Sean Fenske, Michael Barbella, & Sam Brusco, ODT Editors08.17.21
For the last five years, ODT has been chronicling orthopedic companies emerging in the shadows of the revered Top 10. Each year, the ODT editors research the orthopedic rising stars, hidden gems, and diamonds in the rough that pique their interest because of the unique musculoskeletal solutions they offer.
The editors decided after five years of spotlighting companies making their way into the market, it was high time for a checkup on their latest escapades. Some released new technologies, some welcomed firms into their fold, and some were even acquired themselves—emerging just a little farther from their relative obscurity into the mainstream.
ReWalk Robotics
The company earned CE mark certification for its ReStore Exo-Suit stroke rehab device in May 2019, and FDA clearance a month later. Originally developed at Harvard’s Wyss University, its soft, garment-like design connects to a lightweight waist pack and mechanical cables that help lift the patient's affected leg in synchronized timing with their natural walking pattern. The device also provides extensive data during gait training.
4WEB Medical
The firm achieved 510(k) clearance for its Cervical Spine Truss System-Stand Alone (CSTS-SA) Interbody Fusion Device in August 2019. CSTS-SA was formally launched in November of that year. Its complete, zero-profile, construct solution eliminates the need for traditional plate and screw fixation. The Stand-Alone Anterior Spine Truss System rolled out in October 2020. FDA clearance was gained for the Lumbar Plating System in March of this year, and was commercially launched in May.
Paragon 28
Since Paragon 28 was last featured, the company has rolled out a bevy of new products: Gorilla NC Fusion plates (Aug. 2017); Baby Gorilla 5th metatarsal hook plates, Gorilla ankle fracture plates—posterior plates (Sept. 2017); Gorilla ankle fracture plates—Hook plates (Nov. 2017); Gorilla lateral column plates (Dec. 2017); HammerTube Hammertoe system, Joust beaming screw system (March 2018); Expansion to JAWS nitinol staple system (April 2018); Cut Guide System, Bone Graft Harvesting System (July 2018); Gorilla breakaway screw system (Sept. 2018); Baby Gorilla Zig Zag plates and Medial Talar Neck Plate (Oct. 2018); TenoTac soft tissue fixation system (Feb. 2019); Small Bone Phantom 3-hole IM nail (March 2019); Silverback ankle fusion plates (Aug. 2019); PRECISION reduction guide (Oct. 2019); Sterile kits for HammerTube Hammertoe System, TenoTac soft tissue fixation system (Nov. 2020); AVITRAC MTP revision system (Dec. 2019); Paratrooper plantar plates, Phantom ActivCore nail system, Phantom Hindfoot TTC/TC system, larger implant option for TenoTac soft tissue fixation system (Feb. 2020); APEX 3D total ankle replacement system, Gorilla ankle fracture Pilon plating system (July 2020); Phantom ActivCore hindfoot nail system (Aug. 2020); Silverback ankle fusion posterior plating system (Nov. 2020); MgNum magnesium-based Bone Void Filler (Feb. 2021); MAVEN PSI System for APEX 3D total ankle replacement system positioning, BEAST injectable putty, BEAST PLUS, and BEAST osteobiologic sponge (May 2021).
The company also acquired Additive Orthopaedics’ product lines this past June—the 3D-printed patient-specific talus spacer and pre-op surgical planning.
Bioness
Bioness was acquired by active healing and orthobiologics firm Bioventus in a $110 million deal in March this year. The company then became a wholly-owned Bioventus subsidiary. The firm generated about $40 million in revenue in 2020, according to a company press release.
Mainstay Medical
This past February, Mainstay Medical closed equity financing that raised $108 million in proceeds to support the company’s commercial launch of ReActiv8 in the U.S., continued European and Australian expansion, post-market clinical studies and research, and general operations.
Limited ReActiv8 U.S. commercial launch took place in June. To support the launch, the firm rolled out a new corporate website focused on patient and physician education. Mainstay Medical also introduced updated tools, guidance, and training materials to help identify prospective ReActiv8 patients, educate physicians about the system and becoming certified to implant it, and help patients access the technology.
CyMedica Orthopedics
CyMedica completed 159 patient enrollments and launched a rollover study for an e-vive knee osteoarthritis (OA) pain relief clinical trial last June. The rollover study was activated to allow therapy continuation for an additional 14 weeks of treatment to bolster the parent trial’s results. It included subjects already randomized into the original trial.
The firm won FDA clearance for IntelliHab to treat knee OA pain in June this year. The FDA nod made IntelliHab the only neuromodulation strengthening therapy indicated to treat pain associated with OA. IntelliHab is expected to roll out in the U.S. this fall.
Kaia Health
Kaia Health published study results in the Journal of Pain Research last July that showed the firm’s pain management app reduced pain levels, anxiety, depression, stress, and improved wellbeing and body functionality significantly more compared to painkillers, surgeries, or physical therapy. Around the same time, the company received $26 million in Series B funding.
