team encountered challenges, such as high product cost and limited integration with EMR. The team, which included physicians, nurses, clinical engineering, software developers, and others, redoubled its efforts, again proposing ICU monitoring in 2011. Unable to find an existing product that met Cleveland Clinic’s requirements, the team moved forward with in-house designs in 2012.

With prototypes and early validation in hand, the eHospital team began working with Innovations to advance and commercialize the project. By early 2014, the first ICU Pilot was ready for go-live. By 2015, the team added the eCMU telemetry concept to the emerging platform. The eHospital platform has evolved and now enables enterprise-wide critical, constant, and remote patient monitoring for Cleveland Clinic.

Through the eHospital initiative, providers are able to scale limited clinical staff to meet the maximum number of beds with comprehensive, proactive, and on-demand care.


16

The ability to identify and measure ocular inflammation is vital in the management of eye diseases. It is particularly important in the areas of uveitis (the fourth leading cause of blindness worldwide) and post cataract surgery (most common ophthalmic surgery). Currently, ocular inflammation is measured via clinical examination through a slit lamp microscope or indirect ophthalmoscope. These methods are subject to clinical interpretation and variability between observers.

The Breakthrough – ATAC

INVENTORSSunil Srivastava, MDSumit Sharma, MDCareen Lowder, MD, PhD

The breakthrough – the ATAC automated algorithm, developed by Sunil K. Srivastava, MD, Sumit Sharma, MD, and Careen Y. Lowder, MD, PhD, takes an objective, continuous measurement allowing clinicians to assess small changes in inflammation, instead of grading inflammation by a category scale score. Ultimately, the automated analysis evolution will lead to a new standard in clinical trials outcomes in the measurement of inflammation. The ophthalmic, pharmaceutical and device industry community has identified clinical trial end-points for Inflammatory Eye Diseases, a significant area of interest with the goal of incorporating objective measures of inflammation into clinical trials, in lieu of the current subjective measures.

The ATAC software uses a readily available OCT device to image the anterior segment of the eye. Inflammatory cells are identified by the software program, systematically counted, and shared with the clinician for final review. The output results include a continuous measure of the number of inflammatory cells identified per cubic millimeter. In a prospective study evaluating this technology, the software was found to be highly reliable and reproducible. Imaging and analysis could be performed within minutes. Additionally, a prospective study utilizing this software to measure inflammation in cataract surgery patients found the software was superior at detecting inflammation than clinicians and was successful in monitoring patients for improvement or worsening over time. The successful implementation of this software into clinicians hands will allow rapid identification and monitoring of inflammation in patients with a large variety of eye diseases. Additionally, the adaptation of this software method will develop new clinical trial standards for novel drug development.


17

As a provider in the market, we are often seeking innovative ways to deliver care. Many innovations are developed by the frontliners of patient care, but those on the other side of healthcare have the know-how that can lead to innovative solutions that improve the business of healthcare.

Responding to the Call, Led to a Better Way“In healthcare ...traditionally administrators have looked to the clinical side for innovation but in this value-based space, there is knowledge in the administrative side that holds value as well... processes that eliminate administrative burden... that is where the intellectual property of the administrative side can be found.” – Monica Deadwiler, Senior Director, Payment Innovation

In this new era of healthcare, quality measurements, efficiency and good health outcomes achievement led to an idea being born before there was even a market. It all started with a simple statement – we cannot administer bundled payment contracts manually. Prior to the invention, contracts for bundled payment initiatives were calculated manually and that is not helpful if you want to scale any of these programs. Automating the process is essential.

The goal – Bundled Payment Management System.

At the same time the inventors were thinking through how to complete the goal, the Affordable Care Act was being Rolled out. This was leading to heavy discussions about ACOs, bundled payments, and other alternative payment models. Given the directive, they sought to find a solution to assist with bundle payment modeling, contract management, claims adjudication, payment distribution and reporting but they couldn’t find anything in the market. So they went on a hunt for a partner to help them complete the goal.

As with any development process, there were many starts and stops. The initial concept was everything any organization needed to assist with bundled payments but the platform was cumbersome. The inventors figured no one would probably use it. Determined to keep at it, and knowing there was a significant need for such a technology in the market – the re-write occurred. They re-architected the technology to provide a platform that would interface well with the end-users they knew needed the solution the most. The final product

– a technology that is adaptable to other providers and health plans and can be leveraged for growth in other areas.

INVENTORSMonica DeadwilerTony HrudkaDeb LauriciaKaren Mihalik


18

With each passing year, medicine receives greater genomic input. Allowing patients a personalized journey to health, the integration of genomic information is improving treatment results in all specialties.

Charis Eng, MD, PhD, the founding and current Chair of the Genomic Medicine Institute and Director of the Center for Personalized Genetic Healthcare at Cleveland Clinic, has played a large part in this push for precision. Dr. Eng is a pioneer in cancer genetics who has dedicated her career to understanding the genes that play a role in heritable cancers. The first to discover a link between mutations in the PTEN gene and Cowden syndrome, Dr. Eng works to identify genes which predispose patients to several types of cancer. In translating her findings to the clinical space, she is contributing to next generation cancer treatments and improving patient care. Dr. Eng is a highly decorated scientist, holding several esteemed positions including the Sondra J. and Stephen R. Hardis Endowed Chair in Cancer Genomic Medicine at Cleveland Clinic. Dr. Eng is well-respected in the community, having been called out this year as one of the notable women in healthcare by Crain’s Cleveland Business.

Dr. Eng’s impact on improving the lives of cancer patients is a career-long accomplishment appreciated beyond a regional sphere. In October of this year, she added another recognition award to her resume, receiving the American Cancer Society’s Medal of Honor – the organization’s highest award. Honored for her “advances of unique magnitude in the understanding, diagnosis, treatment, cure, and prevention of cancer,” she was presented the distinguished award in Washington, D.C. Other 2018 award recipients include Jennifer Doudna and Emmanuelle Charpentier, co-founders of CRISPR-Cas9 gene editing, and former Vice President Joe Biden.

Dr. Eng is highly involved in other innovative projects at Cleveland Clinic. With an esteemed group of Cleveland Clinic inventors, Dr. Eng has brought creativity and novelty to Innovations including the MyFamily health history platform used by Cleveland Clinic caregivers and patients. Other licensed projects include her cutting-edge PTEN calculator: a diagnostic tool for those with the genetic abnormality. Through her work as an inventor, Dr. Eng has developed a strong relationship with Innovations.

Dr. Eng’s novel work, commitment to innovation, and new award status illustrate her deservedness of this inventor spotlight for the Therapies and Diagnostics domain.

Recognizing Genetic Genius

DOCTORCharis Eng, MD, PhD


19

Temporal Dose Feathering by Using a Combination of Pareto-Optimal Radiation Plans/Temporally Corrected Dose Accumulation

Jacob Scott, MD, DPhil, is not your average doctor. In his every day practice, Jacob leverages a multi-dimensional background. Studying astrophysics and nuclear engineering aboard a submarine, he utilizes his expertise in computer science and mathematical biology to improve patient care. With two innovative technologies, Dr. Scott looks to maximize radiation therapy efficacy and minimize toxicity in his patients.

Says Scott, “In the last 30 years, we’ve seen a lot of technological advances in medical physics to better shape, aim, and target beams, but we’ve come to the point where it’s hard to see how we can get a lot better.” Leveraging his understanding of biological systems over time, Jacob focused on the aspect of tissue repair to give radiation therapy the next-generation capabilities it so desperately needs.

