Year in Review: Companies New on Our Radar in 2018

We’re constantly coming across new companies: in the news, new customers, at meetings. The pool of your peers just keeps growing, and it’s our mission to keep you aware of them.

Here’s a selection of those we identified throughout 2018, whether they were brand new or just new on our radar. All five major market segments are represented, and quite a geographical mix: Denmark, Finland, Israel, Italy, The Netherlands and the U.S.

I like GreenBone’s bamboo-to-bone transformation. What’s your favorite? Share your new companies with me via email.

JOINT RECONSTRUCTION

Rejoint | Bologna, Italy | Founded 2016 | rejoint.life

• Successfully completed mechanical testing of the YourKnee EBM Cobalt Chrome 3D-printed total knee arthroplasty system
• Approach combines elements of 3D printing, patient-specific implants,
• artificial intelligence and wearables to design personalized implants, surgical simulation and post-op rehabilitation
• First surgery will be performed in Italy in 1Q19, with partner Link Orthopaedics
• Limited launch slated for 2H19, following receipt of CE Mark approval

SPINE

FBC Device | Risskov, Denmark | Founded 2005 | fbcdevice.com

• Received first FDA 510(k) clearance in July, granted for the FBC 921 ALIF interbody
• Two-piece fusion device allows for in situ adjustment from nine to 21 degrees before locking
• Device articulation enables larger bone graft windows vs. expandable interbodies
• Also developed Statur-L, a hybrid of fusion and non-fusion technology designed to reduce the number of implants needed in a procedure

HAPPE Spine | Holland, MI, U.S. | Founded 2018 | happeortho.com

• Developed technology to construct partial or fully porous hydroxyapatite whisker-reinforced PEEK for spinal interbody implants and other potential applications throughout the body
• Hydroxyapatite Porous PEEK (HAPPE) provides the optimal mechanical properties of PEEK polymer as well as improved surface texture inviting bony engagement, interconnected porosity for long term fixation and the bioactive properties of HA to provide an effective construct for bone ingrowth; HA further improves mechanical properties above standard PEEK and optimizes imaging for post-operative diagnosis
• Funded by Genesis Innovation and cultivate(MD) Capital

Innovasive | Mission Viejo, CA, U.S. | Founded 2017 | innovasiveinc.com 3/2019 update: Innovasive has rebranded as Amplify Surgical

• Received FDA 510(k) clearance to market DualX titanium dual expanding interbody device for lumbar fusion; product launches by year-end
• Can expand in two independent directions: laterally, then vertically with lordosis to support restoration of sagittal alignment
• Designs address transforaminal, posterior and lateral lumbar interbody fusion
• Portfolio company of IntuitiveX, a life science innovation incubator
• Total funding $1.3MM to date
• See the dual expansion in action:

Vallum | Nashua, NH, U.S. | Founded 2015 | vallumcorp.com

• Received FDA 510(k) clearance to market a PEEK interbody fusion device with a PEEKplus nanotextured surface, created with proprietary Accelerated Neutral Atom Beam technology
• Reportedly the first FDA-cleared nanotextured surface on a PEEK interbody
• PEEKplus is not a coating, is not porous and no chemicals are infused into the PEEK
• Nanotexturing technology may be applied to any fully-manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties
• Management believes that its technology and processing protocols can be developed to improve other devices
• Raised just over $6MM in equity financing in 2017

TRAUMA

Imagen Technologies | New York, NY, U.S. | Founded 2016 | imagen.ai

• Received FDA de novo clearance to market OsteoDetect computer-aided software to detect and diagnose adult wrist fractures
• Uses an artificial intelligence algorithm to analyze 2-D x-ray images for signs of distal radius fracture, then marks the image
• Can be used in a wide range of settings: primary care, ER, urgent/specialty care, and can support early intervention in disease
• Raised $60MM to date from venture cap, health systems and technology entrepreneurs

OrthoSpin | Misgav, Israel | Founded 2014

• Completed first-in-human cases and a $3MM investment round for smart robotic external fixation system, led by Johnson & Johnson Innovation – JJDC; funds will support product development and clinical trial expansion
• Comprises a strut powered by a lightweight motor and a control box placed on top of the circular, hexapod fixation frame; automatically and continuously adjusts and lengthens struts according to a prescribed, pre-programmed treatment plan, obviating patient involvement
• Integrated software allows physicians to chart progress and adjust the regimen quickly, and a desktop or mobile interface allows real-time feedback
• Benefits include elimination of weekly status x-rays and a potential reduction in soft tissue damage, as the adjustments are small and incremental
• View the frame:

Osteo-Pharma | Oss, The Netherlands | Founded 2015 | osteo-pharma.com

• Raised  €4.5 MM (~ US $5.1MM) to support development for local treatment of bone fractures and defects using proprietary OsteoActivator technology
• Coated pericardial collagen membranes with enhanced guided bone regeneration for fracture healing and treatment of dental defects. Distal radius fracture healing clinical trial to start mid-2019 with the goal to show improved time-to-healing using OsteoActivator-F coated membranes placed directly onto fracture.
• OsteoActivator microspheres for intra-osseous treatment of spinal compression fractures or the intra-articular treatment of osteoarthritis
• OsteoActivator implants to improve osseointegration. Preclinical studies in rabbits yielded robust evidence for efficacy and safety.
• Has submitted a composition of matter patent application in various PCT countries. The patent was recently granted in Europe.