This past February Kaia unveiled Kaia Gateway and Premium Partners, its next-generation complete musculoskeletal care solution for U.S. employers and health plans. It contains a clinical triage algorithm and AI-enabled escalation algorithm to monitor clinical and behavioral patterns. Two months later, the firm completed a $75 million Series C funding round to grow its commercial team and accelerate product and partnership development, as well as expand the offering to COPD care.
Xenco Medical
This past June, Xenco unveiled HoloMedX—a glasses-free holographic surgical simulation platform. Users can simulate spine surgery in holographic space without headgear or glasses. The platform translates CT and MRI scan data into a detailed, holographic reconstruction. Holographic anatomy and implants are manipulated with air controllers modeled after the company’s disposable instruments. The holographic implant library is based on Xenco’s single-use spinal implants.
Conventus Ortho
Last May, Conventus completed a deal for single-use, sterile-packaged implant and instrument kit maker Flower Orthopedics. The firm gained the FlowerCube system, which removes expensive set processing, enabling back-to back cases, enhancing efficiencies, and maximizing resources.
In April this year, Conventus-Flower began a partnership with Red One Medical, a private sector scout of medical innovation for the VA and DoD. The firm’s Ready-For-Surgery portfolio will support the country’s service men and women.
I.Ceram SA
Though it had existed for more than a decade, I.Ceram SA was relatively unknown in orthopedic circles at the time of its ODT debut five years ago. Sixteen months earlier, in March 2015, the French firm announced the first clinical implant of its ceramic sternum.
The CERAMIL Sternum is totally inert and biocompatible with a high mechanical resistance, according to the company. Its porosity—similar to human bones—allows cell circulation and osseointegration within six months, boosting post-surgical thorax flexibility and improving patients’ quality of life.
A June 23, 2015, news release touting the CERAMIL Sternum implant stated that I.Ceram “confirms and reinforces its will to be a major actor in bioceramic implants or all type of bone infections.”
I.Ceram is not quite a “major actor” just yet, but it’s well on its way. Since appearing in the pages of ODT in 2016, the firm has forged sternum distribution partnerships in 10 European countries, received CE mark certification for its unloaded sternal implant (July 2018), and expanded its CERAMIL product line to femoral bone infections and cranioplasty applications.
In addition, the company received a 705,000 euro development grant from the French government in late 2017 and acquired a stake in surgical instrument manufacturer Dussarte Company in January 2019. I.Ceram said the deal would allow the firm to develop an instrument kit for its sternal implant, integrating suture threads and needles. “This kit could be delivered with the implant and will offer a turnkey solution to surgeons who will immediately have the appropriate anchoring solution,” a news release read. “This possibility will mechanically optimize future implantations, especially abroad.”
OrthoPediatrics Corp.
Arguably one of the most successful emerging companies profiled in ODT, OrthoPediatrics Corp. has morphed into a major force in the pediatric orthopedic implant market. Five years ago, the firm had a monopoly on the sector with only a handful of products and one U.S. Food and Drug Administration (FDA) clearance. Since then, it has become a publicly-traded company (raising $59.8 million in a 2017 IPO) increased its net sales 56 percent, and launched more than a dozen new products. It markets 35 surgical systems that address pediatric trauma and deformity correction, scoliosis, and sports medicine, and its trauma/deformity correction product line alone consists of more than 5,200 implants and bone fixation devices for the femur, tibia, upper and lower extremities, and external fixation.
Such growth prompted the company to expand its Warsaw, Ind., headquarters in 2018. The $1 million project doubled the firm’s existing warehouse and created additional open-concept office space as well as dedicated training and education facilities.
OrthoPediatrics has grown through acquisition, too. In June 2019, the company purchased foot and ankle surgery company Vilex Inc. for $60 million, adding the firm’s Orthex Hexapod circular fixation technology to its lineup. The deal expanded Orthopediatrics’ treatment capabilities in such pediatric congenital deformities and limb length discrepancies as fibula and tibia hemimelia, radial clubhand, ankle equinus, Blount’s disease, genu recurvatum, and multiapical deformities.
“This transaction closes the biggest gap in our Trauma & Deformity product offering,” former President and CEO Mark Throdahl said, “[increasing] our coverage of the Trauma & Deformity market from 60 percent to 80 percent.”
Six months after purchasing Vilex, OrthoPediatrics divested the adult portion of the business for $25 million to Squadron Capital, which loaned OrthoPediatrics $30 million to buy the company.
Then, four months after the divestment, OrthoPediatrics acquired ApiFix, a Boston and Israel-based startup that received a humanitarian device exemption from the FDA in August 2019 for a device alternative to spinal fusion surgery for treating progressive adolescent idiopathic scoliosis. The company’s MID-C system is an internal brace that corrects spinal deformity without restricting mobility.
“We believe ApiFix fills a major treatment gap that could potentially allow patients to avoid fusion surgery,” Throdahl said last April in announcing the deal. “The acquisition of this technology keeps OrthoPediatrics at the forefront of pediatric orthopedic care with a viable alternative to failed bracing and spinal fusion for the treatment of progressive scoliosis.”
