SEC charges PricewaterhouseCoopers auditor in Burrill fund collapse

The U.S. Securities & Exchange Commission charged a PricewaterhouseCoopers auditor for failing to detect the millions siphoned from the namesake venture capital fund of once-renowned biotech investor Stephen Burrill.

Adrian Beamish, a PricewaterhouseCoopers audit partner who served as engagement partner for the Burrill Life Sciences Capital Fund III, allegedly failed to scrutinize the “advanced management fees” withdrawn from the fund by Burrill, the SEC said.

Beamish allegedly failed to determine whether Burrill had “proper authorization and rationale” for taking the cash and allegedly failed to ensure that the transactions were properly disclosed. Burrill is barred from the securities industry after paying nearly $6 million in March to settle SEC charges that he looted the fund to cover losses in other businesses and pay for his lavish lifestyle.

Beamish faces an administrative hearing to decide whether he should be suspended from practicing before the SEC, which would preclude him from plying his trade with public companies.

“Auditors perform a critical check on fraudulent conduct, especially when related party transactions are involved,” Jina Choi, director of the SEC’s San Francisco office, said in prepared remarks. “We allege that Beamish’s repeated failure to exercise professional skepticism prevented him from recognizing that Burrill was stealing investor money from the fund.”

In the settlement earlier this year, Burrill and his firm Burrill Capital Management agreed to disgorge the nearly $4.8 million prosecutors claimed he siphoned off for personal use, plus a $1 million fine. The firm’s former chief legal officer, Victor Hebert, and former controller Helena Sen agreed to pay civil fines of $185,000 and $90,000, respectively, and are also barred from the securities industry.

The scandal erupted in 2013, when the fund’s managers allegedly discovered that Burrill, Hebert and Sen misappropriated some $18 million, according to a lawsuit filed in a California state court in 2014. Burrill resisted the board’s pressure to step down, but was officially ousted in March 2014, according to the lawsuit.

“Burrill spent his fund’s capital on whatever he pleased, and elevated his own interests above those of investors,” SEC enforcement chief Andrew Ceresney said last March in announcing the settlement. “Even though they are exempt from registration, venture capital advisers like Burrill have fiduciary obligations to their clients.”

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MassDevice.com +5 | The top 5 medtech stories for October 31, 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. ReWalk Robotics raises $12m, forecasts Q3 sales beat

ReWalk Robotics last week priced a stock-and-warrants offering worth more than $12 million and said it expects its 3rd-quarter earnings to beat expectations on Wall Street.

Yokneam, Israel- and Marlborough, Mass.-based ReWalk, which makes a robotic exoskeleton designed to assist patients with spinal cord injuries, said it floated 3.25 million units at $3.75 apiece in the offering, for gross proceeds of $12.2 million. The offering includes a share of RWLK stock and ¾ of a warrant at an exercise price of $4.75 apiece. Oppenheimer & Co., the lone underwriter, has a 30-day over-allotment option for another 487,500 units that’s worth an additional $1.8 million. Read more

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4. NASS 2016: Interest grows in surgical robotics for spinal procedures

Mazor Robotics unveiled its next-generation robot-assisted surgery system and Globus Medical for the 1st time showcased the functional prototype of its Excelsius platform at the NASS 2016 meeting in Boston last week, signifying an increased interest in robotic surgeons among major players.

Mazor developed 3 generations of products over 15 years and does 95% of its business in spine surgery, according to Barclays. The Caesarea, Israel-based company’s next-gen Mazor X system, presented at this year’s North American Spine Society meeting, helps surgeons develop a pre-operative plan, make automated calculations, and provide intraoperative guidance to ensure that the plan is followed for each patient. It can also measure the length of time for each case, demographics and other important variables to improve case management. Read more

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3. Guidance cut, Q3 sales miss push Zimmer Biomet shares down

Zimmer Biomet shares fell sharply this morning after the orthopedics giant posted lower-that-expected 3rd-quarter sales and cut its guidance for the rest of the year.

Warsaw, Ind.-based Zimmer logged profits of $158.8 million, or 78¢ per share, on sales of $1.83 billion for the 3 months ended Sept. 30, putting its bottom-line growth at a whopping 615.3% on sales growth of 4.0% compared with Q3 2015. Read more

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2. TCT 2016: Stents, stents, stents on Day 1

The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning yesterday. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.

Stents took center stage Day1, with a raft of studies covering the latest on the bioresorbable front. Read more

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1. FDA posts another Class I HeartWare HVAD recall

The FDA today posted a Class I recall notice for select Medtronic HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from functioning.

A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. Read more

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Report: CompuGroup Medical woos Agfa-Gevaert

German medical software company CompuGroup Medical is wooing Belgian graphics group Agfa-Gevaert (EBR:AGFB), the companies said last week.

Agfa makes medical IT products, which would bolster CompuGroup’s software for doctors’ offices, pharmacies and hospitals; Agfa also has a portfolio of other products including X-ray machines.

The combined company would have annual sales of more than €3 billion ($3.3 billion).

CompuGroup said it gave Agfa’s board a non-binding indication of interest but said it was not certain that it would end up making a firm offer.

“The discussions between the companies are at an early stage. No response has been given to the indication of interest and CompuGroup Medical SE has not been able to verify or discuss any of the assumptions and conditions underlying its indication of interest,” CompuGroup said.

Agfa, whose market value has shrunk by a third to €616 million this year, said its board would evaluate CompuGroup’s approach carefully.

The news sent shares in Agfa up 6.2% to a 6-month high of €3.80 (about $4.11). CompuGroup shares were down 3.7% in early activity, with traders citing concerns that the German company would be overtaxing itself with a takeover of Agfa.

“We think a takeover offer by CompuGroup will only occur if they have a solution for Agfa Graphics and the€1.25 billion pension liabilities in hand,” analysts at KBC wrote in a note to clients.

CompuGroup has grown through a series of bolt-on acquisitions in recent years, most recently buying a majority in Vega, an Italian distributor of its software, last month.

Agfa, which in 2004 sold the eponymous camera film business that made it a household name, is active in the printing and medical imaging business. Its healthcare business accounts for about 40% of its €2.6 billion in annual revenue.

($1 = 0.9158 euros)

Material from Reuters was used in this report.

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Report: Boston Scientific pauses Lotus Edge heart valve in Europe

Boston Scientific (NYSE:BSX) is reportedly pausing implantations of its next-generation Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue.

Marlborough, Mass.-based Boston Scientific has implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according to Barclays analyst Matthew Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.”

