Dynatronics inks orthopedic distro deal

Dynatronics said today it inked a distribution deal with Orthopedic Outfitters.

Through the deal, Orthopedic Outfitters will distribute its Dynatronics division products, including the Dynatron Solaris Plus, ThermoStim Probe and 125B Portable Ultrasound across Northern California.

“We are delighted to add Orthopedic Outfitters to our growing list of partnersOrthopedic Outfitters has built a reputation for excellent customer service and is recognized as a top dealer in the state of California.  They are an ideal partner to distribute our products in Northern California.  With this agreement, we continue to execute on one of the core pillars of our organic growth strategy – strengthening our domestic distribution,” Dynatronics chair & CEO Kelvyn Cullimore Jr. said in a prepared statement.

“We are incredibly proud of the opportunity to partner with Dynatronics for this exciting new chapter of growth,” Orthopedic Outfitters CEO Jon Dunphy said in prepared remarks.

“This agreement marks an exciting new milestone in the execution of our strategy for our legacy business. We have a great deal of respect for Jon and the business he has built over the years.  We look forward to the exciting work ahead as we strive to provide not only the best products, but also the best service in the industry,” sales & marketing VP Jeff Gephart said in a press release.

Last April, Dynatronics said it raised $7.8 million in a new round of equity and mixed funding to cover its acquisition Hausman Industries assets, including physical therapy and athletic training products.

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NanoVibronix inks UK UroShield distro deal with IMS Ultrasound

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NanoVibronix

NanoVibronix (NSDQ:NAOV) said today it inked a deal with the U.K.’s IMS Ultrasound to make it the exclusive U.K. distributor of its UroShield device, designed to prevent catheter-acquired urinary tract infections.

The UroShield device from the Elmsford, N.Y.-based company is designed to decrease pain and discomfort associated with urinary catheter use while also preventing bacterial colonization and biofilm on indwelling catheters to reduce UTIs.

“CAUTI is a major health concern in the UK and around the world, leading to extended hospital stays, increased costs, as well as increased patient mortality. We are excited to partner with NanoVibronix in order to bring UroShield to market in the UK, which we believe has enormous potential and could help save many lives. Given the strong supporting clinical data to date, we look forward to conducting an additional clinical trial in the UK with the support of NHS, which we believe will help garner even greater support from payors,” IMS Ultrasound managing director Andrew Wakeling said in a prepared statement.

As part of the deal, NanoVibronix said that IMS Ultrasound will also be funding a clinical study in association with the U.K.’s National Health Service.

“We are excited to report the addition of a significant European distributor partnership for UroShield following our recently announced preliminary clinical results, which demonstrate a material reduction in the rate of CAUTI. UroShield already has European marketing clearance, and this latest data is now helping us to attract the leading distributors across Europe. The fact IMS Ultrasound is willing to fully fund the planned clinical trial in the UK is strong validation of their interest and commitment to our UroShield product,” NanoVibronix CEO Brian Murphy said in a press release.

Last month, NanoVibronix released interim results from a trial of its UroShield ultrasound device designed to prevent bacteria and biofilms from forming on urinary catheters, touting a low rate of CAUTIs.

Elekta taps Brainlab as US stereotactic neurosurgery distro partner

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Elekta, Brainlab

Elekta (STO:EKTA B) said today it inked an exclusive deal with Brainlab to make it the authorized distributor of Elekta’s stereotactic neurosurgery solutions.

Through the deal, Brainlab will be the authorized distributor of Elekta’s Leksell Vantage stereotactic system which won CE Mark approval in the European Union this year. The system also has FDA 510(k) clearance and is commercially available in the US.

Stereotactic neurosurgery is a minimally invasive approach to brain surgery designed to treat specific regions of the brain and spare surrounding healthy tissue, and is often used to implant deep brain stimulation leads or to perform lesioning of small brain targets for treating functional disorders.

“Early adopters of the Vantage system are experiencing clinical and patient benefits from its multiple design innovations. These include stereotactic magnetic resonance imaging with fewer restrictions, easier target coordinate setting during surgery as well as improved anesthetic capabilities,” Elekta neuro portfolio VP Jesper Söderqvist said in a prepared statement.

“We strive to make medical technology more impactful and accessible to physicians and their patients. By partnering with Elekta, we are increasing our reach and providing clinicians with advanced and innovative technology on the stereotactic neurosurgery market,” Brainlab functional & stereotactic neurosurgery VP Paolo Jelmoni said in a prepared release.

The deal expands on an earlier distro deal the two companies signed in June that covered distribution in the European Union.