Considering the different repair rates of various tissue types, Scott’s “Temporal Dose Feathering” concept (also known as temporally feathered radiotherapy (TFRT) allows for intricate plans of precisely aimed beams that diffuse harmful radiation to surrounding tissues over time. As with standard treatment, beams are arranged to hit the tumor region of interest. In subsequent treatment, however, the beams are placed in a different arrangement to avoid previously hit tissues – allowing them to regenerate. These highly detailed arrangement plans would continue through said patient’s treatment, keeping in mind the repair of all surroundings. In “feathering” the radiation over time, Scott anticipates delivery of the same amount of radiation with less side effects, or stronger radiation for better results, with the same side effect profile.

Temporal Importance in the Reinvention of Radiation Therapy

DOCTORJacob Scott, MD, DPhil

Scott’s technology has become multi-faceted as he further considers the concept of time in treatment. In light of recent data in support of re-radiating patients with metastatic disease, he began treating some patients up to a dozen times. Pressured to know his patients’ level of toxicity with each treatment, he developed a technology to temporally correct dose accumulation. With his new algorithm, Scott is able to map the body of a patient to see all instances of radiation and where it’s been detained. The technology may one day allow for personalized treatment on par with a professionally crafted radiation plan.

Through Innovations, Scott has patents pending for his technologies. Mid-2018, Scott and team published the TFRT treatment planning strategy and are expecting a second publication early 2019. He has been awarded a small institutional grant to conduct a feasibility study of the treatment with the help of resident physician Shireen Parsai, MD. The trial is underway, having enrolled the first patient in early 2019. An RO1 has been written and submitted to the NIH to expand trials of the technology to show efficacy. Should the trials be successful, Scott expects interest from several tech companies and opportunities for licensing through Innovations.


20

ApoA1 Exchange Rate Assay as a Diagnostic for Major Adverse Cardiovascular Events (LRI)

Jonathan Smith, PhD, is the Geoffrey Gund Endowed Chair for Cardiovascular Research at Lerner Research Institute. With Cleveland Clinic since 2002, he has made major strides in his work toward cardiovascular excellence. Smith’s latest project involves an ApoA1 Exchange Rate Assay as a diagnostic tool for major adverse cardiovascular events (MACE).

ApoA1 is a protein encoded by the ApoA1 gene, and is the major component of high-density lipoprotein (HDL). HDL cholesterol, or “good” cholesterol, transports certain fat molecules through the bloodstream, helping to remove them. Higher levels of HDL cholesterol enable better removal of fat and harmful cholesterol, and are therefore associated with a lower risk of heart disease. HDL, and its negative counterpart LDL, have long been good predictors of MACE. But newer studies indicate that HDL function, rather than HDL levels may be better predictors of heart disease. The existing method to measure HDL function is laborious and expensive, prompting Smith to create something new.

The ApoA1 protein, though often bound in an HDL molecule, also exists lipid-free in the bloodstream. This unbound ApoA1 is periodically exchanged with the HDL-bound ApoA1; an important mechanism in the efflux of bad cholesterol. Smith and his colleagues developed an assay to measure the exchange rate of an exogenous tagged ApoA1 into HDL in clinical samples as an indicator of HDL function. With the development of their assay, Smith and team have learned that a higher rate of exchange indicates greater HDL function for a lower risk of heart disease and associated events.

HDL Quality Over Quantityin Prediction of MajorAdverse Cardiac Events

DOCTORJonathan Smith, PhD

Smith identifies 2018 as a breakout year for his assay as his lab began to see significant data. Through use of patient blood serum samples, they uncovered the inverse association between ApoA1 exchange and adverse cardiovascular events. All samples were provided from a cohort of angiography patients at Cleveland Clinic this past year. Recently, this assay has also been used with serum samples from patients enrolled in Cleveland Clinic’s bariatric STAMPEDE trial. Data from this study is forthcoming.

In 2018, Smith submitted a patent application for the assay through Innovations. The technology has garnered interest from several companies, though no licensing deals have been made at this time. Looking forward, he hopes his assay can be used to screen for patients who may benefit from extensive treatment to improve HDL function. He also believes in use of the technology to identify candidates for cardiovascular drug trials. In 2019, he looks to replicate his findings in new cohorts and explore the possibility of collaboration with other institutions.


21

A member of Cleveland Clinic’s staff since 1997, Stanley Hazen, MD, PhD, is both a practicing physician and researcher with many leadership roles. Dr. Hazen is Chair, Department of Cardiovascular & Metabolic Sciences, Lerner Research Institute, Director, Center for Microbiome & Human Health, and co-Section Head, Preventative Cardiology & Rehabilitation, in the Robert and Suzanne Tomsich Department, Cardiovascular Medicine, Cleveland Clinic. He has received numerous awards and recognitions for his pioneering research, including being an elected member of the National Academy of Medicine, and an elected fellow of the American Association for the Advancement of Science. He has published over 400 peer-reviewed manuscripts and is counted amongst some of the most highly cited investigators in the country – attesting to the high impact his studies have made. But his thirst for research has yet to be quenched.

Dr. Hazen’s latest influential work stems from a 2011 publication heralding the discovery that gut microbes participate in cardiovascular disease (CVD) development. The level of a compound found in blood called trimethylamine-N-oxide (TMAO) was discovered to be strikingly associated with future development of CVD and risk for major adverse cardiovascular events. The discovery, and significance of, the TMAO compound would shape Dr. Hazen’s work from there on. “The whole discovery began without us knowing what we were looking for, says Dr. Hazen. “We just knew the approach should lead us to something new. We didn’t realize exactly where the science would take us.” But Dr. Hazen and team soon learned the importance of TMAO. Through “reverse engineering” the pathway, the team discovered that the compound is ultimately made by gut microbes during the digestion of foods abundant in a Western diet. TMAO is produced by the liver during oxidation of its precursor, trimethylamine (TMA) – a waste product when one eats nutrients like lecithin (phosphatidylcholine), choline and carnitine. Lecithin, choline, and carnitine are nutrients found at high levels in animal products like red meat.

Lifelong Innovation: The TMAO Story

DOCTORStanley Hazen, MD, PhD


22

From his preliminary work, Dr. Hazen knew TMAO and CVD were closely related, but set out to figure exactly how. Teasing out the discovery, subsequent animal model studies would directly show increased TMAO levels to accelerate the heart disease development. With continued work, he noticed a direct connection between TMAO and the reactivity of blood platelets themselves, making them sticky and more likely to clot. Studies spanning from different animal models, to healthy volunteers with diet and nutrient changes, all led to evidence that TMAO has direct effects on the components of blood (platelets) and vessel walls (endothelial cells) that contribute to the occurrence of MACE in patients with high levels.

Honing in on TMAO creation in the body, Dr. Hazen and his team are now focused on both developing inhibitors of the pathway, and detailing how elevated TMAO levels occur by diet and altered kidney handling with change in diet. A research area to be expanded upon, he and his team look to prevent production of TMAO through intervention at the level of the gut microbes. As section head of Preventive Cardiology, Dr. Hazen emphasizes the importance of diet, exercise and other healthy lifestyle habits. But he also sees the need to look beyond dietary efforts, “There will always be people who present with chest pain, a recent heart attack, or some other event with established cardiovascular disease, and these subjects remain at heightened risks for experiencing a heart attack, stroke or death – even with adherence to a strict diet and healthy lifestyle. One day, our medicine cabinets will have drugs that target gut microbial pathways, much like how statins inhibit cholesterol synthesis by our liver, to treat and prevent progression of heart disease.”

