ConMed to acquire Buffalo Filter for $365m

ConMed, Buffalo Filter

ConMed (NSDQ:CNMD) said today that it inked a deal to acquire surgical smoke evacuation tech developer Buffalo Filter for $365 million.

Buffalo Filter develops and produces surgical smoke evacuation technologies, including smoke evacuation pencils, smoke evacuators and laparoscopic solutions, ConMed said.

Utica, N.Y.-based ConMed said that it expects to finance the transaction through a combination of new convertible notes and an expanded and amended credit facility. ConMed expects the acquisition to close in the first quarter of next year.

“We are excited to join ConMed and continue our mission of improving safety in the operating room. We believe that the combination of our dedicated teams, as well as our proven research and development expertise, will enable us to continue to bring best-in-class smoke-evacuation products to a growing global market,” Buffalo Filter prez & CEO Samantha Bonano said in a press release.

In connection with the acquisition, ConMed reiterated its previously issued financial guidance for the remainder of the year. The company said it expects the acquisition to be neutral to adjusted cash earnings per share next year, and between 10¢ and 15¢ er share accretive in 2020. On a GAAP basis, the transaction is expected to be dilutive in 2019 and less dilutive or increasingly accretive thereafter.

“This acquisition is a strong strategic fit with our general surgery portfolio, and the platform technology provides us a leading position in the high-growth smoke-evacuation market. We believe this technology, combined with our focused innovation in the surgical suite, will deliver impactful solutions to address significant challenges confronting healthcare practitioners and their patients. We look forward to welcoming Buffalo Filter’s talented team to ConMed,” ConMed prez & CEO Curt Hartman said in a prepared statement.

In early November, ConMed posted third quarter earnings that met EPS expectations on Wall Street and topped sales consensus.

The post ConMed to acquire Buffalo Filter for $365m appeared first on MassDevice.

Report: Apple hiring dozens of MDs, solidifies venture into healthcare

Apple Health

Apple (NSDQ:AAPL) has hired dozens of medical doctors for positions with various teams at the company, confirming its plans to move into the healthcare biz, according to a recent CNBC report.

Many of the hires have been under the radar, according to the report, which estimates the company has more than 40 and up to 50 doctors on its roster.

The move suggests that Apple may be looking to integrate more health technologies into its platforms, and that it could be looking to branch out into applications for people with specific serious medical conditions and not focus as much on general wellness, CNBC reports.

The medical professionals are influential, according to the report, and are scattered across a number of teams to guide strategy as the tech giant continues to develop for the healthcare market.

Apple hired orthopedic surgeon Sharat Kusuma to manage its partnership with Zimmer Biomet (NYSE:ZBH) as the company explores whether its tech platform can help patients recover from hip and knee surgeries, according to CNBC.

The hires may also help the company deflect criticism, such as the scathing New York Times article criticizing the company’s electrocardiogram-equipped next-gen Apple Watch, and win over the medical community, according to the report.

While many of the doctors the company has hired are working on the Apple Watch, others are working with the health records group and some are employed to treat employees at the company’s headquarters, according to CNBC.

Many of the doctors also have connections to execs at the company, the report indicates. Former Stanford Medicine doctor Sumbul Desai works closely with Apple COO Jeff Williams, according to the report, while Dr. Bud Tribble is a software VP at the tech giant and an original member of the Macintosh design team.

Other notable medical members include family medicine doctor Mike Evans and anesthesiologist Michael O’Reilly, who’s been at the Cupertino, Calif.-based company for six years, CNBC said.

Many of the doctors employed by Apple are still seeing patients, according to the report, which CNBC theorizes could “give Apple an edge by emphasizing the patient experience.”

In November, an atrial fibrillation screening study using Apple’s next-gen Apple Watch enrolled 400,000 subjects, making it the largest study of its kind to date.

The post Report: Apple hiring dozens of MDs, solidifies venture into healthcare appeared first on MassDevice.

Hologic touts win in trade secret case

gavel, legal

Hologic (NSDQ:HOLX) yesterday touted a win in a court case against a Chinese competitor and former employee the company accused of misappropriating trade secrets.

The Marlborough, Mass.-based company said that a Massachusetts Superior Court granted a preliminary injunction against Chinese X-ray device maker Direct Digital Imaging Technology and former employee Lawrence Ibbetson for alleged misappropriation of trade secrets.

In its case, Hologic alleges that DDIT and Ibbetson took trade secrets related to selenium coating technology used in the company’s breast scanning devices, including its Selenia Dimensions and 3Dimensions mammography systems.

