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Conformis, Stryker settle in Wright Medical patent infringement litigation

Conformis (NSDQ:CFMS) announced today that it settled with Stryker (NYSE:SYK) to resolve patent litigation involving Wright Medical.

Billerica, Mass.-based Conformis said in a news release that Stryker, which acquired Wright Medical in November 2020, will make a one-time payment to Conformis and be granted a non-exclusive license with respect to certain Conformis patients.

On April 24, 2020, Conformis filed a lawsuit against Wright in the U.S. District Court for the District of Delaware, alleging in an amended complaint that Wright’s multiple lives of patient-specific shoulder instruments and the implant components used in conjunction with those implants infringed certain Conformis patents.

“We are pleased to have resolved all of the ongoing patent litigation related to the Wright Medical dispute,” Conformis president & CEO Mark Augusti said in the release. “The settlement once again highlights the strength and value of our intellectual propert…

Conformis slides on mixed-bag Q1 results

Conformis (NSDQ:CFMS) yesterday posted first-quarter results that beat the revenue consensus on Wall Street but missed on earnings.

The Billerica, Mass.-based orthopedic company reported losses of -$11.51 million, or -9¢ per share, on sales of $13.84 million for the three months ended March 31, for a sales loss of -16.02% compared with Q1 2020.

Earnings per share were -9¢, 2¢ behind The Street, where analysts were looking for sales of $13.78 million.

“The year is off to a good start. We met our expectations for business activity in the quarter as COVID-19 headwinds impacted elective procedures to the degree we anticipated. Despite these continuing headwinds for our industry, we are pleased with the progress of vaccine adoption nationwide and, as a result, remain cautiously optimistic that we will see procedure levels get back to normal in the second half of 2021. This anticipated acceleration in activity is timed well for our planned product introd…

MedTech 100 roundup: Industry sees largest fall since October

The medtech industry’s hot start to 2021 has finally come to a full halt after stocks fell harder than they had in more than four months.

MassDevice‘s MedTech 100 index ended the week (March 5) at 103.3 points, marking a -3.1% dip from the 106.65-point mark set one week before (Feb. 26). In less than a month, the fall has been more than seven points from the end-of-week tally of 110.63 points on Feb. 12.

Medtech’s lowest point of the week was on Thursday, March 4, when it fell to 102.85. The overall drop of about five points from the 107.88-point mark set on Monday, March 1, is the largest dip since the index slid from 97.2 to 91.01 between Oct. 23, 2020, and Oct. 30, 2020.

The all-time best for the index was 110.96, set just three days after that. The index had never reached even the 100-point mark before November 2020.

Still, the industry is in much better condition than it was around this time last year. Medtech’s latest mark means …

Conformis dips 9% on Street-beating Q4 results

Conformis (NSDQ:CFMS) posted fourth-quarter results that beat the earnings consensus on Wall Street and matched on revenue.

The Billerica, Mass.-based company reported losses of -$6.6 million, or -8¢ per share, on sales of $16.7 million for the three months ended Dec. 31, 2020, for a sales loss of -16.1% compared with Q4 2019.

Earnings per share were -8¢, 2¢ ahead of The Street, where analysts were looking for sales of $16.6 million.

“Though the COVID-19 pandemic continues to create uncertainty in orthopedic procedure levels, Conformis has remained committed to the continuation of our new product development schedule. As such, we expect 2021 to be an exciting year in regards to new product offerings, especially our new total knee system. While this system can be used in the in-patient and out-patient settings, we are particularly focused on the ambulatory care setting,” president and CEO Mark Augusti said in a news release. “Our recently completed …

Conformis soars on news of FDA clearance

Conformis (NSDQ:CFMS) recently received FDA 510(k) clearance for its ITotal Identity cruciate-retaining knee replacement system.

According to a report from SeekingAlpha, Billerica, Mass.-based Conformis received approval for the ITotal Identity posterior-stabilizing knee replacement system along with the cruciate-retaining knee replacement system. The knee replacements have customized fitting properties with specificity for each patient receiving one.

Paperwork for 510(k) clearance made its way to the FDA on Jan. 29 before the administration granted clearance weeks later on Feb. 17.

As a result of the news of clearance, CFMS shares closed the day up 15.9% at $1.24 per share, which marks a rebound from Feb. 12 when the company’s shares dipped -17% after the company priced an offering.

The offering of 81 million shares of common stock at $1.05 per share closed last week, bringing in approximately $79.6 million in net proceeds, which Conformis …

Conformis closes $79.6 million offering

Conformis (NSDQ:CFMS) announced today that it closed an underwriting agreement to sell common stock worth approximately $79.6 million.

The offering made by the Billerica, Mass.-based company includes the sale of nearly 81 million shares of common stock at a public offering price of $1.05 per share, bringing the expected net proceeds to approximately $79.6 million, according to a news release.

Conformis plans to use the net proceeds for general corporate purposes, which could include R&D costs, sales & marketing costs, clinical studies, manufacturing development, the acquisition or licensing of other businesses or technologies, the repayment and refinancing of debt, working capital and/or other capital expenditures.

