Tel: 561-316-3330
Email: mdnewsmagazine@infomeddnews.com
Home Blog Page 2

Enterprise Therapeutics Publishes on Medicinal Chemistry of ETD001 | A Novel Inhaled ENaC Blocker for Treatment of Cystic Fibrosis

Enterprise Therapeutics Ltd (Enterprise), a biopharmaceutical company dedicated to the discovery and development of novel therapies to improve the lives of people with respiratory diseases, today announced the publication of a peer-reviewed study in The European Journal of Medicinal Chemistry1. The paper describes the medicinal chemistry optimisation of a new series of ENaC blockers, resulting in the invention of ETD001, Enterprise’s lead asset, a potential new inhaled treatment for cystic fibrosis (CF).

The paper, titled “Optimization of a novel series of ENaC inhibitors, leading to the selection of the long-acting inhaled clinical candidate ETD001, a potential new treatment for cystic fibrosis” is the first publication outlining the medicinal chemistry story leading to the discovery of ETD001, as well as its detailed pre-clinical profile. A potent ENaC blocker, ETD001 also has class leading low permeability through the airway epithelium, making it an optimal candidate for clinical evaluation as an inhaled treatment for people with CF (pwCF). The chemistry work described in the paper was carried out in collaboration with Evotec.

The Company commenced and is currently undergoing recruitment for a Phase 2 clinical study of ETD001 in pwCF in summer 2024, expected to complete in 2025, to understand whether 28 days of treatment will improve lung function. In September Enterprise announced that ETD001 has been granted ‘rare pediatric disease designation’ in the US by the FDA2.

Dr Steve Collingwood, Head of Chemistry, Enterprise Therapeutics, and lead author of the paper, said: “We are proud of our inhaled medicinal chemistry strategy, the success of which is evidenced by the superior profile of ETD001 compared to other inhaled ENaC blockers. We are grateful to our team of scientists for supporting the development to this stage, and to the pwCF who are currently participating in the Phase 2 clinical trial.”

Prof Martin Gosling, CSO, Enterprise Therapeutics, commented: “The publication of this paper in a leading peer-reviewed medicinal chemistry journal is testament to the great science performed by the chemistry teams at Enterprise and Evotec. We firmly believe that the unique properties of ETD001, giving rise to class leading lung retention, will deliver an effective therapy to people with CF currently unable to benefit from CFTR modulators. We look forward to sharing the results of our Phase 2 study in 2025.”

CF is estimated to affect over 100,000 people worldwide, with an average life expectancy of ~60 years. Failed mucociliary clearance and mucus congestion in the lungs leads to cycles of infection and inflammation and an ongoing decline in lung function. Increasing fluid volume in the lung by inhibiting ENaC with ETD001 will hydrate mucus, improve clearance, reduce mucus congestion, and is expected to drive substantial improvements in lung function. ETD001 has previously demonstrated a well-tolerated profile in healthy subjects in a Phase 1 trial and has been shown to be long-acting in pre-clinical studies3.

  1. https://doi.org/10.1016/j.ejmech.2024.117040
  2. https://enterprisetherapeutics.com/enterprise-therapeutics-granted-rare-pediatric-disease-designation-in-the-us-for-novel-cystic-fibrosis-investigational-therapy-etd001/
  3. https://enterprisetherapeutics.com/enterprise-therapeutics-publishes-preclinical-profile-of-etd001-a-novel-inhaled-enac-blocker/

 

Cytomos Secures £5M | To Scale Up Production of Cell-analysis Technology

Cytomos, an Edinburgh-based biotechnology company, has raised £5 million to scale up production of its unique cell analysis technology.

The oversubscribed funding round was led by existing investors Archangels with participation from Old College Capital, Scottish Enterprise and British Business Bank.

New investment will allow Cytomos to drive sales of its first commercial product, Celledonia™, built on its cell-analysis technology platform AuraCyt, which is already generating significant market traction. Celledonia™ is a benchtop cell analyser which aims to significantly enhance single-cell analysis, potentially transforming biological drug discovery, development processes, and biologics manufacturing, meeting a major unmet need for the biopharma industry.

