ReCor Medical, Inc.

Greenberg Traurig intellectual property lawyer Chris Bolten has worked with medtech companies like Shockwave Medical and Abiomed (both now owned by Johnson & Johnson MedTech ), Recor Medical , Moon Surgical , Tandem’s AMF Medical , JenaValve ( purchase pending by Edwards Lifesciences ), and V-Wave Medical ( purchase pending by J&J ). Those device developers have been making headlines with major product launches and deals to sell their businesses to bigger buyers. But the foundation for all that success was laid years ago with the help of IP lawyers like Bolten, who joined Greenberg Traurig this year from Eversheds Sutherland. J&J, for example, purchased Shockwave for $13 billion just this year. Back when Shockwave’s only employees were its three founders, Bolten did the original due diligence and IP strategy for Sofinnova Partners on their investment in the device developer. “Shockwave was struggling to raise money because nobody believed in the technology,” Bolten said in an interview with Medical Design & Outsourcing. “… They didn’t have any patents yet, we helped, and the rest is history.” Bolten is set to speak on a DeviceTalks West panel with fellow Greenberg Traurig Shareholder Ginger Piggot on Oct. 17 in Santa Clara, California. (Register here.) They (and other panelists yet to be announced) will discuss “Waypoints on the Road to Success,” identifying the major milestones when medtech developers should consult with their IP counsel for key decisions that could affect their ability to secure funding, win regulatory approval and build a business for growth or sale to a strategic buyer. “If someone’s building a medtech company, one would hope that they know that they have to file patents early on. One thing medtech companies get wrong is they don’t necessarily go to the right IP person early enough,” Bolten said. While there are lots of IP attorneys out there, it’s key to find one with the right medtech experience, He said. “If you need a prosthetic heart valve, you don’t go to your general practitioner. You want to go to an interventional cardiologist.”Some of the earliest points at which a medtech developer should contact their IP attorney is when they’re identifying an unmet clinical need, defining what success looks like, and building a team, even if it’s just an informal group. And then there’s the first IP filing. “Once you file that patent application, you’re stuck with it for 20 years,” Bolten said. “Patents last 20 years and you can’t change the original application as filed once you’ve filed it with the patent office. So that’s an important waypoint. Working with someone that knows the field, knows what you can protect and how you should protect it, and how to work a medtech company, the earlier you do it from an IP perspective, the better.” How soon is too soon to talk with an IP lawyer about the first filing? “You have to have identified an unmet clinical need. If you’ve figured out how to solve that, you would want to be talking to an IP attorney and making sure you’re filing as soon as possible, before there is any disclosure outside the company,” Bolten said. “Or if you haven’t formed a company yet, then making sure that you hire the right corporate person to form the company and get your IP filed. The timing of the IP filing can be very fluid. It depends on when you’re ready to do it, but it is something that needs to be looked at early on, certainly before you disclose publicly your inventions and ideally before you’re disclosing it outside of your company circle, even under an NDA.” Expect scrutiny of your IP when you’re seeking funding from potential investors, who will want to know what kind of patents (and to a lesser degree, trademarks) you have and how many, whether they’ve been granted or are pending. “If someone’s going to invest money in you, there will be an IP diligence, especially if it’s a substantial amount of money. Are you ready for that investment? You need someone that can help deal with what is going to be important to the investor,” Bolten said. “They’re going to want to look at freedom to operate, the company’s IP, that your agreements — whether they’re your license agreements or your employment agreements — are well in place from an IP perspective, that the company has the rights that they need. Investors will not invest in a company that doesn’t have the IP rights they think they have.” Successful fundraising then sets a medtech company off toward new waypoints through R&D and testing, regulatory review and commercialization — with pivots and realignments along the way. “You have to continuously keep in contact with your IP attorney, because you’re going to learn new inventions when you put it in animals,” Bolten said. “Unexpected things will occur, unexpected problems will be identified and you have to solve them — especially if you’re in a new area that nobody’s been in before and they haven’t encountered those problems that need to be solved. That’s where you get great new inventions. As you go into clinicals, as you go into humans, as you do testing of your product and figure out it’s not resilient enough for a five-year implant or whatever it is, how are we going to make this better? There’s always new inventions in this development process, in the clinic, in R&D.” And with the IPO market “dead” for medtechs right now, Bolten advises founders to build their companies for commercial sustainability rather than planning to go public or sell to a strategic buyer before they’re bringing in revenue. “Outside of cardiovascular acquisitions aren’t occurring too much until companies are commercial. … Your goal is moving towards commercialization and/or acquisition or a partnership,” he said. “That’s always the end goal.” These are just a few of the waypoints and the tips Bolten and the rest of his DeviceTalks West panel will discuss — but you can register now to attend this panel and many more in person.

