Pavmed (NSDQ:PAVM) today announced it plans to develop and use Canon Virginia’s commercial-grade and scalable aqueous silk fibroin molding process to manufacture its DisappEAR molded pediatric ear tubes.
Under terms outlined in a letter of intent, PAVmed and Canon Virginia propose to enter into two sequential agreements covering a 5-phase project culminating in the commercialization of the ear tubes. DisappEAR has not received FDA clearance or any other regulatory approval, according to the company.
PAVmed licensed the technology from Tufts University on behalf of itself and other academic institutions, including Massachusetts Eye and Ear Infirmary, Massachusetts General Hospital, Massachusetts Institute of Technology and Eidgenössisches Technishe Hochschule Zürich. The tubes are manufactured from a proprietary aqueous silk technology which is designed to slowly be reabsorbed over the intended course of treatment.
Each year, up to one million children with persistent ear infections (otitis media) or middle ear fluid collections (effusions) undergo placement of metal, plastic or latex bilateral ear tubes to drain the middle ear, PAVmed noted. Up to 50% of patients require repeat surgery under general anesthesia to remove the tubes once they are no longer needed or if they become dislodged and do not fall out of the ear canal on their own.
PAVmed believes that DisappEAR has the potential to revolutionize the care of children with complex or recurrent otitis media by avoiding a second procedure and eliminating the need for a seven to 10-day post-operative ear drop regimen, which is challenging for parents to administer. It also expects fewer complications, including fewer ear tubes remaining in the ear canals for years after becoming dislodged, a situation which may lead to pain, bleeding or an obstructed view of the ear drum required to identify recurrent middle ear infection.
Recent advances in molding processes for aqueous silk fibroin have led PAVmed to transition DisappEAR’s design from machining blocks of silk to injection molding, a much less costly and efficient commercial manufacturing process, especially at scale. PAVmed sought to partner with Canon Virginia because the company believed it to be the most technologically capable and respected manufacturer developing a scalable commercial-grade process to produce aqueous silk fibroin for human clinical applications.
“We are very proud to partner with such a highly-respected leading global manufacturer as Canon to develop and commercialize our DisappEAR resorbable pediatric ear tubes,” said PAVmed CEO Dr. Lishan Aklog in a news release. “Canon’s extensive experience and expertise in innovative and efficient production methods and its vast state-of-the-art facilities in Newport News, Virginia, make it the ideal partner to develop this groundbreaking technology for the one million children who currently undergo ear tube placement each year.”