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Livongo and Abbott Take Diabetes Management to New Heights

Pixabay Livongo and Abbott Take Diabetes Management to New Heights

Digital Health specialist, Livongo Health has found a partner that will help it take an in depth look at the total needs of diabetes patients. The Mountain View, CA-based company is working with Abbott Laboratories to use the Freestyle Libre Pro System in its offerings.

The agreement calls for Livongo offering, when appropriate and prescribed, the FreeStyle Libre Pro System to its members with diabetes.

This will provide members with a visual snapshot of their glucose data, known as the Ambulatory Glucose Profile (AGP), offering a clearer overview of not only glucose levels, but also patterns and trends within those levels, the company said. Members also may request the AGP be shared with their personal physicians.

“This agreement makes Livongo the first comprehensive service for people with diabetes,” Glen Tullman, chairman and CEO of Livongo Health, told MD+DI.

 

Livongo has found a unique partner in Abbott because of the strides the medtech giant has recently made in the diabetes management market.

Abbott’s impact in the diabetes space skyrocketed when the FreeStyle Libre Pro received approval from FDA in 2016. The Freestyle Libre Pro includes a disposable sensor that is small, round, and waterproof. Placed on the upper arm with an adhesive pad, it is able to collect glucose level data every 15 minutes, providing up to 1340 glucose results.

A year after the Pro-version of the device was approved, Abbott secured an FDA nod for the FreeStyle Libre Flash, which can be used in the home setting. Late July, Abbott won a nod for a 14-day version of the device.

The device was called a game changer for diabetes treatment and MD+DI named the devices approval as one of five key events that disrupted the diabetes market.

“When someone either pricks their finger, or now uses the Freestyle Libre, that information goes up into the cloud,” Tullman said. “We have a machine learning structure that analyzes what is the best solution for that person at that time. What should that person do? So, it’s personalized medicine being delivered in real-time, right back to you.”

The collaboration is aimed breaking through some of the treatment silos offered to patients. It’s also a partnership that looks at simplifying the management of diabetes.

“This is the first time anyone is thinking about it as an integrated experience and bringing it together,” he said.

Tullman said this is one of the first partnerships Livongo has had with a medical device company. He noted there could be more, but that would be dictated by the needs of Livongo’s customers.

Livongo has been picking up steam since it was launched in 2014. MD+DI even named Mountain View, CA-based Livongo was as one of the 10 digital health startups to watch in 2016.

The company has been involved in M&A activity. Earlier this year, Livongo acquired Retrofit, a weight management firm. Livongo used some of the $105 million it raised during a funding round in April to help with the acquisition of the Chicago-based company, according to its website.

In 2017, acquired Diabeto, which provides comprehensive connectivity to nearly all glucose meters available on the market today.

Biotronik Enters into Distribution Agreement with InfoBionics

Courtesy of Biotronik Biotronik Enters into Distribution Agreement with InfoBionics

Biotronik has become the exclusive US distributor for InfoBionic's MoMe Kardia external cardiac diagnostic monitor.

The device benefits patients suspected of experiencing cardiac arrhythmias.

“When we’re looking at partners - we’re asking ourselves - are these partners able to do the three main things that are important to us,” Rupa Basu, Senior Vice President of Marketing, Corporate Accounts and Strategy, at Biotronik Inc., told MD+DI. “The first thing is, is it going to improve the patient’s experience of care. The second is, is this going to improve the health of the patient population, and at the same time is it going to reduce the per capita cost of healthcare.”

She noted that the InfoBionic MoMe Kardia system checks meets all of these criteria.

MoMe is designed to increase early detection and diagnosis of cardiac arrhythmias by providing physicians with the ability to access near real-time electrocardiographic data. Monitoring can also uncover patients at higher risk of sudden cardiac death. Hospitalizations and life-threatening cardiac events decrease with early diagnosis and treatment.

MoMe creates access to information that enables intervention to prevent negative outcomes. Medication compliance can be identified and managed, symptoms can be correlated with rhythms, and triggers of cardiac events can be found by analyzing the onset and resolution data of an event.

“The other advantage of this product is the data is immediately available to the physician, so they don’t have to go to a third party diagnostic-testing facility to get the information,” Basu said. “They have better control of their patient’s care.”