“In these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events,” Taylor wrote today in a note to investors.

The company pulled Lotus Edge from the market in Europe, where it won CE Mark approval last month, so it can figure out the problem,

“At this time, [Boston Scientific] is doing cases with the classic Lotus,” the analyst wrote. “BSX does not think that correcting Edge will require a valve redesign, but having made this decision [Oct. 28], cannot answer the question as to when it will be back in the market with precision. It does not anticipate that this will change any timelines or financial guidance including the Reprise trials or launch of Lotus in the U.S.”

Yesterday at the annual Transcatheter Cardiovascular Therapies conference in Washington, D.C., Dr. Ian Meredith (who’s slated to replace chief medical officer Dr. Keith Dawkins next year) presented feasibility data on 21 patients treated with the Lotus Edge device, showing 100% technical success, no or only trace paravalvular leakage and a 4.8% stroke rate, a 9.5% rate of new pacemaker implantation and no repeat procedures.

“The company believes it has something very differentiated; it would not comment on pricing strategy but said that looking at major medtech markets where there are three 3 share players that split the market is illustrative. It would be disappointed with 5% to 10% share given the talent and investment that it is putting in the market and expects to be a leader in the [TAVR] space,” Taylor wrote. “Dr. Dawkins noted increased confidence that BSX can be competitive with 2nd-generation valves on pacer rates, driven by changes in technique and technology. Further, BSX outlined plans for its intermediate- and low-risk trials (Reprise IV and V) which will start in 2017; Reprise IV will randomize versus EW’s S3 and Reprise V will go against surgery.”

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Nanoscale features on implant surface reduce bacterial growth

Growing rates of implant infection and the increasing level of antibiotic-resistant bacteria have some surgeons nervous, and rightfully so – antibiotic-resistant bacteria can cause infections that are difficult and sometimes impossible to treat.

“Antibiotic-resistant bacteria are being found in patients who have never taken antibiotics in the first place,” said Thomas Webster, professor & department chair of chemical engineering at Northeastern University, at the North American Spine Society’s annual meeting this year.

But Webster and his research team have developed a way to use nanoscale features on the implant’s surface to combat bacteria, while encouraging bone growth.

“It’s clear that cells in our body reside in and make nano-materials,” he said. “It’s not just about biologically-inspired materials or mimicking the body – you can actually use nanotechnology to control surface energy of materials.”

By altering the surface of an implant with nanoscale features, researchers can change the surface properties without risking added toxicity from chemical treatments.

Webster and his team devised an equation to predict what size the nanoscale features need to be to give the right energy that will repel things like bacteria and promote bone growth and vascularization.

“Not all nano is created the same,” Webster explained to the crowd at NASS. “Just because you’re creating a nano-scale surface on an implant does not mean you’ll see the same results.” Changing the geometry and the size of the features will ultimately change the properties of the surface, so optimization was a big part of their process.

Last year, Tyber Medical licensed the technology from Northeastern University for use with its headless screw system. The BioTy surface treatment won FDA clearance in March of this year.

Webster reported that in-vitro analysis showed significant reduction of bacterial colonization for a variety of bacteria, like 95.6% for S. Aureus and a reduction of 81.1% for ampicillin resistant E. Coli. While these rates aren’t perfect, Webster says his team is impressed with the scope of the treatment and that they will continue to work with Tyber to optimize the solution.

He also said that the different surface properties induce variable levels of bone growth which, when properly controlled, could be differentiated for a permanent or temporary implant, while still maintaining its antibacterial properties.

“We have yet to find bacteria that this approach does not work for,” he said.

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EpiPen price hike cost Pentagon millions

Mylan Pharmaceuticals‘ (NSDQ:MYL) 500% price increase on its epinephrine auto-injector cost the U.S Defense Dept. millions, according to data provided to Reuters. 

The Pentagon spent $57 million on Mylan’s EpiPen last year, up from $9 million in 2008, largely driven by volume and price hikes that affected prescriptions filled at retail pharmacies. Although the Pentagon gets a government discount for EpiPens from military treatment facilities and by mail order, nearly half of its spending was at retail pharmacies. Recently, it paid an average of $528 for a two-pack of the lifesaving allergy treatment. That’s 3 times higher than the discounted rate, according to the news service.

Get the full story at our sister site, Drug Delivery Business News.

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NASS 2016: Interest grows in surgical robotics for spinal procedures

Mazor Robotics (NSDQ:MZOR) unveiled its next-generation robot-assisted surgery system and Globus Medical (NYSE:GMED) for the 1st time showcased the functional prototype of its Excelsius platform at the NASS 2016 meeting in Boston last week, signifying an increased interest in robotic surgeons among major players.

Mazor developed 3 generations of products over 15 years and does 95% of its business in spine surgery, according to Barclays. The Caesarea, Israel-based company’s next-gen Mazor X system, presented at this year’s North American Spine Society meeting, helps surgeons develop a pre-operative plan, make automated calculations, and provide intraoperative guidance to ensure that the plan is followed for each patient. It can also measure the length of time for each case, demographics and other important variables to improve case management.

“The Mazor X system is aimed at addressing unmet needs for a number of stakeholders including hospital management, vendors, patients, payors, and surgeons,” Barclays analysts wrote.

The list price of the robot surgeon is $900,000 and Mazor is also listing a brain model at $199k. Mazor’s agreement with Medtronic (NYSE:MDT) calls for it to receive $1,500 for the disposable and a midpoint $1,000 synergy fee if Medtronic implants are used. Mazor is selling the system and gets the full price, but a 20% commission goes to Medtronic during phase 1 of the agreement. In phase 2, there’s a distributor agreement, so the sale to Medtronic is at 40% to 45% less than list price.

Globus unveiled its investigational robotics system, Excelsius, telling Leerink Partners that it anticipates approval and launch in early- to mid-2017, with revenue unlikely until the 2nd half of next year.

The Pennsylvania-based company touts Excelsius as having a user-friendly set-up and a sturdier console, with better workflow than the competition because it has non-patient bedside docking. Leerink Partners estimated that by the end of 2016, Globus will have hired all of its initial robotic/capital reps.

Leerink said Mazor is poised to remain the leader in robotic surgery, since it’s now on its 3rd-gen robot and has marketing support from Medtronic. But the investment bank noted that it spoke with surgeons who were very interested in trialing Globus’ system once it’s available.