The company develops orthopedic implants, including replacement joints and patient-specific instrumentation. The company most recently launched its FDA-cleared Cordera Match hip system in the U.S.

MedTech 100 roundup: Stocks were practically unchanged last week

Despite plenty of ups and downs coming in the stock market for the medtech industry, there was hardly any movement from week to week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.6 points at the end of last week (Aug. 21). Overall, medtech stocks saw a -0.2% decrease from the 89.77-point total at the same time a week prior (Aug. 14).

Once again, the index nearly reached a high point during the COVID-19 pandemic, as on Aug. 18, it hit 90.4 points for the second time in as many weeks, a total that nearly poked past the previous mid-pandemic high (90.45), which came on Aug. 5.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -2.9% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 0.72% increase from Aug. 14 to Aug. 21, having reached record highs on Aug. 18. Meanwhil…

Conformis reaches second milestone in Stryker deal

Conformis (NSDQ:CFMS) announced today that it completed the second of three milestones in its license and development agreement with Stryker (NYSE:SYK).

Under the agreement, Conformis is set to receive an additional $3 million from Stryker after achieving the milestone as it develops patient-specific instrumentation (PSI) for use in connection with Stryker’s knee implant offerings.

“We are pleased to announce the achievement of the second project milestone,” Conformis president & CEO Mark Augusti said in a news release. “We believe that this project, as well as the long-term distribution agreement under which Conformis will manufacture and supply PSI to Stryker, will create value for our shareholders as we successfully support the increasing demand for efficient outpatient joint replacement.”

Billerica, Mass.-based Conformis initially announced the agreement, worth up to $30 million, in October 2019. The deal called for Stryker to pay $14 milli…

Conformis names new marketing VP

Joint replacement implant maker Conformis (NSDQ:CFMS) announced that it appointed Farzin Kaghani as its new VP of U.S. marketing.

Khaghani, a veteran of more than 20 years in orthopedic and medtech sales and marketing, most recently served as president at NextStep Arthropedix, but before that, he spent more than 10 years at Conformis in a number of roles.

According to a news release, Khaghani also served as product director at Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes for five years. Before that, he served as director of operations at Win Enterprises.

“We are very pleased to announce that Farzin Khaghani has rejoined our team as VP, U.S. marketing,” Conformis president & CEO Mark Augusti said in the release. “Farzin’s product expertise and track record of successfully supporting strategic goals and attracting new surgeon users to the Conformis family will help us continue our successful market expansion. I look forward to the co…

Conformis dips on Q2 losses

Conformis (NSDQ:CFMS) shares dipped today on second-quarter results that highlighted losses influenced by the ongoing COVID-19 pandemic.

The Billerica, Mass.-based joint replacement implant maker posted losses of -$2.1 million, or -3¢ per share, on sales of $19.5 million for the three months ended June 30, 2020, for a 68.4% bottom-line gain on a sales decline of -1%.

Adjusted to exclude one-time items, losses per share also totaled -3¢, coming in 7¢ ahead of Wall Street projections.

Last month, the company released its preliminary results, highlighting a -50% drop in product revenue as a result of the COVID-19 pandemic and the deferral of elective procedures. Its projections from the preliminary results fell in line with what the company announced this week.

According to a news release, Conformis benefitted from $9.6 million in royalty revenue as a result of a settlement and license agreement with Zimmer Biomet.

“We are excited to ann…

The top 5 MassDevice stories of the week — July 31, 2020

The past week has seen a slew of Q2 earnings reports from medical device companies — and the picture overall hasn’t been pretty amid the COVID-19 pandemic.

Still, medtech CEOs during their earnings calls said they’re starting to see some signs of hospital procedures recovering a bit even as the southern U.S. deals with a coronavirus wave. Some of the top MassDevice stories this week actually involved companies providing more solutions to improve management of the pandemic.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. A few bright spots amid the COVID-19 financial toll

Dexcom (NSDQ:DXCM) proved to be one of the few bright spots among medtech Q2 earnings reports, blowing away the Wall Street consensus forecast as it successfully pivoted to making its continuous glucose monitors avail…

Aetna accuses Conformis of trying to use patient’s lawsuit to compel coverage

[Image from Unsplash]

Joint replacement implant maker Conformis (NSDQ:CFMS) is improperly using a Colorado man’s denial of benefits lawsuit to force Aetna to cover its customized knee implants, the health insurer recently argued in a federal court filing.

Billerica, Mass.-based Conformis joined John Michael Schaub of Golden, Colo., in his lawsuit against Aetna, filed in May in U.S. District Court in Massachusetts.

The lawsuit, according to Aetna’s lawyers, turns the federal Employee Retirement and Income Security Act on its head.

“Conformis is a Massachusetts-based medical device manufacturer that has no rights or standing to sue under ERISA. The complaint is Conformis’ novel, but improper, attempt to co-opt Mr. Schaub’s ERISA denial of benefits claim, and convert that claim into something it is not: a quasi-class action intended to force Aetna to cover the Conformis custom total …