The company filed a suit against DDIT in 2016 that alleged a breach in contract for failing to pay for general radiography panels treated with the coatings. This year, the complaint was amended to include trade secret misappropriation claims, the company said.

Hologic said that as part of the preliminary injunction, the court ruled that the company is “likely to succeed in its trade secrets claim,” according to a press release.

The injunction included an order that the plaintiffs stop using or disclosing selenium coating specifications Hologic claimed are misappropriated, and an order that DDIT and Ibbetson not develop an alternative selenium coating unless conditions, including independent monitoring, are met. The injunction is slated to be effective through the end of the trial.

“We are very pleased with the Superior Court’s ruling. As the world leader and innovator in mammography, we will continue to defend our intellectual property against what we believe to be unfair trade practices in order to protect the innovations that drive advances for our customers and outcomes for their patients,” breast and skeletal health prez Pete Valenti said in a press release.

Earlier this week, Hologic said that it launched its next-gen Omni hysteroscope in the U.S. after having received FDA 510(k) clearance earlier in the month.

The post Hologic touts win in trade secret case appeared first on MassDevice.

Bovie to rebrand as Apyx Medical, move to NASDAQ

Bovie Medical

Bovie Medical (NYSE:BVX) said yesterday that it plans to rebrand under the moniker Apyx Medical Corporation, effective January 1.

In connection with the move, the Clearwater, Fla.-based company said that it is shifting its stock exchange listing from the New York Stock Exchange to the NASDAQ Global Select Market. The company plans to trade under the new ticker symbol, “APYX”, beginning January 2.

In August, Bovie dealt its core business, including the Bovie brand, to Symmetry Surgical for $97 million. The all-cash sale augured a pivot for Bovie toward the cosmetic surgery market with its J-Plasma and Renuvion brands.

“We are pleased to join the world’s most innovative and growth-oriented companies listed on NASDAQ and are excited to partner with NASDAQ to leverage trading liquidity, enhanced visibility for issuers, leading technology and cost efficiencies. We also announced a corporate rebranding and company name change to Apyx Medical Corporation which is the final milestone resulting from the previously announced divestiture and sale of the core business segment and Bovie brand to Symmetry Surgical, Inc. The new name and brand emphasizes the company’s goal to be the most innovative, customer and solution focused company in the cosmetic surgery market and the broader medical technology sector. Apyx Medical Corporation endeavors to reshape the cosmetic surgery market by providing unique and creative solutions for the ever-changing needs of our physician customers and their patients,” prez & CEO Charlie Goodwin said in a prepared statement.

In September, Bovie Medical, fresh from the sale of its core electro-cautery business, saw its share price take a hit after it updated its outlook for the rest of the year.

The post Bovie to rebrand as Apyx Medical, move to NASDAQ appeared first on MassDevice.

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

Johnson & Johnson

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 post Report: J&J willing to pay more than $400m to settle Pinnacle hip cases appeared first on MassDevice.

UK preparing for ‘worst-case’ medical supply Brexit plan

Brexit

The UK government is preparing for a “worst-case” Brexit scenario in which no deal is reached between the country and the European Union by March 29, the date the country is slated to leave the EU, according to a recent release from UK health minister Matt Hancock.

Preparations include increasing the stock holding capacity in the country and beginning to stockpile medical supplies to address possible border delays that may result from a ‘no deal’ exit. Efforts are also underway to develop measures to “allow continued movement of products into the UK from the EU at short notice,” according to the release.

Border delays could last as long as six months, Hancock warns, saying that there will be “significantly reduced access across short straits,” with impacts most likely to be felt in crossings into Dover and Folkestone.

“This is very much a worst-case scenario. In a ‘no deal’ exit from the EU we would, of course, be pressing member states hard to introduce pragmatic arrangements to ensure the continued full flow of goods which would be to their benefit as well as ours. Nevertheless, as a responsible Government, we have a duty to plan for all scenarios. And in areas where we cannot tolerate significant risk to the flow of goods, such as with medicines and medical products, we need to have contingency plans in place for this worst-case planning assumption,” Hancock wrote in the release. “The Government recognizes the vital importance of medicines and medical products and is working to ensure that there is sufficient roll-on, roll-off freight capacity to enable these vital products to continue to move freely in to the UK. The Government has also agreed that medicines and medical products will be prioritised on these alternative routes to ensure that the flow of all these products will continue unimpeded after 29 March 2019.”

Hancock said that the Dept. of Health & Social Care has been working with industry members to shore up supply lines, and urged “any company that routinely imports products from other EU countries” that has not yet engaged with them to contact them immediately.

