Elekta taps Brainlab as select EU distro partner for stereotactic neuro devices

Elekta (STO:EKTA B) said today it tapped Brainlab to distribute its stereotactic neurological devices across select markets in the European Union.

The distribution agreement covers Elekta’s Leksell Vantage Steretactic target localization and coordinate referencing neurosurgery system, the company said, which received CE Mark approval in the EU in March. The device is currently pending 510(k) clearance in the US, Elekta added. The agreement also covers the Leksell Stereotactic system and Elekta Microdrive.

“Elekta is a leader of equipment for stereotactic neurosurgery and Brainlab has a strong presence in the neurosurgery market with its software solutions. This collaboration helps to strengthen and streamline the service and support to our customers starting in France, Belgium, Poland, Liechtenstein, Luxemburg, Portugal and Spain. With this, they will be able to access a complete solution from a single source,” Elekta western & central Europe senior VP François Pointurier said in prepared remarks.

Stockholm-based Elekta said it began collaborating with Brainlab last year to improve the interopability and safety of stereotactic surgery through the integration of Elekta’s Leksell Vantage stereotactic system into Brainlab’s Elements Stereotaxy software.

“A distribution partnership between Brainlab and Elekta will provide clinicians with improved and standardized stereotactic neurosurgery workflows,” Brainlab prez & CEO Stefan Vilsmeier said in a prepared statement.

“This latest collaboration between our companies will be mutually beneficial, strengthening our respective combined offer in neurosurgery. By joining forces in sales and support, we aim to strengthen our relationship with the neurosurgery community by offering more solutions from the Elekta portfolio,” Elekta chief strategy officer Maurits Wolleswinkel said in a press release.

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Smith & Nephew

Smith & Nephew (NYSE:SNN) said today that it’s adding a total knee arthroplasty application to the Navio handheld robot-assisted platform.

The European Union’s largest orthopedics player said the Navio system can be used with its Journey II, Legion Primary and Genesis II total knees. Smith & Nephew acquired Minnesota-based Blue Belt Technologies – Navio’s original maker – in January 2016 for $275 million.

“The Navio partial knee replacement application has been commercially available since 2014, including UKA and PFJ options, and has developed a strong surgeon following,” U.S. commerical president Glenn Warner said in prepared remarks. “The full market release of the TKA application provides a robotics-assisted solution for one of the largest markets in orthopaedics. Smith & Nephew is committed to continued expansion and growth of the Navio robotics-assisted platform.”

“The Navio system offers game changing improvements in precision and accuracy without sacrificing efficiency. It allows surgeons the control to create a patient-specific plan in the OR and the confidence to execute with robotic precision,” added Dr. Joseph Burkhardt of Battle Creek Hospital in southwest Michigan. “For the total knee, it provides surgeons the ability to do more than they have ever been able to do with standard instruments, resulting in improved functional outcomes for the patient.”

Blue Belt won its first FDA clearance in 2012, for a partial knee replacement system then called the NavioPFS. U.S. market clearance for its Stride unicondylar knee implant followed in June 2013.

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Zimmer Biomet launches X-PSI customized total knee replacement

Zimmer Biomet (NYSE:ZBH) said on Thursday it launched its X-PSI knee system, an X-ray-based, patient-specific surgical planning system designed for patient specific implant positioning using X-ray tech.

The X-PSI system is designed for use with all of the Warsaw, Ind.-based company’s total knee brands, and allows surgeons to use X-ray images to generate 3D anatomical models. The system is then used to view the patients’ anatomy and develop a customized 3D surgical plan, the company said.

“The use of innovative preoperative planning to enable patient-specific customization has the potential to become the gold standard in joint replacement care; however, its widespread clinical utility has been limited by its reliance on MRI and CT imaging, which are less accessible and not typically used for preoperative evaluation. Conversely, virtually every candidate for joint replacement surgery undergoes X-ray imaging, so we are thrilled to debut the first CE Marked, X-ray-based patient specific instrument system, and extend the benefits of customized surgical planning to joint replacement patients across the European Union. This new offering was conceptualized and developed in collaboration with Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, who pioneered the original concept,” joint reconstruction group prez Dan Williamson said in a prepared statement.

Zimmer Biomet touted the X-PSI system as the world’s 1st X-ray based patient specific system for total knee replacement surgery with CE Mark approval in the European Union. The company said it is its 4th patient specific guide in its personalized solutions franchise, and is slated to be launched in 5 countries in the EU.

“The growing use of MRI and CT-based planning software to customize implant placement has meaningfully improved patient outcomes in joint replacement surgery. Our study found that X-PSI Knee System, which uses X-ray imaging with Zimmer Biomet’s patient specific instruments planner, yields comparably high implant placement accuracy as MRI and CT-based systems, while significantly improving accessibility and clinical utility to a broader patient population,” X-PSI IDE trial lead investigator Dr. Raju Ghate of Evanston, Ill.’s NorthShore University HealthSystem said in a press release.

In May, Zimmer Biomet said it inked a deal with device incubator Bonutti Research for 2 families of patents related to knee technologies. The company licensed a patent which Bonutti says “adds to the strength” of the Persona personalized knee system and its NexGen Complete knee solution.

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CardioFocus launches 3 studies of HeartLight ablation system

CardioFocus today announced the launch of 3 studies of its HeartLight endoscopic ablation system, touting that over 1,000 patients with atrial fibrillation will be enrolled across the studies.

The Marlborough, Mass.-based company’s HeartLight system is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility. The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech, the company said.

