Jay Hallinan Appointed Chief Commercial Officer of Q’Apel Medical

October 31, 2024

Q’Apel Medical (Q’Apel), a private medical device company focused on revolutionizing neurovascular interventions, announced today the appointment of seasoned medical device executive Jay Hallinan as Chief Commercial Officer.

In this role, Jay Hallinan will lead the company’s global sales and marketing organization, oversee Q’Apel’s commercial strategy and drive revenue growth across Q’Apel’s expanding product portfolio.

“I am excited to join Q’Apel at this important time as the company looks to amplify its commercial activities,” commented Hallinan. “The team has developed an impressive portfolio that uniquely addresses the needs of clinicians performing delicate neurovascular interventions. I look forward to working together to accelerate our commercial efforts and build a solid foundation for future growth.”

With over two decades in the medical device industry, Hallinan brings extensive sales and management experience. Most recently, he served as the Vice President of North America for Stryker where he was responsible for the regional sales strategy and structure, new business development, contract negotiation and market position. Prior to that position, Jay Hallinan held commercial positions of increasing responsibility within Stryker’s organization as well as leadership positions with Boston Scientific and Medtronic. He also served as CEO of Tenex Health. Hallinan is a graduate of the University of Georgia and received his M.B.A. from the McColl School of Business at Queens College.

“I am thrilled to welcome Jay to the Q’Apel team. He is a strong leader with a proven track record of commercial success which will be critical as we look to expand our portfolio and strengthen the company’s position within the neurovascular market,” commented Jodie Fam, CEO of Q’Apel Medical. “With a focused discipline on execution, Jay’s expertise will add tremendous value and makes him an ideal fit to spearhead our commercial operations.”

Elixir Medical Reports | LithiX HC-IVL System Data Demonstrate Sustained Safety and Efficacy at Six Months

October 30, 2024

Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced positive six-month data from the PINNACLE I study evaluating the safety and performance of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) for the treatment of moderate to severely calcified coronary artery lesions demonstrating safety and efficacy. The data were presented at Transcatheter Cardiovascular Therapeutics® (TCT®), the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®).

“The cardiology community has long sought solutions that can better treat patients with calcified lesions to achieve optimal PCI outcomes,” said Johan Bennett, M.D., study principal investigator and director of CTO/CHIP program at the University Hospital Leuven in Leuven, Belgium. “The six-month PINNACLE I data are a strong validation of LithiX IVL’s mechanism of action that can safely fragment calcium across a range of complex morphologies without trauma to the soft tissue and can be easily integrated into standard PCI procedure workflow without the need for an energy source.”

LithiX data results demonstrate:

98.3% clinical success (primary effectiveness and safety endpoint) with 100% angiographic success across a range of moderate to severe calcium morphologies
- < 30% residual diameter stenosis was achieved in 100% of the lesions
- No procedural angiographic complications, including no severe dissections, perforation, or abrupt closure post-stenting
Excellent safety and efficacy with only one peri-procedural non-Q-wave myocardial infarction resulting in a 1.7% TLF event rate through 6 months

An intravascular imaging sub-study using optical coherence tomography (OCT) was conducted to accurately assess lesion complexity and calcium fragmentation effectiveness of LithiX IVL across a range of complex calcium morphologies.

OCT sub-study results demonstrate LithiX IVL treatment effect across a broad range of lesions:

In eccentric lesions with 184.38 (± 56.42) degrees of maximum continuous calcium arc with calcium nodules present in 33.3% of lesions:
- 84.6% of eccentric lesions had documented fractures and 61.5% of lesions with two or more fractures with 0.76 mm (±0.28 mm) average fracture depth and 0.51 mm (±0.23 mm) average fracture width
- 97.86% stent expansion at Maximum Calcium Site (MCS) and 101.38% stent expansion at Minimum Stent Area (MSA) site
In concentric lesions with 317.47 (± 22.51) degrees of maximum continuous calcium arc with calcium nodules present in 29.4% of lesions:
- 94.7% of lesions had documented fractures and 84.2% of lesions with two or more fractures with 0.85 mm (±0.36 mm) average fracture depth and 0.75 mm (± 0.29 mm) average fracture width
- 106.58% stent expansion at MCS and 93.95% stent expansion at MSA site

“We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.”

The novel LithiX Hertz Contact IVL system is the first non-energy based IVL technology designed to fragment moderate to severe calcified lesions resistant to optimal stent expansion.¹ The LithiX IVL mechanism of action is based on the physics principle of Hertz Contact Stress propagating the required discrete forces to fragment calcium without causing vessel injury, without the need for energy source or capital equipment, and positively impacting PCI procedure workflow with short procedure times and simpler learning curve.

