Harvard’s Eardrum-Restoring PhonoGraft Enters Commercial Development

3D-printed graft developed by researchers at Harvard’s Wyss Institute, Harvard SEAS, and Mass Eye and Ear to be commercialized by Desktop Health, following the startup’s acquisition

Advanced through a six-year effort in Harvard University’s translational research environment, a biomimetic hearing-restoration technology invented by a multidisciplinary research team at Harvard’s Wyss Institute for Biologically Inspired Engineering, Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), and Massachusetts Eye and Ear, has taken an important step closer to patients.

The PhonoGraft device is a 3D-printed, biocompatible graft that could be implanted to repair a damaged eardrum. If its clinical development is successful, the PhonoGraft technology could mitigate the pain, drainage, and hearing loss associated with ear drum perforations that affect millions of individuals worldwide.

The technology is now entering commercial development. Driven to make their innovations available to patients, entrepreneurial members of the research team launched a startup company, Beacon Bio, with an exclusive license from Harvard’s Office of Technology Development (OTD) to commercialize the PhonoGraft innovations co-owned by Harvard and Mass General Brigham. Beacon Bio was acquired this summer by California-based Desktop Health, a healthcare business within Desktop Metal Inc. that focuses on new 3D printing and biofabrication solutions for personalized medicine. Nicole Black, PhD ’20, who was CEO of Beacon Bio, will continue to lead the platform as Vice President of Biomaterials and Innovation at Desktop Health.

“I am absolutely thrilled to have Beacon Bio become a part of the Desktop Health team, and to see these innovations advance so far from their earliest days in the lab,” said Dr. Black, who is a co-inventor of the PhonoGraft technology and spearheaded its development at Harvard and Mass Eye and Ear. “The general support, manufacturing expertise, and regulatory expertise of an established company will be key to bringing the PhonoGraft platform to patients and to developing a regenerative medicine platform around the technology.”

Dr. Black was initially a doctoral student at SEAS, studying materials science and bioengineering in the lab of Jennifer A. Lewis, ScD, the Hansjörg Wyss Professor of Biologically Inspired Engineering at SEAS and a Core Faculty member at the Wyss Institute. In developing the technology, the Lewis Lab teamed up with two surgeons at Mass Eye and Ear: Aaron Remenschneider, MD, MPH, and Elliott Kozin, MD. Going forward, Drs. Lewis, Remenschneider, and Kozin will participate in the scientific advisory board of Desktop Health.

The researchers at Harvard and Mass Eye and Ear designed the PhonoGraft technology to utilize a novel biomaterial-based approach that guides the regeneration of native eardrum tissue. Its 3D-printed structure mimics the structure of a normal eardrum and effectively stimulates the tissue’s self-healing properties, as demonstrated in animal models. The team believes the PhonoGraft material technology – unlike other methods – could potentially enable permanent repair by first closely mimicking and then restoring the eardrum’s sound-conducting mechanical properties and barrier functions. The eardrum, or tympanic membrane, is a thin membrane evolved to conduct sound in the ear and serves as a protective barrier against invading pathogens. The eardrum can become perforated by blasts, traumatic injuries, and chronic ear infections. Despite the eardrum’s remarkable self-healing powers, many perforations cannot heal by themselves and require reconstructive “tympanoplasty” procedures in which ear surgeons repair the hole with tissue grafts harvested from the patient. Even with modern techniques, surgical failures are common, making revision surgeries necessary. Additionally, patient-derived tissue grafts have imperfect sound-conducting abilities, as their structure does not match that of the normal eardrum.

Envisioning PhonoGraft technology as a regenerative medicine solution

“As ear surgeons, we commonly see patients with perforated eardrums from trauma, chronic infections, or blast injury who in many cases need surgical interventions, for which there definitely is room for improvement,” said Dr. Remenschneider, an otologist and neurotologist, researcher at Mass Eye and Ear, and lecturer at Harvard Medical School. “In the wake of the Boston Marathon bombing on April 15, 2013, many of the eardrum perforations were cared for at Mass Eye and Ear. It was really a catalyzing event that prompted us to look more systematically at our surgical techniques, grafting material, and outcomes, which eventually made us focus on improved eardrum grafting materials to promote better healing and hearing outcomes after eardrum repair.”

“Ear surgery has seen a lot of advances over the last 10 years. An important one has been the development of endoscopic procedures that allow us to treat patients directly through the ear canal, which in many cases avoids skin incisions and drilling behind the ear,” said Dr. Kozin, who is an otologist and neurologist at Mass Eye and Ear, and an assistant professor at Harvard Medical School. ”This approach, together with innovations from the Lewis lab, enabled us to imagine, design, and ultimately, manufacture a device that may one day improve the outcomes of eardrum surgeries.”

In 2014, Drs. Remenschneider and Kozin read an article in The New Yorker titled “Fugitive Ink,” featuring Dr. Lewis and her lab’s 3D printing feats. Soon after, they visited the Lewis Lab to give a chalk talk and explore whether her novel 3D printing method could be used to improve ear surgery. Following a discussion around outcomes after an ear drum surgery and the lack of suitable grafting materials, the newly formed team of surgeons and engineers set out to create a better functioning, next-generation graft.

“When I learned that the native tympanic membrane is composed of a web-like radial and concentric architecture, I was really excited, as it builds upon earlier work from our lab, in which we first demonstrated printing of 3D spider web-like structures,” said Dr. Lewis. Dr. Black, who had just joined the lab as a graduate student, embraced this idea because her goal was to create a new biomedical device to address patient needs.

“Despite this clearly defined problem, the challenges were numerous: we envisioned a device that could enable easier implantation, guide remaining eardrum tissue to remodel and repair the perforation, match the circular and radial structure of the eardrum to allow for efficient conduction of sound, and biodegrade to reduce the risk of biofilm formation that can otherwise result on permanent devices,” said Dr. Black.

A fruitful collaboration between Drs. Black and Lewis working at the Wyss Institute and SEAS, alongside Drs. Remenschneider and Kozin at Mass Eye and Ear, started to take shape with that clear and ambitious goal in mind: an implantable device to enable full reconstruction of the native eardrum in vivo, for which the team later coined the name “PhonoGraft.”

Read more from the Wyss Institute on the technology and new partnership with industry.

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