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In August 2014, we published a list of companies that we thought were at the forefront of trauma/fracture repair. Were we right—that they were worthy of watching? How have they fared since then? We searched funding, regulatory clearance and product launch announcements over the past four years to observe their activity. Let’s recap!
AUDAX MEDICAL
- Developed Arxis, a self-assembling, bioresorbable nanocomposite for minimally invasive orthopaedic reconstruction. Arxis comprises DNA base pairs that form self-assembled nanoscale, structural and functional supramolecules. With their unique biological, physiochemical and mechanical properties, DNA-based supramolecules may serve as the next generation of orthopaedic implants.
- Since founding the company in 2009, President/CEO Mark Johanson has raised over $6.5MM in early-stage funding, supporting the company through its current pre-clinical development stage.
- In 2017, the company was granted an exclusive worldwide license from Northeastern University for a self-assembling, arginine-rich nanomolecule for development in tissue regeneration that may inhibit bacteria without the use of antibiotics.
CONVENTUS ORTHOPAEDICS
- Conventus’ Nitinol-based DRS System (Distal Radius System, shown at right) creates an internal substructure that expands to support articular fragments and provides a core to fix fragments from nearly any angle. Potential irritations to surrounding soft tissue are eliminated. It can produce stability, even in compromised bone.
- Since our report, gained FDA 510(k) clearances for PHS proximal humerus fixation, PRS proximal radial fractures, Distal Ulna and Proximal Ulna systems.
- As of the end of 2016, over 700 patients were treated with the expandable cage technology.
- In 2015 they completed a #23.5MM equity round, followed by completion of a $20MM equity financing in 2017, and in early 2018, closed a $12MM venture loan to support general working capital as they develop new indications, etc.
- New management put in place, including CEO, CFO and vice presidents of marketing, R&D, operations and sales.
DGIMED (Now dba DISTALOCK)
- No updates since the report.
- DISTALOCK comprises a comprehensive set of intramedullary nail implants and instruments plus a disposable drill.
- Product also appears to be distributed by Orthopaedic International, which displayed DISTALOCK among its products at the 2016 Royal College of Orthopaedic Surgeons of Thailand/ASEAN Orthopaedic Association combined meeting, and listed DISTALOCK among its products for AAOS 2017.
ELEMENT ORTHO
- Developer of the Serpentine Composite Grafting System, which allows physicians to concurrently inject bead-chain solids and a fluent settable material into bone, without using pressure, via a minimally invasive cannula. The result is a porous, 3-dimensional implant having isostatic force chains.
- Inactive per Minnesota Secretary of State listings since 2015.
- President has gone on to a different company with completely different products.
EMERGE MEDICAL
- The company’s trauma products, including cannulated screws, drill bits and guide wires, were distributed by Cardinal Health.
- Cardinal Health acquired Emerge in 2014.
- Emerge received one final FDA 510(k) clearance, for an IM nail, after the report was published and before it was acquired.
FLOWER ORTHOPEDICS
- Provides cost-effective Ready-for-Surgery™ treatment concepts, based on standardization: one implant and instrument philosophy, one locking mechanism, one instrument kit, no O.R. rep support, reduced inventory. All instruments are single use and disposable.
- In 2015, the company completed a $4.5MM Series C equity raise to support working capital and growth strategies.
- Also in 2015, received CE Mark approval for the FlowerCube™ bone fixation concept for upper and lower extremities.
- The company has also launched numerous products, including Flower E-Kit™, containing all required cannulated and plating instruments for midfoot, forefoot and ankle in one single-use package; next-gen Ready-for-Surgery™ Guide Wire Kits for the Cannulated Screw FlowerCube™; an MTP Fusion Plate component for the First Ray IndicationCube; a Distal Radius FlowerCube™; the FlowerAdvantage™ initiative, designed to reduce the costs to provide fracture repair in ambulatory surgery centers; etc.
GENOSSIS
- An early-stage device company in advanced stages of selecting commercial partners to leverage near-term market opportunities for its “Optimized Osteogenesis Solutions” (OptOssol).
- Product was 510(k) cleared, company was not actively seeking capital.
- Commercialization in the U.S. was set to begin in 2H14.
- No updates since the report. Company is still viable, with an active website.
ILLUMINOSS MEDICAL
- Produces minimally invasive conforming orthopaedic implants leveraging proprietary bone stabilization technology comprising a combination of balloons, light activated monomers and flexible catheters. The system (shown below) has been used internationally since 2010 for a wide variety of clinical indications, and is CE Marked.
