Associated tags: Pharmaceutical industry, Health, Research, Clinical Trials, Biotechnology, Dentistry, Science, Patient, Medical Devices, FDA, Doctor of Philosophy, Other Health, Pharmaceutical, Dental, Medical device, DDS, Bangladesh Technical Education Board, Regenerative medicine, Safety, NIH
Locations: CALIFORNIA, PENNSYLVANIA, UNITED STATES, NORTH AMERICA, MASSACHUSETTS, TENNESSEE
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Doctor of Philosophy This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.
Key Points:
- This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.
- As part of the surgical closure process, the cranial flap is secured back into place with plates and screws.
- The kerf line, however, is typically not sealed, which compromises the ability of the flap to integrate with the surrounding bone.
- “We are truly excited to move this project into the clinical phase of testing,” said Brian Hess, CEO and Founder of RevBio.
Retrieved on:
Wednesday, October 25, 2023
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Medical device This product is intended to be used to fill extraction sites and mitigate post-operative pain following the removal of wisdom teeth.
Key Points:
- This product is intended to be used to fill extraction sites and mitigate post-operative pain following the removal of wisdom teeth.
- This grant will fund the pre-clinical development of a dental bone graft formulation that will include the release of locally acting non-opioid pain medication.
- Opioid use disorder (OUD) is a major problem in the US, accounting for 107,622 overdose deaths in 2021.
- This also expands upon a Phase II SBIR grant ( 1R44DE032564-01 ) which RevBio received from the National Institute of Dental and Cranial Research (NIDCR).
Medical Supplies,
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Journal of Orthopaedic Trauma,
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Dentistry The sheep were assessed after 4, 12, 26 and 52 weeks post-op for biomechanical and histological outcome measures.
Key Points:
- The sheep were assessed after 4, 12, 26 and 52 weeks post-op for biomechanical and histological outcome measures.
- This grant will expand upon the pre-clinical research funded by a previous $2 million SBIR Phase II grant from the National Institute on Aging ( R44AG060881-02 ).
- “This material is mechanically strong to allow early weight bearing which is something we cannot do currently in peri-articular fractures treated with metal implants.
- The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Retrieved on:
Wednesday, August 2, 2023
Veterinary,
Biotechnology,
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Health,
FDA,
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Dental,
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Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
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Safety,
Dentistry While not osteoinductive, this patent-pending version of Tetranite has shown characteristics which may be described as “osteopromotive.”
Key Points:
- While not osteoinductive, this patent-pending version of Tetranite has shown characteristics which may be described as “osteopromotive.”
This press release features multimedia.
- The current standard of care consists of multiple staged surgical procedures to restore a patient’s dentition with prosthetic crowns supported by dental implants.
- Instead, patients must undergo a costly, complex, and lengthy process including a preliminary bone grafting surgery before receiving a dental implant.
- Having also just recently received IRB approval, we look forward to enrolling our first patients in the coming weeks.”
Health,
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Safety This funding ( 1R44DE032564-01 ) will allow the company to complete the pre-clinical research necessary to advance this product into the clinical stage of development.
Key Points:
- This funding ( 1R44DE032564-01 ) will allow the company to complete the pre-clinical research necessary to advance this product into the clinical stage of development.
- These products do not predictably maintain ridge volume which requires surgeons to undergo re-grafting in over 30% of clinical cases.
- These procedures increase the width and height of the residual jawbone to replace atrophied bone so that a dental implant can be successfully placed.
- This product compliments RevBio’s existing clinical program to treat the larger population of patients who need an immediate dental implant following tooth extraction.
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Medical device RevBio, Inc., announced that it has received ISO 13485 certification for its quality management system.
Key Points:
- RevBio, Inc., announced that it has received ISO 13485 certification for its quality management system.
- Receiving ISO 13485 certification indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical products.
- (Photo: Business Wire)
“Having built my career in quality management over the last 35 years, I have been through over 25 ISO 13485 audits and many FDA audits,” said Gary Bunnewith, RevBio’s Director of Quality.
- The ISO 13485 standard was developed by the International Organization for Standardization (ISO) and is primarily based on the general standard for quality management known as ISO 9001.
Retrieved on:
Tuesday, February 14, 2023
Health,
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Dentistry RevBio, Inc. announced that it has received a strategic investment from Pacific Dental Services® (PDS) to support the clinical development of its bone adhesive biomaterial for implant dentistry.
Key Points:
- RevBio, Inc. announced that it has received a strategic investment from Pacific Dental Services® (PDS) to support the clinical development of its bone adhesive biomaterial for implant dentistry.
- Based in Irvine, California, PDS was founded in 1994 and is one of the leading dental support organizations in the U.S. with over 900 dental practices in 25 states.
- (Photo: Business Wire)
RevBio is currently in the clinical stage of development for its regenerative adhesive biomaterial for stabilizing dental implants .
- “We believe the TETRANITE technology holds great promise in improving the clinical experience for patients in need of implant dentistry.”
Retrieved on:
Wednesday, January 18, 2023
Biotechnology,
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Medicine RevBio, Inc., announced that it has received approval from the Italian Ministry of Health and the Ethics Committee of the University “G.D'Annunzio” of Chieti-Pescara to start a 15-patient pilot clinical trial.
Key Points:
- RevBio, Inc., announced that it has received approval from the Italian Ministry of Health and the Ethics Committee of the University “G.D'Annunzio” of Chieti-Pescara to start a 15-patient pilot clinical trial.
- The primary objective of this study will be to assess the time it takes for Tetranite®, the company’s adhesive biomaterial, to regenerate bone in the mandibular and maxillary dental arches.
- “The design of this study will answer some important questions that will help evidence the key advantages of this biomaterial,” said Dr. Fugazzotto.
- “I believe this technology will be transformative in the way we place dental implants.”
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Stroke RevBio, Inc., announced that an experiment to study Tetranite, the companys regenerative bone adhesive biomaterial, has successfully been initiated onboard the International Space Station (ISS).
Key Points:
- RevBio, Inc., announced that an experiment to study Tetranite, the companys regenerative bone adhesive biomaterial, has successfully been initiated onboard the International Space Station (ISS).
- On Saturday, November 26, 2022, the study materials were launched to the space station on SpaceXs 26th Commercial Resupply Services (SpaceX CRS-26) mission , sponsored by the ISS National Laboratory.
- View the full release here: https://www.businesswire.com/news/home/20221201005635/en/
RevBio Launches an Experiment for its Regenerative Biomaterial on the International Space Station.
- Dr. Intini and RevBio are expected to publish the complete results of the experiment by the end of next year.
