MassDevice.com +3 | The top 3 medtech stories for July 1, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.

 

3. DJO Global closes Zimmer/Biomet buys

DJO Global said its subsidiary Encore Medical has closed on the purchase of Zimmer and Biomet assets that the merging companies were unloading to satisfy U.S. anti-trust regulations.

The purchase included Biomet Cobalt bone cement, Optivac cement mixing accessories, the SoftPac pouch and Discovery elbow system for the U.S. marketplace, DJO Global said. Read more

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2. Sanuwave updates on PMA trial for Dermapace

Sanuwave Health said it met with the FDA to discuss the progress of a pre-market approval trial of its Dermapace diabetic foot ulcer treatment.

The 130-patient study completed enrollment in November last year and each patient has completed a full-24-week follow-up, the Alpharetta, Ga.-based company said. Read more

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1. ConforMIS prices $135m IPO

ConforMIS priced its initial public offering at $15 per share, for total proceeds of $135 million.

The 9-million-share IPO also includes a 1.35-million underwriters over-allotment option, Bedford, Mass.-based ConforMIS said. Read more

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EnteroMedics prices follow-on offering at $35m

EnteroMedics (NSDQ:ETRM) said yesterday it has priced a follow-on offering of 40.2 million shares of stock at 87¢ per share, slated to raise gross proceeds of $35 million.

The St. Paul, Minn.-based company said it expects to net $32.9 million from the offering, which it will use to continue to support its Maestro obesity device.

Each share in the offering consists of a share of common stock, Series A warrants to purchase common stock and Series B warrants to purchase common stock, the company said. Canaccord Genuity is the book-runner and Craig-Hallum Capital Group is co-manager for the flotation, EnteroMedics said.

EnteroMedics won FDA approval for the Maestro device in January 2015, following a mixed vote last year after the device failed to meet its efficacy endpoint in a clinical trial. It’s designed to use what EnteroMedics calls “vBloc therapy,” in which electrical pulses are used to block intra-abdominal vagus nerve signaling between the brain and stomach using a pacemaker-like device.

The company said it plans to use the funds to further the commercialization for Maestro, which saw its 1st commercial implantation in May.The cash will also be used for clinical work, product development and other working capital and corporate needs, EnteroMedics said.

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Maquet recalls Flow-i anesthesia systems

Maquet Cardiovascular, Getinge‘s (PINK:GETI B) medical subsidiary, is recalling its Flow-i anesthesia systems according to an FDA posting.

The company began notifying customers of the product recall on April 2.

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

The recall is related to several patient complaints in which gas flow cassettes of the device come loose due to the locking mechanism accidentally releasing during a change of system. The flaw may cause anesthesia gas to leak and can prevent the ventilator from supplying breathing support if not corrected immediately, according to the FDA filing.

A total 1641 units are affected by the recall, covering products with article numbers 66 77 200, 66 77 300 and 66 77 400, according to the FDA posting. The devices being recalled were manufactured and distributed between May 5, 2014 and July 7, 2015.

Marquet has received 10 device malfunction reports, but no injuries or deaths have been reported.

In April, The FDA issued a Class I recall of the TigerPaw II device that Maquet acquired in 2013. The recall followed an increase in reports of torn tissue on the left atrial wall and bleeding during use of the device, the FDA said.

Maquet acquired the device when it bought LAAx Inc. for an undisclosed amount in May 2013.

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HIMSS survey reports high rate of security incidents

The Healthcare Information and Management Systems Society said yesterday that a survey of healthcare organizations revealed that ⅔ of responders experienced a disruptive cybersecurity incident in the recent past.

The survey reached out to 297 individuals involved in healthcare information technology to examine the state of cybersecurity in the industry, HIMSS said.

The survey reported that 87% of responders have identified cybersecurity as an increased business priority over the past year and 42% said there are too many emerging threats to track.

“The recent breaches in the healthcare industry have been a wake-up call that patient and other data are valuable targets and healthcare organizations need a laser focus on cybersecurity threats. Healthcare organizations need to rapidly adjust their strategies to defend against cyber-attacks. This means incorporating threat data, and implementing new tools and sophisticated analysis into their security process,” veep of technology solutions Lisa Gallagher said in a press release.

While the largest source for security incidents was negligent insiders, 64% of respondents indicated they had experienced an incident from an outside source, the group said. Despite the availability of protective technologies, most respondents said they felt only an average level of confidence in their organization’s ability to protect IT infrastructure and data, HIMSS said.

Most attacks were limited to minor disruption, but 21% reported attacks that resulted in the loss of patient, financial or organizational data, HIMSS said. An additional 8% reported disruption to IT systems, and 8% reported direct damage to those IT systems.