In August, the UK’s Medicines and Healthcare products Regulatory Agency released an update on what medtech and pharmaceutical companies can expect to see as the country begins to implement plans to split from the European Union.

The post UK preparing for ‘worst-case’ medical supply Brexit plan appeared first on MassDevice.

Sanuwave confirms acting CEO Richardson as company head | Personnel Moves – December 12, 2018

Sanuwave CEO Kevin Richardson

Sanuwave said late last month that it lifted acting CEO and board chair Kevin Richardson to a permanent position in the corner office.

Richardson joined the Suwanee, Ga.-based company in 2009 as board chair, and has served as acting CEO since 2014. He also served as managing partner of investment management firm Prides Capital from 2004 to September 2018.

Sanuwave said that Richardson took over as the permanent CEO as of November 30, and that he will continue to serve as board chair alongside his new position heading the company, according to an SEC filing.

 Common Sensing lifts Schmid to CEO, White to board chair

Common Sensing said late last month it lifted COO and board member Kevin Schmid to the role of CEO, and that it appointed co-founder James White as its board chair.

Prior to joining Common Sensing, Schmid held “pivotal roles” at Insulet (NSDQ:PODD), Bose, JDS Uniphase and the Stevanato Group and served as a board member for Sorrel Medical.

“Kevin’s appointment to the chief executive role puts Common Sensing in a very strong position to scale Gocap injector monitoring platforms for insulin and beyond. As we transition from pilot level to commercial level operations over the next year, Kevin’s transformative leadership of the talented and growing Common Sensing team will evolve and drive the execution of our go-to-market strategies for our patented dose sensing technology. Our goal is to provide a smart dose sensing platform for patients, health care providers and payers to embrace injectable medicines for home use,” White said in a prepared statement.

During his time with Insulet, Schmid aided in the development, industrialization and commercialization of wearable, smart drug delivery pumps, Cambridge, Mass.-based Common Sensing said.

Common Sensing said that Schmid will lead top-level strategy, expansion and investor relations, while prez and co-founder Richard Whalley will focus on clinical, quality and regulatory functions.

“We are well underway with the development of our high performance, scalable, and commercial Gen 2 Gocap platform. This, combined with insightful user data from existing studies and patients, lays the foundation for Gocap technology to make a tremendous impact on wireless integrated health care. Gocap is an easy-to-use, cost-effective dose monitoring and reporting solution which will be accessible to millions of self-injecting patients,” Schmid said in a press release.

Read more

 Glympse Bio appoints former Bristol-Myers exec Loew as prez & CEO

Glympse Bio said early this month that it appointed former Bristol-Myers Squibb (NYSE:BMY) exec Dr. Caroline Loew as its new prez & CEO.

Most recently, Loew served as R&D, strategy and planning VP at Bristol-Myers Squibb, the Cambridge, Mass.-based company said. She has also held senior roles with Merck and PhRMA, leading teams in drug development ,regulatory policy, market access and commercial fronts, Glympse Bio said.

“I’m excited to join Glympse and work alongside the exceptional and dedicated team here. Glympse’s powerful, tunable platform technology has the ability to transform how we detect and manage disease, and help both improve and save patients’ lives. I’m looking forward to building the company and fully realizing the potential of this platform for patients,” Loew said in a press release.

In connection with the appointment, Loew will also join Glympse Bio’s board of directors, which the company said it recently expanded. The expansion includes that appointment of co-founder Dr. Sangeeta Bhatia as head of the scientific advisory board and the appointment of Stanley Lapidus as board chair and Robert Langer as a board member.

“Caroline is an outstanding leader who brings a wealth of experience in life sciences, and we are thrilled she is joining Glympse. She is recognized for her acumen and operational execution, her ability to build talented teams and lead organizations, and for strategic development and commercialization of important products that change patients’ lives. We are also fortunate to have Sangeeta’s continuing scientific and clinical leadership on the Scientific Advisory Board,” board member & LS Polaris Innovation Fund partner Amy Schulman said in a prepared release.

Read more

 NovaDip Biosciences taps former Argos CEO Abbey as chief exec

Regenerative medicine company Novadip Bioscences said today that it named former Argos Therapeutics prez & CEO Jeff Abbey as its new CEO, succeeding Jean-François Pollet.

Abbey spent 15 years at immuno-oncology cell therapy company Argos Therapeutics, holding the position of president and CEO during the past eight years, Belgium-based Novadip said. During his time with Argos, Abbey guided the company through a phase 3 trial and helped raise $250 million in equity financings which included an initial public offering.

