KP Biomedical Engineering - Issue #39

-Ruthless Spine Announces Intellectual Property News and 510(k) Clearance on Revolutionary Spinal Instrument

--LOS ANGELES--(BUSINESS WIRE)--Ruthless Spine today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NavJam™ Jamshidi device, and as of, U.S. Patent Office records indicate that the status of the NavJam™ Jamshidi patent application is allowed. The NavJam™ Jamshidi device is also covered by an issued Taiwan patent and is designed to work in tandem with Ruthless Spine’s De Novo cleared RJB™ intraoperative angle measurement instrument. The NavJam marks a significant step forward in spinal screw placement technology, offering hospitals a practical alternative to bulky, capital-intensive traditional navigation systems. By simplifying workflow, reducing surgical time, and eliminating costly infrastructure, the NavJam and RJB together provide a scalable solution to one of the most pressing challenges in modern spine surgery: significantly minimizing radiation and maintaining precision while lowering time and cost.

-NucleoBio and PreCheck Health Services Announce Strategic Collaboration to Advance Non-Invasive Prostate Cancer Testing

--SAN ANTONIO, Texas--(BUSINESS WIRE)--NucleoBio, Corp., a leading biotechnology innovator in precision oncology diagnostics, and PreCheck Health Services, a high-complexity CLIA-certified and CAP-accredited clinical laboratory, announced a strategic collaboration to support clinical development and processing of the proprietary Prostac™ assay. This partnership aims to enable future application of the test across a broader clinical setting, supporting ongoing research and validation efforts for early detection and risk stratification in prostate cancer. The collaboration will leverage PreCheck’s advanced laboratory infrastructure and operational expertise to further validate and process Prostac™—a qPCR-based composite assay developed by NucleoBio to assess expression levels of specific long non-coding RNA biomarkers derived from the PVT1 gene.

-Aspen Surgical Expands Perioperative Portfolio

--CALEDONIA, Mich.--(BUSINESS WIRE)--Aspen Surgical (“Aspen”), a portfolio company of Audax Private Equity ("Audax"), a leading manufacturer of surgical and medical devices, announced an expansion of its portfolio following the recent acquisitions of Cygnus Medical (“Cygnus”) and Flagship Surgical (“Flagship”). These acquisitions represent strategic growth and an expansion of Aspen’s capabilities. Financial terms of the transaction were not disclosed. Based in the United States with a strong presence in hospitals, surgical centers, and healthcare facilities nationwide, Cygnus Medical specializes in healthcare infection control and instrument and scope-care solutions, offering products such as Airtime™ Instrument Channel Dryers, Gator Clips™, and Tray Belts™ to ensure instrument sterility and compliance in sterile environments, like operating rooms and endoscopy suites. Known for quality, Flagship Surgical provides OR safety solutions, including The Surgical Mat™ for fluid management and slip prevention, as well as The Fluid Diamond® for efficient fluid collection during procedures.

-AIRSUPRA® (albuterol/budesonide) US prescribing information updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared with albuterol

--WILMINGTON, Del.--(BUSINESS WIRE)--AIRSUPRA’s US Prescribing Information now includes clinically meaningful evidence from the BATURA study in patients with mild asthma. The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to as-needed albuterol, the most commonly used rescue medication for asthma in the US. The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR] 0.54; 95% confidence interval [CI]: 0.40, 0.72; p<0.001) when compared with albuterol in adult patients with mild asthma.

-Insulet and Pantone® Partner to Launch Omnipod® Mango in Vibrant New Palette

--ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, and Pantone®, the global authority on color and provider of professional color standards for the design industries, announced the creation of Omnipod Mango, a bright and joyful tropical orange yellow. Omnipod Mango was uniquely selected to celebrate the radiance of the diabetes community and symbolizes Insulet’s passion and commitment to improving the lives of people with diabetes and making it a smaller part of life.

-NanoVibronix Launches “Oscar” Training Aid to Accelerate ENvue Adoption and Unlock New Revenue Opportunities

--TYLER, Texas--(BUSINESS WIRE)--NanoVibronix, Inc. (NASDAQ: NAOV) (“NanoVibronix” or the “Company”), a medical technology company specializing in non-invasive therapeutic systems, announced the launch of Oscar, an advanced training aid, introduced through its ENvue Medical (“ENvue” or “ENvue Medical”) division. Oscar is designed to provide clinicians and educators with a standardized, repeatable approach to practicing naso-enteral feeding procedures, addressing a key barrier to adoption of new and current technologies.

-Adagio Medical FULCRUM-VT U.S. Pivotal Study Acute Results to be Presented in Late-Breaking Session at VT Symposium

--LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, announced that acute results from the Company’s FULCRUM-VT U.S. pivotal study have been accepted for presentation in a late-breaking clinical science session at The 20th Annual International Symposium on Ventricular Arrhythmias, being held from October 10- 11, 2025 at the Philadelphia Marriott Downtown. The Investigational Device Exemption (“IDE”) study is the first study powered to evaluate the safety and effectiveness of Ultralow Temperature Cryoablation (“ULTC”) for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT) in patients with both ischemic and nonischemic cardiomyopathy.

