Funding thus far in 2019 has driven research & development and regulatory activity for companies working to get their first product on the market and those seeking to expand globally. Here we describe nine companies with novel technologies—from cobalt chrome additive knees to magnesium ACL screws to the storied Barricaid technology—that have boosted their capital with outside investments. Of note, the venture capital fund cultivate(MD) backed three of the nine companies mentioned.
Rejoint received a €3MM (~$3.4MM) grant from the EU’s Horizon 2020 SME Innovation and Research Program as a recipient of the Fast Track to Innovation award. Funds will support commercialization of YourKnee, a cobalt chrome total knee replacement system, with an approach that combines elements of 3D printing, patient-specific implants, artificial intelligence and wearables to design personalized implants, surgical simulation and post-op rehabilitation tools for every patient. Mechanical testing of the system was successfully completed in 4Q18.
ApiFix completed a Series B equity financing. The company is pursuing 2019 FDA clearance and subsequent U.S. launch of MID-C for the treatment of scoliosis in young patients. Minimally Invasive Deformity Correction (MID-C) is a posterior dynamic deformity correction system that supports curve correction while retaining spine flexibility. The removable system acts as an internal brace and employs a patented unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints, allowing additional post-operative correction over time. Palm Tree IV, a new U.S.-based investor, led the round with participation from existing shareholders.
HAPPE Spine received a second round of financing from Genesis Innovation Group with investments from cultivate(MD) Capital Funds I and II. The company is developing a material technology that allows PEEK to be both porous and bioactive, osteointegrative and radiolucent. Proprietary molding methods support the manufacture of material with fully interconnected porosity, including hydroxyapatite whisker exposure throughout to promote bony ingrowth onto and within an implant. A unique manufacturing method can vary the implant density or porosity optimize osteointegration and biomechanical loading.
HAPPE Spine plans to submit a cervical implant for FDA clearance during 2019.
Intrinsic Therapeutics completed a $52MM Series Growth equity financing. Proceeds will support U.S. commercialization of the Barricaid anular closure device, which is used after discectomy to treat herniated discs. In all, the company has raised ~$219MM in over 10 rounds of funding. The company received FDA Premarket Approval for Barricaid in 1Q19.
Questa Capital led this funding round, with participation from existing investors New Enterprise Associates, Greenspring Associates, Quadrille and Delos Capital.
Embody received $3.6MM led by the cultivate(MD) Capital Fund II. The infusion will support pre-launch and pre-commercial activities for the Tapestry collagen-based microfiber implant, used in Achilles tendon and rotator cuff repairs. Tapestry’s design is based on research of collagen increasing the activity of recellularization by growing new aligned tissue over surgical repairs. Studies will seek to prove that scarring is minimized, and post-op rehabilitation accelerated.
In 2018, Embody received $12.1MM in DARPA funding and an R&D contract, which funded product development.
Hyalex Orthopaedics raised additional funding in expansion of its Series A, increasing from $16MM to $33MM. The company is developing HYALEX synthetic polymer that is designed to mimic hyaline cartilage. HYALEX material can maintain an extremely low wear profile, even at high loads such as those in human joints. Hyalex seeks to retain the joint’s natural anatomy and replace only the lesions in the diseased portion of a joint.
The Series A was originally funded in 2017. In the increase, new investors Strategic Healthcare Investment Partners and DSM Venturing (the venture arm of Royal DSM) joined existing investors Canaan, Osage University Partners and Johnson & Johnson Innovation – JJDC Inc.
Magnesium Development (MDC) received an investment from the cultivate(MD) Capital Fund II. MDC is developing a resorbable magnesium alloy technology that has the same mechanical strength as 316L stainless steel and application in numerous orthopedic implantable devices. The proprietary alloy combines the strength and handling properties of metal with total and controllable absorption. Further, its manufacturing method provides mechanical strength that is reportedly twice that of PEEK polymer. MDC will use it to produce interference screws for anterior cruciate ligament repair, sports medicine anchors, plates, screws and wires for foot and ankle procedures, as well as trauma applications.
Trice Medical (main article image) closed a $18.3MM Series C Extension financing round. Proceeds will support worldwide commercialization of mi-eye 2 and mi-ultra, as well as product development. The company plans to enter large multinational partnerships, per leadership comments.
mi-ultra is a high-powered 15mHz handheld ultrasound transducer optimized for musculoskeletal applications, for use at the first point of care. mi-eye 2 is a handheld, single-use tool comprising a wide-angle camera lens embedded in a disposable needle. Physicians can complete diagnosis on the spot in a clinic, under local anesthetic.
The funding round was led by Charter Capital Partners and the Municipal Employees’ Retirement System of Michigan. Other investors in Trice include Smith & Nephew, Safeguard Scientifics, HealthQuest Capital and BioStar Ventures.
Graftys completed a €4.1MM (~$4.6MM) funding round. Graftys markets Graftys QuickSet calcium phosphate cement and Graftys HBS injectable calcium phosphate bone graft substitute through distribution partnerships in over 25 countries.
Proceeds will support global expansion by building new commercial/business development, clinical/regulatory and production capabilities in Belgium; reinforcing cement bulk production and creating a design unit in France; developing current markets such as Europe and the U.S.; and entering markets where Graftys has no current presence, such as Asia.
Sources: company press releases, websites, ORTHOWORLD®