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Conformis to lay of 10% of workforce (MassDevice)

ConforMIS (NSDQ:CFMS) said yesterday that it plans to lay off about 10% of its workforce as it aims to put black ink in the ledger in 2021.

Billerica, Mass.-based ConforMIS, which makes customized knee and hip implants, had 350 employees as of Feb. 28, according to a regulatory filing. The cuts are expected to cost about $700,000 in severance and other exit charges during the fourth quarter, generating savings of more than $4 million next year, the company said.

“We are taking decisive actions to prioritize our highest-impact new product opportunities, our Conformis hip system and our cementless Press Fit total knee, which we believe provide us an opportunity to build a stronger, more sustainable business. As a result of these actions, we believe we can achieve profitability in 2021,” CEO Mark Augusti said in prepared remarks. “These actions included the difficult decision to part ways with many valued employees. On behalf of the entire company, I thank these colleagues for their many contributions to the business.”

Conformis also said it’s working to improve its balance sheet by paying down half of its $30 million debt facility with Oxford Finance.

With the reduced need for capital and to create an improved capital structure, Conformis and Oxford Finance LLC have entered into an amendment to their current Loan and Security Agreement. Under the amended agreement, the Company used cash on-hand to pay down $15 million of its $30 million debt facility, and thereby reduced the total debt outstanding to $15 million and the associated interest expense going forward. The amendment also adjusted certain financial covenants.

“We believe this new plan will help right-size the company, significantly lowering our cash needs,” added CFO Paul Weiner. “When combined with the planned continuation of gross margin improvements, we believe we can achieve cash flow breakeven within the next three years.”

The company said it expects a full commercial launch for the hip implant during the second half of 2019 and limited release of the iTotal G3 knee. The cementless knee product is slated for limited launch in early 2020, Conformis said, adding that it’s also eyeing “selectively identified opportunities” for its knee offerings outside the U.S. as it looks to offset weak sales in Germany.

“We recently achieved our 100th total hip arthroplasty case at Conformis and remain very positive about the status and value proposition of our Conformis hip system. One of our goals when identifying the cost reductions announced today was to insure that they do not affect our previously announced commitment and investment plans for full commercial launch of our Conformis Hip System in the second half of 2019,” Augusti said. “Entering the $7 billion hip arthroplasty market remains a key growth opportunity and a priority for the Company.”

DePuy is willing to pay $400M to settle Metal-on-Metal Hip cases

Report: J&J willing to pay more than $400m to settle Pinnacle hip cases (MassDevice)

Johnson & Johnson (NYSE:JNJ) is willing to put more than $400 million on the table to settle consumer allegations that its Pinnacle line of metal-on-metal hips were defective and caused problems including metal poisoning, according to a new report from Bloomberg.

Officials at the New Brunswick, N.J.-based company agreed to payments of approximately $125,000 per case on average to resolve about a third of the Pinnacle hips suit pending against the company, according to the report, which references people familiar with the settlement.

So far, J&J has settled or is in the process of settling approximately 3,300 out of 10,000 lawsuits targeting its Pinnacle line of hip-replacement devices, Bloomberg reports.

The $125,000 average payout would mean the company would need to pay approximately $413 million to settle the 3,300 cases, according to the report.

The medical giant is looking to resolve all remaining pinnacle cases before another trial begins next month, Bloomberg said, though the company remains in talks with lawyers for residual hip recipients who have sued.

The settlements mark the first payout after seven years of litigation over the metal-on-metal hip implants which were removed from the market in 2013, according to the report.

J&J has not yet officially commented on the settlements.

The company is set to return to court next month in Dallas, facing allegations from five Pinnacle-hip recipients that it rushed its Pinnacle device to the market and misled doctors about the device’s safety, according to Bloomberg.

Johnson & Johnson is reportedly seeking to settle cases with separate groups as handled by individual lawyers rather than one global settlement, the same tactic it used to resolve vaginal mesh cases.

In August, the Texas Northern District Court entered an approximately $246.1 million final judgement against J&J subsidiary DePuy Orthopaedics after a jury found J&J liable for defects and fraud related to Pinnacle hips.