About the PINNACLE I Trial

PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (IVL) System for the treatment of calcified lesions. The trial includes 60 patients across seven sites in Belgium and the Netherlands. An imaging subset of 32 patients underwent intravascular imaging assessment by OCT.

About LithiX Hertz Contact Intravascular Lithotripsy System

LithiX Hertz Contact IVL System is a transcatheter device comprising multiple discrete metal hemispheres incorporated on a semi-compliant balloon. The system is designed to deliver calcium fragmentation in a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress forces across hemisphere contact points. Using this unique mechanism of action, the LithiX Hertz Contact IVL System aims to improve treatment of moderate to severe calcified lesions without requiring an external power source, positively impacting PCI procedure safety, effectiveness, and workflow.

The LithiX IVL System is not approved for sale in the U.S.

Reference

¹Cialdella P, Sergi SC, Zimbardo G, Donahue M, Talarico GP, Lombardi d’Aquino UM, Di Fusco P, Calò L. Calcified coronary lesions. Eur Heart J Suppl. 2023 Apr 26;25(Suppl C):C68-C73. doi: 10.1093/eurheartjsupp/suad009. PMID: 37125323; PMCID: PMC10132609.

Immorta Bio Reports | SenoVax™ Reduces Growth and Stops Metastasis of Aggressive Breast Cancer Using its First-In-Class Immune Stimulatory Therapy

October 29, 2024

Immorta Bio, a scientific longevity company focused on “Treating Diseases of Aging and Treating Aging as Disease™,” announced today successful treatment of aggressive breast cancer in animal models using its SenoVax™ senolytic immunotherapy. In a series of experiments, scientists at Immorta Bio found that administration of SenoVax resulted in shrinkage of existing breast cancers, as well as reduction of metastasis.

SenoVax has previously been demonstrated to reduce lung cancer growth1, which was the subject of the Company’s IND #307452. It has also been shown to accelerate recovery of blood cell production after chemotherapy3.

“The currently disclosed data, which is covered by several filed patents, is extremely promising and potentially will offer one more weapon in our fight against triple negative metastatic breast cancer,” said Dr. Thomas E Ichim, President and Chief Scientific Officer of Immorta Bio. “Very intriguing is that mice which received SenoVax had an increase in several immunological parameters suggesting that besides cancer suppression, the therapy actually had a “regenerative” effect.”

“I am thankful to our team of scientists and collaborators who are working at a breakneck pace to apply lessons learned from our work in longevity to chronic health conditions such as cancer,” said Dr. Boris N Reznik, Chairman and CEO of Immorta Bio. “To our knowledge SenoVax is the first immunotherapy that works by removing senescent cells that surround the tumor. Once these are removed the body does what it does best, defends itself.”

References

¹ https://www.biospace.com/immorta-bio-reports-successful-inhibition-of-lung-cancer-growth-by-senolytic-immunotherapy-product-senovax² https://www.targetedonc.com/view/senovax-investigational-new-drug-application-filed-with-the-fda-in-nsclc³ https://www.prnewswire.com/news-releases/senovax-breakthrough-cancer-immunotherapy-preserves-immune-function-post-chemotherapy-in-animal-models-302239460.html

Robert Guigley Is Appointed Chief Commercial Officer of DELFI Diagnostics

October 29, 2024

DELFI Diagnostics, Inc., developer of accessible blood-based liquid biopsy tests that deliver a new way to enhance early cancer detection, is announcing the appointment of Robert Guigley as its new Chief Commercial Officer. Drawing on decades of biotechnology and diagnostics experience, Guigley will help shape DELFI’s strategic vision to expand market access and bring breakthrough liquid biopsy technology to healthcare providers and patients.

“Rob is an experienced executive leader in healthcare commercialization and is known for fostering a culture of innovation and collaboration that aligns with our approach to growth,” said Susan Tousi, CEO of DELFI Diagnostics. “With a background in executive-level sales, market access, revenue management, and product strategy and development, Rob will help us drive market opportunities and achieve profitable growth to deliver more business partnerships and clinical integrations with our simple, blood-based test solution for improved cancer screening as well as for our tumor monitoring research service.”

Robert Guigley most recently served as the Chief Commercial Officer at Invitae, where he orchestrated a commercial reorganization to transition from a growth-centric to a sustainable profit model. He led his team to enhance revenue strategies, customer service efficiencies, and sales performance while achieving impressive NPS scores and growth targets. Before Invitae, Robert Guigley was the Chief Commercial Officer at Ambry Genetics, where he led significant commercial growth, including a COVID-19 testing program and an innovative program (Ambry CARE) that helped unlock the sizable untapped TAM in hereditary genetics.