Thanks to the ApiFix purchase and its four-year partnership with Englewood, Colo.-based Mighty Oak Medical, manufacturer of FIREFLY Pedicle Screw Navigation Guides, OrthoPediatrics has corrected more than 500 curved spines (scoliosis) since its 2006 birth. It also has conducted more than 1,000 procedures using its Pediatric Nailing Platform | FEMUR, and has treated 200,000 children globally with orthopedic-related conditions.
Tissue Regenix Group plc
The Leeds, England-headquartered regenerative medicine firm had recently closed a $30 million deal for CellRight Technologies at the time of its ODT profile in 2017. Designed to increase U.S. sales and bolster its presence in America’s healthcare market, the addition of CellRight’s bone regeneration technology was considered complementary to Tissue Regenix’s soft tissue-based platform.
Since closing the deal, Tissue Regenix launched DentalFix (dental biologics), and forged a multi-year distribution agreement with Arthrex Inc. for CellRight’s osteobiologic products. It also signed a distribution agreement with ARMS Medical to dispense DermaPure, a decellularized dermal allograft for soft tissue defects, to U.S. hospitals and surgeons for use in urology and gynecology procedures.
In 2018, Tissue Regenix partnered with Pennine Healthcare to distribute BioRinse products into the U.K. spine market, and last year, the company received CE mark certification for OrthoPure XT, a biological scaffold used to treat patients with a partial or complete tear of the anterior cruciate ligament (ACL). The tissue-regeneration device allows reconstruction of other knee ligaments, including multi-ligament procedures following trauma.
WishBone Medical Inc.
WishBone Medical Inc. has made significant strides in the pediatric orthopedic device market since breaking OrthoPediatrics’ monopoly in early 2017. In the past 36 months, the Warsaw, Ind.-based firm has released a bone pin system (including instruments) and a foot/ankle platform that includes K-Wire Kits and a full plating system for treating juvenile bunions, flatfoot, fractures and other conditions.
Like its rival, the company also has expanded its capabilities through M&A. In November 2018, for instance, WishBone Medical bolstered its supply chain by purchasing injection molded disposable instrument maker Red Star Contract Manufacturing. The procurement of Response Ortho that same month added more than 30 pediatric fixation systems to its lineup (18 of which were cleared or approved for the U.S. market), including the Smart Correction hexapod fixator and Click2Correct surgical preoperative planning software.
“With the acquisition of Response Ortho, we are thrilled about our pediatric orthopedic product offerings,” Board Chairman/CEO Nick Deeter, who founded OrthoPediatrics, said in a news release. “The combination of Response Ortho’s 30 product systems and WishBone’s eight product systems will give WishBone Medical the broadest product portfolio in pediatric orthopedics worldwide.”
WishBone Medical further augmented its portfolio in 2019 and 2020 with the purchases of CSpine Inc., Back 2 Basics Direct, and Orbbö Surgical. The deals enabled the company to enter a key pediatric market segment and address the needs of children with spinal deformities.
Besides the two acquisitions last year (B2B, Orbbö), WishBone Medical obtained $20 million in financing from LKCM Headwater Investments to meet rising demand for single-use procedure kits, and received FDA 510(k) clearance for its Smart Correction External Fixation System, which comprises hexapod external fixator hardware and proprietary planning software.
The Smart Correction System, however, is currently the subject of a patent infringement lawsuit initiated by OrthoPediatrics and Orthex LLC. The pair claim WishBone’s system infringes on their patented invention for external fixator positioning that “improves and automates bone adjustment, reduces guesswork, eliminates reliance on the patient, is more accurate than prior techniques, and simplifies external fixation,” according to the complaint.
The lawsuit also accuses WishBone Medical of advancing its “infringing, copycat system” despite knowing about the patented technology in June 2019. “Plaintiffs are innovators in the field and the patent-at-issue is groundbreaking,” the lawsuit states. “Defendants cannot compete fairly, so instead they have resorted to intentionally infringing Plaintiffs’ patent and disparaging Plaintiffs publicly. Defendants’ conduct has caused great damage to Plaintiffs, thereby necessitating this lawsuit.”
The spat is the latest salvo in longstanding hostilities between WishBone Medical and OrthoPediatrics. The two were embroiled in a legal dispute in early 2019 after OrthoPediatrics sued its rival and a former employee for allegedly violating state (Indiana) and federal trade secrets statutes. OrthoPediatrics accused the former employee, Robert von Seggern, of stealing trade secrets and giving them to WishBone Medical for use in developing pediatric orthopedic devices. OrthoPediatrics fired von Seggern in January 2017, and the defendant signed an agreement prohibiting him from “engaging in certain competitive activities” for 12 months after his termination, the lawsuit stated. WishBone Medical hired von Seggern as its chief commercialization officer shortly after he lost his job.
