Prime Core

Posted by Ken Dropiewski

Boston Scientific Announces Investment and Acquisition Option Agreement with Millipede, Inc.

MARLBOROUGH, Mass., Jan. 24, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has closed an investment and entered into an acquisition option agreement with Millipede, Inc., a privately-held company that has developed the IRIS Transcatheter Annuloplasty Ring System for the treatment of severe mitral regurgitation (MR). Under the terms of the agreements, Boston Scientific has purchased a portion of the outstanding shares of Millipede along with newly issued shares of the company for a total consideration of $90M. Boston Scientific has the option to acquire the remaining shares of the company at any time prior to the completion of a first in human clinical study that meets certain parameters. Upon the completion of the clinical study, Millipede has the option to compel Boston Scientific to acquire the remaining shares of the company. Each company’s option period expires by the end of 2019. Completion of this acquisition would result in an additional $325M payment by Boston Scientific at closing with a further $125M becoming payable upon achievement of a commercial milestone.

MR is caused by a leaking mitral valve, which then causes blood to regurgitate from the left ventricle to the left atrium of the heart. Over time, the condition can lead to or accelerate heart failure and heart rhythm problems. Many patients with severe MR have compromised heart function and are not able to tolerate open-heart surgery to repair or replace the leaking valve. This large and currently underserved patient population could benefit from a fully-percutaneous transcatheter procedure that can repair the dilated mitral annulus and reduce regurgitation without undergoing surgery.

“Intervening with the least invasive approach at earlier stages of severe mitral regurgitation has the greatest opportunity to alter the natural history of the disease and the progression to heart failure,” said Professor Ian Meredith, AM, Executive Vice President and Global Chief Medical Officer, Boston Scientific. “We believe that restoring mitral annular dimensions via a transcatheter mitral annuloplasty ring will be a crucial component to effective, minimally invasive improvement of mitral valve function for appropriately-indicated patients.”

The Millipede IRIS annuloplasty ring, delivered via a transcatheter-transseptal delivery system, follows the standard surgical approach to repair and reduce the size of a dilated mitral annulus. The IRIS device is a complete ring designed to be used as a stand-alone device, or in combination with other technologies in patients with severe MR. The device is designed to be highly customizable to a specific patient’s anatomy and disease state, and is repositionable and retrievable to promote a high-quality outcome.

“We saw an opportunity to bring the gold-standard surgical approach to repairing the mitral valve to an underserved population of severe MR patients with transcatheter techniques, and are excited Boston Scientific also sees the unique abilities of the IRIS transcatheter ring,” said Joe Cunningham, MD, Chairman of the Board, Millipede, Inc. and Managing Director of Santé Ventures.

Millipede is based in Santa Rosa, California. It was founded in 2012 by majority investor Santé Ventures and Steve Bolling, MD, and has been led by CEO and Co-founder Randy Lashinski since 2014.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans, expectations with respect to the Millipede transaction and technology, and product performance and impact.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACTS:
Trish Backes
Media Relations
(651) 582-5887 (office)
Trish.Backes@bsci.com

Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
investor_relations@bsci.com

 

SOURCE Boston Scientific Corporation

Posted by Ken Dropiewski

Non-Culprit Lesions Cause 2x More Subsequent MIs than PCI’d Lesions

A new study published in the Journal of the American Heart Association shows that AMIs following a percutaneous coronary intervention (PCI) is twice as likely to originate from untreated lesions versus previous stented lesions. Interesting since this information seems to differ from previous studies such as PROSPECT which show a near equal risk between culprit and non-culprit lesions.

The Study

This large retrospective study looks at 108,615 patients suffering an initial heart attack between 2006 and 2014. In over 10 percent of those patients, a second heart attack occurred within 4 years. In a majority of patients, the second AMI was found to be attributable to a lesion previously identified as non-culprit.

Previous studies like PROSPECT included a composite of symptoms including death from cardiac causes, cardiac arrest, MI, rehospitalization for unstable or progressive angina, revascularization and stent thrombosis while this study focused specifically on MI.

The Key Takeaways and Questions

We need a better understanding of how long‐term disease progression affects future MIs and whether reinfarction occurs in previously stented lesions or in new or progressive lesions as a result of decisions about medical treatment after the first myocardial infarction. Should patients with multivessel disease have a different follow-up than those with single vessel disease?

It seems that improved stenting techniques, better stents, and improved antithrombotic treatment for intermediate phase do have an impact on adverse outcomes. Is it possible that the impact is less when considering overall disease progress than focusing on the risk of non-culprit lesions related to future adverse outcomes?