“DELFI has the innovative approach, momentum, and leadership team to revolutionize cancer screening,” said Guigley. “I’ve dedicated my career to supporting leaders in healthcare that aim to challenge and disrupt the status quo, and I believe cancer screening markets are ready for DELFI’s approach. I’m thrilled to support the company as it propels market growth and increases patient access.”

Rob’s career also includes impactful roles at Omada Health and Counsyl, where he achieved notable revenue growth, developed strategic health plan initiatives, and built strong partnerships within the industry. He started his pharmaceutical career with AstraZeneca, where he consistently ranked among the top sales performers. He holds an MBA with honors from Boston University and a Bachelor’s degree in Economics from the University of Pittsburgh.

DELFI tests are built to solve the health issues of the highest-burden population, including those in historically underserved demographics. Its flagship test, FirstLook Lung, is for individuals eligible for lung cancer screening and requires a simple blood draw that can be incorporated with routine blood work. DELFI works with leading healthcare systems, including Allegheny Health Network, Indigenous PACT, OSF Healthcare, and City of Hope. In addition, Nature Communications just published a new paper demonstrating the effectiveness of DELFI Diagnostics’ cell-free DNA (cfDNA) fragmentomes in assessing tumor burden for treatment response, monitoring, and clinical outcome prediction.

GT Metabolic Solutions Announces FDA Clearance of their GT Metabolic’s MagDI™ System

October 29, 2024

GT Metabolic Solutions Inc., the global leader in magnetic compression anastomosis surgery, announced today that the U.S. Food and Drug Administration (FDA) cleared GT Metabolic’s MagDI™ System for side-to-side duodeno-ileal (DI) anastomosis.¹The MagDI™ System is the first-of-its-kind minimally invasive surgical technique to create anastomosis without foreign materials left behind.^2-4

With this FDA clearance, the MagDI™ System is poised to launch a new frontier in healthcare as we continue to deliver on our visionary milestones for efficacy in magnetic surgery,” said MedTech entrepreneur Thierry Thaure, CEO and co-founder of GT Metabolic. “After completing over 100 cases in seven clinical trials across eight countries, launching in the U.S. market with this groundbreaking technology is a major progression in our journey to advance minimally invasive surgery in the bariatric space as well as in future areas.”

The MagDI™ System is composed of the GT Metabolic linear DI magnets, the GT Metabolic delivery system, and the GT Metabolic laparoscopic positioning device (LPD). During the MagDI procedure two linear magnets are delivered orogastrically to the patient. The magnets are positioned laparoscopically and self-align through the small bowel. After several weeks the magnets compress the tissue fusing together forming an anastomosis. The magnets detach and are expressed naturally.

The anastomosis created with magnet compressions happens without the cutting or piercing of intestinal tissue that occurs with the current practice of stapling or suturing. The MagDI™ System is designed for more consistent tissue alignment, central necrosis, and circumferential healing while leaving no foreign materials behind to impede the natural tissue healing process.^2-4

The MagDI™ System was cleared after clinical data submitted to the FDA showed the system performed as intended. In all subjects, the MagDI™ System created patent side-to-side duodeno-ileal anastomosis. There were no reports of anastomotic bleeding, leakage, or obstruction.¹

“It’s a paradigm shift creating a new standard of care that democratizes anastomosis creation,” said inventor Michel Gagner, MD, FRCSC, FACS, and chief medical officer and co-founder of GT Metabolic. “We’re providing the surgical community with a novel approach to minimally invasive surgery shown to have zero bleeds and zero leaks. Suturing and stapling bowel tissue for anastomosis creation will become outdated. Magnetic compression anastomosis technology will revolutionize the industry.”

Prominent U.S. bariatric surgeon Paul Enochs, MD, FACS, FASMBS, of Bariatric Specialists of the Carolinas was the first U.S. surgeon to have patients enrolled in clinical trials using the MagDI™ System. “Seeing the science and technology that’s behind this procedure has definitely opened my eyes to what the future could hold,” said Enochs.

GT Metabolic is currently identifying key sites for additional clinical studies. Key opinion leaders in the bariatric surgery specialty interested in participating in the MagDI™ System launch can contact the company at GT Metabolic.

SPYRAL HTN-ON MED Study Update | Shows significant, consistent, long-term blood pressure lowering effect at two years

October 28, 2024

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced new, long-term data from its SPYRAL HTN-ON MED clinical trial that showed subjects who underwent radiofrequency renal denervation with the Symplicity™ Spyral renal denervation (RDN) system had significantly greater reductions in 24-hr ambulatory systolic blood pressure (ABPM), and office-based systolic blood pressure (OSBP) compared to sham patients at two years. The data were presented as a part of the 2024 Transcatheter Cardiovascular Therapeutics Conference (TCT).

“These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension,” stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial. “Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs.”