“OrthoPediatrics welcomes legitimate competition because that means more kids with pediatric orthopedic conditions will have greater opportunities to be helped,” Daniel Gerritzen, OrthoPediatrics vice president and general counsel, said in a statement. “However, we will not tolerate individuals or entities misappropriating our property, in part, to leapfrog years of design and testing work and avoid the significant monetary expense of bringing competing products to market. The trade secrets and confidential information we have become aware von Seggern and WishBone Medical misappropriated relates to aspects of our current Trauma and Deformity Correction medical devices.”
WishBone Medical responded by accusing its competitor of suppression. “Sadly, this legal campaign is designed to eliminate fair competition while doing nothing to promote improved outcomes for children. WishBone fully expects to be vindicated in this lawsuit.”
Emovi
The KneeKG developed by this Montreal-based medical device firm helps clinicians evaluate knee health while the joint is in motion and bearing weight. A computerized assessment provides data on dynamic alignment and other mechanical deficits.
Over the last two years, Emovi’s innovation has been used by doctors in Italy, France, Germany, Poland, Spain, the United Kingdom, and Singapore.
Miach Orthopaedics Inc.
Miach’s approach to torn ACL treatment is considered a paradigm shift from the current standard of care—reconstructing the ligament with a graft. Its less invasive bioengineered implant can potentially restore natural anatomy and knee function, according to the privately-held firm.
The BEAR Implant acts as a bridge between both ends of a torn ACL. The implant is injected with a small quantity of a patient’s own blood and then inserted into the torn ends of the ACL; the combination of the BEAR implant and patient’s blood promotes healing within the torn ends of the ACL while maintaining the ligament’s original attachments to the femur and tibia.
Last December, the Westborough, Mass.-headquartered company secured FDA de novo approval for its BEAR Implant. “FDA approval validates the decades of work our teams have put into this technology and is truly rewarding,” Martha Murray, M.D., founder of Miach Orthopaedics and professor of orthopedic surgery at Boston Children’s Hospital/Harvard Medical School said upon approval. “We are looking forward to seeing this technology become more widely available for patients everywhere.”
Naviswiss AG
This Swiss company provides miniaturized surgical navigation systems to help orthopedic surgeons accurately position acetabular implants. The navigated hip application is image-free and provides surgeons with cup alignment, leg length, and offset; it also includes a single tray of surgical instruments and supports minimally invasive surgery from various surgical approaches.
Over the last year, Naviswiss announced the first successful surgeries with its handheld hip navigation system in the United States and France, and entered a partnership with JRI Orthopaedics for surgical navigation systems distribution in the United Kingdom, Spain, and other European countries.
In April this year, the company added image-based planning and navigation to its handheld hip replacement navigation system. The new workflow includes Naviplan, a pre-operative planning tool that automatically analyzes computer tomography DICOM data and proposes the initial implant configuration.
Augmedics
The company’s revolutionary “x-ray vision” system made its clinical debut in June 2020. Utilizing the Augmedics xvision Spine System surgical guidance system, Dr. Frank Phillips, professor and director of the Division of Spine Surgery and the Section of Minimally Invasive Spine Surgery at Rush University Medical Center performed the first augmented reality minimally invasive spine surgery. He performed a lumbar fusion with spinal implants on a patient with spinal instability.
“Having 3-dimensional spinal anatomic and 2-dimensional CT scan images directly projected onto the surgeon’s retina and superimposed over the surgical field takes spinal surgery to another level,” said Dr. Phillips. “Being able to place minimally invasive spinal instrumentation extremely accurately and efficiently, reducing surgical time and complication risk, is critical to improving outcomes for spinal surgery.”
IlluminOss Medical
In 2020, IlluminOss Medical saw U.S. FDA clearances for a number of clinical applications of its Photodynamic Bone Stabilization System. These clearances expanded upon the indications for the technology to include treatment of fractures of the pelvis, clavicle, the small bones of the hands and feet (i.e., metacarpals, metatarsals, and phalanges), and fibula. Another clearance allowed the system to be used in femur and tibia fractures as supplemental fixation to FDA-cleared fracture fixation systems.
Conformis
The firm proudly announced the 100,000th implant of its patient-specific knee replacement technology. Conformis’ proprietary iFit Image-to-Implant technology platform is used to develop, manufacture, and sell patient-specific knee joint replacement implants designed to fit each patient’s unique anatomy.
The company also rolled out a similar technology to its custom knee solution but for the hip. This system gained FDA clearance in November 2019 and was supported with a full commercial launch. The Conformis Hip System iJigs work in conjunction with anatomic landmarks to ensure the proper placement and orientation of the femoral stem, as well as the acetabular cup. In addition, Conformis’ proprietary reamer system provides a single-use, patient-matched reaming solution that delivers efficient and accurate cup orientation to a controlled depth for each surgical case.
Bioventus
Bioventus has remained quite active in launching new biologics solutions for the orthopedic space since it was featured in ODT’s emerging companies feature back in 2016. The most recent news for the firm, however, involved growth through another means—acquisition. Just prior to this issue going to print, the organization announced it was set to purchase Misonix in a cash and stock transaction worth approximately $518 million. Misonix is a provider of minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products.