The Future of Medical Education looks a lot like Netflix

The Future of Medical Education Looks a lot like Netflix: Interview with Brian Conyer, CEO of GIBLIB (MedGadget)

GIBLIB, named after Dr. John Heysham Gibbon, the revolutionary surgeon that invented the heart-lung machine, is an online streaming platform that provides medical professionals with access to high-fidelity, immersive 360-degree virtual reality (VR) video content of current medical topics and surgical procedures. The videos closely emulate the operating room environment, including camera angles from the surgeon’s point of view, and feature expert physicians at leading academic medical centers.

The company’s content provides students and medical professionals around the world with access to a wide variety of medical lectures and surgeries from places such as Stanford Children’s Hospital and the Keck School of Medicine at the University of Southern California. Besides the clear educational benefit for medical students, the service also allows physicians to stay up-to-date on the latest and most advanced surgical procedures being practiced.

GIBLIB recently announced a partnership with Cedars-Sinai Medical Center to deliver the first ever Continuing Medical Education (CME) accredited course filmed exclusively in 360-degree virtual reality. On the heels of this, we are excited to feature an exclusive interview with the co-founder and CEO, Brian Conyer.

Mark O’Reilly, Medgadget: Thank you for taking the time to speak with us. Can you start by telling us about the gaps in traditional medical education that are being addressed by GIBLIB?

Brian Conyer, GIBLIB: Video is one of the most powerful learning tools. It is scalable. You can easily update its content, publish it on-demand, and track its success. Lastly, it is very cost-effective. Medical information and technological innovation continue to evolve and compound at an unprecedented rate, yet the way the information is created and communicated remains stagnant. Knowledge sharing at a global level is a major challenge, but our team is confident that we can create studio-quality content and deliver it seamlessly anywhere and anytime to medical professionals worldwide while also keeping up with the overwhelming pace of demand. With our medical center partners, including Cedars-Sinai, we are building the largest library in the world of both CME-accredited medical lectures and surgical procedures with expert narration in 4K Ultra HD and 360 virtual reality.

Our innovative approaches to creating and delivering content will help ease the burden of costly travel, conference fees, and lengthy scheduling obstacles that many medical professionals currently face while addressing continuing medical education requirements. We strongly believe that everyone should be able to learn from the best, and that is why we will provide a level of access to the foremost experts in the field that the medical community has yet to experience.

Medgadget: How were these issues brought to your attention?

Brian Conyer: I’ve worked in healthcare for over ten years, and have seen first-hand how physicians struggles to stay up-to-date on the endless amount of information that they are required to master. The reliance on print publications, websites with antiquated user-interfaces and user-generated videos from YouTube further heighten the frustrations of all medical professionals. I also took notice of the growing knowledge gap in medicine between the developed world and the economically poor regions of the world. These are all reasons GIBLIB aims to be the dedicated online destination for medical education with global accessibility similar to the way Netflix is the go-to content platform for online entertainment.

Medgadget: What sorts of challenges are faced when recording in the operating room, and how do you go about addressing those challenges?

Brian Conyer: Our team films surgeries and medical lectures on a daily basis thanks to our strong relationships with six of the top ten medical centers in the US. To respect the operating room environment, we have developed an unobtrusive filming technique that gives us very few challenges when recording surgeries. GIBLIB’s mobile studio equipment fits in a single backpack complete with Bluetooth-enabled, battery-operated, light-weight 4K cameras that capture the best angles and deliver studio-quality video experiences. Our angles include physicians’ points-of-view and digital overlays, such as patient imaging and laparoscopic and robotic camera feeds. In addition to offering immersive 360-degree virtual reality views of procedures, our videos feature the performing surgeon’s narrations that provide key insights into his or her critical thinking during each step of the surgery. Surgeons we collaborate with often tell us they forget they are even being filmed.

Medgadget: What is unique about the experience provided by GIBLIB?

Brian Conyer: Historically, many companies have relied on user-generated videos directly from physicians. GIBLIB is the only company that has successfully captured high-quality 4K and 360-degree virtual reality content that is as close to being present in the OR as possible. In addition, rather than the 5-10 minute highlight reels of the surgery that currently exists, we provide more comprehensive 30-60 minute videos with expert narration throughout the entire surgery. Our medical student viewers often joke with us that we provide a better experience than actually observing physically in the operating room. And our goal is exactly that: to create and deliver this digital educational experience in an equally engaging and informative manner as actually being present in the OR.