The business employs 21, largely based at its new premises in Roslin, and expects to add another four staff over the next year as it continues to scale operations.

With its sights now set on establishing a foothold in North America, the company has a pipeline of trials planned with global partners and strong interest in co-development opportunities from high-profile technology developers and a top 10 pharma company.

The development and manufacture of cell-derived medicines is highly complex and expensive, with a need for solutions to monitor and predict cell parameters in real-time. Scientists are under pressure to bring novel therapies to market, faster and cheaper. However, securing access to the right information at the right time is a major challenge, frequently resulting in crucial information being compromised at critical stages.

Cytomos’ unique technology AuraCyt is an unbiased, scalable cell analysis platform which addresses this unmet need, providing a groundbreaking low-cost, and scalable alternative to current cell analysis systems. Using this platform, Cytomos enables biopharma to bring novel therapies to market by up to 6 months faster and radically reduce costs by enabling critical decision making earlier. Its scalable nature makes it unique in measuring cellular physiology based on intrinsic single-cell properties.

Sarah Hardy, director and head of new investments at Archangels, said: “Cytomos has gone from strength to strength, achieving commercialisation earlier this year marks a critical inflection point for the business. With new premises secured and a robust plan to derisk the supply chain, we’re looking forward to helping David and the team scale their operations and secure access to new markets.”

David Rigterink, CEO at Cytomos, said: “Successfully raising £5 million within a difficult market has been a huge boost for the business. The result is testament to the team’s hard work in delivering our first commercial product with international early adopters. Cytomos now has the right building blocks in place to scale quickly, establish a foothold in the US, and continue developing our single cell analysis technology to support advancements in biological drug development and manufacturing automation.”

 

TactoTek Secures $60 Million in Funding Led by Virala Group

TactoTek, the global leader in In-Mold Structural Electronics (IMSE®) technology, today announced the completion of a $60 million funding round led by Nidoco AB, part of Virala Group. The financing attracted significant investments from a premier consortium of financial and strategic investors including Cornes Technologies, Elo Mutual Pension Insurance Company, European Investment Bank, Finnish Industry Investment Ltd, 3M Ventures, Ingman Group, VTT Technical Research Centre of Finland, Conor Venture Partners, and Turret Oy Ab and several private investors & employees.

“This investment marks a significant milestone for TactoTek,” said Jussi Harvela, CEO of TactoTek. “Our collaborations with industry leaders such as Kyocera, Gentex, Polestar, Valeo, LS Automotive, Yanfeng, and most German Premium Automotive OEMs, validate the transformative potential of our IMSE technology. IMSE is being used to improve products and concurrently decarbonize manufacturing at scale across multiple industries. With this funding, TactoTek will accelerate the adoption of IMSE globally by expanding customer-facing operations and streamlining IMSE solution design by augmenting our software-based delivery system with AI elements and plug-ins for CAD and simulation packages.” 

Pioneering the Future of Electronics

TactoTek develops and validates IMSE technology that is taken to market by a global network of licensees. IMSE solutions integrate electronic functions — such as lighting, touch controls, and antennas — within 3D injection-molded structures. This innovative approach results in lightweight, thin, and durable smart surfaces that provide greater design freedom and sustainability than traditional electronics in practically any industrial vertical, including medical, consumer products, defense, automotive, and aerospace.

TactoTek leads the industry in continuous IMSE technology innovation and supports industry standardization. The company has an unparalleled intellectual property portfolio exceeding 280 granted patents in 48 patent families.