From his research, Dr. Hazen has made many things clear to the medical and scientific communities, and opened numerous doors for future studies. His work is recognized as helping to usher in improved understanding of how important the gut microbiome is to our health, and susceptibility to disease. Some of his latest advancements? Showing one can transplant specific TMAO microbes, into recipient mice and transmit an enhanced risk for clotting in an animal model of stroke – findings published in Circulation Research (November 2018). Or uncovering more precisely the connections between TMAO and red meat. In a chronic diet intervention study in subjects that included isotope tracers, and mass spectrometry analyses of blood, and urine, his work further teased out changes in both the gut microbiome, and kidney function, from a chronic diet rich in red meat – findings published in European Heart Journal (December 2018). Dr. Hazen leads a team that recently reported development of a new class of drugs that target the TMAO pathway, and showed these new drugs prevented clotting risk in a stroke model in studies – findings published in Nature Medicine (September 2018). Developing new approaches for treating microbiome-related disorders, there is increasing opportunity for commercialization of a successful therapeutic through CCI. Dr. Hazen has worked closely with Innovations for years, and has numerous issued and pending patents to protect his research. As he continues to evaluate the role of gut microbes in influencing our health and susceptibility for diseases, Dr. Hazen is always looking for opportunities to INVENT®.


23

Hospitals and the healthcare environment can be stressful places.Patients and families are rarely looking forward to their procedure, appointment or visit. As caregivers at Cleveland Clinic, we recognize that while we can’t reduce or eliminate most of the anxiety and suffering occurring in healthcare, each person can contribute to a positive patient experience. It’s all about behavior and adopting conduct that creates a culture where compassion and empathy are prevalent.

Creating a compassionate and empathetic culture at Cleveland Clinic is integrated into the Patients First culture of the organization.Created out of the Office of Patient Experience, Communicate with H.E.A.R.T. is a service excellence model created to help empower caregivers to interact with patients, and each other, in a caring and compassionate way. It contains both an upfront customer service model, S.T.A.R.T.® with Heart, as well as a service recovery model Respond with H.E.A.R.T.® After utilizing Communicate with H.E.A.R.T. throughout the Cleveland Clinic enterprise for several years and realizing the success,we began to market the program externally to organizations within and outside of healthcare.

2018 marked two milestones for Communicate with H.E.A.R.T., the first of which was the execution of the 50th license of the program.The Business Development team, led by Carol Santalucia, in collaboration with Innovations, has successfully customized and delivered Communicate with H.E.A.R.T. to partners within the United States as well as sharing it with organizations in Canada, Europe, the Middle East and Southeast Asia. To date, over 150,000 people have been trained in the program.

The second milestone was the launch of a website dedicated to all those who had adopted and were using H.E.A.R.T. within their organization. Rolled out in August 2018 it served as a vehicle for license holders to interact with us and each other in order to bolster their own programs. The Communicate with H.E.A.R.T. Community exists to help other organizations implement and sustain their own programs. Users can make use of resources including blogs and webinars, and share their own best practices via a message board.

Continuing the success of the first 50 licenses, the H.E.A.R.T. team plans to continue training organizations on creating and sustaining a culture of compassionate communication, as well as expanding program offerings in order to better serve the ongoing communication needs of the healthcare industry. Says Business Development Director Carol Santalucia: “It is such a privilege to work with organizations across the country and around the world who are passionate about this work.It is gratifying to know that together we are creating more empathy in healthcare.”

Building a Community to Communicate with H.E.A.R.T.®


24

Ventures


25

Chartered in 2016, Cleveland Clinic Ventures was formed to further innovation via spinoff companies that bring return on investment to Cleveland Clinic. With a clear and defined goal to form a team for investment in emerging healthcare companies while remaining consistent to the mission, vision, and values of Cleveland Clinic, Managing Director, Jack Miner embarked on a challenging journey.

2018: The Year of the TeamBuilding a venture team on par with the quality and expertise of Cleveland Clinic is a tall order. In the search for Venture Partners, many valuable lessons were learned. “When this started, I had an idea of what the team should look like,” said Miner – initially envisioning a team with the structure of a traditional tech transfer office. But with the tech transfer mentality, little emphasis is placed on the spinoff’s investor and management team. For successful venture capital transactions, planning for the long term financial success of the company as well as creating a solid management team is crucial. Thus through the interview process, Miner shifted his approach. Realizing he must craft a team able to deliver the same superior level of service demanded by Cleveland Clinic, Miner had to raise his bar.

Leveraging the Cleveland Clinic brand, Miner was able to attract some of the investment world’s best and brightest. With three domain Partners to span all sectors of healthcare, Ventures is delivering on that same high quality service. Partners Dave Eichler, Shripal Meghani, and Akhil Saklecha, MD, bring extensive HIT, medical device, and life science knowledge – all returns focused. Completing the team in 2018 marks a milestone for Cleveland Clinic Ventures. Says Miner, “We’ve finally built the team I think Cleveland Clinic deserves – now we’re executing on it.”

In 2018, Ventures was part of four meaningful exits. Moving into 2019, Miner and newly minted team will implement their go forward strategy with focus on three classes of investment companies: Product Development, Innovator, and Venture Capital. With this framework, Ventures will continue to deliver on the objectives set for the team. They are also exploring the possibility of strategic external investing. Now a full-team effort, Ventures will expand the investment portfolio for meaningful innovation in 2019.


26

Putting the Pieces Together:The Journey of Enhale MedicalFor many, drifting to sleep is a natural, peaceful part of the day. Looking forward to feeling refreshed in the morning, the average American cherishes his/her time spent asleep. For nearly 3 million Americans, however, dozing off can feel more like a nightmare. With episodes of breathing cessation, most wake to gasping or choking up to five times per hour. Challenged by the symptoms of obstructive sleep apnea (OSA), these individuals experience fitful rest, leaving them excessively drowsy during the day. For years, the gold standard treatment for OSA has been Continuous Positive Airway Pressure (CPAP) devices. Providing a constant flow of pressurized air, CPAP machines prevent airway collapse. But unwanted noise, pressure intolerance, mask irritation, claustrophobia, and nasal congestion only begin to describe complications with the therapy. Frustrated and exhausted, more than 40% of patients refuse to wear the device. Noncompliance has made the need for a new gold standard apparent. Enter neuromodulation. The alteration of nerve activity through targeted delivery of a stimulus, neuromodulation therapy allows minimally invasive open airway maintenance. Neurostimulation for obstructive sleep apnea has been gently explored, but several systems do exist today. Though superior to a CPAP device, these next generation systems may still cause the patient significant distress in their insertion and maintenance. Enter Enhale Medical.

The idea for Enhale Medical was brought to Cleveland Clinic Innovations by Frank Papay, MD, Chairman of Dermatology and Plastic Surgery at Cleveland Clinic in 2014. Born from a desire to improve existing medical technology, Enhale’s system would become the most advanced and minimally invasive in neuromodulation for sleep apnea. A veteran inventor, Dr. Papay became interested in neuromodulation after recognizing a need for superior sleep apnea care. In exploring the landscape, he sensed an opportunity to revolutionize the therapy. Leveraging his experience with the nerves and muscles of the face and mouth, he set out to identify a better, less invasive, system for those suffering from OSA. To minimize the risk and maximize efficacy of the treatment, Dr. Papay explored bilateral stimulation of the more distal branches of the hypoglossal nerve. And thus began the journey of Enhale Medical. As the system exists today, its neurostimulator electrode is implanted locally in the jaw and activated externally. Upon activation, the electrode stimulates a portion of the hypoglossal nerve that contracts the anterior lingual musculature responsible for movement of the tongue. With this stimulation, patients show a more open oropharyngeal airway, increased airflow, and relief of apnea events. In contrast to existing sleep apnea technology, Enhale’s technology works proactively to prevent obstruction before it occurs. With an algorithm to sense incoming apnea events, Enhale stimulation maintains a smoother breathing rhythm for more natural sleep.


27

Though a blossoming company today, Enhale came to Innovations as nothing more than a concept. With hopes to build it to exit, the technology was worked through staff at Cleveland Clinic Innovations. Spearheaded by Senior Director of Product Development, Kelly Emerton, PhD, Enhale was set on a path toward success. Working with the Innovations team to apply for foundational grants to fund the technology and file intellectual property, Emerton and Dr. Papay, nurtured the spark of innovation. With their grants for nearly three years, Enhale’s team detailed the system’s foundational science. Said Emerton, “As hypoglossal nerve stimulation for obstructive sleep apnea is an emerging field, there are still many research questions. It’s not your typical class II/class III device with standard product development. This project required a lot of scientific thought and understanding before we could even design what a prototype would look like.” Working together, inventor, Innovations, and outside experts, Enhale’s technology began to take shape.

