Bone Graft Materials/DBM

With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.

SeaSpine introduced a new integrated open-bore hydration syringe for OsteoStrand and OsteoStrand Plus Demineralized Bone Fibers.

Royal Biologics, developer of products for regenerative medicine, received funding to support employee onboarding, operational growth, product development and acquisitions. 

Alphatec launched the PLIF IdentiTi-PS Porous Titanium Interbody for PLIF, and AlphaGRAFT® DBM Fiber. 

Artoss gained FDA 510(k) clearance to market NanoBone® SBX Putty for standalone use in posterolateral spinal fusion.

Retrospective review of 163 patients at one-year follow-up revealed clinical evidence of BONESUPPORT's CERAMENT® bone void filler remodeling into bone in humans.

Enabling technology was the story of the North American Spine Society 2019 annual meeting (NASS), with the top spine players heavily featuring their robotic-assisted surgery ecosystems.

Bioventus introduced OSTEOAMP® SELECT Fiber allograft bone graft substitute for spine, foot/ankle, orthopedic and trauma procedures.

BONESUPPORT launched BONIFY demineralized bone matrix in the U.S.

Medtronic launched Grafton Demineralized Bone Matrix in Japan for spine and orthopedic procedures. 

KICVentures seeks funding to prepare its portfolio companies, AxioMed and NanoFUSE Biologics, to be acquisition targets.

SurGenTec completed initial clinical launch of the GraftGun bone graft delivery system combined with ViBone Viable Bone Matrix prefilled tubes.

Innovasis entered into a private-label agreement with Stability Biologics that includes access to Physio® bone allograft. Product launch is expected by year-end.

CellRight Technologies, a Tissue Regenix company, entered into an agreement granting Arthrex distribution rights to its BioRinse bone portfolio in Europe.

Baxter was granted FDA 510(k) clearance to market ALTAPORE Bioactive Bone Graft as an autograft extender in posterolateral spinal fusion.

LifeNet Health commenced limited launch of PliaFX® Prime precision-engineered cortical fibers.

Synergy Biomedical received FDA 510(k) clearance to market BIOSPHERE® FLEX bone graft. 

Tobra Medical commenced U.S. launch of the Tobra Bone Basket to maximize collection of autograft bone.

NuVasive commenced U.S. launch of three new biologic products for spine, including traditional bone allograft, an amniotic membrane and new formats in the Propel Demineralized Bone Matrix line. 

Cerapedics enrolled the first patients in an IDE clinical trial evaluating P-15L Bone Graft vs. autograft in TLIF.

Cerapedics completed a US $22MM financing. Proceeds will support commercialization and a U.S. lumbar trial of i-FACTOR bone graft.

Artoss completed a US $1MM funding round. Proceeds will support development of new NanoBone® bone graft products for the U.S. market, regulatory requirements and commercialization.

Aziyo Biologics entered into an agreement to supply ViBone viable bone matrix for distribution with SurGenTec's GraftGun delivery system.

Wright Medical commenced U.S. launch of the PROstep Minimally Invasive Surgery System and AUGMENT® Injectable Bone Graft.

Wright Medical received FDA premarket approval for AUGMENT® Injectable Bone Graft, serving as an alternative to autograft in hindfoot and ankle fusion.

RTI Surgical reached a global milestone of >8 million biologic implants processed through proprietary sterilization, with no confirmed incidence of implant-associated infection.

Aziyo Biologics launched OsteGro allograft bone matrix to support new bone growth in orthopaedic procedures.

Collagen Matrix entered the India market with OssiMend® bone graft matrix for spinal applications. 

Ventris Medical has formed to market Cellesta placental allografts for surgical and non-surgical applications. 

SeaSpine received FDA 510(k) clearance to market OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh.

SeaSpine commenced limited launch of OsteoStrand™ Demineralized Bone Fibers, for use in spinal fusion.

Cerapedics' i-FACTOR™ Peptide Enhanced Bone Graft is now in use at >150 U.S. hospitals.