Lake Oswego, OR-based Biotronik is working on a pilot launch of the device in certain regions and areas in the U.S. A full-fledged launch will occur sometime in November. The MoMe Kardia device received FDA clearance in 2016. Biotronik’s CEO, Marlou Janssen once said the company was the cardiac rhythm management space's best kept secret. Yet, the firm effectively competes against titans in the industry, such as Medtronic, Abbott Laboratories, and Boston Scientific.

“I think if you look at the products we manufacture ourselves as well as the partnerships that we get into, we always have something that’s unique and proprietary,” Basu said. “I think that’s what keeps us alive and doing well in this competitive market place.”

Creating the Best Design Plan for Your Device

Creating the Best Design Plan for Your Device
Pixabay

Every medical device on the market once began as a simple idea crafted to solve a problem. Despite the best intentions of every device developer, many of these ideas fail to reach their potential given the challenging road from original concept to delivered product. This is why crafting a quality design plan has become a crucial element to success for device developers, as it helps us define what needs to be done, when it needs to be done, and who will actually do it.

These days, a proper design plan can provide developers with a step-by-step roadmap for medical device creation, ensuring that no detail goes unnoticed. Unfortunately, there are many different ways a design plan can fail, which often leads to failure before development barely gets off the ground.

Walt Murray, a quality management and regulatory affairs specialist, has seen the best and worst when it comes to design plans. Murray has worked as an independent expert for major medical device companies around the world, consulting on a variety of different design plans across the medical device realm. Murray is certified in quality and environmental systems auditing with more than 30 years' experience working with many titans of the medtech industry including Johnson & Johnson, Pfizer, Merck, and Stryker.

Murray will be speaking at the conference at MD&M Minneapolis November 1, discussing all the do’s and don’ts of successful design plans during his talk, “The Role a Design Plan Plays in Technical Transfer.”

Ahead of his discussion, Murray decided to sit down and speak with MD+DI to discuss the basics of a quality design plan and the various roles and responsibilities needed to create and carry out a successful design plan. He also decided to share a few tips that design teams can use to avoid lengthy setbacks that can slow or even completely derail development altogether. Don't miss his talk for even more guidance.

MD+DI: For starters, can you talk a little about the basics of a successful design plan, and the role it can play in the process of product delivery? How crucial is it to craft a meticulous and precise design plan?

Murray: The plan has several aspects to it that validates the full commitment of the team described in the deployment of the plan. In project management terms, key task points are outlined (review phase-gates) along with the documents that must satisfy those tasks. Therefore, it is important as to who is the project manager (not a member of the active team) in driving all critical aspects of the plan, which include: (1) phases are complete and the DHF [device history file] is populated; (2) the MA [market authorization] submission for regulatory approval is also part of the DHF and is meeting its detail and timeline; (3) the RMF [risk management file] is populated as part of the DHF and has completed all risk-based assessment and analysis before the completion of the design and development phase; (4) design transfer is approved by review of the validation phase and the technical transfer occurs as the result of a bonified DMR [device master record] approval by manufacturing; (5) the key freeze points have final technical documentation (design-product-operational freeze) in the DHF; (6) formal closure of the DHF under predetermined description in the design plan has been completed and is under control by the appropriate medium used to store it.

MD+DI: What are some of the roles and responsibilities of the drivers of the design plan? How can they effectively keep design teams on track from start to finish?

Murray: First, the assignment of the project manager who, irrespective of other chores, must keep the DP [design plan] tasks deployed for the plan. Second, the interface team must be confirmed from a predesignated list of roles necessary to complete the phase tasks and the final phase review. Third, an independent QA auditor should audit each completed phase to ensure the plan and its documentation are populating the DHF. No one-party team member can control the key components of the plan—they must all be equally collaborating. This is driven by the project manager in conjunction with the auditor.

MD+DI: What are some common mistakes or miscues that can often lead design teams down the wrong path, and how can teams work to avoid some of these mistakes?

Murray: If the design plan is followed (like a roadmap), then there shouldn’t be any wrong turns. Mistakes can have a process for a fix; however, miscues are a failure to follow the plan. The key is the predetermined documentation and interfacing that must occur. Poor calculated timing for inputs by the team leads to premature deadlines where things are often rushed and signed off without due process. Much worse is the presumption of approving items that need team collaboration. The design plan is designed to eliminate such risks, which is why an independent project manager and auditor can keep things on track.

