BD lifts Bard vet DeFord to CTO | Personnel Moves – June 4, 2018

Becton Dickinson (NYSE:BDX) said last Friday it is lifting former C.R. Bard science, technology and clinical affairs senior VP John DeFord to the role of chief technology officer and exec VP.

Since acquiring Bard in a $24 billion deal that closed last December, DeFord has served as BD interventional segment R&D SVP, the Franklin Lakes, N.J.-based company said.

DeFord originally joined Bard as science & tech VP in 2004, and had previously served life sciences managing director for venture capital fund Early Stage Partners and as prez & CEO of Cook Inc, which is now known as Cook Medical. He also currently serves on NuVasive‘s (NSDQ:NUVA) board of directors, BD said.

“John is a recognized leader with more than 25 years of experience in the medical device industry, with expertise overseeing innovative R&D and technology-based initiatives that have made significant effects on saving and improving lives for patients around the world. He will drive organizational culture, capabilities, products and technology-enabled services to further strengthen the BD innovation funnel, while advancing the world of health through new innovations and solutions for our customers and patients,” prez Tom Polen said in a press release.

 Teleflex global ops SVP Kennedy to retire next year

Teleflex (NYSE:TFX) said last week that its global ops senior VP Thomas Kennedy will retire from the company at the end of next March.

Kennedy will remain in his present position until a replacement is appointed, the Wayne, Penn.-based company said. After a replacement has been named, Kennedy will stay on to aid in the transition.

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 Merit Medical CFO Birkett resigns

Merit Medical (NSDQ:MMSI) said late last month that its chief financial officer and treasurer Bernard Birkett has resigned from the company.

The South Jordan, Utah-based company said that it appointed current accounting VP & corporate controller Raul Parra Jr. as its interim CFO. Parra previously held the position of financial reporting director from December 2009 to July 2012.

Before joining Merit, Parra held the position of auditor with Deloitte & Touche from 2003 to 2009.

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 Integer CFO Haire steps away

Integer Holdings (NYSE:ITGR) said late last month that its exec VP and CFO Gary Haire has separated from the company, effective May 23.

The Frisco, Texas-based company said it has begun a search for a successor, and that until one is found, Jeremy Friedman will serve as interim CFO.

Friedman is currently responsible for the company’s supply chain, environmental, health, safety and security needs, as well as the divestiture of the company’s advanced spinal & orthopedics product line.

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 EctoSense taps McCourt as CEO

Sleep-disorder focused digital health and medical device company EctoSense said last Friday it named Ciaran McCourt as CEO.

Prior to joining Belgium-based EctoSense, McCourt served as CEO of eDiets and Unilever biometric sensor spin out MiLife. He also served as international biz dev director for BiancaMed, which was acquired by ResMed (NYSE:RMD) in 2014.

“We are very pleased to get someone with Ciaran’s depth of experience on board to drive the company’s high ambitions in delivering scalable and clinically validated diagnostics and services in sleep disorder care globally,” co-founder Bart Van Pee said in a press release

“I am very pleased to take up this role with Ectosense operating at the leading edge of developing innovative respiratory diagnostics, beginning in the domain of sleep apnea with the Nightowl device. The device is a perfectly timed step change in sleep apnea screening and diagnosis given its ease of use and cost of delivery just as patients and providers are seeking ever more convenient devices without sacrificing diagnostic efficacy. I believe the engineering, clinical, and design strengths of Ectosense will ensure its place in the new generation of device companies that will improve access to important disease diagnostics and services,” CEO McCourt said in a prepared statement.

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Cook Medical loses Houston-based IVC suit, plans to appeal

Cook Medical said today it lost a suit related to its Celect vena cava filters in Houston, but that it plans to appeal the decision.

The ruling came from a jury in Houston, which ruled in favor of a plaintiff, though the Bloomington, Ind.-based company did not release any detailed information related to the case.

“We are dedicated to providing life-saving treatment options for patients and will continue to defend all of our IVC filters. Our filters have saved thousands of lives, are clinically successful and are critical to patient well-being,” Cook Medical vascular division VP Mark Breedlove said in a prepared statement.

Cook Medical said that it was successful in the first two cases over its IVC filters, winning a complete jury verdict in its favor in the first and through a complete summary judgement verdict in the second.

“We are disappointed in this outcome and do not believe this verdict is supported by the facts or the law. This one case does not change our position on continually defending this important, life-saving technology,” Cook Medical GC & VP Cynthia Kretz said in a press release.

Earlier this month, Cook Medical said it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.

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Cook Medical wins FDA de novo nod for Hemospray

Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.

The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release.

“We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States,” Cook Medical endoscopy VP Barry Slowey said in a prepared release.

“Hemospray gives clinicians another tool for the care of their patients. Patients have been our number one priority for over 50 years and we’ve worked hard to bring this innovation to the field of gastroenterology across the U.S.,” Cook Medical MedSurg VP DJ Sirota said in prepared remarks.

The Hemospray powder is intended to absorb the water in blood to form a gel which acts both cohesively and adhesively to create a barrier to the bleeding site, Cook Medical said.

In its approval, the FDA said it reviewed data from studies of 228 patients with upper and lower GI bleeding alongside real-world evidence from medical literature reports which included data on an additional 522 patients. The Hemospray device was found to have stopped GI bleeding in 95% of patietns within 5 minutes of device usage.

The FDA said that 20% of patients experienced rebleeding between 72 hours and 30 days, and bowel perforations were observed in 1% of patients.

“The device provides an additional, non-surgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” FDA Center for Devices and Radiological Health surgical devices division director Dr. Binita Ashar said in a press release.

Early last month, Cook Medical said it re-launched its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.

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Judge: Firms must have permanent, physical presence in Delaware to file patent suits there

The District of Delaware Chief Judge said this week that businesses must have permanent residences in the state to be sued for patent infringement within it, following a series of US Supreme Court rulings, and transferred a patent spat case to Indiana.

Chief Judge Leonard Stark said the precedent was set after the Supreme Court’s decision in TC Heartland LLC v. Kraft Food Group Brands and Bristol-Myers Squibb Co. v. Superior Court of California earlier this year.

In TC Heartland v. Kraft Foods Group Brands, the Supremes limited the ability of patent holders to sue in other states. Kraft sued TC Heartland in its incorporated state of Delaware over drink powder patents; a lower court blocked TC Heartland’s bid to move the case to its home base of Indiana. In May, the Supreme court reversed that decision, finding that the only place a defendant can be subject to a suit is their home court, a place where infringement occurred or where the defendant has a regular and established place of business.

Similarly, in the Bristol-Myers SquibbCo ruling the pharmaceutical giant was sued by more than 600 plaintiffs alleging injuries from its Plavix drug. The justices overturned a California state court ruling that, although there was little connection between the lawsuits and the Golden State (only 86 plaintiffs hailed from the state), the lawsuits could proceed there because of the company’s extensive links there.

The opinion from Judge Stark comes from a patent spat case between Boston Scientific (NYSE:BSX) and Cook Medical, in which he granted a transfer of venue from Delaware to the Southern District of Indiana, Indianapolis Division.

“After reviewing thorough briefing and hearing oral argument, the Court finds that Defendants do not have a “regular and established place of business” in Delaware. Therefore, the Court concludes that venue is improper in Delaware for this action. Accordingly, the Court will grant Defendants’ motion and transfer this case to the United States District Court for the Southern District of Indiana, Indianapolis Division,” Judge Stark wrote, according to court documents.

Earlier this year, a number medical device makers were reportedly looking to slip patent infringement and product liability lawsuits based on the TC Heartlands U.S. Supreme Court ruling.

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