LifeLink Tissue Bank will provide allografts to treat sports, orthopaedic and spine injuries to HCT Regenerative, for distribution in Taiwan. 

Artoss entered into a Defense Acquisition Purchasing Agreement with Owens & Minor for U.S. Department of Defense access to NanoBone bone graft.

Follow-up data from an IDE clinical trial of Cerapedics' i-FACTOR™ bone graft indicated statistical superiority to autograft in ACDF.

Bone Biologics entered into an exclusive license agreement with UCLA for global application of NELL-1 protein in the treatment of osteoporosis and trauma, through a technology transfer. 

Tissue Regenix completed its acquisition of CellRight Technologies. The purchase price was previously noted as US $30.0MM.

Tissue Regenix proposes to acquire CellRight Technologies for US $30MM, to offer products for bone and soft tissue regeneration.

ChoiceSpine launched a biologics portfolio, adding allograft, synthetic bone graft and amnion offerings to complement its spinal hardware portfolio.

Extremity Medical launched BioFuse, a next-gen viable cell bone graft for use in the foot, ankle, wrist and hand.

Premier is now offering Bioventus' full surgical orthobiologics product portfolio to its U.S. membership, comprising 3,750 hospitals and >130,000 provider organizations. 

Prosidyan received FDA 510(k) clearance of FIBERGRAFT BG Putty for use in posterolateral spinal fusion. 

SurGenTec was granted U.S. Patent No. 9,655,748, Bone Graft Delivery System and Method for Using Same, pertaining to the GRAFTGUN® device.

CURASAN entered the U.S. market with the first U.S. implantation of CERASORB® Ortho Foam bone graft.

TheraCell was issued U.S. Patent No. 9,636,436, "Compositions of and Methods for Cancellous Bone Matrix," addressing its ECS™ enhanced cancellous demineralized bone technology.

Amend Surgical received FDA 510(k) clearance to market NanoFUSE® BA as a bone graft extender for spine and orthopaedic applications.

TheraCell announced pending issuance of a U.S. patent for DBF™ demineralized bone fiber, part of AlloSource's AlloFuse® Cortical Fibers and AlloFuse® Fiber Boats.

Spineology received FDA 510(k) clearance for use of allograft bone with Rampart™ Interbody Fusion Devices.

Stryker Spine launched LITe® BIO, a hand-held bone graft material delivery device.

The Musculoskeletal Transplant Foundation is now sole tissue provider for Spineology's allograft product lines, including the newly-launched Incite™ Cortical Fiber bone graft.

Data from a 12-month study of 1-level ACDF patients treated with Trinity Evolution® + a PEEK interbody spacer demonstrated fusion rates of 78.6% at 6 months and 93.5% at one year.

Pre-clinical studies suggest that multipotent adult progenitor cells (MAPCs), such as the technology used in RTI Surgical's map3® Cellular Allogeneic Bone Grafts, exhibited a more robust angiogenic protein release profile vs. mesenchymal stem cells in vitro.

Preclinical data on adipose-derived mesenchymal stem cells in a rat model, using technology similar to AlloSource's AlloStem® Cellular Bone Allograft process, showed bone formation within a critical-sized defect in all study subjects.

Avitus Orthopaedics launched pilot sales of the Avitus™ Bone Harvester.

Novastep signed an agreement with Vivex Biomedical to launch bioSTART® Tissue Repair products, offering amniotic membranes and liquid to support foot and ankle procedures in the U.S.

At AAOS 2016, Bioventus is introducing the CellXtract™ novel cell and bone marrow extraction tool and SIGNAFUSE™, a bioactive bone graft putty. 

Bone Biologics completed a US $5.75MM funding round to support development of a bone graft substitute for initial focus on spinal fusion.

MiMedx signed a definitive agreement to acquire Stability Biologics for US $10MM in cash and stock. Stability Biologics provides human tissue products for the surgical, spine and orthopaedic industries. The transaction is expected to close in early 1Q16.

Vivex Biomedical raised US $6.6MM of a potential $10MM offering of Series A Convertible Preferred Stock.