Showing all posts written by Mitch Hadley
Prior to joining the firm, Mr. Hadley attended law school at the Brigham Young University, J. Reuben Clark Law School where he graduated magna cum laude and was elected to the Order of the Coif. During law school he served as Lead Note and Comment Editor of the BYU law Review. In 2010, he graduated from Brigham Young University with a B.S. in Mechanical Engineering.
Mr. Hadley joined the firm in 2014 after working as summer associate in the firm's San Diego office during the summer of 2013. Click here to read full bio
Boston Scientific Corporation recently announced an agreement to purchase Swiss medical device maker Symetis SA for $435 million in up-front cash. The acquisition is expected to close in the second quarter of 2017.
Symetis describes itself as the leading European developer of innovative, minimally invasive heart valve replacement devices. Its transcatheter aortic valve implantation (TAVI) products, ACURATE TA™ and ACURATE neo™, and their delivery systems, are currently marketed and sold in Europe.
The agreement to acquire Symetis follows Boston Scientific’s acquisition of certain Neovasc, Inc. manufacturing assets, which closed in December 2016. Regarding its acquisition of Symetis, Ian Meredith, M.D., executive vice president and global chief medical officer of Boston Scientific says:
The steps we are taking reflect our commitment to being a leader in TAVI and structural heart technologies now and over the long-term, as we broaden our portfolio and pipeline to address the needs of our global health care providers and their patients. The ACURATE family of valve products is strongly complementary to our cornerstone Lotus™ valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings for varying patient pathologies and anatomy.
The acquisition also follows Boston Scientific’s recent voluntary recall of its Lotus heart valve devices in February 2017. As reported by Reuters, Needham & Co analyst Mike Matson said in a client note that “[t]his [acquisition] is an offensive rather than a defensive move and not simply a ‘stop-gap’ to address the Lotus recall, shortcomings with Lotus, or IP issues.”
According to the press release, Ivy Sports Medicine’s portfolio includes: the only FDA-approved collagen meniscus implant on the market; an all-inside repair device; and an inside-out meniscal suturing platform.
Ivy Sports Medicine describes its Collagen Mensicus Implant (CMI) as a completely absorbable implant made from a porous structure that serves as a guide for the body’s own cells in order to make use of the body’s own healing ability.
Regarding the acquisition, Matt Moreau, Vice President and General Manager of Stryker’s Sports Medicine business, said:
The acquisition of Ivy Sports Medicine strengthens our capabilities and fits strategically with our current portfolio. Ivy’s complete meniscal platform, coupled with their clinical history, will allow us to provide our customers with multiple solutions to address meniscal repair. This is an area of sports medicine where there is continued opportunity to address unmet customer needs. The Ivy portfolio provides a unique platform for us to build upon as we seek to continue advancing the treatment of meniscal injuries.
Ivy Sports Medicine is only one of Stryker’s several acquisitions during 2016. Some of Stryker’s others notable acquisitions include Sage Products, Physio-Control, Synergetics, SafeWire, and Stanmore Implants.
NuVasive, Inc., has announced it has agreed to acquire Biotronic NeuroNetwork for $98 million cash. According to the press release, the acquisition more than doubles NuVasive’s footprint in the neurophysiology business across the U.S., and extends NuVasive’s efforts to expand its spine service line partnerships in the industry.
Biotronic provides intraoperative neurophysiological monitoring services to surgeons and healthcare facilities nationwide. According to the press release, Biotronic supports more than 45,000 surgeries annually in over 650 hospitals nationwide by providing certified specialists to monitor patients’ nervous systems during surgery. Biotronic reported over $50 million in revenue in 2015. NuVasive also provides intraoperative neurophysiological monitoring services to surgeons and healthcare facilities through its subsidiary, Impulse Monitoring, Inc. With the acquisition, NuVasive plans to combine the service offerings of Biotronic with Impulse Monitoring to create NuVasive Clinical Services. NuVasive Clinical Services is expected to support more than 75,000 cases annually in the United States, and will be headed by Doug Karczewski, who has led NuVasive’s Eastern U.S. Commercial organization for the last three years.
