Newly elected President's plans have major bearing on the medtech industry see more
While former Vice President Joe Biden and the team he builds won't take office for another two months, the campaign’s plans for COVID-19, healthcare and other policy areas offer clues to how changing tides in Washington may impact the medtech industry.
In approaching the top task at hand — getting the pandemic under control — the Democrat's plan includes proposals with implications for the industry, from how diagnostic testing is covered to access to telemedicine services.
In some ways, the act of swapping out administrations, regardless of who's in power, means device makers can anticipate shifts at key government agencies like the FDA.
South Carolina life sciences is booming, with new organizations growing and moving here see more
Comprised of 650 life sciences firms, with wages nearly double state averages and an annual economic impact over $12 billion, South Carolina life sciences employs 43,000 professionals in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. It’s a powerful force in today’s Palmetto State economy.
The fastest growing segment of the state’s innovation economy, life sciences shows no signs of slowing — despite a global pandemic that has advanced public awareness of the vital sector.
Life sciences’ 6 major segments include pharmaceuticals/biotech (including such state organizations as Nephron Pharmaceuticals, Thorne and Thermo Fisher Scientific), medical devices/medtech (Abbott, Arthrex and AVX), Health IT/digital health (ChartSpan), research-testing-diagnostics-labs (Greenwood Genetics Center, Precision Genetics and Vikor Scientific), bioscience distribution (SoftBox Systems), and Bio-Ag. Every sector is well-represented across South Carolina, with life sciences active in at least 43 of our 46 counties.
What makes the industry even more compelling is that it averages triple the R&D spend of all other industries and is highly recession resistant due to its connectivity with healthcare. An $8 trillion annual global healthcare spend is supported by a $1.5 trillion global life sciences industry – with the United States responsible for almost half of the world’s innovations.
To help the Palmetto State become a significant player in life sciences, SCBIO was refocused 3 years ago – with economic development as the focal point. Providing support for existing industry, working with economic development organizations to recruit global life sciences companies, and developing strategies to grow our own companies has had a seismic impact on SCBIO and its stakeholders — and ushered in a new era ripe with opportunity.
Aligning with the SC Department of Commerce in 2017 helped SCBIO to triple revenue in 3 years, more than quintuple membership, develop a full-time multi-disciplinary team, and cultivate an extraordinary board of directors from industry, academia, healthcare, core service providers, and economic development partners.
SCBIO has become a catalyst for and voice of South Carolina life sciences. From offices in Greenville, Columbia, and Charleston, SCBIO represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members and allies include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
Working with allies and partners, SCBIO created the state’s first ever SC Life Sciences Strategic Plan – now in its third iteration — to build a nationally competitive and sustainable ecosystem focused on building, advancing, innovating and growing the industry.
And innovation is the lifeblood of progress. For the state to become an innovation destination for life sciences, the effort requires relentless pursuit – of talent, of transformational ideas, of organizations bringing operations and R&D to our state, and of an enhanced ecosystem that supports existing industry while growing our own companies.
Life sciences innovation has a rich legacy in South Carolina, drawing on the notable talents and creativity of the research universities of Clemson, University of South Carolina, and MUSC… a Top 25 national health system in Prisma Health… plus South Carolina Research Authority, Greenwood Genetics Center and others whose ground-breaking work has earned South Carolina a deserved reputation as a life sciences up-and-comer.
From pioneering medical grade electrolytic capacitors that made thoracic implantable defibrillators possible at St. Jude Medical (now Abbott)… to the recent invention and introduction by MUSC, ZIAN and Rhythmlink of a novel safety electrode that has the potential to reduce needle sticks in surgical settings around the globe, South Carolina life sciences innovation is on the move.
Even facing a global pandemic, SC’s life science companies are on the front lines and performing at a high level. Entrepreneurs and academic institutions have deftly shifted focus or pivoted production to address needs resulting from the crisis. Providing everything from COVID-19 PCR test kits to antibody tests, from respiratory therapies to face shields, and from developing specialty garments for frontline workers to being selected to conduct Phase III vaccine trials in the hunt for a COVID cure, South Carolina is now a part of the global solution team.
A prime example is Columbia’s ZVerse, a digital manufacturer. Seeing desperate need for protective shields for healthcare workers, the early-stage company quickly pivoted to become one of America’s largest manufacturers of reusable face shields. ZVerse then devised a new, proprietary shield that is more comfortable to wear over long periods of time. Sales have soared.