Expanding into Key Industries

  • Automotive: Enhancing vehicle interiors with integrated control panels, ambient lighting, and smart surfaces that reduce weight and assembly complexity;
  • Consumer Electronics: Enabling sleek, functional designs with embedded touch controls and illuminated branding features in devices like audio equipment and wearables;
  • Home Appliances: Offering seamless user interfaces and smart functionality integrated directly into appliance surfaces;
  • Industrial Applications: Providing durable, efficient solutions for control systems and interfaces in challenging environments;
  • Defense: Developing ruggedized electronic components that meet stringent military standards for performance and reliability;
  • Medical: Seamless, elegant consumer medical product designs that are easily sterilized; and
  • Aerospace: Thin, light weight passenger controls and lighting.

Large Scale Investment in Finnish Deep Tech

“This USD60 million funding round is among the largest private financings in the Finnish and European deep tech space during 2024 and the family controlled Virala Group was honored to lead the round with a significant investment,” said Anders Dahlblom, incoming Chairman of TactoTek, and COO of Virala Group. “Our investment reflects the market traction of TactoTek’s IMSE technology across multiple industries, including the defense sector, and its secure, highly-protected, intellectual property foundation. TactoTek and their IMSE technology are poised for rapid growth.”

Fulfilling Customer Needs and Improving Sustainability

“In today’s business climate growing businesses that succeed over time must combine capability to meet market needs, with strong environmental performance,”stated Kari Lehtonen, Portfolio Manager at Elo Mutual Pension Insurance Company. “TactoTek is delivering on both of these dimensions:  TactoTek has identified compelling solutions spanning different markets; and IMSE solutions are produced using clean, additive processes and can reduce carbon emissions significantly relative to conventional electronics.”

Advisors

TactoTek was advised by MP Corporate Finance on financial matters and Bird & Bird on legal aspects during the funding round.

The Future of Precision Medicine Delivering ROI for the Healthcare Industry | By: Gary Turner, Managing Director, Additive Manufacturing, Ricoh USA, Inc.

Gary Turner, Managing Director, Additive Manufacturing, Ricoh USA, Inc.

Gary Turner asks: What do orthopedic surgery and additive manufacturing have in common? 3D surgical guides. He writes.

First, let’s clarify what orthopedic surgery entails. It includes applications such as pediatric and adult osteotomy cases, pelvic surgeries, deformity corrections of the upper and lower limbs, orthopedic oncology, and the sourcing and shaping of allografts.

As you can imagine, these types of surgeries require thorough planning, practice, and minimal margin for error during surgery. While surgical precision has advanced significantly in the last decade, the healthcare industry continues to rely on private practice innovation to propel new technologies for improved surgical tools.

Recent advancements in healthcare have introduced novel approaches such as the implementation of 3D surgical guides[i] to support pre-surgery planning and education, ultimately improving patient outcomes and operational efficiency

For example, Ricoh USA announced a strategic partnership with Insight Surgery to revolutionize the field of patient-specific surgical guides and provide broader access to the technology for care providers and their patients. This collaboration aims to enhance surgical precision and improve patient outcomes in both pediatric and adult orthopedic surgeries.

By combining expertise in providing 3D printing solutions for the healthcare industry and in surgical planning and guide solutions, the two companies will provide broader access to advanced surgical tools, thereby driving value into healthcare systems across the United States1. Here’s three ways the partnership will drive value and ROI for the healthcare industry. 

The Value of Custom Guides for Precision and Efficiency

Innovative surgical guides are tailored for a variety of applications in orthopedic procedures.

Each guide is individually and meticulously designed to translate a bespoke virtual surgical plan onto a patient, ensuring a high degree of precision. This personalized approach not only enhances surgical accuracy but also contributes to better patient outcomes.

For example, recent studies have shown that customized 3D-printed guides minimized overall tissue trauma and reduced the risk of damage to nervous and vascular structures. This, results in fewer complications, shorter recovery times, and lower chances of repeat surgeries[ii]. Not only does this benefit the patient, but it also frees up valuable time for both practitioners and surgical scheduling in an already overwhelmed healthcare system.