The two-year data is consistent with other long-term data for Symplicity RDN, demonstrating clinically meaningful, consistent and sustained blood pressure reductions.^1,2 At two years, the data showed:

Significant group differences in 24-hr ABPM and OSBP in favor of RDN, despite significantly more medications detected in the sham group
- 24 months ABPM: -12.1 mmHg in RDN group vs. -7.0 mmHg in sham group (treatment difference: -5.7 mmHg; p=0.039)
- OSBP: -17.4 mmHg in the RDN group vs. -9.0 mmHg in the sham group (treatment difference: -8.7 mmHg; p=0.0034)
Long-term safety with no confirmed renal artery stenosis greater than 70% in the Spyral group at two years

SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications. After the six-month primary endpoint assessment, the study continued to assess 24-hr ABPM and OSBP from baseline through yearly follow ups.

SPYRAL GEMINI Clinical Program
Medtronic intends to investigate multi-organ (hepatic artery and renal artery) denervation with the Symplicity Spyral catheter. The planned Global Pilot study of rEnal and hepatic coMbINed denervatIon (SPYRAL GEMINI pilot study) will investigate the safety and efficacy of the multi-organ ablation approach in uncontrolled hypertension patients who are both on and off medications.

“Medtronic is uniquely positioned to explore the blood pressure lowering potential of multi-organ denervation. This is supported by both its intellectual property and the Symplicity Spyral catheter design, which enables access and treatment of the Common Hepatic Artery – a vascular target rich with sympathetic innervation – with the same single catheter,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “The promising preclinical data highlight the potential for interventional denervation in the liver to support additional blood pressure lowering effects of the procedure.³This approach underscores our dedication to innovation for both patients and physicians.”

The utilization of Symplicity Spyral in the hepatic artery is investigational and not approved for use.

GSR-DEFINE Expands to the United States
Medtronic will also expand the GSR-DEFINE clinical trial to sites in the United States. The GSR-DEFINE trial is an extension of the Global SYMPLICITY Registry, and is a prospective, all-comer observational study in 251 sites across 55 countries, including 3,000 patients from the GSR study and enrolling up to an additional 2,000 patients globally.

“This year at TCT, we are not only reinforcing the consistent, long-term effects of radiofrequency denervation, but we’re further demonstrating our commitment to evidence generation and innovation,” said Jason Fontana, PhD, general manager Renal Denervation, and vice president of Global Marketing for the Coronary and Renal Denervation business. “As the leader in interventional hypertension treatments, we are excited to extend the largest evidence platform available to U.S. physicians and their patients.”

Approved for commercial use in over 75 countries around the world, the Symplicity Spyral renal denervation system is currently limited to investigational use in Japan.

Reference

¹Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
²GSR 2024 update: Mahfoud et al.EuroPCR. 2024
³Tzafriri, A.R., et al Morphometric analysis of the human common hepatic artery reveals a rich and accessible target for sympathetic liver denervation. Sci Rep 12, 1413 (2022). https://doi.org/10.1038/s41598-022-05475-6

Avania — Building a MedTech Advisory & Clinical Development Partner | By: Jason Monteleone, Chief Executive Officer & President of Avania

October 28, 2024

Jason Monteleone, Chief Executive Officer & President of Avania

The MedTech industry continues to thrive and innovate. According to Markets and Market’s “The Global MedTech Industry Outlook 2024” report, the MedTech market is expected to grow 4% in 2024 to $668.2B. Transformative technologies such as artificial intelligence, robotics, and in vitro diagnostics are expected to drive growth over the next decade. Per Ernst & Young, in 2023, 433 publicly traded MedTech companies combined to spend $34.4B (approximately 6%) on research and development (R&D). Applying 6% to $668.2B would result in $40B R&D spend by MedTech companies in 2024.

The number of industry-funded, interventional medical device study starts were up almost 40% (400 studies per year) prior to an industry-wide slowdown in 2023. With that level of spend and activity, how come the MedTech industry does not have many choices when it comes to MedTech advisory and clinical development partners?

The CRO Industry

The clinical research organization (CRO) has always catered to the pharmaceutical/biotechnology sector due to the sheer volume of work. Statista.com reports the global pharmaceutical industry spent more than $300B on R&D in 2023 (or 7.5x the estimated amount for MedTech). Medpace, a large biotech-focused CRO reported in a June 2024 presentation that the addressable Phase I-IV clinical development market was approximately $125B, with $65B of that spend outsourced to CROs. Working backward, we can infer that approximately 22% ($65B/$300B) of pharmaceutical/biotechnology R&D is outsourced to CROs. Grandview Research estimates the medical device CRO market is approximately $7.75B, which would infer that 19% of MedTech R&D is outsourced ($7.75B/$40B) to CROs.