The Globus device features an optical tracking system, similar to Zimmer Biomet‘s (NYSE:ZBH) acquired Rosa device. That Warsaw, Indiana-based company has FDA approval for its system, but Barclays said that enthusiasm for the system was less than expected and that it may not be ready for a full-scale launch.

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TCT 2016: Stents, stents, stents on Day 1

The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning yesterday. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.

Stents took center stage Day1, with a raft of studies covering the latest on the bioresorbable front.

Stents equivalent to CABG

Drug-eluting stents are as effect as coronary artery bypass grafts in treating patients with blocked left main coronary arteries, according to a study that compared Abbott‘s (NYSE:ABT) Xience DES with CABG in more than 1,900 patients presented today at TCT 2016.

The Excel trial followed the patients, who were randomized to treatment either with Xience or CABG procedure, for at least 2 years and a median of 3 years.

About 15% of patients in each arm had a heart attack, stroke or died within 3 years, lead author Dr. Greg Stone, of New York City’s Columbia University Medical Center, said in a press release.

“In other words, stents were equally effective as bypass surgery,” Stone said.

The study also analyzed 30-day complication rates, showing that the stented cohort had significantly lower rates of death, stroker, heart attack or revascularization than the CABG cohort (4.9% compared with 7.9%). And fewer stent patients had major bleeding, infections, kidney failure or severe abnormal heart rhythms, according to the study, presented at the annual Transcatheter Cardiovascular Therapeutics conference in Washington, D.C., and published online in the New England Journal of Medicine.

“Our study has shown that many patients with left main coronary artery disease who prefer a minimally invasive approach can now rest assured that a stent is as effective as bypass surgery for at least 3 years, and is initially safer, with fewer complications from the procedure,” Stone said. “Our study establishes stents as an acceptable or preferred alternative for patients with [left main coronary artery disease] and low or moderate disease complexity in the other 3 coronary arteries – about ⅔ of all LMCAD patients.”

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Guidance cut, Q3 sales miss push Zimmer Biomet shares down

Zimmer Biomet (NYSE:ZBH) shares fell sharply this morning after the orthopedics giant posted lower-that-expected 3rd-quarter sales and cut its guidance for the rest of the year.

Warsaw, Ind.-based Zimmer logged profits of $158.8 million, or 78¢ per share, on sales of $1.83 billion for the 3 months ended Sept. 30, putting its bottom-line growth at a whopping 615.3% on sales growth of 4.0% compared with Q3 2015.

Adjusted to exclude 1-time items, earnings per share were $1.79, dead even with Wall Street’s consensus forecast, but analysts there were looking for sales of $1.84 billion.

“Zimmer Biomet’s 3rd-quarter performance was highlighted by further acceleration of our global [surgical, sports medicine, foot & ankle, extremities & trauma] category, as well as our continued strength in the Asia Pacific region,” president & CEO David Dvorak said in prepared remarks. “We believe that our comprehensive and expanding portfolio of musculoskeletal solutions positions us extremely well to address the evolving needs of customers in the dynamic healthcare environment in which they operate. Going forward, we will continue to focus on enhancements to our commercial and operational execution to more fully leverage our opportunities to improve the quality of life for patients and create value for our stockholders.”

Zimmer cut the high end of its full-year earnings outlook, saying it now expects to put up adjusted EPS of $7.90 to $7.95, down from prior guidance of $7.90 to $8.00. Sales are now forecast to be between $7.63 billion and $7.65 billion, compared with between $7.68 and $7.71 billion previously.

ZBH shares were down -14.2% at $105.15 apiece today in early trading.

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ReWalk Robotics raises $12m, forecasts Q3 sales beat

ReWalk Robotics (NSDQ:RWLK) last week priced a stock-and-warrants offering worth more than $12 million and said it expects its 3rd-quarter earnings to beat expectations on Wall Street.

Yokneam, Israel- and Marlborough, Mass.-based ReWalk, which makes a robotic exoskeleton designed to assist patients with spinal cord injuries, said it floated 3.25 million units at $3.75 apiece in the offering, for gross proceeds of $12.2 million. The offering includes a share of RWLK stock and ¾ of a warrant at an exercise price of $4.75 apiece. Oppenheimer & Co., the lone underwriter, has a 30-day over-allotment option for another 487,500 units that’s worth an additional $1.8 million.

ReWalk said it plans to use the proceeds for general corporate purposes, “including supporting its ongoing sales, marketing and reimbursement efforts to grow its business and funding research and development activities focused on product development.”

In a separate release, the company said it expects to post sales of $1.4 million for the 3 months ended Sept. 30, ahead of the consensus estimate on The Street of $1.3 million. Analysts there are looking for losses per share of -59¢. ReWalk is slated to release its full 3rd-quarter results Nov. 3.

ReWalk said it sold 23 exoskeletons during the quarter, including 13 that were covered by insurance, and had about $12.4 million in cash and equivalents on hand at the end of the period.

RWLK shares closed down -7.8% at $2.95 apiece Oct. 28.

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Chinese regulators set early 2017 launch date for medical device priority evaluation program

By Stewart Eisenhart, Emergo Group

EMERGO SUMMARY OF KEY POINTS:

• The China FDA’s final rule on its priority review program for medical devices will come into force in January 2017.
• The program is open to Class III devices manufactured in China as well as Class II and III devices from foreign manufacturers.
• Chinese market registrants must apply for priority review qualification as part of their CFDA registration submissions.

Chinese medical device market regulators have finalized rules for their priority evaluation program for devices targeting certain populations and diseases, with an implementation date planned for January 1, 2017.

The China Food and Drug Administration’s (CFDA) final version (link in Chinese) of the rule applies to Class III devices manufactured in China as well as Class II and III imported devices.

Which devices qualify for CFDA priority review?

The types of medical devices that may qualify for CFDA priority evaluation are organized broadly into three groups:

• Group 1
  • Devices that diagnose or treat rare disorders and provide significant clinical advantage
  • Devices to diagnose or treat malignant tumors and provide significant clinical advantage
  • Devices to diagnose or treat diseases affecting elderly populations and that do not currently have effective diagnosis or treatment options
  • Devices to treat children and that provide significant clinical advantage
  • Devices that currently have no predicate products in China and that are urgently needed for public health purposes
• Group 2
  • Devices that fall under the National Science and Technology Major Project or the National Key Technologies R&D Program
• Group 3
  • Other devices for which high-priority evaluation is deemed necessary

Applying for CFDA priority evaluation

Chinese medical device market registrants interested in the priority evaluation pathway should include priority review applications and supporting documentation in their registration dossier submissions to the CFDA.

