Lina Medical settles morcellator lawsuit

Lina Medical reportedly settled a product liability lawsuit filed over its Xcise laparoscopic power morcellator, a type of device that’s been linked with spreading uterine cancer during uterine fibroid removal surgeries.

The lawsuit was filed in March 2014 by Scott Burkart in the U.S. District Court for Eastern Pennsylvania. Burkart’s wife, Donna Burkart, died Feb. 2, 2013, at age 53, 11 months after she underwent a robot-assisted supracervical hysterectomy and bilateral salpingectomy with uterine morcellation, according to court documents. Less than 2 weeks after her procedure, the lawsuit alleged, Burkart was informed that she had metastatic myelosarcoma.

“It is alleged that each and every defendant herein failed to warn about the possibility of seeding an undiagnosed sarcoma throughout the peritoneal cavity,” according to the lawsuit. “Defendants were each aware of the risks, complications, and/or adverse events associated with their products used for uterine morecellation [sic], specifically the Lina Xcise morcellator.”

The case, expected to be the 1st power morcellator lawsuit to go to trial, was settled for an undisclosed amount, Burkart’s lawyer François Blaudeau told the Wall Street Journal.

The FDA warned in April 2014 about power morcellators and the risk that they could spread undiagnosed cancer cells throughout women’s abdomens, prompting Johnson & Johnson (NYSE:JNJ) to shelve its line of the devices later that month. In November 2014 the safety watchdog added a “black box” warning to the labeling requirements for power morcellators, advising doctors that the devices be avoided in nearly all fibroid-removal procedures.

Attorneys for the Lina Medical couldn’t be reached for immediate comment, the newspaper reported, adding that Scott Burkart said he was glad the case didn’t have to go to trial and that his main goal was to make others aware of the risks.

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SteadyMed inks deal for EU, Canada, Middle East

SteadyMed Therapeutics (NSDQ:STDY) said last week that it inked an exclusive deal with Cardiome for commercialization of its Treyvant product in regions outside the U.S., hinging on its regulatory approval in those regions.

Cardiome will have exclusive rights to the territories of the European Union, Canada and the Middle East, SteadyMed said.

SteadyMed is a developer of hypertension and pain treatments given with a discrete, patented drug-delivery device called the PatchPump. The company is focusing on development and approval of Treyvant, a drug to treat pulmonary arterial hypertension.

“SteadyMed has been searching for the ideal partner for ex-U.S. commercialization of Trevyent that has a track record of selling parenteral therapeutics to cardiologists, an excellent regulatory infrastructure, a commercial organization with operations in major European markets and a passion to sell – we found this in Cardiome. In addition, Cardiome has an extensive network of specialty pharmaceutical product distributors in many global markets that will be key contributors to the future success of Trevyent, which if approved is an exciting new potential treatment for PAH. We believe this agreement will help to ensure that Trevyent, if approved, will be available to the patients who need a ready to use and easier to administer alternative product to treat this serious and debilitating condition,” SteadyMed CEO Jonathan Rigby said in a press release.

Cardiome is slated to pay $12.25 million in up-front and milestone payments, with $3 million payable within 7 business days of the effective date, $7.25 million payable upon achievement of “regulatory milestones” by SteadyMed and $2 million payable in connection with “the achievement of a sales milestone by Cardiome,” according to an SEC filing.

Cardiome will also pay SteadyMed a transfer price on finished goods and a scaling royalty ranging from the low-teens to mid-20% on future Trevyent sales by Cardiome, according to the SEC filing.

“We believe that Trevyent will complement our current portfolio of cardiovascular products and will broaden our franchise of specialty products into additional treatment centers and physician specialties. We look forward to working with SteadyMed as we jointly prepare for submission of the request for regulatory approvals for Trevyent beginning in 2016. We are thrilled to have the opportunity to promote this new and exciting product candidate,” Cardiome CEO William Hunter said in a prepared statement.

SteadyMed closed a $40 million initial public offering in March, floating 4.7 million shares at $8.50 per share.