Streamlined Workflow and Rapid Turnaround

The wider expansion of these 3D guides is thanks to Insight Surgery’s advanced software that enables a streamlined planning and production process along with Ricoh’s growing presence in Point-of-Care facilities. This ensures that surgical guides are produced and delivered quickly. The rapid turnaround times—expedited service within 10 working days and standard service within 10 to 20 working days—are crucial for timely surgical interventions.

Expanding Access and Democratizing Technology

Partnerships between additive manufacturing enterprises and healthcare innovators is the handshake the industry needs to further democratize access to advanced 3D printing technologies.

It starts with leaders in the space making these tools more accessible and affordable. Ricoh is helping to level the playing field, allowing more healthcare providers to benefit from cutting-edge solutions – a critical step for underserved areas.

The key to driving access is to have leaders in the additive manufacturing space to pitch in, to advance partnerships, invest in incubator ideas, and explore where 3D printing can live in various areas of healthcare, perhaps even beyond just surgical use.

While surgical technology customization might be offered through an array of potential partners, there is value in working with an established additive manufacturing partner like Ricoh. Ricoh’s ecosystem already includes a range of 3D-printed solutions. By incorporating Insight Surgery’s guides, Ricoh can offer even more precise and customized options

Conclusion

The partnership between RICOH 3D for Healthcare and Insight Surgery marks a significant step forward in the field of personalized surgical solutions. By combining their strengths, these two companies are poised to make personalized surgery accessible to every surgeon in the nation, ultimately improving the standard of care and patient outcomes across the board.

[i] https://pubmed.ncbi.nlm.nih.gov/35601209/

[ii] https://pubmed.ncbi.nlm.nih.gov/35601209/

Intensity Therapeutics Presents INT230-6 Phase 1/2 Data in Sarcoma and an Overview of its Ongoing Global Randomized Phase 3 Sarcoma Trial (“INVINCIBLE-3 Study”) in a Late-Breaking Session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS)

 Intensity Therapeutics, Inc. (Nasdaq: INTS), (“Intensity” or “the Company”) a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University’s Sidney Kimmel Cancer Center, presented final safety and efficacy data from the Company’s Phase 1/2 clinical trial of INT230-6 that was used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, along with an overview of the Company’s ongoing INVINCIBLE-3 Study design (NCT06263231). Dr. Meyer shared the information during an oral podium presentation in a late-breaking session at the 2024 Connective Tissue Oncology Society (“CTOS”) on November 16, 2024, at 9 AM PST. The abstract’s lead author was Albiruni Razak, MB BCh, BM BCh, Clinician Investigator, Princess Margaret Cancer Centre at the University Hospital Network in Toronto, Ontario, Canada. Both Drs. Razak and Meyer, enrolled patients in the Phase 1/2 clinical trial. This year’s annual CTOS conference was held in San Diego from November 13 to 16, 2024 at the Grand Hyatt.

 

“The data in the Phase 1/2 study has shown that INT230-6 causes cell death leading to tumor necrosis, improved cancer recognition by immune cells, and an ignition of a systemic anti-cancer immune response that results in T-cells entering the tumor microenvironment and has shown a favorable safety profile in soft tissue sarcomas,“ said Dr. Razak. “Systemically delivered chemotherapies have severe side effects, including cardiotoxicity, and most sarcoma subtypes have only a minimal response to immunotherapies. In addition, most sarcoma patients remain on current therapies for only a few months prior to progression, death or excessive toxicity. Demonstrating statistically significant improvement in median overall survival for the INT230-6 treatment arm compared to the standard of care arm in the INVINCIBLE-3 Study would be a major step forward in treating patients with these deadly soft tissue sarcomas.”