Often, MedTech companies find themselves in the position of having to choose between a large pharmaceutically focused CRO or a small MedTech CRO without the expertise or scale to adequately support their projects. The four largest publicly traded CROs (IQVIA, Fortrea, ICON, and Medpace) offering MedTech services have almost $64B of backlog. Keep in mind MedTech only outsources $7.75B annually. Combined clinical work outsourced by pharmaceutical, biotechnology, and MedTech companies is estimated to be $72.75B of which 11% comes from MedTech companies. While the large CROs are great companies, the majority of their revenue and focus is with pharmaceutical/biotechnology companies. Overall, MedTech likely makes up less than 10% of their entire backlog. 99% of all MedTech companies would not move the needle from a backlog perspective at any of the large pharmaceutical CROs.

Avania’s ownership group identified this MedTech CRO mismatch and have been diligently filling the void by building Avania into the leading MedTech advisory and clinical development partner.

Vision

The first step in the process was defining the market. MedTech means a lot of different things to different parties. Avania views MedTech as a multifaceted market made up of three verticals: Medical Device, Diagnostics/IVD, and Digital Health (imaging is included under the Digital Health umbrella).

Next was understanding MedTech sponsor needs and creating a clear service offering with a flexible operating model designed to satisfy sponsors ranging from start-up to large multibillion dollar OEMs. Avania landed on two primary service offerings: 1) Advisory and 2) Clinical Development. Each “service line” has subspecialty capabilities designed to assist sponsors with everything from a one-off consultative request to running a large global pivotal study. Avania is uniquely positioned to assist sponsors across the entire life cycle from product design through commercialization: a MedTech partner that truly offers “one-stop shopping” for its clients.

Avania’s Advisory services offering provides industry expert advice in the areas of:

Product Design & Development
Market Access & Reimbursement (which includes a patient hotline service)
Regulatory (both engineering and regulatory approval)

Avania’s Clinical Development offering functions like a traditional CRO with the exception that MedTech is the sole focus. Avania is not a pharmaceutical CRO masquerading as a MedTech CRO — all of its employees, processes, and procedures are designed to support MedTech studies.

Strategy

Once the market and company vision were defined, it was time to execute. Avania embarked on a purposeful, thoughtful, and aggressive acquisition strategy. To date, Avania has completed nine acquisitions, all MedTech focused and complementary to both its service offerings and therapeutic expertise.

Factory CRO — The original acquisition that commenced the journey. Factory provided the initial platform from which Avania was built. Additionally, Factory provided a foothold in Europe, along with multitherapeutic expertise with a strength in orthopedics. Medical reimbursement along with in vitro diagnostic capabilities set the stage for future growth areas.

Milestone Research Organization — U.S.-based niche provider with medical reimbursement, patient hotline capabilities (new service offering), and orthopedic expertise (further strengthening an already strong area).

Five Corners Medical Device Consultants — Australian-based full service MedTech CRO. Key therapeutic areas were urology and ophthalmology. Strategically provided Avania with market leading first-in-human (FIH) trial expertise and presence in the important Australian market providing favorable research tax benefits for MedTech sponsors.

Boston Biomedical Associates (BBA) — Avania’s first sizable U.S. acquisition of a full service MedTech CRO. BBA provided strategic regulatory consulting capabilities and cardiovascular, neuro, endocrine, and orthopedic therapeutic expertise.

IMARC — U.S.-based full service MedTech CRO with strong cardiovascular, neuro, and orthopedics expertise. IMARC also brought a very strong quality function to the group.

MAXIS — A global MedTech CRO that expanded Avania’s presence in the U.S. and Europe. MAXIS was a well-respected advisor to emerging MedTech companies with a “roll up its sleeves” attitude. Avania’s cardiovascular and neuro capabilities were strengthened and a variety of other therapeutic areas were added. Avania’s customers benefitted from an expanded roster of subject matter experts in the global pre-clinical, clinical (in vitro diagnostics, artificial intelligence/machine learning, and Software as Medical Device), and regulatory/engineering functions.

Hull Associates, LLC — One of two acquisitions made the same day focused on adding a niche advisory firm providing Market Access and Market Reimbursement capabilities. Hull Associates is a recognized leader in assisting MedTech companies of all sizes navigate the market access and reimbursement pathways.

Ironstone Product Development (IPD) — Acquired the same day as Hull Associates, IPD brought product design and development capabilities to Avania. IPD’s core focus areas are early product development, quality, and strategic regulatory with projects in the areas of medical robotics and surgical navigation, AI/machine learning, imaging, respiratory devices, IVDs, and wearables.

Anagram — Avania’s most recent acquisition expands its presence in Europe, specifically Spain. Anagram, a full service MedTech CRO, bolsters Avania’s cardiovascular, neuro, and oncology expertise and provides a core lab to expand its service capabilities.