- In late 2014, company received conditional FDA approval to conduct a clinical trial for the treatment of impending and pathologic humerus fractures due to metastatic carcinoma.
- In 2016, IlluminOss entered into an agreement with Orthovative to distribute the Photodynamic Bone Stabilization System for fracture repair in Germany.
- Enrollment completed in 2016, with outcomes data supporting submission of a De Novo marketing application to FDA.
- Study results released in 2017 indicated that percutaneous intramedullary fixation provided by IlluminOss Medical’s light curable monomer system can provide stabilization of fractures without open surgery.
- In 2018, IlluminOss Medical received FDA De Novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures. U.S. launch is slated for 2Q18.
MBD MEDICAL
- Developer of the Self-Contouring Plate Fixation System that aids in the repair of displaced clavicle fractures and other potential indications. The system requires no advance shaping, conforming to the shape of the bone while the plate is screwed into place.
- In July 2016, The Morning Call reported that the company received a $50,000 loan to conduct a series of trials on MBD’s plate and screw platform.
ORTHOCLIP
- Developer of novel medical devices that provide simple local delivery of therapeutic agents to inhibit and treat infection around surgical implants. Initially, focus has been on devices used in fracture repair and spinal fusion for both human and animal markets. OrthoClip is the first spinout of Palmetto Biomedical, a medical device design and consulting firm.
- May 2017, OrthoClip was issued U.S. Patent No. 9,642,658 B2, “Device and Method for Delivery of Therapeutic Agents Via Internal Implants.”
- Company is viable and active per state filings.
PARAGON 28
- Focuses exclusively upon specialization and innovation for the 28 bones of the foot.
- Since the report, company has received FDA clearance for a variety of screws, an osteotomy wedge, a staple, etc.
- The company’s launches of plates, allograft, screws, etc. are too numerous to list here.
SONOMA ORTHOPEDICS
- Acquired by Arthrex in 2017.
- 510(k)s since the report include systems for repair of the fifth metatarsal and fibula, and a cancellous bone screw and washer.
- In late 2014, the company received a $12MM investment to support FDA clearance and launch of an ankle implant for fracture fixation.
STABILIZORTHO
- Stabiliz’s system comprises active screws and active plates made from standard alloys and containing a bioresorbable portion that mates with the locking plate.
- No updates since report. Still a viable company.
TISSUE REGENERATION SYSTEMS
- Developer of scaffold and coating technologies for use in skeletal reconstruction.
- In 2017, DePuy Synthes Products acquired 3D printing technology from Tissue Regeneration Systems to offer patient-specific, bioresorbable implants to treat orthopaedic and craniomaxillofacial deformities and injuries.
TYBER MEDICAL
- Maker of headless and headed compression trauma screws, stainless steel cannulated drills and a full line of spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK, a proprietary titanium plasma sprayed PEEK.
- Six 510(k) clearances since the report, including screws, a PEEK wedge and an interbody spacer.
- In 2016, the company was awarded a $362,500, 10-year state loan to purchase equipment for in-house fabrication.
- In mid-2016, the company’s interbody spinal device line was accepted into the Australian Registry of Therapeutic Goods.
- Launches since the report include a low profile lateral plate, the TyWedge™ Osteotomy Wedge, the sterile Forefoot Procedure Kit of implants and instruments and the TyFix™ all-in-one sterile-packed extremity joint fixation system.
WOVEN ORTHOPEDIC
- Developer of the OGmend Implant, comprising a biotextile/biopolymer to enhance fixation in the short- and long-term.
- Per CrunchBase, the company has raised $29.4MM overall (of that, $20.8MM since our 2014 report).
- Target markets are trauma and spine, with future verticals including joint reconstruction, sports medicine, CMF, dental and veterinary.
- As of May 2017, the company began distributing its woven biotextile devices in Australia and New Zealand for use in human patients.
- In pursuit of U.S. (FDA De Novo submission 4Q16) and EU (spine submission 4Q16, trauma submission 1Q17) clearances, and noted interest in regions like Hong Kong and Singapore.
These 16 companies remain at different stages in their business lifecycles, demonstrating the difficulty of competing in the orthopaedic market. While they had different technologies and market approaches, those focused on the extremities implant or hardware market, to no surprise, seem to have experienced the greatest advancements in terms of commercialization of new products and securing funding.
Sources: ORTHOWORLD Inc., company websites, press releases, SEC filings, information in the public domain; images courtesy of manufacturers.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant. Reach her by email.
In August 2014, we published a list of companies that we thought were at the forefront of trauma/fracture repair. Were we right—that they were worthy of watching? How have they fared since then? We searched funding, regulatory clearance and product launch announcements over the past four years to observe their activity. Let’s recap!
