Beacon Bio — 3D Printed Treatment For Eardrum Perforations
The Problem
Eardrum perforations form due to a variety of causes, including blast injuries, traumatic injuries, and chronic ear infections. These perforations cause hearing loss as sound waves cannot be adequately captured and transmitted to the bones in your middle ear. Additionally, these perforations can also allow water and pathogens to enter the middle ear space, causing serious problems such as meningitis. The treatment for a perforated eardrum is tympanoplasty, which is a multi-hour surgical procedure performed under general anesthesia. However, outcomes post-surgery can be poor and over 30% of these procedures require a revision surgery.
What The Company Does
Beacon Bio, spinning out of the Wyss Institute for Biologically Inspired Engineering at Harvard and Mass Eye and Ear hospital, has developed an innovative device called PhonoGraft. PhonoGraft is a novel 3D printed biomimetic and biodegradable graft for treating chronic eardrum perforations. Importantly, PhonoGraft’s patented design matches the circular and radial architecture of the eardrum, which is crucial for enabling sound conduction across both low and high frequencies. The patent-pending material system behind PhonoGraft matches the mechanical properties of soft tissues, encourages new tissue generation along the print path and degrades into nontoxic byproducts as the tissue is regenerated. Additionally, PhonoGraft is being design to be easy to place and manipulate, potentially negating the need for general anesthesia and enabling grafts to be placed through the ear canal in a clinic setting.
Market
The total available market for PhonoGraft is approximately 30 million people that present with eardrum perforations globally each year. Narrowing that number further to what they consider their initial serviceable available market of the North American and European regions, there are approximately 3.86 million patients with these perforations. Currently, there are 160,000 tympanoplasty procedures performed annually in the US alone.
Business Model
Beacon Bio is pursuing 510(k) FDA clearance of PhonoGraft. They have conducted conversations with medical device purchasing units and learned that ENT surgeons are the main decision makers for devices used in ear surgery. Following FDA clearance, they aim to target the approximately 400 Otology and Neurotology specialists in the US who regularly perform tympanoplasty procedures. After adoption by key opinion leaders, they plan to expand their marketing to the 12,000 specialist and generalist ENTs who operate in the US. Eardrum repair procedures with PhonoGraft can use the same current procedural terminology code as tympanoplasty conducted with traditional autologous tissue grafts. They confirmed that hospitals will be reimbursed this full amount while spending less on overhead expenses. With PhonoGraft, ENT surgeons will be likely to perform more procedures per day, encouraging adoption.
Traction
Beacon Bio has been engaging with potential strategic partners, including Desktop Metal, Cook Medical, Stryker Corporation and Baxter Healthcare. Beacon Bio has also been a member in the 2020–2021 Harvard i-Lab Venture Incubation Program, the 2020 Harvard-MIT Activate Program and the 2020–2021 MassMEDIC IGNITE MedTech Accelerator Programs. They were named the $5k Runner-Up Prize Winner in the 2021 MassMEDIC IGNITE Pitch Competition and the $25k Bertarelli Foundation Prize Winner in the Health and Life Sciences Track of the Harvard i-Lab President’s Innovation Challenge. They have also pitched to the 2021 MedTech Innovator Program. Their venture team has been featured in articles by Business Because, the Harvard Gazette, Harvard SEAS, Ladderworks + Nasdaq, Medical Device and Diagnostic Industry and GlobeNewswire. Additionally, CEO and Co-Founder Nicole Black has given interviews for the GoodMorningScience.com Podcast, Women Ahead of Their Time Podcast and “A Healthy Conversation with Steve Woods” on Newsradio WGAN.
Founding Team Background
Beacon Bio is co-founded by Nicole Black, PhD, Elliott Kozin, MD, Jennifer Lewis, ScD, and Aaron Remenschneider, MD, MPH. Nicole Black, PhD recently completed her doctorate in Engineering Sciences at Harvard University and is currently working as a Gliklich Healthcare Innovation Fellow between Mass Eye and Ear and the Wyss Institute for Biologically Inspired. Elliott Kozin, MD, is a fellowship trained and board-certified otolaryngologist specializing in adult and pediatric otology and neurotology with a research appointment as an Investigator within the Eaton Peabody Laboratory at Massachusetts Eye and Ear. Jennifer Lewis, ScD is a Hansjörg Wyss Professor of Biologically Inspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences. Aaron Remenschneider, MD, MPH is a fellowship trained and board-certified otolaryngologist with a research appointment as an Investigator within the Eaton Peabody Laboratory at Massachusetts Eye and Ear and a clinical appointment as the Otologist/Neurotologist at the UMASS Memorial Medical Center.
The Ask
Beacon Bio will be hiring shortly and is looking for people interested in 3D printing the next generation of medical implants. Connect With The Beacon Bio Team.
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