Smart acquisitions alone do not make a great business; weaving these companies into an integrated comprehensive global MedTech partner provides a seamless customer experience.

Integration & Culture

Avania’s global Clinical Development service line maintains its high quality with standardized global SOPs resulting in the reliability and consistency expected by MedTech sponsors. A project managed out of Europe has the same SOPs as one run out of Australia. Avania is truly a global business not a patchwork of disparate businesses pretending to be an integrated global business. Our quality organization has a seat at the table and ensures quality is taken into consideration every step of the way.

Avania’s size (roughly 300 employees) makes it the perfect partner for large MedTech OEMs or start-up organizations. Our entrepreneurial, solutions-oriented culture encourages a “solutions-based” mindset of solving problems for our customers. Employees are our greatest asset — their passion and dedication make a difference every day. Avania employees understand customers come to us because they have an issue to be resolved, a question that needs an answer, and require a partner they can trust. Employees are encouraged to create novel solutions and are supported along the way. We have the best in the business and are proud of our accomplishments.

The Future

AdvaMed reports on its website there are more than 6,500 MedTech companies in the United States alone. Artificial intelligence is changing the game and will be a major disruptor for years to come. The diagram below demonstrates our capabilities and provides a road map for remaining a relevant MedTech partner.

We plan to invest and expand our capabilities in a variety of ways:

Therapeutic expertise — Therapeutic subject matter experts (SMEs) provide the scientific and operational knowledge necessary to help sponsors design and execute clinical trials. For example, we will be growing our bench of SMEs in cardiovascular, the largest MedTech therapeutic area.
Advisory technical expertise — Regulations are never static and evolve as new technologies and clinical trial strategies emerge. Successful navigation of market access and reimbursement are also critical pathways toward achieving commercialization.
Site relationships — Clinical trials require patients and vast majority of patients come through investigator referrals. Strengthening existing site relationships while forging new ones will help patient and investigator recruitment.
Technology — AI is not only influencing MedTech, it is also impacting how clinical trials are executed. AI is expected to drive efficiencies saving sponsors time and money while also improving quality.
Employees — Employees are Avania’s biggest and most important investment. Continuing to retain, train, and recruit talented team members is essential.

Avania will evolve, invest, and pivot with the industry so it can achieve its mission of partnering with MedTech sponsors to bring life-changing technology to market, resulting in improved healthcare outcomes.

Edwards Lifesciences | Groundbreaking Data Demonstrate Superiority of EARLY TAVR in Asymptomatic Severe Aortic Stenosis Patients

October 28, 2024

Edwards Lifesciences today announced results from the EARLY TAVR Trial, the first randomized, controlled trial designed to study the best strategy for treating asymptomatic severe aortic stenosis (AS) and the benefits of early intervention with transcatheter aortic valve replacement (TAVR). The trial results demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared with guideline-recommended clinical surveillance.

Trial investigators presented the data today during a late-breaking clinical trials session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) and published simultaneously in The New England Journal of Medicine.

With a median follow up of 3.8 years, the data demonstrated superiority of early TAVR, with 26.8% of the 455 patients in the TAVR arm experiencing death, stroke or unplanned cardiovascular hospitalization compared to 45.3% of the 446 patients in the clinical surveillance arm. Additionally, the data showed that early intervention with TAVR:

Prevented unpredictable and rapid progression of symptoms, which sometimes resulted in emergent intervention and/or hospitalization;
Prevented clinically meaningful and rapid decline in quality of life; and
Resulted in numerically lower rate of stroke for patients with early TAVR (4.2% vs. 6.7% at a median follow-up time of 3.8 years).

“What we learned in this trial is that without intervention, patients rigorously confirmed as asymptomatic experienced unpredictable and rapid decline with numerous adverse outcomes. These results shatter 60 years of ingrained belief on the treatment for severe aortic stenosis, with guidelines that currently recommend ‘watchful waiting’ for intervention until symptoms develop,” said Philippe Genereux, MD, director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. “With no demonstrated clinical penalty for TAVR, these trial results strongly support a change to the practice and current guidelines for the treatment of aortic stenosis patients.”

The EARLY TAVR Trial enrolled 901 patients – with an average age of 76 and average KCCQ-OS score of 92.7 – at 75 sites across the US and Canada. Patients were rigorously confirmed as asymptomatic through a protocol-mandated stress test – a first in TAVR trials – and medical history evaluation. Designed specifically to evaluate if early intervention is a better strategy than clinical surveillance, the EARLY TAVR Trial showed that within the first six months, a striking 26.2% of patients in the clinical surveillance arm converted to aortic valve replacement (AVR) with many presenting progressive or advanced symptoms. In the 12-month follow-up period after randomization, the rate of conversion to AVR was 47.2%.

