A recent post from Becker’s Spine highlighted “5 spine, orthopedic biologics companies to know”, so I decided to take a deeper dive into each one. Based on the information provided, these companies were in no particular order (like the first one being the most important); however, I could be wrong, having limited knowledge of the biologics side of spine (at the moment).
Xtant Medical
Xtant Medical’s biologics products include bone allografts, demineralized bone matrix and bone graft substitute. Sean Browne is CEO of the company.[1]
Mission: Our mission is to honor the gift of donation, by allowing our patients to live as full, and complete a life as possible.[2]
- 3Demin®
- a flexible, osteoconductive and osteoinductive graft material from demineralized cortical bone fibers, suitable for various surgical applications.
- Dual Layer Amniotic Membrane
- a minimally processed, dehydrated sheet-like product derived from the amniotic membrane layer of placental tissue, preserving its natural properties for spinal applications.
- Matriform® Si
- a biomimetic, osteoconductive, multiporous matrix composed of β-TCP, silicate, and collagen, designed for spinal fusion procedures.
- nanOss®
- a bone graft substitute composed of nano-structured hydroxyapatite granules in a collagen carrier. (Regulatory approvals vary by country.)
- OsteoFactor™
- a uniquely processed allograft containing a wide array of growth factors, including BMP-2, for bone formation and remodeling.
- OsteoMax™
- a 100% human bone allograft with osteoinductive and osteoconductive properties, offering excellent handling and sterility for bone healing applications.
- OsteoSelect®
- a premixed, osteoinductive bone graft containing demineralized cortical chips and DBM putty, offering superior handling and performance for spinal procedures.
- OsteoSponge®
- a malleable, osteoconductive, and osteoinductive DBM graft derived from 100% cancellous bone, ideal for spinal fusion, arthrodesis, and fracture sites.
- OsteoVive® Plus
- a ready-to-use bone graft containing osteoinductive and osteoconductive components, as well as preserved mesenchymal stem cells.
- OsteoWrap®
- a flexible, osteoconductive, and osteoinductive cortical bone allograft, ideal for various surgical applications.
- SimpliMix™
- this delivery device is designed for targeted delivery of bone graft materials while maximizing material utilization.
- SportsMed
- sterile, frozen tendons for cruciate ligament reconstructions and revisions, offering consistent quality and safety.
- Traditional Allografts
- Xtant Medical offers a variety of sterile, room-temperature stored allografts, including Ilium Tricortical Blocks, Crushed Cancellous Chips, Unicortical Blocks, Fibula Segments, and Femoral Struts.[2]
OssDsign
OssDsign is led by Morten Henneveld and its flagship product is the Catalyst implant for spinal fusion. Catalyst has been used in more than 5,000 U.S. patients.[1]
OssDsign is a developer and global provider of next generation orthobiologics products. Based on cutting edge material science, the company develops and markets products that support the body’s own healing capabilities, giving patients back the life they deserve.[3]
- OssDsign Catalyst nanosynthetic bone graft putty is designed to stimulate both intramembranous and endochondral bone formation pathways, resulting in rapid and reliable bone formation throughout the entire fusion mass.[3]
Vericel
Vericel creates therapies for sports medicine and burn care. It is led by President and CEO Dominick Colangelo. Its Maci orthobiologic recently earned FDA approval for arthroscopy cases.[1]
Vision: Vericel is committed to improving the lives of patients with serious conditions by developing and manufacturing innovative cell therapies and specialty biologics.[4]
Mission: Vericel is passionately committed to meeting significant patient and healthcare provider needs by providing potentially life-enhancing cell therapies to patients with serious medical conditions.[4]
- MACI
- The FDA-approved MACI is the first tissue-engineered product for knee cartilage repair, offering a potential solution for chronic knee pain sufferers.
- EPICEL
- a cultured epidermal autograft used to replace skin for patients with severe burns, providing a potential solution for a significant number of burn victims.
- NEXOBRID
- a botanical drug product used to remove eschar in burn patients, facilitating faster healing and wound assessment.[4]
Ossium Health
Ossium Health was founded in 2016 and is led by President and CEO Kevin Caldwell. The company’s OssiGraft Prime was used in its first successful case, an arthroscopic ankle fusion, in July.[1]
Mission: Our mission is to improve the health, vitality, and longevity of human beings through bioengineering.[5]
- HPC, Marrow
- Cryopreserved whole bone marrow derived from organ donor vertebral bodies using Ossium’s proprietary processing methods, contains Hematopoietic Progenitor Cells (HPCs).
- GMP Mesenchymal Stem Cells (MSCs)
- derived from vertebral bodies and are suitable for use in clinical studies, offering a high-yield alternative to traditional BM-MSCs.
- GMP Selected CD34+ Cells
- cells are selected from bone marrow and are suitable for use in clinical studies, providing a potential source for hematopoietic (relating to, or involved in, the formation of blood cells[6]) cell transplantation.
- RUO Selected CD34+ Cells
- cells are selected from bone marrow and are intended for research use, providing a potential source for hematopoietic (relating to, or involved in, the formation of blood cells[6]) cell studies.
- RUO Mesenchymal Stem Cells (MSCs)
- derived from vertebral bodies and are intended for research use, providing a potential source for mesenchymal (cells that develop into connective tissue, blood vessels, and lymphatic tissue) stem cell studies.
- OssiGraft™ Viable Bone Matrix Allografts
- OssiGraft Prime™ is a premium cryopreserved viable bone matrix allograft designed for musculoskeletal repair and reconstruction, offering optimized handling properties and a variety of sizes.
- OssiGraft™ is a cryopreserved viable bone matrix allograft designed for musculoskeletal repair and reconstruction, offering a variety of sizes.
- OssiGraft and OssiGraft Prime offer high-quality bone matrix allografts with superior source material, rapid thaw time, and pure composition.[5]
Miach Orthopaedics
Miach Orthopaedics is behind the Bridge-Enhanced ACL restoration implant. The company recently raised $20 million in series B financing, which will support commercial expansion for the BEAR implant. Martha Murray, MD, founded the company and created the implant.[1]
Mission: We are dedicated to developing bio-engineered surgical implants for connective tissue restoration.[8]
- BEAR Implant
- (Bridge Enhanced ACL Restoration) Implant is a decellularized, bovine-derived collagen implant that resorbs within 8 weeks and facilitates ACL repair by supporting cell migration and proliferation.[8]
References
[1] Behm, C. (2024, September 23). 5 spine, orthopedic biologics companies to know. https://www.beckersspine.com/biologics/60662-5-spine-orthopedic-biologics-companies-to-know.html
[2] Xtant Medical – Helping people have better lives. (2024, September 23). Xtant Medical. https://xtantmedical.com/
[3] OSSDSign. (2024, September 23). https://www.ossdsign.com/
[4] Vericel Corporation | Advanced cell therapies. (2024, September 23). https://www.vcel.com/
[5] Ossium Health. (2024, October 2). Company about – Ossium Health. Ossium Health -. https://ossiumhealth.com/company/
[6] hematopoietic. (2024, October 2). In Merriam-Webster Dictionary. https://www.merriam-webster.com/medical/hematopoietic#:~:text=adjective,hematopoietic%20stem%20cells
[7] NCI Dictionary of Cancer Terms. (2024, October 2). Cancer.gov. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mesenchymal
[8] ACL implant and treatment options | BEAR® Implant | Miach Orthopaedics. (2024, October 2). https://miachortho.com/
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