The booming ecosystem includes technology incubators and accelerators across the state, providing entrepreneurs with guidance and opportunity to collaborate with peers. A recent SCRA initiative—the creation of the South Carolina Business Incubator Association — is an important step in helping organizations share best practices and stimulate innovation.
Along with Southeastern partners Global Center for Medical Innovation and Health Connect South, SCBIO is championing a unique innovation partnership: The Southeast HealthTech Collaboration. Leveraging complementary strengths, resources and networks, the group will identify pressing health needs in our region without requiring major new investment in infrastructure or capital.
Now a finalist for a major grant in the EDA 2020 Build to Scale Venture Challenge, the Southeast HealthTech Collaboration will launch a three-year program to:
- Convene healthcare leaders to identify top healthcare challenges and innovators working on technology-based solutions to address them;
- Accelerate best solutions through development and into commercialization; and
- Scale startups and networks to drive investment and job creation across South Carolina and Georgia.
With a focus on minority and underserved populations, the initiative will accelerate development and commercialization of technological solutions to address unmet clinical and health needs, leading to scaling of startup growth and a sustainable economic engine.
As American poet Robert Frost penned:
“The woods are lovely, dark and deep, but I have promises to keep,
And miles to go before I sleep.”
Despite miles to go, there is plentiful evidence that our state is “punching above our weight class”, given our relative size and resources. With innovation blossoming and a surging passion for improving prosperity, the promise of South Carolina and its future has never been brighter.
Monday Moment 5-4-2020 see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from University of South Carolina College of Pharmacy Dean Stephen Cutler saluting all those on the front lines of healthcare, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.
AVX stepping up to fight COVID-19 crisis see more
To meet the rapid increase in customer demand for critical medical equipment such as lung ventilators, mobile x-ray, CT systems, ultrasound, and patient monitors, AVX is preparing its plants to actively support the manufacture of all required components to produce the medical equipment needed to prevent the further spread of the COVID-19 virus and treat those who have been infected.
AVX provides a wide range of components that are critical to medical electronics in general and specifically ventilators. AVX NTCs measure gas and patient temperature. Tantalum and ceramic capacitors as well as Schottky diodes are used throughout the power supply system that powers the pumps, motors, displays, and control logic in ventilators. TransGuards are used as transient voltage protection on interfaces, keyboards, touch screens and audio alarms.
AVX provides a wide range of components that are critical to medical electronics in general and specifically ventilators. (Credit: AVX)
“All of us, at every level, function and business, feel the significance and the intensity surrounding the worldwide COVID-19 pandemic situation, both in our personal and professional lives. Teams across the company have been meeting daily to address critical employee and customer issues. What motivates AVX every day is knowing that despite the current situation, we are rising to the challenge as our manufacturing plants continue to deliver for our customers around the globe,” the company notes.
In a recent example, AVX has committed to fast delivery of high-grade tantalum capacitors from its plant in Lanskroun, Czech Republic, directly to UK Smith Medical company in urgent need for building 10,000 ventilators for hospitals and healthcare institutions. The requirement for three TRJ series part types were processed with top urgency to deliver it in the shortest term while keeping its high-quality standard.
According to the company, the plants continue to give their best effort to deliver all parts as soon as possible, with the shortest possible lead times with a focus on functioning effectively and efficiently to minimize all delays.
SCRA added three advisory groups for biomedical sciences, cybersecurity and industry see more
Summerville, S.C.—South Carolina Research Authority (SCRA) announces the formation of three Business and Science Advisory Boards (BSABs). The purpose of the BSABs is to advise SCRA’s Board of Trustees when requested by it. The boards include representatives from South Carolina research universities, the venture capital/angel investment community, South Carolina Department of Commerce, and industry leaders in the following areas:
Each board provides key business and technical expertise, acts as an independent/ unbiased sounding board for input on SCRA’s program implementation and performance and provides guidance to SCRA regarding funding opportunities. One upcoming funding opportunity on which the BSABs will advise is the SCRA-Academia Collaboration Team (SACT) Collaborative Research Grants. These grants will be available for multi-institutional, collaborative research teams that seek to advance commercially relevant research and address key industry challenges to foster technology-enabled growth of the state’s innovation economy. The solicitation will be released in June.
“SCRA serves as a bridge between industry and academia. It is imperative that the applied research SCRA funds benefits not only its academic stakeholders, but also South Carolina’s industrial base. The development of the BSABs ensures that the new SACT program achieves those objectives for both stakeholder groups,” said Christine Dixon Thiesing, SCRA Director of Academic Innovations.