AUDAX...
In August 2014, we published a list of companies that we thought were at the forefront of trauma/fracture repair. Were we right—that they were worthy of watching? How have they fared since then? We searched funding, regulatory clearance and product launch announcements over the past four years to observe their activity. Let’s recap!
AUDAX MEDICAL
- Developed Arxis, a self-assembling, bioresorbable nanocomposite for minimally invasive orthopaedic reconstruction. Arxis comprises DNA base pairs that form self-assembled nanoscale, structural and functional supramolecules. With their unique biological, physiochemical and mechanical properties, DNA-based supramolecules may serve as the next generation of orthopaedic implants.
- Since founding the company in 2009, President/CEO Mark Johanson has raised over $6.5MM in early-stage funding, supporting the company through its current pre-clinical development stage.
- In 2017, the company was granted an exclusive worldwide license from Northeastern University for a self-assembling, arginine-rich nanomolecule for development in tissue regeneration that may inhibit bacteria without the use of antibiotics.
CONVENTUS ORTHOPAEDICS
- Conventus’ Nitinol-based DRS System (Distal Radius System, shown at right) creates an internal substructure that expands to support articular fragments and provides a core to fix fragments from nearly any angle. Potential irritations to surrounding soft tissue are eliminated. It can produce stability, even in compromised bone.
- Since our report, gained FDA 510(k) clearances for PHS proximal humerus fixation, PRS proximal radial fractures, Distal Ulna and Proximal Ulna systems.
- As of the end of 2016, over 700 patients were treated with the expandable cage technology.
- In 2015 they completed a #23.5MM equity round, followed by completion of a $20MM equity financing in 2017, and in early 2018, closed a $12MM venture loan to support general working capital as they develop new indications, etc.
- New management put in place, including CEO, CFO and vice presidents of marketing, R&D, operations and sales.
DGIMED (Now dba DISTALOCK)
- No updates since the report.
- DISTALOCK comprises a comprehensive set of intramedullary nail implants and instruments plus a disposable drill.
- Product also appears to be distributed by Orthopaedic International, which displayed DISTALOCK among its products at the 2016 Royal College of Orthopaedic Surgeons of Thailand/ASEAN Orthopaedic Association combined meeting, and listed DISTALOCK among its products for AAOS 2017.
ELEMENT ORTHO
- Developer of the Serpentine Composite Grafting System, which allows physicians to concurrently inject bead-chain solids and a fluent settable material into bone, without using pressure, via a minimally invasive cannula. The result is a porous, 3-dimensional implant having isostatic force chains.
- Inactive per Minnesota Secretary of State listings since 2015.
- President has gone on to a different company with completely different products.
EMERGE MEDICAL
- The company’s trauma products, including cannulated screws, drill bits and guide wires, were distributed by Cardinal Health.
- Cardinal Health acquired Emerge in 2014.
- Emerge received one final FDA 510(k) clearance, for an IM nail, after the report was published and before it was acquired.
FLOWER ORTHOPEDICS
- Provides cost-effective Ready-for-Surgery™ treatment concepts, based on standardization: one implant and instrument philosophy, one locking mechanism, one instrument kit, no O.R. rep support, reduced inventory. All instruments are single use and disposable.
- In 2015, the company completed a $4.5MM Series C equity raise to support working capital and growth strategies.
- Also in 2015, received CE Mark approval for the FlowerCube™ bone fixation concept for upper and lower extremities.
- The company has also launched numerous products, including Flower E-Kit™, containing all required cannulated and plating instruments for midfoot, forefoot and ankle in one single-use package; next-gen Ready-for-Surgery™ Guide Wire Kits for the Cannulated Screw FlowerCube™; an MTP Fusion Plate component for the First Ray IndicationCube; a Distal Radius FlowerCube™; the FlowerAdvantage™ initiative, designed to reduce the costs to provide fracture repair in ambulatory surgery centers; etc.
GENOSSIS
- An early-stage device company in advanced stages of selecting commercial partners to leverage near-term market opportunities for its “Optimized Osteogenesis Solutions” (OptOssol).
- Product was 510(k) cleared, company was not actively seeking capital.
- Commercialization in the U.S. was set to begin in 2H14.
- No updates since the report. Company is still viable, with an active website.
ILLUMINOSS MEDICAL
- Produces minimally invasive conforming orthopaedic implants leveraging proprietary bone stabilization technology comprising a combination of balloons, light activated monomers and flexible catheters. The system (shown below) has been used internationally since 2010 for a wide variety of clinical indications, and is CE Marked.
