Postoperative Complications

Arjun Luthra, commercial director of BioInteractions, shares how Surface Active Therapeutics represent a leap in safeguarding medical devices. In the ever-evolving landscape of healthcare, the need for advanced protective measures for medical devices has never been more critical. Surface Active Therapeutics represent a groundbreaking leap in safeguarding these devices, ensuring they remain free from infections and complications throughout their lifespan. As healthcare-associated infections (HCAIs) continue to pose significant challenges, innovative solutions like those developed by BioInteractions are pivotal. By integrating cutting-edge antimicrobial and antithrombogenic coatings, BioInteractions is leading the charge in enhancing patient safety, improving implant efficacy, and delivering superior therapeutic outcomes. Surface Active Therapeutics are advanced active treatments which do not need to release their ingredients that are applied directly to the surface of a medical device to help reduce the impact of clinical issues such as thrombosis, Fibrin Sheath Formation or infection. They provide highly effective and sustained protection therapeutic benefits to the patient. They use enhanced materials that form a continuous protective shield over the surface. This shield is made of a polymer matrix, which combines active and passive components to improve the biocompatibility of the implant, enhance the efficacy of the device and elevates the therapeutic benefits to the patient. Recent advancements in Surface Active Therapeutics involve applying effective localised therapeutics to various substrates and geometries, including catheters, drainage systems, ventricular devices, heart valves, and neurological stents. Advanced antimicrobial coatings like BioInteractions’ TridAnt create a continuous protective shield that combines active and passive components to protect against pathogens comprehensively. This matrix ensures a rapid contact-kill mechanism, broad-spectrum efficacy, continuous residual protection, and the ability to disrupt and prevent biofilm growth, effectively combating a wide range of infections for the patient's entire lifetime. These coatings offer the best protection, killing a broad spectrum of pathogens, including bacteria, viruses, fungi, and spores. These include E. coli, MRSA, Influenza, Adenovirus, Norovirus, Clostridium difficile, and SARS-CoV-2. The technology is effective on various geometries and substrates, from soft materials like silicone and fabrics to hard materials like metals (stainless steel and nitinol) and polymers (polyamides, polycarbonates, and polyurethanes). TridAnt is a unique Surface Active Therapeutic that provides a localised effect, making it safe for use throughout the body. It is designed for lifetime efficacy on class 3 implants in chronic areas of the human body. Its polymeric matrix is biocompatible, targeting only microbes (prokaryotic cells) and remaining effective at the local surface to provide sustained efficacy for the patient. This targeted approach enhances safety by avoiding the systemic effects seen with other eluting coatings, which also reduce in efficacy over time. Consequently, TridAnt-coated medical devices maintain a highly effective, fast, durable, and localised protective shield against a broad spectrum of pathogens which disrupts and prevents biofilm throughout the device's lifetime. BioInteractions: Pioneering innovation BioInteractions is at the forefront of innovation in the development of biocompatible coatings for medical devices. Recent surgically implanted devices often require removal, re-insertion, or extensive drug regimens for the patient's lifetime. This has driven the need for coatings that meet both clinical and engineering requirements. Devices like total artificial hearts (TAHs), ventricular assist devices (VADs), vascular stents, and prosthetic mechanical heart valves assist vital organs but face the common challenge of lifetime hemocompatibility, specifically thrombosis. Surface Active Therapeutic technologies offer superior biocompatibility, lifetime antithrombogenicity, and significantly reduce the risk of fibrin sheath formation. BioInteractions developed Astute, an advanced antithrombogenic coating used on chronic, blood-contacting medical implants for over 25 years. Astute combines active and passive components to provide the highest performance and most durable antithrombogenic coating on the market. The active component prevents platelet activation and halts the blood cascade mechanism to inhibit thrombus formation, while the passive components prevent blood components from depositing on the device surface. This multi-faceted approach ensures superior hemocompatibility without compromising performance of the device whilst reducing the risk of clotting over the patient's lifetime. Additionally, the development of miniaturised and minimally invasive procedures presents challenges such as reducing tissue trauma through decreased friction during device insertion and removal. BioInteractions has addressed this challenge by developing Assist, a hydrophilic coating that reduces friction. It is uniquely flexible and durable which enables it to be applied to a wide range of medical devices. Assist fills in surface microstructures, improving the flow of liquids and