NuVasive closes $98m Biotronic NeuroNetwork buyout

NuVasive Inc. (NSDQ:NUVA) said today that it closed the $98 million acquisition of intraoperative neurophysiological monitoring service provider Biotronic NeuroNetwork.

Ann Arbor, Mich.-based Biotronic NeuroNetwork provides neurophysiological monitoring services to surgeons and healthcare facilities in the U.S., as well as remote physician oversight. The company supports more than 45,000 surgeries annually at more than 650 hospitals, NuVasive said.

“We are very excited to announce the completion of the Biotronic acquisition, as it advances NuVasive’s strategy to transform how spine procedures are approached, measured and valued from a clinical and economic perspective. We are confident that Biotronic, together with our existing Impulse Monitoring business, will enable our newly formed NuVasive clinical services division to further deliver our spine service line partnerships and create the standard of care utilizing the NuVasive’s procedurally-integrated offerings,” chairman & CEO Gregory Lucier said in prepared remarks.

NuVasive announced the deal last month.

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Corrections to Australian government’s prostheses list have reimbursement implications

By Stewart Eisenhart, Emergo Group

The Australian Department of Health recently issued several corrections to its list of prosthetic medical devices used to determine reimbursement rates from private health insurers in the country.

According to the Department of Health’s Private Health Insurance Branch, corrections were necessitated due to various omissions, errors and technical issues in the February 2016 update to the Department’s Prostheses List.

Australian authorities reissue the prostheses list every February and August; private insurers must pay mandatory benefits for any device included in the list. As Emergo reported in late 2015, the government’s prostheses list reimbursement requirements and arrangements constitute a major part of Australia’s private insurance industry, so any changes or corrections to the list potentially impact insurance providers as well as prosthetic device manufacturers selling to private healthcare providers.

Broader reform effort

The recent correction of the prostheses list occurred during a broader reform effort by the Australian government. Beginning in February 2016, the Department of Health formed an industry working group charged with exploring ways to reform prosthetic device listing and pricing processes.

The working group was tasked with identifying ways to boost transparency of prosthetic device pricing and reimbursement processes, as well as related issues regarding how prosthetic devices are chosen for inclusion on the Prostheses List.

Following the working group’s final report, the Department of Health set about establishing a Private Health Sector Committee (PHSC) to advise on design and implementation of private health insurance sector reforms. The Department also undertook remaking of the Prostheses List Advisory Committee (PLAC) to improve listing and reimbursement practices for the Prostheses List in particular. The government anticipates a two-year time frame for its reform efforts.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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MassDevice.com +5 | The top 5 medtech stories for July 1, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Nestle poaches Fresenius CEO Schneider

Nestle lured the CEO of Fresenius, Ulf Mark Schneider, to the corner office this week. Fresenius promoted CFO Stephan Sturm to replace Schneider. Read more

 

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4. Biotronik wins CE Mark for Edora MRI-adaptable pacers

Biotronik said today that it won CE Mark approval in the European Union for its Edora line of MRI-adaptable pacers.

The German medical device company said the Edora pacemakers and cardiac resynchronization therapy pacemakers use a sensor called MRI AutoDetect that’s designed to ensure that the device goes into safe mode only during magnetic resonance scans, ensuring that the device continues to deliver therapy for as long as 14 days after the sensor is activated. Once the scan is over, the Edora device automatically resumes therapy without needing to be reset by a physician, Biotronik said. Read more

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3. Spirometrix lands $17m Series C for breath-based diagnostic device

Spirometrix said yesterday that it raised $17.4 million in the 1st tranche of its Series C round for the breath-based diagnostic device it’s developing for asthma patients.

Shanghai Fosun Pharmaceutical led the round, joined by prior investors NGK Spark Plug, South Valley Angels, Iconical, Ohio Innovation Foundation and Carmen Innovation, Spirometrix said. Read more

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2. NuVasive ponies up $45m to settle Medtronic beef

NuVasive Inc. said yesterday that it agreed to pay Medtronic $45 million to settle their long-running patent infringement beef.