- In late 2014, company received conditional FDA approval to conduct a clinical trial for the treatment of impending and pathologic humerus fractures due to metastatic carcinoma.
- In 2016, IlluminOss entered into an agreement with Orthovative to distribute the Photodynamic Bone Stabilization System for fracture repair in Germany.
- Enrollment completed in 2016, with outcomes data supporting submission of a De Novo marketing application to FDA.
- Study results released in 2017 indicated that percutaneous intramedullary fixation provided by IlluminOss Medical’s light curable monomer system can provide stabilization of fractures without open surgery.
- In 2018, IlluminOss Medical received FDA De Novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures. U.S. launch is slated for 2Q18.
MBD MEDICAL
- Developer of the Self-Contouring Plate Fixation System that aids in the repair of displaced clavicle fractures and other potential indications. The system requires no advance shaping, conforming to the shape of the bone while the plate is screwed into place.
- In July 2016, The Morning Call reported that the company received a $50,000 loan to conduct a series of trials on MBD’s plate and screw platform.
ORTHOCLIP
- Developer of novel medical devices that provide simple local delivery of therapeutic agents to inhibit and treat infection around surgical implants. Initially, focus has been on devices used in fracture repair and spinal fusion for both human and animal markets. OrthoClip is the first spinout of Palmetto Biomedical, a medical device design and consulting firm.
- May 2017, OrthoClip was issued U.S. Patent No. 9,642,658 B2, “Device and Method for Delivery of Therapeutic Agents Via Internal Implants.”
- Company is viable and active per state filings.
PARAGON 28
- Focuses exclusively upon specialization and innovation for the 28 bones of the foot.
- Since the report, company has received FDA clearance for a variety of screws, an osteotomy wedge, a staple, etc.
- The company’s launches of plates, allograft, screws, etc. are too numerous to list here.
SONOMA ORTHOPEDICS
- Acquired by Arthrex in 2017.
- 510(k)s since the report include systems for repair of the fifth metatarsal and fibula, and a cancellous bone screw and washer.
- In late 2014, the company received a $12MM investment to support FDA clearance and launch of an ankle implant for fracture fixation.
STABILIZORTHO
- Stabiliz’s system comprises active screws and active plates made from standard alloys and containing a bioresorbable portion that mates with the locking plate.
- No updates since report. Still a viable company.
TISSUE REGENERATION SYSTEMS
- Developer of scaffold and coating technologies for use in skeletal reconstruction.
- In 2017, DePuy Synthes Products acquired 3D printing technology from Tissue Regeneration Systems to offer patient-specific, bioresorbable implants to treat orthopaedic and craniomaxillofacial deformities and injuries.
TYBER MEDICAL
- Maker of headless and headed compression trauma screws, stainless steel cannulated drills and a full line of spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK, a proprietary titanium plasma sprayed PEEK.
- Six 510(k) clearances since the report, including screws, a PEEK wedge and an interbody spacer.
- In 2016, the company was awarded a $362,500, 10-year state loan to purchase equipment for in-house fabrication.
- In mid-2016, the company’s interbody spinal device line was accepted into the Australian Registry of Therapeutic Goods.
- Launches since the report include a low profile lateral plate, the TyWedge™ Osteotomy Wedge, the sterile Forefoot Procedure Kit of implants and instruments and the TyFix™ all-in-one sterile-packed extremity joint fixation system.
WOVEN ORTHOPEDIC
- Developer of the OGmend Implant, comprising a biotextile/biopolymer to enhance fixation in the short- and long-term.
- Per CrunchBase, the company has raised $29.4MM overall (of that, $20.8MM since our 2014 report).
- Target markets are trauma and spine, with future verticals including joint reconstruction, sports medicine, CMF, dental and veterinary.
- As of May 2017, the company began distributing its woven biotextile devices in Australia and New Zealand for use in human patients.
- In pursuit of U.S. (FDA De Novo submission 4Q16) and EU (spine submission 4Q16, trauma submission 1Q17) clearances, and noted interest in regions like Hong Kong and Singapore.
These 16 companies remain at different stages in their business lifecycles, demonstrating the difficulty of competing in the orthopaedic market. While they had different technologies and market approaches, those focused on the extremities implant or hardware market, to no surprise, seem to have experienced the greatest advancements in terms of commercialization of new products and securing funding.
Sources: ORTHOWORLD Inc., company websites, press releases, SEC filings, information in the public domain; images courtesy of manufacturers.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant. Reach her by email.
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