Our strategy focuses on enabling our clients to identify, attract and retain the right people for the structure in which they will perform. Please contact us to learn more about our expertise in Executive Search for Leadership positions in Medical Device and Biotechnology. We look forward to the opportunity to help you consistently improve your performance and your business!

Posted by Ken Dropiewski

Secant Group Develops the First Synthetic Regenerative Cardiovascular Graft

TELFORD, Pa.–(BUSINESS WIRE)–Secant Group, in partnership with its sister company SanaVita Medical, announce game changing technology to advance cardiovascular regenerative medicine with the development of a synthetic, small bore, vessel that encourages endogenous regeneration and new vessel formation. The technology is based on the company’s sophisticated textile forming capabilities that can produce a hollow lumen construct that is infused with Secant’s proprietary Regenerez® bioresorbable polymer technology. The new small bore vessel supports the regeneration of new vascular tissue structures without the need for cell seeding or biologic growth promoters.

In situ vascular regeneration, along with the elastomeric and immunomodulatory properties of the synthetic vessel, could solve the problems of vascular harvesting and the non-resorbable synthetic graft compliance mismatching seen with the current technology available for surgeons today. These regenerative grafts will offer unprecedented benefits for coronary artery bypass surgery, peripheral vascular disease, and renal disease treatments.

Secant has produced small bore grafts with lumen diameters down to 500 μm, closely matching the range of human vessels. Jeff Robertson, President of Secant Group, explains, “By combining our textile manufacturing and biomaterials capability, this small bore graft would provide similar compliance as native vasculature, enabling a seamless connection between graft and vessel. A Regenerez based graft would stimulate regenerative vessel healing and cell growth, eventually degrading to leave only the native tissue behind, creating a new vessel.”

Devices that currently dominate the cardiovascular graft replacement market have numerous limitations including compliance mismatch, low patency rates, calcification, a risk of infection and lack of tissue regeneration capability. The Secant small bore graft addresses many of these limitations. Early pre-clinical studies have confirmed that Regenerez grafts are non-thrombogenic, did not show occlusion and provide excellent suturability. Secant is continuing the development of small bore grafts in collaboration with a leading heart and vascular research university. Secant Group is currently looking for medical device partners to progress this exciting new technology through clinical trials and commercialization.

About Secant Group, LLC:

Secant Group engineers medical textiles and biomedical structures that enable repair, recovery, and regeneration of the human body. Using advanced polymers, metals and composites, Secant Group partners with OEMs to design, develop, and manufacture implantable structures for medical devices that improve quality of life for patients.

About SanaVita:

SanaVita Medical® is a fully integrated contract manufacturer for medical devices. With expertise in advanced biomaterials and textile engineering, SanaVita can solve complex technical challenges and provide unique solutions that improve patient outcomes. In partnership with Secant Group, SanaVita is exclusively positioned to bridge the gap between device design and manufacturing throughout the device development process.

Contacts

Secant Group
Diane Reitter – Director, Marketing
215-257-8680 (X130)
diane.reitter@secant.com

Posted by Ken Dropiewski

4 Key Behaviors of 2018’s Most Effective Leaders

“A true leader has confidence to stand alone, courage to make the tough decisions with the compassion to listen to the needs of others. He doesn’t set out to be a leader, but becomes one though the equality of his actions and the integrity of his intent.” – Douglas MacArthur

Whether you are leading the military, a start-up, or a top achieving sales team, succeeding as a leader in 2018 will require you to get clear on your goals and identify what really matters to your company. Identifying key leadership behaviors will help define your role for the upcoming year. Research shows that certain leadership indicators account for 89 percent of the effectiveness in modern enterprise.

Employs Measured Decision Making

Impulsive decision making can be a hindrance to problem solving. This year, resolve to gather all the facts before finalizing any decision. Avoid the pitfalls associated with reactive decision making, by taking time to identify and carefully consider the most reasonable options. By utilizing a step-by-step approach, you can make more deliberate and thoughtful decisions. First, organize relevant information. Next, define any alternatives. Finally, choose the most satisfying option.

Communicates Their Vision

This is essential to creating a results-oriented culture. This may prove difficult, though, if you struggle with translating the same message across different organizational outfits or teams. Communication expert Ben Decker recommends these tips:

  • Consider the needs of your audience
  • Target your message to ensure its relevance
  • Identify measurable goals, in common, for each group
  • Show each group the benefits of your vision

Strives to Be an Active Listener

This is one of the most powerful tools in your leadership arsenal. Active listening skills is the most effective way to show support, gain new perspective, and solve challenges. Specifically, leaders can exhibit superb listening skills through the following activities:

  • Verbally acknowledge the needs and requests of all stakeholders
  • Focus on the conversation at hand instead of multi-tasking
  • Resist the temptation to interrupt
  • Give the speaker 100 percent of your attention
  • Repeat or paraphrase back to the other party to ensure you are on the same page.