The SCRA fuels South Carolina’s innovation economy by accelerating technology-enabled growth in academia, entrepreneurship and industry. SCRA works with public and private sectors, including industry, to identify market trends and validate the commercial relevance of academic research that SCRA funds. SCRA’s programs and operations had an almost $700 million impact on the state’s economy during the last fiscal year.
Chartered in 1983 by the State of South Carolina as a public, nonprofit corporation, SCRA fuels South Carolina’s Innovation Economy by accelerating technology-enabled growth in research, academia, entrepreneurship and industry.
Arthrex has completed construction on their new South Carolina manufacturing facility see more
Brasfield & Gorrie recently completed construction on a new manufacturing facility in Anderson for Arthrex, a global orthopedic medical device company headquartered in Naples, Florida.
The $36.1 million project includes a 250,000 square foot medical device manufacturing building and a 30,000 square foot central services building. The manufacturing building consists of 175,000 square feet of manufacturing floor space and 20,000 square feet of clean room assembly space for sterile packaging activities for all manufactured medical devices. The remainder of the building is a two-story office space for support staff. Click here for the full story.
Life sciences is booming across South Carolina, experts report see more
The economic future of South Carolina is being profoundly impacted by a rising industry sector that has unexpectedly achieved the distinction of becoming the fastest-growing component of the Palmetto State’s knowledge economy.
Not automotive, not aerospace, but life sciences—a huge and multifaceted trillion-dollar-plus global industry that averages almost triple the R&D of all others, comprised of multiple segments, including drugs and pharmaceuticals, medical devices and equipment, digital health solutions, research-testing-medical labs, bio-science distribution, bio-ag and other life sciences support organizations.
The pharmaceutical segment in the U.S. alone employs approximately 3.5 million people, which exceeds the population of many states. Meanwhile, the medtech and digital health segments also continue to ramp-up dramatically, fueled by innovation and disruptive global trends ranging from the transformation of healthcare delivery to the enormous impact of artificial intelligence.
According to SCBIO’s just released statewide S.C. Life Sciences Strategic Plan (Version 2.0 covering 2019-2021), an influx of new firms into the Palmetto State coupled with a comprehensive recount effort has surprisingly revealed that the number of life science companies with a presence in the Palmetto State has risen to more than 650—a figure which is over 200 more than were recognized in an initial economic impact study conducted approximately three years ago.
That foundational study funded by the state Department of Commerce and SCRA revealed an annual life sciences economic impact now conservatively approaching $12 billion, with more than 43,000 direct and indirect employees receiving wages almost double the state’s average, and an employment growth rate twice that of South Carolina as a whole. Perhaps even more compelling is the fact that life science entities are now present in 43 of 46 SC counties.
Established starring players in the Palmetto State’s rapidly evolving life sciences constellation such as Nephron Pharmaceuticals in West Columbia have grown from 400 employees to over 1,100 in the same time frame, with an accompanying capital investment close to $400 million dollars. Long-time South Carolina life science companies such as ZEUS Industrial Products in Orangeburg, Clemson University spin-out Poly-Med Inc., Sumter’s BD and Charleston’s Charles River Laboratories are achieving record employment numbers boosted by a growing global customer base.
Concurrently, new South Carolina biotech and medtech industry stars recently coming on line such as Thorne Research in Berkeley County and Arthrex in Anderson County have invested tens of millions of dollars in state-of-the-art facilities and are rapidly ramping up to projected employment levels in the hundreds.
Equally encouraging is the fact that scores of highly innovative early-stage life sciences companies like Charleston’s Firststring Research Inc.and Greenville’s Humimic Medical are becoming deeply rooted and committed to building their promising futures in South Carolina. This is a testament to the fact that a robust life sciences industry ecosystem is forming and maturing that not only supports larger scale advanced manufacturing operations, but can also foster and support innovative start-ups and early stage (pre-revenue) companies that must be uniquely bolstered in their early developmental years with a myriad of sophisticated resources, talent and funding sources in order to successfully enter the marketplace.
In years past, a multitude of promising, young South Carolina-born companies often left the state in order to obtain crucial funding and unique talent in more established bastions of life sciences such as Boston, the West Coast or even the nearby Research Triangle in North Carolina.