The Israel- and California-based company said it hoped to bring in $55 million from the offering initially, planning to float 4.25 million shares at $12 to $14 apiece.

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Deka wins $7m Defense Dept. contract for prosthetic arm

The U.S. Defense Dept. awarded a57-month contract worth nearly $7 million to Dean Kamen’s Deka Innovative Solutions for the sensorized prosthetic arm Deka developed.

The Deka arm is the 1st prosthetic arm to translate muscle signals into action that’s approved for the U.S. market. The device won de novo approval from the FDA in May 2014. It’s designed to perform multiple, simultaneous powered movements, controlled by electrical signals from electromyogram  electrodes. The electrodes sense electrical activity in muscles near the prosthesis and send signals to a processor that translates them into movement.

The device, which is the same shape and weight as a human arm, can convert the signals into up to 10 powered movements. The Deka arm as approved by the FDA can be configured for limb loss at the shoulder joint, mid-upper arm or mid-lower arm; it can’t be configured for limb loss at the elbow or wrist joint.

The Defense Dept. contract calls for Deka to advise the Defense Advanced Research Projects Agency’s Hand Proprioception & Touch Interfaces program on the setup and operation of the arm systems under DARPA’s Revolutionizing Prosthetics Follow-on Studies program, according to a press release.

The contract also calls for Deka to provide technical support, maintenance and repair for the arm systems, the Defense Dept. said.

DARPA’s HAPTIX program is slated to develop closed-loop control of the Deka arm “in order to provide amputees with the feel and function of natural limbs,” the DoD said, using a year-long, take-home trial of the arm.

“These efforts will position the government with the required data to seek market approval and deliver the system into the wider patient population,” according to the release. The agency aims to provide the FDA with an approved variation on the Deka arm for use in research, which in turn is aimed at winning reimbursement approval from the Centers for Medicare & Medicaid Services.

“These studies will also validate prescription criteria and explore other control techniques with the aim of ensuring the DISC arm system can accommodate the broadest user community possible,” the Defense Dept. said.

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Allergan to drop $125m on Oculeve

Allergan (NYSE:AGN) said today that it agreed to pay $125 million up front to acquire Oculeve and its dry eye disease device program, plus unspecified commercialization milestones.

South San Francisco-based Oculeve is developing a product called OD-01, a non-invasive nasal neurostimulation device designed to increase tear production in patients with dry eye disease, Allergan said. A pair of pivotal trials are planned ahead of submission for FDA approval, expected next year, with commercialization potentially following in 2017, according to Dublin-based Allergan.

“Allergan is committed to developing a broad range of innovations that help patients address dry eye,” executive vice president David Nicholson said in prepared remarks. “The OD-01 program has been shown to provide a strong safety and efficacy profile, and if approved, would provide an exciting new treatment option for patients that is complementary to our existing product offerings in this important treatment area.”

“Allergan’s position and expertise in eye care will maximize the development and potential commercialization of the OD-01 technology,” added Oculeve president & CEO Michael Ackermann. “I am extraordinarily appreciative and proud of the Oculeve team that has worked so hard to develop our exciting technology, and I am thrilled for us to partner with the Allergan team on the continued development, potential approval and availability of OD-01 to patients worldwide.”

Allergan said its prior 2015 earnings-per-share guidance for $17 to $18 is unchanged as a result of the acquisition, which is expected to close during the 3rd quarter.

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Lima Corporate closes Zimmer Biomet acquisitions

Lima Corporate said last Friday that it has completed its acquisition of knee and elbow assets from the merged Zimmer and Biomet.

The Italian orthopedic company said it purchased Zimmer’s unicompartmental High Flex knee implant and Biomet’s Discovery elbow system within the European Economic Area and Switzerland. Lima Corporate also acquired Biomet’s Vanguard complete knee system in Denmark and Sweden.

“The completion of this acquisition gives Lima a big step up in the knee and extremities markets. The Zimmer ZUK and the Biomet Vanguard complete knee system will open doors for the rapid expansion in the knee market. We are already a market leader in total shoulder arthroplasty and the Biomet discovery elbow system will allow us to expand our position,” CEO Luigi Ferrari said in a press release.

