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Top 10 Medtech Deals of Q2 (Autonomic Technologies)

 No. 3

Name of Company: Autonomic Technologies Inc.

Headquarters: Redwood City, California

Product: Developing the implantable ATI Neurostimulation System which treats patients suffering from chronic, severe headaches using a patient-controlled remote controller.

Amount Raised: $43.2 million

Investors: Aberdare Ventures, Edmond de Rothschild Investment Partners SAS, Forbion Capital Partners, InterWest Partners,Kleiner Perkins Caufield & Byers, Novartis Venture Funds, and an undisclosed firm.


Source: MoneyTree Report and Autonomic Technologies

Top 10 Medtech Deals of Q2 (Shockwave Medical)

 No. 4

Name of Company: Shockwave Medical Inc.

Headquarters: Fremont, California

Product: Developing the Lithoplasty balloon catheter system to treat patients with severely calcified vascular and valvular disease.

Amount Raised: $41 million

Investors: Ally Bridge Group Capital Partners,Deerfield Management Company, RA Capital Management,Sectoral Asset Management Inc, Sofinnova Partners SAS, Venrock and an undisclosed firm.


Source: MoneyTree Report and Shockwave Medical

[Correction: PwC previously recorded Shockwave Medical as having raised $39 million. The data is being revised]

Top 10 Medtech Deals of Q2 (Aegea Medical)

 No. 5

Name of Company: Aegea Medical Inc.

Headquarters: Redwood City, California

Product: Developing the Aegea Vapor System uses water vapor to treat menorrhagia defined as prolonged and abnormally heavy menstrual bleeding.

Amount Raised: $36 million

Investors: Alloy Ventures Inc., Covidien Ventures, Delphi Venture and an undisclosed firm.


Source: MoneyTree Report and Aegea Medical

Top 10 Medtech Deals of Q2 (Intact Vascular)

 No. 6

Name of Company: Intact Vascular Inc.

Headquarters: Wayne, Pennsylvania

Product: Developing the Tack Endovascular System to treat peripheral artery disease. 

Amount Raised: $35.31 million

Investors: H.I.G. Capital, New Enterprise Associates, and Quaker Partners Management.


Source: MoneyTree Report and Intact Vascular

Maximizing Medtech Marketing with Key Opinion Leaders

Maximizing Medtech Marketing with Key Opinion Leaders

Positive exposure from key opinion leaders is an important part of medical device marketing. How can device companies make the most of their KOL relationships?

Julie Wegman

Medical device companies invest heavily in training subject-matter experts (SMEs) and building relationships with key opinion leaders (KOLs) in order to establish themselves as thought leaders and provide peer-to-peer perspective on key topics pertaining to their specialties, therapeutic areas, and/or products. They are contracted to give talks, create content, assist with trials, get involved with grant funding, sit on advisory boards, and more. And they can be paid handsomely to do so.

Companies that manage KOLs are not doing it out of the kindness of their hearts. They’re likely doing it to drive demand and preference for their products. However, these companies often start with the patient in mind and believe that the right way to get the message out about their products, the right way to target the right patients, and the right way to work with the right clinicians is through KOL engagement.

By creating collaborative relationships with these highly respected physicians or key influencers that drive opinion as speakers, authors, and researchers, you can build credibility and increase market share. Often these experts are speaking on behalf of a company or brand at industry events and to the press. Unfortunately, after spending thousands of dollars to get them to the podium and participate in a symposium, many times the talk or panel discussion is captured only in transcript form. Or even worse, a poorly recorded video with too much ambient noise and distractions. Is this how companies want their brands represented?

So how can medical device companies get more out of their subject-matter experts and key opinion leaders for marketing purposes?

Effective thought leadership is half subject-matter expertise and half promotion expertise. Assuming you have the best KOL for your topic, this valuable content can be captured and repurposed for content marketing purposes, sales meetings, and for use in advertising, digital and social media. So, after regulatory approval, mapping out a plan to exploit your KOL’s opinion or educational content in a timely manner is key.

