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GEM 21S Product Image
GEM 21S Product Text
GEM 21S® growth-factor enhanced matrix combines a bioactive protein - highly purified rhPDGF-BB - with an osteoconductive matrix, ß-TCP.

GEM 21S® is the only dental therapy containing PDGF, one of the main growth factors found in the human body and well known for its role in wound healing.

Please click below for Full Prescribing Information.
INDICATIONS
GEM 21S® growth-factor enhanced matrix is indicated to treat the following periodontally related defects: intrabony periodontal defects; furcation periodontal defects; and gingival recession associated with periodontal defects.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
As with any periodontal procedure where bone grafting material is used, GEM 21S® is CONTRAINDICATED in the presence of one or more of the following clinical situations: untreated acute infections at the surgical site; untreated malignant neoplasm(s) at the surgical site; patients with a known hypersensitivity to any product component (ß-TCP or rhPDGF-BB); intraoperative soft tissue coverage is required for a given surgical procedure but such coverage is not possible; or conditions in which general bone grafting is not advisable.


WARNINGS
The safety and effectiveness of GEM 21S® has not been established: In patients with an active malignant neoplasm and should therefore not be used in such patients; in other non-periodontal bony locations, including other tissues of the oral and craniofacial region such as bone graft sites, tooth extraction sites, bone cavities after cystectomy, and bone defects resulting from traumatic or pathological origin. GEM 21S® has also not been studied in situations where it would be augmenting autogenous bone and other bone grafting materials; in pregnant and nursing women. It is not known whether rhPDGF-BB is excreted in the milk of nursing women; in pediatric patients below the age of 18 years; in patients with teeth exhibiting mobility of greater than Grade II or a Class III furcation; in patients with frequent or excessive use of tobacco products. Careful consideration should be given to alternative therapies prior to performing bone grafting in patients: who have severe endocrine-induced bone diseases (e.g. hyperparathyroidism); who are receiving immunosuppressive therapy; or who have known conditions that may lead to bleeding complications (e.g. hemophilia).

The GEM 21S® grafting material is intended to be placed into periodontally related defects. It must not be injected systemically.

The radiopacity of GEM 21S® is comparable to that of bone and diminishes as GEM 21S® is resorbed. The radiopacity of GEM 21S® must be considered when evaluating radiographs as it may mask underlying pathological conditions.


PRECAUTIONS
GEM 21S® contains becaplermin – a recombinantly produced, human platelet-derived growth factor, homodimer BB (rhPDGF-BB), which is a protein that has been shown to promote the formation of bone in periodontal defects. rhPDGF-BB (“PDGF”) is also the active ingredient of another FDA approved product, REGRANEX® Gel, which is a topical gel formulation, indicated for the treatment of lower extremity diabetic neuropathic ulcers.1

An increased rate of mortality secondary to malignancy with use of high quantities (i.e. 3 or more tubes of REGRANEX® Gel) was demonstrated in a single study of its use in treatment of diabetic, neuropathic ulcers. Two subsequent studies did not demonstrate this increased rate. No relationship has been demonstrated regarding use of PDGF in periodontal defects and malignancy or mortality secondary to malignancy.


ADVERSE EVENTS
Although no serious adverse reactions attributable to GEM 21S® were reported in a 180 patient clinical trial, patients being treated with GEM 21S® may experience any of the following adverse events that have been reported in the literature with regard to periodontal surgical grafting procedures: swelling; pain; bleeding; hematoma; dizziness; fainting; difficulty breathing, eating, or speaking; sinusitis; headaches; increased tooth mobility; superficial or deep wound infection; cellulitis; wound dehiscence; neuralgia and loss of sensation locally and peripherally; and, anaphylaxis. Occurrence of one or more of these conditions may require an additional surgical procedure and may also require removal of the grafting material.




1. GEM 21S® [Package Insert]. Shirley, NY: Osteohealth Company, Division of Luitpold Pharmaceuticals, Inc. 2014.
Optimatrix Product Image
Optimatrix Product Text
OPTIMATRIX® extracellular matrix is a resorbable, non-pyrogenic porcine derived dental barrier membrane that consists of collagen as well as extracellular components including laminin, fibronectin, glycosaminoglycans and elastin.1 Provides architecture and barrier protection for bone regeneration and soft tissue esthetics.

Please click below for Full Prescribing Information.
INDICATIONS
Simultaneous use of GBR-membrane and implants; augmentation around implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal defects.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
OPTIMATRIX® extracellular matrix is contraindicated in patients who have acute infection or contaminated wounds in the oral cavity; known allergy to porcine derived products; and clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune or systemic disease, which in the clinician’s judgment, will prevent safe implantation or likely healing.


WARNINGS
Clinicians should use extra care in screening patients for any known allergies to porcine derived products. Hypersensitivity reactions have been noted with the use of other animal derived products; therefore, the possibility exists of developing a local sensitivity response to OPTIMATRIX® extracellular matrix.

PRECAUTIONS
Device is sterile if the package is unopened and undamaged. Do not use if the package seal is broken. Single patient use only. Do not resterilize. Discard all open and unused portions of the membrane. Rinse surgical gloves with sterile fluid to remove any glove powder prior to handling the membrane. Resorption time may be accelerated if the membrane is exposed during the healing phase. Discard device if mishandling has caused possible damage or contamination, or if the device is past its expiration date.

ADVERSE REACTIONS
Possible complications that can occur with any dental or oral surgery include infections, swelling of the intraoral tissue, thermal sensitivity, gingival recession, excessive gingival bleeding, flap sloughing, resorption or ankylosis with loss of crestal bone height, abscess, inflammation, graft rejection, fistula formation, flap dehiscence, pain, or complication associated with the use of anesthesia. Minor discomfort may occur for a few days.




