ConforMIS' CEO believes that Robotics is NOT the answer in Orthopedics

ConforMIS’ CEO Believes Robotics Is Not the Answer in Orthopedics (MDDI)
Dr. Phillipp Lang, who will leave ConforMIS as CEO when a replacement is named, believes robotics in total knee replacements is a marketing gimmick.
Many believe that robot-assisted surgery will transform how surgery is done and it will be a boon for both patients and surgeons.
One person who begs to differ is Philipp Lang, CEO of orthopedics company ConforMIS. The Massachusetts public company makes customized knees for people who are looking to get their knees replaced. ConforMIS uses the patient’s MRI or CT scans to create an implant that is for that patient alone fulfilling the company’s “One Patient One Implant” tagline.
That makes the company different from other orthopedic companies, large and small, that uses off-the-shelf implants of various sizes that surgeons can choose from when performing a total knee replacement. Even in robot-assisted surgery, where much of the variation is eliminated from standard total knee arthroplasty, the implants used are not custom.
Robotic surgery in orthopedics is a “marketing gimmick” charged Lang, in an interview with MD+DI in early March at the annual meeting of the American Academy of Orthopaedic Surgeons in Orlando where Stryker was showing off its Mako surgical robot. Lang added that the robot is merely an instrument that alters the surgical technique, but in terms of outcomes nothing can compare to the fit and function of a knee that is created based on an individual’s anatomy. [Since the interview, Lang has announced that he will resign as CEO but stay on until a successor is named. He he will remain on ConforMIS’ board.]
Lang also believes that the iTotal family of knees from ConforMIS is especially suited for a bundled payment environent that many hospitals in the U.S. are subject to. In these hospitals, Medicare will pay a fixed amount for a knee replacement for a period extending 72 hours before surgery all the way to 90 days following the procedure. Experts believe that many hospitals will look to dramatically cut costs in how they care for patients in the post-acute care – or the period right after surgery.
“Patients with ConforMIS implants are 2.5 times less likely to have an adverse event within 90 days,” he declared adding that these patients are also far less likely to be sent into a surgical nursing facility following the procedure compared with patients using off-the-shelf implants.
Studies have also shown that patients have report high satisfaction rates with their knee replacements when given custom knees. A surgeon, who is a paid consultant of ConforMIS, said he prefers the ConforMIS system because the company’s procedure results in happier patients who complain less of pain and imbalance. Dr. Robert Tait, a Nevada surgeon, described himself as being a  “frustrated surgeon” unable to help patients dissatisfied with their knee replacements until he discovered the ConforMIS implant which has made him enjoy his practice again.
Also from an operational perspective, it has been a big help. Tait performs eight surgeries on the day he does surgeries and on traditional systems it takes two hours to re-sterilize all the instrument trays used. He didn’t want to wait for trays to be sterilized so when Tait used Biomet knees in the past, he had the company bring four sets of instrument trays per surgery — 24 trays in all — in order for him to be able to get through all his patients needing surgeries.
“When I do ConforMIS they have two trays,” per surgery, he said, nothing that everything else is disposable.
ConforMIS has recently launched its iTotal PS (posterior stabilized) knee implant that executives hope will give the company a big boost since it triples the market that the company previously addressed from about 28% to 83%.
“We anticipate that iTotal PS will be the primary growth driver for full year 2016, with meaningful growth in the back half of the year,” wrote Gregory Chodaczek, an analyst with Sterne Agee, in a research note following the product’s launch in early March.
That customized total knee replacement saw better-than-expected demand in the first quarter that beat the company’s own forecast, Chodaczek wrote in a research note after the company reported its financial results last week.
Traditional players in the orthopedics space have responded to the increased demand for customization by developing patient specific instruments — like Zimmer — though they do not have custom knee implants.
It will be interesting to see what happens in 2017 when Stryker will launch it off-the-shelf Triathlon implant on its Mako robotic surgical system. Currently only one other company — OMNI — has a total knee approved and available on a surgical robot. FDA approved Stryker’s total knee on Mako, but the company’s CEO has decided to delay its launch pending two obesStryker’s CEO Kevin Lobo believes that the robot will be preferred by surgeons.
“If you look at a ConforMIS knee, once your implant is done, you’re done. It’s over,” Lobo said in an interview in early March. “You cut with the jigs in place. Frankly jigs are going to seem archaic compared to a robot that you can manipulate, you can make changes on the fly.
Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected]  and on Twitter @aparmarbb
 

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Is transparency the future of research? SI-BONE to share clinical trial data with the world