The new ESC Guidelines for Management of Elevated Blood Pressure and Hypertension were presented at the ESC Congress in London and reinforce the safety and effectiveness of renal denervation, recommending its consideration as a treatment option to improve uncontrolled hypertension. PALO ALTO, Calif. and FRANKFURT AM MAIN, Germany , Sept. 3, 2024 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") have endorsed the updated recommendations for the management of hypertension by the European Society of Cardiology (ESC), which were presented at the ESC Congress on Friday, August 30, 2024. The new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN. Continue Reading Recor Medical Paradise System for uRDN Hypertension, or high blood pressure, affects more than one billion people worldwide. It is known as the "silent killer" because many people do not know they have it and, over time, it can lead to serious health issues. About three-fourths of the patients who are treated for hypertension remain uncontrolled despite making healthy lifestyle changes and taking multiple medications. Recor's Paradise™ Ultrasound Renal Denervation (uRDN) system is a first-of-its-kind ultrasound-based renal denervation technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries in patients whose hypertension is not controlled by medications alone. "This presented guidance from the ESC Congress 2024 is a big step forward for patients who require a safe and effective option to control hypertension when lifestyle changes and medications are unsuccessful. The recommendation is based on the demonstrated efficacy and safety of renal denervation in randomized sham-controlled trials, and I am very pleased that RDN is now recommended in the ESC Guidelines as a treatment option for refractory and non-adherent patients," commented Prof. Dr. Michael Böhm, Cardiologist and Clinic Director of Internal Medicine III, Saarland University Hospital in Homburg. "As presented at the congress the ESC guidelines recommend that renal denervation be performed in medium-to-high volume centers after multidisciplinary assessment and with a shared risk benefit discussion with the patient. It is now up to us to implement these guidelines in everyday clinical practice and provide patients with the services they need." Recor has completed three global, independently powered, sham-controlled randomized clinical trials of the Paradise uRDN system in more than 500 patients with uncontrolled hypertension. The RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II clinical studies met their prespecified primary efficacy endpoints of blood pressure reduction, with positive safety outcomes. The Paradise system received CE mark in 2012, and Recor has been actively working with the European cardiology community to bring ultrasound RDN therapy to patients in the region. The growing support of societies like the ESC provides further momentum for the ongoing adoption of Recor's hypertension therapy. "We are delighted that the ESC guidelines recommend the consideration of renal denervation as an effective option to treat uncontrolled hypertension," said Recor President and CEO, Lara Barghout. "The urgent global need to address the burden of uncontrolled hypertension remains, and we're committed to revolutionizing the way hypertension is treated by bringing the benefits of Paradise ultrasound RDN to patients who need it." About Recor Medical, Inc. Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise system is an investigational device in Japan, is FDA approved in the United States, and bears the CE mark. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System ("GPS") Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United States. Recor Medical Europe GmbH is an Otsuka Medical Devices company. About Otsuka Medical Devices Otsuka Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. (), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578). That press release can be found at . Photo - Logo - SOURCE Recor Medical Inc.