There are three simple elements to consider for success in this process:

1. Ensure your message reaches your target audience.

This may seem basic, but it’s important to find ways to deliver the information in various formats, across a variety of platforms to ensure you’re meeting the informational needs and consumption patterns of your targeted clinicians or patients. Not everyone bothers to download a podcast or white paper. The new generation of physicians and consumers is all about rich media. They want the ability to interact, collaborate, or easily share. This is all good for your engagement and return on investment (ROI) metrics, of course.

2. Sight, sound, and motion are by far the most effective ways to engage.

In today’s multimedia world, people lose interest easily . . . even with well-written marketing material. That’s where video content comes in. It’s just more easily consumed. And, frankly, some KOLs aren’t willing to spend time writing or may not be very good at it, so speaking may be their preferred form of communicating. Speaking is a great way to share their expertise and opinions.

If produced well, a video is a great way to carry a complex message and promote your KOL’s subject and, ultimately, your company. Heavy text on a zillion presentation slides can be deadly, even to a scientific audience. Videos should be well-produced and edited to avoid the same issue. Research has shown that if the content is relevant to the audience, clinicians will watch for 7–10, even 20 minutes. Patient videos should consist of more sound bites that can be easily consumed in shorter periods.

Motion graphics and photos should be used to help demonstrate or visualize the point or argument and complement the audio discussion.

If your video content can demonstrate how adept the KOL is at explaining complex issues, or that he or she has a unique perspective on how your medical device helps patients AND saves time and/or money, there is a greater chance that prospective customers will consider your company.

3. Promoting or building awareness that the content exists is essential, as the old adage of “build it and they will come” is still NOT true.

Whether you’re shooting a video of your KOL or he or she is coauthoring a paper, promoting that content and letting your audiences know where it resides or how to view it is key to further leveraging your KOL investment.

What better message can your banner ad carry than to see an expert’s opinion by clicking here, now? In fact, imbedding a clip of the video into a banner ad can increase click-through rates by up to 25% or more. Increasingly, more and more medical or clinical sites are able to handle rich media formats rather than just static banner ads.

Featuring text ads that are contextually pushed when clinicians or patients are researching your topics, or the KOL’s name in a paid search campaign will efficiently drive traffic to your website or landing page to view the content.

Of course, the beauty of a digital campaign is that it is easily optimized for better ROI and you can see the results of those efforts almost immediately.

  • Adding a video to a landing page can increase conversion by as much as 80% versus those with just static content.  
  • Adding video to LinkedIn or YouTube can deliver thousands or even hundreds of thousands of impressions.

The KOL is held in high esteem by those who follow or accept his or her opinions. In fact, KOLs are seen to have more influence than the media or sales people because they are seen as trustworthy and nonpurposive. The feeling of thought manipulation does not arise in the case of KOLs as they pride themselves on being unbiased with no commercial motives. For this reason, KOLs stand out in their reach and in their respective domains.

So most will agree that KOLs and SMEs are vital for a product's success factor throughout its life cycle. But when the cost for a KOL to lead an advisory panel can be upwards of $2,500 or to deliver a scientific speech at $3,000+ in T&E expenses, it only makes sense to capture and leverage that content in a marketing campaign that can live beyond that one day event and drive broader influence and, ultimately, ROI for your brand.

Enhance your medtech knowledge by attending MEDevice San Diego, September 1–2, 2015, in San Diego.

Julie Wegman is director of the Healthcare practice at Martino Flynn.


Top 10 Medtech Deals of Q2 (Twelve)

 No. 7

Name of Company: TWELVE Inc.

Headquarters: Redwood City, California

Product: Developing heart valves to replace diseased mitral valves in patients. 

Amount Raised: $35.3 million

Investors: Domain Associates, Longitude Capital Management Company , Morgenthaler Ventures and Versant Ventures.