The editors decided after five years of spotlighting companies making their way into the market, it was high time for a checkup on their latest escapades. Some released new technologies, some welcomed firms into their fold, and some were even acquired themselves—emerging just a little farther from their relative obscurity into the mainstream.
ReWalk Robotics
The company earned CE mark certification for its ReStore Exo-Suit stroke rehab device in May 2019, and FDA clearance a month later. Originally developed at Harvard’s Wyss University, its soft, garment-like design connects to a lightweight waist pack and mechanical cables that help lift the patient's affected leg in synchronized timing with their natural walking pattern. The device also provides extensive data during gait training.
4WEB Medical
The firm achieved 510(k) clearance for its Cervical Spine Truss System-Stand Alone (CSTS-SA) Interbody Fusion Device in August 2019. CSTS-SA was formally launched in November of that year. Its complete, zero-profile, construct solution eliminates the need for traditional plate and screw fixation. The Stand-Alone Anterior Spine Truss System rolled out in October 2020. FDA clearance was gained for the Lumbar Plating System in March of this year, and was commercially launched in May.
Paragon 28
Since Paragon 28 was last featured, the company has rolled out a bevy of new products: Gorilla NC Fusion plates (Aug. 2017); Baby Gorilla 5th metatarsal hook plates, Gorilla ankle fracture plates—posterior plates (Sept. 2017); Gorilla ankle fracture plates—Hook plates (Nov. 2017); Gorilla lateral column plates (Dec. 2017); HammerTube Hammertoe system, Joust beaming screw system (March 2018); Expansion to JAWS nitinol staple system (April 2018); Cut Guide System, Bone Graft Harvesting System (July 2018); Gorilla breakaway screw system (Sept. 2018); Baby Gorilla Zig Zag plates and Medial Talar Neck Plate (Oct. 2018); TenoTac soft tissue fixation system (Feb. 2019); Small Bone Phantom 3-hole IM nail (March 2019); Silverback ankle fusion plates (Aug. 2019); PRECISION reduction guide (Oct. 2019); Sterile kits for HammerTube Hammertoe System, TenoTac soft tissue fixation system (Nov. 2020); AVITRAC MTP revision system (Dec. 2019); Paratrooper plantar plates, Phantom ActivCore nail system, Phantom Hindfoot TTC/TC system, larger implant option for TenoTac soft tissue fixation system (Feb. 2020); APEX 3D total ankle replacement system, Gorilla ankle fracture Pilon plating system (July 2020); Phantom ActivCore hindfoot nail system (Aug. 2020); Silverback ankle fusion posterior plating system (Nov. 2020); MgNum magnesium-based Bone Void Filler (Feb. 2021); MAVEN PSI System for APEX 3D total ankle replacement system positioning, BEAST injectable putty, BEAST PLUS, and BEAST osteobiologic sponge (May 2021).
The company also acquired Additive Orthopaedics’ product lines this past June—the 3D-printed patient-specific talus spacer and pre-op surgical planning.
Bioness
Bioness was acquired by active healing and orthobiologics firm Bioventus in a $110 million deal in March this year. The company then became a wholly-owned Bioventus subsidiary. The firm generated about $40 million in revenue in 2020, according to a company press release.
Mainstay Medical
This past February, Mainstay Medical closed equity financing that raised $108 million in proceeds to support the company’s commercial launch of ReActiv8 in the U.S., continued European and Australian expansion, post-market clinical studies and research, and general operations.
Limited ReActiv8 U.S. commercial launch took place in June. To support the launch, the firm rolled out a new corporate website focused on patient and physician education. Mainstay Medical also introduced updated tools, guidance, and training materials to help identify prospective ReActiv8 patients, educate physicians about the system and becoming certified to implant it, and help patients access the technology.
CyMedica Orthopedics
CyMedica completed 159 patient enrollments and launched a rollover study for an e-vive knee osteoarthritis (OA) pain relief clinical trial last June. The rollover study was activated to allow therapy continuation for an additional 14 weeks of treatment to bolster the parent trial’s results. It included subjects already randomized into the original trial.
The firm won FDA clearance for IntelliHab to treat knee OA pain in June this year. The FDA nod made IntelliHab the only neuromodulation strengthening therapy indicated to treat pain associated with OA. IntelliHab is expected to roll out in the U.S. this fall.
Kaia Health
Kaia Health published study results in the Journal of Pain Research last July that showed the firm’s pain management app reduced pain levels, anxiety, depression, stress, and improved wellbeing and body functionality significantly more compared to painkillers, surgeries, or physical therapy. Around the same time, the company received $26 million in Series B funding.
This past February Kaia unveiled Kaia Gateway and Premium Partners, its next-generation complete musculoskeletal care solution for U.S. employers and health plans. It contains a clinical triage algorithm and AI-enabled escalation algorithm to monitor clinical and behavioral patterns. Two months later, the firm completed a $75 million Series C funding round to grow its commercial team and accelerate product and partnership development, as well as expand the offering to COPD care.