-Novanta’s Board of Directors Authorizes Additional $200 Million for Share Repurchase Program

--BOSTON--(BUSINESS WIRE)--Novanta Inc. (Nasdaq: NOVT) (the "Company"), a trusted technology partner to medical and advanced technology equipment manufacturers, announced that its Board of Directors has authorized the repurchase of up to an additional $200 million of the Company’s outstanding common shares, adding capacity to the $31 million remaining from its 2020 Board authorization, for a total capacity of $231 million.

-ForCast Orthopedics and KORU Medical Systems Announce Agreement for Novel Antibiotic Infusion Therapy

--DENVER & MAHWAH, N.J.--(BUSINESS WIRE)--ForCast Orthopedics, Inc. and KORU Medical Systems, Inc. (NASDAQ: KRMD) jointly announced an agreement leveraging KORU Medical’s FreedomEDGE® infusion system as part of ForCast’s technology platform for the treatment of periprosthetic joint infection (PJI). PJI is a rare but serious complication of joint replacement procedures, and is challenging to treat because the infecting bacteria adhere to the prothesis and can form a protective biofilm which is resistant to standard systemic antibiotics.

-Europe Robotic Neurosurgery Market Analysis and Forecast Report 2025-2035 | Development of Long-Distance Teleoperated Surgical Robotic Systems Bolster Opportunities - ResearchAndMarkets.com

--DUBLIN--(BUSINESS WIRE)--The Europe robotic neurosurgery market is projected to reach $585.3 million by 2035 and estimated $93.1 million in 2024, growing at a CAGR of 17.83% during the forecast period 2025-2035. The market for robotic neurosurgery in Europe is expected to increase steadily as medical professionals use more sophisticated technology to treat the growing number of neurological conditions. Surgeons can execute intricate treatments like deep brain stimulation (DBS), epilepsy mapping, and tumour resections with less tissue damage and more accuracy because to robotic systems' unmatched precision. Europe's well-established healthcare system, favourable payment policies, and increasing focus on minimally invasive procedures have all contributed to the continent's thriving industry.

-Tanner Health and Healthliant Ventures Partner with Incision USA on Innovative OR Solutions

--CARROLLTON, Ga.--(BUSINESS WIRE)--Tanner Health and Healthliant Ventures are pleased to announce a partnership with Incision USA, a healthcare technology company dedicated to supporting surgical teams with intuitive, clinician-designed tools that foster confidence, well-being and efficiency. With Incision’s Assist and Academy solutions, operating room (OR) staff can confidently prepare for surgical cases by giving them on-demand access to surgeon preferences, team workflows, visual OR setup guides and surgical training courses.

-Horror Icon Matthew Lillard and Exact Sciences Help Adults 45+ Conquer Fear and Get Screened for Colon Cancer with the Cologuard® Test

--MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, is teaming up with actor and horror icon Matthew Lillard to encourage people 45 and older to get screened for colorectal cancer—the nation’s second leading cause of cancer-related death. Best known for his roles in cult classics like Scream and Scooby-Doo, Lillard is using his horror credentials to flip the script on fear of screening. In a new effort with Exact Sciences, he reminds audiences that while horror movies are scary, colorectal cancer screening doesn’t have to be.

-Revvity and Profluent Collaborate to Launch AI-Enhanced Adenine Deaminase Pin-point Base Editing Systems

--WALTHAM, Mass.--(BUSINESS WIRE)--Revvity, Inc. (NYSE: RVTY) announced a strategic collaboration with Profluent, bringing together a range of its novel AI-engineered enzymes with Revvity’s established Pin-pointTM base editing platform. The result is simplified access for customers to a therapeutically relevant base editing toolkit.

-Thermo Fisher Scientific Launches the Thermo Scientific Hypulse Surface Analysis System to Accelerate the Understanding of Material Surfaces

--WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has introduced the Thermo Scientific™ Hypulse™ Surface Analysis System. This innovative surface analysis instrument represents a leap forward in accurate X-ray photoelectron spectroscopy (XPS) depth-profiling, which is critical for materials scientists around the world.

-Virtuoso Surgical Robotic System Receives FDA Breakthrough Device Designation

--NASHVILLE, Tenn.--(BUSINESS WIRE)--Virtuoso Surgical, Inc., a Nashville-based company developing a groundbreaking, entirely new class of robotic tools for endoscopic surgery, announced that the Virtuoso Surgical Robotic System has received FDA Breakthrough Device Designation for bladder lesion removal via en bloc excision, positioning the company at the forefront of early diagnosis and innovative bladder cancer care. Leveraging a patented surgeon-controlled system that utilizes needle-sized robotic arms, the device is designed to significantly enhance the precision and dexterity of minimally invasive surgery performed via rigid endoscopes, a major component of the global endoscopy market. Virtuoso addresses a significant clinical need for improved specimen quality and staging in bladder lesions, the majority of which are bladder cancer.