Each year ~200K children are born with conditions leading to growth restriction of their skull (craniosynostosis) or lower jaw (micrognathia). Left untreated, these conditions often result in serious complications – impaired neurologic development, difficulty breathing, inability to eat – the very functions necessary for an otherwise healthy child to grow and thrive. Not to mention, differences in appearance become severe and permanent as skeletal growth continues in unaffected areas.
Today’s treatments range from highly invasive reconstructive surgery (imagine a 6-month-old infant on the operating table for 3-4 hours losing ~40% of her total blood volume) to minimally invasive endoscopic surgery that is only curative for a small subset of patients (as in < 3-4 months old with single, sagittal suture fusion). Fortunately, a gentler surgical technique that leverages the body’s natural ability to heal – distraction osteogenesis – is growing in popularity.
Distraction osteogenesis involves surgical placement of a device (distractor) to slowly expand an abnormal bony segment. As the abnormal bone is expanded, new bone regenerates – gradually lengthening and reshaping the affected segment until the desired effect is achieved.
But even though the technique has widely recognized advantages for correcting conditions across the entire skeleton that lead to growth restriction or deformation, technology limitations have hindered its widespread adoption. First, distractors are semi-buried devices that poke through the patient’s skin post-operatively, predisposing these children to a variety of complications – infection (~35%), device dislodgement (3%), increased use of pain medications, visible scarring (~16%). Second, device expansion is typically done at home by parents, leading to treatment noncompliance (~5%) and blinding the surgeon to treatment progress – necessitating an intensive post-operative course of weekly x-rays and clinic visits.
The Ostiio distraction system squarely addresses the chief limitations of current technology.
1. Our distractor is fully implantable. Through elimination of the external component found on all distractors today, we have the potential to reduce associated complications.
2. Our system is automated. Parents and caregivers will still need to perform daily distractions, but it’s as simple as a push of a button. By removing the need for manual expansion via a screwdriver, we may reduce treatment noncompliance and alleviate parental stress.
3. We put the surgeon back in control. Our data-rich system provides surgeons with the means to monitor and control treatment progress in real-time, allowing them to detect deviations from treatment protocols and address potential complications before they become irreversible or cause harm.
The Ostiio distraction system is designed to provide an added level of safety, consistency, and transparency that is not possible with currently available distractors - transforming standard of care and improving patient outcomes and experience
Ari is a Plastic Surgery Resident at the Hospital of the University of Pennsylvania (HUP) and previously worked as a Clinical Research Fellow for the Divisions of Plastic Surgery at HUP as well as the Children’s Hospital of Philadelphia. Ari started Ostiio out of a profound empathy for patients with craniofacial disease and the burden that treatment places on their families. He is driven by the intellectual challenge of fixing the shortcomings of distraction osteogenesis therapy while bolstering the benefits of the technique, which led him to pursue a degree in Translational Research. The strong clinical and translational background Ari brings to the team provides Ostiio with unique insight into the complexities associated with craniomaxillofacial distraction in its current form and clinically relevant methods to improve outcomes.
Ari holds both an MD and an MS in Translational Research from the University of Pennsylvania and a BA in Biology and Economics from Claremont McKenna College.
Jesse is Chief of the Division of Plastic and Reconstructive Surgery at the world-renowned Children’s Hospital of Philadelphia (CHOP) and a specialist and key opinion leader in the treatment of children and adolescents with congenital and acquired differences of the face and skull. Jesse founded Ostiio out of a deep frustration with surgical options for craniofacial disease and an intense desire to improve patient outcomes and experience for these children and their families. He is passionate about developing and using innovative surgical techniques and treatment strategies to optimize results for his patients – he is a pioneer in the use of distraction osteogenesis to treat impaired growth of the craniomaxillofacial skeleton. Jesse enjoys lecturing both nationally and internationally to educate surgeons about the latest techniques in craniofacial surgery. His research is regularly presented at major conferences and widely published in peer-reviewed journals.
Jesse holds an MD from Vanderbilt University. He completed Plastic Surgery Residency at Johns Hopkins University and his Craniofacial Fellowship at the Hospital Gea Gonzalez in Mexico City, Mexico under the guidance of craniofacial-pioneer Dr. Fernando Ortiz-Monasterio. He has a BA in Biology from Washington and Lee University.