Source: MoneyTree Report 

Top 10 Medtech Deals of Q2 (Scanadu)

 No. 8

Name of Company: Scanadu Inc.

Headquarters: Moffett Field, California

Product: Scanadu Scout and Scanadu Urine are part of a ecosystem wherebey consumer medical products linked to smartphones will have the ability to diagnose everyday conditions and recommend treatment options. 

Amount Raised: $34.9 million

Investors: AME Cloud Ventures LLC, CBC Capital, Relay Ventures,Tencent Collaboration Fund,  iGlobe Partners Ltd and two undisclosed firms.


Source: MoneyTree Report and Scanadu

Top 10 Medtech Deals of Q2 (Neuronetics)

 No. 9

Name of Company: Neuronetics Inc.

Headquarters: Malvern, Pennsylvania

Product: NeuroStar transcranial magnetic stimulation therapy, which treats patients with major depressive disorder with a form of neuromodulation.

Amount Raised: $34.3 million

Investors: Accuitive Medical Ventures, GE Ventures, InterWest Partners, Investor Growth Capital, New Leaf Venture Partners, ONSET Ventures, Polaris Venture Partners, Three Arch Partners, and an undisclosed firm.


Source: MoneyTree Report and Neuronetics

510(k) Reform on a High Wire

510(k) Reform on a High Wire

Despite strong interest, bids to overhaul the 510(k) regulatory process have hit a wall. The chances for reform seem to be waning—at least near term. 

Jim Dickinson

As another 510(k) safety issue emerged in July and an injured-patients’ legislative 510(k) reform effort took an unexpected hit on Capitol Hill, the prospects for significant change in the status quo seemed to be wobbling on a high-wire act.

The pivot-point is a basic question first presented by a controversial and widely ignored 2011 Institute of Medicine committee report that concluded that FDA’s 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” It recommended scrapping the process and starting over.

The long-slumbering rationale for introducing untested, redesigned, and new devices as “substantially equivalent” to pre-1976 predicates was next most visibly raised by Pennsylvania cardiac surgeon Hooman Noorchashm whose wife, physician Amy Reed, had suffered a pelvic cancer explosion from a power morcellator used in a routine hysterectomy.

He convinced their local congressman, Republican Mike Fitzpatrick, to introduce a battery of amendments to the 21st Century Cures Act that would, among other things, impose a requirement to prove safety on 510(k) submissions to FDA.

These were swiftly killed in the House Rules Committee by fellow Republican and ex-gynecologist Michael Burgess from Texas, on the grounds that any harms coming from morcellators were due to deficiencies in the state-regulated practice of medicine, not in the federally-regulated medical device clearance for marketing process.

“In this instance, I think that it was clinical judgment that was at fault, not the FDA approval process,” Burgess said dismissively, ignoring the nationwide nature of the morcellator tragedies.

Just as this was happening, a new 510(k) safety issue was being raised for the first time in a JAMA Internal Medicine meta-analysis by five cardiologists that highlighted dire clinical consequences of off-label uses of SentreHeart’s 510(k)-cleared Lariat Suture Delivery Device.

With its associated devices it has become popular in an off-label surgical technique to prevent stroke by sealing the left atrial appendage, a pouch-like region of the left atrium of the heart, in patients with atrial fibrillation.

The cardiologists’ alert came from an analysis they conducted of adverse events reported in four private sector databases from January 2007 through August 2014 plus 45 adverse events reported to FDA’s online MAUDE database.

The reports they found, the five wrote, “describe six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.”

As the industry- and FDA-disparaged IoM committee report found, there have been numerous other, if less-dramatic, indictments of the 510(k) process and its failure to demand evidence of new device safety.

Surely, only the ideologically blinded or uninformed (or both) can fail to see that a 39-year-old statutory mechanism such as Sec. 510(k) could slowly, almost imperceptibly become fossilized to a lethal degree by the dizzying pace of technological advancement.