 

Phase 1/2 Study (Sarcoma Subset Data: 15 Patients):

Demographics:

  • Median (min, max) lines for prior drug therapies: 3 (1.00, 7.00)
  • Mean (SD) age: 62.8 (8.1) years and ranged from 41.9 to 76.1 years
  • ECOG performance status at screening was 0, 1 and 2 for 2 (13.3%), 12 (80.0%), and 1 (6.7%) subjects respectively
  • The sarcoma diagnoses of the Phase 2 patients included liposarcoma, pleomorphic sarcoma, leiomyosarcoma, chondrosarcoma, osteosarcoma (chondroid syringoma), myofibroblastic, osteosarcoma, Kaposi sarcoma and chordoma

 

Efficacy:

  • The mOS in the mixed sarcoma population: 21.3 months for INT230-6
  • The mOS had not been reached with 21.4 months of median follow-up for patients who received a cumulative INT230-6 dose volume that was greater than 40% of their total tumor burden
  • INT230-6 extended overall survival in refractory sarcoma subjects by nearly 15 months as monotherapy when compared to a synthetic control group based on the Royal Marsden Hospital scoring method
  • Sarcoma population’s overall disease control rate (DCR): 93.3% (95% CI: 68.1, 99.8) at 2 months
  • Median duration of response (DOR): 4.0 months (95% CI: 1.7, NA) and 11.3 months (95% CI: 2.8, NA) for subjects who received a cumulative dose of ≥ 40% of the total incoming total tumor burden
  • INT230-6 demonstrated an increase in T-cells within the tumors
  • 27% of patients had uninjected tumors shrink (abscopal effects), though tumors less than 1 cm were uninjected, untracked and unreported by investigators, so the true abscopal percentage is unknown; further radiomics work is on-going

 

Safety

  • INT230-6 demonstrated a favorable safety profile and was well-tolerated
  • 3 subjects (20%) had one or more drug regimen-related Grade ≥ 3 Treatment Emergent Adverse Events (TEAE); all were grade 3 (there were no grade 4 or 5 TEAEs)

 

INVINCIBLE-3 Study Overview

The INVINCIBLE-3 Study is designed to evaluate INT230-6 administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed standard of care (“SOC”) chemotherapy. The study endpoints are overall survival and safety, along with an exploratory quality of life (QoL) assessment using the EORTC-30 survey. This is a global randomized Phase 3 study comparing the efficacy and safety of INT230-6 intratumoral (IT) injection with any of three standard of care therapies (pazopanib, trabectedin, or eribulin) in approximately 333 adult participants with locally recurrent, inoperable, or metastatic soft tissue sarcoma (“STS”) patients who had disease progression prior to study enrollment following standard therapies, which must have included an anthracycline-based regimen unless contraindicated. Participants may also have received a maximum of one additional regimen. Randomization will occur after screening and eligibility confirmation. As this is a survival study, there is no crossover allowed between SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) criteria. Participants will be prospectively stratified into 1 of 3 histologically defined STS strata:

  • leiomyosarcoma
  • liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic)
  • undifferentiated pleomorphic sarcoma

The comparator agents used are all U.S., Europe, Canadian and Australian-approved agents for sarcomas: pazopanib tablets, trabectedin, and eribulin mesylate. Authorizations for the INVINCIBLE-3 Study have been obtained from the U.S. FDA, Health Canada, the European Medicines Agency, and Australia’s Therapeutic Goods Administration. Sites will be opened in 8 countries and the study is presently recruiting participants in the U.S., Canada, and Europe.

“The safety and efficacy data of our lead drug candidate, INT230-6, generated for sarcomas was quite encouraging. Many insights were gained from the over 200 patients treated before initiating the INVINCIBLE-3 study and applied to the ongoing study. Our approach uses sophisticated interventional radiology technologies to guide needles into tumors to inject our novel cytotoxic drug, which is highly absorbed by tumors, and showed a potential meaningful impact on lengthening metastatic sarcoma patient lives, reducing toxicities and improving quality of life compared to current treatments in our first clinical trial,” said Lewis H. Bender, Intensity’s President and Chief Executive Officer. “Our unique chemistry enables water-based products to diffuse throughout tumors and into cancer cells, causing immunologic cell death.”