This news follows NuVasive’s recent acquisition of Ellipse Technologies, Inc., in January of this year for $380 million cash, with a possible $30 million milestone payment in 2017. Ellipse developed and marketed a novel platform of adjustable spinal implant systems based on its MAGnetic External Control, or MAGEC®, technology. The MAGEC® technology allows physicians to customize therapy for patients in a noninvasive manner, using a remote controller to lengthen or shorten an implanted spinal rod.
According to its website, NuVasive is the third largest medical device company in the global spine industry and features more than 90 products spanning lumbar, thoracic, and cervical applications, neuromonitoring services, and a biologics portfolio.
Medtronic PLC recently announced its acquisition of Aptus Endosystems, further adding to its portfolio of medical device products. The acquisition was reported to be valued at approximately $110 million.
According to its website, Aptus Endosystems produces advanced technology for endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Its products are said to secure artificial patches inside weakened aortic arteries, helping to improve a condition known as abdominal aortic aneurysm. These systems are said to be designed for patients whose anatomies may not be ideal for traditional surgical treatment for aneurysms.
Aptus’s website states that its Heli-FX and Heli-FX Thoracic EndoAnchor systems minimize the need for complicated procedures by attaching a variety of aortic endografts to the native vessel wall. The website states that these systems are used to anchor the liner and prevent leakage, and are especially helpful for patients with existing problems with an endograft seal or who are considered high risk candidates for a revision procedure if the initial seal fails.
According to the Aptus website, both systems are approved for distribution in the European Union and are cleared by the FDA for distribution in the U.S. They are said to be compatible with both Medtronic’s Endurant and Valiant graft systems, as well as other commercially available stent grafts.
According to news sources, Medtronic has also acquired several other companies this year including CardioInsight (for $93 million); Dutch diabetes clinic Diabeter; Sophono; and Advanced Uro-Solutions.
St. Jude Medical recently announced that it has completed the acquisition of Spinal Modulation, Inc. In June of 2013, St. Jude invested $40 million in Spinal Modulation for which it received an exclusive option (now exercised) to purchase the company for a maximum of $300 million, plus milestone payments. According to St. Jude Medical’s earlier press release, St. Jude Medical agreed to pay Spinal Modulation $175 million upon closing with milestone payments due upon FDA approval of Spinal Modulation’s Axium Neurostimulator System.
St. Jude Medical describes the Axium system (shown to the right) as a form of spinal cord stimulation (SCS) that targets a neural structure within the spine called the dorsal root ganglion (DRG). The DRG contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain. The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain.
According to St. Jude,
[w]ith the closing of the acquisition, St. Jude Medical has become the only medical device manufacturer in the world to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.
Spinal Modulation, Inc., headquartered in Menlo Park, California, focuses on providing treatment options for patients suffering severe chronic pain.
In a press release issued March 18, 2015, Heraeus Medical Components, a global business unit of Heraeus Holding GmbH, announced that it will acquire NeoMetrics, Inc. According to the press release, Heraeus Medical Components has executed a share purchase agreement to acquire 100% of the stock in the privately owned NeoMetrics. The transaction is expected to occur within the next 60 days. Further details of the deal were not disclosed.
Regarding the acquisition, Dr. Nicolas Guggenheim, President of Heraeus Medical Components, said:
With this acquisition, Heraeus Medical Components will add new interventional technologies to augment their leadership position as a sourcing solution for the world’s medical device companies. We are excited about the potential growth opportunities within the interventional field.
According to its website, Heraeus Medical Components “provides expert, comprehensive medical component manufacturing services, meeting a broad range of functional demands” and provides a range of medical device products.
NeoMetrics’ website indicates that it is headquartered in Plymouth, Minnesota, was founded in 2001, and operates exclusively as an OEM partner of medical device companies. Its website touts expertise in a wide variety of medical device guidewires. The USPTO Assignment Database lists two patents, among several applications, assigned to Neometrics:
- U.S. Patent No. 8,801,633, entitled “High-Modulus Superelastic Alloy Wire for Medical and Dental Purposes”
- U.S. Patent No. 8,308,658, entitled “Medical Guidewire”
Medtronic PLC recently announced its acquisition of Advanced Uro-Solutions, a Tennessee-based privately-held developer of neurostimulation products for treatment of bladder control issues. According to the Star Tribune, the terms of the acquisition, which closed in December 2014, were not disclosed.
