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Thursday, October 21, 2021

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HomeCLINICAL TRIALS, STUDIES, DATALaunchPad Medical Accelerates Enrollment in its First-In-Man Clinical Study

LaunchPad Medical Accelerates Enrollment in its First-In-Man Clinical Study

LaunchPad Medical, Inc. announced that it has successfully enrolled half of the twenty patents approved by the FDA for its two-site pilot clinical study.  This study constitutes the first clinical use of Tetranite®, a bone adhesive biomaterial.  The purpose of the study is to show the safety and efficacy of Tetranite in immediately stabilizing dental implants following tooth extractions and its ability to obviate a costly, complex, and lengthy bone grafting procedure to accelerate the overall treatment timeframe for the many patients who suffer tooth loss.

“We enrolled our first patient on the first of October.  The fact that we have been able to enroll half of the patients in our study in just two months indicates that this is a clinically-relevant product that can address a broad patient population in the field of dentistry,” said Brian Hess, Chief Executive Officer of LaunchPad Medical.

Dr. Michael A. Pikos, an oral surgeon and dental educator, enrolled the first patient in the study.   “I have found this material to be very easy to handle and apply,” said Dr. Pikos.  “Tetranite, in my opinion, has the potential to completely change our approach to many surgical procedures in dentistry, especially in the realm of implant-based surgical reconstruction.”  Dr. Pikos runs a multi-office clinical practice in the Tampa, Florida, region and is also the President of The Pikos Institute which provides advanced training programs on the latest products and surgical techniques in the field of implant dentistry.

Dr. David L. Cochran, the Chair of the Periodontics Department at the University of Texas Health Science Center at San Antonio, leads the second clinical site in the study along with Dr. Ryushiro Sugita.   Dr. Cochran, a widely published clinical researcher in the field of implant dentistry, said “this technology has allowed our patients to have an immediately placed implant after we extracted their tooth.  All patients treated so far have tolerated the procedure well and are healing nicely.  I believe that this technology will change the way dental implants are placed.”

Dr. Cochran was also the study director of the pre-clinical testing that provided the key animal safety and efficacy data which enabled the FDA to approve initiation of this pilot study.  The results from the animal study will be published in the upcoming January/February issue of the prestigious International Journal of Oral and Maxillofacial Implants.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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