As focus shifted to testing the technology, Enhale’s team grew slightly. Still, the collaborative spirit of its team members was clear. Working as a well-oiled machine, Dr. Papay, his industry contacts, and the Innovations staff looked to highlight the technology’s scientific validity. Through several proof-of-concept studies, the science was deemed sound, and the system demonstrated its intended effect with no complications. “Our animal studies came out perfectly,” said Dr. Papay. The first true test of the implant, these successful animal studies paved the way for human testing in the near future. The market opportunity for said devices also drove the project forward. Fortunate to ride the tailwind of existing neurostimulation technology, Enhale, and its enhanced mechanism of functioning, are poised for success. Having laid groundwork and demonstrated interest in the space, Enhale’s competition has made the market salient. Coupled with the feasibility and preliminary success of Enhale’s technology, the growing market has allowed movement forward.

As the company grew and developed into a tangible product, its needs shifted from product development to establishing a sustainable business. With the opportunity to advance given proper funding, Enhale Medical sought the input of Cleveland Clinic Ventures. Representing a different set of strengths, Ventures brought market and business insight, long-term strategy and fund raising experience to the project. Ventures recognized Enhale’s potential and added early focus on company building and investment strategy. Said Shripal Meghani, Partner (Medical Devices) at Ventures, “Ability to gain venture funding is a high bar and ability to drive towards a successful outcome for a company is a higher bar still. Enhale has the potential to be a high value startup. It is Ventures’ goal to help Enhale’s technology reach the market and maximize its value.” Ventures gave credit to the Innovations staff that worked Enhale to that point, enabling it to build a strong investment case to attract capital.

DOCTORFrank Papay, MD


28

With a ‘thumbs up’ from executive financial leadership in 2018, the company was officially spun off as Enhale Medical. To get the new company off the ground, Ventures provided seed funding. Subsequently, Ventures provided business direction and utilized its aforementioned network to find additional investors and successfully secure outside financing. Within 2018, a credible Board was established to oversee company strategy and operations. Ventures also led a search process for a CEO and hired Josh Nickols to lead the company. In its current stage of development, the Ventures and Enhale team is working to secure the next round of VC funding and build the company roster. To date, Innovations and Ventures continue to work together to ensure Enhale’s smooth transition to a standalone company, blending experiences and expertise to give the company a strong framework and chance for market impact.

From all interviews and review of the technology, one message rang true; the team of people working on Enhale was second to none. Dr. Papay spoke of “the tale of three cities,” a metaphor he used to describe the professional relationships that led to the project’s success. The three cities involved people outside Cleveland Clinic’s network, people inside Cleveland Clinic’s network, and those that represent both. Each “city” providing a different view on the technology. Those outside the Clinic gave neutral input and allowed for study of the technology rapidly and with ease. Dr. Papay detailed his strong connections with his staff from past projects. Able to leverage their neurostimulation expertise, these connections brought valuable out-of-house experience. With the connections in-house, the technology was truly able to flourish. Utilizing Cleveland Clinic’s cadre of highly skilled physicians, researchers, and resources, the idea took on the innovative spirit of the Cleveland Clinic itself. Even still, the structure of team members is only a small piece of the puzzle. Said Dr. Papay, “The secret sauce behind entrepreneurship is resilience and energy,” and he felt his team had it in spades. The high energy each team member brought got the project off the ground and relentless work toward the next phase, even in times of uncertainty, is what kept the company alive and on track to meet its targets in development. Recognizing the true life-changing ability of the technology, its support system of inventors, managers, investors, and consultants ensured its movement forward. Poised to revolutionize sleep for apneic patients, the comfort and ease Enhale can provide is worth more than the company may ever know. Projects such as Enhale embody the mission of Innovation at Cleveland Clinic – to remedy health for patients. Given the progress made in the past several years, forging Enhale Medical is a premium example of teamwork and innovation to benefit patient care.


29

Innovat ion Centers


30

Investing in promising cardiovascular technologies

Since establishment, GCIC has granted or invested over $23 million in product development funding to advance promising new cardiovascular technologies. 2018 alone saw GCIC make several notable investments. Having previously funded initial product design and development of the company’s advanced wearable devices for subcutaneous delivery of biologics and high volume therapeutics, GCIC provided follow-on funding to Enable Injections, Inc. in its $50 million Series B financing round. GCIC also provided follow-on funding in Sense Diagnostics, Inc. to support continued development of the company’s non-invasive device to detect hemorrhagic stroke and other neurovascular conditions. New investment in Xact Medical, LLC rounds out the portfolio, adding support for development of the robotic-assisted Fast Intelligent Needle Delivery (FIND) system for adult and pediatric central venous access.

Realizing significant clinical and commercialization progress

Of the 55 technologies funded by GCIC, a significantly high 70% continue to progress in development and commercialization, with 12 now on the market, 16 undergoing clinical trials, and 10 in various earlier development stages. Notable 2018 progress includes the acquisition of Securus Medical Group (funded by GCIC in 2016 to support development of a cardiac ablation thermal monitor system) by Boston Scientific Corp. for $40 million plus future milestone payments, and the first successful in-human implant of Vectorious Medical Technologies’ miniature left-atrial pressure monitoring system for heart failure. Several other GCIC-supported companies hit milestones this year including Cleveland Clinic-originated Cardionomic, Inc. securing $9 million in series B financing to continue development of its cardiac neuromodulation system for treatment of acute decompensated heart failure. The company has met rapid success after GCIC funded initial proof of concept studies.

Global Cardiovascular Innovation Center

Of those GCIC technologies on the market, the CardioInsight™ non-invasive 3D cardiac electrophysiology technology and VentureMed Group, Inc. Flex Dynamic Scoring Catheter made the strongest impressions this year. The GCIC-funded CardioInsight™ (acquired and commercialized by Medtronic) has been used on more than 1,600 patients in Europe and the United States, and has been featured in more than 120 peer-reviewed manuscripts, abstracts and presentations, while the FLEX Dynamic Scoring Catheter for peripheral vascular treatment procedures (developed with GCIC product development support and funding) continues to grow market uptake with over 20 customers in the U.S. and over 1000 procedures conducted.

In total, companies supported with GCIC funding have secured over $1.2 billion in follow-on development/commercialization funding and have created over 1200 new jobs in the state of Ohio.

Also providing incubator and preclinical support to internal and external clients

The GCIC incubator program provided facilities and services to 27 client tenants. The preclinical research and development facility conducted over 160 studies for both Cleveland Clinic investigators and external sponsors, among which were Atricure, Biosense Webster, Boston Scientific and Stryker, along with Cleveland Clinic spinout companies Centerline Biomedical and Renovo Neural.


31

Cleveland Clinic has established an NIH Center for Accelerated Innovations (NCAI) with the mission to advance early stage biomedical and life science innovation from the research laboratory to commercial development and successful deployment to patients. Supported with grants totaling $14 million from the National Heart, Lung and Blood Institute (NHLBI), the NCAI-Cleveland Clinic, including partnering institutions Case Western Reserve University, The Ohio State University, Cincinnati Children’s Hospital Medical Center, the University of Cincinnati, the University of Michigan, and Northwestern University, is one of only three such Centers in the country.

Translating research to development and commercialization

In 2018, the fifth year of the seven-year program, NCAI selected 13 promising new technology projects to receive project funding and expert project management guidance, along with education and mentoring for researchers, clinicians and developers. This brings the total number of supported projects from across the consortium of partner institutions to 60. To date, these projects have generated formation of six new companies, an additional seven licenses optioned or executed, and have attracted disclosed follow-on investment totaling $33.5 million for continued product development.