The companies expect to reach a final agreement within 15 days, putting to rest a battle that began when Medtronic subsidiary Warsaw Orthopedic sued NuVasive in 2008. San Diego-based NuVasive counter-sued; in September 2011 a jury split the verdict, awarding $101.2 million in damages to Medtronic and $660,000 to NuVasive. Read more

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1. Bioventus files for $150m IPO

Orthobiologics maker Bioventus yesterday registered for an initial public offering it plans to use to pay off debt.

Durham, N.C.-based Bioventus was formed in 2012 when Smith & Nephew spun out its biologics and clinical therapies division in a joint venture with venture capital firm Essex Woodlands. In October 2014 Bioventus acquired the OsteoAMP product line from Advanced Biologics for an undisclosed amount; late last year the company added BioStructures, a developer of absorbable bone grafts, also for an undisclosed amount. In January Bioventus named former Medtronic CEO Bill Hawkins as chairman. The company tapped the CEO of Abiomed, Mike Minogue, for a seat on the board last week. Read more

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Lombard touts 1st commercial use of IntelliFlex LP with Aorfix stent graft

Lombard Medical Technologies (NSDQ:EVAR) today touted the 1st commercial use of its IntelliFlex low profile delivery system designed to implant the Aorfix endovascular stent graft in a procedure to treat an abdominal aortic aneurysm.

The procedure was performed by Dr. Nilo Mosquera at Spain’s Complexo Hospitalario Universitario de Ourense on the 28th of June, the Irvine, Calif.-based company said.

“My surgical team and I were very pleased with the performance of IntelliFlex LP. The device’s lower catheter profile was able to successfully navigate this particular patient’s calcified access vessels, something that in our experience might have not been possible with the previous generation’s delivery profile.  The enhanced control of the new Y-mechanism is a significant improvement in stent delivery technology and provides greater control and precision when deploying the proximal end of the devices, allowing for a very precise graft placement.  The integrated exchange sheath is also beneficial in reducing potential vessel trauma and facilitates the less invasive percutaneous approach,” Dr. Mosquera said in an SEC filing.

The Intelliflex system, in addition to allowing for the delivery of the Aorfix endovascular stent, includes an integrated exchange sheath designed for the delivery of ancillary devices during the procedure, the company said. The design removes the need for catheter exchanges, which Lombard said saves procedure time, blood loss and possible vessel trauma.

“The user and procedure advantages of the IntelliFlex LP together with the outstanding long-term Aorfix clinical data will provide physicians with an even more compelling reason to use this technology to treat an even greater range of patient anatomies. We believe our portfolio approach with our patient centered combination of Aorfix with IntelliFlex LP to treat complex anatomy and our new Altura stent graft which delivers multiple advantages for the treatment of patients with more routine AAA anatomy, will provide physicians with greater treatment options.  We believe this product combination will be a significant driver of revenue growth in 2016 and beyond.   We look forward to our European commercial launch of IntelliFlex in July,” CEO Simon Hubbert said in a prepared statement.

Lombard said it plans to begin shipment in July to its direct markets in the U.K. and Germany, with a full commercial launch in other European markets later this year.

In late July, Lombard said it won CE Mark approval in the European Union for its IntelliFlex low profile delivery system for its Aorfix endovascular stent graft.

The system is designed for the delivery of the company’s abdominal aortic aneurysm Aorfix endovascular stent graft, and includes an integrated exchange sheath designed for the delivery of ancillary devices during the procedure, the company said. The design removes the need for catheter exchanges, which Lombard said saves procedure time, blood loss and possible vessel trauma.

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Bovie inks J-Plasma distribution deal with Arteriocyte

Bovie Medical (NYSE:BVX) said this week it inked a sales channel partnership agreement with Arteriocyte Medical Systems to sell Bovie’s J-Plasma to its network of plastic surgeons.

Through the deal, Arteriocyte will offer J-Plasma through its U.S. sales network, which Clearwater, Fla.-based Bovie said will significantly expand its use in office-based practices.