In the 1st study, researchers will compare the acute procedure and safety outcomes along with long-term clinical 2 groups of patients being treated for paroxysmal AF, the company said. The 1st group will be treated with the HeartLight system, while the other will be treated with a commercially available contact force sensing irrigated radiofrequency ablation catheter and possible 3D electroanatomical mapping. The study is slated to enroll 350 patients at approximately 10 centers across Europe.

The 2nd study looks to enroll 400 patients, 4 separate arms. The trial aims to enroll 200 patients with paroxysmal AF and 200 with persistent AF, of which 100 of each will be treated with the HeartLight system and 100 will be treated with a cryoballoon.

In its 3rd study, the company will evaluate clinical outcomes in a cohort of patients treated during commercial use of the HeartLight system, looking to verify results from the company’s successful US clinical pivotal study. The trial aims to enroll 250 patients at 25 sites in the US.

CardioFocus said the 3 studies would help provide additional clinical evidence of the performance of its HeartLight system in patients with AF.

“The data continue to reinforce the chronic efficacy of laser balloon ablation with the HeartLight System in our most recent single center comparative analysis showing freedom from AF at one year of 93 percent,” Dr. Pieter Koopman said in a prepared statement.

“We are greatly encouraged by all the positive data collected to date on the HeartLight System and look forward to the results of these new exciting studies enrolling up to 1,000 AF patients. Our goal is to be a leader in the field of pulmonary vein isolation, which includes supporting the initiation of clinical studies that provide further evidence of the HeartLight System’s impressive safety and efficacy profile and make this technology more widely accessible to the more than 9 million1 patients, in the U.S. and Europe, who are suffering from AF,” exec chair Paul LaViolette said in a press release.

In March, CardioFocus raised $20.2 million in a round of equity and options financing, according to an SEC filing posted this week.

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Titan Medical closes $6m offering

Titan Medical (TSX:TMD) said today that it raised nearly $6 million in a public offering, with company insiders putting up another $217,000.

Toronto-based Titan, which is developing the Sport robot-assisted surgery platform, had said it might float up to 100 million shares, which would have fetched $11.5 million. In the event the company floated nearly 48.4 million shares at 11.5¢ (C15.0¢) apiece, for gross proceeds of almost $5.5 million (C$7.3 million). Each unit in the offering consisted of a stock share and a 5-year warrant priced at 15.3¢ (C20.0¢).

Titan said another 1.4 million shares were issued to company insiders, including all directors and officers, for gross proceeds of $216,896. Bloom Burton Securities was the sole offering agent for the flotation, the company said.

Earlier this month, its shareholders approved a reverse stock split at a range of one share for 5 to 30 shares.

In April, Titan Medical said it spiked talks with Chinese distributor Longtai Medical over its Sport robot-assisted surgery platform so it can focus on winning regulatory approvals in the U.S. and Europe.

Back in October 2015, Titan inked a private placement deal with Longtai, a subsidiary of Chinese medical device distributor Ningbo Long Hengtai International Trade Co., that could have ended up being worth more than $24 million.

($1 = C$1.30927)

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Spineology wins FDA nod for Rampart One lumbar interbody fusion system

Spinal tech developer Spineology said this week it won FDA clearance for its Rampart One anterior lumbar interbody fusion system.

The St. Paul, Minn.-based company said the Rampart One is designed to minimize exposure and vascular retraction requirements associated with traditional anterior spine fusion procedure, and includes both standard and oblique interbody device footprints with integrated fixation screws.

“Variable angle instrumentation and integrated guides are colinear with the access, providing the surgeon the ability to keep the incision to a minimum,” Dr. Jeremy Shore said in a prepared statement.

“For instances where there is limited to no vessel mobility, the Rampart One oblique footprint is an excellent option,” Dr. Clifford Tribus said in prepared remarks.

The Rampart One is manufactured from the company’s Invibio Peek-Optima HA enhanced material, which Spineology claims provides an improved osteoconductive surface for bone in-growth, reduced stress shielding and artifact-free imaging.

“Minimizing exposure and retraction are cornerstone elements of all Spineology anatomy conserving designs. We are very excited about this approval and look forward to entering the anterior market in the near future,” CEO John Booth said in a press release.

In March, Spineology said it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion procedures. The company said it won cleraance for a narrower 10mm version of the device, as well as an extended indication allowing the device to be used with allograft bone.

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NanoVibronix looks to raise $10m

NanoVibronix (NSDQ:NVBXU) is looking to raise approximately $9.6 million in a new offering of shares to support getting its shares listed on the Nasdaq Capital Markets, according to an SEC filing posted this week.

The offering could also be used to support a transition of the company’s headquarters to the US, according to a Globes report. The company’s CEO, CFO and marketing setup would operate out of the US, while R&D would still operate out of Israel, according to the report.

Funds will also support expanding the company’s sales leadership team and field level sales resources, research & development efforts and implementation of its surface acoustic wave platform to other applications, according to the SEC filing. Money from the offering could also be used for complimentary acquisitions, to pay holders of 2017 notes and for general working capital.

In the round, the company said it plans to offer select Series D convertible preferred stock to shareholders with more than 4.9% of its outstanding common stock, and will reduce shares of common stock sold by 1 for each preferred share sold, according to an SEC filing.

NanoVibronix is developing medical devices using its proprietary low intensity surface acoustic wave wound care and pain relief technology, which it claims can be used for a variety of medical applications. The devices are designed to be administered at home without the assistance of medical processionals, and include the CE Marked PainShield and WoundShield. The company’s PainShield also has FDA clearance, the company said.

The company has also won CE Mark approval in the European Union for its catheter based UroShield and NG-Shield devices.

Last December, NanoVibronix said it won approval from Health Canada to sell its WoundShield device in Canada.

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