NIH Center for AcceleratedInnovations


32

External Innovat ion


33

As the pace of innovation in healthcare continues to accelerate, there is increasing pressure to quickly bring solutions to market. To expedite operational, financial, and patient care innovation across Cleveland Clinic’s enterprise, Cleveland Clinic Innovations (CCI) is increasing attention on external innovation.

External InnovationThe primary work of CCI continues to be advancing the inventions of our Cleveland Clinic caregivers. In 2018 CCI received and assessed 281 Invention Disclosures, and completed 43 license agreements for Cleveland Clinic intellectual property. But all too often, our Caregivers are able to identify a healthcare need, and unable to invent the appropriate solution. These “Insights” also have value, as a guide for where the healthcare market needs to go. The quickest way to address these needs is to identify solutions that have been innovated outside Cleveland Clinic’s doors. Often the most disruptive solutions are contained in startup companies. By way of External Innovation, Cleveland Clinic can partner with these companies to help bring need-fulfilling innovations to market.

At a high level, the process for External Innovation consists of three steps. First, the healthcare need must be identified. With the help of a Cleveland Clinic champion, and appropriate enterprise support, under-innovated areas are highlighted. Through a vast network of business partners, potential solutions can then be curated. Here, access to eager startups which house insightful solutions is key. In connecting the needs with the solutions, a process of deeper diligence is then required to draw out the details to achieve success. With a drive to innovate healthcare better and faster than ever before, caregiver insights are realized of their value – increasing opportunity for external innovation.

“Our job is to help our caregivers impact the future of healthcare,” said Pete O’Neill, Executive Director, CCI. “It’s great when our Caregivers bring us inventions that the market values. Our caregiver insights into market trends also have value, which combined with our collaborative culture, makes Cleveland Clinic a great place to accelerate solutions to the market.”

Example of Successful External Innovation: GYANTCleveland Clinic learned of startup company GYANT as part of Plug & Play’s Healthcare Accelerator Batch 1 in Cleveland. GYANT had developed a valuable platform of AI communication tools. Cleveland Clinic’s Executive Administration had a need to improve communication with patients after discharge. Through a collaborative pilot project, Cleveland Clinic experts helped GYANT develop an AI triage tool to communicate with patients post-discharge. In a trial of the solution at Cleveland Clinic with more than 800 patients, post-discharge response rates increased from 54% to 82%. Other groups within Cleveland Clinic are now looking to leverage GYANT’s AI platform to improve patient engagement.


34

Healthcare Innovat ion Al l iance


35

Stemming from an initial 2008 collaboration agreement between Parker Hannifin and Cleveland Clinic, Cleveland Clinic’s Healthcare Innovation Alliance program has since expanded across the country and the world to include more than 140 hospitals and four large industry partners with broad technological and product development expertise.

The goal of the Innovation Alliance is simple: to create and foster an ecosystem of innovative partners across the healthcare and product development landscape that encourages collaboration and connectivity with the shared goal of commercializing products and services to extend human life. The Alliance supports provider partners’ commercialization efforts by sharing Cleveland Clinic’s commercialization policies, procedures and know-how; by reviewing invention disclosures for market and clinical viability; and by bridging the gaps to successful commercialization by connecting ideas, inventions, and people to industry partners and funding sources who can develop, enhance, or license the technologies. Alliance industry partners benefit from working directly with leading clinicians and researchers from across our provider network to refine their products, identify new clinical unmet needs, and jointly development new products to transform the delivery of healthcare.

2018 was a key year for the Innovation Alliance program. Two of the longest tenured provider partners, MedStar Health and Innovation Institute, extended their agreements to remain in the Alliance into the next decade. The Alliance program also welcomed SABIC, a Riyadh-based global leader in diversified chemicals and high performance plastics, in the hopes of extending their leading polymer expertise to the Alliance inventor communities. In August, all Alliance members were invited to participate in an Alliance-wide retreat, to reflect on the successes of the program and ensure.

The Alliance program supported 15 projects across our four industry partners in 2018, providing valuable key opinion leader feedback, technology development expertise, and intellectual property to support product development efforts. Alliance provider partners generated more than 900 invention disclosures during the year, and Cleveland Clinic Innovations provided more than 1,000 hours of direct business analytics support on selected Alliance disclosures. More critically, the level of collaboration between physicians, researchers, scientists, product development experts and others has never been higher.

“The scale of support and expertise that is shared across our Innovation Alliance program is vast,” said Jim Zalar, General Manager at Cleveland Clinic Innovations.

“We are proud to lead this Alliance program and to accelerate innovation across our network that will ultimately improve patient care.”

After ten years, the Alliance program continues to seek opportunities for growth and expansion. In late 2018, letters of intent were signed with two new industry partners, both expected to formally join the Alliance program in the first half of 2019. Additionally, CCI continues to identify and work with provider candidates interested in joining the Alliance and leveraging the collaborative strengths of the innovation ecosystem represented by the Alliance program. “2019 represents a new opportunity for our Alliance to add new capabilities and collaboratively commercialize products and services to transform patient care,” said Zalar. “The best is yet to come.”

Alliance Program Celebrates 10 Yearsas a Model for Collaborative Commercialization

Four corporate alliance partners

CCI supported

17 active or supported projects across the four corporate Alliance partners

>900 total IDFs submitted across all Alliance providers

CCI Business Analytics supported more than

50 projects providing more than

1,000 hours of direct support to our Alliance provider partners>150

participating hospitals across U.S.


36

Business Solut ions


37

In April 2018, CCI Business Solutions partnered with Business Finland to spread their innovative reach to Northern Europe. Hosting a boot camp for nearly two dozen Finnish startups, Business Solutions taught valuable lessons related to healthcare in the United States. The program was structured to provide insight on marketing, supply chain and reimbursement in US healthcare. Additionally, the CCI delegation engaged each startup in a one-on-one setting to provide insight around their solutions and areas to focus for deploying the solution in the US. These international startups energetically engaged with the CCI team and took detailed notes. Leaving the camp, startups were able to better identify and communicate their solutions and build better business models for more efficient operations.

With the four day workshop, the team was able to grow Innovations’ footprint and form a unique partnership. The bond was only strengthened as several startups from their program were invited to attend MIS 2018. With some participating in the Startup Showcase, the connection formed early in the year brought valuable international insight to the Summit. A miniature version of the boot camp was held here in Cleveland, post-Summit, for other interested international attendees. Unique partnerships such as this are expected to increase in value as we look to further incorporate external innovation in the coming year.

The Cleveland Clinic Business Solutions team is a valued resource for the entrepreneurs, startups and established companies they work with. Each year the team works with dozens of entrepreneurs to provide commercialization, business development or operational support services. 2018 saw a continued increase in the amount of deliverables provided to the various constituents who utilize the Business Solutions team services.

In the year 2018, Business Solutions continued their consultation work to several high quality clients. To assist an international Fortune 500 company with a desire to move their product to the US market, the team outlined a number of operational, regulatory, and reimbursement issues for the company to work through. A surgical glue designed to be applied over stitches in the procedure of aortic anastomosis, the product was evaluated by the team at Innovations and a select few Cleveland Clinic cardiac surgeons. Business Solutions assisted several other companies this year with high-value advice regarding their early-stage products. Most notably, a next-generation hospital bed with capabilities far beyond the current standard. Facilitating clinician evaluation of the technology, Business Solutions sent the company with a laundry list of action items and a revised business model for better market integration in the future. And for a small startup looking to address patient mobility, the team assisted with development and review of a comprehensive market evaluation and business plan.

