SBIR and STTR Success Story for
Cleveland Medical Devices Inc. (CleveMed)

(Information Posted/Updated on 03/02/2010)

Cleveland Medical Devices Inc. (CleveMed)
4415 Euclid Avenue
4th Floor Suite
Cleveland, OH  44103

Contact:    Carole Nittskoff
Phone:      216-619-5905
E-mail:      cnittskoff@clevemed.com
Web Site:  www.CleveMed.com

Project Title:  A New Device For Untethered Home Sleep Studies; Intelligent Quantitative CPCP for OSA Therapy; Pre-Operatiave PSG Assessment of Caradiac Surgery InPatients
Related Award(s):  5R44NS42451-3; 2R44HL075983; 5RNSO42451
Technology Developed:
Portable telemetry-based sleep monitors that can be easily deployed in many settings including sleep labs, hospital rooms, patients’ homes, nursing homes, and others. The technology includes miniaturized battery powered hardware with onboard wireless data transmission capabilities. Sophisticated software for data acquisition, review, reporting and analysis was also developed

Key Words:  Home sleep testing, Sleep disorders, Ambulatory monitoring, Wireless, Polysomnography.
Uses of Technology/Products/Service:
The technology can be used to facilitate the diagnosis of many sleep disorders including sleep apnea, insomnia, and parasomnia in environments that are more convenient and cost effective to the patients and providers. Instead of in-laboratory testing, which is expensive, presents an unfamiliar surrounding and is often too far from the patient’s home, CleveMed’s wireless monitoring technologies allow the testing to occur directly from the patient’s home. Other important uses of CleveMed sleep technologies include testing surgical patients in their hospital room. Sleep apnea complicates post-operative care in most surgeries; yet, a significant number of patients who are admitted to the operating room are not tested for sleep apnea due to the complexity of current technologies. CleveMed’s equipment, which can fit in the technologist’s coat pocket, can be deployed quickly on the ward. Another use is patient follow-up care. Like any other chronic disease, sleep apnea can be influenced by long-term health changes like weight gain and emerging co-existing diseases (diabetes, asthma, heart diseases). Therefore, it is important to routinely monitor sleep therapy in order to confirm its benefit. The size and wireless capabilities of CleveMed’s equipment allow it to communicate with sleep therapy devices seamlessly; thus, permitting easier follow-up studies in the home.

Benefit to Company:
The SBIR program has played a critical role in CleveMed’s success. CleveMed is now an ISO / CE company with over 10 FDA approved products that are sold nationally and internationally. CleveMed has increased the number of employees by 30% over the past 5 years. Our company-wide product sales have witnessed double digit growth every year for 5 years in a row. We have entered into a licensing agreement with a major hospital, a co-marketing and development agreement with a large corporation, spun off one company and is in a licensing negotiation with another spinoff company. Finally, we continue to expand the number of Key Opinion Leaders that endorse our technologies.

How Product Was Commercialized:
Our products are sold through our own direct sales force and national and international independent representatives and distributors. Our products are sold in over 10 countries including Columbia, Malaysia, Australia, Philippines, Thailand, India, Dubai, Vietnam, and Singapore.

Other Comments Related to Company's Success Story:
2008 AWARDS: -Inc. 5000 Award (Awarded to fastest-growing privately held companies in the U.S.) -Leading Edge Award (The Leading Edge Award from Entrepreneurs EDGE celebrates the top 101 middle-market companies in Northeast Ohio that create great value for their community. ) -Frost & Sullivan Award (Kinesia was awarded Frost and Sullivan's North American Product Innovation of the Year for mobility disorder monitoring devices.)

2007 AWARDS -Gold Electrode Award (NEUROTECH BUSINESS REPORT Awarded Kinesia BEST NEW PRODUCT in 2007.) -Inc. 5000 Award (Awarded to fastest-growing privately held companies in the U.S.) -Leading Edge Award (The Leading Edge Award from Entrepreneurs EDGE celebrates the top 101 middle-market companies in Northeast Ohio that create great value for their community.) -"30 in their Thirties: 30 Ohioans Shaping the Bioscience World Now" Award (CleveMed Director of New Research, Matthew Tarler, PhD, recognized by Accelerating Excellence Magazine as one of top thirty bioscience professionals in their thirties in Ohio.) -Stevie Award: Best Product Developer Category (CleveMed's Sofware Manager, Craig Frederick, awarded as Best Product Developer in the 2007 American Business Awards for his work on an innovative home PSG system.)

2006 AWARDS -Manny Award: New Product/Innovation Category (The Manny Awards celebrate manufacturing excellence by recognizing the achievements of manufacturing and distribution companies in Northeast Ohio. The awards are presented yearly by Inside Business magazine, in partnership with MAGNET. Nominations were made by individual companies, industry experts and business leaders based on a company's innovation and best practices. CleveMed received the award for the Crystal Monitor® 20-S.) -Pan American Health Care Exchanges (PAHCE) (Special Recognition of Innovative Instruction and Training for CleveLabs.) -2002 & 2006 National Tibbetts Award (U.S. Small Business Administration annually awards companies that are "models of excellence" in the area of high technology.)