MD+DI: How important is it to define any and all risks involved in the design process? What role does documentation play when it comes to the process of validation?

Murray: The risk aspect of a design project is the most crucial aspect of the project charter. Realistic, transparents barriers, assumptions, and commitments must be laid out. Product and process risks are well outlined by tools for analysis and assessment. This early component of risk can use a SFMEA [system failure mode effect analysis] system to capture these risks. Don’t take systematic risk lightly. They can become the root cause of consternation for the design plan and can cause frustration and even covert work within the design plan. Validation is critical, yet the most apprehensive component phase of design control. It should be anticipated that issues will arise from this phase. It is also the final due diligence component of identifying risks, failures, improvements, and opportunities unseen during verification of product ‘freeze.’ How these issues are handled does not have to be a go or no-go scenario, although some will have high-risk consequences if not addressed. It does help to avoid recalls or even market withdrawals, so documentation such as well thought-out protocols, methods of analysis, and results are all crucial. The 2011 process validation guideline from FDA has taken much of this into account. The new qualification process is PD-PPQ-P&PC (not IQ/OQ/PQ) [process design-process qualification-product & process control verification not installation qualification/operational qualification/performance qualification].

MD+DI: What are a few tips that you could share with design teams to help them stay on track during the development process and avoid getting held up or sidetracked on the way toward the finished product?

Murray: The first would be to allow for unforeseen circumstances. Second would be to use good forms and ticklists to keep interfacing reviews on task. Third would be to be transparent, but not over-analytical about risk-based thinking. Lastly, use a formal risk-based factual decision making model to help avoid groupthink.

MD+DI: Finally, in your years of experience, would you say there are still things you’re learning about crafting an effective design plan? What are some of the recent lessons you’ve learned that could help design teams in today’s world of device development?

Murray: The most important is the intimate involvement of management as a peacemaker/decision-enabler in the approval of the overall design control procedure. If necessary, have the top (most influential) executive be a CAPA owner where this process comes under great scrutiny, as necessary improvements will be needed for it to be successful.

Please attend the MD&M Minneapolis November 1 session, “The Role a Design Plan Plays in Technical Transfer.”

Boston Scientific's Aggressive M&A Strategy Continues with Augmenix Deal

Boston Scientific's Aggressive M&A Strategy Continues with Augmenix Deal

Tuck-in acquisitions continue to play a key role in Boston Scientific's strategy this year, as evidenced by the company's latest deal, which also happens to be its largest so far in 2018. 

The Marlborough, MA-based company has agreed to pay $500 million upfront and up to $100 million for sales-based milestones to acquire Augmenix. This private company is based in Bedford, MA and has developed a product called SpaceOAR, which intended to reduce common and debilitating side effects for men who undergo prostate cancer radiotherapy.

Not only is Augmenix the eighth acquisition Boston Scientific has reported this year, it is the company's third acquisition in the urology and pelvic health space. The company aims to be category leaders in each space it participates in, says Dave Pierce, president of the MedSurg business at Boston Scientific. In urology and pelvic health that leadership position is maintained through both internal innovation and M&A, he said.

"We're constantly scanning the horizon for anything from within our space and adjacent to our space that would be complementary and enhance our category leadership. Augmenix falls into that category," Pierce told MD+DI.

There are other companies in the urology and pelvic health space that Boston Scientific is also following, he noted.

The SpaceOAR hydrogel is injected prior to radiation therapy to create additional space between the rectum and prostate during treatment, thereby reducing rectal radiation dose and associated side effects. Boston Scientific estimates that more than 1.1 million men are diagnosed with prostate cancer per year worldwide, and of that population, about 400,000 men will undergo prostate radiotherapy.

The SpaceOAR hydrogel is CE marked, FDA cleared and has been used in more than 30,000 patients worldwide. The company said the total addressable market is valued at $750 million, and Boston Scientific expects product sales to reach $50 million this year, and approach $90 million in 2019.

About 1.1 million men are diagnosed with prostate cancer every year, and roughly 400,000 of those men undergo radiation therapy, Pierce said.

"We're excited about this because when you think about radiation, the biggest challenge is rectal toxicity, meaning the radiation goes beyond the prostate and gets to the rectum. SpaceOAR kind of gives you a safety net, if you will," he said.