Transparency in research: SI-BONE to make clinical trial data accessible via Yale YODA Project (YaleNews)
With the ultimate goal of fostering transparency and improving the health of patients, the Yale University Open Data Access (YODA) Project has entered an agreement with SI-BONE, Inc. that will enable researchers across the world to gain access to the company’s key clinical studies of the iFuse Implant System®, a minimally invasive surgical device used to treat certain disorders of the sacroiliac joint.
SI-BONE will share data from their SIFI (Sacroiliac Joint Fusion With iFuse Implant System) study, and plans to share data from two additional trials within the next six months. This partnership establishes an independent process that promotes open science and has a goal of leveraging prior research investments to produce new knowledge.
The YODA Project, which is part of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation (CORE), will continue in its established role as a trusted intermediary and will perform an independent scientific review of requests for data access by non-study investigators. The YODA Project will have complete decision-making authority over the release of the data, which allows all requests for clinical data to be fairly judged and decided upon by an independent academic partner.
“This is a remarkable action by SI-BONE that should accelerate the movement of the clinical research enterprise toward more cooperative learning and sharing,” said Dr. Harlan Krumholz, professor of medicine and leader of the YODA Project. “By establishing this fair and independent process to release data, SI-BONE has embraced a position of leadership in this emerging era of open science.”
“Our mission at the YODA Project is to advocate for the responsible sharing of clinical research data in an effort to foster transparency and improve the health of patients,” said Dr. Joseph S. Ross, co-director of the YODA Project and associate professor of medicine and public health at Yale University. “The YODA Project applauds SI-BONE’s forward thinking and commitment to open science. This partnership reflects the best practices recently recommended by the National Academy of Medicine for the responsible sharing of clinical trial data. We hope SI-BONE’s action will encourage other entities engaged in clinical research, including industry and academia, to share clinical research data in an effort to inform the public and ultimately raise the quality of evidence used to make decisions for health and healthcare.”
Dr. Daniel Cher, vice president of clinical affairs at SI-BONE, said, “We believe that the individual outcomes data underlying clinical research studies in both the commercial and academic worlds should be available for secondary analysis and confirmation. Data-sharing ensures transparency and allows more detailed analysis of relevant clinical outcomes.”
This partnership is part of the larger YODA Project mission to promote scientific inquiry and lower barriers to data access. Access to these data will allow validation of clinical results, exploration of new hypotheses, and will promote the highest standards for clinical trial transparency and open science for medical device research.
 

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DePuy Synthes acquires BioMedical Enterprises' nitinol extremities implant business

J&J Company DePuy Synthes Buys San Antonio’s BioMedical Enterprises (Xconomy)
–> see all Mergers & Acquisitions in Orthopedics
BioMedical Enterprises, the San Antonio, TX-based maker of nickel-titanium alloy implants used to help small bones heal, has been acquired by a DePuy Synthes, a group of medical device companies owned by Johnson & Johnson (NYSE: JNJ). Terms were not disclosed.
DePuy is interested in BioMedical Enterprises (BME) because of the variety of implants the San Antonio company makes out of Nitinol, a nickel-titanium alloy, DePuy said in a statement. When implanted, Nitinol is able to “provide dynamic continuous active compression, which helps to promote healing after bone fixation,” DePuy spokeswoman Christie Corbett wrote in an e-mail.
BME’s implants are able change shape when exposed to predetermined temperatures, which helps with setting a bone, the company says on its website. The company’s public filings with the U.S. Securities and Exchange Commission indicate that it has raised less than $10 million since it was incorporated in 1991.
DePuy says BME will provide Johnson & Johnson with a more complete offering for physicians who specialize in feet, ankles, hands, and wrists—the primary targets of BME’s devices. The BME products are inserted into the body with a specialized tool that the company also provides, which is sterilized, pre-loaded, and disposable, DePuy said in a press release.
DePuy hasn’t determined the new organizational structure of the company, Corbett wrote, but added that BME’s employees and technologies are now a part of DePuy. DePuy Synthes already works in the foot, ankle, hand, and wrist markets for bone fixation related to trauma, as well as in markets for orthopedic deformities and tumor diseases, the company says.
BME works closely with another San Antonio company, CellRight Technologies, which makes cadaver-derived bone and tissue grafts. Some of CellRight’s products—which are sterilized in a way that lets the product be used in a patient’s body without losing a protein thought to be helpful in bone grafting—are listed on BME’s website. BME announced what it called a partnership with CellRight in 2014.
CellRight CEO Jesus Hernandez says his company is an original equipment manufacturer for BME, and declined to provide any further detail because of a nondisclosure agreement. Hernandez says he isn’t sure what impact, if any, the acquisition might have on the manufacturing agreement.
The acquisition was made by a DePuy Synthes subsidiary, Westchester, PA-based DePuy Orthopaedics. Johnson & Johnson is based in New Brunswick, NJ.
BME President and CEO Keith Peeples did not return a call or e-mail for comment. Corbett said DePuy would not add anything beyond her e-mailed comments.