For companies with products currently on the US market, Business Solutions provides other useful services. For a US-based weight loss company, Business Solutions assisted with a change in business model approach. Per the professional suggestion, the company now looks to partner with healthcare companies for better adoption of their program.

Business Finland Bootcamp

2018 Notable Activity


38

In late 2010, CCI began centralizing its internal market intelligence function with dedicated staffing. Growth in both demand and output led to the formation of the Business Analytics team in 2015, solidifying this shared service as one of the cornerstones of the INVENT® process. Today, CCI Business Analytics operates as a cross-functional team of experienced research professionals determined to provide its key stakeholders with knowledge and tools to optimize strategic decision making and mitigate investment risk. Core capabilities of the team include market opportunity analysis, competitive due diligence and intellectual property assessment leveraging a curated resource library of public and proprietary research databases. Depth and breadth of knowledge and data sources enable the Business Analytics team to find and qualify the right information in order to facilitate timely decision making.

CCI Business Analytics

Listed 2018 Milestones

• Completion of more than 370 deliverables tied to 260 individual projects spread over a diversified range of clients. Well over 80% of BA team activity in 2018 remained focused on Cleveland Clinic technologies.

• Successful rollout of an outreach program with the completion of five Market Focus activities involving research and presentation of market trends across a range of medical specialty segments, including orthopedics, digital health, ophthalmology, neurorehabilitation and cerebrovascular. Additional Market Focus presentations in other areas are planned for 2019.

• Continued engagement with outside clients through the Innovations Alliance program, Business Solutions projects and external innovation initiatives. Notably, the Business Analytics team prepared and delivered market and reimbursement talks as part of the Business Finland Bootcamp, a four day workshop with nearly two dozen startups in Helsinki.

0

50

100

150

200

250

300

Deliverables by Client

Medical Device 31%

CCV 17%

Alliance 14%

Life Sciences 13%

CCI Ops/Infratstructure 7%

Business Solutions 5%

HIT 5%

Ad Hoc/Other 4%

Delivery Solutions 2%

GCIC/NCAI 2%

350

400

Deliverables Projects


39

Medical Innovat ion Summit


40

In 2018, the Medical Innovation Summit expanded, bringing its attendees healthcare’s most pressing content – AI in healthcare, the changing diagnostic landscape, accountable care, non-docs and technology, and a patient-centered healthcare system. Several program additions strengthened the Summit’s message.

MIS2018 RecapThe StartUp Showcase, brought in 42 emerging companies divided into two tracks. The event was hailed for the quality and diversity of participating companies, yielding a number of significant engagements between the startup and venture worlds. Our expansion in programming helped grow the global footprint with the addition of International Insights – bringing in delegations from around the world to share their healthcare perspectives. The Investment Forum broadened our industry scope, adding venture expertise. The Women in Health Tech brass track was highly regarded by its attendees and will be expanded in 2019 with a goal to attract more women leaders to main stage sessions.

Inspiring and humbling in so many ways, the story of Katie Stubblefield and her family’s journey to health brought tears to the eyes of a full exhibit hall. The annual Top 10 Medical Innovations garnered attention and piqued curiosity with their announcement. With another disruptive year in the books, please save the date for MIS2019.


41

Alternative Therapy for Pain: Fighting the Opioid Crisis

The Advent of AI in Healthcare

Expanded Window for Acute Stroke Intervention

Advances in Immunotherapy for Cancer Treatment

Patient-Specific Products Achieved with 3D Printing

12345

Top 10 Medical Innovations2019

Innovation in Robotic Surgery

Mitral and Tricuspid Valve Percutaneous Replacement

RNA-Based Therapies

Virtual and Mixed Reality for Medical Education

Visor for Prehospital Stroke Diagnosis

6789

10


42

Recognit ion


43

CCI Honors Inventors at the 2018 Innovators Awards Recept ionOn May 16, Cleveland Clinic Innovations hosted the Innovators Awards Reception to recognize and celebrate the active Cleveland Clinic inventors and successes from the past year. The event, which took place at the InterContinental Hotel, was held in conjunction with National Inventors Month.

“We always try to recognize and show our appreciation for Cleveland Clinic inventors throughout the year,” said Pete O’Neill, Executive Director of Cleveland Clinic Innovations. “National Inventors Month and our annual reception, however, give us a special opportunity to reflect on the incredible privilege to work with such world class thought leaders across the enterprise.”

The 2018 Innovator Awards marked the inaugural presentation of the Hickey Family Foundation’s Innovation Impact Award, which was created to reward and sustain the caregivers who are using innovation to provide better care to regions around the world, our community, and the most vulnerable patients. Nancy Baldwin, the foundation’s Executive Director, presented the award to Hani Najm, MD, of the Heart & Vascular Institute for his stented pulmonary autograft prosthesis device for children with mitral valve disease.

“Dr. Najm’s valve prosthesis device hopes to offer a scaffold that is partially absorbable and expandable and can grow along with these young patients, giving them the quality of life they deserve,” said Baldwin.

Innovation Awards were then presented to inventors who have demonstrated creativity and persistence in their pursuit to advance care in the categories of Medical Devices, Therapeutics & Diagnostics, Health IT, and Delivery Solutions. CCI also looked into its crystal ball to identify caregivers that has a long and remarkable innovation career ahead. The reception also honored perhaps the

“Greatest of All Time” in Cleveland Clinic’s innovative history, Toby Cosgrove, MD.

The Innovation Award winners follow.Hani Najm, MD


44

Outstanding Innovationin Medical Device

Tom Gildea, MD, Respiratory Institute

For years, Tom Gildea, MD, had been looking to get beyond the one-size-fits all approach to airway stenting. Most stents are cylindrical, rigid tubes that generate scar tissue and significant discomfort for patients who are suffering from a variety of breathing disorders that can be caused by inflammation, a tumor, or a mass. Intent on fixing this problem, Dr. Gildea combined CT scanning and 3D printing to develop stents that are specifically designed for the patient. The stent has already had dramatic results. “With a typical stent, we expect to remove it within 40 days due to the discomfort,” said Dr. Gildea. “With the custom stent, we removed it after 14 months.” In his acceptance of the award, Dr. Gildea credited the infrastructure at Cleveland Clinic to get this new technique to patients in a short period of time, specifically with the help of CCI and Medical Device Solutions at Lerner Research Institute. As of May of 2018, five patients have received a custom stent.

Outstanding Innovation in Health Information Technology

Robb Colbrunn, PhD, Lerner Research Institute

Robb Colbrunn, PhD, was brought to Cleveland Clinic over 12 years ago when the Department of Biomedical Engineering purchased a new robot for simulating joint loads to enhance its understanding of orthopaedic biomechanics. Robb’s directive shifted dramatically over the years from simply making the robot work to changing the way orthopaedic research is done all of the world. The software he developed, called simVITRO, made Cleveland Clinic’s robots faster, easier to use, and flexible in its ability to apply dynamic loads. Recognizing the shared need for these types of capabilities in research labs all over the world, Robb began commercializing the simVITRO software package alongside Cleveland Clinic Innovations in 2013. Robb not only built software that was customizable, but also built a robust team in Tara Nagle and Callan Gillespie who work with Robb to help customers answer their most pressing clinical questions using simVITRO. simVITRO is now in over a dozen labs in North America, Europe, and Australia. In addition to biomechanical testing of joints, Robb has also been approached by those in the manufacturing, product testing and surgical robotics fields who recognize the value of having a robot capable of real-time force-feedback control with minimal programming efforts.

