Osiris Biomed 3D (New York and Lexington, KY), a startup that plans to offer 3D-printed patient-specific implants made in real-time from medical scans using proprietary software, got a big vote of confidence for its project at the Inside 3D Printing Conference and Expo in New York last week. The company prevailed over four other firms to win the event's Startup Competition on April 16. Although there is no monetary prize attached to the award, it "gets the word out about our company and product offering," said COO Christopher Gerstle. "We were told that the last two companies to win have raised over $6 million. I had the opportunity to speak to the CEO of one of the past winners, and he directly credited winning last year's competition for subsequently raising $4.5million!" Gerstle told PlasticsToday. That sort of windfall would come in handy right about now for Osiris Biomed.
|Christopher Gerstle at the Inside 3D Printing
"We are in the prototype stage, and have exhausted family and friends and now need to look for outside funding to finalize our product and have it ready to present to the FDA," explained Gerstle. "The FDA approval process is not only an uncertain one, but it is time consuming and very expensive. We need to raise significant funds to take our company to the next step, which is why this win is such a great feather in our cap," he added.
"This year's competition was stacked with formidable participants who were selected from a competitive pool of applicants," said Tyler Benster, self-described 3D printing evangelist and Program Chair of Inside 3D Printing. "Osiris Biomed 3D stood out for its innovative use of 3D printing in a large, untapped market that has the potential to save lives. The judges were unanimous in selecting Osiris Biomed 3D as the winner," said Benster.
According to Osiris Biomed, 3D printing has the potential to disrupt the way that custom implants and models are currently produced, a process that results in high-cost devices with long lead times that are often a poor fit. The company has applied for a patent for single-anesthetic reconstructive surgery, which will allow a patient to be scanned and a custom device or implant printed, sterilized and surgically implanted on the operating table. The company is calling it all-in-one surgery. This business model will decrease the lead time to surgery and the number of procedures and hospital visits for patients, and reduce cost for patients, hospitals and insurers, says Osiris Biomed. A military version of the technology, which would allow operating suites with 3D-printing capabilities to be established in the field, is also envisioned.
The idea to bring 3D printing into the surgical suite came to Gerstle's brother and company CEO, Theodore, a Harvard-trained plastic surgeon, several years ago when he was in training at a prominent Boston hospital. He and his medical team had spent six weeks with an off-site manufacturer virtually planning the facial reconstruction of a 74-year-old man with squamous cell cancer of the jaw via custom implants. When the oncologic surgeon began the operation, he discovered that he would need to remove more bone that had been consumed by cancer since the patient's CT scan just weeks earlier. This rendered the weeks-old custom implant useless. Instead of one surgery, the patient would need to return to the operating room for at least two more operations, and the $12,000 spent on the implants were wasted. A new CT scan was necessary and a new custom implant needed to be designed.
"Scenarios like this play out in hospitals across the United States every day, costing millions of dollars and resulting in unnecessary surgeries," said Gerstle. "What if a 3D custom implant design studio could be put inside every operating room, empowering surgeons to print implants, cutting guides and surgical tools in minutes during one surgery, instead of days and weeks over several surgeries? We are not just reducing the cost of custom implants, we are eliminating entire surgeries," said Gerstle.
It's easy to see why this idea, pitched by Christopher, handily won over the judges of the Startup Competition at Inside 3D Printing. "I was thrilled to hear that the vote for us was unanimous," Gerstle told PlasticsToday, "because I thought that all of the other contestants had great business plans and products. We were the only biotech offering, so that may have helped us stand out," he added.
Or maybe it's just because the Gerstles have a brilliant idea that, if they can successfully navigate the regulatory process, will fundamentally change healthcare practices.