The CFDA’s Center for Medical Device Evaluation (CMDE) will review applications to determine which devices qualify for priority evaluation. For Group 1 devices, regulators will convene monthly meetings of expert panelists to make qualification decisions. Group 2 devices will undergo reviews lasting five business days.

Qualifying applications will be placed in queue for high-priority evaluation separate from standard registration reviews.  Although no set timelines have been given for priority versus standard CFDA reviews, shorter queue times as well as more active communication between CFDA staff and registrants in the priority evaluation program should result in shorter times to market.

More information on registration and market authorization timeframes can be found in our regulatory process chart.

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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FDA posts another Class I HeartWare HVAD recall

The FDA today posted a Class I recall notice for select Medtronic (NYSE:MDT) HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from functioning.

A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.

The agency identified issues with loose power connectors which could cause the rear portion of the pump’s driveline connector to become separated from the front portion of the connector.

“A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death,” the FDA wrote in its recall notice.

The recall affects approximately 4,586 units worldwide, with 91 units within the U.S. Serial numbers HW001 to HW11270 and HW20001 to HW20296 were identified in the recall, with product codes 1100, 1101, 1102, 1103, 1104 and 1205. The recalled units were manufactured between March 6, 2006 and October 17, 2016.

The FDA said that on June 8, HeartWare sent an urgent medical device correction letter to affected customers, instructing them to inspect controllers for loose connectors and feeling for atypical movement, and to replace any affected units with new controllers.

Medtronic released information on 2 other recalls affecting its HeartWare ventricular assist devices in late September.

The voluntary recall is related to potential damage to controllers on the device from exposure to moisture, caused by loose power and data connectors, according to a Medtronic press release. The company added that, in the U.S., all clinicians have been notified and acknowledged, while 99% of clinician notifications have been acknowledged globally.

In a warning sent in May and June, HeartWare advised hospital clinicians to inspect HVAD HeartWare controllers for loose connectors during scheduled appointments, and to replace affected controllers with new equipment when necessary. Clinicians were also instructed to communicate safe use instructions for the HVAD system, with a focus on moisture and proper connection to power and data sources.

Medtronic closed its $1.1 billion acquisition of HeartWare in late August.

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Cardinal Health inks 4 new distro agreements

Cardinal Health (NYSE:CAH) today announced 4 new strategic distribution agreements, looking to expand its product portfolio with new coronary stents and percutaneous transluminal coronary angioplasty balloon catheters.

“In the past year, since becoming a Cardinal Health company, we have executed several key strategic collaborations that strengthen the Cordis product and solutions offering in interventional cardiology. We strongly believe that agreements like these provide the opportunity to rapidly expand our portfolio and deliver increased value to customers around the world. We will continue to explore additional opportunities to broaden the global Cordis offering,” Cordis prez David Wilson said in prepared remarks.

The Dublin, Ohio-based company said it inked a deal with Kaneka to distribute its PTCA ballon catheters in EMEA and select countries in Asia and Latin America.

Cordis will sell versions of Kaneka’s PTCA balloon catheters in Japan, Korea, Australia and New Zealand under the Neon and Neon NC names, and will distribute the Ikazuchi Rev and Fortis II under Kaneka’s brand in China. Upon receipt of CE Mark approval in the European Union and other regulatory clearances for the regions, Cordis will also distribute the company’s Ikazuchi Zero and Raiden 3 PTCA balloons under Kaneka’s brand name.

The company said it inked a deal with Meril to distribute its Mozec and Mozec NC Rx PTCA balloon dilation catheters in the U.S. and Canada. The company also signed a strategic long-term agreement with Tryton Medical to distribute its coronary side branch stent upon regulatory approval.

Cardinal Health said it expanded a current distribution agreement with Biosensors International (PINK:BSNRY) that will make Cordis the exclusive distributor of its coronary interventional products in Japan, on top of offering Biosensor’s coronary stent portfolio in 27 countries.

“With Cordis’ proud legacy of delivering innovative solutions in the cardiovascular care space and the business and operational expertise of Cardinal Health, we have established an unmatched, combined offering. Our vision is to make significant contributions to the healthcare system by bringing value-based products and solutions that our customers and their patients are seeking,” prez Wilson said in a prepared statement.

Last month, Navidea (NYSE:NAVB) said it inked a letter of intent with Cardinal Health to sell its Lymphoseek injection for up to $310 million.

The sale includes all current FDA-approved indications, as well as future oncology diagnostic indications in North America and other related assets, Navidea said. Through the deal, Navidea is slated to receive $80 million upon closing, with future considerations tied to annual sales of Lymphoseek and sales-based milestones.

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Hospitals may face bigger penalties for readmissions than deaths

(Reuters) – Medicare penalties are tied to fewer repeat hospitalizations for some common health problems, but a new study suggests current policy doesn’t encourage hospitals in the United States to focus on preventable deaths.

Researchers examined nationwide data for both deaths and readmissions within 30 days of discharge for three common problems: heart failure, pneumonia and heart attacks.

About 17% of U.S. hospitals are getting punished for excess readmissions even though they’re keeping patients alive more often than would be expected, the analysis found.

The data came from U.S. hospitals in fiscal year 2014.

Another 16% of hospitals essentially get rewarded for low readmission rates, but their patients are more likely to die in the first month after leaving the hospital, the study also found.

“You could argue that from the individual patient’s perspective, mortality should be weighted much higher than readmission,” said senior study author Dr. Scott Hummel of the University of Michigan in Ann Arbor.

“Aligning financial incentives more closely with this patient-oriented goal would drive hospital behavior towards finding ways to reduce post-discharge mortality,” Hummel added by email.

In 2014, U.S. hospitals could for the first time be penalized for readmission rates that were higher than expected, and earn a financial reward based on a mix of measures that include everything from 30-day death rates to how well patients rated the care they received and the hospital environment, researchers report in JAMA Cardiology.

Under the current policy, hospitals can lose up to 3% of certain Medicare payments for excess readmissions, but can recoup only about 0.2% of such payments for having low mortality rates.

If hospitals got paid less when their patients died soon after a hospitalization, just like they get paid less when those patients end up back in the hospital, it would be a game-changer for one-third of hospitals, the study authors argue.

That’s because some of the hospitals that get penalized for high readmissions are those that may actually do the best job at keeping patients alive – and vice versa, the researchers contend.