Precisely this point was made in a July 17 New York Times op ed by University of California San Francisco cardiologist Rita F. Redberg and Yale University clinical scholar Sanket S. Dhruva.

Writing that today’s device regulatory oversight has not kept pace with increasingly complex technology advances, they slammed the “disingenuously titled” 21st Century Cures Act for enabling high-risk device makers to submit anecdotal safety and effectiveness data and even lower-quality clinical evidence to FDA than is currently required.

Echoing earlier criticisms from former FDA commissioners David Kessler and Margaret Hamburg, they also charged that the bill as passed (overwhelmingly) in the House would shift evidence collection to the postmarket period for many devices, but these postmarketing studies are often delayed for a long time or not completed.

Some might wonder how industry advocates can be so quick in one breath to tout the “next generation” technological innovativeness of the newest devices and then in the next breath claim, in the rush to market, the same products’ scientific backwardness for purposes of regulatory review under Sec. 510(k).

Safety assumptions reasonably made in 1976 have been unable to withstand the assault of scientific developments in a creaky FDA regulatory world of coerced, unwritten interpretational elasticity.

Largely hidden from public view, this world cloisters the post-submission CDRH review of 510(k)s and the sometimes fractious horse-trading that can go on behind the scenes between sponsor and reviewer. Unlike the public PMA process, 90% of 510(k) devices go to market automatically, usually without FDA announcement or explanation.

Rarely does this furtive process burst negatively into the open, as it did a few years ago when FDA admitted that it had wrongly approved ReGen Biologics’ Menaflex collagen scaffold on the basis of inadequate scientific evidence and that the device had been intended by its sponsor “to be used for different purposes and is technologically dissimilar from devices already on the market, called ‘predicate devices.’”

At the time, FDA’s October 14, 2010 news release contended that the Menaflex episode was “unique” and did not implicate any other devices—yet now there emerges the Lariat study involving a substantially equivalent issue: off-label use of a 510(k)-cleared device. In both cases the intended uses of the devices in medical practice were not studied for safety.

Neither was the power morcellator’s intended use—just as the overwhelming majority of other 510(k)-cleared devices all escape safety assessments for their intended uses as well.

Until Rep. Burgess’ intervention, Noorchashm and his large Internet network expected the incubating 21st Century Cures Act would be a vehicle to correct this.

They still hope for this and have not yet folded their tents. But a change of direction will be needed, since the realities of politics on Capitol Hill make it unlikely that Burgess will change his mind, or that Fitzpatrick will keep plugging away at what now must seem a lost cause.

A slender chance exists on the Senate side, where Health and Education Subcommittee chairman Lamar Alexander (R-TN) has said he hopes to get a measure similar to the House’s 21st Century Cures Act through his panel before the end of the year.

However, any such multi-faceted legislative initiative has multiple pitfalls to navigate. In this case, increased funding for the National Institutes of Health is a contentious issue in the Senate that could delay or even defeat 510(k) reformers again.

So as the political season heats up for the coming elections, the prospects for 510(k) reform on the safety front look increasingly like a high-wire act, notwithstanding continuing action by the injured patient community.

Congress, after all, responds first to interests with deep pockets for campaign funding—unless public uproar in a particular district or state puts re-election at stake. Those deep pockets are not the constituencies clamoring for 510(k) reform.

Enhance your medtech knowledge by attending MEDevice San Diego, September 1–2, 2015, in San Diego.

Jim Dickinson is MD+DI's contributing editor.


Top 10 Medtech Deals of Q2

Top 10 Medtech Deals of Q2

Venture capital investment in medical device startups shot up 71% in the second quarter from the first, and there is some indication that investors are feeling confident about the sector. 

A total of 75 companies raised a cumulative $813.7 million in the second quarter. Here is a slideshow, in ascending order, of the top 10. The data comes courtesy of the MoneyTree Report from PricewaterhouseCoopers (PwC) and the National Venture Capital Association (NVCA), based on data from Thomson Reuters. /p>

Begin Slideshow