Pierce noted that clinical data shows that using the SpaceOAR hydrogel prior to radiotherapy lowers the rate of rectal toxicity. It's also possible that the product may allow the radiation oncologist to take a more aggressive approach in terms of dosing, duration, and the number of radiation sessions, but Pierce said that is not yet clinically proven.

Men who are diagnosed with prostate cancer currently have three options. One option is watchful waiting, which a lot of men elect, especially if they are diagnosed at an early stage. The most dramatic and risky option is surgery to remove the prostate. That leaves radiotherapy as the middle-of-the-road treatment option in terms of balancing the benefits with the risks. As more data emerges around the SpaceOAR hydrogel, it is possible that more men will consider radiation therapy because of the reduced side effects, and other benefits that may emerge as Boston Scientific continues to study the product.

Pierce said the acquisition of Augmenix complements other recent deals, such as the NxThera acquisition Boston Scientific announced in March.

"We are thrilled by the combination of SpaceOAR and the Rezūm system, which is the product we got when we purchased NxThera earlier this year," he said.

The Rezūm system is a minimally invasive therapy in a growing category of treatment options for men with symptoms arising from of benign prostatic hyperplasia (BPH).

"So both of these products will predominately be used in the urologist's office," Pierce said.

A randomized U.S. study of the SpaceOAR hydrogel concluded that patients who received the hydrogel spacer reported significantly less rectal pain during prostate radiotherapy and had significantly fewer severe long-term rectal complications. The trial showed zero incidences of grade 2 rectal toxicity versus a 5.7% rate experienced by patients without the spacer.

A single injection of the SpaceOAR hydrogel is designed to maintain the space between the rectum and prostate for three months – within the duration of a standard radiation treatment schedule. The absorbable hydrogel is gradually reabsorbed by the body within six months of injection.

The transaction is expected to be immaterial to adjusted earnings per share in 2018 and 2019, accretive in 2020 and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be less accretive, or more dilutive as the case may be, due to amortization expense and acquisition-related net charges. The acquisition is projected to close early in the fourth quarter of 2018, subject to customary closing conditions.

MD+DI recently reported on the near-term M&A outlook for Boston Scientific and other medical device companies, which can be found here.

The Medical Device Excise Tax: Three Potential Outcomes

The Medical Device Excise Tax: Three Potential Outcomes
Image source Aquir/Shutterstock

The battle to repeal the medical device excise tax (MDET) has been a significant focus of the medical device community since the Affordable Care Act (ACA) was enacted on March 23, 2010. At that time, Congress included a 2.3% excise tax on medical devices to help cover the costs of the expanded health insurance coverage mandated under the ACA. Efforts to repeal the MDET began almost as soon as the ACA was enacted. The medical device industry largely criticized the MDET, insisting that the tax would harm R&D investment and performance, and thus argued it should be abolished. Although there has been significant agreement in the medical device industry to abolish the tax, it remains an ever-present concern for the industry. In July 2018, the House of Representatives voted to repeal the MDET. In this article, we provide a history of the MDET and its related repeal efforts, an overview of the present costs associated with the current state of the MDET, and possible outcomes of the MDET.

Brief History of the MDET and Repeal Efforts

The ACA was signed into law by former U.S. President Barack Obama on March 23, 2010. It included three key mandate provisions to expand health insurance coverage to universal levels. To help cover the costs of the expanded health insurance coverage, the ACA also included new taxes and fees imposed on several business sectors. Section 4191 of the Internal Revenue Code imposed a 2.3% tax on the sale price of “any taxable medical device by the manufacturer, producer, or importer.”[1] But like most tax provisions, the meaning of this language is more complicated than it first appears. The Internal Revenue Service’s final regulations state that for purposes of the MDET, a “taxable medical device” is one that is listed by FDA under section 510(j) of the Federal Food, Drug, and Cosmetic Act.[2]

Outcry over the MDET caused the legislature to take immediate action. Beginning on January 25, 2011, bills were introduced in both the House of Representatives and the Senate to repeal the MDET.[3] The MDET has raised bipartisan opposition. On December 4, 2012, eighteen Democratic senators sent a letter to then Senate majority leader Harry Reid requesting delayed enactment of the MDET, stating, “[W]e must do all we can to ensure that our country maintains its global leadership position in the medical technology industry and keeps good jobs here at home.”[4]

To date, the MDET has been up for repeal or reform more than a dozen times.[5],[6] In July 2018, the Republican-controlled House approved a repeal of the MDET.[7],[8] For the MDET to be repealed, the bill will need to pass the Senate with 60 votes. The bill, H.R. 184, has been received by the Senate to be calendared but no date on a vote has been set as of September 6, 2018.