Tom Gildea, MD

Robb Colbrunn, PhD


45

Outstanding Innovation in Therapeutics & Diagnostics

Nima Sharifi, MD, Lerner Research Institute

Dr. Sharifi and his lab are transforming the way we think about prostate cancer treatment. Dr. Sharifi discovered a major metabolic pathway that tumors utilize for dihydrotestosterone (DHT) synthesis, which circumvents the requirement for testosterone. He then discovered the first example of an enzyme missense that elicits DHT synthesis and clinical development of castration resistant prostate cancer (CRPC). He also discovered a series of new abiraterone metabolites that impinge on the androgen pathway and modify response directing the way to new approaches for treating prostate cancer where current standard of care such as androgen deprivation therapy often fail. Dr. Sharifi’s discoveries have turned heads in the oncology industry, resulting in an exclusive license in 2017.

Outstanding Innovation in Delivery Solutions

Carol Santalucia, Office of Patient Experience

Effectively communicating compassion and empathy for patients and their families can be challenging for caregivers. For over 20 years, Carol has been intent on changing that. As co-creator of the Communicate with H.E.A.R.T.® program, Carol wanted to develop easy-to-remember tools that could empower employees to address patient needs and respond in a way that the person feels he or she was responded to with care. The internal success of these tools led to the idea to translate the H.E.A.R.T. programs to other organizations in 2013. Since then, H.E.A.R.T. has been adopted by over 30 systems worldwide. In 2017, Carol developed Lead with H.E.A.R.T.®, a program that gives leaders within organizations the skills to encourage and sustain a culture of compassionate communication. This new program has already been adopted by a number of institutions with many more on the horizon.Nima Sharifi, MD

Carol Santalucia


46

Young Innovator Award Lifetime Achievement Award

Nitin Yerram, MD, Anup Shah, MD, Residency Fellowship

Drs. Nitin Yerram and Anup Shah are currently resident fellows at Cleveland Clinic, and have quickly made waves in the Clinic’s innovation community. They are being recognized for their efforts to design and develop a minimally invasive device to treat urethral strictures, a technique that has the potential to transform the standard of care. Drs. Yerram and Shah have been working on this device alongside Cleveland Clinic Innovations for over a year, despite their busy schedules as resident fellows in the urological and general surgery departments. “They are approaching the problem of urethral strictures with the ideal mix of clinical expertise, patient compassion, fresh thinking, and entrepreneurial energy,” said Ryan Nowicki, Innovation Manager at Cleveland Clinic Innovations. “Their future is certainly bright.”

Toby Cosgrove, MD, Former CEO & President

The award of the evening was given to Cleveland Clinic’s former CEO & President, Dr. Toby Cosgrove, for his innovations throughout his illustrious career as a surgeon at Cleveland Clinic. Dr. Cosgrove has earned over 31 U.S. patents for a wide variety of surgical technologies. His inventions included the flexible annuplasty ring, which was developed to reinforce the annulus in a mitral valve repair, and the left atrial appendage clip, which has been implanted in over 125,000 patients as of March 2018. Dr. Cosgrove also developed the Cosgrove retractor that helps to better expose the right and left atria during mitral valve surgery, as well as a cardiopulmonary bypass system that uses vacuum-assisted venous drainage, and his novel flexible clamps for aortic occlusion, among many more.

In a recent interview, Dr. Cosgrove said of his innovative tenure “my strength lies solely in my tenacity.” As Peter O’Neill concluded, this tenacity has been illustrated by each of the winning inventors and the many others that have found success by innovating at Cleveland Clinic. Cleveland Clinic Innovations is honored to play a role in continuing Dr. Cosgrove’s innovative legacy.

Nitin Yerram, MD

Anup Shah, MD

Toby Cosgrove, MD


47

US Patent 9,950,101Blood Pump, Dave Dudzinski (Lerner Research Institute); Markus Lorenz (Lerner Research Institute); William Smith, PhD (Lerner Research Institute)4/24/2018

US Patent 9,907,941Convection Enhanced Delivery Device and System, William Kolosi (Chief of Staff); Shengqiang Gao, PhD (Lerner Research Institute); Michael Vogelbaum, MD, PhD (Neurological Institute)3/6/2018

US Patent 9,968,765Convection Enhanced Delivery Device and System, William Kolosi (Chief of Staff); Shengqiang Gao, PhD (Lerner Research Institute); Michael Vogelbaum, MD, PhD (Neurological Institute)5/15/2018

US Patent 9,922,424Automated Centerline Extraction Method and Generation of Corresponding Analytical Expression and Use Thereof, Roy Greenberg, MD (Heart and Vascular Institute); Vikash Goel (Lerner Research Institute)3/20/2018

US Patent 9,977,034Biomarkers for Fatty Liver Disease and Methods Using the Same, Satish Kalhan, MD (Lerner Research Institute)5/22/2018

US Patent 10,024,854Method for Detecting and Purifying Pancreatic Beta Cells, Jan Jensen, PhD (Lerner Research Institute); Xiaoling Qu, PhD (Lerner Research Institute)7/17/2018

US Patent 10,076,232Endoscopic Sheath Assembly, Andrew Zura, MD (Anesthesiology Institute); Rafi Avitsian, MD (Anesthesiology Institute)9/18/2018

US Patent 10,143,391Implantable Pressure Sensor, Margot Damaser*, PhD (Lerner Research Institute)12/4/2018

US Patent 10,022,516Apparatus and Method for Treating a Neuromuscular Defect, Francis Papay, MD (Dermatology & Plastic Surgery Institute)7/17/2018

US Patent 9,878,150Methods and Systems for Increasing Heart Contractility by Neuromodulation, Sandra Machado, MD (Anesthesiology Institute); Marc Penn, MD, PhD (Heart and Vascular Institute); Ali Rezai, MD (Neurological Institute)1/30/2018

US Patent 10,016,488Nitric Oxide Synthase Nanoparticles for Treatment of Vascular Disease, Maram Reddy (Lerner Research Institute); Vinod Labhasetwar, PhD (Lerner Research Institute)7/10/2018

US Patent 9,981,018Compositions and Methods for Modulating Toll-Like Receptor 2 Activation, Tatiana Byzova, PhD (Lerner Research Institute)5/29/2018

US Patent 10,010,416Apparatus and Method for Replacing a Diseased Cardiac Valve, Jose Navia, MD (Heart and Vascular Institute); Brian Davis, PhD (Lerner Research Institute); Ji-Feng Chen (Lerner Research Institute); Samantha Stucke (Lerner Research Institute); Shengqiang Gao, PhD (Lerner Research Institute)7/3/2018


48

US Patent 10,117,711Apparatus and Method for Treating Cardiovascular Diseases, Carlos Oberti, MD (Heart and Vascular Institute)11/6/2018

US Patent 9,877,735System and Method for Assisting with Attachment of a Stock Implant to a Patient Tissue, Jason Bryan (Lerner Research Institute); Joseph Iannotti, MD, PhD (Orthopaedic & Rheumatologic Institute); Wael Barsoum, MD (Orthopaedic & Rheumatologic Institute)1/30/2018

US Patent 9,918,622Device and Method for Determining the Presence of Middle Ear Fluid, Matthew Ford (Cole Eye Institute); Paul Krakovitz, MD (Head and Neck Institute); Rahul Seth, MD (Head and Neck Institute)3/20/2018

US Patent 10,004,881System and Method for Wound Healing, Francis Papay, MD (Dermatology & Plastic Surgery Institute); Ji-Feng Chen (Lerner Research Institute); Shengqiang Gao, PhD (Lerner Research Institute)6/26/2018

US Patent 10,117,879Treating and Preventing Disease with TMA and TMAO Lowering Agents, Stanley Hazen, MD, PhD (Lerner Research Institute)11/6/2018

US Patent 10,064,830Treatment and Prevention of Cardiovascular Disease and Thrombosis, Bruce Levison, PhD (Lerner Research Institute); Stanley Hazen, MD, PhD (Lerner Research Institute); Zeneng Wang, PhD (Lerner Research Institute)9/4/2018

