Showing all posts written by Jessica Achtsam
She practices intellectual property law with an emphasis on U.S. and foreign patent prosecution and patent portfolio management in the medical device and biotechnology fields. Ms. Achtsam currently represents clients in a variety of technologies, including wound care devices and methods, ophthalmic devices and methods, and other medical device related technologies.
Before attending law school, Ms. Achtsam worked in research and development for Rules-Based Medicine, Inc. (now Myriad RBM, Inc.) in the area of biomarker testing development. During law school, Ms. Achtsam served as the Volume 20 Editor-in-Chief of the Texas Intellectual Property Law Journal.
On March 30, 2017, Boston Scientific announced an agreement to acquire Symetis SA, a privately-held Swiss company focused on minimally-invasive transcatheter aortic valve implantation (TAVI) devices, for $435 million in cash.
The acquisition expands Boston Scientific’s structural heart portfolio and Symetis will join the Boston Scientific Interventional Cardiology division. According to the press release, Boston Scientific will begin selling the ACURATE TA™ and ACURATE neo™/TF™ valve systems in Europe and in other geographies outside of the United States.
ACURATE valves are marketed as replacement valves delivered via a transcatheter percutaneous delivery system. As noted in the press release, the ACURATE valves along with Boston Scientific’s LOTUS Valve System platform “are designed to treat patients suffering from severe and symptomatic aortic valve stenosis, who are considered at high risk for surgical valve replacement.” As stated on the Symetis website with reference to the ACURATE TA™ valve system
“[t]he most distinctive aspects of the bioprosthesis design are the self-seating and self-sealing features that allow for optimal positioning of the valve, promote sealing, and reduce paravalvular leak. Combined with the two-step deployment technique of the delivery system, these properties provide outstanding ease-of-use throughout the procedure.”
The ACURATE neo™/TF™ valve system is described as including the same self-seating and self-sealing features and stepped deployment technique.
The executive vice president and global chief medical officer of Boston Scientific, Ian Meredith, M.D., stated:
“Adding the ACURATE family of valve products to our structural heart portfolio presents us with the opportunity to provide two distinctly different but complementary TAVI platforms enabling implanting physicians and hospitals to treat the broadest range of patients and aortic valve anatomies.”
On March 31, 2015, Orthofix International N.V. announced it entered into an 18-month option agreement to acquire eNeura, Inc. Orthofix’s website states that the focus of the company is on “improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide.” In May 2014, eNeura received FDA 501(k) clearance for a portable, non-invasive Transcranial Magnetic Stimulation (TMS) device for the treatment of migraine headache. According to the press release, eNeura’s “SpringTMS™ is the first medical device available to patients in the United States for the acute treatment of pain associated with migraine headache with aura.” The eNeura website states that “The SpringTMS™ is the only non-drug therapy clinically proven to effectively stop or reduce migraine at the first sign of pain.”
According to the press release, “Spring TMS™ is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine.” The press release states that to treat the pain of a migraine headache, the Spring TMS™ device is placed on the back of the head and generates a focused magnetic pulse.
The press release notes that Orthofix agreed to pay eNeura $15 million to assist in commercialization of Spring TMS in the US and Europe, and Orthofix has the option to pay $65 million to complete the purchase.
Brad Mason, President and CEO of Orthofix stated:
“This agreement underscores Orthofix’s commitment to pursue new growth opportunities in its BioStim strategic business unit that leverage our core competencies in pulsed electromagnetic field (“PEMF”) product design and manufacturing as well as our third party billing expertise.”
According to a Boston Scientific Corp. press release from May 15, 2014, the company has entered into a definitive agreement to acquire the Interventional Division of Bayer AG for $415 million. The transaction is expected to close in the second half of 2014. The press release notes that “[i]n 2013, Bayer Interventional generated sales of approximately $120 million.”
Included in the transaction are Bayer Interventional technologies designed to treat coronary and peripheral vascular disease. These technologies include “the AngioJet® Thrombectomy System and the Fetch® 2 Aspiration Catheter, which use endovascular techniques to remove blood clots from blocked arteries and veins, and the JetStream® Atherectomy System, a minimally invasive device used to remove plaque from diseased peripheral arteries.”
According to the press release, “[t]he acquisition is expected to improve Boston Scientific’s access to a number of attractive segments in the peripheral space, including the growing atherectomy and thrombectomy categories.”
Jeff Mirviss, president, Peripheral Interventions, Boston Scientific describes the effects of the transaction saying:
The addition of Bayer Interventional will expand our commercial footprint and enhance our ability to provide physicians and healthcare systems with a complete portfolio of solutions to treat challenging vascular conditions, . . . We believe this acquisition will accelerate the growth of our Peripheral Interventions business and strengthen our position as a global leader in peripheral therapies.