“This is the first pivotal trial to generate evidence about the best strategy for disease management of severe aortic stenosis,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “EARLY TAVR challenges the current standard of care by definitively showing that patients who don’t have symptoms of severe aortic stenosis have a deadly disease that requires urgent treatment.”

Press Ganey Streamlines Magnet® Readiness with AI

October 28, 2024

Press Ganey, the leading provider of experience measurement, data analytics and insights to health systems and health plans, has launched Nursing Intelligence, a new AI-powered tool designed to enhance its Nursing Excellence Solution.

Nursing Intelligence enables nurse leaders to quickly track, monitor, and visualize key data on nurse satisfaction, patient experience, and clinical outcomes, while also comparing their performance to industry benchmarks. This information is critical for organizations pursuing Magnet® recognition—a prestigious designation awarded by the American Nurses Credentialing Center (ANCC) to honor excellence in nursing. 97% of all Magnet® designated hospitals are Press Ganey partners.

Currently, nursing leaders spend countless hours manually reviewing and preparing data to assess their performance against peers. Nursing Intelligence automates this process with machine learning analytics, selecting high-performing areas, comparing them to relevant benchmarks, and generating ready-to-submit reports with clear data visualizations to strengthen an organization’s Magnet® application.

“Nurses play a crucial role in healthcare, and supporting their vital contributions is our highest priority,” said Jeff Doucette, DNP, RN, NEA-BC, FACHE, FAAN, Chief Nursing Officer at Press Ganey. “Nursing Intelligence speeds up and simplifies the reporting and benchmarking processes, providing nurse leaders with the insights needed for informed decision-making and enhanced care delivery.”

Early adopters, including Atlanticare, Children’s Hospital of Philadelphia, and Froedtert Hospital, are already seeing the time-saving benefits of the AI-powered tool.

“Nursing Intelligence has reduced the time we spend reviewing patient experience data by half,” said Nicole Immel, Insights Analyst in the Magnet® Program at Froedtert Hospital. “This has greatly improved our efficiency. The ability to rename units in the report builder is a valuable feature. I’m excited to compare this data with clinical quality indicators to give our leaders and teams actionable insights.”

“Nursing Intelligence provides the unit-level and rolled up organization data in one easy-to-access file,” said Kathleen Yhlen, MSN, RN, NE-BC, Magnet® Director at Atlanticare. “The actionable data is a win-win for the executive team and unit level leaders. In addition, the report is a huge time saver for determining the organization’s outperforming four categories for the Magnet® application.”

“The tool is a game changer in driving operational excellence,” said Aleshia Harrison, MSN, RN, NEA-BC, Director of Shared Governance and the Magnet® Program at Children’s Hospital of Philadelphia. “What I appreciate most about the AI is its simplicity—the report format is intuitive and easy to push out to nurse managers.”

As part of its continuing commitment to nursing excellence, Press Ganey is sponsoring the Magnet Prize® and Pathway to Excellence Award® at the ANCC National Magnet Conference® in New Orleans on Oct. 30.

“Behind our support of these awards is the belief in the vital role nurses play in shaping the future of healthcare,” said Darren Dworkin, President and Chief Operating Officer at Press Ganey. “Nurses aren’t just involved in healthcare innovation; they are leading it, from creating new care models to developing patient-centered technologies.”

Explore Press Ganey’s Nursing Excellence platform, and contact them for a demo.

Dramatic Drop in Marijuana Use Among U.S. Youth Over a Decade: (2011 to 2021)

October 28, 2024

Marijuana has emerged as one of the most commonly used illicit substances among adolescents in the United States. Given the rising number of states legalizing recreational marijuana for adults and the decreasing perception of risk among adolescents, tracking trends in youth marijuana use is more crucial than ever.

Researchers from Florida Atlantic University’s Schmidt College of Medicine conducted a comprehensive study using data from the Youth Risk Behavior Survey between 2011 and 2021, which surveyed 88,183 adolescents in grades nine through 12. Researchers focused on the overall time trends in use of marijuana as well as variations by gender, race/ethnicity, and school grade. These data provide important insights into the changing landscape of marijuana use among American youth.

The study, published in the journal Pediatric Reports, reveals that one of the most striking results from the analysis is the significant decrease in the percentage of adolescents reporting current marijuana use. In 2011, 23.1% of adolescents indicated they were current users, but by 2021, this figure had dropped to 15.8%. Additionally, the percentage of adolescents trying marijuana for the first time before age 13 also saw a notable decline, from 8.1% in 2011 to 4.9% in 2021.

In 2021, marijuana use was most prevalent among 12th graders (22.4%), followed by 11th graders (18.7%), with lower usage rates in the earlier grades. From 2011 to 2021, all grades experienced a notable decline in current marijuana use, especially among ninth graders. While there was an overall downward trend over the years, there were slight increases in use in 2013 and again in 2019.