US Patent 9,981,123Lead Assemblies With Adjustable Contacts, Karl West (Lerner Research Institute); Mark Lobosky (Lerner Research Institute); Andre Machado, MD, PhD (Neurological Institute); Scott Lempka (Neurological Institute)5/29/2018

US Patent 10,130,378Generating Patient Specific Instruments for Use as Surgical Aids, Jason Bryan (Lerner Research Institute)11/20/2018

US Patent 10,086,110Multipurpose Membranes, Methods for Forming, and Applications Thereof, James Trickett (Medicine Institute); Peter Evans, MD, PhD (Orthopaedic & Rheumatologic Institute)10/2/2018

US Patent 9,956,383Medical Devices and Methods for Providing Access to a Bodily Passage During Dilation, Paul Krakovitz, MD (Head and Neck Institute)5/1/2018

US Patent 10,039,644Device, System, and Method for Treating a Regurgitant Heart Valve, Jose Navia, MD (Heart and Vascular Institute); Samir Kapadia, MD (Heart and Vascular Institute)8/7/2018

US Patent 10,028,695Evaluation of Movement Disorders, David Schindler (Executive Administration); Jay Alberts, PhD (Executive Administration); Cameron McIntyre, PhD (Lerner Research Institute); David Schindler (Lerner Research Institute); Jay Alberts, PhD (Lerner Research Institute); Andre Machado, MD, PhD (Neurological Institute); David Schindler (Neurological Institute); Jay Alberts, PhD (Neurological Institute)7/24/2018

US Patent 9,884,098Multivalent Breast Cancer Vaccine, Vincent Tuohy, PhD (Lerner Research Institute)2/6/2018

US Patent 10,047,399ABCA1 Downregulation in Prostate Cancer, Byron Lee, MD, PhD (Glickman Urological & Kidney Institute); Angela Ting, PhD (Lerner Research Institute)8/14/2018


49

US Patent 10,077,777Artificial Heart System Implementing Suction Recognition and Avoidance Methods, Barry Kuban (Lerner Research Institute); David Horvath (Lerner Research Institute); Leonard Golding, MD (Lerner Research Institute)9/18/2018

US Patent 10,028,704Exchange Guidewire, Shengqiang Gao, PhD (Lerner Research Institute); Ferdinand Hui, MD (Neurological Institute)7/24/2018

US Patent 10,078,144Overdetermined Positron Emission Tomograpy, Frank DiFilippo, PhD (Imaging Institute)9/18/2018

US Patent 9,913,691System and Method for Model-Based Surgical Planning, Peter Brooks, MD (Orthopaedic & Rheumatologic Institute)3/13/2018

US Patent 10,105,091Methods of Using Nerve Evoked Potentials to Monitor a Surgical Procedure, Francis Papay, MD (Dermatology & Plastic Surgery Institute)10/23/2018

US Patent 9,946,046Apparatus for Selectively Connecting Items, Justis Ehlers, MD (Cole Eye Institute); Sunil Srivastava, MD (Cole Eye Institute)4/17/2018

US Patent 10,029,098System and Method for Treating Obstructive Sleep Apnea, Francis Papay, MD (Dermatology & Plastic Surgery Institute)7/24/2018

US Patent 10,065,038System and Method for Treating Obstructive Sleep Apnea, Francis Papay, MD (Dermatology & Plastic Surgery Institute)9/4/2018

US Patent 9,856,536Method for Treating Castration-Resistant Prostate Cancer, Kai-Hsiung Chang, PhD (Lerner Research Institute); Nima Sharifi, MD (Lerner Research Institute)1/2/2018

US Patent 9,928,596Motion Corrected Imaging System, Erik Beall, PhD (Imaging Institute); Mark Lowe, PhD (Imaging Institute)3/27/2018

US Patent 10,004,586Biocompatible Tissue Graft, Anthony Calabro, PhD (Lerner Research Institute); Kathleen Derwin, PhD (Lerner Research Institute)6/26/2018

US Patent 9,999,781System and Method for Micromagnetic Stimulation of the Peripheral Nervous System, Hyun-Joo Park, PhD (Lerner Research Institute); John Gale, PhD (Lerner Research Institute); Matthew Johnson (Lerner Research Institute); Susan Thompson (Lerner Research Institute)6/19/2018

US Patent 9,854,964Measurement of Biomechanical Properties in an OCT Image, Matthew Ford (Cole Eye Institute); William Dupps Jr., MD, PhD (Cole Eye Institute)1/2/2018

US Patent 10,141,075Predicting and Mitigating Risk of Ectasia and Optimizing Therapeutic Outcomes, William Dupps Jr., MD, PhD (Cole Eye Institute)11/27/2018

US Patent 10,045,831Instrument Tracking In OCT-Assisted Surgery, Mohamed El-Haddad (Cole Eye Institute); Yuankai Tao, PhD (Cole Eye Institute)8/14/2018


50

US Patent 9,926,326Substituted Thioxanthenone Autophagy Inhibitors, James Phillips, PhD (Taussig Cancer Institute); Jennifer Carew, PhD (Taussig Cancer Institute)3/27/2018

US Patent 9,883,938Endoluminal Prosthesis Having Multiple Branches or Fenestrations and Methods of Deployment, Roy Greenberg, MD (Heart and Vascular Institute); Karl West (Lerner Research Institute)2/6/2018

US Patent 10,052,186Prosthetic Implants, Francis Papay, MD (Dermatology & Plastic Surgery Institute)8/21/2018

US Patent 10,143,430Systems and Methods That Use Multi-Modal Imaging For Enhanced Resolution Images, Francis Papay, MD (Dermatology & Plastic Surgery Institute)12/4/2018

US Patent 10,049,451Automated Lesion Segmentation from MRI Images, Elizabeth Fisher, PhD (Lerner Research Institute)8/14/2018

US Patent 10,028,653Assessment of Low Contrast Visual Sensitivity, David Schindler (Executive Administration); Jay Alberts, PhD (Executive Administration); David Schindler (Lerner Research Institute); Jay Alberts, PhD (Lerner Research Institute); David Schindler (Neurological Institute); Jay Alberts, PhD (Neurological Institute); Robert Bermel, MD (Neurological Institute); Stephen Rao, PhD (Neurological Institute)7/24/2018

US Patent 10,058,243Clinic Evaluation Via Outer Retinal Layer Assessment, Justis Ehlers, MD (Cole Eye Institute); Sunil Srivastava, MD (Cole Eye Institute)8/28/2018

US Patent 10,052,016Automated Clinical Evaluation of the Eye, Justis Ehlers, MD (Cole Eye Institute); Sunil Srivastava, MD (Cole Eye Institute)8/21/2018

US Patent 9,926,316Antitumor Derivatives for Differentiation Therapy, Babal Jha, PhD (Lerner Research Institute); Anand Tiwari, PhD (Taussig Cancer Institute); James Phillips, PhD (Taussig Cancer Institute); Kwok Ng, PhD (Taussig Cancer Institute); Yogen Saunthararajah, MD (Taussig Cancer Institute)3/27/2018

US Patent D820,012Tube Rack, John Etterling (Medicine Institute); Jeffery Holzfaster (Pathology and Laboratory Medicine Institute)6/12/2018

US Patent 9,950,977Enhancement of Electron Scavenging by Water-Soluble Fullerenes, Vijay Krishna (Lerner Research Institute)4/24/2018

US Patent 10,149,960Methods and Devices to Clear Obstructions from Medical Tubes, Sam Kiderman (Chief of Staff); A. Gillinov, MD (Heart and Vascular Institute)12/11/2018


51

10000 Cedar AvenueCleveland, OH44195

Innovations at Cleveland Clinic · Medical Innovation Summit Recognition ... 2018 ANNUAL REPORT 2....

Documents

Transcript of Innovations at Cleveland Clinic · Medical Innovation Summit Recognition ... 2018 ANNUAL REPORT 2....