If the penalties took both readmission and mortality into account, the Medicare system would save the same amount of money, but incentivize good outcomes more fairly, the researchers say.

To calculate this, researchers developed a ratio for each hospital based on observed and expected readmissions and mortality in the first 30 days for heart attack, heart failure and pneumonia.

They adjusted the data for how sick each hospital’s patients were. They didn’t adjust for patients’ socioeconomic status, which can also affect outcomes.

The authors also call for continued improvement in risk models for estimating patients’ risk of readmission, just like current, well-tested models to predict their risk of death.

Other researchers too have shown there isn’t a tight link between a hospital’s 30-day readmission rate and its 30-day mortality rate for these conditions – suggesting that there’s more to the story when thinking about using them as measures of hospital quality.

“It is not surprising that one measure of provider quality may not be strongly correlated with another – we have known this to be the case for years,” said Dr. Michael Williams, a health policy researcher at Harvard University in Boston who wasn’t involved in the study.

“But we must fight the instinct to measure everything and pay on everything, lest we detract from providers’ ability to provide high-quality care,” Williams added by email. “Lack of correlations should not trigger knee-jerk calls for more measures tied to more bonuses and penalties.”

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Skyline Medical pulls trigger on 1-for-25 reverse split

Skyline Medical said its board of directors approved and the company initiated a reverse stock split, effective at the close of business yesterday.

The move put 1 share of Minneapolis, Minn.-based Skyline Medical in the hands of its shareholders for each 25 shares they held previously. The company’s stock began trading today on a post-split basis.

As a result of the split, the number of shares in Skyline Medical has been reduced from 98.3 million to 3.9 million, the company said. No fractional stocks were issued as part of the reverse split.

“Skyline management believes that this reverse-split ratio of 1-for-25 will allow sufficient time to permit compliance while it works to cure its stockholders’ equity deficiency for continued listing.  It also will allow time to permit Skyline Medical to execute its growth strategy including consummating its joint venture with Electronic On-Ramp, Inc. to supply Streamway to U.S. government mobile operating rooms and its partnership with GLG Pharma, LLC, which intends to develop rapid diagnostic tests that utilize fluid and tissue collected by the Streamway System during procedures,” the company wrote in a press release.

Shareholders approved the reverse split in September, a long with a measure doubling the number of authorized shares of common stock.

In late August, Skyline Medical saw shares surge upwards nearly 30% after announcing a joint venture with Electronic On-Ramp, providing the company with access to bids on procurement contracts for up to $550 million or more in federal funds.

The companies expect the joint venture to be in operation by the end of the year, with 51% of the JV owned by EOR. The venture will bid on supplying medical products for mobile operating rooms and other uses. Financial details of the deal were not disclosed.

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AliveCor adds weight, activity monitoring to Kardia app

AliveCor today said that its Kardia Mobile health monitoring app will now integrate weight and physical activity readings, lifting the number of vital stats the application monitors to 5.

The application now monitors blood pressure, heart rhythm, resting heart rate, weight and physical activity, the company said, touting them as “5 of the most important factors for evaluating the risk of cardiovascular disease.”

“Today we’re giving patients and caregivers the ultimate gift, an active role in their total heart health anytime anywhere, not just at office visits. With these new integrations, AliveCor is expanding beyond just atrial fibrillation detection and giving patients more control over their own care. This combination of vital stats gives patients an unprecedented view of their heart disease risk factors, making them more engaged in their heart health care,” CEO Vic Gundotra said in a press release.

The Mountain View, Calif.-based company said the improvements make the Kardia Mobile the 1st consumer-facing app that allows patients and physicians to few all 5 risk factors in 1 place. The upgrades will be available for both Google (NSDQ:GOOG) Android and Apple (NSDQ:AAPL) iOS device users.

Last month, AliveCor said it partnered with Omron Healthcare to integrate data from its Bluetooth-enabled home blood pressure devices into AliveCor’s ECG Kardia mobile application.

The company said the integration marks the 1st consumer-ready, clinically validated electrocardiogram and blood pressure monitor application which provides heart health information and proactive monitoring.

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MassDevice.com +5 | The top 5 medtech stories for October 28, 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. St. Jude calls global stop to Nanostim implants over battery issues

St. Jude Medical said today it is pausing the implantation of its Nanostim leadless pacemaker due to reports of battery related problems with electronic data reporting.

The Little Canada, Minn.-based company, said it pulled implants of the micro-sized leadless, catheter delivered Nanostim pacer after receiving 7 reports of “lost telemetry and pacing output.” The company clarified that there have been no reports of patient injuries associated with the malfunction. Read more

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4. Litmus Health looks to bring wearables to drug development

Litmus Health said yesterday that it launched its clinical data science platform into public beta. The company hopes to use big data from wearables and connected devices to help inform endpoints for Phase I & II clinical trials.

The goal of its platform, according to Litmus, is to get pharmaceuticals to market faster by putting health-related quality of life as the primary motivation for clinical development. Massive sets of data collected from wearables will help to inform researchers about their patients quality of life outside the clinic. Read more

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3. Senseonics submits FDA PMA application for Eversense CGM

Senseonics said today it submitted a premarket approval application to the FDA for its Eversense continuous glucose monitoring system.

The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that allows for the real-time display of glucose readings, the company said. Read more

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2. Corindus wins FDA nod for 2nd-gen CorPath GRX vascular robot-assisted surgery system

Corindus Vascular Robotics said yesterday that it won 510(k) clearance from the FDA for the CorPath GRX, it’s 2nd-generation vascular robot-assisted surgery platform, and plans to have it on the market during the 1st quarter of 2017.

Waltham, Mass.-based Corindus said it added several features to the latest CorPath iteration, including the ability to control the guide catheter in 1mm increments to precisely position balloon or stent catheters during percutaneous coronary interventions. Read more

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1. St. Jude Medical shareholders grudgingly approve executive tax breaks ahead of Abbott merger

Shareholders in St. Jude Medical, who this week voted to approve its pending, $25 billion merger with Abbott, grudgingly approved a measure to give tax breaks to its senior executives if the deal goes through.

Little Canada, Minn.-based St. Jude’s board last year voted to do away with a “gross-up” provision that would have covered the 15% excise tax imposed by U.S. tax laws on stock owned by executives and directors for the 6 months before and after a merger transaction. Read more

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St. Jude wins FDA nod for Amplatzer PFO occluder

St. Jude Medical (NYSE:STJ) today won FDA approval for its Amplatzer patent foramen ovale occluder device, designed to reduce the risk of stroke in patients who’ve experienced a PFO-related stroke.

