ConforMIS & Bioventus
Sean Fenske • Editor

These companies were selected as part of this group due to their forward-thinking approach to the orthopedics sector. Both companies are employing technologies that represent the future for the industry. While one company reflects the movement toward personalized healthcare, the other leverages the body’s natural healing capabilities to achieve the ultimate outcome.

Custom 3D-Printed Knee Implants
ConforMIS is a medical device manufacturer that provides customized knee implants for patients. Utilizing the patient’s own radiology scans, an implant is specifically generated to each person’s unique anatomy via 3D printing technology. This technique optimizes the fit of the implant, resulting in a much greater chance the patient experiences less residual pain following surgery. The company also states that the custom implant offers a more natural feeling as the unique contours of each patient are preserved via the development and manufacturing process. Further, since the surgical guides are customized as well for each individual procedure, there is optimal bone preservation, according to ConforMIS.

“A satisfied patient is the ultimate goal of knee replacement,” said Gregory Martin, M.D., a fellowship-trained orthopedic surgeon in Boynton Beach, Fla., and clinical investigator in a study that found 92 percent of patients were satisfied on average at the one-year post-operative time point following total knee replacement with ConforMIS’ iTotal CR. “A growing body of clinical evidence continues to support my belief that customized implants improve important patient outcome measures like patient satisfaction. With the ConforMIS iTotal CR, I’ve seen a meaningful shift towards happier, more satisfied patients.”

In addition to the clinical advantages personalized knee implants present, there is another significant benefit to the ConforMIS solution. Since each implant is custom developed for the patient, there is no need for a hospital to maintain inventory of stock sizes of knee implants. The ConforMIS implant and guides are delivered just prior to the surgery, ready to be used in the operatory environment. The hospital doesn’t need to sterilize the contents of the package from the company, potentially saving additional costs from cleaning reusable instrumentation.

While custom knee implants are certainly a significant advancement in the orthopedics space compared to standardized stock options that could result in a poor fit for patients, the even greater opportunity for ConforMIS exists in other clinical applications. If the company is able to scale its custom solution technology for hip replacement, spinal degeneration, or other areas that would greatly benefit from the personalized approach the technology offers, it stands to make a substantial impact on the companies who also serve these spaces. Further, since many of the technologies and processes used in the implant development are patented by the company, competitors exploring custom options will need to develop a unique solution of their own that doesn’t infringe on the ConforMIS process. That’s a large impediment for companies who are already trailing behind in terms of the capability.

Helping the Body Heal Itself
Healthcare is currently in an era where patients view surgery as the “last resort.” At the same time, they are also seeking to avoid certain pharmaceuticals that may only treat a symptom of a problem, such as for pain management. In the orthopedic space, a third option might be the use of orthobiologics, a rapidly growing niche of the sector. In terms of medtech, this area leverages devices and technologies that enhance the body’s natural healing process. There are a number of orthopedic companies incorporating these products into their more traditional portfolio (several within the Top 10 companies report) to further enhance their offerings to patients and their physicians. Bioventus, however, is an example of a company that is solely focused on the use of orthobiologics and offers solutions that promote “active healing” over more invasive options.

According to the company’s website, “At Bioventus, we have a different approach to bone health that doesn’t involve drugs or surgery. We call this approach ‘active healing.’ Our products work with the body, enhancing the body’s natural healing processes.”

Bioventus offers several products that promote healing through different techniques and technologies. Its Exogen Ultrasound Bone Healing System is a device that can be used to treat certain types of bone fractures. Instead of surgery to secure the fracture with screws, the low-intensity ultrasound waves enhance the natural healing process to address the issue.
Another product, Supartz FX, addresses osteoarthritis of the knee. More specifically, it helps to eliminate the pain associated with the breakdown of the synovial fluid. The gel-like material is injected into the knee via a needle and helps to prevent the inflammation associated with the synovial fluid degradation.

Also, the company’s acquisition of BioStructures near the end of 2015 provided Bioventus with a portfolio of resorbable bone graft and related products for spinal surgical applications. While used by surgeons during an invasive procedure, the products are intended to support bone regeneration.

Bioventus aligns with the type of healthcare more patients are seeking. They don’t want a pill and they view surgical options as the last choice. A company that can provide a clinically proven alternative to both modalities stands to win over a good number of customers.

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ReWalk & Psyonic Inc.
Sam Brusco • Associate Editor

It’s not just hoverboards and particle accelerators; some medtech inventions take their cues from science fiction as well. In fact, the ongoing $10 million Qualcomm Tricorder XPRIZE competition—based on the titular medical Tricorder from Star Trek that diagnoses anything with a single scan—urges inventors to “turn science fiction into science reality.”