Present Costs to the Industry

It would be an incorrect assumption that since the MDET has not been in full effect that it has not already impacted the medical device industry. In July, a peer-reviewed article was published addressing the impact of the MDET on industry R&D and performance.[9] The study had two objectives: firstly, to assess the effects of the MDET on medical device companies’ performance and R&D investment; and secondly, to estimate how the medical device firms responded to the ad valorem excise tax and pass their tax burdens to customers.[10] The study identified the effects of the MDET on industry R&D investment and performance focusing on: (1) R&D expenditures, (2) sales revenue, (3) gross margins, and (4) earnings (profits). The article indicates that uncertainty surrounding the MDET significantly reduced R&D expenditures, sales revenue, gross margins, and earnings by approximately $34 million, $188 million, $375 million, and $68 million, respectively, for medical device companies—representing a significant $665 million dollar impact.[11]

In addition, the empirical findings of the study suggest that the MDET affected operating costs and market strategies for medical device manufacturers. Medical device companies reduced their operating costs to alleviate the MDET burden. They also significantly increased the global market sales intensity and global market diversification after the MDET incidence because medical device sales outside the United States are tax-exempt. Further, the MDET is attributed to costing the industry some 29,000 jobs nationwide.[12]

Moreover, there have been indirect costs associated with lobbying to repeal the MDET. An estimated $220.6 million was spent on direct lobbying in Washington since 2012 by the medical device industry.[13] Yet, the actual amount of contributions given to PACs and lobbying groups is largely unknown.

Possible Outcomes of the MDET

The U.S. medical device industry has estimated revenues of $155 billion per year, with approximately ten manufacturers accounting for eighty-six percent of the sales of covered medical devices [14],[15] The MDET is expected to raise an estimated $3 billion in tax revenue per year. Proponents have argued that the industry’s grave predictions of vast layoffs and decreased investment in innovation have been greatly exaggerated. Proponents view the MDET as a small, but necessary component of the ACA that needs to remain intact in order to achieve the much larger goal of providing healthcare to all Americans. Thus, proponents acknowledge that the MDET imposes a burden on the medical device industry but reason that such a burden is outweighed by the benefits of the ACA. Proponents will push for the MDET to go into full enforcement after the moratorium expires.

On January 22, 2018, H.R. 195 (Pub. L. 115-120), a bill extending the moratorium on the MDET, was signed into law for an additional two years. Because of the moratorium, the MDET does not apply to the sale of taxable medical devices by the manufacturer, producer, or importer of the device during the period beginning on January 1, 2016, and ending on December 31, 2019. This is the second time a moratorium has been placed on the MDET. During the previous two-year moratorium, it was believed that the MDET would be repealed by Congress through the American Health Care Act of 2017, a bill passed by Congress, or in the recent tax cuts. The MDET is scheduled to be in effect as of January 1, 2020. If Congress is unable to pass a repeal or revise the MDET, a third moratorium would be expected to be introduced into the House of Representatives in early 2019. It is also possible, although unlikely, that the next Congress will vote to repeal the moratorium.

There are two competing stories that arise during the debate on whether or not to repeal the MDET: (1) the medical device industry is correct that the application of MDET does more harm than good to the industry and that reform/repeal ought to be a serious consideration; and (2) the federal government is correct in their prediction that a windfall from the ACA will balance the cost of the tax on the industry. Within each of these scenarios, there is a core issue—who will bear the ultimate economic burden of the tax?

Initially, both sides had limited data to support either claim regarding the impact or the effectiveness of the MDET. Now that eight years have passed since the enactment of the ACA, there are data that both sides could raise in the debate. Proponents can point to a 2014 survey of senior management that shows small- to mid-size companies did not make changes in response to the MDET.[16] There has also been a significant corporate tax reduction that makes the burden of the tax less impactful than it did in 2014. Thus, for the proponents of the MDET, there appears little reason to repeal or revise the law. Advocates for repealing the MDET will point to the hundreds of millions that the MDET has purportedly cost the industry. They will also continue to argue that R&D investment and performance as well as job growth has been directly affected by the MDET. As with all moratoriums, it is the uncertainty that continues to give the industry pause. Advocates have argued that if the MDET were to be repealed, jobs would return, and investment would increase.