Approximately 25-30% of Americans have a PFO, according to the FDA, which typically causes no health problems and does not require treatment. While the cause of most strokes can generally be identified, some patients experience strokes which cannot be medically identified, known as cryptogenic stroke.

A small percentage of cryptogenic strokes are believed to be caused by PFOs, which provide a path for a blood clot to travel to the brain. The FDA said that patients with a cryptogenic stroke and a PFO may be at an increased risk for a second stroke.

“The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO. But as the device labeling clearly states, patients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke and help ensure that PFO closure with the device is likely to assist in reducing the risk of a recurrent stroke,” FDA CDRH cardiovascular devices division director Dr. Bram Zuckerman said in an FDA release.

The Amplatzer PFO occluder is designed to be delivered via catheter to close the hole in the heart between the top right chamber and top left chamber. The approval of the device was based on data from studies of the device which “demonstrated a reasonable assurance of safety and effectiveness,” the FDA wrote.

The federal watchdog warned that the device should not be used in patients with a heart valve infection or other untreated infections, heart tumors or blood clots at the implant site.

The device is also contraindicated for patients with abnormal connections between heart chambers or patients in whom the “cardiovascular anatomy or blood clots would interfere with the ability to move the catheter used to deliver the device to the heart.”

Earlier this month, St. Jude said it launched a pediatric clinical trial of a version of its Amplatzer cardiac implant for treating a congenital heart defect.

The 50-patient ADO II AS study is designed to enroll 2 patient cohorts: at least 15 patients weighing 4.4 lbs. (2kg) or less and at least 25 patients weighing more than that.

Little Canada, Minn.-based St. Jude said the ADO II AS device is designed to treat a common congenital heart defect called patent ductus arteriosus via pulmonary or aortic artery approach. The company said it plans to use data from the study to back a pre-market approval application with the FDA (the device is already approved in more than 50 other countries, St. Jude said).

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St. Jude calls global stop to Nanostim implants over battery issues

St. Jude Medical (NYSE:STJ) said today it is pausing the implantation of its Nanostim leadless pacemaker due to reports of battery related problems with electronic data reporting.

The Little Canada, Minn.-based company, said it pulled implants of the micro-sized leadless, catheter delivered Nanostim pacer after receiving 7 reports of “lost telemetry and pacing output.” The company clarified that there have been no reports of patient injuries associated with the malfunction.

“Patient safety is our top priority, and we are currently working to ensure our physician partners worldwide have the information they need to effectively manage their patients. We remain committed to developing leadless pacing technology and will continue to work to redefine the pacing options available to patients in the future,” chief medical officer Dr. Mark Carlson said in a statement.

St. Jude is allegedly pursuing a software fix to detect any increase in the rate of battery problems, and may be in talks with a battery manufacturer to develop a different battery for the nanostim, according to a release from Barclays.

The banking firm claimed St. Jude is looking to submit an application for approval for the new battery in the 4th quarter of this year.

St. Jude has not responded yet to requests for more information on the battery issues.

Earlier today, St. Jude shareholders grudgingly approved a measure to give tax breaks to its senior execs if its pending $25 billion merger with Abbott (NYSE:ABT) goes through successfully. The same shareholders earlier this week voted to approve its pending, $25 billion merger.

The company’s board last year voted to do away with a “gross-up” provision that would have covered the 15% excise tax imposed by U.S. tax laws on stock owned by executives and directors for the 6 months before and after a merger transaction.

But after inking an $85-per-share deal in April to be acquired by Abbott, St. Jude moved to reinstate the gross-up provision, which could relieve CEO Michael Rousseau and other executives of $18 million in tax payments if they leave Abbott after the deal closes, expected by year-end.

St. Jude and Abbott still plan to close the deal, which must still pass reviews by anti-trust regulators in the U.S. and Europe, by the end of the year. In July, the Federal Trade Commission asked for more information about the merger; the European Commission is slated to decide by Nov. 9 whether to bless the union.

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Novo Nordisk shares dive after long-term growth cut

(Reuters) — Top insulin maker Novo Nordisk (NYSE:NVO) slashed its long-term profit growth forecast today, signaling no let-up in its struggles to crack the U.S. market to which its chief executive said its commitment would not waver.

The Danish firm’s shares fell by as much as 19% to a 30-month low, wiping more than $15 billion off its market value after it halved the growth guidance to 5% from the 10% it predicted as recently as February.

Get the full story at our sister site, Drug Delivery Business News.

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FDA OKs stem cell, gene therapy trial for ALS

The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural stem cells to deliver a particular protein in the hopes of slowing ALS progression, according to researchers at the ALS clinic at Cedars-Sinai Medical Center.

A progressive neurodegenerative disease, ALS affects nerve cells in the brain and spinal cord and patients eventually lose their ability to control muscle movement. The prognosis is dim – patients are totally paralyzed within 2 to 5 years of diagnosis and the disease is fatal. The ALS Assn. pointed out that there is no cure and only 1 FDA-approved drug that modestly extends survival.

Get the full story at our sister site, Drug Delivery Business News.

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OCTANe launches business growth services

Aliso Viejo, Calif.-based medtech business accelerator OCTANe said yesterday it launched OCTANe Growth Services, a new business accelerator program that aims to aid its members and partners in growing their companies.

The new service looks to provide resources for companies in the region that are looking to grow, and will serve as an additional resource for companies completing the LaunchPad accelerator process with OCTANe.

“OCTANe Growth Services is a natural extension of the services we currently provide through our LaunchPad program. It will enable companies who have graduated from the program, as well as other middle market organizations, to connect to the resources, advisors and potential capital they need to accelerate their growth and expand their operations. In some cases, it will also assist them in having a successful liquidity event. Our goal is to provide added value to all of our stakeholders including entrepreneurs, strategic partners and advisors who have a vested interest in expanding and developing this dynamic and innovative ecosystem,” OCTANe CEO Bill Carpou said in a press release.

The new services will supply business with more resources, intelligence, capital and “better deal flow,” according to OCTANe.

“As a former LaunchPad company, I am glad to see OCTANe will provide this critical service for companies which will have a lasting impact on our community. There is exceptional talent and innovation happening in Orange County, and growing a business here has been advantageous,” Mavenlink co-founder & CEO Ray Grainger said in prepared remarks.