Ideas generated in science fiction can be fertile ground for medtech innovation, but could someone actually develop Luke Skywalker’s neurally controlled bionic hand or Darth Vader’s robotic exosuit? (Side note: isn’t it great that “Star Wars” is topical again?) Believe it or not, those particular fictional medtech examples aren’t all that far from reality.

Darth Vader’s Exosuit
“FDA-approved cyborg technology” is not a phrase you expect to hear. Amit Goffer, designer of the ReWalk powered robotic exoskeleton and founder of the Israeli startup ARGO Medical Technologies (now ReWalk Robotics Inc.), built a business on aspirations toward that phrase. But for such a sci-fi concept, ReWalk embarked on quite a humanitarian mission—returning the gift of mobility to paraplegics.

ReWalk Rehabilitation took its first bionic step onto the scene in 2011 with U.S. Food and Drug Administration (FDA) clearance for hospital and rehabilitation centers in the United States, Europe, and Asia. In the clinical rehabilitation environment, ReWalk proved successful as an exercise and physical therapy tool, offering spinal cord injury patients with upper body mobility the chance to build leg strength despite paraplegia.

But ReWalk, much like the patients using it, was determined to get out of the hospital. ReWalk Personal (the home-friendly version) was launched in stages; it was CE marked for home use in late 2012, cleared to sell in Canada in 2013, and finally powered into the United States with FDA approval for home use in June 2014. Since then, the bionic assistance device has undergone multiple iterations in design to make it sleeker, lighter, and smarter—the latest, ReWalk Personal 6.0, launched in July 2015.

If you aren’t up to speed on the latest in cyborg technology, ReWalk is a motorized exoskeleton worn over the legs and part of the upper body. It consists of a metal brace customized for the wearer supporting the legs and upper body; integrated motors that power movement at the hips, knees, and ankles; tilt sensors to detect changes in center of gravity; and a backpack containing the computer and power supply. (Up until ReWalk 6.0, that is, which removed the backpack from the shoulders, further easing the burden. Its battery also lasts an entire day).

The device’s main obstacle is unfortunately one that it can’t walk right over—its price. ReWalk costs anywhere between $69,000 and $85,000, and as of May 2016 has only been reimbursed as part of a comprehensive policy by a commercial insurer once. A staggering issue no doubt—perhaps the dominoes will begin to fall as other insurers follow (exo)suit.

Luke Skywalker’s Bionic Hand
Prosthetics maker Psyonic Inc. is as startup as a startup can be, spun from the University of Illinois at Urbana-Champaign in 2015. Its short run has bore impressive fruit so far—Psyonic was awarded prizes at the 2015 Cozad New Venture Competition, the 2015-2016 VentureWell Stage, and 2015-2016 iVenture Accelerator. The company’s myoelectric prosthetic hand is still late in the prototyping stage.

So why mention a company that doesn’t have any financials to report? Put simply, Psyonic aims to put advanced sensory feedback and muscle recognition into—or rather, on—the hands of upper-limb amputees unable to afford replacement limbs.

The prosthetic itself is produced with a fairly recognizable manufacturing strategy—3D-printed in order to fully customize for the patient and keep the cost down to one-tenth the price of comparable technologies, according to Psyonic. The secret sauce (and the reason I’m highlighting the company) lies in the hand’s ability to produce sensory feedback and muscle pattern recognition.

Pressure sensors in the hand relay sensory information via electrical stimulation of the skin. That way, the wearer can actually “feel” vibration, tingling, or pressure upon making contact. What’s more, the hand intends to operate far beyond the “open and close” functionality of most similar prosthetics. Pattern recognition algorithms integrated into the technology can offer finer motor control than an amputee could ever dream of, including a “pinch grasp” with the thumb and index finger to hold a pencil; a “three-finger grasp” to grab a bottlecap or piece of candy; a generic “power grasp” to shake hands or hold a bottle; a “tool grasp” that lags the index finger behind to grip a drill; and a “key grasp” to hold…a key.

Oh, and a special congratulations to co-founder and CEO Aadeel Akhtar, who as of July 22 is Dr. Aadeel Akhtar, having successfully defended his thesis entitled “Mechanisms for Enabling Closed-Loop Upper Limb Sensorimotor Prosthetic Control.” It will be interesting to see how a startup whose initial R&D was conducted in a University lab will fare once Psyonic’s hand enters the market.

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I.CERAM & Orthopediatrics Corp.
Michael Barbella • Managing Editor

“Two roads diverged in a wood, and I—
I took the one less traveled by,
And that has made all the difference.”