The hospital is the first in the area to use a new FDA-approved device for patients suffering from uncontrolled high blood pressure. TAMPA, Fla., March 14, 2024 /PRNewswire/ -- Doctors with the Tampa General Hospital (TGH) Heart & Vascular Institute are the first in the region to use an innovative new technology to control hypertension or uncontrolled high blood pressure. The Paradise Ultrasound Renal Denervation (RDN) System by Recor Medical uses ultrasound energy to ablate the renal nerves and lower blood pressure. The procedure is minimally invasive and may be performed in an outpatient setting, allowing most patients to go home the same day. Continue Reading (PRNewsfoto/Tampa General Hospital) If the procedure becomes a common therapy, experts say, it could help reduce diagnoses of high blood pressure, which directly or indirectly kills about 700,000 Americans each year. "This is an exciting weapon in the war against the disease,'' said Dr. Fadi Matar, Cardiac Cath Lab Medical Director & Cardiology Section Chief at TGH, and associate professor and interim director of the Division of Cardiovascular Sciences at the USF Health Morsani College of Medicine. "It's critical to bring it under control, and this technology offers a novel way to treat it.'' Patients with life-threatening – or resistant − hypertension that can't be controlled by traditional therapies are candidates for the FDA-approved procedure. It uses ultrasound to deliver a 360-degree ring of energy, reaching about 80 percent of the sympathetic nerves around the renal arteries. This ablation reduces the overactivity that can lead to hypertension. A hydro-cooling balloon circulates sterile water during the procedure, which protects the arterial wall. Under ordinary circumstances, blood pressure normally rises and falls throughout the day, but it can damage your heart and cause other health problems if spiked for long periods, resulting in hypertension. Nearly half of adults suffer from this condition, but only 1 in 4 have it under control, according to the federal Centers for Disease Control & Prevention (CDC). "So, if we can help change the course of hypertension, we can help change the course of coronary diseases that can lead to strokes and heart attacks,'' added Matar, who also serves as Interventional Heart Failure Program Director, TGH Heart & Vascular Institute. Facts about high blood pressure, according to the CDC: Having hypertension puts you at risk for heart disease and stroke, which are leading causes of death in the United States. In 2021, hypertension was a primary or contributing cause of 691,095 deaths in the United States. Nearly half of adults have hypertension (48.1%, 119.9 million), defined as a systolic, or upper, blood pressure measuring greater than 130 mmHg or a diastolic, or lower, blood pressure measuring greater than 80 mmHg or are taking medication for hypertension. About half of adults (45%) with uncontrolled hypertension have a blood pressure of 140/90 mmHg or higher. This includes 37 million U.S. adults. About 34 million adults who are recommended to take medication may need it to be prescribed and to start taking it. Almost 2 out of 3 of this group (19 million) have a blood pressure of 140/90 mmHg or higher. High blood pressure costs the United States about $131 billion each year, averaged over 12 years from 2003 to 2014. Learn more about the TGH Heart & Vascular Institute at . ABOUT TAMPA GENERAL HOSPITAL Tampa General Hospital, a 981-bed, not-for-profit, academic health system, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News and World Report's 2023-24 Best Hospitals, with six specialties ranking among the top 50 best hospital programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic health system's commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings – in the top 100 nationally in the 2023 America's Best Employers for Women and top 25 in Florida in the 2023 America's Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2021, provided a net community benefit of approximately $240.3 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida . It also is home to the Jennifer Leigh Muma 82-bed neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes TGH North which is comprised of three hospitals and several outpatient locations in Citrus and Hernando counties, 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Outpatient Center, TGH Virtual Health, and 21 TGH Imaging outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics. To see a medical care professional live anytime, anywhere on a smartphone, tablet or computer, visit Virtual Health | Tampa General Hospital (tgh.org). As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to . ABOUT USF HEALTH USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health's multispecialty physicians' group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News & World Report's national university rankings than USF. For more information, visit health.usf.edu. SOURCE Tampa General Hospital