Xenco Medical
This past June, Xenco unveiled HoloMedX—a glasses-free holographic surgical simulation platform. Users can simulate spine surgery in holographic space without headgear or glasses. The platform translates CT and MRI scan data into a detailed, holographic reconstruction. Holographic anatomy and implants are manipulated with air controllers modeled after the company’s disposable instruments. The holographic implant library is based on Xenco’s single-use spinal implants.
Conventus Ortho
Last May, Conventus completed a deal for single-use, sterile-packaged implant and instrument kit maker Flower Orthopedics. The firm gained the FlowerCube system, which removes expensive set processing, enabling back-to back cases, enhancing efficiencies, and maximizing resources.
In April this year, Conventus-Flower began a partnership with Red One Medical, a private sector scout of medical innovation for the VA and DoD. The firm’s Ready-For-Surgery portfolio will support the country’s service men and women.
I.Ceram SA
Though it had existed for more than a decade, I.Ceram SA was relatively unknown in orthopedic circles at the time of its ODT debut five years ago. Sixteen months earlier, in March 2015, the French firm announced the first clinical implant of its ceramic sternum.
The CERAMIL Sternum is totally inert and biocompatible with a high mechanical resistance, according to the company. Its porosity—similar to human bones—allows cell circulation and osseointegration within six months, boosting post-surgical thorax flexibility and improving patients’ quality of life.
A June 23, 2015, news release touting the CERAMIL Sternum implant stated that I.Ceram “confirms and reinforces its will to be a major actor in bioceramic implants or all type of bone infections.”
I.Ceram is not quite a “major actor” just yet, but it’s well on its way. Since appearing in the pages of ODT in 2016, the firm has forged sternum distribution partnerships in 10 European countries, received CE mark certification for its unloaded sternal implant (July 2018), and expanded its CERAMIL product line to femoral bone infections and cranioplasty applications.
In addition, the company received a 705,000 euro development grant from the French government in late 2017 and acquired a stake in surgical instrument manufacturer Dussarte Company in January 2019. I.Ceram said the deal would allow the firm to develop an instrument kit for its sternal implant, integrating suture threads and needles. “This kit could be delivered with the implant and will offer a turnkey solution to surgeons who will immediately have the appropriate anchoring solution,” a news release read. “This possibility will mechanically optimize future implantations, especially abroad.”
OrthoPediatrics Corp.
Arguably one of the most successful emerging companies profiled in ODT, OrthoPediatrics Corp. has morphed into a major force in the pediatric orthopedic implant market. Five years ago, the firm had a monopoly on the sector with only a handful of products and one U.S. Food and Drug Administration (FDA) clearance. Since then, it has become a publicly-traded company (raising $59.8 million in a 2017 IPO) increased its net sales 56 percent, and launched more than a dozen new products. It markets 35 surgical systems that address pediatric trauma and deformity correction, scoliosis, and sports medicine, and its trauma/deformity correction product line alone consists of more than 5,200 implants and bone fixation devices for the femur, tibia, upper and lower extremities, and external fixation.
Such growth prompted the company to expand its Warsaw, Ind., headquarters in 2018. The $1 million project doubled the firm’s existing warehouse and created additional open-concept office space as well as dedicated training and education facilities.
OrthoPediatrics has grown through acquisition, too. In June 2019, the company purchased foot and ankle surgery company Vilex Inc. for $60 million, adding the firm’s Orthex Hexapod circular fixation technology to its lineup. The deal expanded Orthopediatrics’ treatment capabilities in such pediatric congenital deformities and limb length discrepancies as fibula and tibia hemimelia, radial clubhand, ankle equinus, Blount’s disease, genu recurvatum, and multiapical deformities.
“This transaction closes the biggest gap in our Trauma & Deformity product offering,” former President and CEO Mark Throdahl said, “[increasing] our coverage of the Trauma & Deformity market from 60 percent to 80 percent.”
Six months after purchasing Vilex, OrthoPediatrics divested the adult portion of the business for $25 million to Squadron Capital, which loaned OrthoPediatrics $30 million to buy the company.
Then, four months after the divestment, OrthoPediatrics acquired ApiFix, a Boston and Israel-based startup that received a humanitarian device exemption from the FDA in August 2019 for a device alternative to spinal fusion surgery for treating progressive adolescent idiopathic scoliosis. The company’s MID-C system is an internal brace that corrects spinal deformity without restricting mobility.
“We believe ApiFix fills a major treatment gap that could potentially allow patients to avoid fusion surgery,” Throdahl said last April in announcing the deal. “The acquisition of this technology keeps OrthoPediatrics at the forefront of pediatric orthopedic care with a viable alternative to failed bracing and spinal fusion for the treatment of progressive scoliosis.”
