Boston Scientific Exercises Option to Acquire Transcatheter Annuloplasty Ring Developer Millipede Inc.
Global medical device company Boston Scientific has announced on December 27, 2018, that it exercised its option to acquire remaining shares of privately-held medical device company Millipede, Inc. upon its recent successful completion of a first-in-human clinical study. Boston Scientific previously announced on January 24, 2018, an agreement to make a $90 million investment in Millipede. The current press release states the prior agreement included an option for Boston Scientific to “acquire [Millipede’s] remaining shares for $325M at closing, with a $125M payment becoming available upon achievement of a commercial milestone.”
Millipede has developed a non-invasive solution for repair of the heart’s mitral valve. According to Millipede’s website, Millipede’s IRIS Transcatheter Annuloplasty Ring System reshapes the mitral valve annulus of the heart to treat severe mitral regurgitation (MR). MR is caused by a leaking mitral valve, which causes blood to flow backward from the left ventricle into the left atrium. Over time, MR can lead to or accelerate heart failure and rhythm problems. Millipede’s website describes the IRIS system as providing the gold standard in surgical heart valve repair – a complete annuloplasty ring implant. The implant reshapes and reduces the mitral valve annulus opening, enabling return of leaflet coaptation and reduction of MR.
According to Millipede, the implant is delivered via catheter, for example through a small cut in the patient’s leg. This allows patients to avoid invasive open heart surgery, which is necessary for implantation of conventional annuloplasty rings. Millipede describes the transcatheter ring as repositionable and retrievable.
“We are very satisfied with the early results of our clinical program and are excited to see this technology further leveraged by Boston Scientific to expand the mitral repair solutions for patients around the world.” – Randy Lashinski, CEO, Millipede Inc.
Millipede is based in Santa Rosa, California and was founded in 2012 by majority investor Santé Ventures and Steve Bolling, MD, and has been led by CEO Randy Lashinski since 2014.
Boston Scientific describes itself as a worldwide developer, manufacturer and marketer of medical devices, providing a broad range of high performance solutions that address patient needs and aim to reduce the cost of healthcare.
Millipede is a client of intellectual property and technology law firm Knobbe Martens. With close to 275 lawyers and scientists nationwide, Knobbe Martens dedicates its practice to all aspects of intellectual property law including litigation and is consistently ranked among the top intellectual property firms worldwide.
Boston Scientific Announces Agreement for Investment & Acquisition Option with Transcatheter Annuloplasty Ring Developer Millipede, Inc.
Global medical device company Boston Scientific has announced on January 24, 2018, an agreement to make a $90 million investment in privately-held medical device company Millipede, Inc. Millipede has developed a non-invasive solution for repair of the heart’s mitral valve. According to the press release, the agreement includes an option for Boston Scientific to acquire all remaining shares of Millipede, upon completion of a clinical study, for an additional $325 million in cash, with an extra $125 million in payments upon completing a commercial milestone.
According to Millipede’s website, Millipede’s IRIS Transcatheter Annuloplasty Ring System reshapes the mitral valve annulus of the heart to treat severe mitral regurgitation (MR). MR is caused by a leaking mitral valve, which causes blood to flow backward from the left ventricle into the left atrium. Over time, MR can lead to or accelerate heart failure and rhythm problems. Millipede’s website describes the IRIS system as providing the gold standard in surgical heart valve repair – a complete annuloplasty ring implant. The implant reshapes and reduces the mitral valve annulus opening, enabling return of leaflet coaptation and reduction of MR.
According to Millipede, the implant is delivered via catheter, for example through a small cut in the patient’s leg. This allows patients to avoid invasive open heart surgery, which is necessary for implantation of conventional annuloplasty rings. Millipede describes the transcatheter ring as repositionable and retrievable.
“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” – Joe Cunningham, MD, Chairman of the Board, Millipede, Inc. and Managing Director of Santé Ventures.
Millipede is based in Santa Rosa, California and was founded in 2012 by majority investor Santé Ventures and Steve Bolling, MD, and has been led by CEO Randy Lashinski since 2014.
Boston Scientific describes itself as a worldwide developer, manufacturer and marketer of medical devices, providing a broad range of high performance solutions that address patient needs and aim to reduce the cost of healthcare.
Millipede is a client of intellectual property and technology law firm Knobbe Martens. With over 275 lawyers and scientists nationwide, Knobbe Martens dedicates its practice to all aspects of intellectual property law including litigation and is consistently ranked among the top intellectual property firms worldwide.
InSeal Medical Receives CE Mark for Vascular Closure Device
InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood vessels. The figures below show InSeal’s InClosure VCD, before (left) and after (right) biodegradation.
