LaunchPad Medical Received FDA Approval to Initiate a Clinical Study
LOWELL, Mass., Sept. 12, 2019 /PRNewswire/ -- LaunchPad Medical, Inc. has received approval from the U.S. Food and Drug Administration to initiate a two-site, 20-patient pilot clinical study to examine the safety and efficacy of the company's bone adhesive biomaterial (known as Tetranite®) to immediately stabilize dental implants for tooth extractions.
Patients will be enrolled in the study if an extraction site is too large for dental implants to achieve primary stability through conventional mechanical engagement, which is often the case. Instead, the use of Tetranite will allow for the immediate placement of implants and, in many cases, obviate a costly, complex, and lengthy bone grafting process, greatly accelerating the overall treatment timeframe for many patients.
"We are excited to take the next step in commercializing this promising bone adhesive technology that has the opportunity to improve and significantly accelerate the current treatment paradigm for dental implant procedures," said LaunchPad Medical's Chief Executive Officer, Brian Hess. "Having also just received investigational review board (IRB) approval, we are ready to start enrolling patients at our clinical sites. This marks a significant milestone since it is the first-in-man trial based on this technology platform."
The unique properties of Tetranite include the ability to provide immediate fixation of fractured bone fragments and stabilization of metal implants to bone. In multiple animal studies this adhesive has been shown to be a non-toxic and effective way of repairing bone fractures and defects as well as securing implant devices. Existing data has also shown that Tetranite is resorbed and replaced with new bone during the natural process of bone remodeling by acting as a scaffold to facilitate bone growth. LaunchPad Medical's Tetranite technology has not yet been approved for commercial use.
About LaunchPad Medical, Inc.
LaunchPad Medical, Inc. is a medical device company engaged in the development and commercialization of a novel injectable, self-setting, and osteoconductive bone adhesive biomaterial called Tetranite®. The Company's initial focus with this technology is for use in the dental market; however, the company is also working to develop adhesive applications in the broader orthopedics market. LaunchPad operates out of the Massachusetts Medical Device Development Center (M2D2), an accelerator program for medical devices.
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SOURCE LaunchPad Medical, Inc.