reducing bodily component deposition and adhesion. This ensures devices remain functional and safe while implanted. Assist is instantly activated through wetting, eliminating the need for pre-soaking and saving preparation time, allowing for straightforward device deployment. Through these innovations, BioInteractions continues to lead the way in enhancing the safety and efficacy of medical devices, improving surgical outcomes, and providing better therapeutic results for patients. Current issues faced by medical product developers Medical product developers and manufacturers navigate a highly regulated environment. Under current European Union (EU) regulations, medical devices are tested by the European Medicines Agency (EMA) following a similar approval processes as pharmaceuticals. BioInteractions' Product Pathway Partnership team works closely with customers to navigate all aspects, including optimising the application process, fixture design, tooling, coating performance testing, regulatory compliance, and providing coating services. This partnership aims to help customers get to market efficiently and effectively with the highest quality coated device. The expanded Product Pathway Partnership alongside BioInteractions' integrated service streamline the research and development of new innovative coating materials. With 30 years of expertise and novel analytical resources, BioInteractions creates optimal coatings for various devices. This service further leverages BioInteractions' experience and technology portfolio to develop bespoke coatings for unique clinical unmet needs that have never been seen before, providing revolutionary and state-of-the-art solutions for their partners. The future of Surface Active Therapeutics Surface Active Therapeutics promises to revolutionise medical device technology, making implants safer, improving medical implant performance, and enhancing patient safety. Advanced antimicrobial and antithrombogenic coatings, such as TridAnt and Astute, will play a pivotal role. The TridAnt coating provides quick and sustained, broad-spectrum protection against pathogens, ensuring enhanced cleanliness and reducing post-surgical infections, leading to quicker recoveries and fewer complications. Astute combines active and passive antithrombogenic protection which prevents platelet activation and fibrin sheath formation, addressing significant risks associated with blood-contacting implants. This innovation will ensure lifetime antithrombogenicity, enhancing the safety and functionality of devices like heart valves and stents, minimising the need for additional surgeries and long-term medication. Personalised, biocompatible coatings tailored to individual patient needs will further improve outcomes by ensuring optimal performance and minimal adverse reactions. Patients will benefit from improved implant longevity, better therapeutic results, and enhanced quality of life.

BALTIMORE, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Rapafusyn Pharmaceuticals, a leader in the field of non-degrading molecular glues, is pleased to announce the upcoming presentation of preclinical in vivo data from its selective ENT1 inhibitor for Acute Kidney Injury (AKI) at the American Society for Nephrology (ASN) Kidney Week 2024 to be held from October 24-27, 2024, in San Diego, CA. Rapafusyn’s lead program, RAP-0001, is advancing rapidly to address a critical unmet need: the prevention of Acute Kidney Injury (AKI) in patients undergoing cardiac surgery. AKI is a severe and common complication, leading to prolonged hospital stays, increased morbidity, and higher mortality rates. With no approved therapies currently available, novel solutions are urgently needed. RAP-0001, a potent and selective inhibitor of the ENT1 transporter, has shown preclinical efficacy in preventing ischemia/reperfusion injury, a major driver of AKI. “This compound was discovered through the RapaGlue™ platform. As a molecular glue, RAP-0001 uniquely binds to the intracellular chaperone protein FKBP12 and ENT1 to form a ternary complex. To our knowledge, it’s the only SLC inhibitor that targets the intracellular domain of a transporter,” said Dr. Matthew Olson, VP of Biological Sciences of Rapafusyn, who will present in vivo data demonstrating RAP-0001’s ability to significantly reduce kidney damage in this high-risk context on October 25 th , 2024. Dr. Sean Hu, CEO of Rapafusyn, stated, “We believe RAP-0001 could change the standard of care for AKI, providing a critical therapeutic option where none currently exist. This is yet another example of recent developments demonstrating how non-degrading molecular glues could potentially tackle challenging disease targets and address high unmet medical needs in ways more effective than other drug modalities.” About Rapafusyn At Rapafusyn, we’re creating non-degrading molecular glues to address hard-to-drug targets. Using our FKBP12-binding macrocyclic peptide platform, we’ve built large DNA encoded libraries (DELs) and arrayed libraries, yielding novel starting points. Our approach targets intracellular proteins and domains of transmembrane proteins like SLCs, ion channels, and GPCRs. With a modular design, we rapidly optimize key drug properties to accelerate drug-discovery. For more information, please visit or contact Heather Lavin at hlavin@rapafusyn.com .