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

 

About Intensity Therapeutics

Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor’s dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity’s clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the “INVINCIBLE-2 Study”) (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the “INVINCIBLE-3 Study”) (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care (“SOC”) with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the “INVINCIBLE-4 Study”) (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response (“pCR”) is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics

Boston Scientific Closes Acquisition of Axonics

Boston Scientific Corporation (NYSE: BSX) today announced the close of its acquisition of Axonics, Inc. (Nasdaq: AXNX), a medical technology company focused on the development and commercialization of differentiated devices to treat urinary and bowel dysfunction.

“Over the last decade, it has been impressive to see the meaningful innovations Axonics has delivered for patients with overactive bladder and incontinence,” said Meghan Scanlon, senior vice president and president, Urology, Boston Scientific. “By closing this acquisition, we’re pleased to welcome the Axonics team into Boston Scientific. The addition of the Axonics product portfolio enables us to expand into sacral neuromodulation, a high-growth adjacency for our Urology business, while bringing a comprehensive portfolio of products to patients around the world who are seeking tailored treatment options based on their life stage and incontinence severity.”

The purchase price of $71 cash per share represents an equity value of $3.7 billion and an enterprise value of $3.3 billion.[i] The transaction is expected to be immaterial to adjusted earnings per share in 2024 and 2025 and accretive thereafter. On a GAAP basis, the transaction is expected to be less accretive, or more dilutive, due to amortization expense and acquisition-related charges.

Additional information about this transaction is available on the Events and Presentations section of the Boston Scientific investor relations website.

 

How to Choose Bags & Cases for Medical Professionals and Students

Cases for Medical Professionals

Medical professionals and students always carry bags around containing their tools of work, books, and other daily use items. Some carry spacious medical bags while others carry simple cases, especially if files and a few other items are all they need.

For entrepreneurs targeting medical professionals and students as their audience, medical bags and cases can be very effective branded items for promoting their businesses. This means giving medical professionals and students bags that are printed with the business’s logo, name, and other details.

So, how can one design bags and cases for medical professionals and students? This guide will share the details you need to know.

Make Them a Fashion Statement

The overall design of bags and cases for medical professionals and students will significantly affect how successful your business is in implementing this marketing plan. These target users value trendy and fashionable items because they are generally young. If you are not sure of the trendy designs to choose, your bag seller will help you to select the best.

You can also research the trendy designs for both bags and cases so that users will want to carry them every day. The main aim is to have the medical personnel or students carry the bags and cases regularly to provide a moving billboard to promote your brand.

Design Functional Compartments and Storage

What makes a medical bag or case useful? It definitely involves the design of compartments and storage spaces. When you work with reputable bag makers, they will guide you on the best designs that will work perfectly for your target audience. In fact, they know the trendy designs for modern medical bags and cases for professionals and students.

They also have detailed catalogues to make it easy for you to customise these bags with functional compartments and storage.

Choose Durable Materials

When we talk about the materials used in making bags and cases for medical professionals and students, the first thing that comes to mind is leather. It is durable and stands out regardless of the type of bag you choose.

However, you can try modern artificial leather, especially when targeting medical students because it is affordable and still durable. Still, there are other materials that are perfect for sturdy branded bags to promote your brand among medical professionals for a long time. Consult your bag maker to pick the best material.

Consider What to Print

The aim in making bags and cases for medical professionals and students is to promote your brand. Therefore, your business logo must appear on the face of the bag.

Some entrepreneurs prefer to use just the logo to make the bags more professional and usable while promoting the brand, but others may choose to include very conspicuous details like the business colours. Select a great balance that will encourage the users to carry the bags every day.

Final Thoughts

It is easy to design bags and cases for medical professionals and students to promote your brand. You can give away the bags and cases either selectively or to everyone at an event like a conference. Be sure to distribute as many bags and cases as possible to promote your brand fast.

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Cartessa Aesthetics
SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment.

Cartessa Aesthetics, a premier North American aesthetic medical device company, has partnered with Classys, Inc, a global aesthetics business leader based in South Korea, to bring EVERESSE by Volnewmer, their world class monopolar radiofrequency technology, to the US market.