Earlier this month, DJO Global acquired Zimmer and Biomet’s Cobalt bone cement, Optivac cement mixing accessories, SoftPac pouch and Discovery elbow system for the U.S. marketplace

In June, Smith & Nephew said they would be acquiring the U.S.  unicompartmental High Flex knee assets.

The U.S. Federal Trade Commission approved the Zimmer/Biomet merger late last month, after Zimmer found buyers for some of the U.S. assets it and Biomet owned.

The European Commission in March approved the merger of the Warsaw, Ind.-based companies, contingent on the knee and elbow asset divestitures.

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Teleflex recalls Hudson RCI manual resuscitator

Teleflex (NYSE:TFX) is recalling its Hudson RCI Lifesaver single patient use manual resuscitator, according to an FDA posting.

The Wayne, Penn.-based company began notifying customers of the issue on May 14.

The FDA has labeled the recall as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The devices are being recalled due to an issue with the intake oxygen port becoming potentially blocked, which may inhibit air flow and breathing support to the patient, according to the FDA posting.

No reports of death or serious injury have been received related to the issue.

A total of 2,405 units manufactured and distributed between June 2014 and April 2015 are being recalled.

Late last month, Teleflex recalled its Hudson RCI Lifesaver neonate manual resuscitator over the same issue, with 9,333 units affected.

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Spectranetics’ AngioScore wins $20m from Trireme, founder Konstantino

AngioScore last week won a $20 million judgment against co-founder and former board member Eitan Konstantino, after a federal judge ruled that Konstantino violated his duties to AngioScore when he started TriReme Medical, Quattro Vascular and QT Vascular.

AngioScore, which Spectranetics (NSDQ:SPNC) acquired last year for $230 million, accused Konstantino of breaching his fiduciary duties to AngioScore by developing the TriReme’s Chocolate balloon catheter, which competed directly with AngioScore’s AngioSculpt balloon. The Chocolate device won 510(k) clearance from the FDA in June 2014. The lawsuit, filed in June 2012 in the U.S. District Court for Northern California, also accused TriReme, Quattro and QT Vascular (SGX:5I0) of abetting in Konstantino’s alleged breaches.

Judge Yvonne Gonzalez Rogers agreed July 1, ordering Konstantino to disgorge $250,000 received for licensing the Chocolate rights and a 2.85% royalty on sales of the device. Gonzalez Rogers also ordered Konstantino to cough up his roughly 15 million shares in QT Vascular, which were worth about $2 million at their July 2 closing price of ¢13.5 (0.182 SGD), and any profits gleaned from sales of the stock and any remuneration from consulting on the Chocolate device.

The judge also awarded nearly $3.0 million in lost profits and another $17.1 million in future lost profits to AngioScore on future sales from 2014 through the 2nd quarter of 2019.

“To say that Konstantino ‘downplayed’ the facts surrounding Chocolate would be an understatement. Konstantino did not inform [AngioScore CEO Tom] Trotter that the development of TriReme’s specialty balloon, which by that point had been called Chocolate for several months, was well underway. He did not disclose his personal role in the development and conceptualization of the device, nor did he disclose that a prototype had been created, a patent application and been submitted, animal testing had occurred, or that he had already engaged potential investors and funding sources,” Gonzalez Rogers wrote.

“Here, the court is confronted with facts establishing that Konstantino, aware of AngioScore’s competition-sensitive information, its then-existing financial condition, design challenges, and business objectives, developed a competing device while on AngioScore’s board and took affirmative steps to exploit it himself while concealing it from AngioScore. At the same time, Konstantino was aware that he owed AngioScore fiduciary duties. On these facts, that Konstantino invented the competitive technology does not serve his argument that he should be absolved of his fiduciary obligations to AngioScore. Rather, it works the opposite effect: Konstantino’s failure to abide by his duty is plainly all the more offensive,” she wrote.

AngioScore said it plans to go after Konstantino for legal costs it advanced him.

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