Integra Logo OPTIMATRIX® is manufactured by DSM Biomedical,
www.dsm.com/medical

1. Hoganson DM, Owens GE, O’Doherty EM, Bowley CM, Goldman SM, Harilal DO, Neville CM, Kronengold RT, Vacanti JP. Preserved extracellular matrix components and retained biological activity in decellularized porcine mesothelium. Biomaterials. 2010, 27: 6934-6940.


Equimatrix Product Image
Equimatrix Product Text
Equimatrix® natural bone mineral matrix is an equine-derived natural bone graft substitute with a complex, porous network that closely resembles natural human bone. The result is a natural bone mineral matrix with osteoconductive properties.

Please click below for Full Prescribing Information.
INDICATIONS
Augmentation or reconstructive treatment of the alveolar ridge; filling of infrabony periodontal defects; filling of defects after root resection, apicoectomy, and cystectomy; filling of extraction sockets to enhance preservation of the alveolar ridge; elevation of the maxillary sinus floor; filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Contraindications customary to the use of bone grafts should be observed. Equimatrix® natural bone mineral matrix should not be used in patients with osteomyelitis at the surgical site, metabolic diseases (diabetes, hyperparathyroidism, osteomalacia), severe renal dysfunction, severe liver disease, high dose therapy with corticosteroids or vascular impairment at the implant site.


PRECAUTIONS
In order to facilitate the formation of new bone, Equimatrix® natural bone mineral matrix should only be implanted in direct contact with well vascularized bony tissue (selective osteoplasty of adjacent cortical bone may be necessary). In larger defects a mixture of autogenous bone or bone marrow may improve the formation of new bone. The implantation of titanium fixtures should not take place until about 6 months after the use of Equimatrix® natural bone mineral matrix.





HELI Product Image
HELI Product Text
HeliPLUG®, HeliCOTE® and HeliTAPE® are absorbable collagen wound dressing products for dental surgery intended to assist in the wound healing process.

Please click below for Full Prescribing Information.
INDICATIONS
The Absorbable Collagen Wound Dressings for Dental Surgery are indicated for application to moist or bleeding clean oral wounds created during dental surgery, to control bleeding and protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. The Absorbable Collagen Wound Dressings for Dental Surgery, are intended for use on moist or bleeding wounds where a stabilized blood clot can help protect the surface of the wound from further injury. The Absorbable Collagen Wound Dressings are indicated during prolonged dental procedures where maintaining a clear surgical field and ease of use are beneficial factors in treating oral wounds. In situations where frequent aspiration is required to remove accumulated blood and exudate, the Absorbable Collagen Wound Dressings can be used to dress bleeding or oozing wounds and thereby improve patient comfort. Since the Absorbable Collagen Wound Dressings can be easily removed without damaging the wound bed, they can be used as temporary dressings prior to surgical closure.

IMPORTANT SAFETY INFORMATION

PRECAUTIONS
The Absorbable Collagen Wound Dressings for Dental Surgery should not be used on infected or contaminated wounds. Although the Absorbable Collagen Wound Dressings will promote hemostasis, they are not intended for use in treating systemic coagulation disorders. Store the Absorbable Collagen Wound Dressings in sealed packages at room temperature. Avoid excessive heat or humidity. Discard all open but unused dressings. Do not attempt to re-sterilize. The material has not been tested on pregnant women. The risk to health has not been established. The long-term effects of leaving the Absorbable Collagen Wound Dressings in situ are presently unknown.


ADVERSE REACTIONS
Adverse reactions reported with another microfibrillar collagen hemostatic agent that were possibly related to its use were adhesion formation, allergic reaction, foreign body reaction and subgaleal seroma (report of a single case). Since the wound dressings are collagen-based products, adverse reactions experienced with another microfibrillar collagen may be related. The Absorbable Collagen Wound Dressings for Dental Surgery differ substantially in source, method of processing, and purity from other microfibrillar and macrofibrillar forms of collagen commercially distributed for hemostatic and wound care applications.





Integra Logo Integra, the Integra logo, HeliCote®, HeliPlug® and HeliTape® are registered trademarks of, Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.


OHD129 Iss. 2/2016
GEM 21S®, OPTIMATRIX® and Equimatrix® are registered trademarks of Osteohealth, a Division of Luitpold Pharmaceuticals, Inc. ©Copyright Osteohealth Company, Division of Luitpold Pharmaceuticals, Inc. 2016.


DAIICHI SANKYO NAMES NEW PRESIDENT OF US SUBSIDIARY LUITPOLD PHARMACEUTICALS, INC.

June 29, 2016 – Effective today, Ken Keller has been newly appointed as President and CEO of Luitpold Pharmaceuticals, in addition to his current position as President, Daiichi Sankyo Administrative and Commercial, Daiichi Sankyo, Inc.

With more than 25 years of experience in the pharmaceutical industry in commercial leadership and joint venture leadership, Mr. Keller will now oversee both the Daiichi Sankyo, Inc. Commercial organization and Luitpold Pharmaceuticals, Inc.

Mr. Keller joined Daiichi Sankyo, Inc. in 2014 and has also served on the Luitpold Board of Directors since 2015. He has successfully led the Daiichi Sankyo, Inc. US commercial organization as it begins its transformation to a specialty focused company.

“While Luitpold and Daiichi Sankyo US businesses serve different customers and markets, they each bring to the table important strengths and focus that are essential to the continued success and growth of the Daiichi Sankyo Group,” said Ken Keller. “I look forward to working with the Luitpold team and driving even further success in the future.”

Luitpold Pharmaceuticals, Inc. is a Daiichi Sankyo Group Company headquartered in Shirley, NY, and manufactures more than 80 pharmaceutical products.