“Brainlab shares our vision for improving care and outcomes for patients undergoing neurosurgical procedures. The expanded partnership with Brainlab, with a large and specialized sales and service team, to distribute Vantage in the United States gives us a strong position from which to realize the potential of the system to advance the care of patients undergoing stereotactic neurosurgery procedures,” Elekta NA exec VP Peter Gaccione said in a press release.

In November, Elekta said it delayed the rollout of its Unity device, designed to combine magnetic resonance imaging with a linear accelerator for radiation therapy, saying it needed more time to finalize and validate the linac control system.

Implanet inks distro deal with Korea’s L&K Biomed

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ImplanetFrance-based orthopedic implant company Implanet said today that it inked a strategic partnership with Korea’s L&K Biomed.

According to the terms of the deal, Implanet America will team up with Aegis Spine, L&K Biomed’s U.S. subsidiary, to accelerate the marketing of its Jazz platform in the U.S. In Asia, L&K Biomed will be responsible for distributing the company’s Jazz platform. In exchange, Implanet plans to distribute L&K Biomed’s implants in Europe.

Both companies said they hope to jointly penetrate the Japanese market, which they cited as the second-largest market for medtech.

“L&K Biomed is very pleased with this partnership with Implanet, leader in latest-generation braided implants for treating spine disorders. We firmly believe that there are substantial synergies between our two companies on both an operating level, with the disruptive and innovative nature of our product ranges, and a commercial level, with our respective distribution networks,” L&K Biomed’s CEO, Lee Seung Joo, said in prepared remarks.

“The search for a strong partner of a significant size with an innovative product range that complements our technology had been a priority for us in recent months. We are delighted with this agreement with L&K Biomed, particularly as it should enable us to significantly accentuate our presence in the United States, given our new partner’s longstanding and successful activity, in Asia, via its natural presence there and its in-depth knowledge of these markets’ specificities, and in Europe, by providing surgeons with an innovative range of high-end implants that complement our own technology,” Implanet CEO Ludovic Lastennet added.

In June, Implanet won CE Mark approval in the European Union and FDA clearance for its Jazz braid device.

Align Technology expands iTero distro, integration deal with Glidewell

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Align Technology (NSDQ:ALGN) said today it expanded a distribution deal with Glidewell Dental to distribute Align’s iTero Element intraoral scanning system in North America.

Through the deal, San Jose, Calif.-based Align’s said its iTero Element scanner will feature Glidewell’s fastdesign.io software which serves to auto-design restorations for clinician approval and to communicate with a lab’s digital design technicians as needed.

“This is an exciting opportunity to join together to deliver a restorative work flow driven by digital precision and enabling the growth of digital dentistry. This collaboration makes same-day restorations more efficient and accessible for our joint customers, and also introduces the benefits of iTero scanning to the more than 50,000 dentists using Glidewell services,” Align chief marketing officer Raphael Pascaud said in a prepared statement.

Align Technology said it expects the iTero Element with Glidewell’s technology to be available during the 1st quarter of 2018.

“Align has long been at the forefront of digital dental technology. Their pioneering spirit and drive for continued innovation are very much in line with Glidewell Dental’s goal to remove barriers to patient treatment, and I couldn’t be more excited about this dynamic pairing,” Glidewell Dental founder & prez Jim Glidewell said in a press release.

In late October, Align saw shares rise over 15% after the orthodontic device maker beat expectations on Wall Street with its third quarter results.

Cardinal Health to deal China biz for $1.2B

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Cardinal HealthCardinal Health (NYSE:CAH) said yesterday that it agreed to a $1.2 billion deal with Shanghai Pharmaceuticals Holding for portions of its business in China.

The deal covers Dublin, Ohio-based Cardinal’s pharmaceutical operations and medical distribution business in the People’s Republic, but does not include other assets there such as Cordis, the patient recovery business for which it paid Medtronic (NYSE:MDT) $6 billion or its medical sourcing team.

“It has been an honor to serve the people of China through our distribution business for the past seven years,” chairman & CEO George Barrett said in prepared remarks. “We recognize that significant scale is required to be a market leader in China and with that in mind, we are delighted to announce that Shanghai Pharma has agreed to purchase our distribution business in China. We are very proud of the work that our colleagues have done and their accomplishments have allowed us to build a business that is now poised for further growth under its new owners. On behalf of all of us at Cardinal Health, I want to thank the team for their continued commitment, hard work and dedication to our customers and the patients they serve.”

“Amid the national healthcare reform, the acquisition of the Cardinal Health China business will further strengthen our leadership in the distribution and retail pharmacy network, and expedite our transformation to become a modern global healthcare provider. This will also facilitate the growth of our pharmaceutical manufacturing business, enabling us to play a significant role in the Government’s ‘Healthy China’ initiative,” added Shanghai Pharma chairman Zhou Jun.