According to PRNewswire, the need for such a device is, at least partially, driven by the increased prevalence of transcatheter heart valve procedures, which involve the delivery of relatively large medical device through a patient’s blood vessels. While superior in some respects to open-heart surgical alternatives, these transcatheter procedures still require making a large puncture in a blood vessel in order to introduce the medical device. The InClosure device is aimed at addressing these punctures.
InSeal Medical, Ltd. is a subsidiary of E-Pacing, Inc., and is based in Caesarea, Israel.
CardiAQ Wins $70 Million in Trade Secrets Suit
A federal jury found in favor of CardiAQ in a lawsuit filed against former service provider, Neovasc. The jury found that Neovasc breached the non-disclosure agreement between the parties, misappropriated CardiAQ’s trade secrets, and breached its duty of honest performance to CardiAQ. The jury awarded $70 million in damages for trade secret misappropriation.
CardiAQ co-founder J. Brent Ratz said in a press release that the company worked for years to develop and create the CardiAQ transcatheter mitral valve, which provides an alternative to open heart surgery. Ratz stated that:
We are proud of this foundational work and grateful that the jury recognized these contributions to the developing field of transcatheter mitral valve replacement.
According to the press release, CardiAQ hired Neovasc in 2009 to provide services for its transcatheter mitral valve replacement (TMVR) program and Neovasc signed a non-disclosure agreement. While working for CardiAQ, Neovasc started its own TMVR program without notifying CardiAQ. After discovering a Neovasc patent publication in late 2011, CardiAQ initiated this litigation in 2014 regarding Neovasc’s transcatheter mitral valve technology, including the Tiara.
According to the press release, the jury also issued advisory findings that Neovasc engaged in unfair or deceptive practices and that CardiAQ’s founders, Ratz and Dr. Arshad Quadri, contributed to the conception of Neovasc’s U.S. Patent No. 8,579,964. The judge is expected to rule later on causes of action under Massachusetts Gen. Law Ch. 93A and patent inventorship.
Edwards Lifesciences Corporation, based in Irvine, Calif., acquired CardiAQ in 2015.
CardiAQ was represented in the litigation by Knobbe Martens LLP, including lead partners John B. Sganga, Jr. and Christy G. Lea.
Edwards Completes Acquisition of CardiAQ
According to PRNewswire, Edwards Lifesciences Corporation recently completed its acquisition of CardiAQ Valve Technologies, Inc, a developer of transcatheter mitral valve replacement systems, which follows from Edwards’ acquisition agreement announced last month. The article reports that Edwards paid $350 million cash for CardiAQ at closing, with an additional $50 million to be paid upon reaching a European regulatory milestone.
Michael Mussallem, Edwards’ Chairman and CEO, stated:
We look forward to the CardiAQ team joining Edwards. We believe the combined knowledge and efforts of the talented CardiAQ and [Edwards’ own] FORTIS transcatheter mitral valve system teams will help us advance a therapy that offers a meaningful solution for patients.
Marketwatch reports that none of CardiAQ’s valve systems are presently approved for sale in any country. However, according to PRNewswire CardiAQ has received U.S. FDA Investigation Device Exemption approval to conduct an early feasibility study of up to 20 patients, and also plans to initiate a CE Mark study in Europe.
Medtronic to Acquire Transcatheter Mitral Valve Startup
Medtronic recently agreed to pay up to $458 million for California-based Twelve, Inc., a privately-held developer of transcatheter mitral valve replacement devices. The terms of the deal include $408 million at closing and $50 million on achievement of CE Marking. The deal is expected to close in October 2015.
Medtronic now joins fellow multi-billion dollar med-tech giants, Edwards Lifesciences and Abbott Laboratories, in the race to stake a claim in the transcatheter mitral valve device space. In July, Edwards paid $400 million for CardiAQ Valve Technologies, a transaction that just recently closed, and Abbott acquired Tendyne Holdings, Inc. for $250 million.
Medtronic presently offers two transcatheter heart valves: “CoreValve Evolut R” for aortic valve replacement and “Melody” for pulmonary valve replacement. Sean Salmon, SVP and President of Medtronic’s Coronary & Structural Heart division stated:
Upon close, this acquisition will strategically augment our existing capabilities in the transcatheter mitral space, which represents an important growth opportunity for Medtronic.
Medtronic’s Coronary & Structural Heart division accounted for nearly $3 billion of the company’s $17 billion FY2014 revenue. The planned acquisition of Twelve suggests that Medtronic seeks to aggressively increase its market-share.
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