Threats were mainly identified by internal security, with 51% being caught by such teams, HIMSS reports.  Fifty percent of responders said they experienced incidents that were reported by non IT staff individuals and only 17% were caught by external resources, such as cybersecurity firms.

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Philips, Teva invest in Israeli medtech

Reuters — Teva Pharmaceuticals (NYSE:TEVA) and Royal Philips (NYSE:PHG) are together investing up to 100 million shekels ($26.5 million) over 8 years in medical device and health technology startups in Israel.

The joint venture, called Sanara Ventures, said today it had already invested in 2 companies: Kaleidoscope Medical, which developed a system for X-ray radiation shielding during catheterization procedures; and MGD, which is creating a portable device for measuring lung function in patients with chronic obstructive pulmonary disease.

Sanara CEO Assaf Barnea said it had made another 2 investments that could not yet be disclosed, and that 2 or 3 more were expected by the end of the year.

“We see Sanara Ventures as a strategic way for Philips to tap into new developments in the health technology industry,” Philips CEO Frans van Houten said.

Erez Vigodman, his counterpart at Israel’s Teva, the world’s biggest generic drugmaker, said the healthcare industry was being transformed as consumers devote more time and money to staying healthy, rather then just waiting to treat an illness.

“That is driving the space. It means we can’t confine our business model to finding a new chemical entity,” Vigodman told a conference to launch Sanara. “We need branded and generic drugs, medical devices and diagnostic capabilities.”

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Glaukos closes $140m IPO, puts up $26m for Dose Medical affiliate

Glaukos (NYSE:GKOS) yesterday said it closed its $140 million initial public offering with it underwriters exercising their over-allotment option, meaning net proceeds for the glaucoma device maker of roughly $112.3 million.

Laguna Hills, Calif.-based Glaukos said J.P. Morgan, BofA Merrill Lynch and Goldman, Sachs & Co. acted as joint book-running managers, with William Blair and Cantor Fitzgerald as co-managers for the $18-per-share IPO.

The Glaukos iStent was the 1st micro-invasive glaucoma surgery device to hit the U.S. market. It’s a tiny titanium stent designed to alleviate the intra-ocular pressure caused by glaucoma.

Pre-market approval from the FDA for the iStent came in June 2012, clearing the device for use during cataract surgeries. Glaukos reported slightly narrower 2014 losses of -$14.1 million on sales growth of 118.2% to $45.6 million, compared with 2013.

Glaukos also said it pulled the trigger on the planned acquisition of affiliate Dose Medical’s glaucoma assets for $25.9 million, including the cancelation of a $10.9 million debt Dose owed Glaukos and $15 million in cash.

The deal gives Glaukos a worldwide exclusive license to existing and future Dose patents related to the treatment of glaucoma or conditions affecting the front of the eye; Dose gets the rights to Glaukos IP related to biosensors treatments for back-of-the-eye conditions, Glaukos said.

GKOS shares were trading at $28.40 apiece in early afternoon activity today, down 2.0%. The stock is up 57.8% over its debut price June 25.

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GlySure wins CE Mark for intravascular glucose monitor

GlySure said today that it won CE Mark approval in the European Union for its continuous intravascular glucose monitoring system.

The CIGMS device was cleared to monitor blood glucose among adult cardiac surgery patients in intensive care units, Abingdon, England-based GlySure said.

In a clinical trial, the device met the primary safety and efficacy endpoints and demonstrated a consistently high level of accuracy compared to intermittent glucose analyzers, the company said.

“For over a decade, the clinical community has been seeking a way to tightly control glucose levels in critically ill patients for both improved outcomes and reduced costs. GlySure’s technology enables them to do this safely with accuracy, reliability and efficiency to support the implementation of improved glycaemic control protocols,” principal investigator Dr. Krishna Prasad of Hyderabad, India’s Care Hospitals, Nampally, said in a press release.

GlySure said it is running a UK-based multicentre trial in hopes of winning indications for the device across all adult intensive care patients.

“We are pleased to bring to market the 1st practical solution to address this significant unmet medical need. Our 1st customers will lead the way in how glucose management is best practiced, enabling improved patient outcomes and reduced healthcare costs. Continuous glucose monitoring in critical care has been a vexing medical challenge. GlySure’s game changing technology and elegant CIGMS solution will be the first in this market to deliver clinical value to patients and savings to healthcare providers,” COO Roger Moody said in prepared remarks.

GlySure said it intends to seek FDA clearance for the device, and is currently finalizing the clinical trial design to support the submission.

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