Classys, which is listed on the KOSDAQ, is one of South Korea’s most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys’s official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

“As the world’s largest energy-based devices (EBD) market, our search for an ideal partner in the U.S. was pivotal and we are excited to join forces with Cartessa. With remarkable growth over the past eight years, Cartessa has demonstrated exceptional commercial strength and an expansive network across multiple customer segments,” says Seung Han Baek, CEO of Classys, Inc.

Designed to overcome patient and provider pain points with legacy monopolar radiofrequency technologies, EVERESSE is a cutting-edge solution to combat skin laxity and smooth fine lines and wrinkles – with maximum efficacy and minimal discomfort. Leveraging Targeted Thermal Precision Technology, EVERESSE’s thermal RF energy is delivered to both the papillary and reticular dermis, while safeguarding the epidermis. This “double depth” approach triggers greater tissue coagulation and new collagen production as a mechanism of action to visibly lift and tighten the skin.

A significant advancement over earlier technologies is how comfortable the EVERESSE treatment is. Instead of multi-pulse energy delivery common with other devices, EVERESSE delivers a single pulse of consistent RF energy coupled with continuous water cooling to improve patient safety and comfort. The unique curved and tilted tip head adapts to the curvature of the treatment area, ensuring continuous stable contact between the tip and the skin. The many technological innovations built into EVERESSE contribute to more efficient energy delivery as well as a faster and more comfortable treatment.

With EVERESSE, providers have two handpieces and can easily customize treatments – choosing between tips to treat the face or smaller areas including around the eyes. Visible skin lifting and tightening can be seen immediately; optimal results are observed around 8 weeks and 12 weeks.

“There has been limited meaningful innovation in the monopolar RF market – treatments are painful for patients and expensive consumables and long treatment times create headaches for providers. Our goal with EVERESSE – as with all our technologies – is to bring devices to market that deliver on an unmet need and offer superior clinical efficacy, patient experience, and return on investment. Working alongside Classys, a world-class leader in energy-based devices, we expect to shake up the U.S. monopolar RF market with EVERESSE in the same way we’ve done for CO2 and laser hair removal,” says Gabe Lubin, Founder & CEO of Cartessa Aesthetics.

“Recognizing that skin tightening and rejuvenation are the fastest-growing indications in the U.S., we are confident that EVERESSE will meet the unique needs of this market. Our advanced, non-invasive solution offers safe and comfortable treatments for patients of all skin types, delivering immediate and lasting skin tightening and lifting results. We look forward to expanding our presence in the U.S. and establishing EVERESSE as the new gold standard in skin tightening and lifting,” adds Seung Han Baek, CEO of Classys, Inc.

Stryker Launches Next-Generation of SurgiCount+

Stryker SurgiCount+
SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment.

Stryker (NYSE:SYK), a global leader in medical technologies, announced its launch of the next generation of SurgiCount+ within its sponge management portfolio. Now integrated with Stryker’s Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals.

Maternal mortality has been rising in the U.S. for decades,1 with approximately 50,000 cases of severe maternal morbidity occurring each year.2 Notably, 70% of pregnancy-related deaths due to hemorrhage are preventable.3 Stryker’s Triton software includes AI technology that can differentiate blood from other fluids and a Bluetooth scale that batch weighs blood-soaked items to help assess blood loss. This provides hospital staff with real-time information to help coordinate the clinical team’s hemorrhage response and make informed patient care decisions.

Surgical sponges continue to be the number one retained surgical item with 88% of retained surgical items occurring with a false correct count.4 For nurses trying to locate a missing sponge in the operating room (OR), that can take up to 10 minutes on average.5 Stryker’s SurgiCount+ software helps address these problems by featuring a wireless reader that counts, tracks and locates surgical sponges in the OR. RFID-tagged sponges enable unique identification, eliminating false-correct duplicate or unknown counts.