“We are delighted to sign this agreement with Arteriocyte, a company with an exemplary reputation in selling innovative cellular therapy based medical devices. J-Plasma’s precision and lack of thermal spread make it a natural fit for the plastic surgeon, and Arteriocyte’s nationwide reach and complementary product portfolio will significantly raise awareness of the technology, and complement our existing sales efforts. This partnership is an important milestone in our strategy to scale J-Plasma across multiple specialties, leveraging the different applications for this unique surgical technology,” Bovie CEO Robert Gershon said in a press release.

Bovie Medical said Arteriocyte’s sales team has previous experience in biologics and medical devices used in plastic surgery, as well as a portfolio of complementary products.

“J-Plasma’s potential to substantially reduce patient down-time aligns well with our strategic priorities, and we look forward to successfully launching this new product to our network of plastic surgeons nationwide,” Arteriocyte CEO Donald Brown said in prepared remarks.

In April, Bovie Medical said it launched its J-Plasma compatible Precise 360 hand piece designed for prostate surgery procedures.

The newly released J-Plasma Precise 360 handpiece is designed with an angled and rotating tip to allow operating surgeons to access to structures that would be difficult to reach with straight laparoscopic devices, the company said.

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IntriCon slips on missed Q2 prelims

Intricon (NSDQ:IIN) saw shares fall over 9% after releasing preliminary 2nd quarter earnings that are off the mark, well under Street analysts expectations.

The Arden Hills, Minn.-based company said it expects losses of approximately $1.4 million, or 19-22¢ per share, on sales of $16.8 million for the 3 months ended June 30.

That amounts to a significant 3-fold slide from profits of $506,000 last year, with sales shrinking 1.8%. Earnings per share were well below expectations, with the Street looking for earnings of 4¢. Revenue also fell below expectations of $17.8 million.

Shares have dipped in mid-day trading, down 9.2% to trade at $4.85 as of 12:23 p.m. EDT.

“While we are disappointed in our results, we believe that this is purely a timing issue beyond our control. Sales were primarily impacted by lower revenue from our largest customer as they manage the transition of their pending product approval and launch. We continue to make progress building the infrastructure required to secure high-potential growth opportunities in value hearing health, and the long-term outlook for our business remains healthy,” CEO Mark Gorder said in a press release.

Last November, IntriCon said it bought the assets of hearing healthcare product manufacturer PC Werth, a leading hearing aid supplier to the U.K.’s National Health Service.

Intricon said it inked an exclusive agreement with PC Werth last December to distribute its hearing aid products in the U.K., but the full acquisition will allow Intricon extra access to the U.K’s NHS.

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InspireMD prices $15m offering

InspireMD (OTC:NSPR)  this week priced a new public offering, looking to bring in approximately $15 million through the sale of 442,424 shares of Series B convertible preferred stock and accompanying warrants to purchase approximately 44.2 million shares of common stock.

Each share of Series B convertible preferred stock being offered in the round is convertible to 100 shares of common stock at a conversion price equal to 33¢ per share, with cumulative dividends at a rate per share of 15% per annum of the value for 5 years.

Gross proceeds from the round, which the company expects to be apprximately $14.6 million, will be used to support sales activities related to its CGuard EPS, MGuard Prime EPS and for product development, as well as general corporate purposes, according to a press release.

The offering is expected to close on or about July 7, 2016, with Dawson James Securities acting as the sole placement agent.

In March, InspireMD said it opened an underwritten public offering looking to bring in approximately $1.1 million through the sale of 1.9 million shares to support its CGuard EPS and MGuard Prime EPS.

The Boston-based company said it will offer up 1.9 million shares of common stock at 59¢ per share, with warrants issued for the purchase of up to an additional 950,000 shares of common stock for the same price for up to 5 years from the date of issuance.

In December, InspireMD said it won European Union regulatory approval, including CE Mark approval, for the manufacturing and commercialization of its CGuard stent delivery catheter.

The approval also allows InspireMD to add-on manufacturing facilities for the device to enable more efficient work flow, the Boston-based company said.

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