“With his extensive experience in cell therapy combined with his expertise in equity financing, business development and strategy, Jeff possesses the skills necessary to lead Novadip through the next phases of its development. The board is highly confident that Jeff’s wealth of international experience and proven leadership will help Novadip in its mission to become a leading regenerative medicine company. As the founding CEO, Jean-François Pollet, along with co-founder and CSO, Denis Dufrane, has led Novadip through a number of important milestones and positioned the company in a strong position to succeed. The board would like to express its gratitude to Jean-François Pollet,” board chair Eric Pâques said in a prepared statement.

Novadip is developing an autologous three-dimensional cell therapy that is currently being studied in a phase I/IIa trial in spinal fusion patients, the company said. It added that it recently launched a second clinical program looking to enroll patients with non-healing bone fractures and that it is developing a regenerative skin product based on its cell therapy platform.

“I am excited to have the opportunity to join Novadip The technology platform and portfolio of products the company is developing offer tremendous opportunities to provide unique solutions to patients with catastrophic conditions in the fields of bone disease and skin regeneration. I look forward to working with the founders and the outstanding team of Novadip to bring truly innovative therapies to market and build a preeminent biotechnology company,” Abbey said in a press release.

Read more

 Owens & Minor lifts interim CFO Snead to permanent chief finance officer position

Owens & Minor (NYSE:OMI) said today that it lifted interim CFO Robert Snead into a permanent role as chief financial officer and exec VP, effective December 6.

Snead has served as interim CFO since June, and will continue to report to board chair and interim prez & CEO Robert Sledd, the Richmond, Va.-based company said. He joined Owens & Minor in 2010 as corp dev VP and has held positions including treasurer and global solutions strategic biz unit finance group VP, the company added.

Prior to joining Owens & Minor, Snead served as Barclays Capital M&A group director in New York, the company said.

“We are very pleased Robert is taking on this important, strategic role for Owens & Minor. Robert’s eight years of service to Owens & Minor in a variety of finance and strategy roles have prepared him well for this leadership position. He brings valuable experience in working with the investor community, providing disciplined financial management oversight, and partnering with other leaders to help drive operating efficiency and profitability. Without question, Robert is the right choice for Owens & Minor as we prepare for the future,” board chair and interim prez & CEO Sledd said in a press release.

Read more

The post Sanuwave confirms acting CEO Richardson as company head | Personnel Moves – December 12, 2018 appeared first on MassDevice.

Appeals court OKs $248m Stryker win over Zimmer Biomet

Stryker, Zimmer Biomet

The U.S. Court of Appeals for the Federal Circuit this week affirmed Stryker‘s (NYSE:SYK) enhanced $248 million win in a surgical tool patent case against Zimmer Biomet (NYSE:ZBH).

The Federal Circuit court affirmed the judgement in a per curiam ruling dated on Monday, according to recently released court documents.

The damages in the case were previously enhanced due to a US Supreme Court ruling which made it easier to award enhanced damages. In July, Western District of Michigan Judge Robert Jonker reaffirmed an earlier decision to award enhanced damages “in light of the Supreme Court’s clarification of the governing standard in Halo Electronics, Inc. v. Pulse Electronics, Inc.,” according to court documents.

The court was also asked to reconsider its award of attorney’s fees, due to a Supreme Court ruling in Octane Fitness, LLC, v. Icon Health & Fitness, Inc., which it also reaffirmed.

Judge Jonker reaffirmed both decisions for triple damages for the 2013 jury verdict, which had been vacated on appeal by the Federal Circuit last year. He ruled that in the case, Stryker had “proven by clear and convincing evidence” that Zimmer had willfully infringed on 1 or more claims in all 3 of the patents-in-suit, according to court documents.

Last September, a federal appeals court overturned the enhanced damages and attorney fees awarded in the $70 million patent infringement case Stryker had won over Zimmer Biomet, but upheld its prior ruling that patents were valid and infringed.

The case was sent back to the U.S. Court of Appeals for the Federal Circuit in June, when the Supreme Court held that the standard for enhanced damages awards in patent infringement cases should be relaxed. The case dates back to December 2010, when Stryker sued orthopedics rival Zimmer, alleging infringement of 3 patents covering wound debridement technology by Zimmer’s Pulsavac Plus device.

In February 2013 a jury in the U.S. District Court for Western Michigan awarded $70 million to Stryker in damages plus royalties, ruling that Zimmer infringed all 3 patents claimed in the suit. Judge Robert Jonker trebled the damages in August of that year, ruling that the infringement was willful, ordering a permanent injunction and granting Stryker’s bid for lost profit damages for another nearly $2.4 million. The judge also granted Stryker’s motion for prejudgment interest, awarding nearly $11.2 million, plus reasonable attorney’s fees and additional prejudgment interest on those fees at a rate of 3.83%.