OCTANe touted the newly launched service, claiming that there are “no services like this available within the Southern California region.” Services will include exclusive access to advisory services in 20 areas and face-to-face support and integration with investors and executives.

“We are excited about OCTANe Growth Services and the opportunity in the technology ecosystem. When we first heard about this earlier in the year it was a concept, now it is a defined strategy that will benefit the greater OC marketplace, established companies and local economy going forward,” RSM managing partner Bob Jacobson said in a prepared statement.

“This is a natural next step in our relationship with OCTANe. As a long-time sponsor of the organization, having the ability to showcase our thought leadership to a larger group of OCTANe members and entrepreneurs is invaluable. We look forward to contributing to the success of Growth Services as we believe it will provide the right platform for Orange County innovation to thrive and for the greater business community to prosper,” Stradling corporate dept. co-chair Mark Skaist said in a prepared release.

In September, OCTANe announced plans to merge with Mission Viejo, Calif.-based Orange County Technology Alliance, with both groups keeping the OCTANe name, effective Dec. 31.

Through the deal, local technology firms will gain access to OCTANe’s network of investors and advisors and other services, while OCTANe will gain access to more established companies, according to Carpou.

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Anika’s pipeline & clinical data create steady growth in Q3

Shares in Anika Therapeutics (NSDQ:ANIK) rose yesterday after the company met expectations on Wall Street with its 3rd-quarter results.

The Bedford, Mass.-based company posted profits of $8.9 million, or 59¢ per share, on sales of $25.8 million for the 3 months ended Sept. 30, for bottom-line growth of 6.8% on sales growth of 8.9% compared with the same period last year.

Earnings per share came in 12¢ ahead of consensus on The Street, where analysts forecast for 47¢.

“We continued to deliver solid financial results in the third3rdquarter, while expanding globally and advancing our deep and differentiated pipeline to drive sustained growth,” president & CEO Charles Sherwood said in prepared remarks. “Last quarter, we had a productive meeting with the FDA regarding the Cingal regulatory submission and continue to gain alignment on additional clinical and non-clinical work required to bring this important treatment to the U.S. Our confidence in the future success of Cingal in the U.S. has been reaffirmed by how well Cingal has been received by physicians in Canada and Europe, where we recently launched. We are well-positioned to achieve our operational and financial objectives for 2016 and to create significant near- and long-term value for patients and shareholders.”

Anika maintained its revenue guidance for the full year, saying it still expects product revenue growth in the mid- to high-teens and total revenue growth in the low double-digits.

ANIK shares were trading at $44.39 apiece yesterday in afternoon trading, up 3.9%, but slid back down -2.3% this morning to $43.03 apiece.

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From Zero to Six Million – Using a Component Management Process to Scale Up Manufacturing of Drug Delivery Devices

Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new and existing drug formulations. However, even good initial designs can’t guarantee that all the parts for these devices can be manufactured correctly and assembled consistently, with few rejects. Success demands that parts suppliers adopt a systematic component management process for delivery of interrelated components. The right process ensures that all parts meet specifications and are inter-assembled efficiently. This paper presents a case history wherein a successful component management process helped provide consistent, cost-effective, extremely scalable, and high-yield drug delivery device production.

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Senseonics submits FDA PMA application for Eversense CGM

Senseonics (NYSE:SENS) said today it submitted a premarket approval application to the FDA for its Eversense continuous glucose monitoring system.

The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that allows for the real-time display of glucose readings, the company said.

“The submission of our PMA marks a significant milestone toward meeting our goal of bringing an accurate, reliable and long-lasting CGM system to people with diabetes in the United States. We look forward to working with the FDA to receive approval as quickly as possible,” prez & CEO Tim Goodnow said in a press release.

The application will be supported by data from a 90-patient pivotal trial of the device, which followed adults with Type 1 or Type 2 diabetes over 90 days of CGM sensor wearing, the company said. Results from the trial are slated to be presented at the Diabetes Technology Meeting in Bethesda, Md. on November 10.

The Germantown, Md.-based company said that, upon receiving FDA approval, it will initiate sales within the U.S.

Senseonics won CE Mark approval in the European Union in May. The device is indicated for continually measuring interstitial fluid glucose levels in adults as an adjunctive device to complement information obtained from standard home blood glucose meters.

The company said plans to conduct post-market surveillance, including long-term safety and performance data now that the device has been cleared in the EU.

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St. Jude Medical shareholders grudgingly approve executive tax breaks ahead of Abbott merger

Shareholders in St. Jude Medical (NYSE:STJ), who this week voted to approve its pending, $25 billion merger with Abbott (NYSE:ABT), grudgingly approved a measure to give tax breaks to its senior executives if the deal goes through.

Little Canada, Minn.-based St. Jude’s board last year voted to do away with a “gross-up” provision that would have covered the 15% excise tax imposed by U.S. tax laws on stock owned by executives and directors for the 6 months before and after a merger transaction.

But after inking an $85-per-share deal in April to be acquired by Abbott, St. Jude moved to reinstate the gross-up provision, which could relieve CEO Michael Rousseau and other executives of $18 million in tax payments if they leave Abbott after the deal closes, expected by year-end.

The provision would save $5 million for Rousseau, a $3.3 million hit for president Dr. Eric Fain and $2.5 million for CFO Donald Zurbay. The benefit only applies if the executives are terminated without cause or leave for good reason after the deal closes, the newspaper reported; Abbott hasn’t publicly outlined its post-merger leadership plans. Former CEO Dan Starks, who is still chairman and the company’s largest individual shareholder, is not eligible for the gross-up provision as the $18 million he set to pull down from the deal is not subject to the excise tax.

In a regulatory filing yesterday, the company detailed the shareholder votes for the merger, the gross-ups and for its executives’ compensation plans. Although the stockowners overwhelmingly approved the Abbot merger (casting nearly 212.2 million of 239.6 million votes, or 88.5%, in favor), only 52.3% approved the gross-up plan (125.3 million votes for). Only 53.5% of shareholders voted for the executive compensation plan, casting 128.3 million “aye” votes, according to the filing.

St. Jude and Abbott still plan to close the deal, which must still pass reviews by anti-trust regulators in the U.S. and Europe, by the end of the year. In July, the Federal Trade Commission asked for more information about the merger; the European Commission is slated to decide by Nov. 9 whether to bless the union.

Earlier this month, the duo agreed to divest some of their vascular access products, likely aiming to appease the anti-monopoly agencies. Japan’s Terumo Corp. (TYO:4543) paid $1.12 billion for St. Jude’s Angio-Seal and Femoseal vascular closure devices and Abbott’s Vado steerable sheath, but Abbott said it would retain its overall vascular closure business.