There are three likely outcomes of the MDET that could occur in the next two years: (1) enforcing the MDET; (2) maintaining the moratorium on enacting the MDET; or (3) repealing or revising the MDET. At this present time, it is unlikely that the 115th Congress will repeal the MDET. Advocates were unsuccessful introducing the bill before the Senate in August. Congressional recesses between now and the mid-term elections, and the appointment of a new Supreme Court justice, also make it unlikely that the Senate will vote to repeal the MDET by the end of the year. As a result, the MDET may remain an ever-present concern for the medical device industry for the foreseeable future.

References

[1] I.R.S. Notice 2012-77 § 6(b), at 785.

[2] Prop. Treas. Reg. § 48.4191-2(a), 77 Fed. Reg. 6028, 6035 (Feb. 7, 2012).

[3] Medical Device Access and Innovation Protection Act, S. 17, 112th Cong. (as introduced in the Senate, Jan. 25, 2011), available at http:// www.gpo.gov/fdsys/pkg/BILLS-112s17is/pdf/BILLS-112s17is.pdf; Protect Medical Innovation Act of 2011, H.R. 436, 112th Cong. (as introduced in the House, Jan. 25, 2011), available at http://www.gpo.gov/fdsys/pkg/BILLS-112hr436ih/pdf/BILLS-112hr436ih.pdf.

[4] Letter from eighteen U.S. Democratic senators to Harry Reid, Majority Leader, U.S. Senate (Dec. 4, 2012), available at http://online.wsj.com/public/resources/documents/MedDeviceLetter12102012.pdf.

[5] Kensington A. Wolgamott, "No Longer Left to Their Own Devices: Evaluating the Non-Traditional Medical Device Excise Tax," 29 ND J. L. Ethics & Pub Pol'y 497, 519.

[6] Elizabeth M. Bolka, "The Medical Device Excise Tax: An Unfair Burden," 89 Ind. L.J. 1691, 1713 (2014).

[7] https://www.irs.gov/newsroom/medical-device-excise-tax

[8] https://www.wsj.com/articles/house-votes-to-repeal-tax-on-medical-devices-1532467519?mod=hp_listc_pos2

[9] Lee, D., “Impact of the excise tax on firm R&D and performance in the medical device industry: Evidence from the Affordable Care Act,” Research Policy, 47, 854-871 (2018).

[10] Id. at 855.

[11] Id.

[12] http://www.lvb.com/article/20180727/LVB01/180729881/us-house-votes-to-repeal-medical-device-tax

[13] https://www.opensecrets.org/industries/lobbying.php?cycle=2016&ind=H4100

[14] MassDevice Staff, "Medical Device Tax Would Mostly Hit the Biggest Firms," MedCity News (Mar. 24, 2010, 12:22 PM), http:// medcitynews.com/2010/03/medical-device-tax-would-mostly-target-the-biggest-companies/ (“The tax's impact on smaller firms might be more pronounced.”).

[15] https://www.statista.com/statistics/248676/projected-size-of-the-us-medical-device-industry/

[16] Medical Devices News, "Half of Small to Mid-size companies make no changes in first year of medical device excise tax," Wolters Kluwer Health Law Daily, Feb. 13, 2014.

Medtronic Is an Example of Why Diversity Matters

Medtronic Is an Example of Why Diversity Matters

Diversity does matter to medtech (we hope), but a recently published list suggests that some companies are doing a better job than others of making diversity and inclusion more than just a box-ticking exercise. In the medical device and diagnostics industry, Medtronic appears to be way ahead of its pure-play medtech peers on this front.

Medtronic ranked third on Thomson Reuters' 2018 Diversity and Inclusion (D&L) Index, jumping ten spots from number 13, which it held in 2016 and 2017 (the D&I Index is in its third year).

"We know that greater diversity inherently drives better decisions — different perspectives enable us to see challenges and solutions from new angles," said Sophia Khan, senior director of Global Inclusion, Diversity, and Engagement at Medtronic. "It’s not only our employees and business that benefit, a stronger and united Medtronic means we’re continuing to drive innovation and devise powerful solutions that help our partners deliver better patient outcomes and contribute to human welfare."