The Federal Circuit court in 2014 rolled back that $228 million ruling, finding that Stryker failed to prove willful infringement. Stryker appealed to the Supreme Court, which vacated the appeals court’s ruling and ordered it to reconsider the case. The Supremes found that the Federal Circuit’s test was too rigid and allowed egregious infringers to evade liability.

The post Appeals court OKs $248m Stryker win over Zimmer Biomet appeared first on MassDevice.

Boston Scientific touts win in continued TAVR patent spat with Edwards Lifesciences

Edwards Lifesciences, Boston Scientific

Boston Scientific (NYSE:BSX) today claimed a win in an ongoing patent spat with Edwards Lifesciences (NYSE:EW) over transcatheter aortic valve replacement system patents.

Marlborough, Mass.-based Boston Scientific said that a jury in the U.S. District Court for the District of Delaware ruled in its favor, finding that their ‘608 patent, related to a transcatheter heart valve sealing skirt, is valid and that Irvine, Calif.-based Edwards Sapien 3 aortic valve infringes on that patent.

The jury determined that Edwards owes Boston Scientific $35 million in infringement damages through to the end of 2016. Damages and interest incurred from 2017 to 2018 will be “determined by the court in post-trial motions,” Boston Scientific said.

In response to the ruling, Edwards said in a press release that it “does not expect to pay the jury award since, earlier this year, the U.S. Patent and Trademark office determined that all asserted claims of the ‘608 patent were invalid.”

Boston Scientific’s Lotus aortic valve system was also found to not infringe upon a number of Edwards’ Spenser patents, the company said. Edwards said that it plans to appeal this decision.

“We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the U.S., which upholds our company’s intellectual property,” Boston Scientific GC, SVP & corporate secretary Desiree Ralls-Morrison said in a press release.

Edwards commented that “Boston Scientific initiated litigation that now involves multiple patents in multiple venues, and will likely yield court actions over an extended period of time. ”

In October, Boston Scientific touted a win in a German court that granted the company’s bid for an injunction barring Edwards’ Sapien 3 Ultra valve from the German market. The decision had no impact on sales of the Sapien 3 or Centera valves in Germany, Edwards said, adding that it planned to appeal and that it “believes it will ultimately prevail.”

The post Boston Scientific touts win in continued TAVR patent spat with Edwards Lifesciences appeared first on MassDevice.

Seisa Medical, CA attorney settle alleged $2m fraud suit

Seisa Medical

Seisa Medical has settled a case against an allegedly fraudulent California-based attorney in which the company claimed damages of approximately $1.8 million, according to court documents.

In its case, filed in the US District Court for the Western District of Texas, El Paso Division, Seisa alleged that defendant Catherine Shiang, and their company Asia Capital Advisor, fraudulently misrepresented themselves and their business and scammed the company out of nearly $2 million.

Both parties in the case agreed to a resolution and sought a dismissal, which was granted by U.S. District Judge Katherine Cardone, according to a court document released this week. Details of the settlement have not been released.

In September, Shiang and ACA filed a motion to dismiss the case, arguing that the Texas-based court had no jurisdiction, but the motion was denied.

Seisa began its relationship with Shiang and ACA in 2016 as the company looked to expand its business in Asia, according to court documents.

The company claimed that Shiang “utilized a scheme of fraud and misrepresentation regarding her background, skills, addresses, business associations as well as her name in order to induce plaintiff . . . to sign a series of agreements,” according to court documents. Seisa added that Shiang created a “phantom staff with their own emails and professional backgrounds,” and that it misrepresented the size and capabilities of the company.

During a visit to El Paso, Texas, in which Shiang was meeting with Seisa president Jacobo Chieu, Seisa claimed that Shiang “sent a series of emails in furtherance of the parties’ business relationships, including several fraudulent messages,” according to court documents.

Those messages include an email received by president Chieu from the account of Rida Lui, which Shiang claimed was ACA’s executive administrator. However, the email included Shiang’s signature and was verified by Chieu as having come from “the same El Paso internet protocol address as others sent by Shiang that same evening,” court documents read.

In the case, Seisa asserted nine causes of action against Shiang and ACA, including a breached non-disclosure agreement and approximately $1.8 million in damages as a result.

The post Seisa Medical, CA attorney settle alleged $2m fraud suit appeared first on MassDevice.