Abbott CEO Miles White last week praised St. Jude’s handling of claims by short-seller Muddy Waters that its implantable heart devices pose cybersecurity risks and said he’s still planning to close the sale by the end of year.

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Litmus Health looks to bring wearables to drug development

Litmus Health said yesterday that it launched its clinical data science platform into public beta. The company hopes to use big data from wearables and connected devices to help inform endpoints for Phase I & II clinical trials.

The goal of its platform, according to Litmus, is to get pharmaceuticals to market faster by putting health-related quality of life as the primary motivation for clinical development. Massive sets of data collected from wearables will help to inform researchers about their patients quality of life outside the clinic.

Get the full story at our sister site, Drug Delivery Business News.

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Monaghan Medical touts Aerobika study

Monaghan Medical yesterday touted data from a 6-month retrospective study showing that its Aerobika device reduced drug use for treatment of chronic obstructive pulmonary device.

The Syracuse, N.Y.-based company says its oscillating positive expiratory pressure therapy device is designed to expand the airways, help expel mucus to the upper airways and aid in drug deposition.

Get the full story at our sister site, Drug Delivery Business News.

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Corindus wins FDA nod for 2nd-gen CorPath GRX vascular robot-assisted surgery system

Corindus Vascular Robotics (OTC:CVRS) said yesterday that it won 510(k) clearance from the FDA for the CorPath GRX, it’s 2nd-generation vascular robot-assisted surgery platform, and plans to have it on the market during the 1st quarter of 2017.

Waltham, Mass.-based Corindus said it added several features to the latest CorPath iteration, including the ability to control the guide catheter in 1mm increments to precisely position balloon or stent catheters during percutaneous coronary interventions.

“CorPath GRX is a critical advance in our core technology and a meaningful step toward realizing our vision of fundamentally changing how PCI procedures are performed,” president & CEO Mark Toland said in prepared remarks. “GRX will enable us to build more robust and sustainable cardiovascular robotic programs with our hospital partners as we remain focused on providing the highest level of care to patients while protecting the health and wellness of the cath lab staff. We are excited to debut the GRX at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference later this week where we will be holding clinician demonstrations.”

“The new features of the next generation CorPath System, particularly the addition of active guide catheter management, will allow physicians to increase the complexity of procedures performed robotically,” added chief medical officer Dr. Aaron Grantham. “This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system.”

In March, Corindus won 510(k) clearance from the FDA for the original CorPath system for a peripheral intervention indication, a year after launching a clinical trial.

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Comparing drug and medical device clinical trials

Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community.

Read on to learn the similarities and differences between drug and medical device clinical trials.

The Differences between Drug and Medical Device Clinical Trials

	Drug	Device
Primary Administrator	Patient or Patient’s Caregiver	Investigator
Principal Investigator Supervision Required?	No	Yes
Patient Responsibility	High	Low
Physician Involvement	Low	High
Training Process	Observational Staff and patients are informed of administration regimen, possible side effects and potential adverse reactions.	Practical Complex devices may require extensive investigator training, including cadaver labs, animal models, or proctoring during live cases.
Cost of Product	Often provided free of charge	Up-front cost with subsequent reimbursement

The Similarities between Drug and Medical Device Clinical Trials

Both drug and device clinical trials require adherence to the following regulations:

• 21 CFR 11 – Electronic medical records
• 21 CFR 50 – Human subject protection
• 21 CFR 54 – Financial disclosure
• 21 CFR 56 – Institutional Review Board (IRB) requirements

On the other hand, drug trials must abide by 21 CFR 312 (investigational new drug application) but device trials do not. Additionally, device clinical trials must abide by 21 CFR 812 (investigational device exemptions) whereas drug trials do not.

However, these two regulations have a number of similarities, some of which are outlined below:

1. The appropriate submission must be made to the FDA before beginning an investigation
2. Amendments are required when changes are made
3. Annual updates on study progress are mandatory
4. Both sponsor and investigator responsibilities are described
5. Investigation must be conducted in compliance with the investigational plan, signed agreement, federal regulations and conditions of approval imposed by the IRB
6. Investigation must be properly monitored
7. IRB approval must be obtained prior to beginning the investigation
8. Labeling requirements are specified
9. Significant new information must be provided to subjects
10. Sponsors must provide information to investigators

Drug and device clinical trials have several similarities and differences, but the end goal is the same: introduce safe and effective products to the public as quickly as possible. To help you further understand how to conduct global clinical research trials and understand the differences between drug and device trials, take a look at this helpful resource.

John Lehmann is the director of marketing of IMARC Research, a clinical research organization (CRO) that specializes in medical device trials. IMARC Research assists study sponsors with clinical monitoring, auditing, training, consulting, project management and more. To learn more, visit imarcresearch.com.

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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Integer Holdings Q3 EPS beats the street

Shares in Integer Holdings (NYSE:INTGR) fell slightly today after the medical device maker topped earnings per share expectations and missed slightly on revenue for its 3rd quarter.

The Frisco, Texas-based company posted profits of $11.5 million, or 37¢ per share, on sales of $346.6 million for the 3 months ended September 30.

The company saw a huge swing from a minimal $22,000 in profits reported last year during the quarter, with sales increasing 136.3% compared with the same period last year.

After adjusting to exclude 1 time items, profits were at $25.8 million, 67.5% up from the same period last year. Adjusted earnings per share were 83¢, 4¢ above the consensus of The Street, though revenue missed the mark, with consensus putting the company at $347.9 million.

“Our 3rd quarter results demonstrate that the steps we have taken to stabilize our business are working. Our internal focus on reducing costs, improving working capital, and business process optimization is progressing well and has allowed us to stem the revenue and adjusted EBITDA declines we saw during the 1st half of the year. Our outlook for the remainder of the year further demonstrates this business stabilization. Integer’s value proposition remains intact and we are well-positioned within the medical technology market, with a broad suite of technologies, capabilities and product offerings to deliver innovative, cost-effective solutions to our customers in order to enrich the lives of patients worldwide,” prez & CEO Thomas Hook said in prepared remarks.

Shares dropped 2.2%, closing down 41¢ at $18.15 for the day.

Integer said it is maintaining its revenue, net income and diluted EPS guidance. The company said it expects to post adjusted EPS between $2.60 and $2.75, on sales of $1.38 and $1.4 billion for the full year.

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