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I’m very interested in sharing companies that we learn about throughout our daily research. This month, we meet four from around the globe and three of which are still in the product development phase.
Joint Replacement
NELA BioDynamics
Aldaia, Valencia, Spain
Founded in 2017
NELA seeks to offer an alternative to implants that are fitted by high impact, resulting in potential complications, frequent post-surgical pain and a high percentage of implant failures.
Modular R-Evolution technology supports a customized fit for each patient and avoids the conventional techniques based on impact press-fit or use of bone cement to achieve fixation. Implantation strength can be adapted to the patient’s bone density, improving load transmission by reducing bone loss around the implant. Applications include replacement of the shoulder, elbow, hip and knee, as well as nails to treat fractures.
NELA is pursuing CE Mark and FDA submissions in early 2024. Future evolutions of NELA’s implant may reflect the company’s interest in use with surgical robots.
Spine
Blue Ocean Spine
Tuttlingen, Baden-Württemberg, Germany
Founded in 2020
Blue Ocean Spine Expandable Cage
Blue Ocean markets functional, additively-manufactured spinal implants to support minimally invasive fusion. The expandable cage designs allow for better adaptation to anatomy and precise restoration of segmental height and realignment of the spinal curvature. Clinical inventory is thereby reduced. Using the latest additive manufacturing technology supports improved functionality and safety, and also reduces manufacturing costs.
The company is pursuing an application for FDA 510(k) clearance by 2022.
Earlier this year, Blue Ocean acquired Prolixo, a German company developing a new limb lengthening technology. While the device can be used to treat leg length discrepancies or to address non-unions after failed fracture treatments or tumors, it could also have application in the treatment of spinal deformities.
Also in early 2021, Blue Ocean announced an investment by SHS. This is the second collaboration for SHS and the founder of Blue Ocean Spine, following a successful investment in EIT Emerging Implant Technologies, which was acquired by Johnson & Johnson in 2018.
Aside from EIT, Blue Ocean leadership brings experience from incubator EISEN OrthoVentures and device companies Aesculap, Diener Implants, Karl Storz, Paradigm Spine, RTI Surgical and Spine Solutions.
Trauma
Reign Medical
Tulsa, Oklahoma, United States
Founded in 2018
Reign Medical Clench Compression Staple System
Developer of a line of foot/ankle and hand products, including the Clench Compression Staple.
The Ratcheting Compression Plate integrates a plate span, cannulated and threaded legs, and a ratcheting hub into a stand-alone implant. Clench is a disposable sterile fixation system for hand and foot bone fragments, osteotomy fixation and joint arthrodesis. Nitinol-based Clench requires no heat activation and provides continuous, active bi-cortical compression throughout the healing process.
Portfolio also includes Amniovo amnion patch allografts, VIA cellular bone matrices and Vivex DBM100 demineralized bone matrix paste.
Orthobiologics
Hy2Care
Oirsbeek, Overijssel, The Netherlands
Founded in 2014
Hy2Care’s injectable hydrogel patch was developed for functional repair of cartilage defects in knee joints. Based on joint tissue-mimicking natural polymers, it aims to protect the injured site and facilitate natural repair.
Hy2Care is a spin-off of the University of Twente. In 2019, the company received €3.7M Series A funding. Product prototyping and first animal testing have been completed; the goal of the Series A period was to scale up technology and initiate human trials, the first of which is slated to commence in 2021. Also, a separate product and venture for veterinary applications is under development.
Company leadership brings experience from roles at DSM Biomedical and DSM Dyneema, as well as IsoTis.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.
I’m very interested in sharing companies that we learn about throughout our daily research. This month, we meet four from around the globe and three of which are still in the product development phase.
Joint Replacement
NELA BioDynamics
Aldaia, Valencia, Spain
Founded in 2017
NELA seeks to offer an alternative to implants that are...
I’m very interested in sharing companies that we learn about throughout our daily research. This month, we meet four from around the globe and three of which are still in the product development phase.
Joint Replacement
NELA BioDynamics
Aldaia, Valencia, Spain
Founded in 2017
NELA seeks to offer an alternative to implants that are fitted by high impact, resulting in potential complications, frequent post-surgical pain and a high percentage of implant failures.
Modular R-Evolution technology supports a customized fit for each patient and avoids the conventional techniques based on impact press-fit or use of bone cement to achieve fixation. Implantation strength can be adapted to the patient’s bone density, improving load transmission by reducing bone loss around the implant. Applications include replacement of the shoulder, elbow, hip and knee, as well as nails to treat fractures.
NELA is pursuing CE Mark and FDA submissions in early 2024. Future evolutions of NELA’s implant may reflect the company’s interest in use with surgical robots.
Spine
Blue Ocean Spine
Tuttlingen, Baden-Württemberg, Germany
Founded in 2020
Blue Ocean Spine Expandable Cage
Blue Ocean markets functional, additively-manufactured spinal implants to support minimally invasive fusion. The expandable cage designs allow for better adaptation to anatomy and precise restoration of segmental height and realignment of the spinal curvature. Clinical inventory is thereby reduced. Using the latest additive manufacturing technology supports improved functionality and safety, and also reduces manufacturing costs.
The company is pursuing an application for FDA 510(k) clearance by 2022.
Earlier this year, Blue Ocean acquired Prolixo, a German company developing a new limb lengthening technology. While the device can be used to treat leg length discrepancies or to address non-unions after failed fracture treatments or tumors, it could also have application in the treatment of spinal deformities.
Also in early 2021, Blue Ocean announced an investment by SHS. This is the second collaboration for SHS and the founder of Blue Ocean Spine, following a successful investment in EIT Emerging Implant Technologies, which was acquired by Johnson & Johnson in 2018.
Aside from EIT, Blue Ocean leadership brings experience from incubator EISEN OrthoVentures and device companies Aesculap, Diener Implants, Karl Storz, Paradigm Spine, RTI Surgical and Spine Solutions.
Trauma
Reign Medical
Tulsa, Oklahoma, United States
Founded in 2018
Reign Medical Clench Compression Staple System
Developer of a line of foot/ankle and hand products, including the Clench Compression Staple.
The Ratcheting Compression Plate integrates a plate span, cannulated and threaded legs, and a ratcheting hub into a stand-alone implant. Clench is a disposable sterile fixation system for hand and foot bone fragments, osteotomy fixation and joint arthrodesis. Nitinol-based Clench requires no heat activation and provides continuous, active bi-cortical compression throughout the healing process.
Portfolio also includes Amniovo amnion patch allografts, VIA cellular bone matrices and Vivex DBM100 demineralized bone matrix paste.
Orthobiologics
Hy2Care
Oirsbeek, Overijssel, The Netherlands
Founded in 2014
Hy2Care’s injectable hydrogel patch was developed for functional repair of cartilage defects in knee joints. Based on joint tissue-mimicking natural polymers, it aims to protect the injured site and facilitate natural repair.
Hy2Care is a spin-off of the University of Twente. In 2019, the company received €3.7M Series A funding. Product prototyping and first animal testing have been completed; the goal of the Series A period was to scale up technology and initiate human trials, the first of which is slated to commence in 2021. Also, a separate product and venture for veterinary applications is under development.
Company leadership brings experience from roles at DSM Biomedical and DSM Dyneema, as well as IsoTis.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
