Geistlich Pharma North America Inc.
Geistlich Pharma North America brings the leader in regenerative dentistry directly to the United States and Canada. For 160 years, our respected family-owned Swiss parent company has pioneered technological advances that make regenerative treatment, with safe and naturally sourced biomaterials, the preferred choice for clinical predictability. As your North American resource for these trusted products, our national sales force and dedicated support staff in Princeton, New Jersey share with you the Geistlich scientific approach and spirit of innovation.
Three decades ago, Geistlich manufactured a flower fertilizer which relied on bone as its secret to success and this expertise was also applied for use in Geistlich glues and high quality food-grade gelatin. With emerging strength in the company’s pharmaceutical division, a small group of researchers under the direction of Dr. Peter Geistlich began developing new and improved compounds for medications used in surgery and general medicine.
The roots of regeneration in the U.S.
In his search for new business ideas and collaborators, Dr. Geistlich came in contact with Dr. Myron Spector of Harvard University. While working together, the two began a fortuitous discourse about the enormous potential for improved healing and regeneration of human tissue using natural biomaterials.
Focusing on the oral cavity
Almost three decades ago, an article in the Journal of Maxillofacial Surgery about a conference in Boston caught Dr. Geistlich’s attention. A scientist named Dr. Philip Boyne had presented results of the reconstruction of a shattered jawbone with purified bovine bone. A new fertile direction for the Geistlich company was born with the realization that a sterile, pure bone material could change the face of dentistry, and usher in a new era in regenerative surgery.
The need for ingenuity
Dr. Geistlich met Professor Boyne and discovered that there was a problem with the bone substitute that he had been using. It consisted of the hard component of bovine bone but not all the soft tissue had been removed, triggering unwanted immunological reactions. Drs. Boyne and Geistlich were convinced that a highly purified material, that was very similar to human bone, would be much more effective in regenerating bone.
Structured like nature
After years of previous experience working with animal bone, Dr. Geistlich had already “solved the chemistry” of purifying bone. And so with his team, he soon developed the patented process for manufacturing Geistlich Bio-Oss®, which removes organic components from the bone material but leaves the natural microstructure and composition of the bone almost unchanged.
Success through persistence
Geistlich Bio-Oss® was implanted in patients for the first time in 1985. Dr. Philip Boyne used this promising new material to reconstruct a jaw, while Swiss orthopedic surgeon Dr. Arnold Huggler conducted the first leg elongation with Geistlich Bio-Oss®. The first clinical results were published in 1986. Dr. Geistlich and his team of collaborators spent years gathering evidence and gaining professional acceptance, while patiently pursuing their vision for improved patient care.
An avalanche of scientific data
Faced with an initial hesitancy of many surgeons, Dr. Geistlich built a solid and methodical foundation of clinical data for Geistlich Bio-Oss® through exhaustive studies and clinical trials. What followed throughout the 1990’s was a scientific avalanche of data, with growing acceptance of trial results and researcher’s desire to test the material for themselves. Today, hundreds of publications confirm the excellent performance and osteoconductivity of Geistlich Bio-Oss®, further evidenced by the millions of successful treatment outcomes.
Barriers become a treatment reality
In the mid-1980’s, the introduction of Guided Tissue Regeneration scientifically demonstrated the possibility of regenerating periodontal tissues and bone. The company’s development of Geistlich Bio-Gide® resulted not only in the regeneration of the periodontal tissues and bone, but also improved ease of use, reduction of complications, and overall predictability.
Our anchor technologies
What started as two fertile ideas at Geistlich have become the cornerstones of the company’s regenerative offerings. Just as Geistlich Bio-Oss® lays the foundation for successful regenerative results, Geistlich Bio-Gide® helps ensure this success by predictably guiding the healing process. Together, our anchor technologies have become the clinician’s choice in achieving oral regeneration. They are also catalysts for developing other innovative treatment solutions in the oral cavity and beyond.
Geistlich Pharma produces Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® bone substitute devices.
Processes fulfill stringent safety requirements:
- Australian bovine material used exclusively; Australia is historically free of bovine spongiform encephalopathy (BSE) and is ranked as a country with negligible BSE risk1.
- Bone is sourced from selected and certified abattoirs, suppliers and animals with certified fitness for human consumption.
- Extremity bone is the only bovine tissue used at Geistlich Pharma - a tissue with no detected BSE infectivity2.
- The collagen portion of Geistlich Bio-Oss Collagen® is derived exclusively from Swiss porcine tissue.
- Stringent and validated process standards result in a highly purified bone mineral substance of consistent quality.
- Manufacturing process consists of several consecutive steps combining different modes of action with high inactivating capacity against potential infective agents.
- Evaluated to reliably inactivate viruses and bacteria.
- Evaluated by experts as highly effective against prions. The risk of BSE agents’ transmission can be regarded as negligibly low.
- The applied risk reducing measures were certified by the European Directorate for the Quality of Medicines and Healthcare (EDQM) as fully compliant with the European Pharmacopoeia monograph 5.2.8 ‘Minimizing the risk of transmitting TSE agents via medicinal products’ and the monograph no. 1483 on ‘Products with risk of transmitting TSE agents’ (Certificate of Suitability No. R1-CEP 2004-122-Rev 01) (TSE: transmissible spongiform encephalopathy).
- Products are sterilized by gamma irradiation.
- Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® are provided sterile in double-layer packaging.
- Allergic reactions are highly unlikely as Geistlich Bio-Oss® does not contain organic components.
- Geistlich Bio-Oss Collagen® contains collagen; allergic reactions and inflammatory tissue reactions may occur in rare cases. The product should not be used in patients with known allergy to collagen.
Geistlich Pharma produces the porcine collagen-based materials Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal.Safety
Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal fulfill strict safety requirements.
- Produced exclusively from Swiss porcine tissue.
- Processing of collagen for medical use is subject to strict safety regulations.
- Fat and other unwanted tissue components are removed.
- Potential micro-organisms are inactivated.
- The process results in a highly purified collagen structure.
- Products are sterilized by gamma irradiation.
- Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal are provided sterile in double-layer packaging.
- Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal contain collagen; allergic reactions and inflammatory tissue reactions may occur in rare cases. Products should not be used in patients with known allergy to collagen.