— Robert Frost,  “The Road Not Taken”

Robert Frost’s most famous poem is arguably one of his most misunderstood. The narrative’s final three lines, wherein the author expresses contentment with his eventual choice of paths, are particularly susceptible to misinterpretation. Although the poem could conceivably be considered a testament to independent (free) thinking, Frost actually intended the prose to be a mockery of indecision—a nod, more or less, to the many walks he took with his close friend and (apparently indecisive) writer, Edward Thomas.

I.CERAM and Orthopediatrics are likely proponents of the former theory, having found success off the beaten path of traditional orthopedic product development. Both companies shunned well-traveled routes in joint repair technology and deformity correction to blaze new trails in ceramic and pediatric implants.

An MoM Alternative
Founded in December 2005, I.CERAM designs, manufactures, and markets alumina-based implants for bone infection and metastases treatment. The French company combines “different ceramic materials and processes” to create biocompatible, porous implants that promote bone ingrowth and become completely integrated with biological tissue within three to six months after implantation.

I.CERAM’s alumina-based devices include wedges, caps (used in neurosurgery to fill trephine-induced orifices during craniotomies), hip heads, cervical corpectomy blocks, semi-anatomical and inclined intersomatic cervical cages (for bone synthesis), intersomatic cylinders (used in neurosurgery), and intersomatic lumbar cages (used in lumbar spine procedures). Its Akile ankle prosthesis combines traditional orthopedic implant materials with ceramics, coating the device’s stainless steel tibial and talus components and high-density polyethylene intermediate piece with a double layer of alumina and a diamond-like carbon. The binary coating, research data show, helps reduce friction between implant components compared to other models on the market.

“The Akile is the only third-generation French ankle prosthesis with a ceramic coating,” CEO André Kérisit said in April, announcing the device’s first implantation in England. “The Akile has over five years of clinical experience that is an essential and important criteria for surgeons. This…confirms…the potential of ceramics in health-related applications.”

I.CERAM further confirmed ceramics’ potential last year with the debut of an alumina sternum that reportedly reduces infection risk compared to a titanium prosthesis or a device molded using bone cement. French doctors implanted ceramic sternums in two patients last year to treat cancer and a sternal infection, the latter of which occurs in roughly 4 percent of cardiovascular surgeries. The implant, developed in collaboration with Limoges University Hospital experts, is part of a pilot study that will form the basis of a larger clinical study, I.CERAM executives said.

Targeting a Lost Patient Population
Children are not small adults, yet they’re treated as such in the operating room.

Most orthopedic implants are designed for fully-grown bodies, which contain fewer bones (206 vs. 300) and heal more slowly than juvenile anatomies. That leaves limited options for surgeons tasked with treating pediatric fractures or bone deformities; in the past, doctors have treated these conditions with improvised adult devices—i.e., implants quickly and crudely modified in the OR to fit kids’ smaller chasses.

“Being little makes a big difference,” Orthopediatrics stated two months ago in a U.S. Securities and Exchange Commission filing outlining a $75 million IPO. “Historically, there have been a limited number of implants and instruments specifically designed for the unique needs of children. As a result, pediatric orthopedic surgeons often improvise with adult implants repurposed for use in children, resort to freehand techniques with adult instruments and use implants that can be difficult to remove after being temporarily implanted. These improvisations may lead to undue surgical trauma and morbidity. [Children’s] skeletal anatomy requires specialized implants and instruments designed to treat their orthopedic disorders appropriately.”

Orthopediatrics addresses this unmet market by developing and commercializing pediatric surgical systems for trauma, long bone deformity and correction, scoliosis, and sports medicine. The company expanded its trauma offerings in June by unveiling the PediLoc Infant Locking Proximal Femur Plating System, a device that treats hip deformity or fractures in babies; the infant-sized plates round out the firm’s PediLoc portfolio to address all patient ages and sizes, from infant to adolescent.

Orthopediatrics currently sells 17 surgical products, the first of which was launched two years after its 2006 founding. In its IPO filing, the Warsaw, Ind.-based company outlined plans to expand its product portfolio into the foot and ankle, hand and wrist, clavicle, and pelvis areas, quoting a goal of one new surgical system launch annually “for the foreseeable future.”

The company hopes to raise enough money through its IPO to support its cash needs for the next two years. Orthopediatrics reported $31 million in 2015 revenue, up 30.9 percent from the previous year; the firm, however, still lost $7.9 million and has yet to turn a profit. Most revenue is generated in the United States, although the company has been expanding overseas in recent years and now sells its products in 29 other countries. Implants and bone fixation devices to treat trauma and deformities accounted for 73 percent of the company’s 2015 revenue, up 16 percent from the previous year.

The largest investor in Orthopediatrics is Squadron Capital, a private equity investor in companies that develop and manufacture orthopedic implants.