On March 14, 2014, according to a press release, Smith & Nephew plc announced the early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, for the proposed merger of ArthroCare Corp. with Smith & Nephew plc. According to the press release and as reported in the Austin Business Journal, the early termination of the waiting period satisfies one of the conditions for closing of the proposed acquisition of ArthroCare by Smith & Nephew.
The Austin Business Journal states that Austin, Texas-based ArthroCare, is “Austin’s largest medical device business and reported $377.9 million in revenue for 2013. The company employs 270 workers in Austin and a total workforce of 1,800, according to the 2014 Austin Business Journal Book of Lists.”
According to ArthroCare’s website:
ArthroCare is a highly innovative, multi-business medical device company that develops, manufactures and markets products based on our internationally patented Coblation technology. This platform technology precisely dissolves target tissue and minimizes damage to surrounding, healthy tissue…. Our devices have been used in millions of cases worldwide across several medical specialties including arthroscopy; spine and neurology; ear, nose and throat; cosmetic; urology; gynecology; and laparoscopy/general surgery.
According to the Austin Business Journal, this “termination paves the way for Austin-based ArthroCare to complete the deal that was announced on Feb. 3 after ArthroCare reached an agreement to be acquired by Smith & Nephew for $1.7 billion, at a price of $48.25 per share.” The press release states that “[t]he transaction remains subject to certain other closing conditions, including approval by ArthroCare stockholders and UK and German regulatory approvals.” In response to the agreement, as reported by the Austin Business Journal on February 11, 2014, an ArthroCare investor has filed a lawsuit in effort to halt the proposed acquisition by Smith & Nephew alleging that “the price agreed upon by ArthroCare’s board of directors was too low and undervalues the company.”
On January 27, 2014, according to a press release, LifeCell Corporation acquired adipose Tissue Injector (aTI) technology for improved fat grafting procedures from the TauTona Group, a medical device incubator based in Menlo Park, California. The press release notes that LifeCell is a sister company of Kinetic Concepts, Inc. (KCI)
The press release also states that aTI is a single-use tool utilized in fat grafting procedures. aTI allows for the controlled delivery of fat, by allowing management of the pressure and flow rates during injection. According to the press release, the controlled rate can minimize damage of the injected fat and reduce the complexity of performing injections.
Furthermore, the press release notes that LifeCell’s fat grafting device, REVOLVE™ Fat Processing System, can “facilitate more efficient processing, filtering, and transferring of a patient’s own fat tissue. It enables high-volume fat processing (up to 800ml lipoaspirate) in less than 15 minutes, offering the potential to reduce operating room procedure time.” According to the press release, the Senior Vice President of LifeCell, Philip Croxford, states that LifeCell believes “the [aTI], in addition to LifeCell’s existing REVOLVE™ Fat Processing System, will offer clinicians valuable solutions from fat grafting processing through reinjection.”
President and CEO of KCI, Joe Woody, describes the effects of the purchase saying:
“With this acquisition, we will leverage the LifeCell sales channel in the reconstructive and plastic surgery fields to commercialize this exciting new technology, . . . We continue to be focused on innovation and acquisitions of technologies and platforms that both complement and further diversify our combined product portfolio.”
According to a Medtronic press release, Medtronic is acquiring TYRX, Inc. for an initial payment of $160 million plus potential future milestones. According to TYRX’s website, TYRX is the developer and manufacturer of “innovative, implantable, combination drug+device products that utilize novel biomaterials.”
According to TYRX’s website, the company has developed the recently FDA-cleared AIGISRx® R Fully Resorbable Antibacterial Envelope, designed to reduce surgical site infections associated with cardiac implantable electronic devices, such as AICDs. Additionally, TYRX’s website also describes their AIGISRx® N Antibacterial Envelope, for use with spinal cord neurostimulators.
“While the risk of infection from an implanted pacemaker or defibrillator is low for most patients, repeated operative procedures after the initial device implant are associated with a substantial incremental risk of infection. This is estimated to cost the U.S. healthcare system more than $1 billion per year . . . . TYRX has developed an innovative, proven technology to reduce infection risk, making the procedure safer for patients and removing significant costs from the healthcare system.”
The press release also quotes TYRX President and CEO Robert White: “We look forward to joining Medtronic as part of a combined portfolio that can positively impact outcomes for patients by reducing implant-related infections, and bring value to our customers.”
On October 30, 2013, Zimmer Holdings, Inc. and Zimmer, Inc. filed a petition with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 7,837,736, assigned to Bonutti Skeletal Innovations, LLC.