Jessica is an accomplished healthcare and life sciences leader who brings a track record of building innovation centers and emerging businesses within several large corporates (J&J DePuy Synthes, Smith & Nephew, Abbott and Becton Dickinson) to the Ostiio team. Prior to joining Ostiio, she enjoyed a successful and rewarding career that encompassed a diverse background across therapy spaces (cardiovascular, interventional and orthopedics), technologies (devices, biologics/biomaterials and combination therapies) and functional leadership roles (R&D, strategy & innovation, marketing, business development and general management). Jessica’s education, experience, passion and proven learning agility uniquely position her to guide technology from concept through commercialization. Throughout her career, she has enthusiastically led cross-functional teams to build and execute global operational plans that supported a diverse portfolio of product clearances/approvals and their subsequent commercialization.
Jessica holds an MBA from the Wharton School of Business at the University of Pennsylvania, a PhD in Chemical Engineering from the University of Illinois at Urbana-Champaign, and a BSE in Chemical Engineering from the University of Michigan.
Brett is Senior Director of Manufacturing Operations at Smith & Nephew. As a key member of the Ostiio team, he brings extensive experience in the design, development and manufacture of medical devices across multiple therapy spaces (orthopedic, urology, women’s health) and business environments (small entrepreneurial VC-funded to large Fortune 500 corporate). Prior to joining Smith & Nephew, Brett held positions of ever-increasing responsibility in product development and quality and design assurance at Boston Scientific and Angiodynamics. These experiences have given him strong insight into what it takes to bring a safe and efficacious product to market and to sustain that performance post-launch.
Brett holds an MS in Technology Management from Bridgewater State University and a BMET in Mechanical Engineering from Wentworth Institute of Technology.
Philadelphia, PA, June 29, 2021 – Yesterday, Ostiio, LLC was selected to participate in the MassChallenge 2021 accelerator program. Ostiio was one of over 3,000 startups that applied to take part in this year’s program. “We are humbled to have been included as part of this select group of startups from around the world working to solve massive challenges in high impact industries” said Jessica DesNoyer, CEO, Ostiio. “MassChallenge has validated what we have known all along… we have a moral obligation to improve treatment and treatment experience for children with complex craniofacial differences.” By participating in this accelerator, Ostiio will receive democratized access to the closed networks that have characterized the startup industry for decades, all at zero cost and for zero equity.
Philadelphia, PA, June 11, 2021 – Ostiio, LLC has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for $256,000 to conduct research and development (R&D) work aimed at miniaturizing a novel, integrated craniofacial distraction system to include neonates as part of the target patient population. “NSF is proud to support the technology of the future by thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering,” said Andrea Belz, Division Director of the Division of Industrial Innovation and Partnerships at NSF. “With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs.” “We are grateful for the NSF’s recognition of the importance of our work” said Jessica DesNoyer, CEO. “With the support of this grant, we will expand the clinical utility of our device, ultimately enabling treatment of a patient population that includes neonates through adults. Once a small business is awarded a Phase I SBIR/STTR grant (up to $256,000), it becomes eligible to apply for a Phase II (up to $1,000,000). Small businesses with Phase II funding are eligible to receive up to $500,000 in additional matching funds with qualifying third-party investment or sales.
Philadelphia, PA, May 11, 2021 – Ostiio, LLC has been awarded follow-on support of up to $1.1 million from the Michigan-Pittsburgh-Wyss Regenerative Medicine (MPWRM) Resource Center, which was established by the National Institute of Dental and Craniofacial Research to improve clinical translation of promising tissue engineering and regenerative medicine technologies for dental, oral, and craniofacial applications. Ostiio has received two prior grants from the MPWRM Resource Center to fund the development of Ostiio’s novel, integrated therapy to treat complex craniofacial abnormalities. This grant, the largest Ostiio has received from the Resource Center, will allow the company to complete feasibility work, and enter the formal design control phase of product development. “The MPWRM Resource Center has been instrumental in helping us advance our technology from the early prototyping phase into a staged, product development process.” said Jessica DesNoyer, CEO, Ostiio. “Unlike typical grants, the Interdisciplinary Translational Project Program enables productization, allowing us to bring our life-altering technology one step closer to reality.”
Philadelphia, PA, August 27, 2019 – Medical technology company Ostiio, LLC announced today that is has raised $520K in a Pre-Seed funding round. The Children’s Hospital of Philadelphia (CHOP) led the round. The pediatric health sector has high unmet medical need but historically has received little innovation focus. Ostiio is tackling this challenge head-on by enabling a gentler, less complication-prone approach to correct skeletal growth restrictions of the skull and face that will transform today’s complex and traumatic treatment of craniofacial defects. Ostiio’s automated device and remote monitoring platform will simplify patient treatment experience, increase surgeon control over outcomes, and expand access to therapy by shifting care from hospital-to-home.
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