“We are committed to helping keep caregivers and patients safe from harm,” said Brandon Jominy, vice president and general manager of Stryker’s Surgical Technologies business. “Integrating our SurgiCount+ and Triton technologies on one platform will set a new industry standard for quantifying blood loss and continuing to help reduce retained surgical sponges in the OR.”

Additionally, recent studies show that nurse burnout is affecting more than half of all U.S. nurses.6 By integrating these two technologies into one solution, it provides additional benefits to hospitals and staff which includes:

  • Helping save time by standardizing clinical protocols for charting
  • Simplifying workflows and aggregating case data with backend data
  • Helping reduce manual data entry errors through real-time EMR integration
  • Tracking and communicating patient information with one seamless workflow

For more information about Stryker’s SurgiCount+ integrated with Triton please visit safeor.com/products/surgicount-triton.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received CE Mark Certification in Europe for its HFX iQ™ spinal cord stimulation (SCS) system. The CE marking allows Nevro to market HFX iQ in all countries that recognize this certification.

HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief.*

“We are thrilled to receive the CE Mark Certification for HFX iQ as it marks an important milestone in our strategic path to drive market penetration through our data-backed, AI-powered SCS therapy,” said Kevin Thornal, Nevro’s CEO and president. “Patients in Europe suffering from chronic pain will now have access to personalized pain relief – and will be able to maintain that pain relief over time.”

“HFX iQ represents a transformative advancement in how we approach chronic pain management,” said Dr. Ganesan Baranidharan, anesthesia and pain management consultant at Leeds Teaching Hospital NHS Trust. “By leveraging AI technology and data-driven programming – developed using over 10 years of outcomes and real-world patient data – HFX iQ has the potential to not only help optimize healthcare resources through reduced in-person programming and unnecessary hospital visits, but it also sets new standards for earlier and effective pain management along with patient engagement in spinal cord stimulation.”

HFX iQ is digitally enabled and designed to optimize care by collecting patient data and guiding the patient through a personalized treatment pathway. It provides several key advantages over other SCS systems, including:

  • Indication-specific HFX Algorithms™ for back and leg pain, non-surgical refractory back pain, painful diabetic neuropathy, chronic upper limb and neck pain.
  • Customized therapy adjustment recommendations informed by patient inputs on the HFX App.
  • The only 10 kHz Therapy™ that has CE-marked labeling for all major SCS indications and outcomes beyond pain relief.

“With HFX iQ, we are entering a new era of patient-centered pain management,” said Prof. Faycal El Majdoub, head of Stereotaxy and Functional Neurosurgery at Cologne-Merheim Medical Center. “The technology’s responsiveness to individual pain levels and real-time adaptation to patient needs means empowering patients in their pain relief journey. Patients experience an enhanced quality of life with few interruptions, allowing them to reclaim their lives with confidence and with less dependence on clinical interventions. HFX iQ is truly redefining what is possible for long-term pain relief.”

HFX iQ starts patients on the program most likely to provide pain relief, based on the HFX Algorithm™, which was built from more than 20 million data points and 80,000 implanted patients.1 HFX iQ combines clinical inputs, such as pain relief and pain score, along with Quality of Life (QoL) inputs, such as pain medication and activity level changes, to provide an individualized program setting for each patient.2 HFX iQ has the ability to program both low frequency and Nevro’s proprietary 10 kHz Therapy, which represents the widest range of frequencies of any SCS system on the market.

The Senza HFX iQ system is comprised of the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator and HFX App. With a new Bluetooth®-enabled IPG that is upgradeable and connects directly to the HFX App, each patient can input assessments into their smartphone and then receive programming adjustments in real-time.

In addition to receiving CE marking, HFX iQ received U.S. Food and Drug Administration (FDA) approval in 2022.

Nevro will offer the HFX iQ system in select European countries starting in the first quarter of 2025.

123...923Page 2 of 923

About us

Medical Device News Magazine

Welcome to Medical Device News Magazine, a digital publication providing up to the minute medical device news and biotechnology news.

Need to know more?

Contact us

Navigation

Florida, New York
United States
Phone Number: 1.561.316.3330