Tympanogen, a medical device company based in the Biotech Park of Richmond, VA, was awarded a $3.23 million Small Business Innovation Research (SBIR) grant from the National Institute on Deafness and Other Communication Disorders (NIDCD). This Commercialization Readiness Pilot (CRP) Program grant, a continuation of a prior Direct-to-Phase II grant, will support the pivotal clinical study for the company’s nonsurgical eardrum repair device. This device, called Perf-Fix™ Otologic Gel Patch, is intended to replace surgical eardrum repair with a clinic visit. It will be for both children and adults suffering from chronic eardrum perforations – a significant issue that follows middle ear infection.
“This SBIR CRP Program award enables us to provide qualifying patients with a faster, safer alternative to current surgical options for eardrum repair through a clinical study. We are honored that the NIDCD has continued to support the commercialization of Perf-Fix so we can reach patients more quickly,” said Dr. Elaine Horn-Ranney, Co-Founder and Chief Executive Officer of Tympanogen and the Principal Investigator for the grant.
“Perf-Fix has been developed alongside otolaryngologists continuously since its inception, and it is exciting to be able to use it in practice for this study,” said Dr. Barry Strasnick, Chair of the Department of Otolaryngology at Eastern Virginia Medical School, Clinical Advisor to Tympanogen, and Study Investigator. “With this clinical study, Perf-Fix could become the leader in noninvasive eardrum repair because it avoids the risk and cost of surgery for this highly prevalent condition.”
The clinical study for Perf-Fix has been approved by an Institutional Review Board and will be conducted at multiple sites across the United States. Enrollment for the study is anticipated to begin in the fourth quarter of 2023.