“While we observed an overall decline from 2011 to 2021 across all grades, older students consistently reported higher usage, particularly 12th graders. This suggests that as adolescents advance through high school, they may have greater access to marijuana, influenced by more developed peer networks and increased independence,” said Panagiota “Yiota” Kitsantas, Ph.D., corresponding author and professor and chair of the Department of Population Health and Social Medicine, FAU Schmidt College of Medicine. “This trend highlights the need for targeted interventions aimed at older adolescents, who are at a greater risk of regular marijuana use.”

One of the most significant findings of this study is the shift in trends by gender, with girls surpassing boys in reported marijuana use by 2021. In 2021, girls reported a higher prevalence of current marijuana use (17.8%) than boys (13.6%). This marks a significant change from 2011 when boys were more likely to use marijuana (25.9%) compared to girls (20.1%). The convergence of usage rates among genders highlights an evolving dynamic that could reflect broader societal changes in attitudes toward marijuana.

The researchers also found variations among Asian, Hispanic and white adolescents, who experienced some of the steepest declines in current use. In 2021, however, Black adolescents reported a notably higher percentage of current marijuana use at 20.5%, compared to their white (14.8%), Hispanic (16.7%), and Asian (5.1%) counterparts. This indicates a persistent racial disparity in marijuana use among adolescents that warrants further examination.

“In the U.S. the current landscape of marijuana legalization in adults adds a complex layer to the issues of adolescent marijuana use. As more states continue to legalize recreational marijuana, the accessibility and perceived normalcy of the drug may increase, particularly for adolescents who may view its legal status as an indication of safety or acceptability,” said Charles H. Hennekens, M.D., FACPM, co-author, the first Sir Richard Doll Professor of Medicine and Preventive Medicine in the departments of medicine and population health and social medicine, and senior academic advisor, FAU Schmidt College of Medicine. “Research suggests that marijuana legalization in adults can influence adolescent behavior through their perceptions of less risk as well as increased availability, both of which may impede efforts to reduce adolescent use.”

The authors emphasize the importance of interventions like parental communication, supervision and modeling, alongside schools offering effective health education and fostering a positive school climate, to sustain the decline in adolescent marijuana use.

Findings from the study highlight the need for ongoing monitoring and intervention strategies to address marijuana use among U.S. adolescents. By focusing on the specific needs of various demographic groups, including different grade levels, genders and racial/ethnic communities, public health initiatives can more effectively address the risks associated with adolescent marijuana use and foster healthier outcomes for future generations.

Regular or heavy marijuana use during adolescence can adversely affect cognitive development, leading to poor learning, working memory issues, and attention deficits, regardless of educational background or verbal intelligence. Adolescents who use marijuana are two to three-and-a-half times more likely to have lower grade point averages and face a fourfold increase in psychosis diagnoses in adulthood. Research shows that marijuana use disrupts brain function by reducing synaptic pruning, resulting in increased gray matter volume and decreased communication efficiency in higher-order brain areas.

Study co-authors are Jack Yang, first author and a second-year FAU medical student; Maria C. Mejia, M.D., a professor; and Lea Sacca, Ph.D., an assistant professor, both within the Department of Population Health and Social Medicine, FAU Schmidt College of Medicine.

– FAU –

About the Charles E. Schmidt College of Medicine:

FAU’s Charles E. Schmidt College of Medicine is one of approximately 157 accredited medical schools in the U.S. The college was launched in 2010, when the Florida Board of Governors made a landmark decision authorizing FAU to award the M.D. degree. After receiving approval from the Florida legislature and the governor, it became the 134th allopathic medical school in North America. With more than 70 full and part-time faculty and more than 1,300 affiliate faculty, the college matriculates 64 medical students each year and has been nationally recognized for its innovative curriculum. To further FAU’s commitment to increase much needed medical residency positions in Palm Beach County and to ensure that the region will continue to have an adequate and well-trained physician workforce, the FAU Charles E. Schmidt College of Medicine Consortium for Graduate Medical Education (GME) was formed in fall 2011 with five leading hospitals in Palm Beach County. The Consortium currently has five Accreditation Council for Graduate Medical Education (ACGME) accredited residencies including internal medicine, surgery, emergency medicine, psychiatry, and neurology.

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Q’Apel Medical (Q’Apel), a private medical device company focused on revolutionizing neurovascular interventions, announced today the appointment of seasoned medical device executive Jay Hallinan as Chief Commercial Officer.

Press Ganey, the leading provider of experience measurement, data analytics and insights to health systems and health plans, has launched Nursing Intelligence, a new AI-powered tool designed to enhance its Nursing Excellence Solution.

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