Speaking shortly after the awards ceremony on Nov. 6 in Philadelphia, Theodore Gerstle commented, "As veterans and healthcare providers, we are passionate about improving patient care and providing improved solutions and better outcomes for trauma patients. 3D medical device printing provides many opportunities to improve patient care and decrease healthcare costs. We believe we are uniquely positioned to bring lifesaving and life-improving changes to the current standard of care for military and civilian patients alike," said Gerstle.
While he was working in the Department of Defense, Gerstle desiged 3D CAD models of modular ceramic body armor. "After becoming a plastic surgeon, it became obvious that there is a huge unmet need in our current biomedical environment," Gerstle told PlasticsToday.
OsirisBiomed 3D has applied for a patent for single-anesthetic reconstructive surgery, which would allow 3D printing a custom device or implant based on a patient scan, and sterilizing and surgically implanting it in one procedure. Currently, high cost, poor fits, and long lead times for custom implants and models limit patient accessibility and overall health outcomes, according to the company. Its unique business model would decrease surgery lead time and hospital visits for patients, and reduce costs. Moreover, the system's mobility would allow operating suites to be set up in the field, reducing time to surgery for wounded soldiers, decreasing costs, and drastically decreasing inventories.
Polylactic acid, acrylonitrile butadiene styrene, and oxepanone are the most commonly used materials in the company's technology, but "our platform is designed to use an array of biocompatible materials," says Gerstle.
While the $10,000 check from GVPN is welcome validation, much more heavy lifting is on the horizon for Gerstle and his partners to get the project off the ground.
"We are looking for funding for the technological and regulatory hurdles we need to overcome," Gerstle told PlasticsToday. The regulatory pathway, in particular, is keeping them up at night. "This is all we think about. We recently participated in a webcast of the FDA's summit on medical 3D printing. We need to ensure that the final product is exactly congruent with the digital model. Our utmost priority is to ensure patient safety," stressed Gerstle.
You can follow OsirisBiomed 3D on its journey @OsirisBiomed3D.