Medgadget: How receptive have medical institutions been to this idea?

Brian Conyer: We’ve seen a tremendous acceptance from the community so far. We are partnered with six of the top ten medical centers in the country. Medical schools and residency programs have adopted our platform. We regularly partner with medical societies to capture and stream their conferences. Most recently, Cedars Sinai accredited 25 hours of the content we filmed with the organization’s surgeons as AMA PRA Category 1 CME Credits. And this is just the beginning.

Medgadget: So what does the future look like for GIBLIB?

Brian Conyer: As mentioned earlier, GIBLIB will be the dedicated online destination for medical video content from the top subject matter experts and leading academic medical centers. The medical community will benefit from our global accessibility and continuously growing library of content, created with studio-like quality and streamed on-demand in the highest quality available.

Link: GIBLIB…

Related announcement: First Accredited Continuing Medical Education Course Filmed in VR…

Mark O’Reilly

Mark is a Master’s candidate in the Biomedical Engineering program at the University of Western Ontario in Canada. He completed a Bachelor’s degree in Biomedical Engineering at the University of Guelph, with a focus on biosignal processing and instrumentation. Mark developed an interest in neuroimaging during an internship at the Center for Addiction and Mental Health in Toronto. His research focuses on comparing the effects of paradigm choice on variability in functional magnetic resonance imaging.

K2M CFO reflects on the year

C-Suite Awards: Gregory Cole (Washington Business Journal)

Greg Cole has spent a decade with K2M Group Holdings Inc., joining in 2008 after helping take XM Satellite Radio public. At the time, he was looking for another early-stage company with similar aspirations. That’s when he connected with a college classmate, K2M CEO Eric Major.

Since then, the spinal device maker has had its ups and down — with more ups. In 2010, Cole and Major signed a deal with their first private equity partner, Welsh, Carson, Anderson & Stowe. “We really scrambled back then to find a funding source to keep the company running and growing,” Cole said. “It’s very stressful when you don’t have a lot of money and you’re searching for options and alternatives, and that ended up being a blessing for us.”

Next came the initial public offering, 10 years after the company was founded. Then in 2016, the company moved into a new $30 million headquarters after receiving $850,000 in state incentives to stay in Leesburg and create 100 jobs. But perhaps the biggest development came this year, when the nearly 500-employee, $258 million business closed its $1.4 billion sale to Kalamazoo, Michigan-based medical device behemoth Stryker Corp.

Now, Cole is serving as a transition adviser to Major, helping combine the two management teams and businesses. Then, he’ll figure out his next move.

“I don’t have any definitive plans yet,” he said. “Certainly, I could stay with the company — that would be wonderful,” he said. “But I will likely be working on another early-stage company to bring it to the public markets or help grow it and nurture it. That’s really what I do. And I think that’s the next chapter: helping another K2M achieve its goals.”

What moment from your work over the last year are you most proud of? This last year was very busy with public market offerings of equity and convertible notes. We did an acquisition of our Spanish distributor and then ultimately, the merger — just a jam-packed year. My wife is a saint for putting up with me because we were very busy this last year.

Biggest current challenge: Transitioning my people and transitioning the business are by far the greatest challenge. It’s a very different kind of challenge, because there’s a combination of human efforts, as well as business efforts. We’re a very close group — there’s a lot of clichés about your work family, and I think we live up to the cliché. I’d really like to see all of the people that I’ve worked with excel in whatever capacity they can in the new combined entity.TRENDINGG

Next big goal: To recharge my batteries and reconnect with my family. I have three kids, and I can’t wait to spend a little bit of time with them over the winter here.

Best piece of advice from a mentor: From a business perspective, listening before speaking is very, very important. And I don’t think we do enough of that. I think the same is true with my personal relationships in my family — my children, my wife. At the end of the day, we all really want to be listened to.

What have you learned through your time at K2M? You really can be very successful in business by being ethical and taking the long road as opposed to the quick, short road. I think that’s lost sometimes. I think we’re very lucky to have a group of people that work so well together in a very ethical manner. I think it’s unusual.