Thanks to the ApiFix purchase and its four-year partnership with Englewood, Colo.-based Mighty Oak Medical, manufacturer of FIREFLY Pedicle Screw Navigation Guides, OrthoPediatrics has corrected more than 500 curved spines (scoliosis) since its 2006 birth. It also has conducted more than 1,000 procedures using its Pediatric Nailing Platform | FEMUR, and has treated 200,000 children globally with orthopedic-related conditions.
Tissue Regenix Group plc
The Leeds, England-headquartered regenerative medicine firm had recently closed a $30 million deal for CellRight Technologies at the time of its ODT profile in 2017. Designed to increase U.S. sales and bolster its presence in America’s healthcare market, the addition of CellRight’s bone regeneration technology was considered complementary to Tissue Regenix’s soft tissue-based platform.
Since closing the deal, Tissue Regenix launched DentalFix (dental biologics), and forged a multi-year distribution agreement with Arthrex Inc. for CellRight’s osteobiologic products. It also signed a distribution agreement with ARMS Medical to dispense DermaPure, a decellularized dermal allograft for soft tissue defects, to U.S. hospitals and surgeons for use in urology and gynecology procedures.
In 2018, Tissue Regenix partnered with Pennine Healthcare to distribute BioRinse products into the U.K. spine market, and last year, the company received CE mark certification for OrthoPure XT, a biological scaffold used to treat patients with a partial or complete tear of the anterior cruciate ligament (ACL). The tissue-regeneration device allows reconstruction of other knee ligaments, including multi-ligament procedures following trauma.
WishBone Medical Inc.
WishBone Medical Inc. has made significant strides in the pediatric orthopedic device market since breaking OrthoPediatrics’ monopoly in early 2017. In the past 36 months, the Warsaw, Ind.-based firm has released a bone pin system (including instruments) and a foot/ankle platform that includes K-Wire Kits and a full plating system for treating juvenile bunions, flatfoot, fractures and other conditions.
Like its rival, the company also has expanded its capabilities through M&A. In November 2018, for instance, WishBone Medical bolstered its supply chain by purchasing injection molded disposable instrument maker Red Star Contract Manufacturing. The procurement of Response Ortho that same month added more than 30 pediatric fixation systems to its lineup (18 of which were cleared or approved for the U.S. market), including the Smart Correction hexapod fixator and Click2Correct surgical preoperative planning software.
“With the acquisition of Response Ortho, we are thrilled about our pediatric orthopedic product offerings,” Board Chairman/CEO Nick Deeter, who founded OrthoPediatrics, said in a news release. “The combination of Response Ortho’s 30 product systems and WishBone’s eight product systems will give WishBone Medical the broadest product portfolio in pediatric orthopedics worldwide.”
WishBone Medical further augmented its portfolio in 2019 and 2020 with the purchases of CSpine Inc., Back 2 Basics Direct, and Orbbö Surgical. The deals enabled the company to enter a key pediatric market segment and address the needs of children with spinal deformities.
Besides the two acquisitions last year (B2B, Orbbö), WishBone Medical obtained $20 million in financing from LKCM Headwater Investments to meet rising demand for single-use procedure kits, and received FDA 510(k) clearance for its Smart Correction External Fixation System, which comprises hexapod external fixator hardware and proprietary planning software.
The Smart Correction System, however, is currently the subject of a patent infringement lawsuit initiated by OrthoPediatrics and Orthex LLC. The pair claim WishBone’s system infringes on their patented invention for external fixator positioning that “improves and automates bone adjustment, reduces guesswork, eliminates reliance on the patient, is more accurate than prior techniques, and simplifies external fixation,” according to the complaint.
The lawsuit also accuses WishBone Medical of advancing its “infringing, copycat system” despite knowing about the patented technology in June 2019. “Plaintiffs are innovators in the field and the patent-at-issue is groundbreaking,” the lawsuit states. “Defendants cannot compete fairly, so instead they have resorted to intentionally infringing Plaintiffs’ patent and disparaging Plaintiffs publicly. Defendants’ conduct has caused great damage to Plaintiffs, thereby necessitating this lawsuit.”
The spat is the latest salvo in longstanding hostilities between WishBone Medical and OrthoPediatrics. The two were embroiled in a legal dispute in early 2019 after OrthoPediatrics sued its rival and a former employee for allegedly violating state (Indiana) and federal trade secrets statutes. OrthoPediatrics accused the former employee, Robert von Seggern, of stealing trade secrets and giving them to WishBone Medical for use in developing pediatric orthopedic devices. OrthoPediatrics fired von Seggern in January 2017, and the defendant signed an agreement prohibiting him from “engaging in certain competitive activities” for 12 months after his termination, the lawsuit stated. WishBone Medical hired von Seggern as its chief commercialization officer shortly after he lost his job.