SYNOSTE | Espoo, Finland | Founded 2012 | synoste.com

• Raised €5.1MM (~US $5.9MM) to support clinical investigations and new application development while pursuing third-generation patient-friendly bone lengthening and deformity correction devices
• Total investments of €10MM, to date, including the AO Foundation-based AO Invest
• Using smart materials and a controllable treatment device, the company seeks to lower complication
• rates and enable faster recovery to daily activity
• The platform could enable various intelligent solutions, from traditional intramedullary nails to flat plates

ARTHROSCOPY/SOFT TISSUE REPAIR

Arcuro Medical | Misgav, Israel | Founded 2013 | trendlines.com/company/arcuro-medical

• In June, received FDA 510(k) clearance to market SuperBall knotless all-suture knee meniscus repair
• Entire procedure is performed inside the joint space using suture material only and requiring just one entry into the joint
• Has submitted patent applications in China, Israel, Europe and the U.S., and was recently granted a patent in the U.S.
• Key executives formerly with TAG Medical

Embody | Norfolk, VA, U.S. | Founded 2014 | embodyparts.com

• In September, raised $1.5MM to support development of a biologic treatment for Achilles tendon and rotator cuff injuries; builds upon the ~$13MM previously raised in a combination of a loan and grants (including Defense Advanced Research Projects Agency)
• Collagen-based nanofiber grafts, formed with electrospinning and microfluidic fabrication techniques, are resorbable and designed to mimic architecture of the native tendon
• Microfluidic techniques enable precise control of the molecular assembly of collagen into small-micron fibers with high “spatiotemporal fidelity;” precise placement of fibers during biofabrication may help address previous limitations in biomechanical performance
• Pursuing FDA clearance and intends to launch product in 2019
• Long-term goal to develop an engineered anterior cruciate ligament replacement

MIACH Orthopaedics | Boston, MA, U.S. | Founded 2016 | miachortho.com

• Closed $22.5MM round of Series A financing to support manufacturing and continued IDE clinical trials for Bridge-Enhanced ACL Repair (BEAR)
• Proprietary bio-engineered sponge used as a bridging scaffold to stimulate healing of a torn ACL; does not require autograft from healthy parts of the leg
• Preclinical studies suggest that knees treated with BEAR have a significantly lower rate of arthritis than those treated with traditional ACL reconstruction
• Initial research funding provided by the NFL Players Association, Boston Children’s Hospital and the National Institutes of Health
• See the bioengineered sponge in place:

ORTHOBIOLOGICS

Axolotl Biologix | Phoenix, AZ, U.S. | Founded 2016 | axobio.com

• Axolotl Biologix is an innovative leader of regenerative medicine through research, technology, and clinical application.
• Its fluid products are acellular, comprised of cellular secretions such as growth factors and cytokines. The company recently released their ambient temperature terminally irradiated fluid product in a preloaded syringe (Axolotl Shot™) and dual layer amnion membrane (Axolotl DualGraft™) for ease of use.

Datum Orthopedics | Har Adar, Israel | Founded 2018 | datum-orthobiologics.com

• Formed to develop bio-programmable collagen-based biomaterials with musculoskeletal applications
• Will first focus on bone grafts for use in fracture healing and spinal fusion
• Proprietary GLYMATRIX technology derives from sugars that crosslink collagen molecules to produce matrices that can be tailored for longevity, degradation rates, etc.
• Currently in a fund-raising round

GreenBone Ortho | Faenza, Italy | Founded 2014 | greenbone.it

• Developer of a process that transforms bamboo into a biomimetic bone substitute while preserving architecture that incorporates xylem-transporting channels, which mimic the way blood vessels run through bone
• For treatment of non-loaded and load-bearing skeletal segments such as long bone non-union fractures, spinal damage, trauma, infected bone
• Sheep study yielded robust evidence of safety and new bone formation with large bone loss in load-bearing bone; a multinational clinical development underway in 2018 includes two first-in-man clinical studies in patients with non-loaded and load-bearing long bone defects
• Company has raised €11.4MM (~US $13.5MM) since 2015

IMAGING

Turner Imaging | Orem, UT, U.S. | Founded 2017 | turnerxray.com

• Developer of Smart-C, a portable mini C-arm imaging system developed to support extremity x-rays at the point of care (hospital, clinic, ER, post-acute care center, etc.)
• 16-pound device is battery-powered and features a collapsible design, as well as an optional stand; an independent articulating arm can be detached for independent, tabletop use
• Not yet FDA-cleared
• View the arm and touchscreen tablet:
  

Sources: Company websites, press releases, information in the public domain, etc.; images courtesy of manufacturers