What are you like to work for? I’m very hands off. I do not like to micromanage my people. I really think that when you have that many experienced people and subject matter experts, and people who can be smarter than the CFO on their various topics, that is the best way to be successful.

What advice would you give your younger self? Make sure that you can find that right balance in your life between work and your personal family. You can be successful in both. And make sure that you surround yourself with talented people, because it will make you better.

What do most people not know about you? I’m a native. I grew up in Loudoun County. I’m not a transplant. My father was a government contractor for many years and we moved here from Detroit. My father was a technician on the very first computer that was ever built, the Sperry Univac. So he’s been in the computer industry his whole life as a contractor, and we moved out to Sterling when Sterling was really the only community west of Reston.

Favorite way to relax outside of work: My wife has gotten me into horse riding. We have some horses and we ride in Leesburg — Western riding — so we’re playing cowboys. I have horses that do what’s called “cow cutting.” They will chase around cows, almost like herding. We’re like these Virginians doing all of these Texas games with our horses. It’s an unbelievable rush.

The basics

Gregory Cole

CFO, K2M Group Holdings Inc.

Age: 49

Residence: Purcellville

Family: Wife Robin, three kids

First job: Started working at age 15 with a worker’s permit at Giant Food as a curbside bag boy

A new startup in Total Knees to keep your eye on!

Website – https://www.rejoint.life

Ortho Streamers, I would like to share a hot new startup in Total Knees based in Milan, Italy.
Rejoint is the first startup to bring together all of the latest technologies for a better TKA product and service. AI + 3D Printing + Wearables.
Artificial Intelligence – REJOINT has partnered with ENHATCH to take advantage of their Fit2Kit system of artificial intelligence tools that allow algorithms to optimize the size, placement and shape of the implant. This feeds into the surgical navigation and clinical plan and reduces the instrumentation down to a mayo stand. All completed in the cloud in seconds.
3D Printing – REJOINT has also taken advantage of 3D Printing of implants with additive manufacturing of CoCr for both the femoral and tibial components.
Wearables – REJOINT will also take advantage of wearables to track clinical performance.
Watch and Read more below.

Press Release
Rejoint announces the successful completion of mechanical testing for the YourKneeTM EBM Cobalt Chrome 3D-Printed Patient Specific Knee for Total Knee Replacement
Rejoint is proud to announce the successful completion of mechanical testing for the YourKneeTM EBM Cobalt Chrome 3D-Printed Knee for Total Knee Replacement.
The Rejoint YourKneeTM uses artificial intelligence to custom fit the implants to the patients’ natural anatomical shape and size. In February 2019, the first custom YourKneeTM surgery will be performed in Milan, Italy, in cooperation with Link Orthopaedics.
“Today marks an incredible milestone for Rejoint, Arcam/GE Additive and the orthopedic industry. After several years of close collaboration with leading orthopedic surgeons, and the team at Arcam, we have validated the use of the material and are prepared to deliver the future of orthopedic surgery”, says Gian Guido Riva, Founder and CEO of Rejoint.
The Rejoint YourKneeTM Total Knee Arthroplasty System will be indicated for use in the reduction of painful knee osteoarthritis and limited range of motion and the company is planning a broader, limited launch of the system in the second half of 2019 following CE mark.
For more information, please visit Rejoint’s booth at the Ortho Center Meeting Humanitas in Milan, Italy, February 22nd-23rd 2019, or visit www.rejoint.life.
About Rejoint
Rejoint is a start-up pioneer in new technology and surgical approaches in Total Knee Arthroplasty.
Rejoint has developed a solution for knee replacement based on the integration of 3D Additive Manufacturing (AM), Artificial Intelligence (AI), and Internet of Things (IoT), which enables the design of personalized implants and surgical simulation based on unique patient anatomy. The company is led by people with more than 20 years in the orthopaedic industry and by previous members of worldwide leading medtech companies like Covidien, Smith & Nephew, Sorin, Bellco.

How does a company that takes in over $400M funding get into this situation?

DePuy is willing to pay $400M to settle Metal-on-Metal Hip cases

The Future of Medical Education looks a lot like Netflix

K2M CFO reflects on the year

A new startup in Total Knees to keep your eye on!

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