Creates a Supportive Environment by Embracing Diversity

Organizations run by diverse teams deliver results. Research by McKinsey proves that diverse companies were more likely to outperform companies without such policies. These companies were more likely to produce innovative new products and develop new business than were more homogenous teams. Here are a few goals for creating diversity:

  • Use unbiased recruitment and selection methods
  • Empower staff to use their strengths, individually
  • Implement diversity training for sensitivity and assimilation

The success and reputation of an organization hinges upon strong leadership. As MacArthur so beautifully expressed, leadership is a multifaceted role that relies on strong performance to achieve industry excellence.

Our strategy focuses on enabling our clients to identify, attract and retain the right people for the structure in which they will perform. Please contact us to learn more about our expertise in Executive Search for Leadership positions in Medical Device and Biotechnology. We look forward to the opportunity to help you consistently improve your performance and your business!

Follow me on Twitter @PrimeCoreSearch.

Posted by Ken Dropiewski

Investors Irate as J.P. Morgan Bars Press From Biggest Biotech Conference of the Year

The J.P. Morgan Healthcare Conference is held every year in early January, and this year it will be Jan. 8-11 in San Francisco, as usual. What isn’t quite as usual, and has some journalists and investors concerned, is a change in policy that limits media coverage.

The meeting is a major event in the industry, and partly because of the media coverage, many of the biggest deals are announced there. An example is two years ago when Shire announced it was buying Baxalta for $32 billion.

But the organizers of the conference this year have said that the media will be barred from the Q&A breakout sessions, which is being interpreted by many in the media and some in the industry as favoring large, institutional investors over smaller ones.

J.P. Morgan told journalists who were covering the event that “press is NOT permitted in the small breakouts that immediately follow the presentations, nor on the (one-on-one) floors.”

When asked why, the organizers claimed it had to do with the small space. Long-time media who have covered the event noted that this has never been an issue going back over a decade.

The Boston Business Journal wrote, “In recent years, there’s been a movement toward making that conference more accessible to small, private investors who want a shot at the potential profits available from the lucrative sector. Those efforts have succeeded in getting more companies to webcast their presentations as well as the subsequent question-and-answer ‘breakout’ sessions—place where the important information is often revealed that could affect investors’ decisions whether to buy or sell shares of specific biotech companies.”

At least one company executive, Alnylam Pharmaceuticals‘ chief executive officer John Maraganore, pushed back a tiny bit on Twitter, writing “unfortunate that media (was) excluded in breakouts at #jpm2018” and noted that the company planned to continue its live webcasts of the event.

But not all companies do. Brad Loncar, a private biotech investor in Kansas City, Kansas, has been pushing for years to get all companies to webcast their Q&A breakout sessions. The Boston Business Journal asked him about this latest policy, and he said, “Making these rooms exclusive to only certain investors implies there is pay-for-play going on. Wealthy and connected investors are getting better info than everyone else, and that shouldn’t be. By barring journalists from attending, it is another avenue through which those who can’t attend will never hear what has been said there.”

The Boston Business Journal wrote, “Naturally, J.P. Morgan has a vested interest in giving its biggest, most loyal investors extra perks (like exclusive stock information), and some speculate that’s what this is really about. But the end result, that large, institutional investors are getting better information on companies than anyone else, to the detriment of small ones, doesn’t sit well with many.”

It’s worthwhile to note that the sourcing for this article is from Boston. In the U.S., the two biggest hubs for biopharma are Boston and San Francisco, and by holding the meeting in San Francisco, does give at least a feeling of precedent to the West Coast’s interests. Although to be fair, most investors, executives and reporters would prefer the meeting be located in California as opposed to Massachusetts if it’s going to be held in early January. J.P. Morgan’s headquarters is in New York City.

The conference brings in more than 400 companies and 8,000 attendees. All J.P. Morgan conferences are by invitation only.

Company Profile

"Prime-Core, Inc is an Executive Search Firm that is passionate about helping med tech companies meet their Human Capital needs in order to foster a team dedicated to success. We believe there is a story behind every successful hire. One that stands the tests of time and truly transforms a good company to great company."

Recent Posts

Tags

advancement Approval biomedicine biotech biotechnology boitech California cancer cardiovascular disease Communication Costs cover letter Employment Empowerment Executive Search FDA generation gap generations goal setting healthcare Hiring HR interviewing jobs labor markets leadership management management skills Medical Companies Medical Device Medical Devices medical spending Motivation networking planning productivity recruiting Recuiting research resume social media talent team work force workplace