LaunchPad Medical has received $1.8 million from the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center to improve the translation of promising tissue engineering and regenerative medicine technologies for dental, oral, and craniofacial practice, the company said.
This grant will allow LaunchPad Medical to conduct a pivotal animal study and generate all of the other required data to file an Investigational Device Exemption with the Food and Drug Administration to start a clinical trial, the company said. It is the third and largest grant that Launchpad Medical has received from the center.
“Unlike most existing dental bone graft materials, this enhanced formulation of Tetranite resorbs and is replaced by bone on a timescale commensurate with existing graft materials but does not require ancillary containment devices like membranes or meshes or fixation aids like tacks and screws,” said Joseph P. Fiorellini, DMD, DMSc, professor and director of the Postdoctoral Periodontics Program at the Pennsylvania School of Dental Medicine and principal investigator for the grant.
“The clinical use of this material will reduce the time and complexity of ridge augmentation procedures and likely lead to more consistent results with regard to maintaining the original volume of grafts,” said Fiorellini.
Approximately 44% of all patients who receive a dental implant have a missing tooth when they start treatment and, depending on how long the tooth has been missing, varying degrees of bone loss, the company said.
These patients must undergo a ridge augmentation procedure in which particulate-based bone graft materials are placed using membranes and fixation aids to contain the graft during the healing process. These procedures increase the width and height of a jawbone to replace atrophied bone so a dental implant can be successfully placed.
But in more than 30% of these causes, LaunchPad Medical said, existing bone graft materials fail to achieve the desired clinical results and another bone graft procedure must be conducted, increasing the overall time and cost of treatment.
Market research conducted in conjunction with Avenues, a marketing company involved with the resource center, confirmed the clinical need for an improved bone graft solution.
“This was a competitive process, and we are pleased with the progress that this research team has made,” said William R. Wagner, PhD, co-principal investigator of the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center. “We look forward to the continued translation of this promising technology for clinical use in the third phase of our program.”