The deal is expected to close by the end of Cardinal Health’s fiscal year in September 2018, the company said, noting that chairman Eric Zwisler retired effective immediately as part of the divestment.

“On behalf of everyone at Cardinal Health, I’d like to thank Eric for many years of leadership and dedication to our organization. We wish him well in his future endeavors,” said Barrett, who is slated to step down himself in January in a planned succession.

Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data

Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair.

The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization of novel endovascular stent graft systems for the treatment of thoracic aortic disease.

Japan Lifeline will gain exclusive distribution rights to the systems in Japan, while Endologix said it will commercialize the system through its existing global sales force in other regions.

“JLL is our exclusive distributor in Japan, and it has done an outstanding job supporting physicians and capturing market share in Japan with our AFX device for the treatment of abdominal aortic aneurysms. We are currently working with JLL on a full market release of our AFX2 bifurcated endograft system in Japan after receiving approval for that device earlier this year. We also anticipate Japanese market launches of Ovation and Nellix in the future. These new agreements with JLL will expand our relationship to include thoracic devices and enable us to provide a complete range of endovascular aortic devices to physicians worldwide,” Endologix CEO John McDermott said in a prepared statement.

Endologix also released data from its 1st-in-human experience from the 1st 7 patients treated with the Ovation Alto. The devices were implanted at Auckland, New Zealand’s Auckland City Hospital between Aug. 2017 and Feb. 2017.

Results from the initial cases indicated successful delivery and deployment in all patients with a 100% technical success rate. No type I or type III endoleaks, stent graft migrations, abdominal aortic aneurysm ruptures, abdominal aneurysm-related deaths or secondary interventions were reported.

“Although limited to only 7 patients, early experience with the Ovation Alto was promising and suggests the device may safely expand EVAR indications beyond that of other available devices,” Dr. Sean Lynden, who presented the results at the VIVA 2017 conference wrote in a summary.

Endologix touted that the device features a low-profile 15-F outer diameter delivery system and the ability to seal at the level of the proximal sealing ring, which is 7-mm distal to the top of the fabric.

Last month, Endologix touted results from its Leopard clinical trial, which compared its AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.

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Viveve inks distro deal with InControl Medical, posts Q2 miss

Shares in Viveve (NSDQ:VIVE) have stayed steady today after the company announced a new exclusive distribution deal with InControl Medical and released 2nd quarter earnings that missed expectations on Wall Street.

Under the agreement, Englewood, Colo.-based Viveve said it will be granted exclusive rights to distribute all of InControl Medical’s products to healthcare providers in the US.

“We are pleased with the opportunity to partner with Viveve to enable wider distribution of our clinically proven devices to U.S. medical professionals who can help the millions of patients suffering from pelvic floor and related incontinence conditions. Our hope is that these products will allow more women to have better control and an improved quality of life. Viveve and InControl share a dedicated commitment to advancing solutions for women’s health,” InControl Medical CEO Herschel Peddicord said in prepared remarks.

Viveve said it will be making a $2.5 million equity investment in InControl as part of the distribution agreement, as well.

“Completing an agreement with InControl Medical represents a significant opportunity for Viveve in the U.S. professional healthcare market. The addition of InControl Medical’s FDA cleared medical devices for stress, urge, and mixed incontinence as well as their products to improve pelvic floor strength enhances our portfolio with a range of high quality products that are used by healthcare professionals within Viveve’s currently targeted specialties. In addition to InControl Medical’s innovative devices to treat incontinence, their products aimed at improving patients’ pelvic floor strength and health complement the effectiveness of Viveve’s Geneveve treatment, that currently has regulatory clearance or approval in over 50 countries for the treatment of vaginal laxity and/or the improvement of sexual function. In the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis,” Viveve CEO Patricia Scheller said in a prepared statement.

In its earnings report, Viveve posted losses of $10.4 million, or 54¢ per share, on sales of $3.1 million for the 3 months ended June 30, seeing losses grow 96.1% while sales grew 97.7% compared to the same period during the previous year.

Losses per share came in ahead of the 43¢ consensus on Wall Street, where analysts were expecting to see sales of $3.2 million for the quarter.

“During the 2nd quarter, we continued to achieve our commercial objectives and experienced growing demand for our innovative technology in the U.S. We also reached a number of important milestones that support our global commercialization strategy,” CEO Scheller said in a press release.

Shares in Viveve Medical are down 0.9% so far today, at $6.99 as of 10:56 a.m. EDT.

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