In the medical device industry, gender diversity has long been an issue. As MD+DI has previously reported, the share of women in executive leadership positions in medtech lags behind other industries.

Last year MD+DI spoke with Luann Pendy, senior vice president of global quality at Medtronic, who shared some interesting insights into the company's diversity programs.

While Medtronic was by far the highest ranking pure-play medtech company on the D&I Index, Swiss pharmaceutical company Novartis, which has dipped its toes into the medical device waters in recent years with Alcon and Google, came in at number two. Other medical device and diagnostic companies that earned a top 100 spot on the index include Roche at number 12, Siemens at number 24, Johnson & Johnson at number 32, GlaxoSmithKline at number 39, Abbott at number 42, 3M at number 68, Bayer at number 80. Also worthy of a mention because of its Watson Health business is IBM at number 35.

The index ratings are informed by Thomson Reuters environmental, social, and governance (ESG) data, designed to transparently and objectively measure the relative performance of more than 7,000 companies and provide investors with differentiated insight. After ranking the top 100 companies as measured by 24 metrics across four key categories (diversity, inclusion, people development, and news controversies), the index is calculated by weighing each metric based on importance in the market and how each company compares with its peers.

Elena Philipova, global head of ESG at Thomson Reuters, Financial & Risk, said the D&I Index highlights public companies that are leading the way in embedding diversity and inclusion into their company strategy.

“The industry is beginning to recognize the societal and business benefits of investing in diverse and inclusive companies and we are working closely with various investment firms who are looking to develop investable products based on our D&I index," Philipova said. "We remain committed to providing industry-leading ESG data to help investors make smarter investment decisions.”

PathMaker Neurosystems Launches European Clinical Trial

Courtesy of PathMaker Neurosystems PathMaker Neurosystems Launches European Clinical Trial

PathMaker Neurosystems, a clinical stage company in the bioelectronic medicine space, is seeking to change the treatment paradigm of patients suffering from spasticity secondary to stroke with the MyoRegulator device.

The company, which has a presence in both Boston and Paris, has initiated the first patient in its European clinical trial for the MyoRegulator. In addition, MyoRegulator is in clinical trials in the U.S.

“We expect to have our first regulatory clearance in less than two years,” Dr. Nader Yaghoubi, president and CEO of PathMaker Neurosystems, told MD+DI. “We’re working to shorten that as much as we really can. Although we haven’t fully disclosed our strategy here, I will say that we will have CE mark clearance before we have FDA clearance.”

The company has received significant support from FDA. In 2017, the agency selected the MyoRegulator as one of the first “breakthrough” medical devices selected for the Expedited Access Pathway (EAP) program.

At the root of the MyoRegulator device is PathMaker Neurosystems’ DoubleStim technology. The company said DoubleStim uses a combination of simultaneous non-invasive spinal and peripheral stimulations. Stimulation from the device is directed to suppression of hyperexcitable spinal cord circuits that are involved in spasticity.

“We really have pioneered a new paradigm of modulating motor circuits …,” Yaghoubi said. “This is entirely novel. This did not exist seven years ago.”

The concept of Bioelectronic Medicine isn’t new by any means. But the concept and the market has been getting a lot of attention lately. A huge spotlight was placed on the space, when GlaxoSmithKline (GSK) and Google's Verily Life Sciences, an Alphabet company, teamed to form Galvani Bioelectronics. The two companies plan to invest about $700 million over seven years into the joint venture.

During the 2017 South by Southwest Conference and Festivals, leaders from the Swiss Federal Institute of Technology Lausanne (EPFL), the Massachusetts Institute of Technology (MIT), the Defense Advanced Research Projects Agency (DARPA), and the Center for Bioelectronic Medicine at the Feinstein Institute for Medical Research at Northwell Health discussed the promise of bioelectronic medicine -bringing much needed attention to the space.

PathMaker Neurosystems was put in the spotlight earlier this year when it received a $5 million grant from the National Institutes of Health to help with the continued development of the MyoRegulator.

And just last month, electroCore, another firm in the bioelectronic medicine market, launched the gammaCore Sapphire, a second-generation device that is non-invasive vagus nerve stimulator for the acute treatment of pain associated with migraine and episodic cluster headache. The handheld device is self-administered by patients and is placed on the neck over the vagus nerve.

