SBIR and STTR Success Story for ARISIL, Inc.

SBIR and STTR Success Story for ARISIL, Inc. (Information Posted/Updated on 06/26/2006)

ARISIL, Inc. 450 Clinton Street Brooklyn, NY 11231 Contact: Dr. Shlomo Silman and Dr. Daniel S. Arick Phone: (718) 624-0222, (718) 951-4869 Fax: (718) 624-7310, (718) 951-4363 E-mail: ssilman@brooklyn.cuny.edu Web Site: http://www.earpopper.com
Project Title: Non-Surgical Device for Treatment of Middle Ear Effusion
Related Award(s): 1R43DC003613-01A1, R44DC003613-03
Technology Developed: Drs. Daniel S. Arick and Shlomo Silman of ARISIL, Inc. developed and patented (Patent # US 5,419,672 and 5,885,242) the EarPopper, which has FDA 510(k) approval for marketing as a prescriptive medical device. The EarPopper is a hand-held, battery-operated modified Politzer autoinsufflation device that emits controlled air pressure and flow that can be adjusted according to the patient's age and magnitude of hearing loss. It is used for non-surgical and non-pharmaceutical treatment of otitis media with effusion with associated hearing loss and Eustachian-tube dysfunction.
Key Words: EarPopper, otitis media, middle-ear effusion, eustachian tube, autoinsufflation, Politzer method, manufacturing.
Uses of Technology/Products/Service: Middle ear fluid is one of the most common reasons that U.S. children visit the doctor, second only to the common cold, resulting in more than 30 million doctor visits each year and adding $4 billion in medical costs to the health care system. Although increasing concerns about the risks of resistance to antibiotics recently led doctors to recommend "watchful waiting" as the first line of treatment, more than 10 million antibiotic prescriptions are written annually to treat middle ear fluid or otitis media with effusion (OME). Persistent OME often is treated with ear surgery. More than 700,000 children undergo this procedure each year. In many cases, both antibiotics and surgery have proven problematic and often unsuccessful. The Ear Popper directs a steady, controlled stream of air into the nose, and swallowing diverts the air into the Eustachian tube, opening the Eustachian tube and relieving pressure imbalance in the middle ear. The EarPopper can be used in the physician’s office or parents can use the EarPopper at home on their children for a period of approximately 7 weeks. The results of the feasibility study and clinical trials conducted by ARISIL, Inc. revealed that the EarPopper was easy to use and well tolerated by children (4 or more years of age) as well as adults. The results also revealed that treatment with the EarPopper brought 73.9% of the treated ears were within normal limits as compared with only 26.7% of the control ears that did not receive the EarPopper. When the treatment period was extended for those who did not recover within 7 weeks, the recovery rate for the EarPopper increased to 84%. In these children, use of the EarPopper meant that they did not have to undergo ear surgery and they did not suffer the possible sequelae of ear surgery such as permanent hearing loss or permanent damage to the middle ear.
Benefit to Company: ARISIL, Inc. was privileged to receive two grants totaling $1,024,123 from the National Institutes of Health (NIH) National Institute on Deafness and Other Communication Disorders (NIDCD) via the Small Business Innovation Research (SBIR) Program. With this NIH NIDCD funding, ARISIL was able to construct the prototype EarPopper and to conduct the feasibility study and clinical trials with the device at Brooklyn College, CUNY, which kindly, under the aegis of President Christoph M. Kimmich, also provided ARISIL, Inc. with support. ARISIL also benefited from the advice and consultation provided by Lynn E. Luethke, Ph.D., Program Director, Hearing Program, NIDCD/NIH. The feasibility and clinical trials results were extremely successful and two articles based on the clinical trials were published in Ear, Nose & Throat Journal in 2005.
How Product Was Commercialized: In early 2005, ARISIL, Inc. enabled the technology for the intended application to be commercialized when it leased the EarPopper to Micromedics, Inc., an innovative surgical products company located in St. Paul, MN. Micromedics, Inc. was one of several companies to approach ARISIL, Inc. for a leasing agreement for the EarPopper. Micromedics, Inc. had conducted its own successful feasibility study on the EarPopper before the leasing agreement between ARISIL, Inc., and Micromedics, Inc. was finalized. Micromedics, Inc. made the EarPopper commercially available beginning October, 2005. The company widely promotes the EarPopper in the U.S. and abroad. The website for Micromedics, Inc. is http://www.micromedics-usa.com and it maintains a site for the EarPopper at http://www.earpopper.com.
Other Comments Related to Company's Success Story: The EarPopper received media coverage through more than 45 health/medical reports on television stations, radio, newspapers, and professional health journals throughout the country and on health/medical websites. Examples of media coverage include Washingon Post, Wall Street Journal, ABC, CBS and NBC, National Public Radio, the New York Daily News. It also has appeared on several health websites. Numerous letters of appreciation from parents and physicians were sent to Drs. Arick and Silman and some also appear on the EarPopper website.