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The Status of Additive Manufacturing in the Orthopedics Industry

Additive Manufacturing Status in the Orthopedics Industry (Orthopedic Design & Technology)
see all 3D Printing stories
Implants expo organizer offers a brief synopsis of the sector.
Zimmer, one of the major orthopedic companies, penetrated this market 15 years ago with a proprietary technology acquired from Implex, thereby opening the trabecular structure market with an investment of several hundred million U.S. dollars.
In 1997, Zimmer used clinically trabecular metal based on the tantalum vapor deposit process for the hip cup. In 2007, Adler Ortho (Italy) used its first trabecular titanium cup—Fixa Ti-Por. Between 2008-2011, 109 Lima Delta TT cups were implanted in 98 patients. In 2009, Medtronic launched the Fuse Lumbar PLIF Cage made via additive manufacturing. In 2011, Exactech was the first U.S. company to offer FDA-cleared implants made via additive manufacturing technology; its Intergrip porous metal acetabular represented the first implantation.
The main benefit of additive manufacturing for orthopedics is the bone ingrowth capabilities. It also enables the manufacture of complex metal parts simultaneously for different sizes, shapes, and design. In the industrial field (mainly aeronautics), the additive manufacturing users are looking for weight reduction or advanced cooling.
Additive manufacturing is now a mature technology in orthopedics as it has been used for more than 15 years in the industry. With additive manufacturing, Italy offers the most advanced market; following Zimmer, the historical player, challengers like Lima Corporate and Adler Ortho have invested heavily in this technology. The main trabecular products are hip cups (several thousand are sold in Italy each year) followed by other products such as shoulder implants, knee tibial plates, and mini-hip stems.
Spinal cages manufactured via additive manufacturing represents one of the most dynamic orthopedic segments. For example, in Europe, PEEK cages are expected to lose market share (-4.5 percent CAGR by 2018) and titanium cages are anticipated to see a decrease of 2 percent in the five main countries. Meanwhile, additive manufacturing and trabecular cages are expected to increase by 19 percent and reach 61,000 units in 2018.
Industry Invests in Additive Manufacturing
In 2014, almost 25 orthopedic products that were manufactured via additive manufacturing received 510(k) clearance in the U.S. More specifically, Stryker, another major orthopedic company, has received 510(k) clearance for several orthopedic implants manufactured with additive manufacturing technologies. Stryker’s CEO, Kevin Lobo, announced that an additive manufacturing facility was being built in 2016, which partially accounted for a high level of planned capital expenditure (approximately $400 to $450 million). During the company’s Q4 2015 earnings call, the company’s CEO also said additive manufacturing knee implants bolstered sales of the company’s orthopedic devices. An additive manufacturing spinal implant is scheduled for launch this year, and the company has a “huge line-up of other divisions with ideas and prototypes to get into 3D-printed titanium products.”
In early 2016, Smith & Nephew announced the launch of the Redapt Revision acetabular fully porous cup manufacturered using additive manufacturing technology. The Redapt gained FDA clearance in November 2015.
Conclusion
In 2015, if the orthopedic industry used 1,500 to 2,000 tons of titanium, additive manufacturing required less than 50 tons (<3 percent of the total). This year, Lima Corporate will need almost 2 tons of titanium for additive manufacturing and Adler Ortho will require 0.7 tons.
From 2014-2021, the market growth for additive manufacturing in metal will be between 18 and 30 percent, according to several industry forecasts. Orthopedic applications will be one of most dynamic segments.
Since 1990, Ali Madani, the managing partner at Avicenne Consulting, has been working on strategic and marketing studies in the medical sector. He has advised major players in this industry (Medtronic, Stryker, Zimmer, Depuy, etc.) on strategy development and implementation, technical and economic appraisals, and mergers and acquisitions. Madani has also advised multiple private equities firms on acquisitions and build-up (Deals: Tecomet, Lima Corporate, Amplitude Ortho, Marle, etc.). He has also advised medium- and small-sized companies for market research and strategic partnerships in the U.S., Europe, and BRICs. In 2005, Madani founded the annual medical industry conference and exhibition, Implants, over which he has presided ever since.
 

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RoundTable Healthcare Partners to acquire Symmetry Surgical for $129M

RoundTable Healthcare Partners to Acquire Symmetry Surgical for $129M (HealthPointCapital)
RoundTable Healthcare Partners, a healthcare focused private equity firm, entered into an agreement to acquire Symmetry Surgical for an enterprise value of $129.5 million, valuing the business at 1.5x LTM revenues of $85.0 million, or 15.5x LTM EBITDA of $8.4 million.
Under the terms of the agreement, Symmetry shareholders will receive $13.10 in cash for each share of Symmetry common stock they own. The offer price represents a 26% premium to Symmetry’s closing price of its common stock on April 29, 2016.
Symmetry Surgical focuses on developing reusable, single-use and reposable general surgical instruments for the orthopedic, cardiovascular, arthroscopy, endovascular, neurovascular, ophthalmology, colorectal, gynecology, otolaryngology and pediatrics markets. The company has a product portfolio consisting of 20,000 products.
In August, 2016, Symmetry Surgical announced the divestiture of its Original Equipment Manufacturer (OEM) Solutions business, Symmetry Medical, which it sold to Tecomet for $450 million at 1.4x LTM revenues. The separation occurred in order to allow Symmetry Surgical to focus on the reusable general surgical instrument market, optimize its sales channels and cost structure, provide capital for a wider scope of strategic M&A in orthopedic implants and adjacent medical device marketplaces, and to free the company from the financial limitations associated with OEM customers. When Symmetry Surgical finally completed the divestiture, the new company closed its first day of trading at a stock price of $7.74.
The transaction is expected to close in the late 2Q:16 or early 3Q:16.

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