Supplier Stories for the Week of September 2

This is a compilation of the latest news from suppliers in the medical device industry.If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Gore Enhances Structural Heart Portfolio with Pipeline Deal

Gore Enhances Structural Heart Portfolio with Pipeline Deal

W. L. Gore & Associates is piping some money into a company that has been stealthily developing an entirely catheter-based repair procedure for patients with mitral valve disease. Flagstaff, AZ-based Gore has acquired Santa Rosa, CA-based Pipeline Medical Technologies for an undisclosed sum.

Pipeline is developing a device designed to replicate the outcomes of a highly effective surgical procedure via a catheter, avoiding the trauma and many of the risks associated with open heart surgery.

"Pipeline's cutting-edge repair procedure, for patients with mitral valve disease, has the potential to expand Gore's growing portfolio of treatments for structural heart disease, and it echoes our commitment to innovation across cardiac therapies," said David Abeyta, leader of Gore's medical products division.

Gore said it intends to keep the acquired company as a wholly owned subsidiary that will retain the Pipeline name and operate independently of Gore.

“We see an array of synergies working with Gore. The company is well recognized for its advanced material capabilities. Its long history of designing solutions for DMR [degenerative mitral regurgitation] treatment challenges already includes the Gore-Tex Suture for Chordae Tendineae used in surgical chordal repairs and we are excited to collaborate on future innovations in transcatheter mitral chordal repair,” said Pipeline founder Steven Bolling, MD, a mitral valve surgeon. “Together we aspire to significantly advance DMR patient outcomes and improve recovery speed.”

Gore recently scored regulatory approvals and clearances in the United States, Europe, and Japan for its Molding and Occlusion Balloon.

Theranos is Reportedly Shutting Down for Good

Pixabay Theranos is Reportedly Shutting Down for Good

Scandal-ridden Theranos is closing up shop, according to a report from the Wall Street Journal.

WSJ published an email from Theranos’ CEO David Taylor to shareholders, that said the company will dissolve after it attempts to pay creditors with its remaining cash. Taylor took the helm of Theranos in June.

To independently verify the report and the email,  MD+DI attempted to contact Theranos, but the company could not be immediately reached for comment.

According to the WSJ report, the company will be liquidated over the next six to 12 months. The firm will give its remaining $5 million in cash to creditors, the WSJ reports. That means those who invested in the company aren’t likely to receive anything.

Theranos, a company that once was valued at $9 billion, had a story that started off like a fairy tale – before it turned into a nightmare and a cautionary tale for device and diagnostic firms.

At one point, the Palo Alto, CA-based company’s former CEO, Elizabeth Holmes was poised to change medtech forever. At 19, Holmes left Stanford University to start a lab-testing company with the goal of providing consumers access to cheap, fast, and high-quality diagnostic tests that used just a drop of blood from a fingerstick. Even Former Vice President Joe Biden called Theranos the "laboratory of the future."

Dressed in all black, Holmes went to tradeshows and speaking engagements spreading Theranos’ message. She wooed physicians, patients, and investors alike with the promise of Theranos’ technology.

Holmes star was so bright in medtech, that she was made MDDI’s list of Medtech Billionaire’s in 2015.

But things began to quickly unravel for the company because of claims from executives that the technology was better than it actually was. The results were catastrophic causing Theranos to lose a high-profile partnership with Walgreens. Things escalated even more as Walgreens sued Theranos for $140 million.

The two reportedly came to an agreement that would have Theranos paying Walgreens less than $30 million.

As for Holmes – well earlier this year she was stripped of her control based on fraud charges. The SEC charged Theranos, Holmes, and its former president Ramesh "Sunny" Balwani with raising more than $700 million from investors through an elaborate, years-long fraud in which they exaggerated or made false statements about the company's technology, business, and financial performance.

 In March, Holmes settled civil charges brought by the Securities and Exchange Commission, agreeing to pay a $500,000 penalty and to refrain from serving as a director or officer of a publicly traded company for 10 years. As part of the settlement, Holmes and Theranos did not admit or deny the allegations.

A poll conducted in March by MD+DI  showed that out of 59 total respondents, 47 people (79.66%) said Holmes got off too easy. About 12% (7 of 59) said the settlement was fair, and 5 people (8.47%) said it was too harsh.

In April, Theranos had laid off most of its staff to fight off bankruptcy. The WSJ reported that the remaining workers – all but support staff and its CEO, Taylor – were let go on Aug. 31.