The ‘736 Patent is entitled “Minimally Invasive Surgical Systems and Methods.” The ‘736 Patent states that it relates to a method “for performing a total knee arthroplasty.” Figure 90 from the ‘736 Patent, described as “a schematic illustration of a tibial component of a knee implant[,]” is shown below:
The petition seeks to review claims 15-28 and 31-36 of the ‘736 Patent. The petition discloses that Bonutti Skeletal has accused Zimmer of infringing the ‘736 Patent in a lawsuit filed in the U.S. District Court for the District of Delaware. Bonutti Skeletal filed an amended complaint in that lawsuit on January 15, 2013. In addition to the ‘736 Patent, the amended complaint also alleges infringement of U.S. Patents 6,702,821, 7,749,229, 7,806,896, 7,959,635, and 8,133,229.
On August 19, St. Jude Medical, Inc. announced the acquisition of Endosense SA. The press release notes that St. Jude Medical has made an initial payment of approximately $170 million with additional cash payments of up to $161 million contingent on achievement and timing of regulatory milestones.
According to the press release, Endosense SA, a Switzerland-based company, “has pioneered contact-force measurement in catheter ablation.” The press release notes that Endosense’s TactiCath irrigated ablation catheter provides physicians a real-time, objective measure of the force applied to the heart wall during a catheter ablation procedure.
Frank J. Callaghan, president of the Cardiovascular and Ablation Technologies Division of St. Jude Medical stated:
This transaction significantly accelerates our timeline to providing an irrigated ablation catheter that incorporates force sensing in both international and U.S. markets, and has potential future applications across other St. Jude Medical technology platforms as well.
The press release states that St. Jude Medical can incorporate the force sensing technology for use with their technologies including offering a “MediGuide-enabled force-sensing ablation catheter and to incorporate force sensing data into the company’s EnSite Velocity™ Mapping System.”
According to a company press release, Techne Corporation has agreed to acquire a 100% ownership stake of Bionostics Holdings Limited and its operating subsidiary Bionostics, Inc. for $104 million in cash.
The press release identifies Bionostics as “a global leader in the development, manufacture and distribution of control solutions that verify the proper operation of in vitro diagnostic (IVD) devices primarily utilized in point of care blood glucose and blood gas testing.” Techne, through its subsidiaries R&D Systems and R&D Systems Europe, describes itself as involved in “the development, manufacture, and sale of biotechnology products and hematology calibrators and controls.”
According to the press release, the acquisition is expected to close in the first quarter of fiscal year 2014. After the close of the transaction, the Bionostics and Techne’s Hematology Division “will collectively operate under a new Clinical Controls Division of R&D Systems.”
The press release states:
Controls for blood glucose and blood gas devices are the largest portion of Bionostics’ business. Bionostics recently launched coagulation device control products and is developing new controls for other growing diagnostic uses, particularly controls for cholesterol and HbA1c point-of-care testing (POCT) devices. Bionostics is positioned to take advantage of continuing growth driven by the increasing prevalence of diabetes and other diseases, the migration of diagnostic testing from the laboratory to the operating room, bedside, clinic, and home points of care, the implementation of controls regulations in global markets and new controls being required for emerging diagnostic and (POCT) products.
Cynosure, Inc. announced last week the completion of its acquisition of Palomar Medical Technologies, Inc. According to the press release, Palomar was purchased in a cash and stock transaction valued at approximately $287 million.
Cynosure’s Chairman and Chief Executive Officer Michael Davin stated:
“Combining with Palomar brings together two world class research and development organizations creating what we believe is one of the world’s premier aesthetic laser and light-based companies.”
According to the press release, Cynosure develops and markets laser and light-based treatments for minimally invasive and non-invasive aesthetic applications, such as aesthetic treatment systems to remove hair, treat vascular and benign pigmented lesions, remove multi-colored tattoos, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite, treat toe fungus and ablate sweat glands.
According to Palomar’s website, Palomar produces cosmetic lasers and intense pulsed light systems to improve the appearance of skin.
Cardiocom files for Inter Partes Review of University of Rochester’s Patient Monitoring and Treatment Patent
The ‘985 patent is entitled “Methods and System for Monitoring and Treating a Patient.” The patent specification states that the patent relates to “a method and system for monitoring and treating a patient who has one or more diagnosed conditions and is located at a remote location from a treatment processing system.”
The ‘985 patent is the subject of a lawsuit filed in the U.S. District Court for the Eastern District of Texas by University of Rochester and purported licensee My Health, Inc. against Cardiocom. The complaint refers to Cardiocom’s use of allegedly infringing “sales of products incorporating the University’s technology[,]” including “a unique technology that assists healthcare providers in monitoring and treating patients.”