It has been a blockbuster year for women’s health as the federal government and medtech place particular focus on the wellbeing of women. At the start of the year, President Joe Biden announced the federal government would focus its health initiatives on improving women’s health outcomes. Since then, his administration has announced two other federal initiatives to improve the care continuum for women. The medical device industry has also had many wins this year for women’s health. Several studies focused on women’s heart health and how TAVI affects them. Some companies launched improved breast cancer locator and imaging systems, and surgical robotics companies started using robots in gynecological procedures. At DeviceTalks West in Santa Clara, California, Oct. 16–17, a wide range of women’s health technologies will be featured. (Learn more about the event and register at West.DeviceTalks.com.) As we enter the last quarter of the year, here are ten women’s health stories that caught the attention of our MassDevice readers: Jill Biden launches $100M initiative to transform women’s health research First Lady Jill Biden and the White House in February announced that $100 million in federal funding will go toward research and development into women’s health. The First Lady said the funding is part of a White House Initiative on Women’s Health Research that the White House announced in November 2023. The Federal Department of Health and Human Services set aside money from the Advanced Research Projects Agency for Health (ARPA-H) for this initiative. ARPA-H’s $100 million funding will go toward early investment in “life-changing” work by women’s health researchers and startup companies. The “Sprint for Women’s Health” initiative will invest in discoveries early when private companies are less likely to take the investment risk. Read the full story here >> Biden signs executive order for women’s health research and innovation President Joe Biden signed an executive order in March that will direct funds and actions toward expanding and improving research on women’s health. Biden’s executive order will create directives that will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, according to the White House. It will also motivate new research on a wide range of topics in women’s health. It also intends to integrate women’s health across the federal research portfolio, prioritize investments in women’s health research, galvanize new research on women’s midlife health and assess unmet needs to support women’s health research. about the administration’s initiatives >> Edwards reports ‘excellent’ outcomes for TAVI in women Edwards Lifesciences announced positive results in August from its RHEIA trial, showing superior outcomes for women who received transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR). The findings involved female patients treated with Edwards’ Sapien 3 and Sapien 3 Ultra valves. The independently-run RHEIA trial included 443 women, aged 73 on average, with severe symptomatic aortic stenosis. One year after treatment, 8.9% of TAVI patients experienced death, stroke, or rehospitalization, compared to 15.6% in the SAVR group, highlighting TAVI’s advantages for this demographic. Edwards continues to focus on improving heart valve replacement outcomes for women. Dr. Hélène Eltchaninoff, a cardiology expert, noted that women are often underrepresented in severe aortic stenosis treatment, emphasizing the significance of this trial’s findings. Get the full story >> Melodi Health raises $10.75M, enrolls first patient in study of absorbable mesh for breast cancer patients Melodi Health raised $10.75 million in an oversubscribed Series A round and launched a clinical trial for its Matrix mesh technology. The Minneapolis-based company began its ARIA FDA investigational device exemption (IDE) trial to improve outcomes for women undergoing breast reconstruction after mastectomy, enrolling the first patient at University of Utah Health. Melodi has raised $15 million, with Series A funding led by HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital. The funds will support clinical activities and further product development for its innovative implantable medical device. The Matrix mesh is an absorbable device that supports soft tissue while releasing antibiotics to reduce post-surgical infections. Co-founder and CEO Sarah Worrell said the device addresses a significant unmet need, as no FDA-approved soft tissue support products with antibiotic properties currently exist for breast surgery. about the fundraising >> Cairn Surgical raises $4.5M for breast cancer locator system Cairn Surgical announced it closed a $4.5 million Series A2 financing round to advance its Breast Cancer Locator (BCL) System. The funds will support completing a U.S. pivotal trial and initiate a limited commercial launch in Europe. The BCL system aims to improve the accuracy of breast-conserving surgeries by providing surgeons with detailed information about the tumor’s size, shape, and precise location. Current tumor localization methods often fail to remove the entire tumor in 20% of cases, leading to additional surgeries. Mick Sawka, investment advisor at Morningside Ventures, which led the funding round, highlighted the system’s promising results in European trials, noting its potential to improve patient care and reduce healthcare costs. Cairn Surgical’s approach is expected to transform the surgical experience for both patients and healthcare providers, he said. Get the full story >> GE HealthCare, UCSD to collab on female-specific imaging GE HealthCare is collaborating with the University of California San Diego School of Medicine to advance imaging technology for female-specific pelvic disease. The partnership focuses on developing new magnetic resonance imaging protocols and educational materials to improve diagnoses and access to care for women’s pelvic health. The project, led by Dr. Rebecca Rakow-Penner at UCSD’s Center for Translational Imaging and Precision Medicine (CTIPM), covers conditions like endometriosis and ovarian cancer. It aims to enhance visualization using MRI in both clinical and academic research settings. GE HealthCare plans to distribute the protocols and educational materials globally to its MRI users. about the partnership >> Virtual Incision announces first completed hysterectomy with MIRA surgical robot Virtual Incision completed the first surgery in a study evaluating its MIRA robotic-assisted system for hysterectomy procedures. The clinical study focused on the safety and efficacy of MIRA, a miniaturized robotic system the company designed to reduce hospital stays, blood loss and complications associated with open surgery for benign hysterectomies. The study is part of Virtual Incision’s broader efforts to expand MIRA’s applications. Following its first clinical evaluation, which supported FDA authorization for colectomy procedures, the company continues to develop new versions of MIRA for general surgery, urology, and other specialties. about the procedure and the robot >> FDA clears new cervical cytology AI tech from Hologic Hologic won FDA 510(k) clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm in February. The company said it is the first FDA-cleared digital cytology system that combines AI with volumetric imaging to detect pre-cancerous lesions and cervical cancer cells. It digitally images glass slides of cervical cells and applies AI to highlight areas of concern for cytologists and pathologists. Hologic’s new process improves sensitivity without sacrificing specificity, reducing false negatives for high-grade squamous intraepithelial lesions by 28% compared to traditional microscopic review. The system enables faster, more effective treatment decisions and supports remote collaboration across healthcare settings. Get more about the technology >> Moon Surgical expands surgical robot indications to gynecological laparoscopy Moon Surgical announced in April its Maestro surgical robot is being used clinically in gynecological laparoscopic procedures. The recent gynecological use was for hysterectomy, cystectomy, adnexectomy and ovariectomy procedures. Moon Surgical designed Maestro to provide an accessible, enhanced version of traditional laparoscopy. Maestro acts as a robotic surgical assistant to augment the precision and control of laparoscopic surgery. The small, adaptable system can integrate into existing clinical workflows. It features capabilities that bolster operating room efficiency and allow for alternative labor models. about the procedures >> FDA approves Lumicell’s breast cancer visualization system Lumicell announced in April it received FDA approval for its LumiSystem direct visualization system for breast cancer removal. According to the company, the LumiSystem allows surgeons to scan the breast cavity post-lumpectomy in real time to detect and resect residual cancer that could have been missed with 84% diagnostic accuracy. The LumiSystem with the company’s LumiSight optical imaging agent is indicated for fluorescence imaging in adults with breast cancer as a supplement for the intraoperative detection of cancerous tissues within the resection cavity after removing primary specimens during lumpectomy surgery. Lumicell used data from more than 700 breast cancer patients across five clinical studies to assess the safety of the system. The most common side effects of LumiSight are hypersensitivity and an abnormal color in urine. Get the full story >>