“OrthoPediatrics welcomes legitimate competition because that means more kids with pediatric orthopedic conditions will have greater opportunities to be helped,” Daniel Gerritzen, OrthoPediatrics vice president and general counsel, said in a statement. “However, we will not tolerate individuals or entities misappropriating our property, in part, to leapfrog years of design and testing work and avoid the significant monetary expense of bringing competing products to market. The trade secrets and confidential information we have become aware von Seggern and WishBone Medical misappropriated relates to aspects of our current Trauma and Deformity Correction medical devices.”
WishBone Medical responded by accusing its competitor of suppression. “Sadly, this legal campaign is designed to eliminate fair competition while doing nothing to promote improved outcomes for children. WishBone fully expects to be vindicated in this lawsuit.”
Emovi
The KneeKG developed by this Montreal-based medical device firm helps clinicians evaluate knee health while the joint is in motion and bearing weight. A computerized assessment provides data on dynamic alignment and other mechanical deficits.
Over the last two years, Emovi’s innovation has been used by doctors in Italy, France, Germany, Poland, Spain, the United Kingdom, and Singapore.
Miach Orthopaedics Inc.
Miach’s approach to torn ACL treatment is considered a paradigm shift from the current standard of care—reconstructing the ligament with a graft. Its less invasive bioengineered implant can potentially restore natural anatomy and knee function, according to the privately-held firm.
The BEAR Implant acts as a bridge between both ends of a torn ACL. The implant is injected with a small quantity of a patient’s own blood and then inserted into the torn ends of the ACL; the combination of the BEAR implant and patient’s blood promotes healing within the torn ends of the ACL while maintaining the ligament’s original attachments to the femur and tibia.
Last December, the Westborough, Mass.-headquartered company secured FDA de novo approval for its BEAR Implant. “FDA approval validates the decades of work our teams have put into this technology and is truly rewarding,” Martha Murray, M.D., founder of Miach Orthopaedics and professor of orthopedic surgery at Boston Children’s Hospital/Harvard Medical School said upon approval. “We are looking forward to seeing this technology become more widely available for patients everywhere.”
Naviswiss AG
This Swiss company provides miniaturized surgical navigation systems to help orthopedic surgeons accurately position acetabular implants. The navigated hip application is image-free and provides surgeons with cup alignment, leg length, and offset; it also includes a single tray of surgical instruments and supports minimally invasive surgery from various surgical approaches.
Over the last year, Naviswiss announced the first successful surgeries with its handheld hip navigation system in the United States and France, and entered a partnership with JRI Orthopaedics for surgical navigation systems distribution in the United Kingdom, Spain, and other European countries.
In April this year, the company added image-based planning and navigation to its handheld hip replacement navigation system. The new workflow includes Naviplan, a pre-operative planning tool that automatically analyzes computer tomography DICOM data and proposes the initial implant configuration.
Augmedics
The company’s revolutionary “x-ray vision” system made its clinical debut in June 2020. Utilizing the Augmedics xvision Spine System surgical guidance system, Dr. Frank Phillips, professor and director of the Division of Spine Surgery and the Section of Minimally Invasive Spine Surgery at Rush University Medical Center performed the first augmented reality minimally invasive spine surgery. He performed a lumbar fusion with spinal implants on a patient with spinal instability.
“Having 3-dimensional spinal anatomic and 2-dimensional CT scan images directly projected onto the surgeon’s retina and superimposed over the surgical field takes spinal surgery to another level,” said Dr. Phillips. “Being able to place minimally invasive spinal instrumentation extremely accurately and efficiently, reducing surgical time and complication risk, is critical to improving outcomes for spinal surgery.”
IlluminOss Medical
In 2020, IlluminOss Medical saw U.S. FDA clearances for a number of clinical applications of its Photodynamic Bone Stabilization System. These clearances expanded upon the indications for the technology to include treatment of fractures of the pelvis, clavicle, the small bones of the hands and feet (i.e., metacarpals, metatarsals, and phalanges), and fibula. Another clearance allowed the system to be used in femur and tibia fractures as supplemental fixation to FDA-cleared fracture fixation systems.
Conformis
The firm proudly announced the 100,000th implant of its patient-specific knee replacement technology. Conformis’ proprietary iFit Image-to-Implant technology platform is used to develop, manufacture, and sell patient-specific knee joint replacement implants designed to fit each patient’s unique anatomy.
The company also rolled out a similar technology to its custom knee solution but for the hip. This system gained FDA clearance in November 2019 and was supported with a full commercial launch. The Conformis Hip System iJigs work in conjunction with anatomic landmarks to ensure the proper placement and orientation of the femoral stem, as well as the acetabular cup. In addition, Conformis’ proprietary reamer system provides a single-use, patient-matched reaming solution that delivers efficient and accurate cup orientation to a controlled depth for each surgical case.
Bioventus
Bioventus has remained quite active in launching new biologics solutions for the orthopedic space since it was featured in ODT’s emerging companies feature back in 2016. The most recent news for the firm, however, involved growth through another means—acquisition. Just prior to this issue going to print, the organization announced it was set to purchase Misonix in a cash and stock transaction worth approximately $518 million. Misonix is a provider of minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products.