Medtronic describes itself as a leader in the field of neuromodulation, the targeted and regulated delivery of electrical impulses and pharmaceuticals to specific sites in the nervous system. Medtronic states that its current portfolio includes implantable neurostimulation and targeted drug delivery systems for management of chronic pain, common movement disorders, spasticity, and urologic and gastrointestinal disorders.
Advanced Uro-Solutions manufactures a percutaneous tibial nerve stimulation system called the NURO™. The NURO is promoted for use in therapy that involves a small external stimulator and a single, reusable lead. It is described as providing temporary stimulation to the tibial nerve and treatment to patients with overactive bladder (OAB) and other urinary irregularities. According to the FDA’s 510(k) Premarket Notification Database, the NURO device was cleared by the FDA for the treatment of OAB as being substantially equivalent to a predicate device, the Urgent PC Stimulator (manufactured by Uroplasty, Inc.).
The USPTO Assignment database includes records for three patents and patent applications that have been assigned to Advanced Uro-Solutions LLC, including: U.S. Pat. Pub. No. 2014/0288613, U.S. Pat. No. 8,818,520, and U.S. Pat. No. 8,660,646. Each of these is entitled “Percutaneous Tibial Nerve Stimulator.” FIG. 2 of the ‘646 patent is shown to the left.
Medtronic states that it plans to implement the NURO system in the U.S. within the next 12 months, adding to its portfolio of urinary and bowel control therapies. Medtronic’s acquisition of Advanced Uro-Solutions follows shortly after its recent $49 Billion acquisition of Covidien.
(January 26, 2015) Medtronic announced today that it has finally completed its previously announced acquisition of Covidien. According to the press release provided by Medtronic, the “cash-and-stock transaction is valued at approximately $49.9 billion.”
Regarding the acquisition, Omar Ishrak, chairman and CEO of Medtronic said:
“The culmination of this acquisition marks a significant milestone in our industry, creating a company uniquely positioned to alleviate pain, restore health and extend life for more patients around the world. We can now bring together the extensive and innovative capabilities of both Medtronic and Covidien with an underlying objective to solve healthcare’s biggest challenge – expanding access and improving clinical outcomes, while lowering costs.”
A new page on Medtronic’s website welcomes Covidien to the “new Medtronic” and outlines their future together. It notes, “[t]ogether, Medtronic and Covidien are working to improve healthcare by addressing the needs of more people, in more ways and in more places around the world.”
The previously announced acquisition had been on hold pending approval of the deal by the Irish Supreme Court, which issued earlier. The deal had previously been approved by both the Federal Trade Commission in the United States and the European Union’s European Commission.
According to the Boston Globe, the acquisition is among the largest in the medical device sector.
Bonutti Skeletal Innovations, LLC brought a patent infringement suit against Globus Medical, Inc. in the Eastern District of Pennsylvania on November 19, 2014. The lawsuit alleges that several of Globus Medical’s spinal spacer products and related instruments infringe Bonutti Skeletal patents.
The asserted Bonutti Skeletal patents include U.S. Patent No. 6,099,531, entitled “Changing Relationships Between Bones,” which issued on August 8, 2000. The patent discusses the use of a wedge member in a joint to alter the relative positioning of a patient’s bones.
Specifically, Bonutti Skeletal alleges that Globus Medical’s CALIBER, CALIBER-L, COALITION, COLONIAL, CONTINENTAL, FORGE, FORTIFY, FORTIFY I PEEK, FORTIFY I-R, INDEPENDENCE, INTERCONTINENTAL, MONUMENT, NIKO, RISE, SIGNATURE, SUSTAIN ARCH, SUSTAIN LARGE, SUSTAIN MEDIUM, SUSTAIN-O, SUSTAIN SMALL, and TRANSCONTINENTAL spinal spacer products each infringe various Bonutti Skeletal patents.
According to the Complaint, Bonutti Skeletal has been built on the work of Dr. Peter M. Bonutti, an orthopedic surgeon that has performed over 20,000 orthopedic surgical procedures and been the inventor or co-inventor on over 150 U.S. patents.
Globus Medical’s website states that “Globus Medical, Inc. is a leading musculoskeletal implant manufacturer and is driving significant technological advancements across a complete suite of spinal products.”
The complaint and asserted patents are available here.