Gratefully, South Carolina is becoming a rising destination for both mature and early-stage life science companies that are fueled by all three of our major research universities and their extraordinary life sciences core competencies, renowned institutes such as the Greenwood Genetics Center, medical schools anchoring three major regions, the MUSC and Prisma Health science centers, and major healthcare providers.
They are also tapping into a growing bullpen of content experts in the Palmetto State ranging from experienced FDA navigators to reimbursement specialists to intellectual property attorneys and other highly specialized consultants
Based on the positive momentum of this burgeoning industry—which is virtually recession-proof and a huge diversification for South Carolina’s economy—hard-fought funding for SCBIO has reached a record high with new members joining forces with the organization on a weekly basis.
This crucial fuel is enabling unprecedented life sciences economic development strategies to be successfully mounted in the Palmetto State, including the active recruitment of a new generation of leading-edge life sciences companies into South Carolina from all over the world, in tandem and full alignment with vital state, regional and local partners—with recent economic development missions generating measurable results in Switzerland, Italy, Germany, Dubai (UAE), and across the U.S.
To achieve SCBIO’s bold vision of building the nation’s most industry-friendly and innovative life sciences ecosystem and business environment to fuel a knowledge economy in South Carolina, there is much work to be done—and it will be an endless journey. And in some respects, the Palmetto State is still somewhat fledgling as a global player in this complex and ever-changing industry. However, South Carolina’s progress over the past decade has been nothing short of remarkable, and the opportunities are endless and unlimited.
Life sciences is now uniquely igniting and demonstrably contributing to a brilliant future for the state of South Carolina. Please stay tuned—the best is yet to come.
TSO3 to Commercialize the STERIZON VP4 Sterilizer and Support Getinge Transition see more
Myrtle Beach, United States and Quebec City, Canada August 1st, 2018 – TSO3 Inc. (TSX: TOS) (“TSO3” or the “Company”), an innovator in sterilization technology for medical devices, today announced that TSO3 and a fund (the “Fund”) of which Courage Capital Management LLC, (“Courage”) is the investment advisor, have entered into a binding US$20 million debt financing to fund commercialization initiatives for its STERIZONE® VP4 Sterilizer, the only terminal sterilization method that is FDA cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as certain colonoscopes, gastroscopes and duodenoscopes. Courage is a Nashville, TN headquartered alternative asset management firm with a 20-year track record of investments in health care services, medical devices, and pharmaceuticals.
Concurrent with the Courage financing, TSO3 and Getinge Infection Control AB (“Getinge”) mutually decided not to renew the distribution agreements between the parties, and have agreed to: 1) provide TSO3 unrestricted independent commercialization of its STERIZONE® VP4 Sterilizers; 2) the Company’s purchase of approximately 230 STERIZONE® VP4 Sterilizers, 220 of which are from Getinge’s inventory, for $33,000 per sterilizer; 3) transfer Getinge’s existing sales pipeline to TSO3 in exchange for shared economics at the completion of sale; and 4) transition to TSO3 the service, maintenance and consumables sales of all existing STERIZONE® VP4 Sterilizer customers in the United States and Canada. Getinge and TSO3 envision maintaining an ongoing collaborative relationship where TSO3 supplies and supports the STERIZONE® VP4 Sterilizer to satisfy Getinge customers looking for a total sterilization solution.
About the STERIZONE® VP4 Sterilizer
The STERIZONE® VP4 Sterilizer is a low-temperature sterilization system that utilizes the dual sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisturesensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective sterilization process with error-free cycle selection. The device’s unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the 3 load composition, weight and temperature. This capability removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.
The STERIZONE® VP4 Sterilizer is the only terminal sterilization method that is FDA cleared to sterilize multichanneled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes, duodenoscopes and gastroscopes – an industry first for any medical device sterilization process.
The STERIZONE® VP4 Sterilizer is also the only cleared low temperature sterilizer that can process a mixed load consisting of general instruments, single channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lb. The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity).
More information about the STERIZONE® VP4 Sterilizer is available through TSO3‘s website, under the Products section.
Founded in 1998, TSO3‘s activities encompass the sale, production, maintenance, research, development and licensing of sterilization processes, related consumable supplies and accessories for heat-sensitive medical devices. The Company designs products for sterile processing areas in the hospital environment that offer an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals. TSO3 also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.
To read more about any of the following, please click here:
- Key Financing Terms with Courage
- The key financing terms of the transactions
- A Conference Call discussing these events
- Information on Courage Capital Management, LLC.